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Penwest and Endo to Merge; Watson Makes Senior Appointments; And More.
BioStorage Technologies (Indianapolis), a provider of cold-chain logistics, was recently approved as a certified cargo screening facility by the US Transportation Security Administration. The designation allows the company to prescreen shipments at its facility, thereby avoiding possible screening delays at the airport.
Catalent Pharma Solutions (Somerset, NJ) released the Optiform compound optimization platform, a solid-state and automated analysis platform for salt, crystal-form, and cocrystal screening. The platform was developed over the past 10 years with GlaxoSmithKline (GSK, London), and GSK made an agreement with Catalent to use it with its internal screening activities.
Conatus Pharmaceuticals (San Diego), a drug-development company focused on liver disease and oncology, acquired the Idun Pharmaceuticals subsidiary of Pfizer (New York). Idun is a biopharmaceutical company. Financial terms were not disclosed.
Depomed (Menlo Park, CA) formed a license agreement with Johnson & Johnson’s (New Brunswick, NJ) Janssen Pharmaceutica (Beerse, Belgium) for the rights to Depomed's Acuform gastric retentive drug-delivery technology to be used for the nonexclusive development of a fixed-dose combination formulation of canagliflozin, a sodium glucose transport 2 (SGLT2) inhibitor, and extended-release metformin. Under the terms of the service agreement, Depomed will formulate the fixed-dose combination product and Janssen will have the commercialization rights.
Eli Lilly (Indianapolis) announced that the US Court of Appeals for the Federal Circuit has upheld a prior ruling by the US District Court for the Eastern District of Michigan that Gemzar's (gemcitabine HCl for injection) method-of-use patent is invalid. The court decision does not allow for the immediate entry of generic gemcitabine in the US market. Lilly expects to maintain market exclusivity for Gemzar until Nov. 15, 2010.
GlaxoSmithKline (GSK, London) exercised its option to obtain an exclusive license to develop and commercialize GSK2251052 (GSK ‘052), formerly known as AN3365, from Anacor Pharmaceuticals (Palo Alto, CA). GSK ‘052 is a systemic antibiotic derived from Anacor’s boron chemistry platform that has shown effectiveness against multiresistant gram-negative bacteria in early-stage studies. Under the terms of the agreement, Anacor will receive an option exercise fee of $15 million and is eligible for milestone payments and royalties on any future product sales.
In other GSK news, the company formed a drug-development pact with Amplimmune (Rockville, MD) for fusion proteins. GSK will obtain exclusive worldwide rights to AMP-224 as well as other potential next-generation fusion proteins that target PD-1. Under the terms of this agreement, GSK will pay Amplimmune an upfront payment of $23 million, up to $485 million in milestone payments, and up to double digit royalties on global product sales.
Biopharmaceutical company GenVec (Gathersburg, MD), formed a supply pact with Novartis (Basel) related to the companies’ collaboration in hearing loss and balance disorders. Under the new agreement, GenVec could receive approximately $13 million over four years to manufacture clinical-trial material for up to two lead candidates.
Contract research organization (CRO) Lambda Therapeutic Research (Ahmedabad, India), acquired Biovail Contract Research, the contract-research division of Biovail Corporation (Mississauga, Canada), through its subsidiary Lambda Therapeutic Research Inc. (Lambda Canada). Lambda Canada will operate two facilities with more than 46,000-ft2 dedicated to clinical/bioanalytical services in Toronto, Canada. These facilities house six study clinics and a total capacity of 194 beds, a clinical-contact center, subject-screening unit, bioanalytical laboratory, and a clinical-data-management department.
Lexicon Pharmaceuticals (The Woodlands, TX), a biopharmaceutical company, exercised a restructured purchase option under its drug development financing collaboration with Symphony Icon Holdings LLC and acquired all the equity of Symphony Icon, Inc. (Rockville, MD), thereby reacquiring all rights to LX1031, LX1032, LX1033 and the other drug programs subject to the collaboration. The drug candidates are serotonin-synthesis inhibitors: LX1031 is for irritable bowel syndrome, LX1032 is for carcinoid syndrome, and LX1033 is for other gastrointestinal disorders.
Norwich Pharmaceuticals (Norwich, NY), a provider of contract development and manufacturing, is expanding its services to include small-scale feasibility and initial product development for prescription and over-the-counter pharmaceuticals. The company’s non-GMP facility consists of an analytical laboratory designed for potent compound handling and a development area for formulation and product transfer verification.
