|Email Newsletters from Pharmaceutical Technology and Pharmaceutical Technology Europe|
Providing the latest business, scientific, and regulatory news for the pharmaceutical and biotech industries.
News from Europe's pharmaceutical manufacturing industry coupled with upcoming events, and exclusive articles and interviews from industry experts.
Week of June 2, 2011: Company and People Notes: Valeant agrees to acquire Sanitas Group; Geron makes several senior appointments; and More.
The biopharmaceutical company Amarin has entered into several supply agreements regarding AMR101, a prescription-grade omega-3 fatty acid. Equateq and Chemport, manufacturers of polyunsaturated fatty acids for pharmaceutical and nutraceutical products, have agreed to provide Amarin with the active pharmaceutical ingredient (API) for AMR101. Equateq and Chemport, as well as Amarin's current API supplier, are each executing phased capacity expansion plans to create sufficient capacity. These suppliers are self-funding the expansions plans with some contribution for Amarin. In return for certain exclusivity provisions and subject to product approval, Amarin is obligated to make minimum annual purchases from Equateq ranging from approximately $10 million to $20 million and has agreed to pay Equateq a development fee up to a maximum of $0.5 million and up to $5.0 million for purchasing initial raw materials to be credited against future API purchases. Amarin is obligated to make minimum annual purchases from Chemport ranging from approximately $7.5 million to $15 million. Concurrent with its agreement with Chemport for commercial supply, Amarin agreed to take a minority-share equity investment in Chemport of up to $3.3 million. Amrin is also further considering adding a fourth API supplier. Additionally, Catalent Pharma Solutions, a contract development and manufacturing organization, and Banner Pharmacaps Europe, a provider of gelatin-based drug delivery technologies, have agreed to provide softgel encapsulation services for AMR101.
Eli Lilly commented on a ruling issued by the US District Court for the Southern District of California that granted a request by Amylin Pharmaceuticals for a temporary restraining order related to litigation involving the two companies’ diabetes collaboration agreement. “We are disappointed with the Court's decision to grant a temporary restraining order in this case,” said Robert A. Armitage, senior vice-president and general counsel for Lilly. “We have complied with our contractual obligations under our agreements with Amylin in a manner fully consistent with all applicable laws. We believe that Amylin's allegations against Lilly are entirely without merit and we fully expect to prevail in this litigation.”
Johnson & Johnson reports that it is reviewing its growth strategies for its pharmaceutical business with leaders from the company’s executive committee and pharmaceuticals segment. The company’s four strategies to grow its pharmaceuticals business include: focusing on differentiated medicines by expanding in immunology, oncology, and vaccines; prioritizing investments in internal research and development (R&D), strategic licensing, partnerships and select acquisitions; strengthening its geographic presence and increasing investments in emerging markets as well as in certain developed markets, such as Japan; and investing in talent and organizational capabilities locally, regionally, and globally.
Labtec GmbH, a transdermal drug-delivery developer, has opened a GMP manufacturing facility for transdermal patches and oral dispersible films in Hamburg, Germany. The facility was certified as GMP-compliant following a three-day inspection by Hamburg health authorities in March 2011. The facility provides industrial mass production and includes coating and drying lines with variable coating widths, as well as slitting machinery and converting and packaging equipment dedicated to transdermal drug-delivery systems and oral dispersible films.
Pfizer has formed strategic partnerships with the contract research organizations Icon and Parexel International, both of which will serve as strategic providers of clinical-trial implementation services during a five-year period beginning in June 2011. The new partnerships will be fully implemented during an 18-to-24 month period.
Canadian generic-drug company Pharmascience has opened new R&D and production facilities in Montreal. The company invested approximately $40 million in the expansion. Pharmascience also has acquired Aegera Therapeutics, a clinical-stage biopharmaceutical company. Financial terms were not disclosed.
Radius Health, a developer of osteoporosis drug therapies, and 3M Drug Delivery Systems, a provider of inhalation and transdermal drug delivery technologies, have agreed to collaborate on the development of a transdermal delivery option for BA058, Radius’ parathyroid hormone-related protein analog, for the treatment of osteoporosis, now in Phase I clinical trials. The BA058 Microneedle Patch will use 3M’s microstructured transdermal-system microneedle technology to administer BA058 through the skin as an alternative to subcutaneous injection.
Schott, a provider of specialty materials and pharmaceutical packaging, has opened a primary pharmaceutical packaging facility in Zavolzhe, Russia. The new production site will initially employ approximately 60 employees and will produce ampuls and vials.
SGS, a contract analytical and testing firm, has announced its plan to open a second life-science services facility in Mumbai, India. The new 15,000-ft2 facility will provide analytical development and quality-control testing services and is scheduled to become fully operational by mid-2012.
Sigma-Aldrich has acquired all outstanding shares of Vetec Quimica Fina, a Brazilian manufacturing and laboratory chemical supplier, to expand its presence in Latin America.
Valeant Pharmaceuticals International a specialty pharmaceutical company, has agreed to acquire Sanitas Group, a specialty pharmaceutical company with products in Central and Eastern Europe, for approximately EUR 314 million ($452.1 million). The deal is subject to customary closing conditions and regulatory approval and is expected to close in the fourth quarter of 2011.
Watson Pharmaceuticals, a generic-drug company, has acquired the Greek generic-drug company Specifar Pharmaceuticals for EUR 400 million ($575.3 million). Under the terms of the agreement, Specifar's former owners could also receive additional consideration based upon future profits of esomeprazole tablets during its first five years of sales, up to a maximum of EUR 40 million ($57.5 million). Specifar manufactures generic pharmaceutical products in a facility located in Athens with capacity for approximately 1 billion doses annually. A new facility is currently under construction outside of Athens. This facility will provide capacity to manufacture an additional 3 to 5 billion. EU certification of the new facility is expected in mid-2012. This capacity will permit Watson to convert additional third-party manufactured products to own-manufactured products. The transaction was signed and closed simultaneously and announced on May 25, 2011.
The biopharmaceutical developer Geron has made several senior management appointments. Stephen Kelsey, PhD, has been named executive vice-president, head of R&D, and chief medical officer; Jane Lebkowski, PhD, has been appointed as senior vice-president and chief scientific officer; and Melissa Kelly Behrs has been named senior vice-president of strategic portfolio management.
Christian Holtmann has been named as CEO of Klöckner Pentaplast Group, a producer of pharmaceutical films, effective June 1, 2011, succeeding Tom Goeke who will continue as an advisor to the company. Holtmann most recently served as CEO of PolymerLatex.