Vivus Inc. (VVUS : 893380) Der neue Celgene (CELG)? - 500 Beiträge pro Seite
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Letzter Kurs 20.07.20 Düsseldorf
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| Wertpapier | Kurs | Perf. % |
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Feedback
With its innovative products, VIVUS aims at extending cures for sexual dysfunction in both men and women
Published Nov. 27, 2000, at www.redchip.com
Ten million to 20 million men in the United States and roughly 50 million men worldwide suffer from erectile dysfunction, or ED, as Bob Dole has informed us in television commercials. And that is only half the story: Just as many women, if not more, experience sexual dysfunction.
Authorities say that over 40 million women, 25% of those before menopause and 70% after menopause, experience some degree of sexual dysfunction, either loss of sexual desire or sexual arousal disorder, which is marked by the lack of lubrication and lack of blood flow to the
genitalia.
VIVUS, Inc. (Nasdaq: VVUS) addresses the sexual dysfunction market with several products for male dysfunction. It also has several products under development for women.
What about Viagra? Well, Viagra seems to help only half of the men who are unable to maintain an erection and therefore enjoy and complete coitus. (What a frustrated world we must live in!). Even more problematic is that Viagra, the wonder medication of the 1990s and the classic example of an unfathomably successful “blockbuster”, drug, is now accused of playing a part in the deaths of several hundred men after several million prescriptions have been issued. Sexual dysfunction is projected to increase rapidly in the years ahead because the condition is related to age. There probably will be less “boomly” in the baby boomer bracket as this demographic segment grows older over the next several decades.
Why Invest?
We are recommending the purchase of VVUS shares for long-term capital appreciation. The company has just completed eight quarters of profitable operation and sports a strong, cash-laden balance sheet. The market opportunity for untreated erectile dysfunction broaches $1 billion dollars despite the success of Viagra. Even this remarkable market represents only half the opportunity because VVUS has a potential drug, Alista, in development for the larger market for female sexual dysfunction. Since its founding, the company has invested heavily in raising competitive barriers via its sizable patent portfolio, and it has added competitive prowess by partnering with Abbott Laboratories (NYSE: ABT) for international marketing. Lastly, VVUS also has other drugs and therapies in development that should, if successful, help round out its product offering and establish VVUS as is “The Sex Pharmaceutical Company”.
Our investment thesis is based on the company’s interesting and attractive risk/reward profile. At $3.31, roughly half of the share price is covered by the $46 million of cash on the balance sheet:
Therefore, one could presume that the downside risk at this juncture is modest. The operation is actually spinning off a small profit, while management continues to invest about $10 million of operating profits a year in research and development. The market is large enough that minor penetration by its current intraurethral product for ED should provide a modestly growing EPS trend. That, in turn, should cause investors to reevaluate VVUS as something more than a “candidate for bankruptcy”. and push its shares to the low double-digit level. And if VVUS has a tremendous success, say from any one of its developmental products, investors could see the share price rise to the high teens or low $20s. We reaffirm that the shares are not risk-free, however, and that only those investors who can tolerate business risk plus higher price volatility should consider VVUS as an investment.
A History of Ups and Downs
In 1991, VVUS was established to develop treatments for erectile dysfunction and other urological and sexual disorders. It introduced a penile suppository for ED containing the active ingredient alprostadil in January 1997. The company immediately enjoyed enviable growth in sales even though the drug is delivered transurethrally, or inserted in the tip of the penis like a minute grain of rice using a miniature plastic straw of VVUS™ own patented design. This medicated urethral system for erection, or MUSE, as it came to be known, became one of the 25 most successful drug launches in the United States. Sales roared to nearly $130 million by 1997’s year-end and investors believed that they had struck gold. Then Pfizer introduced Viagra (sildenafil citrate) in April 1998 and snipped VVUS’s success. Sales fell to about 15% of their
former levels.
The incident has two important lessons. First, a drug for ED that can be delivered orally, like Viagra, stands a much better chance than a more-involved method like MUSE. Viagra promptly commandeered the existing market for impotence drugs. The introduction of Viagra also created demand for treatment of an affliction that was heretofore left alone in the depths of men’s psyches and rarely, if ever, adequately addressed by the medical field. Viagra, if you think about it, legitimized talking about sex in ads and made ED an “out of the closet” disorder that could be talked about, treated and commercialized. Viagra expanded the arena to nearly $1 billion.
Second, VVUS management has proven that it can survive disaster. The calamitous collapse of VVUS’s sales reduced the company’s top line by 85% and left the former stock market star a mere shadow of its former self. Shares fell from the $40s to a new low of $2, and the company experienced losses of $80 million.
But the company survived. Management was forced to restructure and streamline radically so the operation could continue to operate profitably on much-lower sales. The company returned to profitability in 1999 and, as we stated earlier, has remained profitable ever since. While management plugged many holes in operations to save the company, it also succeeded in increasing production of MUSE while reducing the number of people employed for manufacturing. It also increased the quality of the product and boosted manufacturing yield. Today, VVUS™ 90,000-square-foot certified manufacturing plant is running at roughly 20% of capacity and supports sales approaching $25 million. With the addition of just 19 people, VVUS could double production and support sales of $50 million.
