October 5, 2006 Notes: Amgen Acquires Avidia, Millipore Opens New R&D Center, More

October 5, 2006
Pharmaceutical Technology Editors

ePT--the Electronic Newsletter of Pharmaceutical Technology

Amgen, Ash Stevens, Aveo, Millipore

Company Notes

Thousand Oaks, CA (Sept. 29)-Amgen (www.amgen.com) announced that it will acquire Avidia (Mountain View, CA, www.avidia.com). The acquisition will provide Amgen with Avidia's lead product candidate, an inhibitor of interleukin 6 for the treatment of inflammation and autoimmune diseases. Under the terms of the agreement, Amgen will pay $290 million in cash and up to $90 million when certain milestones are reached. The transaction, which has been approved by the boards of directors of both companies, is expected to close in the fourth quarter of 2006.

Detroit, MI (Oct. 2)-Ash Stevens (www.ashstevens.com) has been awarded two multi-year contracts from the National Cancer Institute (NCI, Bethesda, MD, www.cancer.gov) totaling $12.4 million. The first contract, "Manufacture of Bulk Chemicals and Bulk Pharmaceutical Ingredients for Preclinical and Clinical Studies," is worth $10.6 million, and the second, "Synthesis of Non-GMP Small Molecules," Is valued at $1.8 million. Ash Stevens and NCI have worked together for more than 30 years to develop anit-cancer drugs. They previously partnered to develop "Fludarabine Phosphate" treatment for certain types of leukemia and "5-Azacitidine" to treat myelodysplastic syndromes.

Cambridge, MA (Sept. 28)-Aveo Pharmaceuticals (www.aveopharma.com) has entered into a $6-million agreement with Xoma Ltd. (Berkeley, CA, www.xoma.com) under which Xoma will manufacture and supply AV-299, Aveo's anti-HGF antibody, for early clinical trials. Xoma previously created four versions of the original AV-299, and Aveo selected one as its lead development candidate. In return for work conducted and licenses granted, Xoma received an up-front license fee and is eligible for development milestones and royalty payments on sales of the antibody. Aveo retains all development and commercialization rights.

Leiden, The Netherlands (Oct. 2)-Crucell N.V. (www.crucell.com) has completed the purchase of Berna Products Corp. from Acambis plc. The purchase will allow Crucell to gain control of all US sales of Berna Biotech AG's “Vivotif” oral tyhoid fever vaccine. The purchase totaled $16.5 million.

Dusseldorf, Germany (Sept. 25)-Degussa AG (www.degussa.com) will be placing the NCN business at its Trostberg and Schalchen sites into a new entity known as AlzChem Trostberg GmbH. According to Klaus Engel, chairman of Degussa's board of management, the move is meant to give the NCN business the necessary future prospects and help it develop and meet profitability targets by increasing the flexibility of the operation and reducing costs by implementing the structures of a mid-sized enterprise with a regional focus.

Visakhapatnam, India (Sept. 26)-Dr. Reddy's Laboratories (www.drreddys.com) inauguated their first finished dosages plant at Visakhapatnam. This is the company's seventh finished dosage facility. It is designed to manufacture a broad range of products, including cytotoxic and anti-hormonal products and injectibles for the treatment of cancer, hormonal imbalances, and other diseases. The plant is capable of manufacturing 40 million cytotoxic OSD capsules, 40 million anti-hormonal formulations, and seven million injectibles each year.

Centreville, VA (Sept. 28)-A report by consulting company Barnett International (www.barnettinternational.com) says that in the last 18 months, the United States Food and Drug Administration (FDA, Rockville, MD, www.fda.gov) approved most new active drug ingredients after only one review. The report also said that the ingredients under standard review often required a second look, while those under priority review were approved after one review. According to the report, of the 27 new molecular entities (NMEs) approved between 2005 and mid-2006, 17 were approved after one review cycle, while seven took two review cycles and three required a third cycle. Of the 18 NMEs under priority review, 14 were approved after one cycle. Three of the nine NMEs under standard review were cleared after the first cycle. In addition, the report found that the FDA is taking longer to complete its first review of an application to market an NME-8.4 months this year compared with 7.6 months last year-but less time for priority reviews and more time for standard reviews. Drugmakers who want to market an NME are also taking longer submitting a response when the FDA deems an application approvable or not approvable.

London, UK (Sept. 28)-GlaxoSmithKline (GSK, www.gsk.com) signed a licensing agreement with Simcere Pharmaceutical Group (Nanjing, China, www.simcere.com) giving Simcere the right to manufacture and sell the anti-viral influenza treatment zanamivir in China, Indonesia, Thailand, Vietnam, and all least developed countries. The agreement is part of GSK's effort to prepare for a global influenza pandemic by expanding available supplies of zanamivir in parts of the world that may be on the front line of a pandemic.

