November 30, 2009
Posted on November 30, 2009 @ 03:44 pm
The Special Committee of independent directors at
Patheon and equity investor
JLL Partners Inc. have entered into a settlement agreement in respect of the pending legal actions between the parties.
The settlement's main points include:
- until March 2011, the Board will consist of nine directors who will initially be four nominees of JLL, the chief executive officer of the company (Wesley P. Wheeler), Joaquin B. Viso and three independent directors. The three independent directors will include two members of the Special Committee, Derek J. Watchorn and Roy T. Graydon, and a new independent director, Brian G. Shaw;
- JLL has agreed not to acquire any additional restricted voting shares of Patheon for a one-year period, including through any take over bid. Thereafter, and until April 27, 2012, JLL will not acquire any additional shares unless, among other things, the acquisition complies with the standstill provisions of the Investor Agreement between Patheon and JLL and, if the acquisition is to be effected by means of a takeover bid, the bid is subject to an irrevocable condition requiring the valid tender to the bid of at least a majority of the minority held Shares;
- until April 27, 2012, certain transactions by Patheon, including certain rights offerings, issuer bids and related party transactions, would require independent director approval;
- JLL will also end its current third party claim against the members of the Special Committee, and
- Patheon will pay to JLL (U.S.) $1.5 million in connection with the settlement.
The settlement is subject to court approval, which Patheon and JLL will seek as soon as possible. The changes to Patheon's board and the other provisions of the settlement will become effective immediately upon court approval.
According to a statement from the Special Committee, "Given the current circumstances, the settlement of the litigation on this basis is in the best interests of the company and all of its shareholders. The settlement provides additional meaningful ongoing protections for minority shareholders, and allows the company to focus on its business, without the distraction of litigation."
Posted on November 30, 2009 @ 09:03 am
The FDA sent a "refuse to file" letter to
EMD Serono, an affiliate of Merck KgA, for the NDA for Cladribine Tablets, an oral formulation of Serono's cladrribine therapy for relapsing multiple sclerosis.
"The company will work closely with the FDA to fully understand FDA's concerns and define a path forward for a successful resubmission of this application at the earliest point in time," said Elmar Schnee, Merck KGaA's head of pharmaceuticals. "We remain focused on delivering on our promise to transform the way people living with multiple sclerosis approach their therapy options."
Once an NDA is submitted to the FDA, the Agency has 60 days to review thesubmission and assess whether it is sufficiently complete to permit a substantive review. If it determines that the NDA does not reach that goal, the FDA issues a refuse to file letter to the applicant. EMD Serono plans to request a meeting with the FDA as soon as possible to discuss its comments on the NDA submission and to reach an understanding on what would be required for the Cladribine Tablets NDA to be accepted for review.
Posted on November 30, 2009 @ 08:51 am
PPD, Inc. has completed its acquisition of BioDuro LLC, a drug discovery outsourcing company focused on integrated drug discovery programs and services. As a result, PPD now employs more than 1,400 people in Asia Pacific and nearly 1,000 people in China, making it the largest CRO to offer clinical development and discovery services in that country, according to a PPD statement.
"Our acquisition of BioDuro positions us to capitalize on the tremendous growth in Asia Pacific and to become the CRO of choice in China," said David Grange, chief executive officer of PPD. "BioDuro has a premier reputation for delivering quality service and has built an exceptional team of researchers and scientists. We are very pleased to welcome BioDuro's 660 employees into PPD."
Founded in 2005, BioDuro operates a state-of-the-art, 110,000-sq.-ft. laboratory in Beijing. With the vast majority of its employees based in China, the company focuses on providing fully integrated programs to synthesize and optimize novel compounds to generate drug development candidates. PPD paid approximately $77 million in cash to acquire BioDuro.
PPD also recently acquired Excel PharmaStudies, one of the largest CROs in China, expanding PPD's Phase II-IV clinical, data management, biostatistics, regulatory and quality assurance services in that rapidly growing market.
November 25, 2009
Posted on November 25, 2009 @ 08:19 am
Paul Burns has been appointed vice president of Global Sales,
Catalent Pharma Solutions, Inc. In this newly created role, Mr. Burns will be responsible for developing and driving the company’s global sales strategy, with a focus on enhancing Catalent’s sales capability for all offerings.
Prior to joining the company, Mr. Burns served as chief executive officer of Brighter Ideas, Inc., a NJ-based biotech company that advances green fluorescent protein technology for assay development. Earlier in his career, he was the general manager and national sales manager for the cardiovascular CT business at GE Healthcare. He held several other positions at GE Healthcare, including CT product manager and growth market account manager.
“Paul brings significant experience to Catalent, having worked in a range of commercial roles over the years, and I am excited to have him join the Catalent team,” said Will Downie, group president, Sterile Technologies and senior vice president of global sales and marketing for Catalent.
Posted on November 25, 2009 @ 08:17 am
Merck, through an affiliate, has extended its research collaboration with
Idera Pharmaceuticals, Inc. for a fourth year. The companies entered into an exclusive license and research collaboration in December 2006 to develop and commercialize vaccine products containing agonist compounds targeting Toll-like Receptors (TLRs) in the fields of oncology, infectious diseases, and Alzheimer’s disease.
As part of the agreement, the companies engaged in a two-year R&D collaboration to generate novel agonists targeting TLR7 and TLR8, incorporating both Merck and Idera chemistry for use in vaccines in the licensed fields, with Merck having the option to extend the collaboration for two additional one-year periods.
“During the first three years of our agreement, scientists at Idera and Merck have created a large portfolio of novel agonists of TLRs 7, 8, and 9 using Idera’s chemistry-based approach together with Merck’s innovations in chemistry and adjuvant formulation,” said Tim Sullivan, Ph.D., vice president of development programs at Idera. “We look forward to continued studies with selected TLR agonist candidates as vaccine adjuvants.”
“Throughout this collaboration, scientists at Merck and Idera have collaborated closely to characterize novel TLR agonists as adjuvant candidates,” said Amy Espeseth, Ph.D., director of virology and vaccines, Worldwide External Basic Research, Merck Research Laboratories. “We look forward to continued progress on the program.”
November 24, 2009
Posted on November 24, 2009 @ 08:26 am
Jubilant Organosys, the
University of Alabama at Birmingham (UAB), and
Southern Research Institute formed a joint venture leveraging their collective technologies in the areas of oncology, metabolic disease and infectious diseases. The goal of the partnership is to select and develop new drugs from promising biological targets discovered by researchers at UAB, Southern Research and Jubilant; use early research data to secure federal funding to create new research jobs; develop drugs through preclinical and or Phase II trials and license the drugs in exchange for milestone payments and royalty streams.
Shyam S. Bhartia, chairman and managing director, and Hari S Bhartia, co-chairman and managing director, Jubilant Organosys, said, "This novel academic and industrial collaboration demonstrates our commitment to partner with globally renowned academia in order to identify and deliver affordable innovation and healthcare solutions to the patients worldwide. We are happy to join hands with UAB and Southern Research Institute, known for its strengths in the areas of oncology, metabolic disease and infectious diseases. The collective capabilities of this partnership further augments our mission to be the most innovative Drug Discovery and Development group in India, accelerating global drug development."
"UAB has tremendous strength in research that identifies the targets—usually proteins—that contribute to the disease process, whether it is cancer or diabetes, which develop when our bodies malfunction, or a virus or bacterial infection that invades from outside," said Richard B. Marchase, UAB vice president for research and economic development. "Southern Research and Jubilant have the expertise, scientific workforce, and the equipment to take those findings and move them rapidly through the drug discovery and testing phases that lead to new commercially viable products."
"Southern Research has proven that it can help move promising drug candidates into the marketplace—our clients' drugs as well as own discoveries," said John A. "Jack" Secrist III, Ph.D., president and chief executive officer of Southern Research Institute. "What we are creating through this joint venture is a powerful new drug discovery engine that will leverage research strengths in Alabama, as well as our collective industry strengths, to drive products to market."
Posted on November 24, 2009 @ 08:24 am
Matthew T. Mullarkey, chief operating officer of
West Pharmaceutical Services, Inc. has left the company. President and former chief operating officer,
Steven A. Ellers, will delay his previously announced 2010 retirement in order to provide support for the company following Mr. Mullarkey's departure.
November 23, 2009
Posted on November 23, 2009 @ 09:40 am
Mark Lanfear has been promoted to vice president of strategic alliances,
Kforce Clinical Research, Inc. He will be responsible for leading strategic client relationship management and development efforts, as well as forging the partnership strategy for multinational expansion.
Mr. Lanfear joined the company in 2006 as a regional manager, where he managed clinical research associate staff. Prior to joining Kforce, he worked as the associate director of clinical research at a major pharmaceutical company.
Posted on November 23, 2009 @ 08:55 am
Asterand has extended its collaboration with
Bristol-Myers Squibb for as many as three years, for access to Asterand's PhaseZERO drug discovery services and XpressBANK of human tissue and clinical samples for validation of early drug targets and support for compound optimization.
Asterand chief executive officer, Martyn Coombs, commented: “This decision by BMS is an important validation of Asterand's products and services. Asterand provides human based solutions that improve decision-making during the development of medicines. Our customers incorporate human tissue-based models at all stages of development from target identification to preclinical research. We are delighted that BMS has renewed our collaboration and our team looks forward to continuing to support their target validation and compound optimization programs.”
Asterand will continue to undertake a range of PhaseZERO studies for BMS in the areas of compound profiling and target validation that include gene and protein expression profiling and cell-based pharmacology assays. BMS will use Asterand's XpressBANK of human tissue, bio-fluid, and cell lines and possibly its ProCURE custom clinical sample collection service.
Posted on November 23, 2009 @ 08:52 am
Seattle Genetics, Inc. and
Agensys, Inc., an affiliate of Astellas, expanded their antibody-drug conjugate (ADC) collaboration. Under the agreement, Agensys will pay $12 million for exclusive rights to ADC licenses against additional antigen targets. Seattle Genetics also receives an option to co-develop another ADC at the time of IND submission.
“Combining Agensys’ proprietary antibodies, directed to novel cancer targets, with Seattle Genetics’ industry-leading ADC technology has already led to product candidates for different cancer indications, including ASG-5ME, an ADC for cancers including prostate, pancreatic and gastric that is being co-developed by both companies,” said Aya Jakobovits, Ph.D., executive vice president and head of R&D of Agensys. “Expansion of the collaboration will allow Astellas to further enhance its growing pipeline in oncology.”
“Through this broadened collaboration, we continue to leverage the increasing value of our ADC technology to generate revenue as well as to obtain product rights that expand our pipeline of ADCs for the treatment of cancer,” said Eric L. Dobmeier, chief business officer of Seattle Genetics. “We look forward to continuing our work with Agensys to bring ADC programs into clinical trials, including ASG-5ME planned for phase I trials in 2010.”
Under the expanded collaboration, Agensys receives the right to obtain exclusive ADC licenses for multiple additional targets in exchange for an upfront payment fee. Seattle Genetics also receives an option for 50:50 cost and profit-sharing of a third ADC program at IND filing. The remaining ADC programs will be developed and commercialized exclusively by Agensys. Seattle Genetics is entitled to success-based fees, milestone payments and royalties on worldwide sales of ADC products developed and commercialized by Agensys. Under the terms of the amendment, Seattle Genetics is eligible to receive as much as $250 million in development milestones and $100 million in sales milestones if all of the additional ADC programs are successful.
