Ferring Degarelix Prostate Cancer Drug To Launch In First Quarter

FDA approves the gonadotropin-releasing hormone receptor antagonist, which hasn’t shown the initial surge in testosterone seen with other therapies.

FDA approved Ferring Pharmaceuticals' hormonal therapy degarelix for the treatment of advanced prostate cancer Dec. 24, with a claim that could give it a distinct advantage over existing hormone depravation therapies.

Degarelix, a gonadotropin-releasing hormone receptor antagonist that suppresses testosterone, could offer a benefit to patients over existing hormonal treatments because it hasn't shown the initial surge in testosterone production that has been seen with some other agents, according to FDA.

Testosterone plays an important role in the growth of prostate cancer, so suppressing testosterone can slow the growth and progression of prostate tumors. Commonly used hormonal therapies for advanced prostate cancer are luteinizing hormone-releasing hormone (LHRH) agonists, which lower testosterone levels by decreasing the androgens produced by the testicles. However, the LHRH agonist drugs can increase levels of LH initially, boosting testosterone and causing temporary tumor flare, before shutting hormonal levels off. Flare may be controlled with anti-androgen treatment.

GnRH antagonists bind to receptor cells in the pituitary gland. While agonists stimulate the release of LH and testosterone production initially, receptor antagonists directly block the release of LH, eliminating the surge in testosterone at the start of treatment, according to Ferring.

The leading LHRH is Abbott's Lupron Depot (leuprolide). Other LHRH agonists approved for prostate cancer include AstraZeneca's Zoladex (goserelin) and in Europe, Wyeth's Prostap-SR (leuprorelin).

Degarelix versus Abbott's Lupron Depot

"We think this is a real exciting product for the market because we know it is at least as effective as leuprolide," VP-Sales and Marketing, Ferring Pharmaceuticals USA William Garbarini said.

The Phase III study that was the basis for the degarelix approval compared degarelix to leuprolide, demonstrating that degarelix treatment did not cause the temporary increase in testosterone that is seen with some other drugs, FDA said. Patients on both drugs had suppression of testosterone to levels seen with surgical removal of the testes.

In the 12-month Phase III trial, testosterone levels fell to less than or equal to 50 ng/dL within three days in more than 96 percent of patients on degarelix, compared to no patients in the leuprolide arm. In addition, testosterone levels increased by a median of 65 percent in 80 percent of those receiving leuprolide at day three. Degarelix was as effective as leuprolide in suppressing testosterone levels from day 28 through one year.

The most commonly observed adverse reactions associated with degarelix include injection site reactions, hot flashes, increased weight and increases in serum levels of transaminases and gamma-glutamyltransferase.

Treatment initiation is recommended at a starting dose of 240 mg given as two injections of 120 mg, followed by maintenance doses of 80 mg administered as a single injection every 28 days.

Launch slated for first quarter

Ferring, a Swiss drug maker, is gearing up to launch degarelix in the U.S. in the first quarter after finalizing a trade name with FDA. The company has requested to use the brand name Firmagon , the same one it is looking to use in Europe, but has not received final clearance. The drug received a positive marketing recommendation on Dec. 18 from the European Commission's Committee for Medicinal Products for Human Use, so Ferring is also gearing up for a first quarter launch in Europe.

Degarelix represents the first global launch for Ferring, a private drug company focused in the areas of urology and infertility.

"We are at all levels of the company, from development to marketing, in step in terms of how to launch this product," Garbarini said of the global rollout.

In the U.S., the company plans to expand its existing urology sales force, which currently markets Prosed DS for the relief of urinary tract infections, ahead of the launch of degarelix, Garbarini added. The company expects to increase the force from 85 reps to 115.

-Jessica Merrill ([email protected])