We see VVUS as a classic turnaround story, with substantial growth as an upside. It is challenging enough to manage an operation going up on a rocket-shiplike growth trajectory. Turnarounds, or recoveries like the one VVUS accomplished, are far harder feats. From this demonstration of operating pluck, we should derive that the management team is well above average and should be up to the challenges ahead and able to maximize the considerable upside potential there.
The Other Side of the Story
Women suffer from a range of organic and psychological sexual conditions. In fact, female sexual dysfunction is believed to affect approximately 43% of women, according to The Journal of the American Medical Association, and it is one of the most common complaints from women who are nearing, experiencing or past menopause. Because female sexual dysfunction was overshadowed by the excitement surrounding the success of medications for men, the medical community had all but overlooked the other half of the equation. Recognizing this, VVUS set about developing a remedy for women. It came up with Alista, a topical product based on alprostadil, the active ingredient in MUSE. Alista, the “dream cream” acts as a vasodilator when applied directly to the clitoris and labia, helping to stimulate blood flow and engorge the clitoris. This results in enhanced lubrication and arousal, and helps to facilitate stronger orgasms in women.
The number of women affected by inorgasma (the inability to achieve orgasm), let alone normally functioning females who want to experience multiple or stronger orgasms, could be larger than the number of men able to benefit from Viagra. It is estimated that the demand for female arousal drugs could become a $500 billion industry (The New York Times, as reported by Glamour, August 1999). That figure is probably excessive, but nevertheless, even a fraction of the estimated market value leaves significant dollars to chase.
Doctors have even tried prescribing Viagra off-label to women, but Viagra has not proven effective for female sexual dysfunction, and there is no current leader in this market segment. VVUS has a strong patent position surrounding Alista, covering domestic commercial rights for topical formulations of vasodilating agents and other compounds for female sexual dysfunction. It also has a European Union patent pending.
The marketing possibilities for a “dream cream”, including an eventual over-the-counter version, are endless and have sent competitors scurrying to the lab. VVUS opened enrollment for Alista Phase III clinical trials in late October. Results from this initial clinical study of Alista are expected to aid in the design of larger studies that are required for regulatory approval worldwide.
Not Giving Up on Men
The promise of Alista for women does not mean VVUS has turned away from the men’s market. It is focusing on the large segment of the market that is not helped by Viagra’s magical powers. First, it is expanding awareness of MUSE by spreading the word with urologists. It has also signed a marketing partnership for MUSE with the giant Abbott International, Ltd. VVUS has restarted its R&D efforts to broaden its product pipeline for erectile dysfunction.
Though MUSE is not as handy as the “little blue pill”, it still is a far more agreeable therapy than the third, longstanding alternatives an intracavernosal injection of a vasoactive substance, or use of a needle to deliver a shot you know where. MUSE has posted an excellent safety profile since being approved by the FDA in 1996, and it is currently approved in 48 countries and still well protected by patents.
In June, VVUS signed a marketing agreement with Abbott International, Ltd. granting the latter exclusive worldwide marketing rights to MUSE. Abbott launched the product in the United Kingdom in September. During the third-quarter conference call, management disclosed that ihsell-inle shipments by Abbott to the U.K. had been proceeding above expectations. Soon thereafter, in late October, MUSE was launched in Germany and Sweden. Two more countries are to be added to the rollout in November.
VVUS acknowledges that MUSE, as a first-generation product, still has its problems, however. A key one is that patients must titrate doses of MUSE for effectiveness, that is, try increasing levels of alprostadil in the urologist’s office until they attain and maintain a rigid erection before a prescription can be prepared. Obviously, this procedure limits the market to those visiting a urologist, and the need for a physician™s supervision tends to dampen interest and suppress its use.
Therefore, VVUS developed Alibra, its second-generation therapy for erectile dysfunction. It’s a penile suppository like MUSE, but contains alprostadil and prasozin hydrochloride and is specifically designed for prescription by a primary care physician. The company received its patent for the new compound in March 1999 and filed for FDA marketing approval and European Union approval in December 1999. Late in October, the company withdrew its new drug application for Alibra, stating that additional meetings with the FDA were required to determine what additional data would be needed to obtain marketing clearance for the product.
We still believe that this second product, despite the setback, should receive FDA approval in the next year and re-affirm the company’s position in the erectile dysfunction market. VVUS remains excited about Alibra™s prospects because it could be more broadly available than MUSE and address more of the remaining market.
ABT signed on to distribute Alibra, once approved, outside the United States. The agreement also includes an option for ABT to codevelop and license VVUS future transurethral products for erectile dysfunction outside the country. VVUS is working on a treatment for premature ejaculationŠdescribed by some as the cruelest disorder. The market is substantial; the condition is believed to affect nearly 10% to 20% of men, mostly young men, making the potential market about a billion dollars. There is no existing FDA-approved therapy, so the market is substantially a wide-open opportunity. We think this therapy for premature ejaculation could also make the company a stand-alone pharmaceutical concern.