Posted on November 23, 2009 @ 08:50 am
Pfizer received approval from the FDA for Geodon (ziprasidone HCI) Capsules for maintenance treatment of bipolar I disorder as an adjunct to lithium or valproate in adults. The approval is based on clinical data demonstrating that Geodon is an effective and generally well-tolerated adjunctive treatment for long-term symptom control in patients with bipolar disorder.
The efficacy and safety of Geodon for the adjunctive maintenance treatment were studied in a six-month, double-blind, randomized, placebo-controlled trial in 240 adult patients with bipolar I disorder. The primary endpoint was time to recurrence of a mood episode requiring intervention. The data demonstrated that Geodon plus lithium or valproate was superior to placebo plus lithium or valproate in increasing the time to recurrence of a mood episode. The adjunctive Geodon treatment regimen was generally well-tolerated.
"The recurrence of mood episodes associated with bipolar disorder can have a devastating impact on patients’ lives,” said Dr. Ilise Lombardo, senior medical director, Pfizer Specialty Care. “This approval underscores Pfizer’s commitment to supporting people suffering from serious mental health disorders.”
Geodon is also FDA-approved for the treatment of acute manic and mixed episodes associated with bipolar disorder, with or without psychotic features, and for the treatment of schizophrenia.
November 20, 2009
Posted on November 20, 2009 @ 09:18 am
The Almac Group has completed a 67,000-sq.-ft. expansion to its facility in Durham, NC, which now houses the company’s Clinical Services and Diagnostics Divisions. Staff from Almac Diagnostics’ nearby facility in Durham has relocated to the site.
This expansion increased storage capacity for clinical supplies with an additional 3,000 pallet locations. In recent months, the company also completed a specialist clinical supplies storage facility in Craigavon, U.K. and is developing of a 240,000 sq.-ft. North American headquarters facility in Pennsylvania, which is scheduled for completion in 2010. This new facility will initially house Clinical Services and Clinical Technologies operations with expansion from other divisions in the Almac Group.
Donna Christopher, vice president of operations at Almac Clinical Services, Durham site, said, “This latest investment by Almac will act as a platform for us to serve the increasing demands of our client base who are seeking faster routes to get their products through the clinical development process. We now have 200 employees at our NC operations, which is more than five times the number we had when we first started out in 1998 with a team of 35. With over 20 years’ experience in clinical supply management Almac are recognized as a strategic partner in the clinical supply process by most of the world’s pharma and biotech companies. This increase in capacity is a sign of our commitment to offer market driven solutions to our customers.”
Posted on November 20, 2009 @ 09:16 am
Samir Ghodbane, Ph.D., has been appointed as the new general manager of CMC services and CTM manufacturing at
Frontage. Dr. Ghodbane has extensive experience and expertise in product development and technical operations spanning the complete product development cycle, as well as a comprehensive understanding of branded and generic pharmaceutical environments. He has led drug development and technical services at Actavis, Alpharma, and Wyeth. Most recently, he served as vice president of product development and technical services at Actavis, where he oversaw an organization of 180 people located at three different locations.
Daniel Tang, Ph.D., has been appointed vice president of DMPK and bioassay at the company’s operations in Shanghai. Dr. Tang brings experience from ChemPartner, where he managed DMPK operations and business development. He also served as director of bioanalytical services at Quest Pharmaceutical Services and supervised a bioanalytical group of thirteen scientists conducting GLP bioanalysis.
Ron Connolly has been appointed to a new role as senior vice president of business development.Mr. Connolly will be responsible for sales, marketing, and strategic business initiatives at Frontage. He has held several roles at Frontage, including developing and expanding client relationships, as well as various operational roles as head of U.S. operations.In addition, Ron has 20 years of drug development and FDA inspection experience from Flavine, Wyeth, Sanofi Aventis, and GlaxoSmithkline.
“The strategic hiring of Daniel and Samir will add to the experience of our senior management team, providing management to some of our key service areas of growth opportunities both in the U.S. and China,” stated president and chief executive officer Song Li, Ph.D. “Additionally, transitioning Ron to business development will help the development of our sales organization through his in-depth industry experience, providing Frontage the ability to continue to grow our core service offerings.”
Posted on November 20, 2009 @ 09:15 am
Ligand Pharmaceuticals, Inc. has received $2 million in milestone payments from N. V. Organon, a subsidiary of
Merck, through its research collaboration, which is due to expire at the end of December.
“We have had a long and productive drug discovery relationship with Organon and Schering-Plough (which acquired Organon in November 2007) over the years for a range of research programs,” said John L. Higgins, president and chief executive officer of Ligand. “These activities reflect Ligand’s strong R&D engine and the potential of our partnership portfolio.”
November 19, 2009
Posted on November 19, 2009 @ 09:37 am
PPD, Inc. has signed an agreement to acquire
BioDuro LLC, a drug discovery outsourcing company. The acquisition will expand PPD's drug development capabilities in China. PPD and BioDuro will perform a range of R&D services from early stage through Phase IV.
BioDuro operates a 110,000-sq.-ft. lab in Beijing. Most of its approximately 660 employees are based in China, where it provides medicinal chemistry, biology, pharmacology, drug metabolism, pharmacokinetic and safety services. The company offers resources and services to synthesize novel compounds and optimize compounds to generate drug candidates.
"Under the leadership of Masood Tayebi and the entire senior management group, BioDuro has built an exceptional team of researchers and scientists whose experience extends across a broad range of drug discovery," said David Grange, chief executive officer of PPD. "This acquisition will strengthen PPD's presence in China and position us to provide services for the growing global discovery outsourcing industry."
Masood Tayebi, founder and chairman of BioDuro said, "PPD shares our commitment for delivering world-class, quality services to clients. Combining our drug discovery expertise with PPD's global drug development resources will allow us to move our clients' programs from drug discovery into late-stage drug development and build upon our strong growth in China."
The acquisition, subject to various closing conditions, is expected to close in 4Q09.
Posted on November 19, 2009 @ 09:35 am
PharmaNet Development Group has been selected to conduct and manage
Scancell Ltd.’s Phase I/II trial with SCIB1 scheduled for 1H10. SCIB1 is a DNA ImmunoBody vaccine for the treatment of melanoma.
David Evans, chairman of Scancell, commented, “We are delighted to have selected PharmaNet to manage Scancell’s Phase I/II trial program with SCIB1. PharmaNet’s extensive experience, particularly in the management of early stage oncology clinical trials, will be of critical importance to Scancell as SCIB1 moves into clinical development.”
Jeffrey McMullen, president and chief executive officer, PharmaNet Development Group, commented, "This is our first project with Scancell. We are thrilled to work on Scancell’s innovative therapeutic cancer vaccine, SCIB1, and are very pleased that they have entrusted PharmaNet with their study.”
Posted on November 19, 2009 @ 09:33 am
Patheon has named
Francisco R. Negron as vice president and general manager of its Puerto Rico operations. Mr. Negron will be based at the company's Manati site.
Mr. Negron has more than 19 years of experience in the pharmaceutical industry. Most recently he served as global vice president for Novartis Consumer Health, OTC and Pharmaceutical Products, with a specific focus on global process improvement initiatives. He also served as vice president of manufacturing and supply for Valeant Pharmaceuticals and as site general manager for McNeil Consumer Healthcare in Piedras, PR.
"Franco is the right person at the right time to manage our organization in Puerto Rico," said Mr. Wes Wheeler, Patheon's chief executive officer and president. "His experience leading complex and highly efficient manufacturing teams for a variety of world class pharmaceutical organizations will help us transform our business in PR and will support our stated goal of creating a strong manufacturing presence in that region. He has my full support and I look forward to his contributions to Patheon in the future."
Posted on November 19, 2009 @ 09:31 am
AstraZeneca has submitted a NDA to the FDA for Brilinta, an investigational oral antiplatelet treatment for the reduction of major adverse cardiac events in patients with acute coronary syndrome (ACS).
This submission is based on data from PLATO (A Study of Platelet Inhibition and Patient Outcomes), a Phase III trial comparing ticagrelor plus aspirin with clopidogrel (Plavix) plus aspirin.
Brilinta is the first reversibly binding oral P2Y12 adenosine diphosphate (ADP) receptor antagonist. ADP receptor antagonists work to prevent platelets from sticking together, thereby reducing recurrent thrombotic events.
November 18, 2009
Posted on November 18, 2009 @ 09:13 am
Asterand has signed an agreement to acquire
BioSeek Inc., a drug discovery services company, for $1.0 million payable in Asterand shares. The acquisition is part of Asterand’s strategy to enhance its position in the global human tissue services market, and according to a company statement, will be Asterand’s first step in its “buy and build” strategy.
A further payment of as much as $13 million will be payable in 2011, pending sales growth achieved by BioSeek by December 31, 2010. If further payment is made, the first $3.0 million will be paid in Asterand shares and additional payments will be either cash or shares.
BioSeek has developed a human primary cell based, high throughput assay system (BioMAP) designed to replicate the intricate cell and pathway interactions present in inflammatory, autoimmune and cardiovascular diseases. The system predicts clinical activities of a potential drug candidate through comparison of results to a database of profiles for known compounds.
BioSeek is located in South San Francisco, CA and has 14 employees. BioSeek’s key managers will join Asterand’s senior management team. Additionally, BioSeek’s chief executive officer, Dr. Mike Venuti, has agreed to act as a consultant to Asterand for a transition period.
Posted on November 18, 2009 @ 09:12 am
Formatech has selected
KAI Pharmaceuticals’ KAI-4169 compound as the second clinical candidate to receive “free” manufacturing services under its Fillanthropy Program. KAI-4169 is being evaluated for the treatment of secondary hyperparathyroidism. Under the program, Formatech will donate the services required to aseptically fill and finish one lot of the drug product for use in KAI’s upcoming trials.
Formatech plans to complete the production run of KAI-4169 in 1Q10. “We’re excited to have the opportunity to work with KAI on this program,” said Jeffrey Bernard, Formatech’s director of business development. “KAI’s technology for developing selective Protein C Kinase inhibitors is very promising and has the potential to be very impactful in the treatment of a number of diseases. We’re pleased to donate our services for this program and we wish KAI success with this candidate.”
“It is an honor to receive this award from Formatech as part of their philanthropic effort,” said Steve James, president and chief executive officer of KAI Pharmaceuticals. “We appreciate Formatech’s commitment to this program. Secondary hyperparathyroidism is leading cause of morbidity and mortality in patients with chronic kidney disease. This fill will help support our program and we look forward to exciting results in the year ahead.”
Posted on November 18, 2009 @ 09:10 am
Genzyme Corp. reported results of a Phase II/III study of its advanced phosphate binder (APB). Although the trial met its primary endpoint, which was to show that the APB lowered phosphate levels compared to placebo, the APB did not show a significant improvement in phosphate lowering compared to Genzyme’s Renvela.
As a result, the company is discontinuing further development of the drug. The company was looking to develop a product with higher potency that would more effectively bind phosphate, while maintaining all the benefits of Renvela.
