March 30, 2007
Posted on March 30, 2007 @ 09:20 am
GlaxoSmithKline has submitted a BLA to the FDA for Cervarix (human papillomavirus vaccine, AS04 adjuvant-adsorbed), its cervical cancer vaccine. If licensed, the vaccine will be indicated for the prevention of cervical cancer and precancerous lesions associated with the most common cancer-causing human papillomavirus types. The proprietary adjuvant system called AS04 is intended to enhance immune response and increase duration of protection.
The BLA includes data from clinical trials that included almost 30,000 females 10 to 55 years of age and reflects an ethnically diverse population. The submission also contains data from the largest Phase III cervical cancer vaccine efficacy trial to date, which was conducted around the world in more than 18,000 females 15 to 25 years of age.
Posted on March 30, 2007 @ 09:18 am
Astellas Pharma, Inc. and
Regeneron Pharmaceuticals, Inc. have entered into a non-exclusive license agreement that will allow Astellas to use Regeneron's VelocImmune technology in its internal research programs to discover human monoclonal antibody product candidates.
Astellas will pay $20 million upfront and will make as many as five additional annual payments of $20 million. Astellas will also pay royalties on product sales derived from any antibody products discovered using VelocImmune.
"VelocImmune is the centerpiece of Regeneron's suite of technologies for the discovery and development of fully human monoclonal antibodies," said George D. Yancopoulos, M.D., Ph.D., president of Regeneron Research Laboratories and Regeneron's chief scientific officer. "We are pleased that Astellas, a company with a clear strategic commitment to developing therapeutic antibodies, has selected the VelocImmune platform for its internal development programs."
"We are excited about this license agreement with Regeneron," said Toshinari Tamura, Ph.D., Astellas' executive vice president and chief scientific officer. "As described in our recently announced medium term plan, Astellas is building a new technological platform for the development of antibody drugs, and VelocImmune will become an important cornerstone for our R&D capabilities."
Posted on March 30, 2007 @ 09:15 am
Michael E. Steadman has been appointed group president and chief operating officer of
DFB Branded Pharmaceuticals, a new segment of Fort Worth-based DFB Pharmaceuticals, Inc., which is made up of four divisions: Healthpoint, Ltd., Tissue Management, Coria Laboratories, Ltd., Healthpoint International, and Healthpoint Surgical. Mr. Steadman will manage all operations of the enterprise.
DFB Branded Pharmaceuticals is one of three DFB business segments. The other two are DFB Pharmaceutical Services, represented by DPT Laboratories, Ltd. (San Antonio, Texas, and Lakewood, NJ) and DFB Biotechnology, represented by Phyton Biotech, Inc. (Princeton, NJ, and Ahrensburg, Germany).
"Michael has been an indispensable member of the DFB leadership team since Healthpoint's inaugural year," said Mr. Dorman. "He has taken ownership of our company's destiny and guides us along our path to success. He will no doubt replicate his exemplary leadership for Branded Pharmaceuticals during this next stage of our growth."
Mr. Steadman has been with DFB for 15 years and was most recently president of Healthpoint Tissue Management. He joined the original Healthpoint, Ltd. in 1992 as director of sales during the company's first year of business, establishing the field sales organization for Healthpoint's first branded business, Tissue Management.
Mr. Steadman will work directly with Rob Bancroft, general manager of Healthpoint, and other division leaders for DFB Branded Pharmaceuticals: Steve Clark, president of Coria and Jay Nisbet, senior director of International, as well as DFB Branded Pharmaceutical leaders Duncan Aust, Ph.D., senior vice president, R&D; Mike Bernstein, MPH, vice president, regulatory affairs; Herbert Slade, M.D., chief medical officer; Mike Carmena, senior director, finance and administration; Gerry Keith, deputy general counsel; and Mary Beth Dudley, senior director, human resources.
Mr. Steadman will continue to serve as chairman of the board, DFB Biotech of Curacao N.V. and senior vice president, DFB Pharmaceuticals.
Posted on March 30, 2007 @ 09:13 am
Metrics, Inc. has been recognized as a “Business Champion” by
Business Leader magazine and Wake Technical Community College for its workplace development programs. Business Champions is an annual awards program that honors organizations that offer comprehensive workplace education and development efforts to employees. Phil Hodges, president of Metrics, accepted the award at a luncheon on Tuesday. Metrics provides quality formulation, clinical trial manufacturing and analytical development/validation services to the pharmaceutical industry.
Jeff Basham, vice president of marketing and sales, said, "Metrics’ workplace development programs encourage employees to think creatively. Innovation and excellence thrive at Metrics."
He added, “Our staff has a patent pending for a controlled release technology, and another pending for unique formulations for diabetic patients. These intellectual properties emerged when employees creatively sought solutions to our clients’ problems.”
The company’s GMP standards were used by Metrics and East Carolina University to develop a curriculum on the subject for the University's chemistry department. Mr. Basham cited several factors that make Metrics stand out in workplace development. On average, new Metrics employees spend their first three months immersed in training. Other employees spend about 12 days in training annually, representing a company investment of 80% of its wages budget. “Here at Metrics, there’s a palpable sense of teamwork, camaraderie and commitment to doing the highest quality work,” Mr. Basham said.
March 29, 2007
Posted on March 29, 2007 @ 09:14 am
Laureate Pharma has officially opened its newly constructed Pilot Plant in Princeton, NJ for pre-clinical biopharmaceutical manufacturing. The plant is now available for early engineering runs and product production for uses such as formulation and toxicological testing.
The plant is designed for process development, production and purification of early-phase preclinical proteins. The facility features two separate production suites and two expanded purification suites to support preclinical production of recombinant proteins from mammalian-cell culture. The plant includes stainless steel, stirred-tank bioreactors and disposable, single-use bioreactors. The purification suites feature the same process chromatography and filtration technologies used in Laureate's larger scale cGMP facility.
"The equipment in our pilot plant facility is designed to facilitate a direct, seamless scale-up from development to cGMP production for our clients' projects," said Robert Broeze, Ph.D., Laureate's president and chief executive officer. "With the new pilot plant in operation, we can accelerate our manufacturing of preclinical material and save on several months' worth of critical product development time."
Posted on March 29, 2007 @ 09:12 am
Riccardo Trecroce has been appointed chief executive officer of
Patheon, Inc. Mr. Trecroce was initially appointed to this position on an interim basis in September 2006.
"Since joining Patheon in 2000, Mr. Trecroce has played a key role in the development and execution of Patheon's business strategy," said Peter Green, chairman of Patheon. "Riccardo's in-depth knowledge of the company, strong client focus and vision are qualities that will serve Patheon well as we move forward to advance Patheon's positioning as a global leader in our sector."
Also, Patheon has entered into an agreement with J.P. Morgan Securities Inc. and GE Commercial Finance for new credit facilities to refinance its North American and UK debt. The refinancing is based on the completion of the $150 million convertible preferred share investment by JLL Partners Fund V, L.P., which is expected to close, together with the JLL Partners investment, by April 30th.
The new credit facilities total $225 million, comprising a seven-year $150 million term loan facility and a five-year $75 million revolving facility. The proceeds of the term facility, together with the proceeds of the JLL Partners investment, will be used to repay the company's obligations under its existing North American and U.K. credit facilities.
"Today's agreement with JPMorgan and GE Commercial Finance marks the next major milestone in our capital restructuring process," said John Bell, chief financial officer, Patheon. "With the investment by JLL Partners and the new long-term debt facilities, we will have the appropriate long-term financial structure in place to operate and grow our business effectively."
"The JLL investment and bank refinancing are important to the future of Patheon and represent the culmination of an extensive strategic and financial alternatives review process undertaken over the past six months," said Mr. Trecroce.
The Toronto Stock Exchange has granted approval for the issuance of the convertible preferred shares to JLL Partners. However, the TSX requires Patheon's common shareholders have the right to elect six of the nine members of Patheon's board of directors, but will not be entitled to vote to elect the three directors who will be JLL Partners' representatives under the terms of the agreement.
Posted on March 29, 2007 @ 09:10 am
Hollis-Eden Pharmaceuticals, Inc. filed an IND application with FDA to begin a Phase I trial with its next-generation drug candidate, HE3286, for the treatment of metabolic disorders, which include diabetes, obesity and dyslipidemia. The trial program, designed to assess the safety of HE3286 in healthy volunteers, could support both a Phase II study in type 2 diabetes, and a Phase II study in rheumatoid arthritis under a separate IND the company plans to file for autoimmune disorders later this year.
In preclinical studies, HE3286 has been shown to regulate signaling pathways of inflammation common to both metabolic and autoimmune disorders. In preclinical models of type 2 diabetes, HE3286 produced glucose lowering activity and increased insulin sensitivity when administered orally. These findings suggest that HE3286 may be the first in a new class of insulin sensitizers with a novel mechanism of action, since it appears to regulate the pro-inflammatory NF-kappa B pathway without acting on the PPARgamma receptor, which is the target of insulin sensitizing drugs currently prescribed today. This new pathway appears to avoid the side effect of weight gain commonly seen with these existing therapies.
HE3286 has also demonstrated a benefit in rodent models of both initial-onset and established rheumatoid arthritis. Potential mechanisms of action for HE3286 in this indication include regulation of NF-kappa B and increasing the production of regulatory T cells, or Treg cells, which play a key role in keeping the immune system from attacking the body.
March 28, 2007
Posted on March 28, 2007 @ 08:54 am
Astellas Pharma, Inc. has entered into a license agreement with
MorphoSys AG for the use of its HuCAL technology. Under the terms of the agreement, Astellas will have access to the HuCAL GOLD antibody library for use in its internal drug discovery programs. MorphoSys will receive an upfront payment and annual user fees for the duration of the agreement.
