By Randall Osborne
West Coast Editor
Anything but timid about moving ahead with its testosterone blocker for prostate cancer, Praecis Pharmaceuticals Inc. has submitted a new drug application (NDA) to the FDA, just over six months after disclosing favorable Phase III trial data.
¿From the Phase I/II studies to the filing of a complete NDA was three years, which was really rapid,¿ said Marc Garnick, vice president and chief medical and regulatory officer of Cambridge, Mass.-based Praecis.
¿We had all the templates of how the data would be presented and put together [for the NDA] from our Phase II study,¿ Garnick told BioWorld Today. ¿Not only was there very little wasted effort ¿ there was no wasted effort.¿
The drug, abarelix depot-M, is a gonadotropin-releasing hormone antagonist ¿ also called an inhibitor of luteinizing hormone releasing hormone ¿ that works by quickly reducing the production of testosterone, the male hormone that helps prostate tumors grow and often is stimulated, at first, by existing hormone-based cancer therapies.
Data from two pivotal Phase III studies, disclosed in May, showed the drug acted faster to keep testosterone levels lower than Lupron (leuprolide), a current hormone therapy, and better than Lupron combined with bicalutamide. All three regimens were well tolerated. (See BioWorld Today, May 24, 2000.)
In the U.S., Japan, Canada and Asia-Pacific regions, abarelix depot-M is being developed with Amgen Inc., of Thousand Oaks, Calif., along with another formulation that suppresses the hormone estrogen, to treat endometriosis.
¿The control from the brain is identical in men and women ¿ it just affects a different organ ¿ and abarelix immediately shuts off the signal from the brain,¿ Garnick said.
Data show that, in men, ¿100 percent avoid the testosterone surge,¿ he said, which means abarelix¿s rapid onset of action can be used in advanced patients, about 85 percent of whom would be at risk of worsening if they used other therapies.
¿In general, it¿s given as a stand-alone treatment,¿ Garnick said. ¿Patients who come in with moderately elevated prostate-specific antigen, or a large tumor in the prostate gland, require an extensive diagnostic evaluation to make sure they don¿t have a cancer that would become worse [with existing therapies]. We can treat all those patients with abarelix.¿
Kevin McLaughlin, senior vice president and chief financial officer of Praecis, said the NDA could get expedited handling.
¿We believe we have submitted a complete document that may qualify for a quicker review,¿ shortening the potential 12-month review period as Praecis and Amgen managed to shorten the development period overall.
Amgen had three news items of its own Wednesday. First, the company said it has authorized the repurchase of up to $2 billion in stock between Jan. 1, 2001, and December 2002. Based on the $68.25 closing price Tuesday of Amgen shares (NASDAQ: AMGN), the buyback is about 29 million shares, or about 3 percent of Amgen¿s currently outstanding 1 billion-plus shares.
Also, the company upped to $350 the exercise price for preferred stock purchases in its rights agreement. Since the agreement was approved in 1997, the company has done a pair of two-for-one stock splits, and the increase was made to discourage ¿abusive takeover tactics¿ ¿ although the company said it knows of no efforts by outsiders to take control. The plan¿s expiration date was extended to Dec. 12, 2010.
Third, Amgen named as chairman of the board Kevin Sharer, currently CEO and president, who will assume the new position as well on Jan. 1. Sharer became CEO May 11. He joined Amgen as president and chief operating officer, and was elected to the board in 1992. Sharer replaces 10-year chairman Gordon Binder, who is retiring at the end of this year.
Praecis¿ stock (NASDAQ: PRCS) closed Wednesday at $22.75, down 50 cents. Amgen¿s shares (NASDAQ: AMGN) ended the day at $67.125, down $1.125 cents.