November 17, 2009
Posted on November 17, 2009 @ 09:14 am
William B. Gerraughty, Jr. has been promoted to chief operating officer at
Sparta Systems. Mr. Gerraughty will be responsible for overseeing the company’s day-to-day operations, providing strategic planning and resource allocation, and advising the chief executive officer and management team on key planning issues and important business decisions. Mr. Gerraughty will also continue to serve in his current position as chief financial officer and manage the company’s legal and human resource departments.
Prior to joining the company, Mr. Gerraughty served as chief financial officer at NMS Communications and Infinium Software. He also held a number of executive positions, including president, chief operating officer and chief financial officer, at Intellution, a software company serving the industrial automation markets. He began his career at Coopers and Lybrand.
“William Gerraughty’s success in ensuring the financial health of Sparta Systems makes him a natural choice to oversee the company’s daily operation as we head into 2010,” said James E. McGowan, chief executive officer, Sparta Systems.“I’m confident that with his unparalleled record of accomplishment and complete knowledge of the company’s inner workings, his promotion to COO will help position Sparta for continued growth in the coming year and beyond.”
Posted on November 17, 2009 @ 09:11 am
PPD, Inc. has entered an agreement with
Janssen Pharmaceutica to develop and commercialize two Phase II therapeutic compounds, one for diarrhea-predominant irritable bowel syndrome (IBS-d) and one for complicated skin and skin structure and respiratory infections.
PPD in-licensed the two compounds and will advance them through Phase II development. At the completion of Phase II, Janssen will have the option to resume development and commercialization. In exchange, PPD will receive as much as $330 million in clinical and sales milestones, as well as royalties on sales. If Janssen doesn’t chose to take over the program, PPD will have the option to continue development and commercialization and Janssen will receive as much as $250 million in clinical and sales milestones and royalties.
"Our agreements with Janssen diversify and strengthen our compound partnering portfolio and may gain us entry into two large markets," said Fred Eshelman, executive chairman of PPD. "The IBS-d market holds significant drug development potential because of the lack of approved products for this indication, and new antibiotics are needed to address increasing incidences of resistant strain bacterial infections."
The IBS-d compound is a potential locally active mu opioid receptor agonist and delta opioid receptor antagonist. The anti-bacterial compound is a broad-spectrum fluoroquinolone potential antibiotic with activity against gram positive and gram negative bacteria and methicillin-resistant staph aureus (MRSA). It is being developed as both an oral and intravenous therapy to treat skin and respiratory infections.
Posted on November 17, 2009 @ 09:10 am
Genentech has submitted two sBLAs to the FDA for Avastin for the treatment of women who have not received chemotherapy for advanced (metastatic) HER2-negative breast cancer (first-line treatment). One sBLA is based on the Phase III study AVADO that evaluated Avastin in combination with docetaxel chemotherapy. The other is based on the Phase III study RIBBON 1 that investigated Avastin in combination with a taxane, anthracycline-based or capecitabine chemotherapy. Both studies met the primary endpoints of improving the progression-free survival.
"We look forward to working with the FDA to evaluate the data from more than 2,600 women with advanced breast cancer who participated in these studies that showed Avastin in combination with various chemotherapies helped them live longer without the disease worsening,” said Hal Barron, M.D., executive vice president, Global Development and chief medical officer.
Avastin is currently approved in combination with paclitaxel chemotherapy for first-line treatment of advanced HER2-negative breast cancer.
Posted on November 17, 2009 @ 08:47 am
Azopharma Product Development Group (Booth 1801) has integrated its eight service divisions as part of an effort to streamline its approach to product development for small biotechs and large pharma alike, supporting both full development and specialty stand-alone projects.
The Azophrma Product Development Group — previously made up of Azopharma, APIcross, IQsynthesis, AniClin, Cyanta, ADMEQuant, AvivoClin, and Acromon — has been consolidated into three divisions: Azopharma Contract Pharmaceutical Services, AniClin Preclinical Services, and AvioClin Clinical Services.
At a press event during AAPS, a spokesman for the company said that Azopharma is focusing on its core services and has no acquisition plans for the near future. In the past year, Azopharma expanded despite the down economy, adding to its analytical services in Welwyn Garden City, UK and in Maryland Heights, MO, microdosing and central lab services to its pharmacology research facility in Daytona Beach FL, and more recently, new cytotoxic manufacturing suites for clinical trial materials at its (south Florida) Hollywood location.
Microdosing, a trend among pharmaceutical and regulatory agencies, allows companies to make “kill or carry” decisions with earlier pharmacokinetic and pharmacodynamic data in humans. In microdosing studies, drug substance is dosed sufficiently low not to have observable pharmacological activity, but to screen the ADME properties of several drug candidates. These studies have seen a big push from the FDA through its Critical Path initiative.
Cytotoxic compounds are becoming more prominent in the oncology drug realm. These compounds are difficult and dangerous to work with. With its three new manufacturing suites, equipment, and analytical instrumentation, the company is better positioned to support cytotoxic and highly potent compounds for development. Currently Azopharma is manufacturing two niche commercial products for clients: a cytotoxic product and a highly potent compound. With use of cytotoxics predicted to grow, the spokesman contended that the company is very interested in this smaller volume market.
Azopharma is also tapping into strategic partnerships. The group recently entered ones with Pharmanet to leverage complementary services through business development and co-promotion, and Immunregen, under which Azopharma provides development services in exchange for taking equity in the company.
Posted on November 17, 2009 @ 08:39 am
Although active-only powder in capsule approaches are increasingly popular for Phase I trials, they may result in significantly slower, more erratic and less complete in vitro dissolution for some poorly soluble compounds – with the potential to skew in vivo results and delay or abandon work into promising new drugs. So says Dr. Michael Ruff, CPIP, vice president of pharmaceutical development at
Metrics Inc. (Booth 2133). Dr. Ruff presented his research findings during a poster session on Nov. 9 at AAPS.
In a recent study, Dr. Ruff compared the in vitro dissolution of a non-formulated, active-only powder in capsule to that of a formulated capsule in the case of a poorly soluble drug intended for Phase I trials. He reported that his findings represent a cautionary tale for the pharmaceutical industry, which has increasingly taken an active-only, powder-in-capsule approach towards conducting Phase I first-time-in-man trials. This approach enables companies to skip significant formulation and analytical development activities and put prospective new compounds into patients more quickly.
“Going with a drug-only-in-capsule approach can move up first-time-in-man clinical dosing by two to four months, depending on the complexity of the intended dosage form,” Dr. Ruff said. But in his study examining a typically poorly soluble compound, he found that the powder-in-capsule approach resulted in significantly slower, more erratic and less complete in-vitro dissolution. This situation could potentially yield false negative in vivo results, delaying future trials or causing researchers to abandon studies of potentially beneficial new drugs, he warned.
“I recognize that there’s tremendous pressure to reach that first-in-man milestone – it’s what the industry and shareholders expect,” Dr. Ruff said. “So I’m not suggesting that researchers never do active-only powder in capsule. But this limited data supports the theory that agglomeration of micronized, poorly soluble active ingredients can pose a problem for this approach.”
Headquartered in Greenville, NC, Metrics provides pharmaceutical formulation development, clinical trial material (Phase I, II and III) and commercial manufacturing, and analytical development/validation services to the pharmaceutical industry.
November 16, 2009
Posted on November 16, 2009 @ 03:41 pm
Almac Sciences, part of
Almac Group (Booth 2600), has made several appointments.
Denis Geffroy has been named vice president Business Development, with global responsibility. Mr. Geffroy was most recently senior business manager Europe and had been leading Almac Sciences’ rapidd™ early stage development offering.
He joined Almac Sciences in 2004 and has notably developed the European business by adding numerous major pharmaceutical clients to the Almac Sciences portfolio. His new remit includes lab synthesis, PRD chemistry, GMP manufacturing, analytical services, peptide synthesis, radio-labelling, solid state chemistry and biocatalysis. He previously held technology and commercial roles with Chiroscience/ChiroTech and ICI/Synetix Chiral Technologies.
Dr. Charles Shields is joining Almac Sciences as vice president Peptides Operations. Dr. Shields was formerly U.S.-based vice president Global Business Development for Avecia’s oligonucleotides (DNA medicines) business. Prior to 2003 he held a series of senior positions with Avecia, including New Products Development Manager with its Ink Jet Printing Materials business.
Helen McKeever has been named as preclinical program manager, responsible for implementation of rappid™ early stage development programmes. A biochemist with more than 20 years’ CRO experience, Ms. McKeever was most recently senior project manager with Covance.
Almac Sciences president and managing director Stephen Barr remarked, “These appointments bring high levels of proven customer service leadership and delivery in key areas of Sciences’ business, and further increase our emphasis on added value services.”
Posted on November 16, 2009 @ 03:35 pm
Quay Pharma (Booth 2412) is investing nearly $4 million to move to a new purpose-designed factory and headquarters, allowing the company to greatly increase its development and clinical trial manufacturing capacities. The move is expected to create around 52 jobs in the next three years.
The new facility in North Wales, UK, is close to Quay Pharma’s existing premises in the Wirral, and brings together the company’s entire range of services — currently housed in two separate facilities — under one roof.The 40,400-sq.-ft. building, which is four times the size of its existing premises, will feature a variety of state-of-the-art equipment that will enable the company to meet increasing demand for its specialist capabilities, including formulation development, novel drug delivery design, analytical method development and clinical trial manufacture and packaging.
In particular, the expanded operation will provide the opportunity for the further development of Quay Pharma’s expertise in oral dosage form design and development, especially for new chemical entities that exhibit poor solubility and bio-availability, according to the company.
“Our extensive knowledge and experience can play a crucial role in the critical early stages of drug development and in recent years we have seen increasing demand for our services,” said Quay Pharma’s chief executive, Mike Rubinstein. “By creating this new advanced facility to our specific requirements, we will be able to offer an enhanced level of support to our clients.”
The move is planned for January 2010, and will be phased to ensure work on existing client projects is maintained throughout. The new facility is being part funded by a grant from the Welsh Authority Government.
Posted on November 16, 2009 @ 03:29 pm
Avantium (Booth 2061) and Avant-garde Materials Simulations (AMS) have entered into a collaboration for the further development and commercialization of Crystal Structure Prediction (CSP) with AMS’ GRACE software. Pharmaceutical companies can use CSP to predict the crystal structures of their drug compounds. CSP provides an essential approach to significantly reduce the risk of missing a more stable crystal form.
AMS will further develop the software to accelerate the calculations and broaden the range of compounds for which it can be used. AMS will also perform the predictions for third parties. Avantium will develop efficient experimental strategies to physically generate the predicted crystal forms and commercialize Crystal Structure Prediction as a stand-alone service or in combination with experimental programs.
CSP, as developed by AMS, is a breakthrough approach, showing for the first time that the reliable prediction of crystal forms is feasible. AMS in collaboration with the Institute of Pharmaceutical Innovation at the University of Bradford were the first participants ever to score a 4 out of 4 success rate at the 2007 CSP Blind Test.
“The scope of applicability and the accuracy of CSP will continue to improve rapidly,” said Marcus Neumann, managing director of AMS. “The next key challenge is to actually produce predicted but not yet observed forms by rational experiment design. With Avantium Pharma we have found the ideal partner to write the next chapter of the story.”
“The CSP technology is a great extension of our service portfolio,” remarked Guus Scheefhals, chief operating officer of Avantium Pharma. “The predictions will prevent overlooking the most stable crystal form, which will strengthen the IP position of our clients and will help to reduce the risk of crystal form inter-conversions in drug development.”
