The Almac Group has completed a 67,000-sq.-ft. expansion to its facility in Durham, NC, which now houses the company’s Clinical Services and Diagnostics Divisions. Staff from Almac Diagnostics’ nearby facility in Durham has relocated to the site.

This expansion increased storage capacity for clinical supplies with an additional 3,000 pallet locations. In recent months, the company also completed a specialist clinical supplies storage facility in Craigavon, U.K. and is developing of a 240,000 sq.-ft. North American headquarters facility in Pennsylvania, which is scheduled for completion in 2010. This new facility will initially house Clinical Services and Clinical Technologies operations with expansion from other divisions in the Almac Group.

Donna Christopher, vice president of operations at Almac Clinical Services, Durham site, said, “This latest investment by Almac will act as a platform for us to serve the increasing demands of our client base who are seeking faster routes to get their products through the clinical development process. We now have 200 employees at our NC operations, which is more than five times the number we had when we first started out in 1998 with a team of 35. With over 20 years’ experience in clinical supply management Almac are recognized as a strategic partner in the clinical supply process by most of the world’s pharma and biotech companies. This increase in capacity is a sign of our commitment to offer market driven solutions to our customers.”

Samir Ghodbane, Ph.D., has been appointed as the new general manager of CMC services and CTM manufacturing at Frontage. Dr. Ghodbane has extensive experience and expertise in product development and technical operations spanning the complete product development cycle, as well as a comprehensive understanding of branded and generic pharmaceutical environments. He has led drug development and technical services at Actavis, Alpharma, and Wyeth. Most recently, he served as vice president of product development and technical services at Actavis, where he oversaw an organization of 180 people located at three different locations.

Daniel Tang, Ph.D., has been appointed vice president of DMPK and bioassay at the company’s operations in Shanghai. Dr. Tang brings experience from ChemPartner, where he managed DMPK operations and business development. He also served as director of bioanalytical services at Quest Pharmaceutical Services and supervised a bioanalytical group of thirteen scientists conducting GLP bioanalysis.

Ron Connolly has been appointed to a new role as senior vice president of business development.Mr. Connolly will be responsible for sales, marketing, and strategic business initiatives at Frontage. He has held several roles at Frontage, including developing and expanding client relationships, as well as various operational roles as head of U.S. operations.In addition, Ron has 20 years of drug development and FDA inspection experience from Flavine, Wyeth, Sanofi Aventis, and GlaxoSmithkline.

“The strategic hiring of Daniel and Samir will add to the experience of our senior management team, providing management to some of our key service areas of growth opportunities both in the U.S. and China,” stated president and chief executive officer Song Li, Ph.D. “Additionally, transitioning Ron to business development will help the development of our sales organization through his in-depth industry experience, providing Frontage the ability to continue to grow our core service offerings.”

Ligand Pharmaceuticals, Inc. has received $2 million in milestone payments from N. V. Organon, a subsidiary of Merck, through its research collaboration, which is due to expire at the end of December.

“We have had a long and productive drug discovery relationship with Organon and Schering-Plough (which acquired Organon in November 2007) over the years for a range of research programs,” said John L. Higgins, president and chief executive officer of Ligand. “These activities reflect Ligand’s strong R&D engine and the potential of our partnership portfolio.”

PPD, Inc. has signed an agreement to acquire BioDuro LLC, a drug discovery outsourcing company. The acquisition will expand PPD's drug development capabilities in China. PPD and BioDuro will perform a range of R&D services from early stage through Phase IV.

BioDuro operates a 110,000-sq.-ft. lab in Beijing. Most of its approximately 660 employees are based in China, where it provides medicinal chemistry, biology, pharmacology, drug metabolism, pharmacokinetic and safety services. The company offers resources and services to synthesize novel compounds and optimize compounds to generate drug candidates.

"Under the leadership of Masood Tayebi and the entire senior management group, BioDuro has built an exceptional team of researchers and scientists whose experience extends across a broad range of drug discovery," said David Grange, chief executive officer of PPD. "This acquisition will strengthen PPD's presence in China and position us to provide services for the growing global discovery outsourcing industry."

