Contract Pharma Breaking News

Genmab Reaches GSK Milestone

Gil Roth — Mon, 13 Oct 2008 08:26:00 -0500

Genmab has reached the sixth milestone in its collaboration with GlaxoSmithKline for ofatumumab (HuMax-CD20), as the first patient received treatment in the Phase I study of ofatumumab in relapsed/refractory follicular non-Hodgkin's lymphoma and chronic lymphocytic leukemia in Japan. The milestone payment was approximately $5.6 million.

Ofatumumab is an investigational, new generation, human MAb that targets a distinct membrane proximal, small loop epitope of the CD20 molecule on the surface of B-cells. Ofatumumab is being developed to treat chronic lymphocytic leukemia, follicular non-Hodgkin's lymphoma, diffuse large B-cell lymphoma, rheumatoid arthritis and relapsing remitting multiple sclerosis.

Executive Moves: Antares Pharma

Gil Roth — Mon, 13 Oct 2008 08:22:00 -0500

Paul K. Wotton, Ph.D., has been named president and chief executive officer of Antares Pharma. Dr. Wotton previously served as president and chief operating officer, the titles he held upon joining the company in July 2008. Concurrently, Jack E. Stover has resigned as both chief executive officer and vice chairman of the board.

Dr. Wotton previously served as chief executive officer of Topigen Pharmaceuticals, following a stint as head of global business development at SkyePharma, as well as senior level positions at Eurand, Penwest Pharmaceuticals, Abbott, Merck, Sharp and Dohme.

Commenting on his new responsibilities, Dr. Wotton said, “I look forward to building shareholder value at Antares. The depth of our product pipelines in both our pharma and parenteral device divisions as well as our key partnership activities provide near and long-term growth opportunities for our business and share price.”

Abbott Opens Research Facility/Pilot Plant in Germany

Kristin Brooks — Fri, 10 Oct 2008 09:22:00 -0500

Abbott opened its new development labs and a pilot plant facility based in Ludwigshafen, Germany. The facility will research technologies and test large-scale production of newly developed drug formulations. The expansion is part of the company's global drug delivery business, SOLIQS.

"Abbott is committed to advancing scientific innovation and bringing new medicines to patients," said John M. Leonard, M.D., senior vice president, Pharmaceuticals, Research and Development, Abbott. "Innovative drug formulation is critical to the development of effective new treatments that make a difference for patients."

"Nearly 40% of pharmaceutical compounds never reach the clinical study phase because they cannot be absorbed in the human body," said Jorg Breitenbach, Ph.D., senior director of drug product development and head of SOLIQS. "The SOLIQS expansion builds on Abbott's expertise in drug delivery technology and addresses the rising demand for innovative, patient-focused formulations."

The facility will evaluate new processes for its current technologies, Meltrex, Xellex, NanoMorph and smartCrystals that target the formulation of soluble complex pharmaceutical substances. Using the Meltrex technology for example, Abbott developed a new tablet formulation of its drug Kaletra that does not require refrigeration and can be taken with or without food. This tablet formulation also offers the convenience of fewer pills.

FDA Continues NDA Review for Alogliptin

Kristin Brooks — Fri, 10 Oct 2008 09:19:00 -0500

Takeda Pharmaceutical Co. Ltd. received notification that the FDA will not be able to complete its review of the alogliptin NDA by the Prescription Drug User Fee Act (PDUFA) date of October 27, 2008.

The agency indicated that due to internal resource constraints it would not be able to complete the alogliptin review by the PDUFA date. According to a Takeda statement, the FDA did not provide guidance as to when the review might be completed. If the FDA does not complete its review of the NDA by the end of the year, development partner PDD will not receive the $25 million alogliptin approval milestone in 4Q08. The NDA was submitted in December 2007 for the treatment of type 2 diabetes.

CEL-SCI Takes Delivery of Manufacturing Facility

Kristin Brooks — Fri, 10 Oct 2008 09:16:00 -0500

CEL-SCI Corp. has taken delivery of the new manufacturing facility for its lead drug candidate Multikine. This facility, located in the Baltimore area, will produce Multikine for use in CEL-SCI's Phase III trial for first-line therapy of previously untreated head and neck cancer, and for manufacturing the drug upon approval. The facility cost about $22 million to build and will soon be commercially ready. Currently the facility can produce about $600 million worth of drug per year and can be built out to produce nearly $2 billion worth of drug product per year.

