Endo Pharmaceuticals Partners Pending FDA decision (ENDP, LON:PSK)

Endo Pharmaceuticals (NASDAQ: ENDP) has announced they have partnered up with the U.K. based corporation ProStrakan Group plc (LSE: PSK). The agreement includes the right to commercialize in America, FORTESTA their testosterone gel that is 2 percent. The testosterone transdermal gel is used in testosterone replacement therapy and stays in the categories of the other prescription medications the company is known for.

In a statement from Endo Pharmaceuticals, president and chief executive officer David Holveck stated that the corporation is committed to the advancement of men’s health and this treatment option expands their therapeutic growth in both urology and endocrinology.

This will add to the area of expertise for this pharmaceutical company, with their prescription drugs that are used to manage pain, prostate cancer, over active bladder and other serious conditions.

The U.S. Food and Drug Administration is currently reviewing the U.K. company’s application to market its hypogonadism treatment and the FDA is also scheduled to decide September 2nd on the resubmitted New Drug Application by ProStrakan for Nebido. Endo plans to market Nebido alongside Fortesta.

The Edno Pharmaceuticals agreement states they will make a $10 million dollar upfront payment for the exclusive rights to the male hypogonadism drug. They have also agreed to $40 million in milestone payments to be paid by the end of 2010 to ProStrakan and with the attainment of certain target sales and the exclusive supply of the drug to Endo Pharmaceuticals they have agreed to $160 million dollars.

The new drug in its 2 percent form, will be used to treat patients with low testosterone, which an estimated 13.8 million Americans males suffer. Remember to visit our forum for other important FDA action dates.