OR WAIT 15 SECS
Alpharma, Bayer, MicroTest, NexMed, Penwest
Specialty pharmaceutical company Alpharma Inc. (Fort Lee, NJ, www.alpharmaapi.com)and bulk API manufacturer ZhejiangHisun Chemical Co., Ltd. (Taizhou,China, www.hisunchem.com)entered into a manufacturingagreement for one of Alpharma's major active pharmaceutical ingredients(API), "Vancomycin," subject to regulatory approval. The API currentlyis manufactured at Alpharma sites inCopenhagen, Denmark and Budapest, Hungary. Beginning in 2006, Alpharmawill purchase Vancomycin from Hisun until a new Vancomycinmanufacturing plant is constructed at the Hisun facility in China. Thenew facility, which will be owned and operated by Alpharma, willincorporate technologies from Hisun and Alpharma.By late 2007, Alpharma hopes to secure the necessary regulatoryapprovals to enable Vancomycin produced at the new site to be sold inthe global marketplace, including the United States and worldwide. Inaddition, under the agreement, Hisun will provide certain services inconnection with the operation of the new plant.
BayerPharmaceuticals Corporation (West Haven, CT, www.pharma.bayer.com)granted Pfizer Inc. (New York,NY, www.pfizer.com)exclusive worldwide rights to its "DGAT-1" inhibitors, a class ofcompounds that modify lipid metabolism. The lead compound in the class,BAY 74-4113, is a potential treatment for obesity, type 2 diabetes, andother related disorders. The compound is in Phase I clinicaldevelopment. Under the terms of the agreement, Bayer will receive anupfront fee, milestone payments, and royalties on sales of anycompounds commercialized. The deal is expected to close in the secondhalf of 2006.
BioCrystPharmaceuticals, Inc. (Birmingham, AL, www.biocryst.com)entered into an agreement with GreenCross Corporation (Seoul, South Korea) for the development andcommercialization in Korea of peramivir, BioCryst's potent influenzaneuraminidase inhibitor. Under the terms of this agreement, Green Crosswill conduct clinical trials with peramivir in South Korea and willshare with BioCryst all data from these studies. In addition tofacilitatingdevelopment of peramivir in South Korea, these trials will addimportant data to BioCryst's clinical studies planned for the UnitedStates and Europe and those planned in Thailand, Viet Nam, andIndonesiato be conducted in collaboration with the National Institute of Allergyand Infectious Diseases and the World Health Organization.
Egalet a/s (Copenhagen, Denmark, www.egalet.com)signed a long-term manufacturing agreement with SP Medical A/S (Juelsminde,Denmark, www.sp-group.dk)by which SP Medical will manufacture clinical-grade quantities ofEgalet products for hypertension and pain management for Phase IIItesting using injection moulding. If the products gain regulatoryapproval, SP Medical will be responsible for commercial scale-up andmanufacture of both products. All manufacturing will take place in aGMP environment and is subject to approval by the Danish authoritiesand the US Food and Drug Administration.
MicroTest(Agawam, MA, www.microtestlabs.com)invested $7.50 million to expand its pharmaceutical andvirology testing services and fill-finish contract manufacturingcapabilities. The expansion includes constructing and equipping newpharmaceutical testing laboratories, a series of segregated virologytesting laboratories, and aseptic fill-finish manufacturing facilitiies.
Pending approval by the Romanian CompetitionCouncil, Ranbaxy Netherlands BV(Haryana, India, www.ranbaxyusa.com)will acquire generics company Terapia (Romania) for $324 million.
RNAi therapeutics maker Alnylam Pharmaceuticals, Inc.(Cambridge, MA, www.alnylam.com)appointed Saraswathy (Sara) Nochur,PhD, to the position of vice-president of regulatory affairs.Nochur has experience in regulatory affairs and overalldrug development. At Alnylam, she will lead the global regulatorystrategy for the company's development-stage programs, overseeregulatory operations, and serve as a member of the management team.
Vivian Liuwas named executive vice-president and chief operating officer of NexMed, Inc. (East Windsor, NJ, www.nexmed.com), adeveloper of transdermal products. Liu joined the company in 1994 andwill oversee NexMed's day-to-day operations in her new position.
PenwestPharmaceuticals Company (Danbury, CT. www.penw.com), adeveloper of drugdelivery technology, named JenniferL. Good to the position of chief executive officer and member ofthe Board of Directors. Good had been president and chief operatingofficer of Penwest since November 2005.
Deborah M. Autorwas selected as the director of the USFood and Drug Administration's (Rockville, MD,
) Center for Drug Evaluation and Research's Officeof Compliance. Autor joined the Office of Compliance in October2001 as a senior advisor and has been the associate director forcompliance policy since July 2002. StevenNiedelman, deputy associate commissioner for regulatoryoperations, announced his retirement from FDA. He will join Quintiles Consulting (ResearchTriangle Park, NC,
)as executive vice-president.