Geert Kersten, CEL-SCI's chief executive officer, said, "Having our own Multikine dedicated manufacturing facility gives us control and eliminates a great deal of risk from our product development. Our next step is to completely validate the facility and to bring it on line for manufacturing."

CEL-SCI's upcoming Phase III trial is an 800-patient study designed to demonstrate that administration of Multikine to head and neck cancer patients before they receive any conventional cancer treatment will increase their survival. Head and neck cancer affects about 650,000 people per year.

Patheon Completes ISPS Expansion

Kristin Brooks — Thu, 09 Oct 2008 08:49:00 -0500

Patheon has completed its expansion of services using a new Intermediate Scale Processing Suite (ISPS) at its Cincinnati, OH facility. The ISPS provides increased manufacturing capacity, bridging the company's development and commercial scale facilities.

The ISPS equipment includes an intermediate scale Diosna-P300 high shear granulator coupled with Niro-MP4 fluid bed dryer with solvent and high potency compound handling capabilities. This suite will allow the production of batch sizes ranging from 35-115 kg. The ISPS will allow the company to provide development, clinical, registration, scale-up, validation and commercial services to customers. The ISPS provides greater flexibility in scheduling experiments on a larger scale, using less active pharmaceutical ingredients (API) compared to commercial scale, according to the company.

Terry Novak, Patheon's president, North America and chief marketing officer, stated, "The ISPS provides us with another valuable service to address the unique needs of our customers. By adding this equipment we will be able to reduce time and resources it takes to moving a new product though development."

Executive Moves: Charles River Laboratories

Kristin Brooks — Thu, 09 Oct 2008 08:47:00 -0500

Dr. Christophe Berthoux has been named executive vice president, global sales and marketing and chief commercial officer, Charles River Laboratories. In this newly created position, Dr. Berthoux will lead the global realignment of the company's sales and marketing organization, with the goal of enhancing the company's interface with its customers.

"Given Dr. Berthoux's scientific and business training, his in-depth customer knowledge, as well as his considerable sales and marketing experience, I am confident that he will provide extraordinary levels of leadership in driving this newly created global organization," said James C. Foster, chairman, president and chief executive officer of Charles River.

Executive Moves: Irvine Pharmaceutical Services

Kristin Brooks — Thu, 09 Oct 2008 08:43:00 -0500

Muhammad Asif, Ph.D. has been named director of analytical development, and Paul Maffuid, Ph.D. has been named senior vice president of operations, Irvine Pharmaceutical Services.

Dr. Asif has more than 17 years of experience including supporting the development of pharmaceutical products through his various roles at MannKind Corp., DEY, L.P. (an associate of Merck KGaA), Wyeth, and Fujisawa, USA. His expertise ranges from analytical method development and validation to extractables/leachables, product characterization studies and preparation of analytical portions of the CMC sections of INDs, NDAs and ANDAs.

Dr. Maffuid has 20 years of experience in the pharmaceutical industry having worked at various companies, including Arena Pharmaceuticals, Inc., Magellan Laboratories, Inc., Cabrillo Laboratories, Amylin Pharmaceuticals, Inc., Glaxo research, California Biotechnology and Syntex, Inc. He is a member of the American Association of Pharmaceutical Scientists and the American Chemical Society, and has authored several publications.

Irvine Pharmaceutical Services welcomes Dr. Maffuid and Dr. Asif as part of the company's ongoing efforts to continually improve its client services through employment of unparalleled professionals. "I am proud to have Dr. Maffuid and Dr. Asif join our staff," said Assad J. Kazeminy, chief executive officer and founder of Irvine Pharmaceutical Services. "Each brings an impressive depth of knowledge and experience, which I am confident will prove invaluable to our current and future clients."

Pfizer To Reorganize

Kristin Brooks — Wed, 08 Oct 2008 09:13:00 -0500

Pfizer, as part of its strategy to improve growth, plans to reorganize its business units in an effort to better coordinate drug development and commercialization. These changes are part of chief executive officer Jeffrey Kindler's plan to "establish smaller operating units that can enhance innovation and accountability, but will draw upon the advantages of scale and resources Pfizer offers," said Raymond Kerins, a spokesman for Pfizer. The changes will take effect in January.