VVUS has completed a proof-of-concept study for its approach, which is an oral medication. It is currently enhancing its patent position; VVUS has already received patents covering oral, topical transdermal and transurethral application of serotonin antagonists for premature ejaculation. Current thinking by management is that VVUS will itself fund Phase I and Phase II trials and, if successful, then find a partner for the final research steps and marketing rollout.
VVUS is also pursuing a third-generation product to treat ED. The company says it is building a strong ring of patents on both the formulation and delivery method to protect the proposed therapy, which is still heavily underwraps. This new product, which combines alprostadil and a phosphodieterase inhibitor, is said to work on those patients who have not responded to MUSE or Viagra. Recent research studies performed here and abroad show that patients reported improved sexual intercourse or overall satisfaction using the two-ingredient therapy over a single-element drug.
We need to make sure that readers and potential investors understand that this last therapy, while exciting, is still a considerable ways out, probably at least three years away. Any near-term investment decision should be founded on the prospects of the first two, more-immediate opportunities for treating ED, as well as the potential for VVUS™ therapies for female sexual dysfunction.
The Next Celgene?
For 3Q00, ending Sept. 30, VVUS reported net income of $208,000, or $0.01 per share, on revenues of $5.0 million, compared with net income of $897,000, or $0.03 per share, for the same quarter a year ago. The decline was primarily due to lower use of MUSE by Veterans Administration hospitals after Viagra was added to the VA formulary earlier this year. Product revenue for 3Q00 internationally was $256,000 compared with $1.1 million for the year-ago period as the ramp-up of shipments to VVUS™ new overseas marketing partner, ABT, was just beginning in late September. VVUS ended the period with $44.2 million in cash and near-cash items, while total liabilities during the period decreased to $6.4 million. With Viagra™s limitations and potential side effects becoming better known, VVUS is well positioned to gain market share as the provider of the more palatable alternative to Viagra or the provider of a next-generation combination therapy that seems to have even greater efficacy.
VVUS is also leading the way in the development of products for two niche markets, premature ejaculation and female sexual dysfunction. Additionally, the company recently achieved another milestone by signing a marketing agreement with ABT for the distribution of MUSE and Alibra in international markets such as Europe, Japan, Australia, Central America and South America. The company has already started shipping to ABT for the European market, and sell-through reports indicate that acceptance is high. That should further establish VVUS™ track record for a growing top and bottom line. VVUS is facing plenty of other opportunities as its other drugs in development, specifically Alista and the product for premature ejaculation, wend their way through the development pipeline and approach commercialization.
Erin Dailey, our analyst on this company, believes that earnings should show some growth in 2001. She originally estimated that VVUS would put $0.20 per share on the bottom line in non-taxed profits. Based on the prospects of VVUS™ portfolio for treating sexual dysfunction, she used a 50x P/E multiple to yield an 18-month price target of $10.
I’m not as sanguine on the near-term operating course as Erin is. However, I am far more optimistic about the prospects for the shares in the long run. I believe that VVUS’s stock market success should follow the unparalleled trajectory of Celgene, Inc. (Nasdaq: CELG), which RedChip helped discover back in the fall of 1998.
As you may remember, Celgene sought and received FDA approval to use the old, notorious drug thalidomide to treat leprosy, although there are only 500 cases in the United States. Thalidomide was then found to be quite helpful in the off-label treatment of cancer, certain AIDS conditions and Crohn’s disease. When the market accepted that the drug’s past should be forgiven in light of its new benefits, the stock was embraced by the investment community and traded up to nearly $200 per share. VVUS, of course, still has modest revenues and thin operating profits, but it also seems to enjoy huge new drug prospects.
VVUS story is similar to CELG’s, but actually more tantalizing. Its market opportunities are every bit as exciting, if not greater, than CELG’s were. Like Celgene, it is coming from behind the market favorite and scientific leader. But the success of any one of its three major development opportunities could make the company’s future. We believe that significant profitability, unlike in CELG’s case, is a year away, if not a couple of years out. On the other hand, shares like VVUS usually reflect substantial prospects well before their realization. Our published target price of $10 makes sense for now. But if news about VVUS’s other therapies becomes better understood, the shares should rise to the mid-to high ($17-19) teens.
~~~~~~~~
Kursziel 12 Monate $17-19!
Published Nov. 27, 2000, at www.redchip.com
Ten million to 20 million men in the United States and roughly 50 million men worldwide suffer from erectile dysfunction, or ED, as Bob Dole has informed us in television commercials. And that is only half the story: Just as many women, if not more, experience sexual dysfunction.
Authorities say that over 40 million women, 25% of those before menopause and 70% after menopause, experience some degree of sexual dysfunction, either loss of sexual desire or sexual arousal disorder, which is marked by the lack of lubrication and lack of blood flow to the
genitalia.
VIVUS, Inc. (Nasdaq: VVUS) addresses the sexual dysfunction market with several products for male dysfunction. It also has several products under development for women.
What about Viagra? Well, Viagra seems to help only half of the men who are unable to maintain an erection and therefore enjoy and complete coitus. (What a frustrated world we must live in!). Even more problematic is that Viagra, the wonder medication of the 1990s and the classic example of an unfathomably successful “blockbuster”, drug, is now accused of playing a part in the deaths of several hundred men after several million prescriptions have been issued. Sexual dysfunction is projected to increase rapidly in the years ahead because the condition is related to age. There probably will be less “boomly” in the baby boomer bracket as this demographic segment grows older over the next several decades.
