|Email Newsletters from Pharmaceutical Technology and Pharmaceutical Technology Europe|
Providing the latest business, scientific, and regulatory news for the pharmaceutical and biotech industries.
News from Europe's pharmaceutical manufacturing industry coupled with upcoming events, and exclusive articles and interviews from industry experts.
Week of Oct. 17, 2011: Pfizer Signs Drug-Development Pact with GlycoMimetics; Lilly Announces Changes in Senior Management; and More
The CRO BASi (Bioanalytical Systems) has renovated space at its preclinical toxicology site in Evansville, Indiana, and will relocate several research services to its facility at Purdue Research Park in West Lafayette, Indiana, creating several new positions. In addition, BASi also has added research instrumentation at its bioanalytical laboratories at three sites. The company is using some proceeds of a $5.5-million public offering in May 2011, to make capital improvements and purchase laboratory equipment. In addition, BASi is relocating its in vivo discovery services in 2012 to its West Lafayette facility. Several new positions will be created to staff the laboratories.
The Bristol-Myers Squibb Foundation has announced a collaboration with the World Health Organization’s Stop TB Department for a two-year pilot initiative to strengthen community-based prevention, care, and control of tuberculosis (TB), including coinfection with HIV in South Africa, Tanzania, Kenya, Ethiopia, and the Democratic Republic of the Congo. These five countries collectively represented more than 13% of global TB and more than one-third of the TB/HIV coinfection burden in 2009.
The CDMO DPT Laboratories has announced continued investments in its manufacturing facilities. Since completing $45 million in capacity expansion and equipment upgrades for its San Antonio, Texas, and Lakewood, New Jersey, facilities in mid-2010, DPT plans to invest another $14 million in the facilities. DPT will invest almost $4 million in additional upgrades to its compounding and packaging facilities, including a washroom expansion for capacity and process-flow improvements at its center for semisolids and liquids in San Antonio. Equipment upgrades over the next few months will include a new small-scale compounding suite with two new dissolvers, as well as new infrastructure to handle larger deliveries from suppliers to support increased production at the facility. After completing $30 million in expansions and upgrades at its sterile and specialty products facility in Lakewood last year, DPT will invest another $10 million in the facility. Equipment upgrades expected to be in place within the coming months include installation of a new small-volume parenteral filler that is designed to be fully automated, integrated, and isolated from vial wash through tray filling.
Ligand Pharmaceuticals, a biotechnology company, has entered into a global licensing agreement with the biopharmaceutical company Chiva Pharmaceuticals for Fablyn (lasofoxifene), a selective estrogen receptor modulator for treating osteoporosis in postmenopausal women at increased risk of fracture. In return for the license, Ligand will receive $4 million in licensing payments over the next eight months and is also eligible to receive milestones and royalties on worldwide sales of Fablyn.
US Senator Robert Menendez (D-NJ), New Jersey Lieutenant Governor Kim Guadagno, and regional leaders of the biopharmaceutical industry unveiled the new Cranbury, New Jersey, home of Oncobiologics a biotechnology firm. Earlier this month, the company signed two agreements. The first was with Parilis Biopharmaceuticals, an early-stage biotech company, and involves worldwide licensing for an undisclosed biotherapeutic product. The second is with an undisclosed US-based pharmaceutical company to conduct research focused on solving issues related to downstream processing of monoclonal antibodies. The combined value of the agreements to Oncobiologics totals approximately $80 million.
The biopharmaceutical company Onyx Pharmaceuticals and Bayer HealthCare restructured their partnership for the global development and marketing of Nexavar (sorafenib) tablets and entered into a new agreement related to regorafenib, a late-stage oncology compound. Under the terms of the agreements, regorafenib is a Bayer compound, and Bayer will have the final decision-making authority for global development and commercialization. Onyx will receive a royalty on any future global net sales of regorafenib in oncology. In addition, Bayer will contract the Onyx sales force to promote regorafenib, along with Bayer sales representatives, in the US. The status of Nexavar under the revised collaboration agreement remains largely unchanged. Onyx and Bayer are free to use their respective Nexavar sales forces to promote regorafenib and additional products outside of the collaboration in the future. Bayer will purchase Onyx’s royalty rights for sales of the product in Japan in exchange for a one-time payment to Onyx. Bayer will have no obligation to pay Nexavar royalties to Onyx on Japanese sales after Dec. 31, 2011. Further, in the event of a change of control or acquisition of Onyx, the current profit-sharing, codevelopment, and US copromotion of Nexavar will be preserved.