During the term of the agreement, Astellas will have access to the HuCAL GOLD library at its research site in Tsukuba, Japan and has the option to start antibody projects during the span of the agreement. Also, MorphoSys may use its HuCAL GOLD antibody library to generate novel HuCAL antibodies against targets provided by Astellas. Astellas will then be responsible for preclinical and clinical development of these compounds, as well as the marketing of resulting products. MorphoSys stands to receive research funding, plus licensing and milestone payments, as well as royalties on end-product sales. The agreement may extend as long as five years.
"Today's deal adds another representative of Japan's leading pharmaceutical companies to MorphoSys's roster of partners and increases at the same time our market share among the 20 largest drug makers worldwide,'' commented Dr. Simon Moroney, chief executive officer of MorphoSys. "This new therapeutic partnership with Astellas once again shows the potential for innovative technology such as our HuCAL GOLD antibody library in Japan -- a market we set out to explore just some 24 months ago.''
Posted on March 28, 2007 @ 08:52 am
PPD, Inc. has opened offices in Athens, Greece, and Seattle, WA, in an effort to expand its global footprint for clinical development services. Both offices serve as hubs for previously regional-based employees in providing development services for Phase II-IV studies in key therapeutic areas. The office in Athens focuses on patient recruitment, clinical monitoring and regulatory support and the Seattle office houses clinical monitoring and project management teams.
"The new offices enable us to address the organic growth of our business driven by client needs for Phase II-IV services as well as enhance support for our employees located in these areas," said Fred Eshelman, chief executive officer of PPD. "We plan continued investment in infrastructure, systems and people to align with the global research needs of our clients."
Posted on March 28, 2007 @ 08:49 am
Perrigo Company has restructured in an effort to enhance the management of the company's global operations.
John Hendrickson has been named executive vice president of global operations and supply chain. Mr. Hendrickson will be responsible for the global manufacturing and supply chain functions for all of Perrigo's finished dosage consumer healthcare and Rx products. He will oversee operations in the U.S., UK, and Mexico as well as Perrigo New York and Perrigo Israel. Most recently, he managed the company's consumer healthcare business.
Joe Papa, Perrigo's president and chief executive officer, stated, "John brings more than 20 years of industry experience to his new position. He will establish our manufacturing strategic direction, determine capital allocation and maximize the effectiveness of our entire supply chain. I believe the company is extremely fortunate to have a leader of John's caliber to spearhead this integration effort."
Also,
Sharon Kochan has been promoted to executive vice president of U.S. Generics. Mr. Kochan will be responsible for expanding the generic business in the U.S. market and coordinating the business development activities of our global generic business. He has served in a number of strategic leadership roles since joining Perrigo Israel in 1994, including three years in operational management positions at Perrigo New York. Most recently, he served as senior vice president of global generic/API strategy and business development.
Mr. Kochan is replacing
Adam Levitt who is leaving the company to pursue other interests. Mr. Papa commented, "Following the acquisition of Perrigo Israel in 2005, Adam led the development of our generic drug sales in the U.S., provided guidance to our global R&D functions, and, as a member of the executive committee, helped coordinate the integration of our two major businesses. I appreciate his contribution during the past two years and wish him the best in his future endeavors."
March 27, 2007
Posted on March 27, 2007 @ 09:40 am
Microtest has signed an agreement with UK-based biopharmaceutical company
Antisoma to begin the aseptic manufacturing of AS1411, a new drug being developed for the treatment of various cancers. Under the terms of the agreement, Microtest will be responsible for the formulation and aseptic fill/finish of AS1411 material for upcoming Phase II trials. Microtest will also be responsible for stability testing of the AS1411 product.
“AS1411 is the first aptamer to be tested in cancer clinical trials. After successfully completing Phase I trials, we are now advancing to Phase II trials in renal cancer and AML. We are pleased to be supported in this work by expert specialist collaborators such as Microtest.” said Glyn Edwards, Antisoma’s chief executive officer.
“This agreement provides a strategic opportunity for us at Microtest to form a strong working partnership with an important category leader like Antisoma,” said Steve Richter, Microtest’s president. “Our flexibility, skills, and manufacturing expertise seamlessly compliment Antisoma’s scientific strength and clinical trial plans.”
Posted on March 27, 2007 @ 09:38 am
Barrier Therapeutics achieved positive results from its Phase IIb dose ranging study for its antifungal candidate pramiconazole (previously known as Azoline). Pramiconazole met the primary endpoint of effectively treating tinea (pityriasis) versicolor, a common skin fungal infection characterized by a discolored, scaly, itchy rash primarily on the back, chest and upper arms. Also, the secondary endpoints of complete cure, mycological cure and investigators' global assessment achieved statistical significance.
The randomized, double-blind, placebo-controlled study enrolled 147 patients in six treatment groups. Results showed a positive linear dose response for the primary endpoint "effectively treated" at day 28, which was defined as significant reduction in disease signs and symptoms, including redness, scaling and itching, and complete mycological cure. Response rates for the primary endpoint ranged from 35% for the lowest dose to 85% for the highest dose as compared to 16% for placebo. The drug was well tolerated across all treatment arms and no serious adverse events were reported.
Posted on March 27, 2007 @ 09:35 am
AppTec and
Boehringer Ingelheim's first year of partnering is providing enhanced capabilities and a smooth transition to large-scale manufacturing for clients, according to the companies. Last spring, AppTec announced that Boehringer Ingelheim had become a preferred partner for its commercial cell culture production, including supply of Phase III material and CMC submission to meet specific customer needs. Through this collaboration, AppTec has non-exclusive access to Boehringer’s comprehensive manufacturing technology platform for cell culture products, including its state-of-the-art mammalian high expression system (BI HEX).
For AppTec, the collaboration has resulted in the ability to provide customers with a seamless path to large-scale manufacturing capabilities, according to the company.
“AppTec has been very pleased to be able to include this high-value option in our service offerings for mammalian-cell-based biologics," said Bonnie Baskin, Ph.D., chief executive officer of AppTec. “It further strengthens our ability to provide customers with one-stop solutions that can minimize the time required to move from preclinical to commercial supply of their products.”
“As shown over the past year, AppTec has proved to be an excellent partner for Boehringer Ingelheim, broadening our presence in the U.S. and providing our IP to even more new customers for their time-to-market product development,” commented Prof. Dr. h.c. Rolf G. Werner, senior vice president of the corporate division biopharmaceuticals at Boehringer Ingelheim GmbH.
March 26, 2007
Posted on March 26, 2007 @ 09:21 am
Comar, Inc. has plans to sell its glass manufacturing operation, with the exception of its glass pipette manufacturing business, to
Gerresheimer's Kimble Glass, Inc. Terms of the agreement were not disclosed. The closing of the transaction is expected by end of this month.
The transaction includes real estate, manufacturing equipment, plant operations and management personnel. Comar's glass pipette manufacturing equipment and associated operating personnel will be relocated to the company's plastic operations in Buena, NJ. The full transition of the glass operation to Kimble is expected to take place within six months.
Henry Tamagni, Jr., president and chief executive officer of Comar, commented, "We appreciate all of the wonderful relationships we have developed over the years in the glass industry and, the loyalty and devotion of our workforce. We are confident that Kimble will maintain the same attention to quality and responsiveness that has been a Comar trademark, and that the same talented and professional workforce will continue to serve its customers as they have for so many years."
According to Mike Ruggieri, Comar's general manager, "The sale of the glass division is the first step of a multi-year strategy to refocus Comar's resources on dramatic growth in the pharmaceutical and health care plastics packaging industry. We intend to expand our presence through the addition of new and innovative plastics solutions while maintaining our leading market share in glass and plastic dropper assemblies."
Posted on March 26, 2007 @ 09:19 am
DSM Biologics and
Crucell N.V. have signed a non-exclusive PER.C6 research licensing deal with Taipei, Taiwan-headquartered Development Center for Biotechnology (DCB). DCB will use the human cell line for its in-house production of undisclosed recombinant proteins. This PER.C6 license is Crucell's second license in Taiwan for recombinant protein production. The PER.C6 technology platform has been developed for the large-scale manufacture of biopharmaceutical products including vaccines.
Posted on March 26, 2007 @ 09:16 am
Merck has entered an agreement to begin development of a Zetia and Lipitor combination product in collaboration with
Schering-Plough. The Merck/SP Pharmaceuticals joint venture was formed in 2000 to develop and market new medicines in the U.S. in cholesterol management and respiratory disease. The cholesterol collaboration was expanded in 2001 and includes worldwide markets (excluding Japan). The joint venture/partnership also markets Zetia and Vytorin in the U.S. (and marketed as Ezetrol and Inegy, respectively, in countries outside the U.S.)
"Everyone at Merck is delighted that we have entered into this agreement with Schering-Plough," said Richard T. Clark, president and chief executive officer of Merck. "This agreement exemplifies Merck's 'Plan to Win' by expanding our lead in cutting-edge science through investments in our own internal research as well as through external collaborations and is a logical next step for our very strong and successful partnership with Schering-Plough."
The development program is designed so that a combination product could be available when the patent for Lipitor expires in 2010.
Posted on March 26, 2007 @ 09:02 am
The European Commission has approved
Merck's Januvia, a once-daily oral treatment for patients with type 2 diabetes. Januvia is the first medication in a new class of drugs known as dipeptidyl peptidase-4 inhibitors (DPP-4 inhibitors), which enhance the body's own ability to lower blood sugar, to be adopted by the European Commission.
