Silicon Investor (SI) -- The First Internet Community

STOCKTALK

We've detected that you're using an ad content blocking browser plug-in or feature. Ads provide a critical source of revenue to the continued operation of Silicon Investor. We ask that you disable ad blocking while on Silicon Investor in the best interests of our community. If you are not using an ad blocker but are still receiving this message, make sure your browser's tracking protection is set to the 'standard' level.

Biotech / Medical : Don't Floss, You Lose - (ATRX) To the RESCUE. -- Ignore unavailable to you. Want to Upgrade?

To: Arthur Radley who wrote (174)	4/15/2002 3:01:05 PM
From: tuck	Read Replies (1) \| Respond to of 182

Answering one of my own questions re the initial hormone surge. Eligard doesn't address this, Abarelix does, but has its own problem. Further, eligard looks very similar to TAP's depot: From FDA's labeling documents (first TAP - that's the Takeda/Abbot JV): >>LUPRON DEPOT is available in a prefilled dual-chamber syringe containing sterilelyophilized microspheres which, when mixed with diluent, become a suspension intended as a monthly intramuscular injection. The front chamber of LUPRON DEPOT 7.5 mg prefilled dual-chamber syringe contains leuprolide acetate (7.5 mg), purified gelatin (1.3 mg), DL-lactic and glycolic acids copolymer (66.2 mg), and D-mannitol (13.2 mg). The second chamber of diluent contains carboxymethylcellulose sodium (5 mg), D-mannitol (50 mg), polysorbate 80 (1mg), water for injection, USP, and glacial acetic acid, USP to control pH. During the manufacture of LUPRON DEPOT 7.5 mg, acetic acid is lost, leaving the peptide. CLINICAL PHARMACOLOGY Leuprolide acetate, an LH-RH agonist, acts as a potent inhibitor of gonadotropin secretion when given continuously and in therapeutic doses. Animal and human studies indicate that following an initial stimulation, chronic administration of leuprolide acetate results in suppression of ovarian and testicular steroidogenesis. This effect is reversible upon discontinuation of drug therapy. Administration of leuprolide acetate has resulted in inhibition of the growth of certain hormone dependent tumors (prostatic tumors in Noble and Dunning male rats and DMBA-induced mammary tumors in female rats) as well as atrophy of the reproductive organs. In humans, administration of leuprolide acetate results in an initial increase in circulating levels of luteinizing hormone (LH) and follicle stimulating hormone (FSH), leading to a transient increase in levels of the gonadal steroids (testosterone and dihydrotestosterone in males, and estrone and estradiol in premenopausal females). However, continuous administration of leuprolide acetate results in decreased levels of LH and FSH. In males, testosterone is reduced to castrate levels.<< And then Atrix' (couldn't get an html version to copy, the similar stuff is near the top, though): fda.gov It looks like a marketing war between Sanofi and Abbott/Takeda, in which the former must take share. Roche is exploring its own version, with delivery times even longer than those Atrix is exploring. Granted, Atrix seems to have a head start here. But it would seem safety issues, an entry barrier for Abarelix to date, are not a barrier for any leuprolide depot. Yes, I'd say the price fully values the Eligard approval. Will have to see how their acne treatment is, and try to come up with a valuation model for this puppy. May not get it done before a climbing road trip to Arizona, starting this Thursday. Cheers, Tuck