Week of June 28, 2010: Company and People Notes: Pfizer Suspends Tanezumab Program; Actavis Appoints CEO; And More.

July 1, 2010
Pharmaceutical Technology Editors

ePT--the Electronic Newsletter of Pharmaceutical Technology

Pfizer Suspends Tanezumab Program; Actavis Appoints CEO; And More.

Company notes

Almac (Craigavon, Northern Ireland) expanded the storage capacity in its new North American headquarters, located in Souderton, Pennsylvania.  The facility features 271,000 ft3 of 2–8 °C cold storage, or space for up to 1600 pallets. Additionally, storage for 15–25 °C products can hold 6300 pallets, a 6131-ft3 storage unit for products between -25 to -15 °C is available, as well as mobile freezer units for products between -80 to -60 °C. Operations will transfer to the new facility during fall 2010, according to a company press release.

AstraZeneca (London) and Medicines for Malaria Venture (MMV), a not-for-profit public–private partnership, announced a collaborative agreement designed to identify candidate drugs for the treatment of malaria. The agreement will initially allow MMV access to AstraZeneca’s extensive compound library with the goal of identifying compounds with the potential to treat malaria, including drug-resistant strains of the disease.

Bayer Schering Pharma (Berlin) launched Sativex (delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD)), a cannabinoid medicine derived from whole plant extracts from the cannabis sativa plant, in the United Kingdom. Sativex is used to treat spasticity associated with multiple sclerosis and is available as a mouth spray. The drug was developed by GW Pharmaceuticals (Salisbury, UK) and will be marketed by Bayer in the UK.

Cadence Pharmaceuticals (San Diego), a biopharmaceutical company, signed an option agreement to acquire Incline Therapeutics (Redwood City, CA), a specialty pharmaceutical company. Incline is developing Ionsys (fentanyl iontophoretic transdermal system), an investigational product candidate intended to provide patient-controlled analgesia for adult inpatients requiring opioids following surgery. Ionsys was approved by both the US Food and Drug Administration and the European Medicines Agency in 2006; however, it is not currently marketed anywhere in the world. Upon closing of the transaction, David Socks, senior vice-president of corporate development and strategy of Cadence, resigned from Cadence to join Incline as president and chief operating officer.

Celator Pharmaceuticals (Princeton, NJ), a pharmaceutical company focused on cancer therapies, expanded its research agreement with the biopharmaceutical company Cephalon (Frazer, PA). The research agreement provides for the use of Celator's proprietary technology in an ongoing drug-development and life-cycle-management program at Cephalon.Terms and conditions of the research agreement are confidential.

Dyax (Cambridge, MA) and Defiante Farmaceutica, a subsidiary of the pharmaceutical company Sigma-Tau (Rome), formed a drug-development pact for subcutaneous DX-88 (ecallantide) for the treatment of hereditary angioedema and other therapeutic indications throughout Europe, North Africa, Middle East, and Russia. Dyax retains its rights to subcutaneous DX-88 in other territories, including the US, where DX-88 has been approved by FDA and is marketed as Kalbitor (ecallantide). Sigma-Tau will make a $2.5 million upfront payment and will purchase $2.5 million in equity shares at a 50% premium above market value. Dyax will be eligible to receive more than $100 million in milestone payments, plus royalties on sales.

GlaxoSmithKline (GSK, London) obtained the rights to the over-the-counter cold sore treatment Xerclear (acyclovir and hydrocortisone) from Medivir (Huddinge, Sweden). Under the terms of the agreement, GSK gains exclusive rights to commercialize and distribute Xerclear as part of the Zovirax (acyclovir topical) franchise, across multiple markets, including Europe, Russia, Japan, India, Australia, and New Zealand. The agreement excludes North and South America, China, South Korea and Israel. In addition to funding the commercial development of Xerclear, GSK will pay up to EUR 3 million ($3.66 million) in upfront and prelaunch milestones and up to double-digit royalties on sales.

Gilead Sciences (Foster City, CA) and CGI Pharmaceuticals (Branford, CT), a pharmaceutical company focused on small-molecule chemistry and kinase biology, signed an agreement under which Gilead will acquire CGI for up to $120 million. Gilead anticipates that the deal would close in the third quarter of 2010, and that CGI will continue operations in Branford as a wholly owned subsidiary of Gilead.

Marcadia Biotech (Carmel, IN) and Eli Lilly (Indianapolis) signed a drug-development agreement for Marcadia's short-acting glucagon program, covering glucagon analogs that may provide greater convenience than the current recombinant glucagon for the treatment of severe hypoglycemia. The program includes MAR531, a glucagon analog that is in preclinical development at Marcadia, as well as related backup compounds. Marcadia will continue to oversee development of MAR531 through regulatory approval in the US, and Lilly will be responsible for obtaining approval outside the US and for commercialization worldwide. Financial terms were not disclosed.

Merck & Co. (Whitehouse Station, NJ) will challenge the decision returned by a New York jury in the retrial of a federal Fosamax case, Boles v. Merck. This case was the Plaintiffs' Steering Committee's top choice to take to trial and involved a Florida woman who blamed her dental and jaw problems on Fosamax (alendronate sodium), a Merck drug to treat and prevent osteoporosis. Merck said in a press release that it “believes the verdict is contrary to the evidence presented at trial and that the award of compensatory damages is unjustified and excessive.”