Januvia is indicated in patients with type 2 diabetes to improve glycemic control in combination with metformin when diet and exercise plus metformin do not provide adequate glycemic control. For patients with type 2 diabetes when the use of a PPAR-gamma agonist (i.e. a thiazolidinedione) is appropriate, Januvia is indicated in combination with the PPAR-gamma agonist when diet and exercise plus the PPAR-gamma agonist alone do not provide adequate glycemic control.
Januvia will be launched shortly in the EU countries. Januvia is now approved for use in 42 countries around the world including Mexico, the U.S., and the Philippines.
March 23, 2007
Posted on March 23, 2007 @ 09:19 am
Charles River Laboratories International, Inc. has plans to expand its global footprint in Asia as part of its strategy to support customers' R&D efforts in this growing market. The first phase of expansion includes the signing of a joint venture agreement with Shanghai BioExplorer Co., Ltd., a Shanghai, China-based provider of preclinical services, to form Charles River Laboratories Preclinical Services – China. The joint venture will be majority owned and controlled by Charles River. The transaction is subject to customary closing conditions, including Chinese regulatory approval, and is expected to close by the end of 2Q2007.
As part of this agreement, Charles River will construct a 50,000-sq.-ft. preclinical services facility in Shanghai. The facility, which is expected to open in mid-2008, will provide discovery and development services, including GLP and non-GLP toxicology studies, in accordance with FDA and the company's quality standards, as well as stringent animal welfare policies.
James C. Foster, chairman, president, and chief executive officer of Charles River, commented, "Charles River Laboratories intends to be the leading global contract research organization to provide preclinical services in China that are compliant with international regulatory agencies. This exciting project is the next step in a strategy that demonstrates our continued commitment to invest in the growth of our business and to support our global customer base. We expect demand for both research models and preclinical services in Asia to significantly increase over the next several years as pharmaceutical and biotechnology companies expand their research efforts in this market, and we intend to play a leading role in this emerging opportunity."
Posted on March 23, 2007 @ 09:17 am
Analytical Bio-Chemistry Laboratories (ABC) broke ground for its new lab facility in MO. The $14.4 million, 90,000 sq.-ft. facility will house the company's growing pharmaceutical development business and will more than double its capacity. Last May, the company and the University of Missouri announced that ABC would become the first tenant of the university's new Discovery Ridge Research Park.
"This building is designed to be a model of efficiency," said Byron E. Hill, ABC's president and chief executive officer. "It will be modular and scalable, which will enable us to grow quickly without disrupting business, and to adapt to our customers' needs. The expansion will also provide a more attractive work environment for our scientists and support staff," said Mr. Hill.
Posted on March 23, 2007 @ 09:14 am
C. Richard Piazza has been appointed chief executive officer of
Chemokine Therapeutics Corp. Mr. Piazza succeeds
Dr. Hassan Salari who held the position since he founded the company in 1998. Dr. Salari will continue to serve as president and his role will be expanded to include the additional responsibilities as the chief scientific officer. These changes will allow Dr. Salari to focus on the company's product development while Mr. Piazza will use his financial and biotechnology industry experience to drive corporate initiatives.
Mr. Piazza has been a member of the board of directors for since June 2001 and is currently the chairman of the board. Mr. Piazza has more than 35 years of experience managing both public and VC-backed healthcare companies. He is currently managing director of Healthios, a healthcare merchant banking firm. He has served in numerous chief executive positions including MAXIA Pharmaceuticals, VitaGen Inc., Marquest, Smith & Nephew SoloPak, Stimetics and Biolectron.
March 22, 2007
Posted on March 22, 2007 @ 09:19 am
Eisai Co., Ltd., Eisai Corp. of North America (ECA), has signed a definitive agreement to acquire Morphotek, Inc. for $325 million in cash.
Morphotek develops therapeutic monoclonal antibodies through the use of proprietary human antibody technologies, including Human Morphodoma and Libradoma. The company is using these technologies to enrich its pipeline that includes therapeutic antibody leads for the treatment of cancer, rheumatoid arthritis, and infectious disease. Two of its programs are currently in early stage trials for the treatment of ovarian cancer and pancreatic cancer, respectively, with several others in preclinical development.
Eisai currently has an extensive global oncology research program for discovering small molecule anti-cancer agents, and upon completion of the acquisition, will expand its capabilities into the biologic therapeutics field.
Eisai president Haruo Naito, said, "I sincerely respect Dr. Nicolaides' innovative and courageous endeavor in developing human monoclonal antibody therapeutics. He has made a tremendous contribution to that effort. By combining Morphotek's proprietary technologies and promising therapeutic antibodies with Eisai's existing research programs and infrastructure, we will be able to meet our goal of addressing the unmet medical needs of patients, especially cancer patients, all around the world. Morphotek's rich pipeline, unique and proprietary antibody generation technology platform, and highly skilled management and scientific team will become the core of our R&D efforts in biologics."
Nicholas Nicolaides, chief executive officer of Morphotek, said, "Eisai's substantial intellectual and managerial resources will enable us to accelerate the development of our current therapeutic antibody pipeline as well as develop a number of additional clinical compounds to targets accessed from our broad network of research collaborations and to those discovered by Eisai researchers globally."
Once the transaction is complete, Morphotek will become part of Eisai's global discovery and development research network, which is comprised of research labs in Japan, Europe and the U.S. The addition of Morphotek further extends Eisai's research presence in the U.S., which includes the Eisai Research Institute of Boston, Inc., a discovery operation based in Andover, MA, Eisai Medical Research Inc., for clinical development, located in Ridgefield Park, NJ, and RTP lab for formulation research in NC.
The acquisition, which is subject to clearance under the Hart-Scott-Rodino Antitrust Improvements Act and other customary closing conditions, is expected to close during Eisai's 1Q2007.
Posted on March 22, 2007 @ 09:09 am
Vion Pharmaceuticals has extended its agreement with
SAFC Pharma for the manufacture of the API in Cloretazine, an anti-cancer drug currently in a Phase III trial in combination with Ara-C for relapsed acute myelogenous leukemia (AML), and a Phase II trial for elderly de novo poor-risk AML. The agreement extends the original 2003 supply agreement to 2009. Production for the API will continue to be provided by SAFC Pharma's high-potency manufacturing facility in Madison, WI.
SAFC president Frank Wicks commented, "Vion Pharmaceuticals' decision to extend its involvement with SAFC Pharma for Cloretazine API is a tribute to the consistency of high performance manufacturing at our Madison facility. The continuation of this appointment highlights our strengths as a premiere provider of process development and the production of complex, multi-step synthesis for highly potent and cytotoxic APIs."
Posted on March 22, 2007 @ 09:04 am
The Dow Chemical Co. has entered a strategic alliance with
Colorcon, Inc. for the global marketing, sales, technical service and development, and distribution of Dow's excipient products for use in controlled release applications. The agreement applies to select Methocel hypromellose polymers, Ethocel ethylcellulose polymers and Polyox poly(ethylene) oxide resins. Distribution of these polymers for controlled release applications will be transitioned to Colorcon from Dow's existing distributor network.
This alliance combines Dow's excipient technology with Colorcon's drug dosage formulation expertise. Controlled release excipients provide the benefits of consistent drug release over time. The goal of the collaboration is to bring more technologically advanced excipients to more drug manufacturers worldwide.
"The alliance between Dow and Colorcon is a natural outcome of a 28-year-old cooperation between the two companies and our answer to the global pharmaceutical industry's demand for faster development and more efficient production of drug ingredients," says Philip Pilnik, commercial director for Dow Pharmaceutical Excipients.
Jim Coward, vice president and general manager for Colorcon Modified Release Technologies said, "We see this global alliance as a natural progression for both companies in providing increased value to the pharmaceutical formulator. Our goal is to provide a full range of products, tools and services for modified release application in tablet, multi-particulate and osmotic formulations. By expanding our relationship with Dow we expect to accelerate our new product development efforts, as well as improve existing solutions for controlled release."
March 21, 2007
Posted on March 21, 2007 @ 09:18 am
Emergent BioSolutions, Inc. has submitted an IND application with the FDA for its Anthrax Immune Globulin (AIG) product candidate. AIG is a therapeutic treatment for patients with symptoms of anthrax disease resulting from the release of anthrax toxins into the body. Pending the FDA's 30-day review period, the company expects to begin a clinical trial this year to evaluate the safety and pharmacokinetics of AIG in more than 100 healthy volunteers.
"The filing of this IND for our AIG product candidate is a significant step as we continue to expand our anthrax biodefense product franchise, which includes BioThrax (Anthrax Vaccine Adsorbed), the only FDA-licensed vaccine against anthrax infection, as well as development programs focused on improvements to BioThrax and an enhanced anthrax vaccine," stated Fuad El-Hibri, chairman and chief executive officer of Emergent BioSolutions. "Our AIG product, which we are developing in part with grant funding from the NIAID, is an important element of our efforts to develop safe and effective medical countermeasures to help protect the nation against biological attack."
Once initiated, the company anticipates that the trial for AIG will be completed within a year and that no additional trials will be required prior to submitting for marketing approval.
Posted on March 21, 2007 @ 08:50 am
A federal court in the District of New Jersey (Newark) has upheld
Pfizer's three main U.S. patents covering Celebrex, a selective non-steroidal anti-inflammatory (NSAID) medicine used to treat pain and inflammation. Generic manufacturer Teva Pharmaceuticals USA had challenged the patents.
Judge John C. Lifland ruled that the patents covering the active ingredient, pharmaceutical composition, and method of use for Celebrex are valid, enforceable and infringed by the generic manufacturer's product. The decision, which may be appealed, prohibits Teva from launching a competitor drug in the U.S. until December 2015.