Posted on November 16, 2009 @ 09:14 am
GlaxoSmithKline and
Nabi Biopharmaceuticals entered an exclusive worldwide option and licensing agreement for nicotine conjugate candidate vaccine NicVAX, an investigational vaccine for the treatment of nicotine addiction and the prevention of smoking relapse, as well as for the development of a second generation nicotine vaccine.
Nabi will receive $40 million upfront and GSK will have an option to exclusively in-license NicVAX on a worldwide basis and a license to develop follow-on next-gen nicotine vaccines using Nabi's intellectual property. Nabi is eligible to receive more than $500 million in option fees and regulatory, development and sales milestones. Nabi will also receive royalties on global sales of NicVAX and next-gen nicotine vaccines, should GSK exercise its option.
NicVAX is currently in Phase III trials. Nabi will be responsible for the Phase III development costs. Upon successful completion of the Phase III studies, GSK can exercise its option to take over further development and commercialization.
"If approved, this smoking cessation vaccine technology could be a novel solution to help the millions of smokers who want to stop smoking and remain abstinent, a habit that is well documented to be very hard to stop permanently," said Jean Stephenne, president of GSK Biologicals. "This technology builds our capability in the therapeutic uses of vaccines and is a great addition to our smoking cessation portfolio."
"We are very pleased with this deal and proud it is with GSK, one of the world's leading vaccine companies, to further develop and commercialize NicVAX," said Dr. Raafat Fahim, president and chief executive officer of Nabi Biopharmaceuticals. "We look forward to addressing one of the largest unmet medical needs of our time with what we believe will be an effective tool to help people quit smoking and remain smoke-fee for the rest of their lives."
The transaction, subject to approval and customary closing conditions, is expected to close in 1Q10.
Posted on November 16, 2009 @ 09:10 am
Sciele Pharma, Inc., a U.S.-based group of Shionogi & Co., Ltd., has entered an agreement to acquire and
Addrenex Pharmaceuticals, a private, specialty pharmaceutical company, for approximately $29 million in cash.
Addrenex specializes in developing drugs that regulate the adrenergic system. Sciele previously licensed three products from Addrenex: Clonicel for attention deficit hyperactivity disorder (ADHD), Jenloga XR for hypertension, and ADX-415 for the treatment of vasomotor systems and hypertension. The NDA for Clonicel was filed with the FDA in October 2009.
With the acquisition, Sciele will gain two additional mid-stage development products and access to a large library of compounds in various therapeutic areas, including pain management, cardiovascular, and dermatology.
Patrick Fourteau, president and chief executive officer of Sciele Pharma, said, “We are pleased to announce the acquisition of Addrenex, a company we established a partnership with more than two years ago. Addrenex has an exciting development platform and several compounds that have the potential to further expand and diversify our product portfolio.”
Moise Khayrallah, Ph.D., chief executive officer of Addrenex, said, “Sciele Pharma has been a valuable partner and catalyst for the success of Addrenex. The partnership has enabled our team to expand the development pipeline and now gives Sciele access to a large portfolio of products that offer tremendous promise for patients and their families.”
Posted on November 16, 2009 @ 09:07 am
Robert A. Stewart has joined
Watson Pharmaceuticals in the newly created position of senior vice president, Global Operations, effective immediately. Mr. Stewart will be responsible for global manufacturing, supply chain, quality and technical operations. He joins the company from Abbott Laboratories, where he most recently served as divisional vice president, Global Supply Chain.
Also,
Thomas R. Russillo has been named executive vice president, Global Generics and will head the company's newly formed Global Generics commercial function. Mr. Russillo will have overall responsibility for generic sales and marketing for the U.S. and Canada, as well for all international markets once the acquisition of Arrow Group is complete. Previously, he served as executive vice president and president of Watson’s Generics Division since 2006. Both Mr. Stewart and Mr. Russillo report to Paul Bisaro, president and chief executive officer of Watson.
"As we prepare to maximize our global footprint following the acquisition of the Arrow Group, we are refining our management structure in ways that will enhance our ability to aggressively capitalize on expanded opportunities," said Mr. Bisaro. "Bob brings more than 20 years of experience in global pharmaceutical supply chain management. By centralizing all quality and supply chain functions under his leadership, we can ensure that we more effectively continue to pursue additional cost and operational efficiencies under our Global Supply Chain Initiative and Operational Excellence programs. In addition, Bob's extensive international experience will help us maximize the increased international capabilities we gain following the closing of the Arrow acquisition."
Mr. Bisaro continued, "By creating this Global Generics commercial structure, we will look to Tom to develop the strategies that will strengthen and grow Watson's and Arrow's current product portfolios and market positions around the world. He will also have responsibility for ensuring that our commercial needs are appropriately aligned with new product R&D and that Watson efficiently expands its generics position with key product introductions across the 20 countries in which we will operate, including established, expanding and emerging markets."
November 13, 2009
Posted on November 13, 2009 @ 10:17 am
Steven M. Paul, M.D., executive vice president, science and technology, and president,
Lilly Research Laboratories, will retire, effective February 28, 2010.
Jan M. Lundberg, Ph.D., executive vice president and head of global discovery research, AstraZeneca, will succeed Dr. Paul. Dr. Lundberg plans to join Lilly in Indianapolis as early as January 2010.
"Under Steve's leadership, we now have the most robust pipeline in Lilly's history, including approximately 60 unique potential medicines, both small molecules and biologics, in human testing. Additionally, Steve has helped to recruit many of the top leaders we have in LRL today. Steve has also been actively involved in advancing Lilly's research in the area of Alzheimer's disease, including solanezumab, one of Lilly's two late-stage Alzheimer's molecules," said John Lechleiter, Ph.D., Lilly’s chairman and chief executive officer.
"Advancing our pipeline to patients as quickly and as safely as possible is the biggest challenge Lilly faces in 2010 and beyond. We are confident that Dr. Lundberg will be able to deliver on this challenge," said Lechleiter.
During the last 10 years at AZ, as head of global discovery research, Dr. Lundberg was instrumental in delivering more than 150 drug candidates to the company's pipeline. He had responsibility for discovery research and supported clinical development of therapies for cancer, infection, central nervous system disorders, pain, cardiovascular, metabolic and respiratory diseases, gastrointestinal conditions, and inflammation. Dr. Lundberg was also responsible for discovery-enabling technologies, discovery informatics, drug metabolism and pharmacokinetics, translational science and safety assessment. He has had a leading role in external activities, including in-licensing of projects and technologies, as well as acquisitions of biotech companies.
"I have always had tremendous respect for the quality of people, science and products at Lilly. Therefore, I feel honored to be the successor to Steve Paul. I'm really looking forward to meeting my colleagues at Lilly and together with them conquering the future challenges and advancing innovative medicines that meet the needs of patients, payers and prescribers," said Dr. Lundberg.
Posted on November 13, 2009 @ 10:14 am
Abbott has entered into a definitive agreement to acquire the global rights to PanGenetics BV's PG110 fully humanized antibody to Nerve Growth Factor (NGF). The agreement includes an upfront payment of $170 million plus additional milestone payments, for a total of $190 million, as well as royalties.
PG110 is a biologic in Phase I development for the treatment of chronic pain. NGF is released at sites of tissue damage and inflammation, and plays a significant role in the transmission of pain signals by the central nervous system. PG110 is currently being studied in a Phase I trial in patients with osteoarthritis. If successful, Abbott anticipates evaluating the compound in a number of other pain states, including chronic lower back pain, cancer pain and diabetic neuropathic pain.
"The goal for treatment of chronic pain continues to be potent, long-lasting analgesia that is tolerable for patients without the potential for dependence and abuse," said John Leonard, M.D., senior vice president, global research and development, Abbott. "NGF blockers have demonstrated the potential to address all of these needs, making them a promising treatment for chronic pain patients."
This transaction, subject to customary closing conditions and regulatory approvals, is expected to close in 4Q09.
Posted on November 13, 2009 @ 10:11 am
BioInvent International has entered into a license and discovery agreement with
Daiichi Sankyo Co. for the development of therapeutic antibodies against multiple targets. Daiichi Sankyo will have access to BioInvent's discovery and development technology platform, n-CoDeR library, and in-house antibody expertise. As part of the agreement, BioInvent has secured certain co-promotion rights in Scandinavia and the Baltic countries.
BioInvent will receive an upfront access fee and annual maintenance fees for its antibody library, and success-based milestone payments. Daiichi Sankyo will fund all research work and BioInvent is entitled to royalties on any commercialized products. Financial terms were not disclosed.
As well as working with Daiichi Sankyo in Japan, BioInvent will also work with the company’s German affiliate U3 Pharma GmbH. A joint steering committee will oversee the discovery and development process.
Svein Mathisen, chief executive officer of BioInvent, commented, “We are pleased that our technology platform and expertise continue to attract the attention and long term commitment of big pharma. BioInvent is established as a trusted partner for the discovery and development of therapeutic antibodies, and with this agreement we are continuing to grow our presence and recognition in the Japanese market.”
The n-CoDeR library contains more than 20 billion diverse, fully human antibody fragments that have been created using BioInvent's technology platform.
November 11, 2009
Posted on November 11, 2009 @ 10:59 am
Sanofi-aventis and
Regeneron Pharmaceuticals, Inc. entered into agreements to expand and extend their existing global collaboration established November 2007, to discover, develop, and commercialize therapeutic monoclonal antibodies.
Sanofi-aventis will increase its annual funding from $100million to $160 million beginning in 2010, and the research funding will extend through 2017. The companies plan to advance an average of four to five antibodies into clinical development each year. Sanofi-aventis has an option to extend the discovery program for an additional three years. Regeneron will contribute its VelocImmune technology to the collaboration and its next generation technologies for antibody generation.
"The first two years of our collaboration with sanofi-aventis have been extremely productive, with five VelocImmune human antibodies in or entering clinical development," commented Leonard S. Schleifer, M.D., Ph.D., president and chief executive officer of Regeneron. "The expansion of our collaboration provides even greater resources over a longer time horizon and will boost our efforts to build a deep pipeline of new human antibody product candidates. Sanofi-aventis is an ideal partner with the expertise and global reach to collaborate with us on our mission to bring important new medicines to patients around the world."
"This collaboration expansion demonstrates sanofi-aventis' commitment to become a key player in the field of monoclonal antibodies and our confidence in our partner Regeneron," declared Marc Cluzel, executive vice president, R&D, sanofi-aventis. "It will further fuel our product pipeline and will allow us to bring multiple antibody product candidates into the clinic, thereby significantly increasing the chance of providing patients access to innovative drugs in various therapeutic areas."
To date, the two companies have advanced four therapeutic antibodies into clinical development and have filed an IND for a fifth additional antibody.
Posted on November 11, 2009 @ 10:57 am
GlaxoSmithKline received approval from the FDA for its sBLA for unadjuvanted influenza A (H1N1) pandemic vaccine. The approval, which was filed as a strain change supplement to GSK’s FluLaval seasonal flu vaccine, allows the company to manufacture a flu vaccine for use in adults to prevent the 2009 pandemic H1N1 influenza A strain.
The United States Department of Health and Human Services has placed an order to fill 7.6 million doses of the vaccine.The vaccine will be produced in multi-dose vials from bulk vaccine manufactured at GSK’s facility in Quebec, Canada.GSK expects to begin shipping vaccine in December and to provide all 7.6 million doses by the end of the year.
