Week of Dec. 7, 2009: Company and People Notes: PhRMA adds biopharm members; Dow spins off expression technology; and more.

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ePT--the Electronic Newsletter of Pharmaceutical Technology

Company and People Notes: Also, Pfizer and Protalix enter agreement; Watson acquires Arrow Group; and more.

Aegis Therapeutics (San Diego), a drug-delivery technology company, signed a license agreement with Roche (Basel, Switzerland) to provide Roche with access to Aegis’s ProTek stabilization technology. The technology covers the use of specific excipients as stabilizers in certain manufacturing processes and formulation of protein-based therapeutics.

Alkermes (Cambridge, MA), a biopharmaceutical company, has licensed the Medifusion technology platform for long-acting fusion proteins from the biopharmaceutical company Acceleron Pharma (Cambridge, MA). Medifusion is designed to extend the circulating half life of proteins and peptides. The first drug candidate (ALKS 6931) being developed with this technology is a long-acting form of a TNF receptor-Fc fusion protein for treating rheumatoid and related autoimmune diseases. Under the agreement, Alkermes will have worldwide rights to the Medifusion technology in return for an upfront payment, an equity investment in Acceleron, and future development, regulatory, and sales milestones and royalties on product sales. Acceleron will retain all rights to the technology for products derived from the TGF-beta superfamily. Acceleron will also develop up to two selected drug compounds using the Medifusion technology through preclinical studies, at which point Alkermes will assume responsibility for all clinical development and commercialization of these two compounds and any other compounds Alkermes elects to develop resulting from the platform. Alkermes expects to file an investigational new drug application for ALKS 6931 in 2010.

Biogen Idec (Cambridge, MA) has increased its offer to purchase all of the outstanding shares of the biopharmaceutical company Facet Biotech (Redwood City, CA) to $17.50 per share. Biogen Idec says the bid represents its “best-and-final” offer. Biogen Idec currently owns a 50% interest in daclizumab, a drug to treat relapsing multiple sclerosis, which it is jointly developing with Facet Biotech.

Celgene (Summit, NJ) has agreed to acquire Gloucester Pharmaceuticals (Cambridge, MA), a privately held pharmaceutical company, for $340 million in cash plus $300 million in future US and international regulatory milestone payments. Gloucester’s key drug is Istodax (romidepsin), which was approved in November 2009 by the US Food and Drug Administration for treating cutaneous T-cell lymphoma.

The Dow Chemical Company (Midland, MI) has spun off its expression technology, Pfenex, into an independent company, Pfenex Inc. (San Diego, CA). Dow will hold a minority stake in the new company along with Signet Healthcare Partners, a life-sciences investment group. The new company will focus on strain engineering and protein production based on the Pfenex expression technology, a Pseudomonas fluorescens-based platform.

Jubilant Organosys (Noida, Uttar Pradesh, India) through its subsidiary, Jubilant Biosys (Bangalore, Karnataka, India), has extended its research and development (R&D) agreement with Eli Lilly (Indianapolis) for an additional five years. Jubilant and Lilly first entered an R&D pact in late 2005.

La Jolla Pharmaceutical (San Diego, CA), a biopharmaceutical company, has agreed to merge with Adamis Pharmaceuticals (Del Mar, CA), a specialty pharmaceutical company. Adamis Pharmaceuticals has two subsidiaries, Adamis Laboratories, focused on niche prescription drug products in the allergy and respiratory area, including a prefilled epinephrine syringe product that was launched in July 2009, and Adamis Viral Therapies, which is focused on vaccine development. Closing of the deal is subject to customary closing conditions, shareholder approval from both companies, and a minimum net-cash requirement for La Jolla. The companies expect shareholders to vote on the transaction in the first quarter of 2010.

Mylan (Pittsburgh, PA) reported that its subsidiary Mylan Pharmaceuticals has entered into settlement and license agreements with Wyeth (Madison, NJ), now part of Pfizer (New York), for venlafaxine hydrochloride (HCl) extended-release (ER) capsules (37.5 mg, 75 mg, and 150 mg), the generic version of Wyeth’s Effexor ER capsules. Mylan will be granted a nonexclusive license to the relevant patents that would allow the company to launch venlafaxine HCl ER capsules in the US on or after June 1, 2011, or earlier in limited circumstances. The drug had US sales of approximately $2.9 billion for the same strengths in the 12-months ending Sept. 30, according to a Mylan release.

Novo Nordisk (Copenhagen) has in-licensed a fully human anti-IL2 monoclonal antibody (IL-21mAb) and intellectual property right covering IL-21mAb and the development of other IL-21 antibodies from ZymoGenetics (Seattle), a biopharmaceutical company. Under the agreement, Novo Nordisk will pay ZymoGenetics an initial upfront payment of $24 million, plus additional milestones of up to $157.5 million. ZymoGenetics retains the option to fund a portion of Phase III development costs in exchange for an increased royalty rate on US sales and copromotion rights. IL-21mAb is a preclinical drug candidate to treat autoimmune and inflammatory disease.

