OR WAIT null SECS
Roche Establishes R&D Institute in France; Sanofi Appoints Peter Guenter as Senior Vice-President, Europe; and More.
Abbott Laboratories and Biotest, a provider of plasmatic and biotherapeutic drugs, have agreed to develop and commercialize BT-061, an anti-CD4 antibody for treating rheumatoid arthritis (RA) and psoriasis, currently in Phase II clinical trials. Under the terms of the agreement, Abbott and Biotest will both promote BT-061 in the five major European markets (France, Germany, Italy, Spain, and the United Kingdom), and Abbott will have exclusive global rights to commercialize BT-061 outside those countries. Biotest will receive an upfront fee of $85 million. Pending achievement of certain development, regulatory, commercial, and sales-based milestones, Biotest would be eligible to receive additional milestone payments from Abbott, potentially amounting to a total of $395 million and royalties. Biotest will be responsible for the manufacture of initial clinical supply of BT-061, and the parties will share responsibility for commercial production.
AstraZeneca has agreed to sell its subsidiary, Asta Tech, a provider of dental and healthcare products, to Dentsply, a developer and manufacturer of dental products, for $1.8 billion. The transaction is anticipated to be completed during the second half of 2011, subject to customary closing conditions and regulatory approval.
The biopharmaceutical company BioMarin Pharmaceutical has agreed to acquire a bulk biologics-manufacturing plant from Pfizer, located in Shanbally, Cork, Ireland, for $48.5 million. The 133,000-ft2 plant was completed and validated in 2009 and received regulatory approved from the Irish Medicines Board in 2010. The purchase is expected to close in the third quarter of 2011 (following winding down of current operations and the transfer of the Irish EPA license). The plant will be occupied in a phased transition with substantial manufacturing activities being tied to results of the ongoing Phase III clinical study for N-acetylgalactosamine 6-sulfatase (GALNS) for treating mucopolysaccharidosis IVA. Maintenance expenses for the facility are expected to be approximately $4 million per year. The facility is expected to be licensed for GALNS production by 2015.
CABB, a fine- and specialty-chemicals company, has acquired the fine-chemicals company KemFine Group Oy through its Swiss subsidiary, AXCABB, for an undisclosed sum. The deal is subject to regulatory approval.
Cambridge Major Laboratories Europe, a contract manufacturing organization (CMO), has been selected by the biotechnology company Summit Corp. to provide medicinal chemistry synthesis, perform solid–state studies, and manufacture cGMP material for use in clinical studies for Summit’s preclinical development candidate SMT 19969, an antibiotic that targets infection caused by the hospital “superbug” Clostridiumdifficile.
The specialty-chemicals company Evonik Industries has increased its production capacity for the pharmaceutical amino acid glycine by 50%. In addition, Evonik is investing in a new plant in Nanning, China, to expand its portfolio of specialty-chemical products by milling and sieving processes. The new products are expected to be introduced to the market by the end of 2011.
Fujifilm and Mitsubishi have entered into a partnership for contract manufacturing for biopharmaceuticals. Under the partnership, the companies have signed an agreement to transfer the ownership of 20% equity interests in Fujifilm's wholly owned biopharmaceutical contract manufacturing subsidiaries, Fujifilm Diosynth Biotechnologies U.S.A. (FDBUS) and Fujifilm Diosynth Biotechnologies UK (FDBUK), to Mitsubishi. Mitsubishi is set to become involved in the business management of FDBUS and FDBUK alongside Fujifilm in a joint effort to promote the expansion of the biopharmaceutical contract manufacturing business.
GlaxoSmithKline (GSK) has agreed to pay $40.75 million, which will be divided among 37 states and the District of Columbia as part of an agreement reached related to events that occurred during the early 2000s at its former manufacturing facility in Cidra, Puerto Rico. The company chose to settle the matter, which it initially disclosed in its 2010 fourth quarter results and its 2010 annual report, to avoid the expense and uncertainty of protracted litigation and trial according to a GSK press release. The company did not admit to any wrongdoing or liability of any kind under these states’ consumer protection laws in this settlement. GSK closed the plant in 2009 and sold it in 2010.
The biologics CMO Laureate Pharmaceutical Services has received FDA approval for an Electronic Submissions Gateway to the agency. The gateway will allow Laureate to offer clients a direct electronic path for investigational new drug, new drug application, and biologic license application submissions.