Why Invest?
We are recommending the purchase of VVUS shares for long-term capital appreciation. The company has just completed eight quarters of profitable operation and sports a strong, cash-laden balance sheet. The market opportunity for untreated erectile dysfunction broaches $1 billion dollars despite the success of Viagra. Even this remarkable market represents only half the opportunity because VVUS has a potential drug, Alista, in development for the larger market for female sexual dysfunction. Since its founding, the company has invested heavily in raising competitive barriers via its sizable patent portfolio, and it has added competitive prowess by partnering with Abbott Laboratories (NYSE: ABT) for international marketing. Lastly, VVUS also has other drugs and therapies in development that should, if successful, help round out its product offering and establish VVUS as is “The Sex Pharmaceutical Company”.
Our investment thesis is based on the company’s interesting and attractive risk/reward profile. At $3.31, roughly half of the share price is covered by the $46 million of cash on the balance sheet:
Therefore, one could presume that the downside risk at this juncture is modest. The operation is actually spinning off a small profit, while management continues to invest about $10 million of operating profits a year in research and development. The market is large enough that minor penetration by its current intraurethral product for ED should provide a modestly growing EPS trend. That, in turn, should cause investors to reevaluate VVUS as something more than a “candidate for bankruptcy”. and push its shares to the low double-digit level. And if VVUS has a tremendous success, say from any one of its developmental products, investors could see the share price rise to the high teens or low $20s. We reaffirm that the shares are not risk-free, however, and that only those investors who can tolerate business risk plus higher price volatility should consider VVUS as an investment.
A History of Ups and Downs
In 1991, VVUS was established to develop treatments for erectile dysfunction and other urological and sexual disorders. It introduced a penile suppository for ED containing the active ingredient alprostadil in January 1997. The company immediately enjoyed enviable growth in sales even though the drug is delivered transurethrally, or inserted in the tip of the penis like a minute grain of rice using a miniature plastic straw of VVUS™ own patented design. This medicated urethral system for erection, or MUSE, as it came to be known, became one of the 25 most successful drug launches in the United States. Sales roared to nearly $130 million by 1997’s year-end and investors believed that they had struck gold. Then Pfizer introduced Viagra (sildenafil citrate) in April 1998 and snipped VVUS’s success. Sales fell to about 15% of their
former levels.
The incident has two important lessons. First, a drug for ED that can be delivered orally, like Viagra, stands a much better chance than a more-involved method like MUSE. Viagra promptly commandeered the existing market for impotence drugs. The introduction of Viagra also created demand for treatment of an affliction that was heretofore left alone in the depths of men’s psyches and rarely, if ever, adequately addressed by the medical field. Viagra, if you think about it, legitimized talking about sex in ads and made ED an “out of the closet” disorder that could be talked about, treated and commercialized. Viagra expanded the arena to nearly $1 billion.
Second, VVUS management has proven that it can survive disaster. The calamitous collapse of VVUS’s sales reduced the company’s top line by 85% and left the former stock market star a mere shadow of its former self. Shares fell from the $40s to a new low of $2, and the company experienced losses of $80 million.
But the company survived. Management was forced to restructure and streamline radically so the operation could continue to operate profitably on much-lower sales. The company returned to profitability in 1999 and, as we stated earlier, has remained profitable ever since. While management plugged many holes in operations to save the company, it also succeeded in increasing production of MUSE while reducing the number of people employed for manufacturing. It also increased the quality of the product and boosted manufacturing yield. Today, VVUS™ 90,000-square-foot certified manufacturing plant is running at roughly 20% of capacity and supports sales approaching $25 million. With the addition of just 19 people, VVUS could double production and support sales of $50 million.
We see VVUS as a classic turnaround story, with substantial growth as an upside. It is challenging enough to manage an operation going up on a rocket-shiplike growth trajectory. Turnarounds, or recoveries like the one VVUS accomplished, are far harder feats. From this demonstration of operating pluck, we should derive that the management team is well above average and should be up to the challenges ahead and able to maximize the considerable upside potential there.
The Other Side of the Story
Women suffer from a range of organic and psychological sexual conditions. In fact, female sexual dysfunction is believed to affect approximately 43% of women, according to The Journal of the American Medical Association, and it is one of the most common complaints from women who are nearing, experiencing or past menopause. Because female sexual dysfunction was overshadowed by the excitement surrounding the success of medications for men, the medical community had all but overlooked the other half of the equation. Recognizing this, VVUS set about developing a remedy for women. It came up with Alista, a topical product based on alprostadil, the active ingredient in MUSE. Alista, the “dream cream” acts as a vasodilator when applied directly to the clitoris and labia, helping to stimulate blood flow and engorge the clitoris. This results in enhanced lubrication and arousal, and helps to facilitate stronger orgasms in women.