Posted on March 21, 2007 @ 08:46 am
Dr. Matthias Grossmann, M.D., Ph.D. and
Dr. James Wong, Ph.D. have joined
Parexel International Corp.'s clinical pharmacology network. Dr. Grossmann and Dr. Wong have both been appointed to the position of vice president, clinical pharmacology consulting services. They will provide consultation to clients sponsoring early phase clinical trials across a broad range of therapeutic areas.
"With more innovation across the bio/pharmaceutical industry driving new compounds into clinical research, clients are increasingly turning to us for a combination of deep scientific knowledge and drug development experience," said Dr. Herman Scholtz, M.D., corporate vice president and worldwide head, clinical pharmacology, Parexel. "The wealth of therapeutic and clinical pharmacology expertise that Dr. Grossmann and Dr. Wong bring will further strengthen Parexel's support of clients in their early phase clinical development programs."
Dr. Grossmann is a clinical pharmacologist with extensive experience in early drug development research, particularly in cardiopulmonary physiology and pharmacology. Prior to joining the company, he was managing director and head of medical affairs at a clinical pharmacology research group based in Mannheim, Germany. Previously, he held clinical pharmacology research positions at Charite Hospital in Berlin, Germany, the University of Texas Health Science Center at San Antonio, and the Stanford University School of Medicine in California.
Dr. Wong joins the company from The Medicines Co. where he was director of clinical pharmacology leading global teams in early drug development. Previously, he held senior positions in clinical pharmacology and pharmacokinetics at AstraZeneca and Schering AG. He is a trained pharmacist with a broad range of therapeutic expertise, including cardiology, oncology, dermatology, and central nervous system (CNS). Dr. Wong has been involved in the development of various well-known compounds.
Dr. Grossmann is based at Parexel's clinical pharmacology research unit in Berlin and Dr. Wong is based at the Baltimore, MD unit.
March 20, 2007
Posted on March 20, 2007 @ 10:02 am
Thermo Fisher Scientific has signed a joint venture agreement with the
Gerresheimer Group to create a business that manufactures disposable and reusable glass labware for scientific labs. Gerresheimer is a global supplier of specialty glass and plastic devices for life sciences markets. The new business, called Kimble/Chase Life Scienceware, LLC, will be based in NJ, with additional operations in the U.S., Germany, Mexico and China. The closing of the joint venture is subject to customary closing conditions and applicable regulatory approvals.
Under the agreement, Thermo Fisher will own 49% of the joint venture, contributing its Chase Scientific, Scherf and Pfeiffer glassware lines manufactured in the U.S. and Germany. Gerresheimer will own 51% and contribute its life science research products including certain Kimble, Kontes and Bomex brands manufactured in the U.S., Mexico and China. Combined, these products generated sales of approximately $123 million in 2006. The agreement expands an existing sales and marketing joint venture that was established in 2001.
"This joint venture will reshape the glass consumables marketplace," said Guy Broadbent, senior vice president and president of laboratory products for Thermo Fisher Scientific. "The combination of well-known glass labware brands from Thermo Fisher and Gerresheimer will form a leading supplier with an extensive product portfolio and a global footprint. With its significant production capabilities in China, the new business will be able to more effectively deliver its products to customers in that growing market as well as other parts of the world."
Dr. Axel Herberg, president and chief executive officer of the Gerresheimer Group, said, "This combination of mutual strengths marks an important step in the logical expansion of our businesses in the highly specialized pharma and life science markets. Through the formation of this joint venture, we will gain new dynamism in an important market segment of life science research."
Posted on March 20, 2007 @ 09:56 am
AtheroGenics, Inc.'s AGI-1067, which is being developed in partnership with
AstraZeneca, did not meet its primary endpoint in a Phase III trial. AGI-1067 is aimed at reducing the buildup of plaque inside arteries by addressing the inflammation behind heart disease.
The study compared the effect of AGI-1067 to placebo in more than 6,000 patients with heart disease on the time to first incidence of a composite of major adverse cardiovascular events such as resuscitated cardiac arrest, heart attacks, stroke, need for coronary revascularization and hospitalization for unstable angina.
AtheroGenics will continue to develop the drug based on positive results in reducing events such as cardiovascular death, heart attack and stroke, as well as improving several key diabetes parameters.
In a company statement, AtheroGenics will review the data to prepare for discussion with the FDA on how to proceed. AstraZeneca has 45 days to decide whether to continue the collaboration.
Posted on March 20, 2007 @ 09:53 am
Adventrx Pharmaceuticals, Inc. has entered into an agreement with
Pharmatek Laboratories for the manufacture of ANX-201 (Thiovir) capsules for clinical studies.
"Pharmatek is an experienced contract manufacturer and we are confident in their ability to produce reliable cGMP material for our clinical trials," said Michele Yelmene, vice president of regulatory affairs. "The drug supply they generate under this contract is expected to provide the company with inventory for our Phase 1/2 study in HIV, which we anticipate initiating later this year."
Adventrx plans to file an IND with the FDA in 2Q2007, pending appropriate clearances, and to initiate a Phase 1/2 trial of ANX-201 as a component of multi-drug therapy for the treatment of HIV, in 3Q2007.
March 19, 2007
Posted on March 19, 2007 @ 09:33 am
PharmaNet Development Group and
Analytica International, a wholly owned subsidiary of Accentia Biopharmaceuticals, have entered into a strategic alliance that will allow the companies to provide a broader range of clinical development and commercialization services to their clients.
PharmaNet provides clinical development services including early and late stage trials and related services. Analytica is a healthcare research consultancy that provides outcomes research, pricing and reimbursement analysis for global pharmaceutical, biotechnology, and medical device companies.
"Analytica International's outcomes research will enhance PharmaNet's clinical trial services offering when health outcomes are part of the sponsor's large scale, Phase III-IV trial protocol," commented Jeffrey P. McMullen, president and chief executive officer, PharmaNet Development Group, Inc.
"Our global biopharmaceutical clientele are looking for an integrated approach to designing and implementing clinical trials that incorporate outcomes research endpoints to maximize the value proposition of their products," commented Dr. John Doyle, president and chief operating officer, Analytica International, Inc.
Posted on March 19, 2007 @ 09:32 am
Stephanie Wells has been appointed corporate senior vice president, marketing and chief marketing officer,
Charles River Laboratories International, Inc. In this new position, Ms. Wells will be responsible for establishing and implementing global marketing strategies and branding initiatives. She will also participate as a member in the strategic planning process of the company.
Prior to joining the company, Ms. Wells was vice president worldwide marketing, clinical labs for Ortho-Clinical Diagnostics, a Johnson & Johnson company in Raritan, NJ, where she was responsible for the clinical lab global marketing strategy and several product launches. Ms. Wells also served as vice president marketing for the lab testing business unit at Bayer Diagnostics. She has more than 25 years of healthcare business experience, including extensive sales, marketing and general business management experience.
James C. Foster, chairman, president and chief executive officer of Charles River said, "Stephanie brings a wealth of life sciences marketing experience to Charles River. Her expertise and business acumen will add significant strength to our executive management team. We are very pleased to bring her aboard."
March 16, 2007
Posted on March 16, 2007 @ 03:37 pm
Thomas B. Smith, M.D., has joined
Kendle as Global Medical Director. In this role, Dr. Smith will provide medical and therapeutic expertise to Phase I-IV clinical development projects and proposals for the company’s biopharmaceutical customers, with an emphasis on projects in the Central Nervous System (CNS) therapeutic area. Dr. Smith brings to Kendle significant experience in CNS drug development, having led a clinical team in the preparation and submission of an IND for a novel compound for Alzheimer’s disease. He also was involved in the successful filing of an sNDA of Depakote ER for bipolar mania. CNS is an important focus area for Kendle, with the company’s experience including more than 500 CNS projects in 53 countries involving nearly 110,000 patients.
“CNS now ranks as the second most researched therapeutic area worldwide in terms of drug development,” said
Martha Feller, Ph.D., senior vice president, Global Clinical Development. “Dr. Smith’s expertise in this area will further strengthen our therapeutic experience in this significant and growing area of global clinical development.”
Dr. Smith brings nearly 20 years of pharmaceutical industry experience to Kendle. Serving most recently as senior director, Clinical Research and Development, Akros Pharma, he was responsible for assisting in the implementation and execution of clinical studies and for the preparation of clinical sections of regulatory submissions for new products and therapies. Prior to that, he served as medical director, Global R&D, Genzyme Corp., and associate medical director, Neuroscience Development, Abbott Laboratories. Dr. Smith’s background includes working across all phases of drug development and the full spectrum of therapeutic areas.
Posted on March 16, 2007 @ 08:06 am
Exelixis has submitted an IND application to the FDA for XL147, a novel anticancer compound. XL147 is an orally available small molecule inhibitor of phosphoinositide-3 kinase (PI3K). Activation of PI3K is a frequent event in human tumors, promoting tumor cell growth, survival, and resistance to chemotherapy and radiotherapy.
"A growing body of data indicates that inappropriate activation of the PI3K signaling pathway is a common feature of human tumors and may result from dysregulation at multiple points along the signaling cascade," said Gisela M. Schwab, MD, senior vice president and chief medical officer at Exelixis. "We are therefore evaluating multiple compounds that inhibit distinct components of the PI3K pathway. XL147 potently and selectively inhibits PI3K. In January, we filed an IND for XL418, which inhibits AKT and S6K, key components of the signaling cascade downstream of PI3K, and later this year we expect to file an IND for a third compound targeting both PI3K and mTOR. With this strategy, we believe that we are well positioned to maximize the potential of inhibiting the PI3K pathway for the treatment of multiple cancers."
This is the twelfth IND that Exelixis has filed from its internal discovery and development programs. The company expects to file at least two additional INDs by the end of 2007.
