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Biotech / Medical : Duramed (DRMD) Synthetic Estrogen Product -- Ignore unavailable to you. Want to Upgrade?


To: Doug Bean who wrote (1056)4/2/1999 12:47:00 PM
From: Benchman  Respond to of 1837
 
Thanks. I'll take a look. Rob (EOM)



To: Doug Bean who wrote (1056)4/3/1999 12:07:00 PM
From: Thure Meyer  Respond to of 1837
 
Doug,

The 10-K can be found in the SEC daily reports at URL
sec.gov

I will read over the weekend, lets discuss this week.

Thure



To: Doug Bean who wrote (1056)4/3/1999 12:10:00 PM
From: Thure Meyer  Respond to of 1837
 
Doug,

I've looked at the views.com site and I don't think there is a daily short report. As to shorting DRMD, with a low float of 18 million shares or so, and a lot of people holding for the long term (my opinion); it will be somewhat difficult for you or me to borrow shares that we can short. This makes me think that our thread "players" are shorting very small positions at best.

Thure



To: Doug Bean who wrote (1056)4/3/1999 12:34:00 PM
From: Thure Meyer  Respond to of 1837
 
re: Tamoxifen

The following is from the 10-K.

" IMPROVED TAMOXIFEN SYNTHETIC PROCESS PROJECT -- One women's health project that is being overseen by Duramed Europe is an exclusive option, which Duramed purchased in December 1998, to an improved Tamoxifen synthetic process from Generic Biologicals Limited, ("GBL") a United Kingdom-based product development company. Under the terms of the option, milestone payments are being made by Duramed to GBL based on successful completion of the drug substance scale-up process. With this process, Duramed may pursue commercialization of the drug substance as well as a branded finished drug product. Duramed will have exclusive rights to this technology in the United States, Canada and Mexico. GBL will receive royalties on Duramed's North American sales.

Tamoxifen, which has been used for the past 25 years for the treatment of patients with advanced breast cancer, was recently approved by the FDA for prophylactic use for patients with a high genetic risk of developing breast cancer. This was the first instance when a medicine won formal FDA approval as a way of reducing the risk of breast cancer. GBL's novel patent-pending synthetic process yields a purer form of the Z-Tamoxifen drug substance. The currently
available preparations of Tamoxifen contain a low level of the E-isomer impurity of Tamoxifen, which may be associated with an increased risk of endometrial cancer. Tamoxifen is one of only a few approved drug substances in the U.S. Pharmacopeia ("USP") for which there is a limit on the amount of a single isomer (E-Tamoxifen) that can be present. GBL's purer form of Z-Tamoxifen, with greatly
reduced levels of the E-isomer, may have the potential for reducing the risk associated with endometrial cancer, particularly when the drug is prescribed for long-term prophylactic use. In addition to producing purer Z-Tamoxifen, GBL's patent-pending process is less complex, which should lower production costs...."

What do you know about this market and the process for getting this approved and marketed in the US? I will try to read up on this, I believe there are a number of medical sites which discuss this drug.

Thure



To: Doug Bean who wrote (1056)4/3/1999 1:30:00 PM
From: Thure Meyer  Respond to of 1837
 
re: Tamoxifen - 2

What is tamoxifen?

"Tamoxifen (trade name Nolvadex) is a drug in pill form, taken orally, that interferes with the activity of estrogen (a female hormone). Tamoxifen has been used to treat both advanced and early stage breast cancer. It has been used for nearly 20 years to treat patients with advanced breast cancer. More recently, it also is being used as adjuvant, or additional, therapy following primary treatment for early stage breast cancer...."

More at the following URL
breastcancerinfo.com

There are also a number of articles if you do a yahoo search. An interesting description is found at:
unisci.com

This looks like another interesting drug market to be in. Cardinal would be the right partner to market this as well.

Thure



To: Doug Bean who wrote (1056)4/3/1999 1:55:00 PM
From: Thure Meyer  Read Replies (1) | Respond to of 1837
 
re: Tamoxifen - 3

See following URL for current patent status of Tamoxifen as well. Apparently it expires in 8/2002.

barrlabs.com

"
FDA Affirms Barr's 180 Day Generic Tamoxifen Exclusivity

Pomona, NY, March 9, 1999 -- Barr Laboratories, Inc. (NYSE-BRL) today announced that the U.S. Food and Drug Administration has granted its Citizen Petition clarifying that the Company will have 180 days of market exclusivity for its generic version of Tamoxifen Citrate when the patent protecting the brand version expires in 2002..."

There is more having to do with patent disputes. Unless I read this the wrong way, the generic market won't be available to Duramed until
2003. Nonetheless, this market fits in well with their current product line as well as the emerging demographics. Maybe 4 years is to far out for most people, but I think this company has some good prospects.

Thure