The number of women affected by inorgasma (the inability to achieve orgasm), let alone normally functioning females who want to experience multiple or stronger orgasms, could be larger than the number of men able to benefit from Viagra. It is estimated that the demand for female arousal drugs could become a $500 billion industry (The New York Times, as reported by Glamour, August 1999). That figure is probably excessive, but nevertheless, even a fraction of the estimated market value leaves significant dollars to chase.
Doctors have even tried prescribing Viagra off-label to women, but Viagra has not proven effective for female sexual dysfunction, and there is no current leader in this market segment. VVUS has a strong patent position surrounding Alista, covering domestic commercial rights for topical formulations of vasodilating agents and other compounds for female sexual dysfunction. It also has a European Union patent pending.
The marketing possibilities for a “dream cream”, including an eventual over-the-counter version, are endless and have sent competitors scurrying to the lab. VVUS opened enrollment for Alista Phase III clinical trials in late October. Results from this initial clinical study of Alista are expected to aid in the design of larger studies that are required for regulatory approval worldwide.
Not Giving Up on Men
The promise of Alista for women does not mean VVUS has turned away from the men’s market. It is focusing on the large segment of the market that is not helped by Viagra’s magical powers. First, it is expanding awareness of MUSE by spreading the word with urologists. It has also signed a marketing partnership for MUSE with the giant Abbott International, Ltd. VVUS has restarted its R&D efforts to broaden its product pipeline for erectile dysfunction.
Though MUSE is not as handy as the “little blue pill”, it still is a far more agreeable therapy than the third, longstanding alternatives an intracavernosal injection of a vasoactive substance, or use of a needle to deliver a shot you know where. MUSE has posted an excellent safety profile since being approved by the FDA in 1996, and it is currently approved in 48 countries and still well protected by patents.
In June, VVUS signed a marketing agreement with Abbott International, Ltd. granting the latter exclusive worldwide marketing rights to MUSE. Abbott launched the product in the United Kingdom in September. During the third-quarter conference call, management disclosed that ihsell-inle shipments by Abbott to the U.K. had been proceeding above expectations. Soon thereafter, in late October, MUSE was launched in Germany and Sweden. Two more countries are to be added to the rollout in November.
VVUS acknowledges that MUSE, as a first-generation product, still has its problems, however. A key one is that patients must titrate doses of MUSE for effectiveness, that is, try increasing levels of alprostadil in the urologist’s office until they attain and maintain a rigid erection before a prescription can be prepared. Obviously, this procedure limits the market to those visiting a urologist, and the need for a physician™s supervision tends to dampen interest and suppress its use.
Therefore, VVUS developed Alibra, its second-generation therapy for erectile dysfunction. It’s a penile suppository like MUSE, but contains alprostadil and prasozin hydrochloride and is specifically designed for prescription by a primary care physician. The company received its patent for the new compound in March 1999 and filed for FDA marketing approval and European Union approval in December 1999. Late in October, the company withdrew its new drug application for Alibra, stating that additional meetings with the FDA were required to determine what additional data would be needed to obtain marketing clearance for the product.
We still believe that this second product, despite the setback, should receive FDA approval in the next year and re-affirm the company’s position in the erectile dysfunction market. VVUS remains excited about Alibra™s prospects because it could be more broadly available than MUSE and address more of the remaining market.
ABT signed on to distribute Alibra, once approved, outside the United States. The agreement also includes an option for ABT to codevelop and license VVUS future transurethral products for erectile dysfunction outside the country. VVUS is working on a treatment for premature ejaculationŠdescribed by some as the cruelest disorder. The market is substantial; the condition is believed to affect nearly 10% to 20% of men, mostly young men, making the potential market about a billion dollars. There is no existing FDA-approved therapy, so the market is substantially a wide-open opportunity. We think this therapy for premature ejaculation could also make the company a stand-alone pharmaceutical concern.
VVUS has completed a proof-of-concept study for its approach, which is an oral medication. It is currently enhancing its patent position; VVUS has already received patents covering oral, topical transdermal and transurethral application of serotonin antagonists for premature ejaculation. Current thinking by management is that VVUS will itself fund Phase I and Phase II trials and, if successful, then find a partner for the final research steps and marketing rollout.
VVUS is also pursuing a third-generation product to treat ED. The company says it is building a strong ring of patents on both the formulation and delivery method to protect the proposed therapy, which is still heavily underwraps. This new product, which combines alprostadil and a phosphodieterase inhibitor, is said to work on those patients who have not responded to MUSE or Viagra. Recent research studies performed here and abroad show that patients reported improved sexual intercourse or overall satisfaction using the two-ingredient therapy over a single-element drug.
We need to make sure that readers and potential investors understand that this last therapy, while exciting, is still a considerable ways out, probably at least three years away. Any near-term investment decision should be founded on the prospects of the first two, more-immediate opportunities for treating ED, as well as the potential for VVUS™ therapies for female sexual dysfunction.
The Next Celgene?