Posted on March 16, 2007 @ 08:01 am
MedImmune has signed an agreement with
Human Genome Sciences to lease a portion of the HGS headquarters facility in Rockville, MD, for the development and manufacturing of clinical trial material for cell culture-based seasonal and pandemic influenza vaccine. The expanded capability will support MedImmune's commitment to pandemic influenza vaccine development per a five- year, approximately $170 million contract awarded last year by the U.S. Department of Health and Human Services (HHS). Financial terms of the lease were not disclosed.
"While we are currently expanding our biologics manufacturing facility in Frederick, MD for potential use in producing pandemic vaccine as well as other products in our pipeline, the immediate availability of the existing HGS facility allows us to expedite certain development steps toward expanding our capacity to produce cell culture-based influenza vaccines," stated Alan Taggart, MedImmune's vice president of government project management. "This should be particularly useful as we prepare to initiate our clinical trials of cell culture influenza vaccine under our HHS contract commitment."
MedImmune currently develops, manufactures and markets FluMist (Influenza Virus Vaccine Live, Intranasal), a live, attenuated, needle-free seasonal influenza vaccine. The company is also working with the National Institute of Health's National Institute of Allergy and Infectious Diseases (NIAID) to apply MedImmune's proprietary technology to develop pandemic influenza vaccines.
March 15, 2007
Posted on March 15, 2007 @ 09:21 am
Albany Molecular Research, Inc. has named
Jonathan D. Evans as vice president of pharmaceutical development and manufacturing. In this newly created position, Mr. Evans will assume responsibility for AMRI's Chemical Development, Small Scale cGMP Manufacturing, Analytical, Quality Control Quality Assurance, and Large Scale Commercial Manufacturing business components, including operations in both Albany and Syracuse, NY; Hyderabad, India; as well as AMRI's Large Scale Manufacturing facility in Rensselaer, NY. In addition, he will serve as a key advisor to AMRI chairman, president and chief executive officer
Thomas E. D'Ambra, Ph.D., and as a member of the company's senior leadership team.
Mr. Evans brings 16 years of experience in operations and management, including 13 years at General Electric's Advanced Materials Division, where he served in a variety of roles, including operations manager, global business manager for the elastomers / specialty sealants business, and general manager of specialty operations, leading GE plants in North and South America. Most recently, he served as general manager of elastomers / specialty polymers, where he led an international team responsible for global business development and global marketing.
"We are pleased to announce the addition of Jonathan Evans to AMRI's senior leadership team," said Dr. D'Ambra. "Jon has compiled an exceptional track record at General Electric, and we expect him to play a key leadership role in the ongoing restructuring of our Large Scale Manufacturing operations. His background includes technical, engineering expertise coupled with business acumen and experience in a wide range of business functions, from manufacturing operations to business development. His prior roles integrating corporate acquisitions and reengineering supply chain operations at GE will be key skill sets as we continue to improve operational efficiency, customer service and bottom-line performance."
Posted on March 15, 2007 @ 09:12 am
Hyaluron Contract Manufacturing (HCM) has promoted
Paul Souza to the position of chief financial officer, with responsibility for all financial operations, including investor relations, at the privately-held company.
“Hyaluron has achieved a level of growth that entails more complex financial operations,” said company founder and president,
Shawn Kinney. “Among other things, we are looking to expand our investor base and felt it was imperative to have a man of Paul’s expertise and experience in the role of CFO.”
In 2006, the company reports that its revenues increased 68% over the previous year, for an average annual growth rate of 60% during the last three years.
March 14, 2007
Posted on March 14, 2007 @ 08:50 am
GlaxoSmithKline has received approval from the FDA for Tykerb in combination with Xeloda for the treatment of patients with advanced or metastatic breast cancer whose tumors overexpress HER2 and who have received prior therapy including an anthracycline, a taxane, and trastuzumab. It is the first targeted, once-daily oral treatment option for this patient population. Tykerb was granted Priority Review by the FDA in November 2006.
Tykerb inhibits two validated targets in oncology, the kinase components of the EGFR (ErbB1) and HER2 (ErbB2) receptors, commonly associated with cancer cell proliferation and tumor growth. As a targeted therapy, Tykerb is designed to interfere with discrete cellular processes or disease mechanisms prevalent in cancer. Tykerb will be available in the U.S. in the next couple of weeks and, as an oral therapy, offers added convenience for patients.
"The approval of Tykerb is an important milestone in our commitment to become a major oncology company that focuses on scientific innovation and genuine patient needs," said Chris Viehbacher, GSK's president, U.S. Pharmaceuticals.
Posted on March 14, 2007 @ 08:48 am
Bristol-Myers Squibb has plans to expand its R&D capabilities in India in collaboration with
Biocon Ltd. and
Accenture Ltd. According to a company statement, BMS will work with Biocon, India's largest biotechnology firm, to set up a research facility in Bangalore to help its discovery and early drug development. The Bangalore facility will have the potential to accommodate more than 400 scientists.
BMS also entered a multi-year agreement with Accenture, a consulting firm, to include support for clinical data and document management, pharmacovigilance, and scientific writing functions in India. Accenture will also provide maintenance and support for R&D information systems, according to BMS.
"This broad expansion of R&D in India will allow us to grow competitively while maintaining our industry-leading position in productivity and innovation," said Elliott Sigal, executive vice president of BMS.
Posted on March 14, 2007 @ 08:46 am
CytoDyn, Inc. has selected the
Waisman Clinical BioManufacturing Facility (WCBF) at the University of Wisconsin at Madison to manufacture its DNA-based pre-flu vaccine. The pre-flu vaccine provides an alternative approach to immunization that could enhance the efficacy of flu vaccines for seasonal flu and bird flu. It uses DNA technology to implant a false memory of previous exposure to the flu virus, including the inactivated virus contained in standard vaccines. The company hopes to have clinical trials underway before the end of next year's flu season, according to Allen D. Allen, chief executive officer of CytoDyn.
The WCBF is designed to manufacture clinical-grade biological pharmaceuticals for Phase I and II trials. WCBF also has facilities for processing cell therapeutics, aseptic filling of parenteral therapeutics, and for producing recombinant proteins expressed in bacterial or mammalian systems.
March 13, 2007
Posted on March 13, 2007 @ 08:46 am
Takeda Pharmaceutical Co. Ltd. has entered an agreement to acquire
Paradigm Therapeutics Ltd. Paradigm will become a subsidiary of Takeda Europe Holdings B.V., and will be renamed Takeda Cambridge Ltd., while its subsidiary in Singapore will be renamed Takeda Singapore Pte Ltd. The transaction is expected to close within the next few weeks. Financial terms were not disclosed.
Paradigm has target identification and validation capabilities based on genetic engineering and in vivo pharmacology. The company has developed a pipeline of drug discovery targets and compounds in key areas including pain, CNS disorders, prostate and breast cancer, diabetes, hyperlipidemia, and obesity.
This merger builds upon Takeda and Paradigm's 2005 CNS therapeutic alliance. Paradigm's technologies and researchers will be integrated into Takeda and will be used to accelerate multiple scientific processes such as the validation of drug targets derived from genomic research, the creation of animal models reflecting the human pathologic conditions, and the optimization of drug candidates.
"Takeda has been an excellent partner in our CNS collaboration and this deal represents a logical and positive extension to that. The company looks forward to continuing with its drug discovery and development activities within the global reach and long-term planning horizons of Takeda," said Alastair Riddell, chief executive officer of Paradigm.
"We are very excited with this deal, which will add to Takeda another research base equipped with the state-of-the-art technologies expected to further improve Takeda's research efficiency," said Yasuchika Hasegawa, president of Takeda. "We now have research functions in Japan, the U.S., Europe, and in Singapore. This acquisition represents our initiatives for establishing global research infrastructures and for pursuing the world's highest standard of productivity, which we believe will support enhancement of our R&D pipeline as source for future growth, and the realization of our goal to become a truly world-class pharmaceutical company."
Posted on March 13, 2007 @ 08:44 am
Cellzome, Inc. has received the first milestone payment from
Ortho-McNeil Pharmaceutical, Inc. for its Gamma Secretase Modulator (GSM) program in connection with the selection of a lead compound by Ortho-McNeil. The two companies entered into a collaboration and license agreement in May 2005 and it was extended for a further year in January 2007.
Tim Edwards, Cellzome's chief executive officer, said, "I am delighted with the progress we have made in our collaboration. This milestone payment is a reflection of the continued productivity of Cellzome's drug discovery group in working with our collaborator to advance toward preclinical development a potential oral therapeutic for patients with Alzheimer's disease, and further demonstrates the utility of our leading chemical proteomics technology."
Posted on March 13, 2007 @ 08:39 am
Array BioPharma and VentiRx Pharmaceuticals have entered into a license agreement granting VentiRx exclusive worldwide rights to Array's Toll-like receptor (TLR) program. The program contains development candidates targeting TLRs to activate innate immunity. VentiRx expects to develop its first two candidates in oncology and allergy.
Array will receive an equity stake in VentiRx as well as an upfront payment, potential milestone payments and royalties on product sales. Array retains the option to acquire a 50% ownership position in all VentiRx clinical oncology products developed under this agreement. Financial details of the agreement were not disclosed.
"These novel small molecule compounds from Array represent a significant opportunity for VentiRx and are ideally suited for our core competencies," said Michael Kamdar, executive vice president and chief business officer at VentiRx. "This licensing agreement, coupled with our $28.9 million financing, puts us in a strong position to develop novel TLR-based therapeutics."
