AstraZeneca reports that Axanum, a fixed-dose combination of 81-mg low-dose acetylsalicylic acid and 20-mg esomeprazole, used to treat cardiovascular events, has received positive agreement for approval in 23 European Union member countries and in Norway. The EU decision took place under the decentralized procedure, with Germany acting as reference member state. This process will be followed by national approvals and local pricing and reimbursement discussions.
Biotica Technology, a biotechnology company, has regained full rights from Pfizer to its rapamycin analogue program, including transfer of data and materials. Biotica partnered with Wyeth Pharmaceuticals (acquired by Pfizer in October 2009) in 2006 to begin the program, which includes clinical candidates for treating neuro-inflammatory and other diseases.
Catalent Pharma Solutions’ Clinical Supply Services division has expanded its global cold-chain supply operations in the United States, United Kingdom (UK), and Germany, to meet increasing demands for more global supply. The expansions will be implemented in all major areas of Catalent’s cold-chain storage and distribution, including 2°C to 8°C, and -80°C capabilities, and more than triple existing capacity for storage and distribution in some instances. Catalent expects that the cold-chain expansion at Catalent’s European sites in Bolton, UK, and Schorndorf, Germany, will be completed by the end of 2011.
Daiichi Sankyo and Ranbaxy Laboratories, an Indian pharmaceutical company, have announced the expansion of the companies’ hybrid business model to develop generic drugs. The expansion includes the development of olmesartan medoxomil, a drug to treat conditions associated with high blood pressure, which is expected to launch in Mexico before the end of 2011.
The biopharmaceutical company Dendreon reported in its second-quarter 2011 results that it expects to reduce expenses, including workforce reductions, to align costs to its near-term manufacturing requirements for Provenge, an immunotherapy to treat prostate cancer. In June 2011, FDA approved Dendreon’s Seal Beach, California, immunotherapy-manufacturing facility, and in April 2011, Dendreon filed a post-approval supplement for its Atlanta facility, for which there is an FDA action date of Aug. 28, 2011.
Forest Laboratories reports that the Office of the Inspector General, Department of Health and Human Services (HHS–OIG) has notified Howard Solomon, Forest’s chairman, CEO, and president, that it has decided not to pursue his exclusion from federal healthcare programs. Solomon was notified that HHS–OIG was considering his exclusion in connection with matters that were settled by Forest in 2010. Mr. Solomon received a notification in a letter from HHS–OIG on Aug. 5, 2011, that it had decided not to seek his exclusion.
The biopharmaceutical company Gilead Sciences has agreed purchase from Roche’s Genetech a 70,000-ft2 clinical biologics manufacturing facility in Oceanside, California. The agreement covers the facility as well as certain other process-development assets. Genentech will continue to operate and maintain ownership of the Oceanside commercial manufacturing facilities. As part of the acquisition, approximately 55 current Genentech clinical-manufacturing and process-development employees will be offered employment at Gilead. The transaction is expected to close in the third quarter of 2011, subject to satisfaction of certain conditions.
MolMed, a biotechnology company, and GlaxoSmithKline (GSK) have agreed develop a production process for an investigational gene therapy for treating adenosine deaminase deficiency–severe combined immune deficiency (ADA–SCID). Under the agreement, MolMed will receive up to EUR 5.5 million ($7.8 million) in revenues over a two-year period.
Unigene Laboratories, a CDMO, has entered into a development-services and clinical-supply agreement with GSK. Under the agreement, Unigene will receive up to approximately $2.2 million in milestone payments from GSK to undertake certain development and manufacturing activities. These activities are related to the API and finished-drug product for an oral formulation of a recombinantly produced investigational parathyroid hormone analog for treating osteoporosis in postmenopausal women in advance of GSK’s potential decision to study the molecule in a Phase III program.
Gore, a producer of pharmaceutical components, is combining a portfolio of products sold into the pharmaceutical, biopharmaceutical, and life-science markets. The integration will focus and expand business by unifying sales, operations, quality, and technical functions. As part of the expansion, Gore plans to comply with ISO 13485 requirements, and the integrated operations are expected to begin in early 2012.