Posted on November 11, 2009 @ 10:55 am
Particle Sciences Inc. has acquired additional space bringing its total to approximately 21,000 sq.-ft. The company expects the new space to be operational in 1Q10.
"Our current workload and existing pipeline simply necessitates this addition," said Dr. Mark Mitchnick, chief executive officer. "2009 has been a record year for us and we have pretty good visibility on the next 12 months. The additional space will be used to expand our cGMP warehouse capacity. Also, we will construct a purpose-built sampling and weighing area for highly potent materials.
According to Robert Lee, Ph.D., Particle Sciences vice president of Pharmaceutical Development, "Increasingly, clients are coming to us for clinical trial material manufacturing and to work with a greater number of highly potent compounds. We are fortunate that we are able to expand into both of those needs."
November 10, 2009
Posted on November 10, 2009 @ 09:39 am
Pfizer has plans to close six R&D sites and cut an unspecified number of jobs in the U.S. and the UK as part of its integration with Wyeth.
According to a company statement, Pfizer will reduce its global R&D square footage by 35%, and will discontinue R&D operations in Princeton, NJ; Chazy, Rouses Point and Plattsburgh, NY; Sanford and Research Triangle Park, NC; and Gosport, Slough/Taplow, UK.
Pfizer will now have five main R&D sites for BioTherapeutics, PharmaTherapeutics and Vaccines. These sites are: Cambridge, MA; Groton, CT; Pearl River, NY; La Jolla, CA; and Sandwich, U.K. These research labs will be supplemented by specialized research capabilities, such as monoclonal antibody discovery in San Francisco, regenerative medicine work in Cambridge, UK, and R&D activities in Shanghai, China.
“By focusing our R&D operations in these centers, we are building the world’s premier biopharmaceutical R&D enterprise,” said Mikael Dolsten, president of BioTherapeutics R&D. “This new structure puts Pfizer in the best position to conduct cutting-edge research within and beyond our own laboratories and to deliver a portfolio of high-impact medicines to patients.”
While these changes are expected to bolster productivity and reduce costs, they will result in staff reductions, according to Martin Mackay, president, PharmaTherapeutics R&D.
Posted on November 10, 2009 @ 09:36 am
Bristol-Myers Squibb and
Alder Biopharmaceuticals, Inc. entered a global agreement for the development and commercialization of ALD518, a biologic that has completed Phase IIa development for the treatment of rheumatoid arthritis.
Under the terms of the collaboration, BMS gains worldwide exclusive rights to develop and commercialize the drug for all potential indications except cancer, for which Alder will retain rights and BMS has an option to co-develop and commercialize outside the U.S. Alder will receive an upfront cash payment of $85 million, development and regulatory-based milestone payments of as much as $764 million, sales milestones which, under certain circumstances, may exceed $200 million, and royalties on sales. Additionally, Alder has an option to require BMS to make an equity investment of as much as $20 million in Alder during an initial public offering.
“With its novel mechanism of action, ALD518 has the potential to offer an exciting new option for patients with rheumatoid arthritis,” said Brian Daniels, M.D., senior vice president, Global Development & Medical Affairs, BMS. “We are pleased to have the opportunity to develop this novel monoclonal antibody. As part of our String of Pearls strategy, this transaction provides Bristol-Myers Squibb with the opportunity to strengthen our immunoscience pipeline, and leverage our company’s experience in developing and delivering novel biologics to help patients prevail over rheumatoid arthritis and, potentially, other autoimmune diseases.”
“Bristol-Myers Squibb and Alder share the vision that ALD518 could become an important part of treating patients with rheumatoid arthritis,” said Randall C. Schatzman, Ph.D., president and chief executive officer of Alder Biopharmaceuticals. “Bristol-Myers Squibb’s extensive development and commercial experience in immunology translate into an exceptionally good fit for Alder, especially at this stage of our corporate development.”
Posted on November 10, 2009 @ 09:29 am
Novavax, Inc. initiated a Phase IIa study of its trivalent seasonal influenza VLP vaccine candidate in healthy adults 60 years of age or older. This randomized, double-blind, active-controlled study is evaluating the safety, tolerability and immunogenicity of two different doses of Novavax's VLP vaccine compared with a commercially available trivalent inactivated vaccine (TIV, Fluzone). Novavax's vaccine contains VLPs made up of the hemagglutinin (HA), neuraminidase (NA), and matrix 1 (M1) proteins against the H3N2, H1N1, and B strains recommended for 2009-2010 flu vaccines.
"This is a very important study because it will help establish the safety and immunogenicity of our trivalent seasonal influenza VLP vaccine in older adults and allow us to select a dose for a future Phase IIb confirmatory, non-inferiority clinical trial in this population. Moreover, it will also give us a clear signal of how our seasonal influenza VLP vaccine compares to the current standard of care, TIV (Fluzone)," said Dr. Rahul Singhvi, president and chief executive officer of Novavax. "Recall that in a recent Phase II study in healthy adults ranging in ages from 18-49 years, we showed that our seasonal influenza VLP vaccine was safe and immunogenic at 15 and 60 mcg dose levels. These data give us great confidence as we move forward in this current clinical trial in older adults."
A total of 480 subjects will be enrolled at approximately six sites in the U.S. and one site in India. Preclinical studies have shown that influenza VLP vaccines have stronger T-cell responses than TIV (Fluzone), indicating the potential for better immunologic responses in trials particularly in older adults.
Posted on November 10, 2009 @ 09:06 am
SMI Manufacturing (Booth 1709) has agreed to invest $10 million into HealthSport, Inc., a formulator and developer of edible, multi-layer film strips that deliver drug and dietary supplement actives through buccal and sublingual absorption as well as oral ingestion. The investment is expected to accelerate HealthSport's growth and strengthen its alliances with large pharmaceutical companies.
"The first phase of our relationship with HealthSport was accomplished in July of this year with the signing of the manufacturing agreement between the two companies. This investment represents the next step in that relationship, which is to begin the process of making this breakthrough technology available to the pharmaceutical industry on a worldwide basis," stated Kevin Taheri, SMI's chief executive officer.
"It has been apparent for some time that there is a very strong synergistic relationship between SMI and HealthSport. We are looking to take advantage of that relationship to not only produce dietary supplement and OTC film strip products, but also to begin working with pharmaceutical companies to enter the highly profitable prescription pharmaceutical market," stated Hank Durschlag, chief executive officer of HealthSport. "Our drug delivery platform is ideal for many drugs already used everyday."
SMI and HealthSport signed a stock purchase agreement pursuant to which SMI will invest the $10 million into HealthSport in exchange for a 55% percent stake in HealthSport. Closing of the transaction is anticipated to occur in the next 15 to 20 days. At the time of the closing, SMI will deliver to HealthSport $2 million and a promissory note for $8 million that SMI will pay in five installments through the final scheduled payment on June 30, 2010. Funds from the investment will be used to strengthen HealthSport's working capital position, provide funds for R&D and enhance HealthSport's current manufacturing plant, creating a state-of-the-art, GMP compliant R&D and production facility.
Posted on November 10, 2009 @ 08:52 am
Patheon (Booth 1232) has named William E. Weiser, Ph.D. to the role of group director, Pharmaceutical Development Services (PDS), Analytical Development at the company's Kit Creek laboratory in Research Triangle Park, NC. Also, Anthony Qu, Ph.D. has been named group director of the PDS operation in Cincinnati, OH.
"We are so pleased that we have been able to add these two individuals to our organization," said Dr. Colin Minchom, Patheon's vice president PDS North America. "I am confident that our customers and employees will benefit from their broad expertise as leaders and as scientists in research and development."
Dr. Weiser has over 20 years experience in the pharmaceutical industry. Most recently he served as general manager for Liquidia Pharmaceuticals with responsibility for establishing pharmaceutical development operations for nanoparticle therapeutics as well as formulation and analytical development capabilities. He was vice president of analytical chemistry at Cardinal Health/Magellan Laboratories, where he contributed to the growth of their contract pharmaceutical analytical services business. Dr. Weiser also held positions of increasing leadership in Pharmaceutical Development at Burroughs Wellcome Co.
Dr. Qu, with almost 20 years experience in the pharmaceutical industry, is returning to Patheon from his most recent position as vice president of product development at Apotex. His previous Patheon experience included responsibilities as senior director of PDS Global Analytical Operations and director/manager, PDS Analytical Development in Mississauga, ONT, Canada. He has also held positions in R&D and regulatory affairs at Biovail and Taro Pharmaceuticals.
Visit Patheon at Booth 1232!
November 9, 2009
Posted on November 9, 2009 @ 12:08 pm
AMRI 3Q09
3Q Revenues: $47.7 million (-22%)
3Q Earnings: $0.4 million
YTD Revenues: $153.0 million (-12%)
YTD Earnings: $2.5 million
Comments: Total contract revenues dropped 27% to $39.7 million from 3Q08; Discovery Services was $11.9 million (-27%), Development/Small Scale Manufacturing was $9.7 million (-33%) and Large Scale Manufacturing was $18.2 million (-22%). Contract revenues are down 17% YTD to $121.8 million. Recurring royalties for the quarter were up 39% to $7.9 million.
Posted on November 9, 2009 @ 12:02 pm
Evotec AG and Boehringer Ingelheim have extended their research collabration for four more years. The collaboration was initiated in August 2004 and has been extended on two previous occasions. Based on the success to date in the areas of CNS, inflammation, cardiometabolic and respiratory diseases, the companies have elected to expand the scope of the collaboration to also include oncology targets. Through the term of the extension, Evotec will receive research funding of $22 million, as well as milestones and royalties.
In 2004, Evotec and BI entered into a multiyear drug discovery collaboration to jointly identify and develop preclinical development candidates for the treatment of various diseases. BI has full ownership and global responsibility for clinical development, manufacturing and commercialization of the compounds identified.
In return, Evotec receives ongoing research payments and preclinical milestones. Furthermore, the contract provides substantial long-term upside for Evotec through potential payments for successful milestone achievements during clinical development and royalties when new drugs reach the market.
Dr. Werner Lanthaler, chief executive officer of Evotec, commented, "We are extremely pleased and proud that Boehringer Ingelheim continues to see the value that we bring to their research, by committing to one of the largest and most innovative integrated research projects in the industry. This extension speaks volumes for the excellent scientific results achieved."
Dr. Wolfgang Rettig, corporate senior vice president research of BI, remarked, "Evotec has continually demonstrated exceptional scientific expertise in support of our research. We are very pleased to be able to continue our collaboration with Evotec and expand it into new areas of research and have no doubt that they will continue to assist us in achieving our drug discovery goals."
Posted on November 9, 2009 @ 08:54 am
Enzon Pharmaceuticals (Booth 611) will sell its specialty pharmaceutical business, including its CMO operations, to the sigma-tau Group for $300 million plus an additional amount of up to $27 million based on success milestones. Enzon will also receive royalties of 5 to 10% on incremental net sales above a 2009 baseline amount from Enzon’s four marketed specialty pharmaceutical products through 2014.
Enzon’s specialty pharmaceutical business includes four marketed products: Oncaspar, Adagen, DepoCyt, and Abelcet, as well as the manufacturing facility in Indianapolis, IN which will be purchased by a U.S. subsidiary of Sigma-Tau Pharmaceuticals, Inc., based in MD. Sigma-Tau Pharmaceuticals will distribute the products in the U.S. market.