The reorganization will create three new units: primary care, specialty care and emerging markets. The primary-care unit will handle the drugs often prescribed by first-line doctors, such as the cholesterol treatment Lipitor. Specialty care will include drugs marketed to specialist doctors, such as anti-HIV drug Selzentry. The emerging-markets unit will handle the marketing of Pfizer drugs in emerging markets. The divisions will be responsible for drug development through sales and marketing. Research focused on the discovery of potential new drugs will continue to be handled by Pfizer's R&D arm, which is led by Martin MacKay.

Each unit will be led by a general manager who will report to Ian Read, president of worldwide pharmaceutical operations. Pedro Lichtinger, previously Pfizer's area president for European pharmaceuticals, will lead the new primary-care unit. Olivier Brandicourt will lead the specialty-care division. He was previously senior vice president of a unit focused on cardiovascular drugs. Jean-Michel Halfon will lead the new emerging-markets unit.

The reorganization plans do not include job cuts or changes to senior management, according to Mr. Kerins. The company previously created business units for oncology and established products. It also has an animal-health unit.

Bridge Labs Awarded NIDA Tox Contract

Kristin Brooks — Wed, 08 Oct 2008 09:10:00 -0500

Bridge Laboratories has been awarded a follow-on contract by the National Institute on Drug Abuse (NIDA). The five-year contract has an estimated value of $4.1 million if all options are exercised. Under the new contract, Bridge will provide toxicological evaluations for potential medications used to treat drug abuse.

“We appreciate the confidence NIDA has shown in Bridge Laboratories over the past five years and look forward to collaborating with them to find ways to significantly improve prevention, treatment, and policy as it relates to drug abuse and addiction,” said Tom Oakley, president and chief executive officer, Bridge Laboratories.

Millipore Opens Facility in Ireland

Kristin Brooks — Wed, 08 Oct 2008 09:09:00 -0500

Millipore Corp. opened a new membrane casting manufacturing facility in Carrigtwohill, County Cork, Ireland. The 30,000-sq.-ft. facility nearly doubles the company’s membrane production capabilities in Ireland.

“Millipore is celebrating 20 years in Cork. By opening this new facility, we are illustrating our strong commitment to continue our work in Ireland,” said Millipore's chairman, president, and chief executive officer, Martin Madaus. “Since 1988, our Cork operation has grown from the ground up into a Millipore Manufacturing Center of Excellence employing more than 580 people. We are very proud of our strong track record in process manufacturing.”

The new $83 million membrane casting facility is expected to produce a majority of the company’s membrane. These membranes are used in a range of Millipore products requiring filtration and purification. The company’s products are used to sterilize drug solutions, test beverages for purity, filter IV fluids in patient care and to support other applications in the medical device, pharmaceutical and biotechnology industries.

Alnylam Earns $20 Million Payment from Takeda

Kristin Brooks — Tue, 07 Oct 2008 09:16:00 -0500

Alnylam Pharmaceuticals has earned a $20 million technology transfer milestone from Takeda Pharmaceutical Co. Ltd. as part of the companies' strategic alliance formed in May 2008. The payment is related to the transfer of Alnylam’s platform technology, including documents, materials, and intellectual property, to Takeda for the development of RNAi therapeutics. Alnylam also received a $100 million upfront payment when the deal was executed. Alnylam is eligible to receive an additional $30 million in technology transfer milestone payments.

“We are excited about the progress we have already made in enabling Takeda with Alnylam RNAi drug discovery capabilities and intellectual property,” said Barry Greene, president and chief operating officer at Alnylam. “We look forward to continuing our efforts in this strategic collaboration which is focused on advancing the development of RNAi therapeutics on a global basis, including Alnylam’s right to co-develop and co-commercialize certain Takeda RNAi therapeutic products in the U.S. market.”

The agreement provides Takeda with worldwide, non-exclusive access to and enablement with Alnylam’s RNAi therapeutics platform technology and intellectual property in the fields of oncology and metabolic disease, with the right to expand the number of therapeutic fields in the future. It also includes a collaboration and cross-license of delivery technologies between the two companies, and a drug discovery collaboration on certain RNAi targets. Alnylam has opt-in rights to co-develop and co-commercialize Takeda RNAi therapeutic programs in the U.S.

Rituxan Study Meets Endpoint

Kristin Brooks — Tue, 07 Oct 2008 09:15:00 -0500

Genentech and Biogen Idec's Phase III study of Rituxan in combination with fludarabine and cyclophosphamide chemotherapy met its primary endpoint of improving progression-free survival (PFS), as assessed by investigators, in patients with previously treated CD20-positive chronic lymphocytic leukemia (CLL), compared to chemotherapy alone. There were no new or unexpected safety signals reported in the study.

