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AstraZeneca Receives FDA Approval for Brilinta; Sanofi Makes Several Senior Appointments; and More.
AstraZeneca has received FDA approval for Brilinta (ticagrelor) a new molecular entity for treating acute coronary syndrome.
The sterile injectables contract manufacturing organization (CMO) JHP Pharmaceuticals has agreed to produce clinical-trial batches of a drug used to treat heart failure with an undisclosed biotech company.
Laureate Biopharmaceutical Services, a biopharmaceutical contract development and manufacturing organization (CDMO), has entered into a multiyear development and manufacturing agreement with a generic pharmaceutical company to produce a biosimilar product. Under the agreement, Laureate’s services will include transfer of the manufacturing process to Laureate and cGMP manufacture of this product for clinical trials through 2013. The agreement includes a customer option for long-term commercial supply. Laureate expects to supply the first batch of clinical product during the first half of 2012. Terms of the manufacturing agreement were not disclosed.
Cellectis bioresearch, a provider of genome-engineering tools and expertise and a subsidiary of Cellectis, and the CMO Lonza have reached a milestone in the development of a newly bioengineered cell line. Using their meganuclease technology, Cellectis bioresearch has deactivated the cell-based glutamine synthetase (GS) in CHO-K1SV, Lonza’s host cell line.
In other news, Lonza has signed an exclusive contract for the production of Immune Pharmaceutical’s human immunoglobulin monoclonal antibody, Bertilimumab, under investigation for the potential treatment of several inflammatory disorders. Under the agreement, Lonza will produce Phase II clinical-trial material at its mammalian development and manufacturing facility.
Merck and Astellas US, the US subsidiary of Astellas Pharma, have formed an agreement under which Merck, through a subsidiary, will acquire from Astellas the exclusive rights to develop and commercialize the investigational intravenous formulation of vernakalant (vernakalant IV) in Canada, Mexico, and the US. Vernakalant IV is currently approved in more than 10 European countries for the conversion of recent onset atrial fibrillation (AF) to sinus rhythm. Under the terms of the agreement, Merck will pay Astellas an undisclosed upfront fee, and Astellas will be eligible for milestone payments associated with development and regulatory approval as well as sales thresholds achieved in Canada, Mexico, and the US.
Additionally, Merck has has signed a joint venture with the Chinese pharmaceutical company Simcere Pharmaceutical. The establishment of the joint venture is subject to satisfying certain agreed to closing conditions. The potential partnership will focus on development, registration, manufacturing, and sales with an initial focus on branded pharmaceutical products for metabolic diseases.
Pfizer and the biopharmaceutical company Icagen have entered into a definitive merger agreement. Pfizer, which currently owns approximately 11% of Icagen’s fully diluted shares, will acquire the remaining 8.3 million shares at a price of $6.00 per share. The aggregate transaction value, including the value of the shares currently owned by Pfizer, is approximately $56 million. The agreement, subject to customary conditions and regulatory approval, has been targeted to close before the end of 2011. Icagen partnered with Pfizer in 2007 for developing compounds that modify specific ion channels for treating pain and related disorders.
The specialty pharmaceutical company Adventrx has appointed Gregory D. Gorgas as senior vice-president of the company’s commercial division. He was previously with Biogen Idec, where he was head of global marketing.
The biopharmaceutical company Amylin Pharmaceuticals has appointed Robert MacKay as general manager of its West Chester, Ohio, manufacturing facility. His previous experience includes leadership roles at Eli Lilly.
Patheon, a CDMO, has appointed Gary Shope to the newly created position of chief of staff. Shope will report to James C. Mullen, Patheon’s CEO.
RecipharmCobra Biologics, a biopharmaceutical CMO, has named Julian Hanak as commercial director. Hanak was formerly the senior vice-president of development at Renovo, a biopharmaceutical drug-development company.
has announced the appointments of two senior executive positions. President and CEO Greg Irace was appointed to the newly created role of senior vice-president of global services. He will lead Sanofi’s global information systems funtion and will manage the development of a global strategy for shared services. Anne C. Whitaker has been named president of Sanofi’s North American pharmaceutical division, effective Sept. 1, 2011. She will report to Hanspeter Spek, Sanofi’s president of global operations, and join the global management committee.