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News from Europe's pharmaceutical manufacturing industry coupled with upcoming events, and exclusive articles and interviews from industry experts.
Mergers, acquisitions, and restructuring
Princeton, NJ (Sept. 24)—Reflecting a strategic interest in strengthening its position in biologics, Bristol-Myers Squibb (BMS) agreed to acquire the biopharmaceutical company Adnexus Therapeutics (Waltham, MA) for $430 million.
Adnexus is a developer of a proprietary class of biologics called "Adnectins," which are derived from fibronectin, an extracellular protein that is naturally abundant in human serum. Fibronectin binds to other proteins using protein structures called targeting domains. An Adnectin consists of a backbone of the natural amino-acid sequence of a certain domain of human fibronectin and one to three targeting loops redirected to enable an Adnectin to specifically recognize a therapeutic target of interest, according to the company. The Adnectins are generated using the company's "Profusion" proprietary protein-engineering system. Adnexus says that although Adnectins and antibodies have targeting domains with three-dimensional shapes that resemble each other, the amino-acid sequences of each protein class are distinctly different.
Under the deal, BMS will pay $430 million in cash for Adnexus. The net purchase price is $415 million after deducting Adnexus' net-cash balance at closing. An earn-out structure could make BMS pay roughly $75 million more, in three increments of approximately $25 million each, in the event that certain developmental and regulatory milestones are achieved. The closing of the transaction is subject to customary regulatory approvals. Upon closing of the deal, Adnexus Therapeutics will become a BMS subsidiary and will remain located in Waltham, Massachusetts.
Hamburg, Germany and South San Francisco, CA (Sept. 19)—Evotec and Renovis entered into a definitive agreement under which Evotec will acquire Renovis, a biopharmaceutical company, in a stock-for-stock transaction valued at approximately $151.8 million. The merger is expected to create a global pharmaceutical company with three clinical candidates, a late-stage preclinical pipeline focused on neurological and inflammatory diseases, and pro forma cash of approximately $175 million. The merged company will be called Evotec.
Pompey, France (Sept. 18)—Groupe Novasep is finalizing discussions to acquire PharmaChem Technologies (Grand Bahamas) for an undisclosed amount. The companies hope to combine Novasep's research and development capabilities and technologies with PharmaChem's manufacturing capacity to produce pharmaceutical actives and intermediates. PharmaChem's facility, based in Freeport, Bahamas, complies with current good manufacturing practices and is inspected by the US Food and Drug Administration.
Huntsville, AL (Sept. 17)—Funds advised by Apax Partners agreed to acquire generics manufacturer and distributor Qualitest and Vintage Pharmaceuticals. The company produces tablets, capsules, liquids, suspensions, suppositories, creams, and ointments across a portfolio of more than 160 products. It is currently ranked among the top ten suppliers of generic pharmaceuticals based on the total number of prescriptions filled.
Franklin, MA and Durham, NC (Sept. 17)—Sontra Medical, a company focused on transdermal technology, and Echo Therapeutics, a privately held specialty transdermal therapeutics company, merged to form a single, publicly held company to operate under the name Echo Therapeutics. The newly combined company will have corporate offices in Philadelphia and research and development facilities in Franklin, Massachusetts, and Durham, North Carolina. Patrick T. Mooney and Shawn K. Singh, both formerly of Echo, will serve as chief executive officer and interim president of the combined company, respectively. Harry G. Mitchell of Sontra will continue to serve as chief operating officer and chief financial officer of the combined company.
Berlin (Sept. 14)—Bayer Schering Pharma officially completed the acquisition of Novartis's (Basel, Switzerland) biologics manufacturing facility in Emeryville, California. Bayer will manufacture its "Betaseron" (interferon beta-1b) drug at the Emeryville site. The company maintains control of all manufacturing and process technology used to produce Betaseron, a multiple-sclerosis drug, and has retained the employees who manufacture the product.
As part of the transaction, which was announced in March 2007, Novartis transferred manufacturing responsibility for Betaseron to Bayer and received a total payment of roughly $200 million for the transfer of production equipment, inventory, and the leasing of buildings at the site.
Bayer will pay Novartis royalties on the net sales of Betaseron manufactured at the Emeryville facilities until the original regulatory filing, development, and supply agreement expires in October 2008.
Bayer will help Novartis submit a regulatory filing for the latter's 250-μg version of interferon beta-1b. If Novartis's drug is approved, Bayer will manufacture the product for Novartis from 2009 onward. In return, Novartis will make royalty payments to Bayer.
Sandwich, UK (Sept. 11)—Pfizer (New York) plans to cease all remaining manufacturing operations at its facility in Sandwich, Kent, United Kingdom. The closure will result in the loss of approximately 420 jobs, phased over the next two years, according to a company release.
The move is part of Pfizer's ongoing efforts to consolidate worldwide manufacturing operations to manage global capacity and demand more efficiently, as well as establish a smaller and more flexible cost base, the company specified.
The Sandwich facility manufactures active pharmaceutical ingredients (APIs) for human and veterinary drugs. Also located at Sandwich are a bioprocess development group, which develops new processes for the manufacture of pharmaceuticals using living (biological) systems, and a process analytical support group, which develops technologies to improve process understanding and control within Pfizer's plants.
A small API development function, comprising around 10–15 roles, will remain at Sandwich to support the development of regulatory starting materials. Site infrastructure services (e.g., provision of utilities and waste management) will also continue at Sandwich.
In January 2005, Pfizer announced a rationalization of manufacturing at Sandwich, which scaled down manufacturing activity at the site to API manufacture only.
Cambridge, MA and Carlsbad, CA (Sept. 7)—Alnylam Pharmaceuticals and Isis Pharmaceuticals launched Regulus Therapeutics, a joint venture focused on the discovery, development, and commercialization of microRNA therapeutics. Regulus will combine the strengths and assets of Isis's and Alnylam's technologies, intellectual property, and leadership.