Peter C. Gonze has been appointed executive vice president of Global Business Development at Averion International Corp. In this role, he will oversee the company’s global business development and marketing activities, and will serve on the company’s executive management team. “Peter brings the necessary sales, marketing and operational management [...]
Meda has reached an agreement with Roche to acquire four of its pharmaceutical products, strengthening its key therapy areas: cardiology, CNS and pain/inflammation. Meda acquired worldwide rights to the products, with the major markets including Germany, Spain, Switzerland, the U.S. and France. The purchase price is approximately $180 million, equivalent [...]
Stora Enso has signed the first Pharma DDS packaging license agreements in the U.S. and in Europe. The company will partner with Sharp Corp. to package pharmaceutical products into Pharma DDS cartons. An agreement has also been reached with Cadmus Whitehall Group and with RLC Packaging Group to produce printed [...]
Abbott and AstraZeneca have entered into an agreement for Abbott to promote AZ's cholesterol drug Crestor. Under the terms of the agreement, Abbott will obtain the non-exclusive right to promote the drug alongside AZ in the U.S., excluding Puerto Rico. Financial terms were not disclosed. This agreement is the [...]
Ronald Kershner has been appointed to lead AAIPharma's North American Biostatistics and Data Management Services groups. Mr. Kershner has more than 25 years of industry experience at several large pharmaceutical, biotechnology and contract research companies. His previous roles include oversight of biostatistics and data management across a variety of therapeutic [...]
CSL Ltd. has signed an agreement to acquire Talecris Biotherapeutics Holdings Corp. for $3.1 billion, enhancing its position in the global plasma market. Talecris produces plasma medicines in the U.S. and operates 56 plasma collection centers and two manufacturing facilities. For the year ended June 30, Talecris had sales of [...]
BioFocus DPI, Galapagos' service division, has signed a contract with UCB to supply chemistry services in the UK for one of UCB's medicinal chemistry programs. The total contract value for Galapagos could potentially exceed $6 million. Galapagos is also eligible to receive as much as $749,000 in success-based payments. [...]
DSM Biologics and MorphoSys AG signed a biopharmaceutical manufacturing agreement covering process development and cGMP manufacturing of MOR202, a fully human HuCAL antibody being studied for the treatment of multiple myeloma. DSM will manufacture MOR202 in its cGMP facilities in Groningen, the Netherlands. Financial details were not disclosed. "Based [...]
Schering-Plough has expanded its presence in China by establishing Shanghai Schering-Plough Pharmaceutical Co. Ltd. A wholly-owned operation based in Shanghai, the unit was formed through the acquisition of shares of its former joint venture partners. SP entered into an agreement in 1994 with Shanghai Pharmaceutical Industry Co., Ltd. and Shanghai [...]
Alnylam Pharmaceuticals has formed an exclusive research agreement with the Max Planck Institute of Molecular Cell Biology and Genetics in Dresden, Germany, to investigate the molecular mechanisms of small interfering RNA (siRNA), the molecules that mediate RNAi. Alnylam scientists will work with the lab of Marino Zerial, Ph.D., a [...]
Michael Mallon has been appointed business development manager, DPT Laboratories. Mr. Mallon was most recently with Catalent Pharma Solutions, where he was responsible for managing selected accounts in the northeastern U.S. The contract service portfolio included oral solids, sterile fill and packaging services ranging from clinical development to commercial operations. [...]
Valeant Pharmaceuticals and Meda AB have agreed to form joint ventures in Australia, Canada and Mexico to develop, market and commercialize certain current and future products. The joint ventures will be majority-owned by Meda; Valeant will own a minority interest. The joint ventures will initially include insomnia drug Sublinox and [...]
Scott Watson has joined Girindus to lead its sales and marketing efforts. Mr. Watson has more than 25 years of experience in general management, operations, business development and sales. Prior to joining Girindus he was senior director, North American Sales for Aptuit and director, Business Development for DSM. A 1983 [...]
