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Week of August 15, 2011: Xcelience Expands its Facility in Tampa, Fla.; Delta Pharma Names John Ebeid as VP of Outsourcing; and More
Array BioPharma, a biopharmaceutical company, has entered into an oncology agreement with Roche’s Genentech for the development of each company’s small-molecule checkpoint kinase I (ChK-1) program. The programs include Genentech’s compound GDC-0425 (RG7602), in Phase I, and Array’s compound ARRY-575, which is being prepared for an investigational new drug application for a Phase I trial to treat cancer. Under the agreement, Genentech is responsible for all clinical development and commercialization activities. Array will receive an upfront payment of $28 million and is eligible to receive clinical and commercial milestone payments up to $685 million and up to double-digit royalties on sales of any resulting drugs.
The biochemical company Bachem has renewed its supply agreement with AstraZeneca under which Bachem will continue to supply goserelin, an active peptide ingredient for AstraZeneca’s Zoladex, a luteinizing hormone-releasing hormone agonist.
Boehringer Ingelheim and the CDMO ProBioGen have signed a nonexclusive licensing agreement regarding ProBioGen’s GlymaxX technology, which is used in the production of afucosylated proteins. Boehringer Ingelheim’s contract-manufacturing business will apply the technology to enhance antibody-dependent cell-mediated cytotoxicity activity of antibodies. Both parties agreed to jointly market the technology and to offer it to customers royalty free.
Deloitte has acquired all assets of the regulatory-consulting firm Intrasphere Technologies. The acquired assets include Intrasphere’s PharmaCM, a software platform that enables life-sciences companies to register clinical trial information on government-mandated registries. The PharmaCM product will be provided as a service within Deloitte’s managed analytics division.
Eli Lilly, Amylin Pharmaceuticals, and the biotechnology company Alkermes have announced that FDA has acknowledged the companies’ Bydureon (exenatide extended-release for injectable suspension) resubmission. FDA has categorized it as a Class II resubmission, requiring up to six months for review, and assigned a new Prescription Drug User Fee Act action date of Jan. 28, 2012. Byduren is a drug for treating Type II diabetes.
Gilead Sciences reported that it has resolved all outstanding issues raised in a Warning Letter issued by FDA in September 2010, related to its San Dimas, California, manufacturing facility. FDA notified Gilead on Aug. 10, 2011, that the company’s response and the actions that have been adopted and implemented at the San Dimas site sufficiently addressed FDA’s observations, which were primarily related to the manufacturing environment for AmBisome (amphotericin B) liposome for injection, as well as general observations related to systems, procedures, and controls focused on ensuring product quality at the San Dimas facility.
In other news, FDA has approved Complera (emtricitabine/rilpivirine/tenofovir disoproxil fumarate), a single-tablet treatment for HIV-1 in treatment-naïve adults. Complera combines three antiretroviral medications in one daily tablet—Gilead’s Truvada is a fixed-dose combination of the two nucleoside-reverse transcriptase inhibitors emtricitabine and tenofovir disoproxil fumarate, and Tibotec Pharmaceuticals’ non-nucleoside reverse transcriptase inhibitor, rilpivirine (marketed as Edurant in the United States by the Johnson & Johnson subsidiary, Janssen Therapeutics).
Ipca Laboratories, a CMO, has acquired 100% share capital of the CMO Onyx Research Chemicals’ holding company of Onyx Scientific through its wholly owned subsidiary Ipca Laboratories UK. Onyx Scientific will continue to operate out of the Silverbriar (Sunderland, United Kingdom) facility under the Onyx Scientific trade name.
Jubilant Life Sciences, a CMO, announced that it has signed a long-term supply agreement with an undisclosed life-sciences company. The $80-million contract is scheduled for the April–June 2015 fiscal quarter. This contract has a minimum volume ‘take or pay’ commitment and has an opportunity to go over $100 million, according to the company.
Pfizer reports the United States District Court for the Eastern District of Virginia has ruled in the company’s favor in its patent-infringement action against Teva Pharmaceuticals USA. The court’s decision, which is subject to appeal, prevents Teva from receiving approval for a generic form of Viagra (sildenafil citrate) until October 2019. Litigation on the same patent remains pending against other generic-drug companies, but no trials are currently scheduled in those other cases, according to Pfizer.
West Pharmaceutical Services, an injectable drug-service provider, is expanding its R&D center in St. Petersburg, Florida. West’s advanced development center will focus on new elastomer formulations, process technologies, and products for West’s global component-manufacturing network. The center will feature the technologies for mixing, compounding, molding, and finishing elastomer-packaging components. West expects the facility to be online by October 2011.
Xcelience, a CRO, is expanding its existing 24,000-ft2 facility in Tampa, Florida, with the addition of nine rooms (1000-ft2) and is adding another new 24,000-ft2 facility in proximity to the existing facility to accommodate 45 new employees.
Delta Pharma, the life sciences subsidiary of Randstad Professionals, has named John Ebeid as vice-president of its outsourcing division. Ebeid previously served as a principal with PRTM Management Consultants’ healthcare practice, where he focused on helping biopharmaceutical companies facilitate global operating models, governance structures, strategic-sourcing strategies, and portfolio and project management capabilities.