International Chemical Investors Group (ICIG), a privately owned industrial holding company focusing on mid-sized chemicals and pharmaceutical companies, has agreed to acquire Roche Colorado, which includes Roche’s pharmaceutical production facility in Boulder, Colorado. Under the agreement, ICIG will acquire the Roche affiliate company in Boulder with its technical-development and small-molecule manufacturing capabilities. ICIG intends to operate the Boulder site, which will be renamed Corden Pharma Colorado, and be a part of its pharmaceutical business within the Corden Pharma organization. Under their agreement, Corden Pharma Colorado will supply Roche with a number of APIs that the Boulder site currently produces.
Marken, a logistics and supply-chain service provider, has announced the planned Sept. 1, 2011, launch of its Latin American regional depot network with facilities in Mexico City and Buenos Aires. Additional depot facilities are planned in the Middle East, Europe, Asia, and the Americas. Each of Marken’s depots will also offer specimen kit distribution, collection, storage, and management as well as reverse logistics for dosage kits, drugs, and equipment, including reconciliation and certified destruction.
Merck & Co. and the vaccine manufacturer Serum Institute of India have agreed to develop and commercialize a pneumococcal conjugate vaccine (PCV) for use in emerging markets and developing countries. The companies will form a product advisory committee to oversee the activities required to develop and seek approval for PCV and World Health Organization prequalification. Under the agreement, Merck, through an affiliate, will receive specific rights to market PCV in certain designated territories, and Serum will receive specific rights in other territories. Both companies will contribute to the development and manufacture of PCV.
Dey Pharma, a subsidiary of the specialty pharmaceutical company Mylan, reports that the US Patent and Trademark Office intends to reissue both of the patents related to Perforomist (formoterol fumarate) inhalation solution 20 mcg/2-mL vial that had been placed into re-examination by Sepracor (now known as Sunovion Pharmaceuticals). Including the two expected reissued patents, Dey believes that seven US patents are infringed by Sunovion’s Brovana product. In addition, Dey believes that Teva’s formotorol fumarate product pending before the FDA also infringes several of Dey’s US patents. The terms of the patents protecting Perforomist extend into 2021.
NPS Pharmaceuticals, a specialty pharmaceutical company developing orphan therapeutics for rare gastrointestinal and endocrine disorders, has entered into a new agreement with GSK, which terminates and replaces a prior research and license agreement between NPS and GSK from 1993, which focused on the discovery and development of small-molecule antagonists of the calcium receptor that increase secretion of parathyroid hormone (calcilytics). As part of the new agreement, GSK will assign to NPS the investigational new drug filings for two calcilytic compounds, SB-423557 and SB-423562 (NPSP790 and NPSP795). The new agreement expands the research for ronacaleret, which was discovered under the 1993 agreement and studied as a treatment for osteoporosis in post-menopausal women, to allow GSK to pursue stem-cell transplants, in addition to treatments for osteoporosis and other bone disorders. GSK will be responsible for all development, manufacturing, and commercialization of ronacaleret. NPS will be entitled to development milestones and royalties on any future sales of ronacaleret. GSK will no longer have rights to other calcilytic compounds discovered or developed under the 1993 agreement.
SynCo Bio Partners, a biopharmaceutical CMO, reports that its aseptic-filling facility is fully operational, and it has produced and released the first drug-product batches after the expansion of the Class A zone.
Takeda and the biopharmaceutical company Amylin Pharmaceuticals are discontinuing development of pramlintide/metreleptin, an investigational combination therapy for treating obesity. The joint decision was based on a commercial reassessment of the pramlintide/metreleptin program, which had been in Phase II development as a twice-a-day injection formulation. The companies will continue to evaluate other assets as potential candidates for the treatment of obesity and related indications under the terms of their existing collaboration agreement.
Nycomed US has appointed Brian A. Markison as president and CEO and member of the board for what will be the newly formed standalone corporation following the acquisition of Nycomed A/S by Takeda Pharmaceuticals. The company also appointed Jeff Bailey to the newly created position of chief operating officer, and John Golubieski as chief financial officer.
Pfizer’s Gary Pelletier has been appointed as chairman of the board of managers to the Together Rx Access Program, a prescription savings program sponsored by many of the nation’s leading pharmaceutical companies. He previously served as vice-chairman of the board of Together Rx Access.