After the sale of these assets, Enzon’s businesses will consist of its royalties, Peg SN38 and our LNA and PEG technology platforms. “Enzon’s board is evaluating options to return most of the value of this sale to shareholders,” stated Alex Denner, chairman.
“sigma-tau is a great strategic fit for this business, as they have the presence and expertise to effectively market these products in all geographic areas,” said Jeffrey H. Buchalter, Enzon’s president and chief executive officer.
sigma-tau is a global R&D driven, Italian-owned pharmaceutical company dedicated, among other areas, to developing and commercializing medicines for rare diseases. This acquisition will expand sigma-tau’s current presence in the U.S. and in new therapeutic areas.
Marc Tewey, vice president, commercial operations of Sigma-Tau Pharamceuticals, confirmed that the company plans to continue the CMO business.
“sigma-tau is dedicated to providing novel therapeutics to patients suffering from rare diseases and other unmet medical needs,” said Claudio Cavazza, sigma-tau’s president. “Through the acquisition of Enzon’s specialty pharmaceutical business, we will increase our presence in the field of rare diseases with products of great value which are the result of an outstanding research activity. sigma-tau is determined to continue Enzon’s excellent work, especially in the field of rare diseases which is a particularly stimulating one as it aims at tackling life-threatening conditions which all too often affect the very young.”
Posted on November 9, 2009 @ 08:32 am
Win free registration and hotel for 2010 AAPS, courtesy of DPT (Booth 1701)!
Register with DPT for a chance to win FREE registration and hotel stay during the 2010 AAPS Annual Meeting & Expo in New Orleans. Entry tickets are in AAPS registration bags (or you can stop by DPT's booth to pick one up).
Drop off your entry ticket at booth 1701 for your chance to win.One winner will be selected each day of the tradeshow!
(NOTE: must be a pharmaceutical, biotechnology or consumer healthcare employee to enter.)
Posted on November 9, 2009 @ 08:28 am
Catalent Pharma Solutions (Booth 1301) has entered into a strategic alliance with Endotis Pharma for the development of oral formulations of synthetic oligosaccharides.
Using Catalent's drug delivery technologies, the two companies will collaborate exclusively to develop certain oral formulations of small-glycol drugs. Oral formulations of synthetic oligosaccharides will allow full exploitation of the therapeutic potential of small-glycol drugs, which to date are administered only intravenously or subcutaneously.
Catalent and Endotis are initially focusing on the preclinical development of Endotis' EP37151 compound. EP37151 is a first-in-class oral synthetic oligosaccharide anticoagulant which, as an indirect factor Xa inhibitor, acts via antithrombin activation. The companies expect to initiate a Phase I clinical trial program during the second quarter of 2010, and hope to have more oral anticoagulants enter development within the next year.
"This collaboration with Endotis, based upon a unique combination of complementary expertise, has been providing exciting results, proving that the various technical hurdles associated with the oral delivery of small-glycol drugs can be overcome," said Tom Stuart, group president of Catalent's Oral Technologies segment.
Visit Catalent Pharma Solutions at Booth 1301!
Posted on November 9, 2009 @ 08:27 am
DSM Pharmaceutical Products (Booth 1333) has entered a manufacturing alliance with Galenix of Saint Jean D'Illac, France, in which DSM will be the preferred commercial scale manufacturing partner for Galenix commercial products on a global basis.
DSM and Galenix will collaborate on business development opportunities co-marketing Galenix drug delivery technologies, based on the strength of Galenix in drug product development and clinical services and DSM in process development, scale up and commercial scale pharmaceutical manufacturing.
Pieter de Geus, DSM Pharmaceuticals' senior vice president, R&D stated, "These innovative drug delivery technologies enhance our offering in the field of pharmaceutical development services and complement our portfolio of drug delivery technologies. The collaboration with Galenix clearly demonstrates DSM's commitment to bringing improved drug delivery to markets globally."
Hans Engels, president of DSM Pharmaceuticals, added, "The alliance brings out the best of both parties. Combining innovative formulations with flawless transition into commercial products creates an attractive value proposition for any drug company."
Jerome Besse, chief executive officer of Galenix, commented, "This is truly a win-win situation. Galenix is privileged in working with DSM to generate value for our customers. The partnership fits with our strategic intention of expanding service offerings to the North America market, and also with DSM's expansion of sales & marketing focus in Europe."
No financial terms were disclosed.
Posted on November 9, 2009 @ 08:26 am
Analytical Bio-Chemistry Laboratories (ABC, Booth 1119) has expanded its offerings to include comprehensive support for large molecule development.
"This recent investment in biotech development services complements ABC's long history of ELISA, RIA and EIA experience and bioanalytical support. It also leverages ABC's extensive analytical capabilities to provide our clients with more comprehensive support for both large and small molecules," said John Bucksath, general manager and senior vice president of ABC's Pharmaceutical Services division.
To lead the development of a dedicated biotech team and laboratory, ABC recruited industry veteran, John C. Anders, Ph.D., who brings more than 24 years of experience in biopharmaceutical development from both the sponsor and CRO sides of the business. Dr. Anders has held several leadership positions building and leading advanced CGMP biotechnology analytical laboratories, and has expertise in time-tested and new technologies in protein chemistry, analytical methods and analysis of macromolecules by various methods. He played a major role in developing a pipeline of seven genomic expression tests for diagnosis and risk assessment of various types of cancer, including the successful completion of a pre-IND application to the FDA and development of a clinical protocol slated to begin soon.
Dr. Anders has assembled a team of biopharmaceutical experts, each with more than 18 years of experience in protein chemistry and chromatography. To ensure the team is well equipped to meet client demand, ABC has invested in a leading-edge biotech lab housed in ABC’s new, 90,000-sq.-ft. pharmaceutical development facility in Columbia, MO.
“Despite a challenging economic environment, 2009 was a positive year for ABC Laboratories,” said Mr. Bucksath. "Recent investments in people, processes and systems have resulted in 13% growth over 2008 and positioned us well to deliver on our customer’s needs in the years to come.”
Posted on November 9, 2009 @ 08:22 am
ProChon Biotech, Ltd. has selected Lonza (Booth 2800) to manufacture its fibroblast growth factor (FGF2v) variant at its Hopkinton, MA facility. FGF2v is a key regulator of cellular processes involved in blood vessel formation, wound healing and the remodeling of bone and cartilage and is a component of ProChon's BioCart Cartilage Regeneration System.
"With an unparalleled track record in contract manufacturing, Lonza is the ideal partner to manufacture our fibroblast growth factor system," said Patrick O'Donnell, chief executive officer of ProChon. "As we accelerate the BioCart clinical program at medical centers across the country, it is vitally important to have immediate access to our core technology and working with Lonza will make this a reality. We look forward to working with Lonza to develop FGF2v as we move toward our goal of bringing mobility to millions of people who suffer from cartilage injuries."
"We are very pleased to enter this collaboration with ProChon to advance a critical new biotherapy for cartilage regeneration," said Dr. Stephan Kutzer, head of Lonza Custom Manufacturing. "We look forward to supporting ProChon with innovative development services and the latest in biopharmaceutical manufacturing technologies and expect this to be the basis for a successful, long-term relationship."
See Lonza at Booth 2800!
Posted on November 9, 2009 @ 08:20 am
Althea Technologies (Booth 819) has added customized formulation development services to its portfolio. The services will be overseen by newly appointed Dr. James Matsuura, who takes the title director of Formulation Development.
According to a company statement, "This investment in an experienced team of formulation and analytical scientists, along with new laboratory facilities and state-of-the-art equipment, enhances and complements Althea's existing expertise and capabilities in cGMP biologics manufacturing and aseptic filling of injectable products, and completes the full integration of development and manufacturing services available for clients from early-stage development through commercial supply."
The new formulation laboratories are an expansion to the clinical manufacturing facility located on the San Diego campus and are further supported by the analytical expertise of Windrose Analytica, which Althea acquired earlier this year. "The addition of our new formulation development laboratories is the perfect complement to our advanced protein and peptide analytical capabilities, and will allow us to bring our clients' products into the clinic with unmatched speed, efficiency and effectiveness," noted Dr. Alan Herman, vice president of Product Development & chief scientific officer.
"We are delighted to have Dr. James Matsuura join Althea. His many years of experience bring added value to clients in helping them with the complexities of developing protein formulations for both clinical trials and product launch in our new commercial manufacturing facility," commented Dr. Shabbir Anik, Althea's president and chief executive officer.
The expanded facilities include a new development lyophilizer, which allows the group to optimize lyophilization cycles for products requiring enhanced stability. The new formulation laboratory and staff, operating closely with the analytical development group, complete Althea's product development group and enable Althea to support clients with critical development steps, as well as the manufacture of API and finished product.
Posted on November 9, 2009 @ 08:18 am
Surface Measurement Systems Ltd. (Booth 2147) and Particulate Systems, a brand of Micromeritics Instrument Corp. (Booth 2251), have signed a global strategic collaboration. The collaboration will draw on the combined knowledge and experience of both companies in the design and development of advanced analytical equipment for the characterization of particulate, porous, and complex materials. Working together, both companies will strengthen their ability to deliver customer-focused instrumentation solutions globally, according to a joint statement.
In the initial phase of this collaboration, Particulate Systems will have the exclusive distribution rights for key SMS products in selected regions of the U.S. as well as in South America, Central America, and the Middle East. These products include the DVS Dynamic Vapor Sorption systems that utilize dynamic gas flow and the gravimetric technique to produce high-resolution adsorption and desorption isotherms of water and organic vapors on essentially any solid material. In addition, SMS will extend its service and support for customers in the U.S. via the Particulate Systems’ extensive aftercare network. Particulate Systems will also have co-distribution rights to sell Surface Measurement Systems products in China.
Particulate Systems and SMS will begin organizing joint academic meetings, symposia, and other academic training programs to advance the development of particle and sorption technology starting in October 2009.
Preston Hendrix, president of Micromeritics, stated, “Collaboration between the two organizations enhances our ability to offer advanced analytical tools to guide research, resolve problems in production and QC, and to expand the understanding of material structure in general. Joining forces with SMS provides the customers of both companies additional options for solving their analytical needs.”
Dr. Daryl Williams, managing director and founder of SMS, added, “This new relationship builds on both a business and product synergy between our two companies which will allow us to provide total instrumentation solutions for many new research and development sectors.”
November 6, 2009
Posted on November 6, 2009 @ 09:35 am
Quintiles officially opened its expanded regional headquarters facility in Singapore’s Science Park I. The new facility doubles the size of the company’s previous space in Singapore and provides additional room for future expansion.
Quintiles is leasing a total of 79,000 sq.-ft. of space in the new Cintech IV building, which is capable of accommodating approximately 550 employees when fully occupied.
The new, 13,000-sq.-ft. central lab facility doubles the size of the previous Singapore lab, providing the additional space necessary to accommodate the demand for central lab services in the region. The lab facility provides globally harmonized lab services and plans are underway to expand these capabilities to include an assay development lab (ADL) and an anatomic pathology lab.
