Company and People Notes: Daiichi Sankyo to Acquire a Controlling Stake in Ranbaxy, Amgen Appoints Anna S. Richo Senior Vice-President of Worldwide Compliance, More...

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ePT--the Electronic Newsletter of Pharmaceutical Technology

Also, Shire voluntarily recalls ADHD patch Daytrana

Company Notes

Thousand Oaks, CA (June 4)-Amgen and Wyeth Pharmaceuticals (Collegeville, PA), a division of Wyeth, issued a statement in response to the US Food and Drug Administration Early Communication regarding an ongoing safety review of Tumor Necrosis Factor (TNF) blockers (marketed as “Remicade,” “Enbrel,” “Humira” and “Cimzia”) and the possible association between the use of these medicines and the development of lymphoma and other cancers in children and young adults. The companies support FDA’s review of the safety information for TNF blockers and will continue to assist FDA. View the full statement.

Tokyo, Japan (June 11)-Daiichi Sankyo will acquire a controlling stake in Ranbaxy Laboratories (New Delhi, India) in a tender offer worth as much as $4.6 billion. The closing of the deal is subject to shareholder and customary regulatory approvals. The acquisition is expected to be completed by the end of March 2009, at which time Ranbaxy is expected to become a subsidiary of Daiichi Sankyo.  Malvinder Singh will continue to lead the company as its chief executive officer and managing director and will assume the position of chairman of the board upon closure.

Bergisch Gladbach, Germany (June 2)-Girindus sold its industrial activities at its production site in Halle-Kuensebeck, Germany, to Central Glass Germany GmbH, an affiliate of Central Glass Co., Ltd., Japan. Central Glass Germany will take over process development, upscaling, CGMP production of active pharmaceutical ingredients as well as the fine-chemical business and all related analytical activities. Financial details were not disclosed.

London (June 6)-GlaxoSmithKline (GSK) completed its acquisition of Sirtris Pharmaceuticals (Cambridge, MA) for approximately $720 million through a cash tender offer of $22.50 per share. Through the acquisition of Sirtris, GSK gains a presence in the field of sirtuins, a recently discovered class of enzymes that is believed to be involved in the ageing process. Christoph Westphal, chief executive officer and vice-chair of Sirtris, and team will continue to lead this new unit of GSK.

Paris (June 5)-Ipsen announced three transactions designed to build a commercial presence in North America. In the field of endocrinology, Ipsen entered into a definitive merger agreement by which it would acquire all of the publicly held shares of the biotechnology company Tercica (Brisbane, CA) at a price of $9.00 per share in cash. This move will give Ipsen an initial 25% stake in Tercica with the potential to increase its stake up to 40%. In the field of neuromuscular disorders, Ipsen signed an agreement with Vernalis (Winnersh, UK), a biotechnology company, to acquire its US operations, Ipsen’s future platform for the launch of “Dysport,” and the rights to market “Apokyn.” In the field of hematology, Ipsen entered into a purchase agreement with Octagen (Wilmington, DE) to acquire all related assets of OBI-1 in order to fully control its future development and commercialization. The company is developing OBI-1, recombinant porcine Factor VIII, for the treatment of congenital and acquired hemophilia in patients who develop inhibitory antibodies to human Factor VIII.

Basel, Switzerland (June 4)-Novartis signed a definitive agreement to acquire the biotechnology company Protez Pharmaceuticals (Malvern, PA) along with the rights in North America and Europe to PZ-601, a hospital antibiotic in clinical development. PZ-601 is a new antibiotic in a class of agents known as carbapenems. Under the terms of the agreement, Novartis agrees to fully acquire Protez for $100 million. Protez's owners are eligible for additional payments of up to $300 million, based on clinical milestones, regulatory approval for PZ-601, and the achievement of commercialization targets.

Philadelphia, PA (June 9)-Shire, a biopharmaceutical company, announced a voluntary recall of two lots of the ADHD patch “Daytrana” (lots 2750211 and 2764111). Shire is taking this action because some patches do not meet their release-liner removal specification, and as a result, patients and caregivers could have difficulties removing the liners. This voluntary recall is not due to safety issues. Noven Pharmaceuticals continues to manufacture the product and Shire continues to promote it in the United States.

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Hawthorne, NY (May 28)-The board of Taro Pharmaceutical Industries terminated the May 18, 2007 merger agreement with Aditya Acquisition, a subsidiary of Sun Pharmaceutical Industries (Mumbai, India) because it deemed the merger to be no longer in the best interests of the company. The agreement provided for the acquisition of Taro by Sun for $7.75 per share and allowed either party to terminate after December 31, 2007.

People news

Thousand Oaks, CA (June 6)-Amgen appointed Anna S. Richo as senior vice-president of worldwide compliance. Richo will head the organization responsible for the company's corporate-compliance and business-ethics programs. She will report to Amgen's Chairman and Chief Executive Officer Kevin Sharer.

Malvern, PA (June 10)-Gemin X Pharmaceuticals, a privately held pharmaceutical company, appointed Glenn J. Gormley president and chief executive officer. Gormley has held senior executive positions at Novartis, AstraZeneca, and Merck.

Bothell, WA (June 11)-Shareholders of Nastech Pharmaceutical, a biotechnology company developing RNAi-based therapeutics, approved the decision to change the company's name to MDRNA, Inc. Effective Wednesday, June 11, 2008, the company’s stock will trade on NASDAQ under the symbol MRNA. The company named J. Michael French as chief executive officer, effective June 23, 2008. French succeeds Steven C. Quay, PhD, who has been appointed chief scientific officer and chairman of MDRNA’s scientific advisory board and will remain chairman of the board of directors.

Holmdel, NJ (May 21)-Sparta Systems, a provider of compliance-management software, appointed William B. Gerraughty, Jr. as the company’s senior vice-president and chief financial officer.