In a separate announcement, Merck (known as MSD outside the United States and Canada) announced a collaboration between MSD South Africa and Adcock Ingram (Midrand, South Africa), a publicly held South African healthcare company, to market a number of established MSD products in South Africa. The products include over-the-counter products and selected prescription medicines currently registered in South Africa by MSD and Schering-Plough. Financial details were not disclosed.

Minapharm Pharmaceuticals (Cairo), a US-Egyptian joint-venture pharmaceutical company, has completed the acquisition of 95% of the share capital of ProBioGen (Berlin), a contract biologics manufacturer. The total purchase price of EUR 30.4 million ($37 million) includes earn-out milestone payments. ProBioGen appointed Wieland Wolf as its new CEO.

The National Institutes of Health (NIH), an agency of the US Department of Health and Human Services, and the Wellcome Trust, a global charity based in London, will support population-based genetic studies in Africa of common, noncommunicable disorders such as heart disease and cancer, as well as communicable diseases such as malaria. Called the Human Heredity and Health in Africa project, or H3Africa, the effort will receive $5 million each year from NIH for five years starting in 2011. NIH also provided $750,000 to begin organizing the project. The Wellcome Trust will contribute at least $12 million over the next five years, as well as administrative support, training, and scientific consultation.

Pfizer (New York) suspended its osteoarthritis clinical program for the investigational compound tanezumab following a request by FDA, effective immediately. The worldwide suspension follows a small number of reports of tanezumab patients experiencing the worsening of osteoarthritis leading to joint replacement. To date, this adverse event has not been observed in non-osteoarthritis patient populations taking tanezumab. Pfizer is working with FDA to determine the appropriate course of action, according to a company press release.

Quotient Bioresearch (Cardiff, UK), a provider of drug-development services, opened a radiochemistry facility in Cardiff, United Kingdom and shipments of radiolabelled products have commenced. The new facility follows the company’s acquisition of Amersham Radiolabelling Services from GE Healthcare in June 2009.  The facility will produce radiolabelled compounds for the custom synthesis of carbon-14 and tritium labelled compounds. Quotient manufactures custom radiolabelled drugs for use in both preclinical and clinical settings.

Contract manufacturer Saltigo (Leverkusen, Germany) passed an audit by FDA in its Leverkusen, Germany, facility. The audit focused on testing production and quality-assurance processes for an active ingredient that a Saltigo customer intends to supply in the United States in the near future.

sanofi-aventis (Paris) and Metabolex (Hayward, CA), a biopharmaceutical company, formed a licensing agreement for MBX-2982, an oral agent, GPR119 receptor agonist, for the treatment of Type II diabetes. sanofi-aventis will receive an exclusive worldwide license to develop, manufacture, and commercialize MBX-2982, currently in Phase IIa, and related compounds. Metabolex will receive an upfront payment and milestone payments up to a total of $375 million, plus royalties on product sales.

TraceLink (Woburn, MA), a provider of supply- collaboration technology, and Catalent Pharma Solutions (Somerset, NJ), a contract services provider, formed a partnership aimed at improving visibility for Catalent customers across their manufacturing and packaging product life cycle. Catalent plans to continuously evolve the collaboration program based on customer feedback of data-sharing and business-process needs. The program will be launched throughout its network starting in the third quarter 2010.

People notes

Actavis Group (Reykjavik, Iceland), the generic-drug pharmaceuticals company, appointed Claudio Albrecht as its new CEO. Sigurdur Oli Olafsson is stepping down as CEO. Albrecht previously served as CEO of the generic-drug company Ratiopharm (Ulm, Germany).

Ariad Pharmaceuticals (Cambridge, MA) named Timothy P. Clackson as the company's first president of research and development. Clackson, who joined the company in 1994, also retains his position as chief scientific officer.

Stephen Tindal, director of softgel formulation and operations for contract services provider Catalent Pharma Solutions (Somerset, NJ), was accepted as a member of the United States Pharmacopoeia (USP) advisory panel focusing on liquid-filled gelatin capsules. The panel will discuss dissolution testing of liquid-filled gelatin capsules for prescription, over–the–counter medicines, and other healthcare products manufactured or sold in the United States.

Codexis, a biotechnology company, appointed Peter Strumph senior vice-president of commercial operations, a new position. Strumph will be responsible for the company’s pharmaceutical product management and manufacturing operations worldwide. He will report to Joseph Sarret, chief business officer and president of pharmaceutical services and enzyme products.

Lancaster Laboratories (Lancaster, PA), part of Thermo Fisher Scientific, named Jeri Ann Boose director of biopharmaceutical services. Boose will focus on the company’s biopharmaceutical testing business, which includes biochemistry, cell and molecular biology, and virology.

NanoString Technologies (Seattle), a biotechnology company, appointed Brad Gray as president and CEO. Gray joins NanoString from Genzyme Genetics, the diagnostic services division of Genzyme (Cambridge, MA), where he was most recently vice-president of product and business development.

Noxxon Pharma (Berlin) announced that its CEO, Frank Morich, will leave the company, effective Aug. 15, 2010. Morich will become executive vice-president of international operations at Takeda Pharmaceutical. Iain Buchanan, a current director of Noxxon, will serve as interim CEO as of Sept. 1, 2010.

Rivertop Renewables (Missoula, MT), a renewable chemicals company, named James Stoppert as its CEO. Stoppert previously served as president and CEO at Segetis (Golden Valley, MN), a renewable chemical company.