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Biotech / Medical : VVUS: VIVUS INC. (NASDAQ) -- Ignore unavailable to you. Want to Upgrade?

To: VLAD who wrote (9215)	6/5/1998 8:02:00 AM
From: James Baker	Read Replies (2) \| Respond to of 23519

Management responds and the negative study report stinks!!!!! If the authors claim "highest dose failed" and only 10% got 1000 mg they should be sued for liable! Friday June 5, 7:31 am Eastern Time Company Press Release VIVUS Responds to Reports of "Disappointing Results" With MUSE MOUNTAIN VIEW, Calif.--(BW HealthWire)--June 5, 1998--VIVUS, Inc. (NASDAQ:VVUS - news) today responded to media reports about ''disappointing results'' data presented at the American Urological Association (AUA) annual meeting earlier this week in San Diego, CA. VIVUS would like to refer patients and physicians to the efficacy data of MUSE(R)(alprostadil) amassed from 71 worldwide clinical trial sites and involving nearly 1,800 patients. Additional new data on the efficacy of MUSE in clinical practice are scheduled for presentation at the American Diabetes Association meeting to be held June 13-16 in Chicago, IL. The abstract presented at the AUA by researchers from Presbyterian Hospital in Dallas, TX stated that ''only 27% of patients achieved rigidity sufficient for intercourse despite being challenged to the highest dose.'' In discussing his study results, the presenting physician clarified that not all men were challenged to the highest doses (500 or 1000 mcg) of MUSE, and that only 10 of these 115 patients (or 9%) were administered the 1000 mcg dose. In VIVUS' clinical trials of MUSE, between 41% and 65% of men required the 1000 mcg dose to achieve rigidity sufficient for intercourse. The efficacy of MUSE was established in part through the VIVUS Phase III clinical study which was the basis of Food and Drug Administration (FDA) approval of MUSE in November 1996. This 58-site U.S. study reported in the New England Journal of Medicine in January 1997 found that 66% (996/1511) of men with severe, organic erectile dysfunction were able to achieve an erection sufficient for intercourse in a clinic setting. A more recent 13-site study of MUSE conducted in five European countries and reported in this month's issue of the British Journal of Urology found that 64% (159/249) of men with severe, organic erectile dysfunction achieved an erection sufficient for intercourse in a clinic setting. Patients in these two VIVUS-sponsored clinical studies received doses of MUSE up to and including the highest (1000 mcg) dose. Currently, over 80% of all prescriptions for MUSE are at the 500 or 1000 mcg dose level. ''Efficacy of MUSE is clearly dose dependent,'' said Tom Lue, MD, Professor of Urology, University of California, San Francisco. ''In my clinical practice, most patients require dosing of MUSE at the 500 or 1000 mcg level.'' Founded in 1991, VIVUS, Inc. is a leader in the development of advanced therapeutic systems for the treatment of erectile dysfunction, commonly referred to as impotence. VIVUS has pioneered a novel therapy for erectile dysfunction known as MUSE(R)(alprostadil). MUSE is a therapy which consists of a proprietary, non-invasive drug delivery system applied into the urinary opening, and is not for men with sickle cell trait, disease or other blood disorders. One third of men reported genital pain, causing some to stop use. A few men reported dizziness and, rarely, fainting. Note to Editors: MUSE is a registered trademark of VIVUS, Inc. Additional written materials, recent releases and Company information are available through a variety of sources, including: the VIVUS home page (www.vivus.com) and the VIVUS Fax-On-Demand Service (1-888-329-5719). Contact: VIVUS Nina W. Ferrari or David Yntema, 650/934-5200

To: VLAD who wrote (9215)	6/5/1998 8:51:00 AM
From: DaiS	Read Replies (1) \| Respond to of 23519

Vlad, I have succeeded in getting in touch with a local physician who started and is running an ED clinic - this is not a private clinic, but part of the National Health Service. The doctor holds the clinic one day a week but also sees ED patients at other times. His partners in the practice direct all ED patients to him because of his interests in this area, he is not a consultant urologist. We are dealing with a catchment of 5-10K people for the surgery, but some men from the town (200K) attend the clinic. I know this doctor because I visit this practice myself. This was his experience, He has recieved written information/ads from Pharmacia and Vivus via drug reps. Pharmacia info: injections 75%-80% effective, muse 40% effective Vivus info: injections and muse equally effective. From his experience so far, 60% of men trying muse find it successful and stick to it. When I challenged him that muse was really not very effective he was surprised and insisted that it was OK. His only negative comment in this respect was that muse was rather less effective than injections in contrast to Vivus claims. He does muse titrations with patients to find appropriate dose in the surgery. His experience was that men found muse was easy to use, easier than injections. It appeared that he retained some fondness for the pump which he used pre-muse, but said that many men found the pump fiddly to use and this was less of a problem with muse. One interesting thing is that he thought that the softer erection frequently obtained with muse compared with injection could actually be an advantage. He felt that the injection erection was frequently abnormally hard and of course could persist too long. He used the words 'the muse erection is natural...'. I asked him about Actis. Generally he appeared to dissociate the use of bands and muse. He knew that the band prevents backflow of the drug out of the penis but said that only a small proportion of his patients (10% out of the 60% when I pushed him) use a band with muse and that these may keep the band on as with the pump. I did not want to embarrass him so I did not push him on Actis use. I mentioned that I had looked at the AUA abstracts and we talked about the VA study. I told him that 25 of the men in the VA study had failed on injections, and he thought that these would fail on muse. Of course he was awaiting viagra in three months time. He told me about the 6 deaths and the eye damage and said that it would be necessary to take great care in prescribing the drug in UK. He was concerned too about the emotional problems that he might have with dealing with viagra failures. In the end he emphasised to me that all the methods have failures and it was necessary to be careful to choose the right one for the patient. At no time did he hint to me that muse was no good - these suggestions came from me and he was anxious to refute them. Remember I am not a physician when assessing the above comments, but I tried my best to get accurate picture and feeling of the situation. My researches re- UK script data are continuing but unsuccessful so far. I have been told that the information is not in the public domain and been told to refer to the manufacturer for information - but I will continue to look. I hope all the good news coming out about the effectiveness of muse is not to late for Vivus and that there will be a rebound. DaiS