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Providing the latest business, scientific, and regulatory news for the pharmaceutical and biotech industries.
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Week of Mar. 31, 2011: Company and People Notes: Greenstone Initiates Voluntary Recall for Possible Mislabeling; Tim McFadden Hired at Catalent; and More.
The contract development and manufacturing organization (CDMO) Almac has expanded its commercial facilities to include an additional 6124-ft2 of cold and frozen storage.The expansion is a joint investment with a commercial client, for which Almac provides central EU importation, warehousing and distribution services. This includes dedicated -70 °C, -20 °C, and 2–8°C storage for drug antibody, drug linker, bulk drug substance, placebo, and filled vials.
Astellas Pharma has exercised its option to purchase all of Maxygen’s equity interests in Perseid Therapeutics, a company specializing in protein pharmaceutical development, at the current exercise price of $76.0 million. Under the terms of the companies’ 2009 joint venture arrangement, Maxygen transferred substantially all of its protein pharmaceutical programs and related assets and research and development personnel to Perseid and granted Astellas an option to acquire all of Maxygen’s ownership interest in Perseid at specified exercise prices that increased each quarter over the term of the option, which was scheduled to expire on September 18, 2012.
Boehringer Ingelheim formally acquired Amgen’s biopharmaceutical development and manufacturing facility in Fremont, California. This acquisition involves leasing buildings, acquiring physical equipment, and assuming manufacturing processes done at the Fremont site. The facility currently employs more than 300 employees and consists of more than 200,000 feet2 for laboratories, manufacturing, and process development suitable for clinical and market supplies. The purchase agreement was signed in January 2011.
Gerresheimer, a pharmaceutical packaging company, has acquired the Brazilian company Védat to strengthen its pharmaceutical plastic packaging business in South America.
JHP Pharmaceuticals, a provider of contract manufacturing services for sterile injectable products, has entered into a multiyear contract-manufacturing agreement with an undisclosed biotechnology company. JHP will be responsible for manufacturing and supply of a sterile liquid product used in processing biologics.
Lonza, a contract development and manufacturing organization, has formed an agreement with biopharmaceutical company Athera Biotechnologies. Lonza will initiate cell line and process development for Athera’s monoclonal antibody PC-mAb. Athera’s PC-mAb is intended for the treatment of patients with acute coronary syndrome who are at an increased risk of secondary cardiovascular events and death. This agreement secures a development and cGMP manufacturing plan for Athera. Lonza will initiate cell line and process development using Lonza’s GS Gene Expression System.
Merck & Co. and the biopharmaceutical company Portola Pharmaceuticals have announced that Merck plans to return to Portola all rights for betrixaban, an investigational oral Factor Xa inhibitor anticoagulant being evaluated for the prevention of stroke in patients with atrial fibrillation.
Merck KGaA has agreed to acquire the microbiology business of Biotest, a company specializing in immunology and hematology. This business consists of heipha Dr. Müller GmbH, located in Eppelheim, Germany, as well as the Hycon business located in Dreieich, Germany, the subsidiaries in France, Japan, and the US as well as further activities and employees in several European countries. Closing of the transaction is expected in the second half of 2011.The acquisition allows the Merck Millipore division to complete its product portfolio in industrial microbiology for contamination detection. Specifically, the business will add to Merck Millipore’s existing dehydrated cell-culture media and testing systems the so called “ready-to-use” culture media and instruments.
PerkinElmer has signed a definitive agreement to acquire CambridgeSoft, a provider of software, scientific services, and professional services to the pharmaceutical industry, and has completed the purchase of ArtusLabs, a provider of data integration for electronic laboratory notebooks.
Greenstone, a Pfizer subsidiary, is voluntarily conducting a recall, to the patient level, of medicines with lot number FI0510058-A on the label. The recall applies to citalopram 10-mg tablets (100-count bottle) and finasteride 5-mg Tablets (90-count bottle), both distributed in the US market. The recall is due to the possibility that incorrect labels were placed on the bottles by a third-party manufacturer.
Procter & Gamble and Teva Pharmaceutical Industries have signed a master agreement to create a partnership in consumer healthcare by bringing together both companies' existing over-the-counter medicines.
Sanofi-aventis formed a cooperation agreemtn with Fovea Pharmaceuticals, its Ophthalmology Division, and the Vision Institute (Institut de la Vision), one of the main eye-disease research centers in Europe, for research in the diagnosis, prevention, and treatment of ocular diseases. The agreement aims to set up a privileged partnership between sanofi-aventis and the Vision Institute on the model of translational research and developoment and to strengthen the collaboration of sanofi-aventis with the bodies constituting the Vision Institute, such as the Pierre and Marie Curie University (UPMC), INSERM, the French National Institute of Health and Medical Research, and CNRS, the French National Center for Scientific Research.
Mark Larsen has been hired as senior vice-president of Alfa Laval’s Hygienic Division. In this role, Larsen will be responsible for implementing sales and marketing strategies to drive profitable growth for the company’s life-science, sanitary, food and vegetable oil segments.
The contract development and manufacturing organization Catalent Pharma Solutions has appointed Tim McFadden as vice-president/general manager of Consumer Health Softgel, effective immediately. McFadden will be located at Catalent’s corporate headquarters in Somerset, New Jersey. Jorge Castro, the incumbent in this role, is retiring from Catalent at the end of March.
Richard J. Meelia will retire as president and CEO of Covidien, effective July 1. Meelia will serve as nonexecutive chairman of the board for a transition period of up to one year following his retirement as CEO. In addition, Jose (Joe) E. Almeida, president of Covidien's medical-devices business segment, has been elected to succeed Meelia as president and chief executive officer.
Laureate Biopharmaceutical Services, a provider of contract biologics manufacturing services, announced that Ann M. Daus, PhD, has joined the company as vice-president, quality. Daus will lead the implementation of Laureate’s strategic quality plan, recruit new leaders to supplement the quality management team, lead the strategic expansion of testing services, and improve companywide systems.
Pharmaceutics International (Pii), CDMO, announced the appointment of Rampurna Prasad Gullapalli as vice president of drug delivery technologies. Gullapalli is responsible for providing strategic scientific and technical leadership in areas of softgel, liquid‐filled hard capsules, and drug-delivery technologies for Pii’s contract development and manufacturing business.