New York, NY (Sept. 28)-Inyx, Inc. (www.inyxgroup.com) has agreed to acquire Pharmapac UK Ltd. (Manchester, UK, www.pharmapacuk.com). The purchase price is GBP 9 million (approximately $17 million) in cash plus up to another GBP 1.5 million (approximately $2.9 million) in cash if certain milestones are met in 2007 and 2008. The acquisition is expected to be completed by November 14, 2006.

Billerica, MA (Oct. 3)-Millipore Corporation (www.millipore.com) opened a $50-million research and development center in Bedford, Massachusetts. The 110-square-foot building contains 47,000 square feet of lab space and consolidates multiple functions, thus fostering a collaborative approach for the up to 500 professionals who will work there. The facility will support Millipore's bioprocess division, which helps pharmaceutical and biotechnology companies optimize their manufacturing productivity, ensure the quality of drugs, and scale up the production of difficult-to-manufacture biologics.

Mattawan, MI (Oct. 2)-MPI Research (www.mpiresearch.com) has acquired Exygen Research (State College, PA, www.exygen.com) as part of its growth initiative in response to customer demand. The purchase will allow MPI to offer an expanded range of analytical capabilities and will give customers access to an expanded range of non-clinical drug discovery and research services. Exygen will continue to operate from its State College location, and it will manage all analytical services, including those offered by MPI at the Mattawan site.

East Hills, NY (Oct. 3)-Pall Corporation (www.pall.com) announced plans to expand its life sciences manufacturing operations in Fajardo, Puerto Rico by establishing a life sciences center of excellence. The company expects to invest about $50 million in facilities, machinery, and equipment and add more than 250 full-time jobs by the year 2010.

Bethesda, MD (Oct. 3)-Sucampo Pharmaceuticals, Inc. (www.sucampo.com) announced that it has acquired all of the capital stock of its affiliated European and Asian operating companies, Sucampo Pharma Europe Ltd. and Sucamp Pharma, Ltd. The transaction closed on September 28 and the affiliates became wholly owned subsidiaries of the company. In addition, Sucampo realigned its senior executive team. Sachiko Kuno, PhD., Sucampo co-founder and board member, has been elected chairman of the board of directors. He will remain president of the company. Co-founder Ryuni Ueno, MD, PhD, will relace Kuno as chief executive officer.

Woburn, MA (Oct. 5)-SupplyScape (www.supplyscape.com), a provider of electronic pedigree systems, announced that the Florida Department of Health (Tallahassee, FL, www.doh.state.fl.us) has designated it as the first certificate authority for the state's electronic drug pedigrees.

Berkeley, CA (Oct. 2)-Xoma Ltd. (www.xoma.com) has signed a cross-license and collaboration agreement with Affimed Therapeutics, AG (Heidelberg, Germany, www.affimed.com) for antibody-related technologies.


People Notes

Greenwich, CT (Oct. 2)-Marcello DiMare has been appointed senior director of chemistry development with Aptuit, Inc. (www.aptuit.com). DiMare will be responsible for building the company's process development and custom syntheses business. He also will build and extend the radiolabeling expertise recently acquired from EaglePicher and consolidate Aptuit's capabilities with those of EaglePicher. DiMare previously served as senior director of business development at Dr. Reddy's Laboratories and held senior positions at Rhodia ChiRex and ChiRex, Inc.

Stockholm, Sweden (Oct. 2)-Andrew Z. Fire and Craig C. Mello were awarded the Nobel Prize in Physiology or Medicine for their discovery of a fundamental mechanism for controlling the flow of genentic information. Fire, a Stanford University medical school professor of pathology and genetics, and Mello, a professor of molecular medicine at the University of Massachusetts, discovered a mechanism, known as RNA interference, that can degrade mRNA from a specific gene. The RNA interference is activated when RNA molecules occur as double-stranded pairs in the cell. It helps regulate gene expression, patricipates in defense against viral infections, and keeps jumping genes under control. RNA interference is being used in basic science as a method to study the function of genes, and it might be used to combat diseases such as cancer and AIDS in the future.

Framingham, MA (Oct. 3)-Transport Pharmaceuticals, Inc. (www.transportpharma.com) has appointed Navneet Sharma vice-president of quality systems and operational excellence. He will be responsible for providing leadership and quality assurance in the company's engineering, chemistry, biology, drug develpment, and manufacturing programs. He will also work with senior management to identify, share, and deploy best practices throughout the organization. Sharma has previously held leadership positions at Tyco Healthcare, Ortho-Clinical Diagnostics, and Convatec.

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