Medicago USA, a biotechnology company, has received a third milestone payment of $5.6 million for a vaccine-manufacturing facility by the Defense Advanced Research Projects Agency (DARPA) as part of a $21-million project for Medicago to demonstrate the scalable manufacturing of plant-expressed viruses-such as particles from the influenza vaccine. A 90,000-ft2 cGMP facility in Research Triangle Park, North Carolina, is currently under construction. The facility, which is expected to start operations in the second half of this year, is part of DARPA’s project to produce a large volume of vaccine-grade proteins for pandemic threats.
Merck Serono, the biopharmaceutical division of Merck KGaA, has announced it will no longer pursue the global approval process of cladribine tablets-for the treatment of relapsing-remitting multiple sclerosis-following recent regulatory feedback from FDA and prior feedback from the European Medicines Agency.
Neuland Laboratories, a CMO, is launching new commercial-scale, peptide-production services. The company offers peptide production using standard sequential chemical peptide syntheses and segment condensation strategies. The company uses solid-phase peptide synthesis procedures as well as solution-phase methods for shorter length peptides and segment condensation and ligation techniques for very long peptides.
The biotechnology company NovaBay Pharmaceuticals has regained worldwide rights to its aganocide compounds in a collaboration with Alcon, a subsidiary of Novartis. An agreement to finalize the collaboration has been entered into by the companies, terms of which include a payment of $2,972,245 to NovaBay. The payment includes a termination fee, as well as final reimbursement for research and development (R&D) and personnel costs related to the collaboration. In keeping with the terms of their agreement, Alcon will return the worldwide technology license for the lead aganocide compound, NVC-422, as well as other backup compounds to NovaBay. Rights to be returned to NovaBay include all previously licensed areas in ophthalmic, otic, and sinus applications. Additionally, all FDA-regulatory filings made by Alcon will be transferred to NovaBay, and NovaBay is free to continue the development of aganocides for these areas on its own or in collaboration with new partners.
OSO BioPharmaceuticals Manufacturing (OsoBio), an injectables CMO, has been granted approval for researcher registration by the Drug Enforcement Administration (DEA) for Schedule II–V controlled substances. The new DEA registration allows OsoBio to execute the development of manufacturing processes for controlled substances.
Pfizer and the biopharmaceutical company Pain Therapeutics have received a Complete Response Letter from FDA on the resubmission to the new drug application for Remoxy (oxycodone) extended-release capsules. Pfizer has announced that it is working to evaluate the issues described in the Complete Response Letter and plans to have further discussions with FDA concerning the regulatory action.
RecipharmCobra Biologics, a biologics CMO, and KAHR Medical, a biopharmaceutical company focused on developing single converter proteins, have agreed to continue their KAHR-102 partnership for the development of cancer and autoimmune disease drugs. Under the terms of the agreement, RecipharmCobra Biologics will continue to advance KAHR-102, a fusion protein, for future preclinical and clinical testing using RecipharmCobra’s maxXpress service, a protein expression service.
Roche and the drug-development company Evotec AG have formed a collaboration in protein activity-based biomarkers for Roche’s oncology drugs under development. Evotec will use its PhosphoScout platform to discover protein-phosphorylations that predict favorable dosage and efficacy of targeted cancer drugs in patients. Roche will conduct clinical trials and assess the development of companion diagnostics for patient stratification. Under the initial three-year term, Roche and Evotec will conduct multiple biomarker programs for therapeutic antibodies or small-molecule inhibitors.
In other news, Roche has established a new R&D institute in France under the company’s Pharma Research and Early Development (pRED) unit. The pRED French R&D institute will focus on collaborative translational research and medicine, with the objective to build in-depth strategic partnerships with leading French academic centers in areas of mutual interest. The institute will serve as the single entry-point for academic collaborations in France across multiple disease areas and scientific disciplines: oncology, neurosciences, metabolism, inflammation, virology, translational research, and toxicology.
Tibotec Therapeutics, a division of Johnson & Johnson’s Centocor Ortho Biotech Products, announced that it has changed its name to Janssen Therapeutics, Division of Janssen Products LP. The change, effective immediately, is part of the global adoption of a common identity for all Janssen Pharmaceutical Companies.
Sanofi has announced the appointment of Peter Guenter as senior vice-president, Europe. He will report to Hanspeter Spek, president of global operations, and will join the management committee.