“Quintiles’ expansion today, to make Singapore its strategic home-base in Asia to drive regional expansion, represents a strong endorsement of Singapore’s capabilities in regional clinical trial coordination and research. Coupled with our capabilities in translational research, pharmaceutical and biotech companies can leverage Singapore as a one-stop location to carry out through-train drug discovery and development,” said Gan Kim Yong, Minister for Manpower, Singapore.
Posted on November 6, 2009 @ 09:34 am
Gloucester Pharmaceuticals received approval from the FDA for Istodax (romidepsin) for the treatment of cutaneous T-cell lymphoma (CTCL) in patients who have received at least one prior systemic therapy.
The approval was based on disease response defined as the number of patients with confirmed complete response or partial response. The NDA included efficacy data from two studies involving 167 patients. Istodax is a member of a new class of cancer drugs known as histone deacetylase (HDAC) inhibitors and is expected to be commercially available in January 2010.
“The approval of Istodax is the result of an extraordinary commitment by our clinical investigators and the patients and their families who volunteered to participate in the Istodax clinical trials,” said Jean Nichols, Ph.D., president and chief operating officer of Gloucester Pharmaceuticals. “Gloucester would also like to recognize the National Cancer Institute which played an invaluable role in the development of Istodax.”
Posted on November 6, 2009 @ 09:30 am
Ziopharm Oncology, Inc. achieved positive data from the multicenter randomized Phase II trial of palifosfamide (ZymafosTM, ZIO-201) in patients with unresectable or metastatic soft tissue sarcoma.
Having achieved the study’s efficacy milestone following safety and efficacy review, it was determined that the data is sufficient to proceed to a pivotal study in support of product registration and to conclude enrollment in the trial.
In the Phase II trial, patients are randomized either to doxorubicin (the only currently FDA-approved agent in sarcoma) or to palifosfamide in combination with doxorubicin. As of the October 5th cut-off date, there were 67 patients randomized to the trial, with 65 treated and 61 eligible for analysis. The 61 patients were evaluated for progression-free survival (PFS).
The median (PFS) for doxorubicin is 4.4 months, the median PFS for palifosfamide + doxorubicin has not yet been reached; the 1st PFS was 1.5 months for doxorubicin vs. 3.5 months for palifosfamide + doxorubicin. PFS is a biologically important end point in sarcoma, and has been well demonstrated to be a relevant measurement of the effect of treatment on outcome.
The interim safety data indicate that the addition of palifosfamide does not add to the toxicity of single agent doxorubicin. The company is in the process of finalizing a registration trial plan in soft tissue sarcoma for review by regulatory authorities.
November 5, 2009
Posted on November 5, 2009 @ 09:12 am
Ligand Pharmaceuticals and
Pfizer have extended their JAK3 research collaboration for another year. Ligand will receive $3.1 million in research payments to continue drug discovery and lead candidate optimization. Under the original agreement, Ligand is entitled to receive as much as $175 million in success-based milestones for the development and commercialization of multiple products. In addition, Ligand will receive royalties on product sales.
“We are very pleased to learn that Pfizer has elected to extend the JAK3 research collaboration with Ligand,” said John L. Higgins, President and chief executive officer of Ligand. “We view JAK3 inhibitors as a very promising market opportunity, and given Pfizer's clinical success with its own internal program we are convinced that they are highly committed to this category. Ligand has an exceptional record of drug discovery while serving major pharmaceutical companies in a number of research collaborations. We are pleased with the team’s progress and look forward to continued success as we drive the program forward for Pfizer.”
Posted on November 5, 2009 @ 09:10 am
Kendle 3Q09
3Q Revenues: $133.8 million (-26%)
3Q Earnings: $8.8 million (-6%)
YTD Revenues: $421.0 million (-19%)
YTD Earnings: $12.9 million (-35%)
Comments: Early Stage revenue was $10.8 million (-4%) and YTD was $27.2 million (+7%). Late Stage revenue was down 17% to $91.5 million in the quarter and down 14% to $284.7 million YTD. New business awards for the quarter totaled $137.2 million, up from $132 million in 2Q09. Contract cancellations for the quarter were $53.8 million or 6% of the company's backlog at June 30, 2009.
Posted on November 5, 2009 @ 09:08 am
Omnicare 3Q09
3Q Revenues: $1.5 billion (-6%)
3Q Earnings: $72.5 million (+35%)
YTD Revenues: $4.6 billion (flat)
YTD Earnings: $132.1 million (+17%)
Comments: CRO business revenues were $36.9 million in the quarter (-28%). Backlog at September 30, 2009 was $235.7 million. The Pharmacy services business generated sales of $1.5 million in the quarter (-1%). Results in 3Q08 include the impact of special items and an accounting change totaling $28.8 million.
Posted on November 5, 2009 @ 08:53 am
Stelmi (Booth 1000) will host a seminar at 9:30 a.m. on Tuesday, Nov. 10, covering the mastery of microbiological and particulate cleanliness in the production RTS and RTU elastomeric closures for pre-filled syringes and vials.
Drawing on Stelmi's experience as a specialist in rubber components for pharmaceutical primary packaging, the seminar will feature targeted presentations on the reduction of microbiological and particulate contamination in the production of rubber closures, with special emphasis on sterile components and visual quality.
This event will also be the cover Stelmi’s newly in-line production concept, PremiumFill. In a globally controlled area, this concept is aimed at optimizing the microbiological and particulate cleanliness levels in the production of sterile (ready-to-use) and cosmetic quality components (visual aspect).
For an invitation, e-mail
contact@stelmi.com or visit Booth 1000.
Posted on November 5, 2009 @ 08:50 am
Addressing the continuing pharmaceutical market trend of manufacturing medication in smaller but more potent doses,
Almac (Booth #2600) has successfully completed the design, manufacture and installation of state-of-the-art containment technology to facilitate the processing of potent compounds in its Product Development facility.
The company says that its in-house engineered containment solutions employ rigid and flexible film Isolator technology around the processing zones of equipment that require containment of airborne particulates. Extensive dust monitoring exercises have determined the effectiveness of these containment solutions; and demonstrate Almac can process compounds with an OEL as low as 30 ng per m3.
Almac has the capability to process batch sizes ranging from 0.1Kg to 100Kg, manufacturing development, clinical & small-scale commercial solid, oral dose products.
Visit Almac at Booth #2600 Posted on November 5, 2009 @ 06:37 am
Phase Forward (Booth 702) has signed a multi-year agreement with Quotient Clinical (Booth 2446) to implement Phase Forward’s InForm Global Trial Management (GTM) electronic data capture (EDC) solution to support data collection, management and analysis for its clinical trials. Quotient Clinical will use Phase Forward’s Central Designer™ module to enhance eCRF design efficiency and improve workflow in the study development process for EDC trials.
“As an innovative provider of early drug development services, we want to ensure that our customers can take advantage of the benefits inherent in using EDC in Phase I trials, including access to high quality data within hours of collection, streamlined process efficiencies and rapid qualification of data,” said David Chalmers, Quotient’s vice president, Biometrics. “We selected InForm because of Phase Forward’s strong position in the marketplace and the company’s experience with Phase I trials.”
By supporting faster accessibility and greater visibility into trial data, the EDC implementation will help Quotient to expand its full-service, in-house Biometrics offering, according to the company. In addition, Quotient plans to offer customers on-line access to trial data, making it easier for them to track progress to date or to review summary reports.
“Quotient’s team is committed to continual expansion of its technical infrastructure to provide advanced services that help customers speed the development process,” said Steve Powell, senior vice president, Phase Forward. “The organization joins the growing number of CROs adopting our InForm product as part of a broader initiative to automate and streamline their Clinical Research Units.”
Posted on November 5, 2009 @ 06:31 am
Vetter (Booth 839) will open Vetter Development Service (VDS), a technologically advanced customer service facility located in Chicago, IL. The site will allow the company to provide greater commitment and support toward the product needs of its North American customers, according to a Vetter statement. Vetter will be capable of aseptically filling very small quantities of products in the new facility, providing faster and more streamlined product delivery and customer service. Headquartered in Ravensburg, Germany, Vetter sees the new facility as a significant investment in Vetter Pharma International GmbH. The 25,000-sq.-ft. facility will open end of 2009.
With its new location in the heart of the U.S., Vetter can now process and test small quantities of materials by bringing the development process closer to key customers, enabling greater cooperation at the earliest stages of development and minimizing the need to transport products, according to the company.
The site is intended to facilitate a shorter time to market for Vetter's North American customers. Peter Soelkner, managing director at Vetter, remarked, “The opening of this new cutting-edge VDS facility shows Vetter’s firm, strategic commitment to the North American market by bringing the state-of-the-art technology to the heart of the U.S.,” said Peter Soelkner. “The support VDS delivers throughout the entire product development cycle can now start earlier, and the proximity to our customers will contribute to streamlining the process and delivering the final product faster.”
Posted on November 5, 2009 @ 06:24 am
Toxikon Corporation (Booth 1161) has expanded the offerings in its immunotoxicology department. To meet increased demand for biologics research, Toxikon has added flow cyctometry to its service offerings, which enables the direct analysis of cells to detect a variety of specifically labeled components.
Christopher Brynczka, Ph.D., head of immunotoxicology, clinical and histology services at Toxikon, remarked, “This is an opportunity for Toxikon to promote the development of our sponsors’ drugs and medical devices,” said Dr. Brynczka. “If there are findings related to immune function in other preclinical studies, a more extensive evaluation of immunotoxicology is often necessary.”
Immunotoxicology study designs examine the physiological functioning of the immune system and the impact treatment with a test article may have in normal function. “The flow cytometer is so powerful that you can detect virtually any entity or event that occurs within a cell,” said Dr. Brynczka.
A study published last fall by the Journal of the American Medical Association stated that almost 25% of biologic drugs approved in the U.S. and Europe since 1995 have been at the forefront of at least one safety-related regulatory action in the decade since initial market approval, while 11% of the biologic therapies within that one-quarter percentile have been issued a black box warning, the study revealed.
While all newly developed drugs carry risks, said a Toxikon statement, biologics are in a special class because they are derived from biological sources, including antibodies, enzymes and hormones.
The new equipment is just one of several additions Toxikon has added to its immunotoxicology department, offering everything from quantitation of splenic B and T cells to a full battery of host resistance models.
Posted on November 5, 2009 @ 06:12 am
Norwich Pharmaceuticals (Booth 2639) has a newly built and commissioned pilot scale development facility. The new area's features state-of-the-art equipment, according to Norwich, and a company statement said the facility "offers greatly expanded contract outsourcing capabilities enabling them to work with customers earlier on in the development cycle, continuing right through scale up and commercial launch."
With the addition of compatible bench scale equipment, the facility has significantly increased its capabilities. The new equipment includes a four, eight, sixteen quart PK Blend Master with intensifier bar, an Aeromatic MP1 Fluid Bed Dryer, a Vector GMX-10 and GMX-25 Hi-Shear Mixer and a Vector FL-M-1 Flo-Coater. These new additions provide a working range of one to 25 Kgs.
Norwich also recently added new commercial large scale facility capabilities, including a Niro precision coater for the Niro MP5 commercial scale fluid bed to support customer product scale up from the development suite. This three-column coater has a volume range of 30 to 245 liters.
November 4, 2009
Posted on November 4, 2009 @ 09:16 am
Merck has completed its merger with
Schering-Plough Corp. and has outlined its new global strategy. The new Merck will operate as MSD outside the U.S. and Canada, and according to the company, is a global health care leader “aimed at providing innovative, distinctive products and services that save and improve lives, while satisfying customer needs and creating long-term shareholder value,” according to a statement from the new company.
