SI
SI
discoversearch

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 : Biotech Valuation -- Ignore unavailable to you. Want to Upgrade?


To: Icebrg who wrote (8721)6/21/2003 7:23:39 PM
From: Icebrg  Respond to of 52153
 
U.S. FDA warns consumers about dietary supplements
Friday June 20, 8:43 pm ET

[Perhaps they should try a lower dose next time. Then they will be able to sell more of the supplements. Is this type of foodstuff unregulated in the US? Should have the potential to open up a lot of new possibilities for enterprising types in China and India. (Where they are already busy manufacturing generics of Viagra nd possibly also of Cialis). As far as I know Lilly/Icos has claimed that there is no interaction with nitrates. FDA may think otherwise. Perhaps that is why approval of the drug was held up.]

WASHINGTON, June 20 (Reuters) - The U.S. Food and Drug Administration (News - Websites) on Friday warned consumers against taking certain dietary supplements containing a prescription drug ingredient that could cause a sharp loss in blood pressure.

The FDA said consumers should not purchase or consume SIGRA, STAMINA Rx and STAMINA Rx for Women, Y-Y, Spontane ES or Uroprin manufactured by NVE Inc., in Newton, New Jersey and distributed by Hi-Tech in Norcross, Georgia.

The agency said the products contain the prescription-strength ingredient, tadalafil, the active ingredient in Cialis, a product of Eli Lilly and Co. (NYSE:LLY - News) that is approved in Europe to treat male erectile dysfunction.

"An interaction between certain prescription drugs containing nitrates (such as nitroglycerin) and tadalafil may cause a drastic lowering of blood pressure," the FDA said in a statement.

The agency's Office of Criminal Investigations executed federal search warrants in Georgia and New Jersey after finding the dietary supplements.

Spokesmen for NVE Inc. and Hi-Tech could not be reached for comment.



To: Icebrg who wrote (8721)6/22/2003 3:23:32 PM
From: Biomaven  Respond to of 52153
 
<MGYN>

It would be really interesting to do some "where are they now" type stories on some past PR releases from biotech companies, like the following from MGYN from back in 2001:

Myriad Genetics Discovers Novel Anti-Cancer Drug

SALT LAKE CITY, Oct. 9 [2001]/PRNewswire/ -- Myriad Genetics, Inc. (Nasdaq: MYGN) has discovered a novel drug target for the treatment of a broad range of cancers, and has initiated lead optimization with a series of compounds that selectively kill cancer cells, the Company announced today. The anti-cancer target was discovered using Myriad's ProNet(R) proteomics technology to investigate the protein interactions that lead to normal programmed cell death (apoptosis). Pre-clinical studies have demonstrated strong anti-cancer activity without harming normal human cell survival.

Myriad researchers found that MPI-176716 induces apoptosis in several cancers, including prostate cancer cells and T cell lymphomas. In a series of experiments designed to test the selective ability of the compound to drive cancer cells into apoptosis, Myriad researchers used cell lines that are not responsive to current chemotherapy drugs. After the addition of MPI-176716, the percentage of cells killed increased in a dose-dependent manner, reaching 98% of prostate cancer cells and 99% of T cell lymphoma cells that were forced into apoptosis. In addition, Myriad scientists were able to block the activation of apoptosis by inhibiting a key enzymatic step in the pathway. In this case, the cancer cells survived following the addition of MPI-176716, demonstrating that the drug is not generally toxic to cells, but uses the cell's own biological mechanism to kill them.

These encouraging results have led to a series of experiments that are underway at Myriad to use medicinal and organic chemistry techniques to maximize the desired characteristics of the compound, while maintaining their selective ability to eliminate cancer cells and leave normal cells unharmed.

"The compounds we are developing against this target show broad anti-cancer activity," said Dr. Adrian Hobden, President of Myriad Pharmaceuticals, Inc. "They further our cancer emphasis by joining our prostate cancer drug, MPC-7869, which is in human clinical trials, and our colon cancer drug, MPI-42511, which is in advanced pre-clinical testing."

The target of MPI-176716 is a protein that, Myriad believes, has not been explored previously for drug development, and represents a totally new approach to killing cancer cells. Cancer is essentially uncontrolled cell growth. Normal cells are destroyed after they have served their function or have become senescent. If this process, called apoptosis, is not functioning properly or damaged, cells may continue to divide and grow, resulting in cancer. Alternatively, if cancerous cells could be forced into the apoptotic pathway, they would be destroyed and control restored. Myriad has discovered a novel approach to inducing this cellular destruction.

Current cancer therapies are designed to kill cancer cells, however they are not selective in their action. Traditional chemotherapy and radiation therapy kill all rapidly dividing cells, including those that are normal and healthy. Broadly active anti-cancer therapies without such toxic effects on healthy cells are needed. By selectively inducing cell death in cancer cells, Myriad hopes to eliminate the toxicity associated with the current generation of therapies.


I recall thinking at the time that that sounded pretty neat. Any update some 18 months later? Or has this fallen into a different sort of BBH? (Biotech Black Hole <g>)

Actually MGYN has done some kind of neat stuff, so maybe I'm being unduly harsh on them, especailly as they actually have some revenues to call their own.

Peter



To: Icebrg who wrote (8721)6/23/2003 12:57:14 PM
From: A.J. Mullen  Respond to of 52153
 
MYGN,

I bought several years ago based on their genetic testing. They have a deal with the Mormon church to gain access to a population within which hereditary links are known. MYGN have a number of tests commercially established, principally the Brac-1 gene for increased susceptibility to breast cancer. They have a deal to provide this through Lab Corp, and many insurance companies will pay for those with a family history.

It seems to me that this is the future of pharmacology. Screen patients for risk, target monitoring and lifestyle changes, and possibly give prophylactic treatment. Finally, prescribe drugs that fit their genome.

Ashley