"We believe VentiRx is a strong partner for developing this program based on their extensive background and focus on innate immunity," said David Snitman, Ph.D., chief operating officer, Array BioPharma. "As Array continues to progress its clinical pipeline of small molecule therapeutic products, we will look for novel opportunities, such as this licensing agreement with VentiRx, to maximize the value of our preclinical assets."
March 12, 2007
Posted on March 12, 2007 @ 09:06 am
Schering-Plough Corp. will acquire
Organon BioSciences N.V., the human and animal health care businesses of Akzo Nobel N.V., for approximately $14.4 billion in cash. The transaction is expected to close by the end of 2007. "With this transaction we take another major step in our action agenda to transform SP into a global high-performance company for the long term," said Fred Hassan, SP's chairman and chief executive officer. "It is the right deal at the right time as we accelerate into the build the base phase of our transformation."
"Organon BioSciences will be an excellent fit with SP, strategically, scientifically and financially," said Mr. Hassan. "It builds on our growing strength in primary care, giving us immediate access to central nervous system (CNS) and women's health care products. The acquisition of Organon BioSciences also fills a gap in our late-stage pipeline by adding five compounds in Phase III development and a number of promising projects in Phase II development. And, we believe that the two cultures are very much in tune."
He added, "In addition, the acquisition of Organon BioSciences enhances Schering-Plough's strength in human and animal biologic products, including the potential to develop human vaccines. In light of SP's expanding early pipeline, Organon BioSciences's strong biologics manufacturing capability is a further important asset for the combined company. With this acquisition, SP will become a leading animal health care company, with premier biologics capabilities."
The pharmaceutical business, Organon, had sales of $3.4 billion in 2006, which includes lead products such as Follistim/Puregon, a follicle-stimulating hormone for infertility; Esmeron/Zemuron, a muscle relaxant; and NuvaRing and Implanon for contraception. The animal health business had sales of $1.5 billion in 2006.
Posted on March 12, 2007 @ 09:04 am
Pfizer CentreSource (PCS) has commented on the impact of a recent announcement made on January 22nd regarding
Pfizer’s intention to divest the Feucht, Germany site and the related Heumann PCS business unit.
“As a result of an extensive review of the Pfizer Global Manufacturing (PGM) Plant Network, it was determined that the capacity and capability of the Heumann PCS site are not strategic for PGM or Pfizer,” said Michael J. Kosko, PCS president. “The planned sale does not impact the Fine Chemicals and Contract Manufacturing business units, which focus on steroids and drug products respectively.”
According to Mr. Kosko, the Heumann PCS business unit targets specialty APIs and solid dose manufacturing, and is entirely supported by manufacturing activities at the Feucht site, making the sale of the unit together with the Feucht site a logical decision. He noted that a particular growth area for the site is the high containment drug product manufacturing for potent compounds. PGM has begun searching for a buyer to support the activities of the site and the Heumann PCS business unit.
The targeted completion date of the divestment is 4Q2007.
Posted on March 12, 2007 @ 09:02 am
Lonza has extended a supply agreement with
Bristol-Myers Squibb to make the active ingredient of Bristol-Myers' rheumatoid arthritis drug, Orencia, through 2013. Financial details of the agreement were not disclosed.
The extension of the deal, for manufacturing the biologic agent abatacept at Portsmouth, NH, will give BMS more production capacity for Orencia, Lonza said in a statement.
March 9, 2007
Posted on March 9, 2007 @ 09:19 am
Ricerca Biosciences has completed a financial restructuring that includes new equity and term facilities approaching $50 million.
The company has been focused in the past several years on assembling a range of chemistry and biological capabilities to service North American biotechnology and pharmaceutical clients. Ricerca provides integrated chemistry and biological solutions to biotechnology and emerging pharmaceutical clients from discovery to IND at a single site location, according to a company statement.
Executive chairman R. Ian Lennox remarked, "Ricerca is embarking on the implementation of a multi-year business plan to invest over $15 million to add chemistry and biological laboratories, instrumentation and training for over 250 people at its site in Concord, Ohio. Growth in client demand for our capabilities necessitates our continued expansion and investment."
Posted on March 9, 2007 @ 09:18 am
Roche has filed a sNDA with the FDA to market Tamiflu capsules in pediatric doses of 30 mg and 45 mg. Tamiflu, which is indicated for the prevention and treatment of flu types A and B in patients one year and older, is currently available in a 75 mg capsule for adults and a liquid suspension formulation for children. Tamiflu pediatric capsules have a longer shelf life than the liquid suspension formulation (five years vs. 24 months) and provide a better option for government pandemic stockpiling and can be administered to children for seasonal influenza.
The application was filed based on information already available for the 75 mg capsule. The method of manufacturing will remain the same, with exception of the size of the capsule and the amount of the active ingredient, oseltamivir phosphate. Roche anticipates that the FDA will complete its review of the sNDA by mid-2007.
Posted on March 9, 2007 @ 09:15 am
Patheon
1Q Revenues: $171.7 million (+9%)
1Q Loss: $2.6 million (loss of $11.5 million 1Q2006)
Comments: Revenues from Rx manufacturing services grew 13% to $14.2 million, reflecting higher volumes at the Canadian, European and PR operations. Pharmaceutical development services (PDS) revenues increased 23% to $5 million, due to growth at the Toronto, Cincinnati and Swindon operations. Repositioning expenses -- related to workforce reduction and the expansion of the company's manufacturing efficiency review process -- were $3.7 million in the quarter. During the quarter, the company further reduced the size of its global workforce by approximately 300 positions, or 5%.
Posted on March 9, 2007 @ 09:13 am
Norbert W. Bischofberger, Ph.D. has been named executive vice president, R&D and chief scientific officer and
John F. Milligan, Ph.D. has been named chief operating officer,
Gilead Sciences, Inc.
Dr. Bischofberger joined the company in 1990 from Genentech, where he held roles of increasing responsibility within R&D, and was most recently appointed executive vice president, R&D in 2000. In his new role, Dr. Bischofberger will oversee all aspects of Gilead's R&D efforts, including the recently acquired Seattle, WA and Westminster, CO programs in the fields of respiratory and cardiopulmonary therapeutics and the company's Edmonton, Alberta operations.
A. Bruce Montgomery, M.D., senior vice president, head of respiratory therapeutics will now report to Dr. Bischofberger.
Dr. Milligan joined the company in 1990 as a research scientist. He has held leadership roles in project management and corporate development. He was appointed senior vice president and chief financial officer in 2002 and was promoted to executive vice president in 2003. In his new role, Dr. Milligan will oversee the company's commercial organization, manufacturing, finance and business operations.
Kevin Young, executive vice president, commercial operations will continue to lead Gilead's commercial organization and will report to Dr. Milligan.
Anthony Caracciolo, senior vice president, manufacturing will also report to Dr. Milligan. Dr. Milligan will continue to serve in the role of chief financial officer until a new CFO is appointed.
"Gilead has grown tremendously over the last several years, and these organizational changes will ensure our company is positioned to continue delivering new, innovative therapies to those patients most in need," said John C. Martin, Ph.D., president and chief executive officer, Gilead Sciences. "I am confident in the abilities of Gilead's senior leadership team -- Norbert, John, Kevin, Gregg Alton, senior vice president and general counsel and Kristen Metza, vice president, human resources -- to guide the continued success of our company."
March 8, 2007
Posted on March 8, 2007 @ 09:16 am
Pfizer has received FDA approval for Lipitor Tablets for five new indications: to reduce the risk of nonfatal heart attacks, fatal and non-fatal strokes, certain types of heart surgery, hospitalization for heart failure, and chest pain in patients with heart disease. Lipitor is the first cholesterol-lowering medication to receive FDA approval for the reduction of the risk of hospitalization for heart failure.
This new approval expands the use of Lipitor to patients at high risk for cardiovascular events because of established heart disease such as prior heart attack, prior heart surgery, or chest pain with evidence of clogged arteries. Previously, Lipitor was approved to reduce cardiovascular events in patients without heart disease.
The approval is based on results from two trials, the TNT trial and the Aggressive Lipid Lowering (IDEAL) trial. The five-year TNT study, evaluating efficacy and safety of Lipitor 80 mg, involved 10,000 patients with both heart disease and elevated LDL levels. Results showed a 22% reduction in the risk of major cardiovascular events over and above patients taking Lipitor 10 mg. In addition, patients treated with Lipitor 80 mg had a 26% reduction in the risk of hospitalization for heart failure.
While there were more serious adverse events and discontinuations with Lipitor 80 mg compared with Lipitor 10 mg, there was no difference in the overall frequency of treatment-related adverse events.
Posted on March 8, 2007 @ 09:15 am
MDS
1Q Revenues: $250 million (+3%)
1Q Earnings: $13 million (earnings were $47 million 1Q2006)
Comments: Revenue growth in the quarter was driven by late-stage businesses, up 25% to $55 million. Early-stage revenue was $66 million, down 1% in the quarter. Backlog at the end of the quarter was $450 million, up 5%. Results for the quarter reflect the impact of $13 million in restructuring charges. In the quarter, the company announced plans to acquire Molecular Devices corp. for $615 million and recently closed the sale of its MDS Diagnostic Services.
Posted on March 8, 2007 @ 09:07 am
Galapagos NV's service division,
BioFocus DPI, has entered into an agreement with
Johnson & Johnson Pharmaceutical Research & Development Division of Janssen Pharmaceutica NV (J&JPRD) to supply small molecule compounds for drug discovery. Under the terms of the two-year agreement, BioFocus DPI will provide access to compounds from its SoftFocus small molecule libraries and will also generate customer specific compound library sets for use in J&JPRD's drug discovery programs. Financial terms were not disclosed.