For 3Q00, ending Sept. 30, VVUS reported net income of $208,000, or $0.01 per share, on revenues of $5.0 million, compared with net income of $897,000, or $0.03 per share, for the same quarter a year ago. The decline was primarily due to lower use of MUSE by Veterans Administration hospitals after Viagra was added to the VA formulary earlier this year. Product revenue for 3Q00 internationally was $256,000 compared with $1.1 million for the year-ago period as the ramp-up of shipments to VVUS™ new overseas marketing partner, ABT, was just beginning in late September. VVUS ended the period with $44.2 million in cash and near-cash items, while total liabilities during the period decreased to $6.4 million. With Viagra™s limitations and potential side effects becoming better known, VVUS is well positioned to gain market share as the provider of the more palatable alternative to Viagra or the provider of a next-generation combination therapy that seems to have even greater efficacy.
VVUS is also leading the way in the development of products for two niche markets, premature ejaculation and female sexual dysfunction. Additionally, the company recently achieved another milestone by signing a marketing agreement with ABT for the distribution of MUSE and Alibra in international markets such as Europe, Japan, Australia, Central America and South America. The company has already started shipping to ABT for the European market, and sell-through reports indicate that acceptance is high. That should further establish VVUS™ track record for a growing top and bottom line. VVUS is facing plenty of other opportunities as its other drugs in development, specifically Alista and the product for premature ejaculation, wend their way through the development pipeline and approach commercialization.
Erin Dailey, our analyst on this company, believes that earnings should show some growth in 2001. She originally estimated that VVUS would put $0.20 per share on the bottom line in non-taxed profits. Based on the prospects of VVUS™ portfolio for treating sexual dysfunction, she used a 50x P/E multiple to yield an 18-month price target of $10.
I’m not as sanguine on the near-term operating course as Erin is. However, I am far more optimistic about the prospects for the shares in the long run. I believe that VVUS’s stock market success should follow the unparalleled trajectory of Celgene, Inc. (Nasdaq: CELG), which RedChip helped discover back in the fall of 1998.
As you may remember, Celgene sought and received FDA approval to use the old, notorious drug thalidomide to treat leprosy, although there are only 500 cases in the United States. Thalidomide was then found to be quite helpful in the off-label treatment of cancer, certain AIDS conditions and Crohn’s disease. When the market accepted that the drug’s past should be forgiven in light of its new benefits, the stock was embraced by the investment community and traded up to nearly $200 per share. VVUS, of course, still has modest revenues and thin operating profits, but it also seems to enjoy huge new drug prospects.
VVUS story is similar to CELG’s, but actually more tantalizing. Its market opportunities are every bit as exciting, if not greater, than CELG’s were. Like Celgene, it is coming from behind the market favorite and scientific leader. But the success of any one of its three major development opportunities could make the company’s future. We believe that significant profitability, unlike in CELG’s case, is a year away, if not a couple of years out. On the other hand, shares like VVUS usually reflect substantial prospects well before their realization. Our published target price of $10 makes sense for now. But if news about VVUS’s other therapies becomes better understood, the shares should rise to the mid-to high ($17-19) teens.
~~~~~~~~
Kursziel 12 Monate $17-19!
Hallo Leute!
Bin neu hier, und einer von vielen, der des englischen nicht so mächtig ist. Könnte deshalb mal jemand den letzten beitrag evtl. zusammenfassend, in deutsch schreiben? Das Datum kann ich allerdings lesen. Scheint Ja nicht gerade die neueste Nachricht zu sein!
Bin neu hier, und einer von vielen, der des englischen nicht so mächtig ist. Könnte deshalb mal jemand den letzten beitrag evtl. zusammenfassend, in deutsch schreiben? Das Datum kann ich allerdings lesen. Scheint Ja nicht gerade die neueste Nachricht zu sein!
Shares of VVUS are currently trading at 1.5x book value and 1.6x sales. With its marketing partner Abbott exceeding expectations abroad and its new Canadian marketing partner, Paladin Labs, on board, we feel there is much room for appreciation.
Redchip 22.12.00
COMPANY OVERVIEW: MAKING ‘IT’ HAPPEN
Sex was once considered a topic to be discussed only in hushed tones, and those who suffered from sexual dysfunction were often shamed into silence. Today, because of education and the media, it is more acceptable than ever to be open about and expressive of one’s sexuality. Medicine is paralleling our social progress. Formed in 1991 to develop treatments for impotence, VIVUS, Inc. (Nasdaq: VVUS) makes products to enhance quality of life including therapeutic systems designed to treat male sexual dysfunction, or erectile dysfunction (ED), as well as male and female urologic disorders. The company makes an erectile suppository that is delivered transurethrally, called MUSE (medicated urethral system for erection), containing the active ingredient alprostadil. The company also makes Actis, a latex band to help control blood flow used in the treatment of ED caused by venous leakage.
VVUS is currently developing a treatment for female sexual dysfunction (FSD) called Alista, a topical product based on alprostadil. The company filed an investigational new drug application with the FDA for Alista and is currently engaged in clinical trials of Alista on humans. Additionally, VVUS completed a proof-of-concept study to evaluate commercial applications for the oral treatment of premature ejaculation (PE). Abbott Laboratories is the company’s international marketing and distribution partner for MUSE and, pending approval, Alibra, except in Canada where Paladin Labs is the company’s international marketing partner for MUSE.