Merck now has approximately 106,000 employees, and operations in more than 140 countries around the world. The company expects to generate more than 50% of its revenue outside the U.S.
Merck will now market more than 530 pharmaceutical, consumer and animal health products, employ approximately 1,800 people, and invest more than $121 million in R&D in Canada, as part of the company's expanded global presence. Merck operations in Canada include research, manufacturing, and sales.
"This is an exciting time for our company as we advance our position as a strong, global health care leader that will make a substantial difference to patients around the world," commented Carlos Dourado, president, Merck Canada. "Thanks to the talent and dedication of our scientists and employees, the company will offer an outstanding clinical development pipeline that will greatly increase our ability to deliver important new medicines to patients. We look forward to continuing to meet and exceed the needs of our customers and providing them with the high-quality products and service they have come to expect."
Posted on November 4, 2009 @ 09:15 am
Pramod Gupta, Ph.D. has been appointed vice president of quality and chief scientific officer,
Coldstream Laboratories, Inc. (CLI). In his new role, Dr. Gupta will focus on strengthening the company’s quality systems, R&D capabilities and overall project execution.
Dr. Gupta has more than 20 years of experience in the pharmaceutical and medical device industries. Most recently, he served as vice president of R&D at Bausch & Lomb with focus on the global development of drugs and devices. Previously, he held leadership positions at Baxter Healthcare Corp., TAP Pharmaceuticals and Abbott Laboratories. He has been involved with the development, approval and commercialization of more than 30 drug and medical products.
Joe Wyse, president and chief executive officer of CLI, said, “I am pleased to have recruited Dr. Gupta at this critical stage of Coldstream’s growth. His extensive industry experience and successful track record will be key to achieving our goal of becoming a leader in research, development and manufacture of clinical and commercial healthcare products.His record of excellence in R&D, technology transfer and regulatory interactions will greatly benefit our organization and our partners.”
Posted on November 4, 2009 @ 08:53 am
Emerson Resources, Inc. has formed a strategic partnership with Bio Research, a CRO specializing in agrichemical and related industries, to extend its business development capabilities. Robert Westbrook, chief executive officer of Bio Research, will spearhead Emerson's business development and sales efforts in an effort to establish a greater footprint in the pharmaceutical and biotech sectors.
Currently, Emerson serves global organizations including branded, generic and OTC pharmaceutical companies, virtual and emerging pharmaceutical research organizations, raw material suppliers, equipment manufacturers, and intellectual property attorneys.
"Our partnership with Bio Research will strengthen our position as the leader in value-added service, ingredients and expertise," said Adolfo Gomez, president of Emerson Resources. "Robert brings a strong combination of business development skills and diverse industry insight to Emerson and I am confident that he and his team will vastly expand our industry presence — particularly on the West Coast, an area that is ripe with opportunity."
Bio Research, based in Fresno, CA, and its subsidiary, Bio Research Services, represents select products and services related to clinical diagnostics, drug discovery, drug development, and agrichemicals.
As Emerson Resources' new business development executive, Mr. Westbrook will focus on creating new sales channels and building client and industry relationships in support of the Emerson's strategic growth objectives.
November 3, 2009
Posted on November 3, 2009 @ 09:53 am
Johnson & Johnson has announced plans for a global restructuring designed to “prioritize its innovation efforts,” according to a company statement. The plans are expected to increase operational efficiency and generate annual savings of $1.4-$1.7 billion, when fully implemented in 2011, with $800-$900 million expected in 2010. The savings will be allocated to new growth platforms; new product launches; core businesses; as well as provide more flexibility to adapt to the changing market. Along the way, the company will lay off 6-7% of its headcount, which equates to 7,000-8,000 people. The expected restructuring charge will be $1.1-$1.3 billion in 4Q09.
"Johnson & Johnson has long adhered to a broad-based operating model and set of sound management principles that have driven our success," said William C. Weldon, Johnson & Johnson chairman and chief executive officer. "Today, we are announcing a series of actions and plans designed to ensure that our company remains well-positioned and appropriately structured for sustainable, long-term growth in the health care industry."
The company plans to cut layers of management, increase individual spans of control, and simplify business structures and processes across the company's global operations. Mr. Weldon said, “These types of changes are difficult under any circumstances, and will have a very personal impact on people who have been dedicated to the mission of Johnson & Johnson. We recognize their contributions to the achievements of our business, and are committed to treating them fairly and with respect throughout this process.”
Posted on November 3, 2009 @ 09:51 am
Enzon 3Q09
3Q Revenues: $44.6 million (-9%)
3Q Earnings: $0.1 million (loss of $2.0 million in 3Q08)
Comments: Product sales in the quarter were down 1% to $28.6 million.
Contract manufacturing revenue was $2.3 million (-57%), primarily due to cancelled shipments and early discontinuation of processing for a CMO customer scheduled for termination in early 2010. Royalty revenue, for which Pegintron accounts for the majority, was $13.7 million (-6%).
Posted on November 3, 2009 @ 09:49 am
West 3Q09
3Q Revenues: $258.9 million (-1%)
3Q Earnings: $17.2 million (+27%)
YTD Revenues: $762.3 million (-5%)
YTD Earnings: $52.3 million (-24%)
Comments: Pharmaceutical Systems segment sales for the third quarter of were $198.1 million (+4%). Unfavorable foreign exchange accounted for 4%. H1N1 flu vaccination-related sales were $9.7 million in the quarter. Tech Group sales were $62.9 million (-8%).
The company also announced operational restructuring plans for its Tech Group and Pharmaceutical Systems segments. The Tech Group will consolidate manufacturing operations and support functions to better align capacity to contract manufacturing activity. Approximately 65 positions will be eliminated, which is expected to cost between $2 - $3 million. The company expects to generate annual operating cost savings of approximately $2 million in 2010 and $4 million once the restructuring is complete.
Under the Pharmaceutical Systems restructuring, the company will exit certain specialized lab service offerings; retire information technology applications and associated support; and abandon plans to expand its U.S. metals facility. Approximately 35 positions are being eliminated. The costs is expected to be $6 - $7 million, with cost savings in the range of $4.0 million annually.
Posted on November 3, 2009 @ 09:48 am
Kenneth A. Berlin has been appointed president and chief executive officer,
Rosetta Genomics, Ltd., and has been recommended to serve on the company’s board of directors.
Mr. Berlinpreviously served as worldwide general manager at Veridex, LLC, a Johnson & Johnson company. Under his leadership the organization grew to more than 100 employees, and he spearheaded the launch of three cancer diagnostic products. Mr. Berlin joined J&J in 1994 and served as corporate counsel for six years. He led and participated on the legal team that oversaw several mergers, acquisitions, divestitures and commercial transactions. He then held positions of increasing responsibility within J&J and a number of its subsidiary companies.
“Ken is a proven business leader whose background, accomplishments and commercialization experience in the novel diagnostics space are particularly well-suited for Rosetta Genomics at this time,” said Yoav Chelouche, chairman of the board of directors. “We have commercialized three microRNA diagnostic tests and have licensed or formed distribution agreements with six separate parties on five continents for these tests. As we further develop the markets for our paraffin-based microRNA diagnostic tests and pursue avenues to leverage our platform technology, we expect that Rosetta will benefit from Ken’s strong leadership, negotiating and alliance management skills as well as his portfolio management experience.”
November 2, 2009
Posted on November 2, 2009 @ 09:12 am
Amylin Pharmaceuticals and
Takeda Pharmaceutical have entered into a worldwide exclusive license, development and commercialization agreement to co-develop and commercialize compounds for the treatment of obesity and related indications.
The agreement includes Amylin's pramlintide/metreleptin and davalintide, which are currently in Phase II development for treatment of obesity. The agreement also includes additional compounds from both companies' obesity research programs. Amylin will receive a one-time up-front payment of $75 million and is eligible to receive additional payments based on certain development, commercialization and sales milestones that could exceed $1 billion. The agreement also provides for future royalty payments to Amylin based on global product sales.
Amylin will be responsible for development activities through Phase II with the aim of regulatory approval in the U.S. Takeda will then take over further development in the U.S., and all development activities outside the U.S. Amylin will be responsible for 20% of development costs and Takeda will be responsible for 80%. Takeda will cover all development costs associated with obtaining approval for products outside the U.S. Takeda will be responsible for all product commercialization and costs. Amylin will have the option to co-commercialize the first two approved products in the U.S. and any follow-on products containing the identical active ingredients.
"Takeda is excited to realize this partnership with Amylin focused on the treatment of obesity and related indications. By leveraging Takeda's global development and commercial infrastructure we look forward to maximizing the significant potential of the products under this agreement," said Yasuchika Hasegawa, president and chief executive officer, Takeda. "Both Amylin and Takeda have extensive experience in the diabetes and metabolic disease area, and this collaboration should allow us to more quickly bring promising new treatments to patients in need."
"This collaboration will leverage Amylin's experience and expertise with peptide and protein science and Takeda's worldwide development and commercial expertise," said Daniel M. Bradbury, president and chief executive officer, Amylin Pharmaceuticals. "Amylin recognizes the enormous potential of this collaboration to advance more options in obesity treatment more quickly than either company could do alone. Amylin and Takeda are excited about working together to address the significant unmet need for the millions of patients who need better solutions to manage obesity."
Posted on November 2, 2009 @ 09:10 am
ICON has signed an extension to its strategic agreement with
Lilly to manage the company’s clinical data outside the U.S. ICON will now also oversee Lilly’s needs in Japan in addition to those in Europe, Canada, Latin America, Australia and Asia.
“Today’s announcement is a continuation of a very successful partnership between ICON and Lilly,” commented Peter Gray, chief executive officer at ICON. “Through our existing data management partnership, we have brought significant process efficiencies to Lilly in helping them progress their drug development pipeline. That Lilly has chosen ICON to manage this important business function in such a key region as Japan is a measure of our global data management expertise and our local capabilities in the region.”
"With this transaction, Lilly Data Sciences and Solutions realizes its objective to leverage external, scalable clinical data management capabilities around the globe,” said Jeff Kasher, Lilly’s vice president and chief operating officer of Global Clinical Development. “We’re pleased to extend our relationship with ICON to include Japan, and their proven ability to reliably deliver work within differing cultural climates provided Lilly the opportunity to take another significant step in our ongoing agenda to increase flexibility, reduce fixed cost, and focus internal resources on core capabilities.”
Posted on November 2, 2009 @ 09:06 am
Penn Pharma has completed the first phase of its $19.7 million expansion program with a $.5 million investment extending its facilities by 2,400m
2 and changing the transport and delivery infrastructure at its Tredegar headquarters.
Darren Hassey, chief operating officer at Penn Pharma, said, “The recent developments to the site only add to our established offerings. By altering the externals of the site and moving the delivery and collection points we have in turn altered the internal factory processes, ensuring the smooth flow of people, process and materials.”
Peter George, chief executive officer of Penn Pharma, said, “By heavily investing in our Tredegar site it strengthens our commitment to the local community and as a leading Welsh company we will endeavor to pay back the Assembly Government’s faith in us by driving sustainable growth and employment.”
Additional phases of the expansion will take place during the next five years.
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