"This supply agreement is a natural expansion of our drug discovery relationship with J&JPRD. It will give J&JPRD access to highly targeted drug building blocks for their drug discovery programs," said Onno van de Stolpe, chief executive officer of Galapagos.
March 7, 2007
Posted on March 7, 2007 @ 10:08 am
Novartis AG has received approval from the FDA for Tekturna, the first new class of drug in more than a decade approved for treating high blood pressure. The drug acts by inhibiting renin, an enzyme secreted primarily by the kidneys that raises blood pressure.
According to the company, it's expected to be available later this month. According to the company, high blood pressure affects almost one billion people worldwide and is uncontrolled in about 70% of them. According to analysts, the drug may generate annual sales of approximately $1 billion.
Tekturna, which will be known as Rasilez outside the U.S., was developed with Swiss-based biopharmaceutical company, Speedel.
Posted on March 7, 2007 @ 10:06 am
Charles River Laboratories International, Inc. has opened its new, state-of-the-art, 450,000 sq.-ft. preclinical facility in Shrewsbury, MA. Custom-designed for optimal workflow, this new facility will enable flexible and more rapid study starts for both discovery and development programs, according to the company.
Dr. Craig Mello, 2006 Nobel Prize Laureate and a Shrewsbury resident gave a keynote address at the new facility on RNA interference, a natural process that allows a cell to turn its genes on and off according to its needs. "By understanding this process, researchers can switch off genes in human cells, providing a way to study what genes do and creating the possibility of a new class of drugs that could shut down known genetic culprits. RNA interference has revolutionized our understanding of gene function and opens an entirely new field in biology," said Dr. Mello.
The company began operations in the new facility in January of this year. Construction of a similar lab to support its West Coast customers is underway. The first is expected to open in this summer.
Posted on March 7, 2007 @ 10:05 am
Avalon Pharmaceuticals, Inc. has entered a drug discovery, development and commercialization collaboration with
Merck & Co. to identify and develop inhibitors for an undisclosed target related to the development of cancer.
Avalon will use its AvalonRx platform to screen a select set of compounds from Merck's compound library and identify hits against this target that is referred to as "intractable" based on the difficulty in identifying inhibitors. Avalon will select compound families and optimize these compounds to a preclinical candidate selection stage. Merck will be responsible for the clinical development, regulatory approval and commercialization of any potential product candidates.
Under the terms of the agreement Avalon is eligible to receive discovery, development, regulatory and commercial milestones payments exceeding $200 million as well as royalties on any potential future marketed products.
"We are excited about this innovative collaboration with Merck," said Kenneth C. Carter, Ph.D., president and chief executive officer of Avalon. "The combination of Merck's considerable drug discovery and development capabilities and Avalon's unique approach for targeting otherwise intractable cancer pathways should result in the identification of first-in-class drug candidates. This will provide further validation for the AvalonRx technology and its potential for identifying therapeutics based upon the ability to modulate pathways or targets within living cells."
Posted on March 7, 2007 @ 10:01 am
Wyeth Pharmaceuticals and
Progenics Pharmaceuticals will begin clinical testing of a new formulation of oral methylnaltrexone for the treatment of opioid-induced constipation. Preliminary results from the Phase II trial, conducted by Wyeth, showed that the initial formulation of oral methylnaltrexone was generally well tolerated but did not show sufficient clinical activity to advance into Phase III testing. If the new formulation is successful, the companies plan to file an NDA for oral methylnaltrexone in late 2009 or early 2010.
"Both the subcutaneous and intravenous formulations of methylnaltrexone have shown a high degree of activity in clinical trials. Therefore, the companies believe that the findings from the oral trial appear to be due to the orally administered formulation tested rather than the methylnaltrexone compound itself," says Robert R. Ruffolo, Jr., Ph.D., senior vice president, Wyeth, and president, Wyeth Research. "We remain strongly committed to the methylnaltrexone program and intend to file an NDA later this month for the subcutaneous dose form."
March 6, 2007
Posted on March 6, 2007 @ 09:44 am
Eisai Co., Ltd. has established its first European pharmaceutical manufacturing subsidiary, Eisai Manufacturing Ltd., (EML) in Hatfield, UK. EML is owned by the company's European regional headquarters, Eisai Europe Ltd. and will function as the core base of quality assurance and supply chain management for its European operations. EML will be recruiting manufacturing/QA experts for the targeted operation launch in 2008.
Eisai has been expanding its European operations with the planned construction of the European Knowledge Center located to the north of London Hatfield, which will consolidate Eisai's key value chain components in the region, including headquarters, discovery and clinical research, production, and marketing. The new manufacturing subsidiary in Hatfield is part of Eisai's effort to further progress its knowledge creation in manufacturing, according to the company.
Posted on March 6, 2007 @ 09:34 am
The Perrigo Company has entered into a purchase agreement to acquire nine generic prescription dermatological products and four pipeline products from
Glades Pharmaceuticals, Inc. for $56 million in cash plus other consideration for future R&D collaborations. The transaction is expected to close by the end of March.
Perrigo president and chief executive officer, Joe Papa, stated, "We have enhanced our existing U.S. product portfolio and future pipeline with this strategic acquisition, demonstrating our on-going commitment to the generic prescription dermatological space. We believe that these new and future products will expand our leadership position in this category. This acquisition is also an opportunity for us to improve returns on our existing asset base. We look to identify more such opportunities in the future."
Posted on March 6, 2007 @ 09:32 am
InterMune, Inc. has discontinued the Phase III INSPIRE trial evaluating Actimmune in patients with idiopathic pulmonary fibrosis (IPF) based on the recommendation of an independent data monitoring committee (DMC). Interim analysis included a total of 115 deaths and the DMC found the overall survival result crossed a predefined stopping point for lack of benefit of Actimmune relative to placebo. There wasn't a statistically significant difference between treatment groups in overall mortality (14.5% in the Actimmune group as compared to 12.7% in the placebo group). The adverse events associated with Actimmune were consistent with prior clinical experience, including constitutional symptoms, neutropenia and possibly pneumonia.
The randomized, double-blind, placebo-controlled trial included 826 patients and was designed to evaluate the safety and efficacy of Actimmune in IPF patients with mild to moderate impairment in lung function. The primary endpoint was survival time and the lack of benefit stopping boundary allowed for early study termination in the event interim data were statistically inconsistent with a clinically meaningful treatment effect of Actimmune.
Dan Welch, president and chief executive officer of InterMune, said, "Although we are disappointed by this result with Actimmune, we remain committed to addressing the significant unmet medical need in IPF with pirfenidone through our Phase III CAPACITY program. A positive treatment effect of pirfenidone on lung function has been supported in several Phase II studies and in a Phase III study as recently reported by Shionogi & Co., Ltd. We also are focused on advancing our novel hepatitis C virus drug candidate, ITMN-191. In collaboration with our partner Roche, our Phase Ia study of ITMN-191 is proceeding as planned."
March 5, 2007
Posted on March 5, 2007 @ 09:28 am
Eli Lilly and Co. has signed a definitive merger agreement to acquire
Hypnion, Inc., a neuroscience drug discovery company focused on sleep disorders. The transaction is expected to close by the end of the first quarter of 2007, contingent upon customary closing conditions. Financial terms of the agreement were not disclosed.
"The acquisition of Hypnion provides Lilly with a broader and more substantive presence in the area of sleep disorder research," said Steven M. Paul, M.D., executive vice president, science and technology for Lilly. "Hypnion has leveraged its expertise in this area to develop both innovative technologies and molecules, including the promising insomnia compound HY10275. We are excited to bring this expertise to Lilly and continue the efforts to discover better treatments for patients struggling with insomnia and other sleep disorders."
Nick Galakatos, Ph.D., chairman of Hypnion, commented, "Having demonstrated the promise of our pipeline of sleep medicines in the clinic and our enabling SCORE technology, we recognized that a partnership with a leading pharmaceutical company was our best strategy for moving forward quickly. Given Lilly's long record of achievement in neuroscience, we are confident that together we can produce safer and more efficacious sleep medications."
Hypnion's compound, HY10275, recently met the primary and secondary endpoints in an initial Phase II trial at doses of 1 mg and 3 mg in adults with transient insomnia. HY10275 is a proprietary compound discovered and developed by Hypnion as a dual-acting H1/5HT2a compound using the SCORE-2004 technology.
Posted on March 5, 2007 @ 09:24 am
Biovail Corp. has reached a settlement, following a review by the Federal Trade Commission, with
Anchen Pharmaceuticals LLP,
Impax Laboratories, Inc.,
Watson Pharmaceuticals, Inc. and
Teva Pharmaceutical Industries Ltd., related to Wellbutrin XL. Biovail had initiated patent-infringement litigation against companies that had filed aNDAs seeking approval to launch generic formulations of Wellbutrin XL, prior to the expiry of its patents.
Terms of the settlement include: dismissal of Biovail's legal actions against Impax and Watson; Teva, Anchen, Impax, and Watson may not market a generic version of the 150mg strength of Wellbutrin XL until 2008; Biovail has granted an exclusive license under its patent to Teva, Anchen, and Impax to market a generic version of the 300mg strength of Wellbutrin XL, from December 13, 2006 until June 13, 2007, and Biovail has granted these companies an exclusive license to market a generic version of the 150mg strength for a period of 180 days following market entry. Thereafter, each of the licenses becomes non-exclusive. Biovail may be required to supply Teva with a limited amount of 150mg and 300mg Wellbutrin XL product, at a pre-determined supply price, for specific periods of time.
Also, the terms of an agreement between GlaxoSmithKline and Andrx Corp. regarding Andrx's patent-infringement suit for its patent supposedly covering the 150mg Wellbutrin XL product, was dismissed. GSK was granted a license to continue to market the product. Biovail has agreed to pay one-third of the license costs. As a result of this settlement, all outstanding impediments affecting the 150mg Wellbutrin XL product were extinguished.
