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 : PFE (Pfizer) How high will it go? -- Ignore unavailable to you. Want to Upgrade?

To: BigKNY3 who wrote (7645)	5/9/1999 11:16:00 PM
From: VLAD	Respond to of 9523

Too bad that Pfizer's decision to sue the NHS because of their policy towards Viagra didn't result in much more than a mildly expanded definition of eligibility. Of course Pfizer wants every man in England who thinks he needs a little spice in his sex life to claim impotence and expect the government to pick up the tab. Ain't gonna happen.

To: BigKNY3 who wrote (7645)	5/10/1999 5:11:00 PM
From: VLAD	Respond to of 9523

BigK, Your beloved Pfizer is breaking down below its 200 day moving average: quote.yahoo.com That's not a terribly good thing to see with such a strong company. Analysts on CNBC still think that big drug companies are well over valuated and still will continue to drop before any fresh buying comes in.

To: BigKNY3 who wrote (7645)	5/10/1999 6:56:00 PM
From: BigKNY3	Respond to of 9523

Zonagen and Schering-Plough Report Status of Vasomax Regulatory Filings THE WOODLANDS, Texas and MADISON, N.J.--(BW HealthWire)-- May 10, 1999--Zonagen, Inc. (Nasdaq:ZONA - news; Pacific:ZNG) and Schering-Plough (NYSE:SGP - news) today announced that the companies have decided to forego a June FDA Advisory Panel review of the New Drug Application (NDA) for Vasomax® until the results of additional clinical studies being conducted by Schering-Plough can be submitted to the FDA. As a result of this decision, Zonagen expects that the FDA will issue a non-approvable letter for the NDA. Vasomax® is Zonagen's oral treatment for erectile dysfunction. ''Although we are disappointed with this delay, we believe that the additional data from Schering-Plough's studies are important to the long-term success of Vasomax®,'' said Joseph S. Podolski, president and chief executive officer of Zonagen. ''Since we began working together in November 1997, we have been impressed by Schering-Plough's ability to further clinical development and plan for the launch of Vasomax®. Based on this ability, we are confident that this strategy for Vasomax® will maximize our product's potential in the marketplace.'' Zonagen completed two positive pivotal clinical trials that form the basis of the NDA for Vasomax®. Zonagen and Schering-Plough believe that inclusion of the new data from the ongoing studies should enhance the regulatory filing and the commercial product profile for Vasomax®. Both companies are committed to obtaining approval of Vasomax with the optimal safety and efficacy product profile. Zonagen expects to submit the data to the FDA as an amendment to the NDA. It was not possible to extend the deadline for completion of the FDA review therefore it was decided to accept a non-approvable letter. Schering-Plough is continuing to seek regulatory approvals for Vasomax® in countries outside the United States, having launched the product in Mexico in June 1998 and in Brazil in April 1999. A regulatory application was filed in the United Kingdom in August 1998 as the first step in a mutual recognition procedure for the European Union. Zonagen Inc. is engaged in the development of pharmaceutical products for the reproductive system, including sexual dysfunction, urology, contraception and infertility. Schering-Plough Corporation is a research-based company engaged in the discovery, development, manufacturing and marketing of pharmaceutical products worldwide. A copy of this press release may be obtained via facsimile by dialing 888/329-0920 or via the Internet by accessing www.zonagen.com.

To: BigKNY3 who wrote (7645)	5/10/1999 7:04:00 PM
From: BigKNY3	Read Replies (1) \| Respond to of 9523

Zonagen Shares Tumble As Review Of Impotence Drug Is Put On Hold ====================================================================== THE WOODLANDS, Texas -(Dow Jones)- Shares of Zonagen Inc. plunged Monday after the company said its experimental impotence drug Vasomax won't be reviewed by a Food and Drug Administration advisory panel next month, as had been planned. In morning trading, shares of Zonagen (ZONA) were down $9.719, or 49%, at $10.094 on volume of 1.4 million. If eventually approved by the FDA, Vasomax would compete with Pfizer Inc.'s Viagra. Industry analysts have said safety data from trials of Vasomax trials were good, but indicated Viagra is seen as more potent. The experts don't expect Vasomax, if approved, to reach the blockbuster status that Viagra has attained. Zonagen and Schering-Plough Inc., which would market Vasomax, said they have agreed to forego the planned June review by the FDA panel until Schering-Plough (SGP) submits additional clinial studies. Zonagen expects to submit the data as an amendment to the new drug application. The companies are "committed to obtaining approval of Vasomax with the optimal safety and efficacy product profile." As a result of the companies' decision to forgo the panel review, Zonagen said it expects the FDA will issue a "non-approvable" letter for Vasomex's new drug application, as currently filed. The company said it expects that additional data from Schering-Plough's studies will "enhance the regulatory filing and the commercial product profile for Vasomex." Schering-Plough is continuing to seek regulatory approvals for Vasomax in other countries, having launched the drug in Mexico last June and in Brazil last month. A regulatory application was filed in the United Kingdom in August 1998 as the first step for approval in the European Union.