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Also, Roche to end HIV/AIDS research program, WuXi PharmaTech makes appointments, more...
Wilmington, NC (July 10)-AAIPharma’s Wilmington, North Carolina, facility received a certificate for European Union Good Manufacturing Practices (EU GMP) from Sweden’s Medical Products Agency. This certification from a European member state regulatory authrority allows AAIPharma to produce tablets, capsules, and other solid-dose drug products for shipment to countries in Europe. This is the company’s second EU GMP-certified facility; the first was its Charleston, South Carolina, plant. AAIPHarma is a contract service provider.
Indianapolis, IN (July 8)-Eli Lilly will acquire SGX Pharmaceuticals (San Diego, CA), a biotechnology company, in an all-cash transaction. Under the terms of the agreement, Lilly will acquire all of the outstanding shares of SGX's common stock for $3.00 per share, for a total purchase price of approximately $64 million.
Boston, MA (July 10)-Enlight Biosciences was launched by PureTech Ventures, Merck & Co., Pfizer, and Eli Lilly, as a new, collaborative company focused on drug discovery and development. Enlight announced that it will direct up to $39 million to advance breakthrough technologies. For more, see “If You Can't Beat Them, Join Them” at PharmTech Talk, the blog of Pharmaceutical Technology.
Mumbai, India (July 3)-The contract manufacturer Hikal received an investment of $15 million from the International Finance Corporation (IFC), a member of the World Bank group. The investment will be used for Hikal’s expansion plans.
Basel, Switzerland (July 11)-Novartis entered an agreement with Lonza (Basel, Switzerland) by which Lonza will provide development and clinical production services for part of Novartis’s biologics pipeline. Under the terms of the agreement, following successful development of a compound, Novartis can choose to transfer the commercial manufacturing in-house. Lonza will provide Novartis with extra manufacturing capacity, to be used in a flexible way.
In other Novartis news, on July 10 the company purchased an additional 51.7% stake in Speedel (Basel, Switzerland), a biopharmaceutical company, and plans to acquire the remaining shares through a mandatory public tender offer. The total acquisition costs are estimated at CHF 907 million ($880 million). Following completion of the transaction, Novartis will own a 61.4% stake in Speedel.
Basel, Switzerland (July 11)-Roche will end its AIDS research program. The company sent an email last week to AIDS activist groups saying its current candidates do not offer a significant improvement over existing drugs and further research will be suspended. Research scientists working on the drugs will be reassigned to other projects. Roche says it will continue making its existing AIDS drugs, “Fuzeon,” “Viracept,” and “Invirase,” and diagnostics.
Bothell, WA (July 8)-Seattle Genetics formed a collaboration agreement with Daiichi Sankyo (Tokyo, Japan) for the development of antibody-drug conjugates targeting a single antigen found on multiple types of solid tumors. Under the terms of the collaboration, Seattle Genetics will receive an upfront payment of $4 million, milestone payments, and royalties on worldwide sales. Daiichi Sankyo is responsible for research, product development, manufacturing and commercialization. Seattle Genetics will receive material supply and annual maintenance fees as well as research support payments for assistance provided to Daiichi Sankyo.
Brussels, Belgium (July 9)-Solvay Pharmaceuticals raised its bid to acquire Innogenetics (Gent, Belgium), a biotechnological company, by increasing its initial conditional tender offer to EUR 6.50 ($10.32) per share, a total cash transaction of EUR 200.7 million ($319 million) for the outstanding shares. On April 25, 2008, Solvay made an offer of EUR 5.75 per share, and on June 3, 2008, Gen-Probe offered Innogenetics shareholders EUR 6.10 ($9.69) per share. Gen-Probe said last week that it will not raise its bid to acquire Innogenetics.
Rockville, MD (June 30)-Travanti Pharma (Mendota Heights, MN), a drug delivery company, received a warning letter from FDA. The letter (dated June 30 and recently posted on FDA’s website) states that during a clinical trial for a device-drug combination product, Travanti was cited for failure to submit investigational new drug applications, failure to get investigator statements before the investigation, failure to select a monitor of the investigation’s progress, failure to maintain drug disposition records, and failure to maintain accurate records. After FDA visited Travanti February 19–28, 2008, the agency issued a Form 483. The company responded in a March 11, 2008, letter that corrective actions would be taken. FDA stated in the warning letter that a detailed outline of the corrective actions was not provided.
Somerset, NJ (July 14)-Catalent Pharma Solutions, a provider of packaging services, appointed Victor Dixon vice-president and general manager for the Printed Components business of its Packaging Services segment. Dixon will be based in the company’s Red Lion Road facility in Philadelphia, Pennsylvania.
Chicago, IL (July 10)-Celsis International, a provider of rapid microbial detection solutions, appointed John H. Albright as the head of regulatory affairs and compliance for Celsis Rapid Detection. In this role, Albright will serve as liaison to regulatory bodies and industry associations.
New York (July 14)-ImClone Systems, a biotechnology company, announced that Michael P. Bailey resigned his position as senior vice-president of commercial operations, effective August 1, 2008. The company appointed Joseph I. DePinto as vice-president of commercial operations, effective July 14, 2008, and DePinto will take over for Bailey on August 1.
Miami, FL (July 14)-Noven Pharmaceuticals appointed Joel S. Lippman as vice-president of clinical development and chief medical officer, effective immediately. In this role, Lippman will lead all aspects of the clinical, regulatory, and medical affairs functions at Noven.
Shanghai, China (July 14)-WuXi PharmaTech named Richard M. Soll as WuXi’s vice-president of medicinal chemistry. Soll will report directly to Shuhui Chen, chief scientific officer of the company. On July 10, WuXi appointed Debra Yu as vice-president of strategy. Yu will report directly to Ge Li, chairman and chief executive officer.