New Developments: Clinical trials for Alista, the female sexual dysfunction drug, commenced this past quarter and thus far seem to be going well. In early December, VVUS was awarded its third phosphodiesterase (PDE) inhibitor patent for the treatment of erectile dysfunction. This patent will broaden its patent protection in the eventual commercialization of its third-generation ED product currently in development. VVUS also filed and received over-the-counter marketing approval with the FDA for Actis, an erectile dysfunction treatment product that is made up of an adjustable constriction band used to control the flow of blood in the penis and enhance the erection process.
Ramping Up Abroad: Management has already seen a significant ramp up in sales for 4Q00 and anticipates international sales could be more than $1 million for the current quarter. However, it should be noted that international sales currently only include three countries, Germany, the United Kingdom and Sweden. MUSE has been approved for sale in 48 countries and will continue to enter new markets with Abbott. Abbott has targeted new countries for new MUSE sales during 1Q01. On Nov. 21, VVUS also partnered with Paladin Labs, Inc., granting it the exclusive distribution and marketing rights for MUSE in Canada. Abbott still retains the rights to VVUS’ current and future erectile dysfunction products in all other international markets. In a surprise move, the FDA did not approve the NDA filing for Alibra, VVUS’s second-generation erectile dysfunction drug. The FDA requested additional data to answer questions about the significant difference between the new drug and MUSE. The company has since met with the FDA to discuss any discrepancies and will submit additional data and continue meeting in order to resolve issues.
Model Modifications: We scaled back our 2001 estimates slightly to give Abbott time to progress and to reflect VVUS’ focus on investing in its R&D pipeline going forward. We think, however, there could be considerable upside not built into the model between international sales, potential in-house licensing agreements, the potential of Actis—with its recent over-the-counter approval—and any favorable settlement received from a currently pending lawsuit against VVUS’ former international marketing partner, Janssen. We anticipate net income for 2000 to be somewhere in the neighborhood of $3.2 million, or $0.11 a share, on revenues of $26.8 million. For 2001, we anticipate net income of $3.6 million, or $0.10 per share, on revenues of $40 million.
INVESTMENT CONCLUSION: POTENTIAL IN THE PIPELINE
Due to a biotech industry slump and market volatility, shares of VVUS hit a 52-week low of $1.93 since our last report and are currently trading around $2.00. With approximately $1.36 in cash per share on the books and trading at just over book value at 1.4x, VVUS appears to be a screaming value. However, we would caution investors to acknowledge the risk involved in speculating on the outcome of new drug development, especially with the market’s volatility of late. We applied a 5x multiple to 2001 estimated sales per share of $1.12 to yield a short-term target of $6-8. Based on the strength of the company’s patent portfolio and potential product pipeline in addition to having zero debt and ample cash, we are upgrading VVUS to an "A". But if news about VVUS’s other therapies becomes better understood, the shares should rise to the mid-to high ($17-19) teens.
Redchip 22.12.00
COMPANY OVERVIEW: MAKING ‘IT’ HAPPEN
Sex was once considered a topic to be discussed only in hushed tones, and those who suffered from sexual dysfunction were often shamed into silence. Today, because of education and the media, it is more acceptable than ever to be open about and expressive of one’s sexuality. Medicine is paralleling our social progress. Formed in 1991 to develop treatments for impotence, VIVUS, Inc. (Nasdaq: VVUS) makes products to enhance quality of life including therapeutic systems designed to treat male sexual dysfunction, or erectile dysfunction (ED), as well as male and female urologic disorders. The company makes an erectile suppository that is delivered transurethrally, called MUSE (medicated urethral system for erection), containing the active ingredient alprostadil. The company also makes Actis, a latex band to help control blood flow used in the treatment of ED caused by venous leakage.
VVUS is currently developing a treatment for female sexual dysfunction (FSD) called Alista, a topical product based on alprostadil. The company filed an investigational new drug application with the FDA for Alista and is currently engaged in clinical trials of Alista on humans. Additionally, VVUS completed a proof-of-concept study to evaluate commercial applications for the oral treatment of premature ejaculation (PE). Abbott Laboratories is the company’s international marketing and distribution partner for MUSE and, pending approval, Alibra, except in Canada where Paladin Labs is the company’s international marketing partner for MUSE.
New Developments: Clinical trials for Alista, the female sexual dysfunction drug, commenced this past quarter and thus far seem to be going well. In early December, VVUS was awarded its third phosphodiesterase (PDE) inhibitor patent for the treatment of erectile dysfunction. This patent will broaden its patent protection in the eventual commercialization of its third-generation ED product currently in development. VVUS also filed and received over-the-counter marketing approval with the FDA for Actis, an erectile dysfunction treatment product that is made up of an adjustable constriction band used to control the flow of blood in the penis and enhance the erection process.