Masood Tayebi, founder and chairman of BioDuro said, "PPD shares our commitment for delivering world-class, quality services to clients. Combining our drug discovery expertise with PPD's global drug development resources will allow us to move our clients' programs from drug discovery into late-stage drug development and build upon our strong growth in China."

The acquisition, subject to various closing conditions, is expected to close in 4Q09.

PharmaNet Development Group has been selected to conduct and manage Scancell Ltd.’s Phase I/II trial with SCIB1 scheduled for 1H10. SCIB1 is a DNA ImmunoBody vaccine for the treatment of melanoma.

David Evans, chairman of Scancell, commented, “We are delighted to have selected PharmaNet to manage Scancell’s Phase I/II trial program with SCIB1. PharmaNet’s extensive experience, particularly in the management of early stage oncology clinical trials, will be of critical importance to Scancell as SCIB1 moves into clinical development.”

Jeffrey McMullen, president and chief executive officer, PharmaNet Development Group, commented, "This is our first project with Scancell. We are thrilled to work on Scancell’s innovative therapeutic cancer vaccine, SCIB1, and are very pleased that they have entrusted PharmaNet with their study.”

Patheon has named Francisco R. Negron as vice president and general manager of its Puerto Rico operations. Mr. Negron will be based at the company's Manati site.

Mr. Negron has more than 19 years of experience in the pharmaceutical industry. Most recently he served as global vice president for Novartis Consumer Health, OTC and Pharmaceutical Products, with a specific focus on global process improvement initiatives. He also served as vice president of manufacturing and supply for Valeant Pharmaceuticals and as site general manager for McNeil Consumer Healthcare in Piedras, PR.

"Franco is the right person at the right time to manage our organization in Puerto Rico," said Mr. Wes Wheeler, Patheon's chief executive officer and president. "His experience leading complex and highly efficient manufacturing teams for a variety of world class pharmaceutical organizations will help us transform our business in PR and will support our stated goal of creating a strong manufacturing presence in that region. He has my full support and I look forward to his contributions to Patheon in the future."

AstraZeneca has submitted a NDA to the FDA for Brilinta, an investigational oral antiplatelet treatment for the reduction of major adverse cardiac events in patients with acute coronary syndrome (ACS).

This submission is based on data from PLATO (A Study of Platelet Inhibition and Patient Outcomes), a Phase III trial comparing ticagrelor plus aspirin with clopidogrel (Plavix) plus aspirin.

Brilinta is the first reversibly binding oral P2Y12 adenosine diphosphate (ADP) receptor antagonist. ADP receptor antagonists work to prevent platelets from sticking together, thereby reducing recurrent thrombotic events.

Asterand has signed an agreement to acquire BioSeek Inc., a drug discovery services company, for $1.0 million payable in Asterand shares. The acquisition is part of Asterand’s strategy to enhance its position in the global human tissue services market, and according to a company statement, will be Asterand’s first step in its “buy and build” strategy.

A further payment of as much as $13 million will be payable in 2011, pending sales growth achieved by BioSeek by December 31, 2010. If further payment is made, the first $3.0 million will be paid in Asterand shares and additional payments will be either cash or shares.

BioSeek has developed a human primary cell based, high throughput assay system (BioMAP) designed to replicate the intricate cell and pathway interactions present in inflammatory, autoimmune and cardiovascular diseases. The system predicts clinical activities of a potential drug candidate through comparison of results to a database of profiles for known compounds.

BioSeek is located in South San Francisco, CA and has 14 employees. BioSeek’s key managers will join Asterand’s senior management team. Additionally, BioSeek’s chief executive officer, Dr. Mike Venuti, has agreed to act as a consultant to Asterand for a transition period.

Formatech has selected KAI Pharmaceuticals’ KAI-4169 compound as the second clinical candidate to receive “free” manufacturing services under its Fillanthropy Program. KAI-4169 is being evaluated for the treatment of secondary hyperparathyroidism. Under the program, Formatech will donate the services required to aseptically fill and finish one lot of the drug product for use in KAI’s upcoming trials.