Separately and independently of these settlements relating to Wellbutrin XL, Biovail and Watson have terminated their existing agreement, which provided Biovail certain access to reference Watson's diltiazem toxicity data. As a result, Biovail is no longer obligated to pay Watson an annual royalty.
Posted on March 5, 2007 @ 09:20 am
Memory Pharmaceuticals' Phase IIa study of MEM 1003 in acute mania in bipolar disorder, based on primary and secondary outcome measures in the trial, did not prove effective.
The multi-center, double-blind, randomized, placebo-controlled study evaluated the safety and efficacy of MEM 1003 for the treatment of acute mania in bipolar disorder in 84 subjects. The primary outcome measure was a comparison of the percentage of subjects in the placebo and MEM 1003 treatment groups with at least 50% improvement from baseline in the Young Mania Rating Scale (YMRS) at 21 days. The secondary outcome measures were the mean change from baseline in the YMRS, the Modified Clinical Global Impression - Bipolar Scale and the Montgomery-Asberg Depression Rating Scale at 21 days. None of these outcome measures was achieved.
MEM 1003 was safe and generally well-tolerated in the study. There were no serious adverse events reported in the MEM 1003 treatment group during the study, in contrast to three serious adverse events of worsening of mania reported in the placebo treatment group.
"We are obviously disappointed that MEM 1003 did not prove effective in the treatment of mania in our study," said Stephen R. Murray, M.D., Ph.D., vice president of clinical development. "However, the target symptoms and the nature of the assessments in our ongoing Phase IIa study in Alzheimer's disease are very different from those in this mania study, and we do not believe that the negative results in this study are predictive of the effects of MEM 1003 in Alzheimer's disease.
"We are committed to finishing the ongoing Phase IIa study in Alzheimer's disease and expect results in the fourth quarter of this year," said David A. Lowe, Ph.D., chief scientific officer. "We are currently completing a full analysis of the bipolar results in order to learn as much as we can from this data set."
March 2, 2007
Posted on March 2, 2007 @ 09:31 am
Patheon, Inc. has entered into a definitive agreement with
JLL Partners, under which JLL will purchase $150 million of Patheon shares. The transaction, subject to shareholder approval and customary closing conditions, is targeted to close by April 30, 2007. Patheon plans to use the investment proceeds (approximately $138 million) towards its outstanding debt of $238 million under its existing North American credit facilities.
"This investment will establish a stronger financial foundation for Patheon that will allow the company to continue to build on its position as a leader in pharmaceutical manufacturing and development services," said Peter Green, chairman of Patheon. "In JLL Partners, we have found an experienced long-term investor who recognizes the strong fundamentals of Patheon's business and shares our goal of building greater sustained value for all of our shareholders."
"This capital restructuring is an important step forward for Patheon," said Riccardo Trecroce, chief executive officer of Patheon. "We will now have the financial certainty and stability to ensure continued focus on superior client service, profitability improvement and manufacturing excellence -- key elements of our plan to grow our business successfully."
"Our investment in Patheon is based on our great confidence in the company and the tremendous opportunities before it," said Ramsey Frank, senior managing director of JLL. "The company is extremely well positioned as a leader in the attractive market for drug development and contract manufacturing services for the pharmaceutical industry, with a talented management team and world-class operations."
As a result of the investment, JLL will initially hold approximately 25% of the voting rights of Patheon. In addition, JLL will be entitled to elect three directors to the company's nine-member board of directors (subject to reduction if JLL sells some of its shares), and will have certain other special approval rights and registration rights, according to a statement from Patheon.
Posted on March 2, 2007 @ 09:29 am
Astellas Pharma U.S., Inc. received approval from the FDA for Vaprisol, a receptor antagonist for the treatment of hypervolemic hyponatremia in hospitalized patients. Vaprisol, discovered and developed by Astellas, is the first drug specifically indicated for the treatment of both euvolemic and hypervolemic hyponatremia, potentially life-threatening conditions that occur when the body's blood sodium level falls significantly below normal. Vaprisol was approved by the FDA as a treatment for euvolemic hyponatremia in December 2005.
Hyponatremia is estimated to affect 4% of hospitalized patients in the U.S. each year. Severe cases are medical emergencies that can result in swelling of the brain, respiratory arrest and death. Hypervolemic hyponatremia results in edema (swelling of body tissues) and is often associated with congestive heart failure, severe liver disease and kidney failure.
In a randomized, double-blind, placebo-controlled study, intravenous administration of Vaprisol 40 mg/day for four days resulted in increased serum sodium levels in hospitalized patients with hypervolemic hyponatremia. Significant increases in serum sodium levels were observed within the first day of treatment with Vaprisol and continued throughout the treatment period. The most common adverse events associated with Vaprisol were infusion-site reactions.
Posted on March 2, 2007 @ 09:24 am
Cegedim S.A. has entered a definitive merger agreement to acquire
Dendrite International, Inc. for approximately $751 million in cash. The acquisition combines Cegedim's European strength with Dendrite's U.S. and Asia Pacific position, expanding sales, marketing, clinical and compliance solutions offered to the global life sciences and pharmaceutical industry. The combined company is expected to have estimated annual revenues of $1.1 billion and operate in more than 75 countries throughout Europe, the Americas and Asia Pacific.
Jean-Claude Labrune, founder, chairman and chief executive officer of Cegedim, said, "We are very excited to join forces with Dendrite's talented team to create a truly global business with increased international reach, a broader scope of product offerings and the strength to invest in the development of innovative technologies. As a combined organization we can achieve an even higher quality of service and will be better able to serve our clients in our competitive global marketplace."
Edward J. Kfoury, lead independent director on Dendrite's board, said, "Following an extensive and thorough review process, in which we considered a number of alternatives, including interest from various strategic and financial third parties, the board believes that the offer from Cegedim maximizes value for Dendrite's shareholders."
The merger, subject to the approval of Dendrite shareholders and other customary closing conditions, is expected to close within the next few months.
March 1, 2007
Posted on March 1, 2007 @ 09:18 am
The Association of Clinical Research Organizations (ACRO) has elected new officers for 2007.
Jeffrey McMullen, president and chief executive officer of PharmaNet Development Group, was elected chair of ACRO in December 2006.
David Spaight, president of MDS Pharma Services, will serve as chair-elect of the association. Mr. McMullen and Mr. Spaight are respected leaders of the CRO industry who have been part of the association's efforts to educate stakeholders on the benefits of clinical outsourcing and the expertise CROs provide in clinical trials.
"As ACRO celebrates its fifth anniversary this year, the association will continue to provide a unified presence and voice as the principal organization representing the CRO industry," said Mr. McMullen. "In 2007, we will increase ACRO's role as a leader in discussions around patient safety, regulatory issues in the US and abroad, and the development of research best practices."
"ACRO's member companies are committed to demonstrating the growing importance of our industry to the development of new drugs and biomedical products," added Mr. Spaight. "We encourage other CROs to consider membership in ACRO so that they might contribute their energies, perspectives and leadership to this effort."
Posted on March 1, 2007 @ 09:15 am
Ismail Kola, Ph.D. has been appointed senior vice president, discovery research,
Schering-Plough Research Institute (SPRI), and the company's chief scientific officer. Dr. Kola reports to
Thomas P. Koestler, Ph.D., executive vice president and president, SPRI. Dr. Kola is responsible for a team of 1,000 people at the company's discovery research sites in NJ, CA, MA and Milan, Italy. He will also become a member of the company's Operations Management Team (OMT).
Dr. Kola succeeds
Catherine Strader, Ph.D., who has been named senior vice president, science and technology, reporting to
Fred Hassan, the company's chairman and chief executive officer. In this new position, she will be involved in the company's external science and technology-centered actions, including business development and licensing.
Dr. Kola joins the company from Merck, where he most recently served as senior vice president and site head, basic research, and was responsible for atherosclerosis and cardiovascular diseases, diabetes, obesity, infectious diseases, immunology and rheumatology, animal pharmacology and basic and medicinal chemistry. He also chaired Merck's antibacterial and antifungal worldwide business strategy team. Prior to Merck, he held positions of increasing responsibility at Pharmacia Corp. and also served as a consultant to SmithKline Beecham Pharmaceuticals.
Dr. Strader has been with the company since 1995 when she joined as vice president, CNS, cardiovascular and genomics research. She held positions of increasing responsibility and was appointed chief scientific officer in 2006.
Posted on March 1, 2007 @ 09:05 am
KineMed, Inc. and
Roche have entered a collaboration to jointly validate KineMed's translational KineMarker technology, which measures the on-mechanism activity of compounds in animals and humans. This technology helps to accelerate the translation of promising therapeutic agents into advanced clinical studies. The two companies will clinically validate its proprietary KineMarker of collagen synthesis, a therapeutic target underlying tissue fibrosis, in an undisclosed disease area.
David Fineman, president and chief executive officer of KineMed, commented, "Fibrosis is a critical process underlying important diseases affecting major organ systems, including the lungs, kidneys and liver. The research collaboration with Roche will help to establish our approach as a possible surrogate for an important indication and as a means for monitoring on-mechanism activity of drug candidates in ensuing clinical studies."
"As part of our commitment to develop innovative therapies for inflammatory and autoimmune disorders, we are intensifying our focus on developing novel biomarker modalities to better monitor disease processes and the effect of our therapies on pathways driving these outcomes," commented Anthony Manning, Ph.D., vice president and global head of inflammation, autoimmunity and transplantation research at Roche Palo Alto LLC in CA.
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