To: Bill Wexler who wrote (325 ) 4/5/2004 10:27:35 AM From: Hank Read Replies (1) | Respond to of 6370 Sometimes it takes a long time for frauds to die. Looks like the situation is finally becoming terminal for ZONA. Zonagen's new strategy focuses on hormonal products -------------------------------------------------------------------------------- Scrip, April 02, 2004 Zonagen is to restructure its business because of limited resources and is to focus on its two lead hormonal products. It will out-license all other programmes, including the oral impotence therapy, Vasomax (phentolamine mesylate). Revenues have been dwindling at the company, down from $5.3 million in 2002 to just $1 million last year, as Schering-Plough terminated its licence agreement on Vasomax. At the end of last year, it had $22.9 million in cash and cash equivalents. The two product candidates come from the company's anti-hormone small molecule programme. It plans to start clinical trials outside the US with Progenta, a selective progesterone receptor modulator (SPRM) for the treatment of uterine fibroids, in the middle of the year. This family of compounds was licensed from the US National Institutes of Health in 1999. SPRMs may also have the potential to treat endometriosis and breast cancer. At the recent annual meeting of the American Association for Cancer Research in Orlando, Florida, Zonagen presented data generated in collaboration with scientists at the University of Illinois-Chicago showing that Progenta had significant activity against hormone-dependent breast cancer induced in rats by DMBA. DMBA is a tumour-inducing agent used in a well-accepted breast cancer tumour model, Zonagen says. Research also continues on a second candidate - Androxal, an orally active agent developed for testosterone deficiency. Zonagen believes that Androxal could be the first significant oral therapy approved in the testosterone replacement market. The product candidates that the firm is looking to out-license include Vasomax for male erectile dysfunction and a female version of the product in the form of a vaginal suppository. Zonagen experienced several years of difficulties in obtaining regulatory approval of Vasomax in some major countries, because of safety issues in the US and the UK relating to carcinogenicity studies in rats. In the US, a two-year rat carcinogenicity study uncovered brown fat proliferation. Since Schering-Plough ended its collaboration in 2002, the product has remained unpartnered (Scrip No 2765, p 10). Other research programmes that Zonagen would consider out-licensing include: Bimexes, a combination oral tablet for erectile dysfunction using alpha blockade as well as the nitric oxide pathway; ERxin (multiple component penile injection) for erectile dysfunction; two different chitosan-based vaccine adjuvants; zona pellucida and hCG immunocontraceptive vaccines; a therapy for the treatment of genital herpes; and therapeutic vaccines for both hormone-dependent and hormone-independent prostate cancer. Last year, Zonagen failed to complete a merger with Lavipharm, a US drug formulation and drug delivery company (Scrip No 2839, p 9). SCRIP - World Pharmaceutical News FILED 2 April 2004 COPYRIGHT 2004 PJB Publications Ltd Copyright (c) 2004 PJB Publications, Ltd. Received by NewsEDGE/LAN: 04/02/04 10:21 AM --------------------------------------------------------------------------------