Novartis (Basel) received a letter from the FDA’s Division of Drug Marketing, Advertising, and Communications (DDMAC) regarding its website for its leukemia drug, Tasigna (nilotinib) 200 mg capsules. DDMAC objected to the company’s use of a “Facebook Share” social media widget, which generates Novartis-created information for Tasigna that can be shared with Facebook users. The letter said the shared content is misleading because it makes representations about the efficacy of Tasigna without communicating any risk information about the drug. DDMAC also said the content “inadequately communicates Tasigna’s FDA-approved indication and implies superiority over other products.”
Two specialty pharmaceutical companies, Penwest Pharmaceuticals (Patterson, NY) and Endo Pharmaceuticals (Newark, DE), entered into a merger agreement. Endo agreed to acquire all of the common stock of Penwest for $5.00 per share in cash, for a total equity value of approximately $168 million.
Pfizer (New York) received approval from the US Food and Drug Administration for its prefilled dual-chamber syringe for administration of Xyntha antihemophilic factor (recombinant) plasma/albumin-free to hemophilia A patients. The company’s first syringe will provide 3000 IU of Xyntha, the highest dose, and other dosages will be available in 2011. The device is used to deliver Xyntha by intravenous (i.v.) infusion after reconstitution of a freeze-dried powder with the diluent (0.9% sodium chloride), and the Xyntha powder and the diluent are supplied within the prefilled dual-chamber syringe.
Contract manufacturing organization SCM Pharma (Prudhoe, UK) extended its contract with sanofi aventis (Paris) for the fast-tracked fill–finish of a radiolabelled product. The potent oncology product will be filled into vials under aseptic conditions, packaged at sanofi aventis, and distributed to clinical-trial sites.
Biotechnology company Seattle Genetics (Bothell, WA) expanded its antibody-drug conjugate (ADC) collaboration agreement with Genentech (South San Francisco, CA), a member of the Roche Group (Basel). Under the expanded agreement, Genentech will pay an upfront fee of $12 million for rights to use Seattle Genetics' ADC technology with additional antigens to be named by Genentech. In addition, Seattle Genetics is eligible to receive more than $900 million in fees and milestones if all ADCs in the expanded portion of the collaboration are commercialized, as well as royalties on product sales.
Shire (Dublin), a specialty biopharmaceutical company, plans to acquire Movetis (Turnhout, Belgium), a specialty gastrointestinal company. A Luxembourg-incorporated subsidiary of Shire will launch a voluntary public takeover offer for all the shares of Movetis, according to a Shire press release. Movetis’s board unanimously supports the transaction and will recommend acceptance of the offer to its shareholders.
Vectura Group (Chippenham, UK) licensed its dry-powder inhalation technology to GlaxoSmithKline (London). Under the terms of the agreement, Vectura will receive up to £20 million ($31.6 million) in upfront and milestone payments, as well as a maximum of £13 million ($20.5 million) annually in royalties.
World Courier (Stamford, CT), a provider of investigational drug and trial-related transport, storage and distribution, will expand its GMP-compliant clinical trial supply-chain services (CTSCS) network to 13 strategic and emerging markets, including a new 135,000-ft2 (12,500 m2) regional distribution facility in Singapore.
Avid Radiopharmaceuticals (Philadelphia) appointed Mark A. Mintun to the newly created position of chief medical officer. Mintun will report to Avid’s president and CEO, Daniel M. Skovronsky.
Penwest Pharmaceuticals (Patterson, NY), a drug-delivery company, selected Kevin C. Tang as chairman of its board.
The International AIDS Vaccine Initiative (IAVI) appointed Michael Caulfield executive director of the IAVI AIDS Vaccine Design and Development Laboratory. Caulfield previously held research positions at Merck (Whitehouse Station, NJ) and the Cleveland Clinic.
Nycomed US (Melville, NY), a specialty pharmaceutical company, named Jeff Wasserstein senior vice-president of business development and strategy. He will report to Steve Andrzejewski, CEO of Nycomed US.
Signum Biosciences, a dermatology-focused pharmaceutical company, appointed Braham Shroot, formerly chief science officer of Barrier Therapeutics (Princeton, NJ), as its CEO. Shroot replaces Gregory Stock, who will remain a member of the company's board.
Sly (Cleveland, OH), a manufacturer of dust-collection systems, appointed Mike Maxwell to the position of engineering manager. Maxwell will be based in Sly’s Strongsville, Ohio, office.
Watson Pharmaceuticals (Morristown, NJ) appointed Sigurdur Oli Olafsson executive vice-president of global generics, effective Sept. 1, 2010. Olafsson most recently served as CEO of the Actavis Group (Hafnarfjordur, Iceland). In addition, Robert Stewart, who joined Watson in November 2009 as senior vice-president of global operations, has been promoted to executive vice-president of global operations. Stewart and Olafsson will report to Paul Bisaro, president and CEO of Watson.