Pfizer (New York) and Protalix (Carmiel, Israel), a biopharmaceutical company focused on developing proprietary recombinant proteins, have agreed to develop and commercialize taliglucerase alfa, a plant-cell expressed form of glucocerebrosidase as a potential treatment for Gaucher’s disease. Under the terms of the agreement, Pfizer will receive exclusive worldwide licensing rights for the commercialization of taliglucerase alfa, while Protalix will retain the exclusive commercialization rights in Israel. Taliglucerase alfa is the first enzyme-replacement therapy derived from a proprietary plant cell-based expression platform using genetically engineered carrot cells, according to a Pfizer release. Protalix is preparing to complete a rolling new drug application with the US Food and Drug Administration, which has granted the drug orphan drug and fast-track status. Under the agreement, Pfizer will make an upfront payment of $60 million to Protalix and potentially additional regulatory milestone payments of up to $55 million. Pfizer and Protalix will share future revenues and expenses for the development and commercialization of taliglucerase alfa on a 60% to 40% basis, respectively.

The Pharmaceutical Research and Manufacturers of America (PhRMA) reported that seven new member companies have joined the association. They are Cubist Pharmaceuticals (Lexington, MA), OSI Pharmaceuticals (Melville, NY), Alexion Pharmaceuticals (Cheshire, CT), Ferring Pharmaceuticals (Parsipanny, NJ), Talceris Biotherapeutics (Raleigh, NC), Vifor Pharma (Basking Ridge, NJ), and Xoma (Berkeley, CA). The addition of the new companies follows a recent decision by PhRMA to establish a new committee of small biopharmaceutical companies.


Ranbaxy Laboratories (Gurgaon, Haryana, India) and Nippon Chemiphar (Tokyo) have dissolved their joint venture (JV), Nihon Pharmaceutical Industry, in Japan, following an agreement between the two companies that allows Nippon Chemiphar to purchase the entire shares of the JV. Ranbaxy will continue to supply existing generic products manufactured and supplied from its manufacturing plants in India to Nippon Chemiphar to enable the transition in ownership.

Stirling Products (Sydney, Australia) has agreed to acquire a 46,400-ft2 pharmaceutical manufacturing facility in Canada from an undisclosed company. The sale is subject to final ratification through the Canadian courts, which is expected later this month, according to a company press release.

Targacept (Winston-Salem, NC), a biopharmaceutical company, and AstraZeneca (London) have formed a collaboration and license agreement for the global development and commercialization of TC-5214, a late-stage investigational compound being developed by Targacept to treat major depressive disorder. Under the agreement, AstraZeneca will make an upfront payment of $200 million upon effectiveness and up to an additional $540 million if specified development, regulatory, and first commercial-sale milestones are met. Targacept will also be eligible to receive an additional $500 million if other sale milestones are met. The companies will jointly design a Phase III clinical program that is scheduled to begin in mid-2010 and hope to file a new drug application with the US Food and Drug Administration in 2012.

Trellis Bioscience (South San Francisco, CA), a biotechnology company, has granted an exclusive worldwide license to MedImmune (Gaithersburg, MD), the biologics unit of AstraZeneca (London), to develop and commercialize Trellis’s antibodies directed against the respiratory syncytical virus. MedImmune will pay Trellis an upfront payment and additional payments for potential development, regulatory, and commercial milestones up to $338 million.

Vetter (Ravensburg, Germany), a contract manufacturer of prefilled injection systems and fill-finishing, dedicated a new 24,000-ft2 facility at the Illinois Science and Technology Park in Skokie, Illinois. Scheduled to be operational by the end of 2010, the Skokie facility will focus on preclinical through Phase IIb projects and will fill very small quantities of products required for early studies. For Phase III, the projects will be transferred to the company’s German facilities for large-scale production.

Watson Pharmaceuticals (Corona, CA) has completed its $1.75-billion acquisition of Arrow Group, a generic-drug company with 2008 sales of approximately $650 million. As a result of the acquisition, Watson also acquires a 36% interest in Eden Biodesign (Liverpool, UK), a contract service provider of development and manufacturing services for biologics, which provides Watson with a foundation for generic biologics, according to a Watson press release.


People notes

Azopharma Product Development Group (Hollywood, FL), a contract provider of preclinical services, analytical R&D, formulation development, clinical-trial manufacturing, drug-delivery technologies, and clinical services, has announced that Shri Thanedar, PhD., will be Azopharma’s new chief executive officer. Since 1990, Thanedar has been chairman and owner of Azopharma as well as of Chemir Analytical Services, a chemical-testing company. John Gilbert has been named as vice-president of analytical services and will direct the teams responsible for method development/validation, quality-control release, and stability services at the company’s Florida and Missouri sites. Bruce Hardee, vice-president of clinical services, will head the clinical facility that conducts Phase I–III studies. Robert Buta, vice-president of preclinical services, will continue to be responsible for the preclinical facility that supports early-phase development. Kevin Kane has been appointed vice-president of business development. Working with Blair West, senior vice-president of technical affairs, and John McCarty, vice-president of formulation sciences, Kane will promote Azopharma’s Phase I Express development platform. Rod Hartwig, vice-president of formulation and commercial manufacturing, will ensure that development and manufacturing programs are executed on time. Melissa Porazzo, vice-president of corporate compliance, will lead the quality assurance, regulatory affairs and program-management teams. Dan Cammarata will continue as chief financial officer.

The Society of Chemical Manufacturers and Affiliates (SOCMA) has appointed Lawrence D. Sloan as president and CEO, effective Feb. 10, 2010. Sloan succeeds Joseph Acker, who will retire from SOCMA at the end of the month. Sloan previously served as president of the Adhesives and Sealant Council. SOCMA is the US-based trade association of custom and batch manufacturers, including contract manufacturers of active pharmaceutical ingredients and intermediates.