By Jim Shrine
Praecis Inc. and Amgen Inc. entered into a collaboration under which Amgen will contribute $100 million this year toward development and commercialization of Praecis¿ abarelix, a product in Phase III trials for treating hormonally responsive prostate cancer.
The drug is a gonadotropin-releasing hormone (GnRH) antagonist, designed to quickly reduce testosterone levels. The drug, which has been called PPI-149, also can be referred to as an inhibitor of luteinizing hormone releasing hormone.
Malcolm Gefter, chairman and CEO of Cambridge, Mass.-based Praecis, told BioWorld Today the deal is a departure from those crafted by most biotechnology companies, in which up-front, milestone and royalty payments are specified.
¿Praecis is operating as a profitable company and has significant capital in the bank, and is not looking to this collaboration as an alternative to financing, but as a true collaborative effort to commercialize its product,¿ he said.
Privately held Praecis will retain responsibility for conducting clinical studies to approval in prostate cancer, as well as for manufacturing. Praecis also will fund clinical expenses this year related to a formulation of abarelix that is being tested in an ongoing Phase I/II trial for endometriosis, a gynecologic condition.
Gefter said Thousand Oaks, Calif.-based Amgen, upon signing the deal, is covering all of Praecis¿ expenses for abarelix. ¿There¿s no equity involved,¿ he said. ¿A significant fraction of those monies will be coming to Praecis.¿
Amgen gained rights to all human indications of the drug in North America, Australia, Asia and certain other markets, and will be responsible for all sales and marketing activities. The parties will ¿share significantly¿ in profits, Gefter said.
Amgen said it expects to spend about $100 million this year for expenses related to this deal. But the company said it still was comfortable with analysts¿ earnings estimates of $1.80 to $1.85 per share.
Separately, Praecis is collaborating on abarelix with Synthelabo, of Paris, which has rights in Europe, Latin America, the Middle East and certain African countries. Amgen has the rest of the world. Praecis had granted Hoffmann-La Roche Inc., of Nutley, N.J., rights to the rest of the world, but that relationship dissolved a few months ago because ¿both parties did not share a vision of what the product should be and how it should be developed,¿ Gefter said.
David Kaye, Amgen¿s associate director of corporate communications, told BioWorld Today the deal with Praecis was ¿a great opportunity. This is unique to Amgen, in that it¿s the first in-the-clinic drug we¿ve licensed, let alone a Phase III drug. It fits right in with our oncology research and development expertise and focus.
¿We look for breakthrough drugs, and this is the first in a class of drugs that appears to have significant benefits over the currently available super-agonists,¿ Kaye said. ¿It fits with our franchise.¿
Abarelix is an antagonist of GnRH, rather than an agonist ¿ like currently available therapies ¿ and is the only one of its kind in development, Gefter said. Agonists cause a surge in testosterone levels, then a reduction to target levels over three to four weeks. Abarelix, however, reduces testosterone levels in hours or days.
¿It is suited for any stage of prostate cancer,¿ he said, ¿and not only does it act quicker, but its mechanism of action does not cause the clinical flare, or the need for secondary drugs to modulate the clinical flare.¿
The Phase III trial, which began in November, is expected to complete patient accrual of 550 within a few weeks, Gefter said. The treatment period is expected to be completed by the end of the year, he said, and ¿we hope the drug could be launched in approximately two years.¿
Praecis¿ collaboration with Synthelabo was initially valued at $78 million. Abarelix also is in Phase III trials in Europe. (See BioWorld Today, June 6, 1997, p. 1.) n