Astellas Pharma Inc., CoMentis, Inc. Sign $760M Alzheimer's Deal
TOKYO and SOUTH SAN FRANCISCO, CA -- Apr 25, 2008 -- Astellas Pharma, Inc. and CoMentis, Inc. announced today that the companies have entered into an exclusive worldwide collaboration agreement to develop and commercialize products from CoMentis' beta-secretase inhibitor program, including CoMentis' lead candidate compound CTS-21166, an orally bioavailable, small-molecule beta-secretase inhibitor which is being developed as a disease-modifying treatment for Alzheimer's disease. The agreement also includes a research collaboration to develop additional beta-secretase inhibitors.
"We are pleased to initiate a great partnership with CoMentis," stated Hirofumi Onosaka, Astellas's Senior Corporate Executive. "I strongly believe that CoMentis is very sophisticated in small-molecule drug discovery and development in CNS, the area of attention. Astellas is committed to developing the CNS therapeutic area as one of our prioritized therapeutic areas, and this partnership is expected to be a driving force to accelerate the establishment of our CNS infrastructure."
"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."
Upon closing, CoMentis will receive an upfront payment of $80 million and an equity investment of $20 million. CoMentis has the opportunity to receive up to $660 million in development milestones and may also receive performance-based commercialization milestones. In addition, CoMentis has the right to receive development milestones for next-generation beta-secretase inhibitors discovered under the terms of the research collaboration. Astellas will fund 100% of 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 profit will be shared. CoMentis will receive royalties on sales outside the U.S.
About Beta-Secretase Inhibitors
The action of the beta-secretase enzyme on the amyloid precursor protein leads to the formation of plaques in the brain and is implicated in the development of Alzheimer's disease. Inhibition of beta-secretase reduces amyloid beta production and could slow the progression of Alzheimer's disease. CTS-21166 is the first of several highly selective, potent and orally active beta-secretase inhibitors being developed by CoMentis.
CoMentis recently reported results from a Phase I trial in healthy volunteers. The trial was designed as a dose escalation study to measure the safety, tolerability and pharmacokinetics of CTS-21166 following intravenous administration. Forty-eight subjects received one of six different doses or placebo. The study measured levels of CTS-21166 and levels of amyloid beta in the plasma. 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 once a day dosing and will support a commercial product.
Astellas Pharma Inc., located in Tokyo, Japan, is a pharmaceutical company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceutical products. Astellas has approximately 13,900 employees worldwide. The organization is committed to becoming a global category leader by rapidly establishing a business model in Urology, Immunology and Inflammatory, Diabetes, CNS/Pain, Infectious diseases (virus), and Cancer. We have discovered an over-active bladder (OAB) medication, VesicareÂ®, and an immunosuppressive agent, PrografÂ® (tacrolimus), which have enabled us to become an established leader in both Urology and Immunology. For more information on Astellas Pharma Inc., please visit the company's website at http://www.astellas.com.
CoMentis, Inc. has its headquarters in South San Francisco, with research operations in both South San Francisco and Oklahoma City. The company is engaged in the discovery and development of small-molecule drugs to treat Alzheimer's disease, age-related macular degeneration (AMD) and cognitive disorders. The company has two fundamental technology platforms: (i) aspartic protease inhibitors, including beta-secretase inhibitors for Alzheimer's disease; and (ii) nicotinic acetylcholine receptor (nAChR) agonists and antagonists for the treatment of angiogenesis mediated diseases and cognitive disorders.
CoMentis currently has three product development programs based on its two technologies: ATG-3, a topical (eye drop) anti-angiogenesis compound for neovascular AMD; CTS-21166, an orally active beta-secretase inhibitor for Alzheimer's disease; and GTS-21, an oral agonist of the alpha-7 nACh receptor pathway for cognition enhancement. For more information: www.comentis.com.