Johnson & Johnson has submitted an NDA for rivaroxaban to the FDA. The drug, an investigational, oral, once-daily anticoagulant for the prevention of deep vein thrombosis (DVT) and pulmonary embolism (PE) in patients undergoing hip or knee replacement surgery, was co-developed with Bayer HealthCare AG. Ortho-McNeil, a division of Ortho-McNeil-Janssen [...]
Javelin Pharmaceuticals and Baxter Healthcare have expanded their commercial supply relationship for Dyloject, Javelin’s proprietary injectable diclofenac product. The drug is currently marketed in the UK and is in Phase III trials in the U.S. for acute post-operative pain. The expanded relationship provides additional manufacturing capacity for Dyloject, principally for [...]
AstraZeneca 2Q08 2Q Revenues: $8.0 billion (+9%, +2% at Constant Exchange Rate) 2Q Earnings: $1.6 billion (+13%, +6% CER) YTD Revenues: $15.6 billion (+10%, +3% CER) YTD Earnings: $3.1 billion (+4%, -3% CER) Comments: Sales were buoyed by 35%/27% growth in Crestor, which reached $916 million in 2Q08. Toprol sales [...]
Amgen has licensed a clinical stage molecule for the treatment of chronic and neuropathic pain to Ortho-McNeil-Janssen Pharmaceuticals, Inc. (OMJPI), a Johnson & Johnson company. The terms of the agreement include a $50 million upfront payment, $385 million in success-based milestones and additional sales based milestones and royalties on sales. [...]
Matthew T. Mullarkey has been named chief operating officer of West Pharmaceutical Services. Mr. Mullarkey was previously chief executive officer and president of Impact Materials Group of Cleveland, OH, a privately owned engineered materials business. He succeeds Steve Ellers, who will remain President of the company through a transition period [...]
Sanofi-Aventis has offered $550 million to buy out UK-based vaccine maker Acambis. Acambis' board has agreed to the acquisition. Sanofi's vaccine division, Sanofi Pasteur, has worked with Acambis for more than a decade and is currently partnered with it for three projects. Sanofi Pasteur president and chief executive officer Wayne [...]
Ortho-McNeil Neurologics, a division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., itself a division of Johnson & Johnson, received approval from the FDA for pediatric exclusivity for Topamax for use in patients aged 1 to 24 months with partial onset seizures. The FDA is continuing its review of the application to determine [...]
Symyx Technologies, Inc. launched its new client-directed and collaborative research services for Life Sciences. These services allow clients to access Symyx’s installed base of parallel experimentation and testing capabilities through packaged offerings for solubility studies, polymorph screening, salt selection, co-crystallization, API stability in liquid and solid formulations, excipient compatibility, organic [...]
Bristol-Myers Squibb and AstraZeneca have submitted an NDA to the FDA and a MAA to the EMEA for Onglyza (saxagliptin) for the treatment of type 2 diabetes. The submissions are based on data from a clinical program conducted in addition to standard therapies, as well as in treatment [...]
Schering-Plough 2Q Revenues: $4.9 billion (+55%) 2Q Earnings: $436 million (-16%) YTD Revenues: $9.6 billion (+56%) YTD Earnings: $726 million (-34%) Comments: Pharmaceutical sales were $3.7 billion in the quarter (+47%) and $7.3 billion YTD (+48%) driven by Remicade sales ($557 million in the quarter, up 41% and $1.1 billion [...]
The FDA has completed an inspection of Synomics Pharmaceutical Services' facilities and operations in Wareham, MA. The inspection included both PAI and general regulatory compliance, as Synomics Pharma had been named in three NDAs. No 483's were issued. John Pirro, vice president and chief operating officer of Synomics Pharma, [...]
HollisterStier Contract Manufacturing received its certificate of GMP compliance by the Medicines and Healthcare Products Regulatory Agency (MHRA). This certification was issued following an inspection of the company's facilities, quality systems and processes and includes the manufacture of Investigational Medicinal Products for clinical trials, as well as the a terminally [...]