An independent review of the primary endpoint is being conducted for U.S. regulatory purposes. Data from the study, REACH, will be submitted for presentation at a future medical meeting.

"REACH, the largest relapsed CLL trial ever conducted, is the first Phase III study of this treatment combination to show an improvement in progression-free survival for patients," said Hal Barron, M.D., Genentech's senior vice president, development and chief medical officer. “We look forward to collaborating with Biogen Idec to discuss these data with the FDA in the future.”

"Patients with CLL currently have few approved treatment options after the disease progresses following initial chemotherapy," said Cecil Pickett, Ph.D., Biogen Idec's president of R&D. "The REACH results are promising, and pending confirmation of the results by independent review, we look forward to submitting an application to the FDA for Rituxan’s potential approval in this indication."

Pharmatech To Design Biomanufacturing Facility in China

Kristin Brooks — Tue, 07 Oct 2008 09:13:00 -0500

Pharmatech Associates has been chosen by Pacific Biopharma Group (PBG) to provide the design for the first FDA- and EMEA-approved biomanufacturing facility to be built in China, which will represent the first reference document reviewed by the FDA as part of any licensure activity in China.

The new 181,000-sq.-ft. facility is a cGMP lab that uses single-use technology throughout the biomanufacturing process. The facility will be located in Taizhou, Jiangsu Province, in the emerging biomedical science park known as China Medical City (CMC). The project is a joint venture between PBG and CMC. In addition to manufacturing biotechnology products for late-stage clinical supplies, the facility will be used for development projects from the California Institute for Quantitative Biosciences (QB3).

“Pharmatech Associates understands every phase of the drug development lifecycle, not just pharmaceutical construction,” said Dr. S. Chang, vice president manufacturing, Pacific Biopharma Group. “Their ability to integrate the critical considerations necessary for international biological market approval is essential to the success of our program in China.”

“We are delighted that PBG chose Pharmatech for this endeavor. The project caters directly to our deep understanding of product development, technology and international compliance,” said Bikash Chatterjee, president and chief technology officer, Pharmatech Associates.

Lilly to Acquire ImClone

Kristin Brooks — Mon, 06 Oct 2008 08:48:00 -0500

Eli Lilly and Co. and ImClone Systems have entered a definitive merger agreement under which Lilly will acquire ImClone for approximately $6.5 billion in cash. The acquisition of ImClone supports the Lilly's strategy to increase its focus on biopharmaceuticals and adds oncology therapies Gemzar, Alimta and Erbitux to its biologics pipeline.

The combined companies creates a biopharmaceutical oncology franchise offering targeted therapies and oncolytic agents along with a pipeline spanning all phases of clinical development. The combined oncology portfolio will target various solid tumor types including lung, breast, ovarian, colorectal, head and neck, and pancreatic. The acquisition also expands Lilly's biotechnology capabilities with ImClone's development and commercial manufacturing facility, which will provide flexibility to develop and manufacture complex biomolecules.

"We think very highly of ImClone's ground-breaking work in oncology, particularly its success with Erbitux, a blockbuster targeted cancer therapy, and its ability to advance promising biotech molecules in its pipeline," said John C. Lechleiter, Ph.D., Lilly's president and chief executive officer. "We are excited about the possibilities of improving outcomes for individual patients and building value for shareholders. This transaction will broaden our portfolio of marketed cancer therapies and boost Lilly's oncology pipeline with three promising targeted therapies in Phase III in 2009. By bringing together ImClone's and Lilly's marketed oncology products, pipelines, and biotech capabilities, we are taking a very important step forward in addressing the challenges of patent expirations we will face early in the next decade. We look forward to working with the ImClone team and their partners to ensure a smooth transition."

John H. Johnson, ImClone's chief executive officer, said, "We believe this is an important step forward in ImClone's and Lilly's shared goal of addressing the medical needs of cancer patients around the world. The significant progress ImClone has made over the last few years is a direct result of the important contributions of our employees, and joining forces at this stage of our growth will allow us to leverage Lilly's global capabilities and make even greater advancements in our proprietary pipeline."

Erbitux is marketed by ImClone's two partners, Merck KGaA and Bristol-Myers Squibb. ImClone co-promotes Erbitux in North America with BMS. In 2007, worldwide sales of Erbitux were approximately $1.3 billion.