Formatech plans to complete the production run of KAI-4169 in 1Q10. “We’re excited to have the opportunity to work with KAI on this program,” said Jeffrey Bernard, Formatech’s director of business development. “KAI’s technology for developing selective Protein C Kinase inhibitors is very promising and has the potential to be very impactful in the treatment of a number of diseases. We’re pleased to donate our services for this program and we wish KAI success with this candidate.”

“It is an honor to receive this award from Formatech as part of their philanthropic effort,” said Steve James, president and chief executive officer of KAI Pharmaceuticals. “We appreciate Formatech’s commitment to this program. Secondary hyperparathyroidism is leading cause of morbidity and mortality in patients with chronic kidney disease. This fill will help support our program and we look forward to exciting results in the year ahead.”

Genzyme Corp. reported results of a Phase II/III study of its advanced phosphate binder (APB). Although the trial met its primary endpoint, which was to show that the APB lowered phosphate levels compared to placebo, the APB did not show a significant improvement in phosphate lowering compared to Genzyme’s Renvela.

As a result, the company is discontinuing further development of the drug. The company was looking to develop a product with higher potency that would more effectively bind phosphate, while maintaining all the benefits of Renvela.

William B. Gerraughty, Jr. has been promoted to chief operating officer at Sparta Systems. Mr. Gerraughty will be responsible for overseeing the company’s day-to-day operations, providing strategic planning and resource allocation, and advising the chief executive officer and management team on key planning issues and important business decisions. Mr. Gerraughty will also continue to serve in his current position as chief financial officer and manage the company’s legal and human resource departments.

Prior to joining the company, Mr. Gerraughty served as chief financial officer at NMS Communications and Infinium Software. He also held a number of executive positions, including president, chief operating officer and chief financial officer, at Intellution, a software company serving the industrial automation markets. He began his career at Coopers and Lybrand.

“William Gerraughty’s success in ensuring the financial health of Sparta Systems makes him a natural choice to oversee the company’s daily operation as we head into 2010,” said James E. McGowan, chief executive officer, Sparta Systems.“I’m confident that with his unparalleled record of accomplishment and complete knowledge of the company’s inner workings, his promotion to COO will help position Sparta for continued growth in the coming year and beyond.”

PPD, Inc. has entered an agreement with Janssen Pharmaceutica to develop and commercialize two Phase II therapeutic compounds, one for diarrhea-predominant irritable bowel syndrome (IBS-d) and one for complicated skin and skin structure and respiratory infections.

PPD in-licensed the two compounds and will advance them through Phase II development. At the completion of Phase II, Janssen will have the option to resume development and commercialization. In exchange, PPD will receive as much as $330 million in clinical and sales milestones, as well as royalties on sales. If Janssen doesn’t chose to take over the program, PPD will have the option to continue development and commercialization and Janssen will receive as much as $250 million in clinical and sales milestones and royalties.

"Our agreements with Janssen diversify and strengthen our compound partnering portfolio and may gain us entry into two large markets," said Fred Eshelman, executive chairman of PPD. "The IBS-d market holds significant drug development potential because of the lack of approved products for this indication, and new antibiotics are needed to address increasing incidences of resistant strain bacterial infections."

The IBS-d compound is a potential locally active mu opioid receptor agonist and delta opioid receptor antagonist. The anti-bacterial compound is a broad-spectrum fluoroquinolone potential antibiotic with activity against gram positive and gram negative bacteria and methicillin-resistant staph aureus (MRSA). It is being developed as both an oral and intravenous therapy to treat skin and respiratory infections.

Genentech has submitted two sBLAs to the FDA for Avastin for the treatment of women who have not received chemotherapy for advanced (metastatic) HER2-negative breast cancer (first-line treatment). One sBLA is based on the Phase III study AVADO that evaluated Avastin in combination with docetaxel chemotherapy. The other is based on the Phase III study RIBBON 1 that investigated Avastin in combination with a taxane, anthracycline-based or capecitabine chemotherapy. Both studies met the primary endpoints of improving the progression-free survival.

"We look forward to working with the FDA to evaluate the data from more than 2,600 women with advanced breast cancer who participated in these studies that showed Avastin in combination with various chemotherapies helped them live longer without the disease worsening,” said Hal Barron, M.D., executive vice president, Global Development and chief medical officer.