The biotechnology company GlycoMimetics has entered into an exclusive worldwide licensing agreement with Pfizer for the GlycoMimetics investigational compound GMI-1070. GMI-1070 is a pan-selectin antagonist currently in Phase II development for treating vaso-occlusive crisis associated with sickle-cell disease. GMI-1070 has received Orphan Drug and Fast Track status from FDA. The potential value of the agreement to GlycoMimetics is approximately $340 million, which includes an upfront payment, and development, regulatory, and commercial milestones.
The CRO Quintiles has opened its new European headquarters in Reading, United Kingdom. The company will begin operations with employees from each of its clinical, commercial, consulting, and capital disciplines.
The pharmaceutical company Servier and Hybrigenics, a French biopharmaceutical company, have signed a license and research collaboration agreement in the field of deubiquitinating enzymes (DUBs) applied to oncology, neurology, psychiatry, rheumatology, diabetes, and cardiovascular disease. Hybrigenics will identify and validate new targets among DUBs in these therapeutic areas. Hybrigenics will also screen potential therapeutic agents able to modulate four undisclosed targets, already chosen as exclusive DUBs of interest under the collaboration. Servier will provide the compounds to be screened, develop the selected compounds, and commercialize the approved drugs. Hybrigenics’s activities under this collaboration may also lead to the discovery of companion diagnostics, potentially needed for such therapeutic drugs. During the three years of collaboration, Hybrigenics will receive an upfront payment and research funding totaling EUR 4 million ($5.5 million). Depending on the achievement of predefined research, development, and registration milestones, Hybrigenics is further eligible to receive payments amounting to EUR 9.5 million ($13.1 million) for each target successfully leading to registration of a new drug and for royalties on sales of companion diagnostic kits.
Teva Pharmaceutical Industries has completed its acquisition of the biopharmaceutical company Cephalon. The combined company has pro-forma sales of $20 billion for the 12 months ending June 2011.
WuXi PharmaTech, a pharmaceutical and biotechnology services company, has acquired Abgent, a provider of biological research reagent products and services based in Suzhou, China, and San Diego, California. The acquisition of Abgent provides WuXi with development and production facilities, consisting of a 34,000-ft2 laboratory in Suzhou, and a 10,000-ft2 laboratory and office in San Diego.
Amgen has appointed Robert A. Bradway, president and chief operating officer, to the company’s board of directors. Bradway joined Amgen in 2006 as vice-president of operations strategy and served as executive vice-president and chief financial officer from April 2007 to May 2010.
The CMO AMRI has named Subramanyam Maddala as president of its India operations. Maddala will manage AMRI’s Indian API manufacturing operations as well as AMRI facility operations in Hyderabad and Aurangabad, India.
BASi has appointed John Devine, Jr., as vice-president of nonclinical services. Devine was previously general manager of BASi’s Evansville, Indiana, facility.
Covance, a drug-development services company, announced that Raymond Kaiser has joined the company as the new global science leader and vice-president for biotechnology services. Kaiser will replace Carl Martin, who will be retiring from this role, after 35 years with Covance.
Eli Lilly has announced appointments due to the Dec. 31, 2011 retirements of senior leaders, Bryce D. Carmine and Frank Deane. Dave Ricks, president of Lilly USA, is being promoted to succeed Bryce D. Carmine as senior vice-president and president of Lilly Bio-Medicines. Maria Crowe, senior vice-president for global drug-product manufacturing, is being promoted to succeed Frank Deane as president of manufacturing operations. Alex Azar, following Ricks’ promotion, is being promoted to president of Lilly USA. The new appointments will take effect on Jan. 1, 2012.