BioCentury
ARTICLE | Company News

Cellegy, ProStrakan deal

October 2, 2006 7:00 AM UTC

PSK agreed to acquire worldwide rights to three CLGY products on a royalty- and milestone-free basis for $9 million in cash. The deal, which is expected to close by the end of November, includes Tostrex ( Tostran, Fortigel) testosterone gel for male hypogonadism, Rectogesic ( Cellegesic) nitroglycerin ointment to treat pain associated with chronic anal fissures, and Tostrelle testosterone gel to treat hypoactive sexual desire disorder (HSDD) in women. PSK's rights to Rectogesic exclude Australia, New Zealand, Singapore, South Korea and South Africa, where an undisclosed third party has rights. PSK already markets Tostrex and Rectogesic in Europe. In July, CLGY received an approvable letter from FDA for Cellegesic in which the agency asked for another clinical trial. PSK said it expects to submit data to FDA in 2007 or 2008. CLGY stopped enrollment in a Phase II trial of Tostrelle in 2004 and decided to move into Phase III testing based on an interim analysis that showed Tostrelle gave a 65% improvement in the number of satisfying sexual events compared to baseline, which was a 30% increase over placebo (see BioCentury, Sept. 13, 2004). The Phase III trial has not started yet.

Separately, CLGY agreed to pay $250,000 in cash to Neptune Pharmaceutical Corp. (New York, N.Y.) to settle milestone obligations related to Cellegesic and $3 million in cash to PDI Inc. (PDII, Saddle River, N.J.) to settle all debts related to Fortigel. CLGY acquired Cellegesic (then Anogesic) from Neptune in 1998 (see BioCentury, Jan. 12, 1998). CLGY originally owed PDII $6 million under a 2005 settlement related to a marketing deal for Fortigel that PDII terminated after CLGY received an approvable letter for the product (see BioCentury, April 18, 2005). ...