Avastin is currently approved in combination with paclitaxel chemotherapy for first-line treatment of advanced HER2-negative breast cancer.

Azopharma Product Development Group (Booth 1801) has integrated its eight service divisions as part of an effort to streamline its approach to product development for small biotechs and large pharma alike, supporting both full development and specialty stand-alone projects.

The Azophrma Product Development Group — previously made up of Azopharma, APIcross, IQsynthesis, AniClin, Cyanta, ADMEQuant, AvivoClin, and Acromon — has been consolidated into three divisions: Azopharma Contract Pharmaceutical Services, AniClin Preclinical Services, and AvioClin Clinical Services.

At a press event during AAPS, a spokesman for the company said that Azopharma is focusing on its core services and has no acquisition plans for the near future. In the past year, Azopharma expanded despite the down economy, adding to its analytical services in Welwyn Garden City, UK and in Maryland Heights, MO, microdosing and central lab services to its pharmacology research facility in Daytona Beach FL, and more recently, new cytotoxic manufacturing suites for clinical trial materials at its (south Florida) Hollywood location.

Microdosing, a trend among pharmaceutical and regulatory agencies, allows companies to make “kill or carry” decisions with earlier pharmacokinetic and pharmacodynamic data in humans. In microdosing studies, drug substance is dosed sufficiently low not to have observable pharmacological activity, but to screen the ADME properties of several drug candidates. These studies have seen a big push from the FDA through its Critical Path initiative.

Cytotoxic compounds are becoming more prominent in the oncology drug realm. These compounds are difficult and dangerous to work with. With its three new manufacturing suites, equipment, and analytical instrumentation, the company is better positioned to support cytotoxic and highly potent compounds for development. Currently Azopharma is manufacturing two niche commercial products for clients: a cytotoxic product and a highly potent compound. With use of cytotoxics predicted to grow, the spokesman contended that the company is very interested in this smaller volume market.

Azopharma is also tapping into strategic partnerships. The group recently entered ones with Pharmanet to leverage complementary services through business development and co-promotion, and Immunregen, under which Azopharma provides development services in exchange for taking equity in the company.

Although active-only powder in capsule approaches are increasingly popular for Phase I trials, they may result in significantly slower, more erratic and less complete in vitro dissolution for some poorly soluble compounds – with the potential to skew in vivo results and delay or abandon work into promising new drugs. So says Dr. Michael Ruff, CPIP, vice president of pharmaceutical development at Metrics Inc. (Booth 2133). Dr. Ruff presented his research findings during a poster session on Nov. 9 at AAPS.

In a recent study, Dr. Ruff compared the in vitro dissolution of a non-formulated, active-only powder in capsule to that of a formulated capsule in the case of a poorly soluble drug intended for Phase I trials. He reported that his findings represent a cautionary tale for the pharmaceutical industry, which has increasingly taken an active-only, powder-in-capsule approach towards conducting Phase I first-time-in-man trials. This approach enables companies to skip significant formulation and analytical development activities and put prospective new compounds into patients more quickly.

“Going with a drug-only-in-capsule approach can move up first-time-in-man clinical dosing by two to four months, depending on the complexity of the intended dosage form,” Dr. Ruff said. But in his study examining a typically poorly soluble compound, he found that the powder-in-capsule approach resulted in significantly slower, more erratic and less complete in-vitro dissolution. This situation could potentially yield false negative in vivo results, delaying future trials or causing researchers to abandon studies of potentially beneficial new drugs, he warned.

“I recognize that there’s tremendous pressure to reach that first-in-man milestone – it’s what the industry and shareholders expect,” Dr. Ruff said. “So I’m not suggesting that researchers never do active-only powder in capsule. But this limited data supports the theory that agglomeration of micronized, poorly soluble active ingredients can pose a problem for this approach.”

Headquartered in Greenville, NC, Metrics provides pharmaceutical formulation development, clinical trial material (Phase I, II and III) and commercial manufacturing, and analytical development/validation services to the pharmaceutical industry.

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