Catalent Pharma Solutions plans to more than double its bioreactor capacity, adding a 1,000-liter bioreactor train at its Middleton, WI facility by 2009. The expansion is in response to increased demand for production to support clinical trials. The company has supplied two biopharma companies with GPEx-produced proteins that are currently being used in FDA-approved IND clinical trials.
The GPEx technology is designed to aid in the development of new biopharmaceuticals in a compliant, timely and cost-effective manner. According to the company, the GPEx system produces stable, high-yielding mammalian cell lines for protein production more quickly and efficiently than competing technologies. In addition, GPEx technology has generated more 150 cell lines for production of recombinant proteins and antibodies, one of which is currently being used to manufacture a commercially available biosimilar product.
Amgen
1Q Revenues: $3.6 billion (-2%)
1Q Earnings: $1.1 billion (+2%)
Comments: Worldwide sales of Aranesp decreased 25% to $761 million, with U.S. sales down 38% to $405 million due to prescribing restrictions as a result of adverse cardiovascular events. Epogen sales were $554 million (-11%) due to a reduction in dose/utilization due to ESA label changes and implementation of the Erythropoietin Monitoring Policy (EMP). Combined sales of Neulasta and Neupogen were $1.1 billion (+7%). Sales of Enbrel were $951 million (+30%). Sensipar sales were $133 million (+27%). R&D expenses were $661 million (-18%), reflecting cost recoveries derived from licensing transactions with Daiichi Sankyo and Takeda in Japan.
Astellas Pharma and
CoMentis have entered into an exclusive worldwide collaboration agreement to develop and commercialize products from CoMentis' beta-secretase inhibitor program, including its lead candidate CTS-21166, an orally bioavailable, small-molecule beta-secretase inhibitor being developed as a disease-modifying treatment for Alzheimer's disease. The agreement also includes a research collaboration to develop additional beta-secretase inhibitors.
CoMentis will receive an upfront payment of $80 million and an equity investment of $20 million. CoMentis may receive as much as $660 million in development milestones and performance-based commercialization milestones. CoMentis also has the right to receive development milestones for next-generation beta-secretase inhibitors discovered under the terms of the collaboration. Astellas will fund the pre-Phase III global development costs and CoMentis will share the Phase III development costs. Astellas has exclusive worldwide commercialization rights while CoMentis retains the right to co-promote in the U.S., where profits will be shared. CoMentis will receive royalties on sales outside the U.S.
"CoMentis' beta-secretase inhibitors have the potential to become first-in-class disease modifying therapeutic agents and we believe that Astellas has the expertise and commitment necessary to develop and commercialize these compounds," said W. Scott Harkonen, M.D., CoMentis' president and chief executive officer. "This licensing agreement will allow CoMentis to benefit through significant up-front licensing fees and milestones, while retaining substantial economic participation in the commercialization of beta-secretase inhibitors."
CoMentis recently reported results from a Phase I trial assessing safety, tolerability and pharmacokinetics of CTS-21166 following intravenous administration. CTS-21166 demonstrated excellent pharmacokinetic properties including dose proportional exposure and very low inter-subject pharmacokinetic variability. In addition, the pharmacokinetic profile is consistent with daily dosing and will support a commercial product.
Magazine