Ramping Up Abroad: Management has already seen a significant ramp up in sales for 4Q00 and anticipates international sales could be more than $1 million for the current quarter. However, it should be noted that international sales currently only include three countries, Germany, the United Kingdom and Sweden. MUSE has been approved for sale in 48 countries and will continue to enter new markets with Abbott. Abbott has targeted new countries for new MUSE sales during 1Q01. On Nov. 21, VVUS also partnered with Paladin Labs, Inc., granting it the exclusive distribution and marketing rights for MUSE in Canada. Abbott still retains the rights to VVUS’ current and future erectile dysfunction products in all other international markets. In a surprise move, the FDA did not approve the NDA filing for Alibra, VVUS’s second-generation erectile dysfunction drug. The FDA requested additional data to answer questions about the significant difference between the new drug and MUSE. The company has since met with the FDA to discuss any discrepancies and will submit additional data and continue meeting in order to resolve issues.
Model Modifications: We scaled back our 2001 estimates slightly to give Abbott time to progress and to reflect VVUS’ focus on investing in its R&D pipeline going forward. We think, however, there could be considerable upside not built into the model between international sales, potential in-house licensing agreements, the potential of Actis—with its recent over-the-counter approval—and any favorable settlement received from a currently pending lawsuit against VVUS’ former international marketing partner, Janssen. We anticipate net income for 2000 to be somewhere in the neighborhood of $3.2 million, or $0.11 a share, on revenues of $26.8 million. For 2001, we anticipate net income of $3.6 million, or $0.10 per share, on revenues of $40 million.
INVESTMENT CONCLUSION: POTENTIAL IN THE PIPELINE
Due to a biotech industry slump and market volatility, shares of VVUS hit a 52-week low of $1.93 since our last report and are currently trading around $2.00. With approximately $1.36 in cash per share on the books and trading at just over book value at 1.4x, VVUS appears to be a screaming value. However, we would caution investors to acknowledge the risk involved in speculating on the outcome of new drug development, especially with the market’s volatility of late. We applied a 5x multiple to 2001 estimated sales per share of $1.12 to yield a short-term target of $6-8. Based on the strength of the company’s patent portfolio and potential product pipeline in addition to having zero debt and ample cash, we are upgrading VVUS to an "A". But if news about VVUS’s other therapies becomes better understood, the shares should rise to the mid-to high ($17-19) teens.
Der Nächste Celgene?
Für 3Q00, Ende Sept.2000, berichtete VVUS ein netto Einkommen von $208,000, oder $0.01 pro Anteil, auf Einnahmen von $5.0 Million, verglichen mit einem netto Einkommen von $897,000, oder $0.03 pro Anteil, für das gleiche Viertel vor einem Jahr (1999).
Der Rückgang war hauptsächlich wegen der niedrigeren Verwendung von MUSE, nachdem Viagra früher zum Veteranen-Verwaltung-Krankenhäusern dieses Jahr hinzugefügt worden war. Produkt-Einnahmen für 3Q00 war international $256,000 verglichen mit $1.1 Million für das voherige Jahresquartal.
Auframpen von Überseelieferungen
Der neue Übersee-Marketing-Partner, Abbott Laboratories (ABT), fing gerade in spätem September an. VVUS endete das Quartal mit $44.2 Million in Bargeld und andere Gegenstände, während totale Verpflichtungen verringerte sich um $6.4 Million. Mit der klinische Einschränkungen VIAGRA und dessen potentielle Nebenwirkungen, die langsam besser gekannt werden, hat VVUS gute Chancen, Marktanteil als der Versorger der schmackhafteren Alternative zu Viagra zu gewinnen und auch als der Versorger eines nächsten Generation-Kombination ED Therapie, die scheint, noch größere Wirksamkeit zu haben. VVUS führt auch den Weg in der Entwicklung von Produkten für zwei Nische; erstens vorzeitiger Ejeculation und zweitens weibliche sexuelle Funktionsstörung (FSD). Zusätzlich jübelt die Gesellschaft, um die vor kurzem erreicheten Meilenstein vom Unterschreiben einer Marketing-Kooperation mit ABT für die Verteilung von MUSE und Alibra im internationalen Märkten wie Europa, Japan, Australien, Mittelamerika und Südamerika. VVUS hat schon angefangen, ABT für den europäischen Markt zu liefern, und es wird berichtet, daß die Annahme hoch ist. Das sollte VVUS bedeuten, wachsende Umsätze und Gewinne zu erwirtscaften. VVUS hält genauso viel von anderen Gelegenheiten als seine anderen Drogen in der Entwicklungphase, ausdrücklich Alista und das Produkt für vorzeitigen Ejecualtion, mit den sie langsam aber sicher durch die Entwicklungphasen bis zur Kommerzialisierung bringen wird.
Erin Dailey, unsere Analytikerin für dieser Gesellschaft, glaubt, daß ihr Einkommen zunehmend wachsen wird uund 2001 zeigen sollten. Sie schätzte ursprünglich, daß dieser VVUS setzen würde, $0.20 pro Anteil steuerfrei Gewinne erwirtscften wird. Basierte auf den Aussichten von VVUS`s Aktentasche für das Behandlung von sexueller Funktionsstörung, benutzte sie einen 50x KGV, um einen 18 Monats Kursziel von $10.
Ich bin nicht als optimitisch für den Kurs als Erin ist. Aber langfristig bin ich weit über die Aussichten für die Aktien optimistischer. Ich glaube, daß VVUS`s Börsenerfolg sollte der einmaligen Flugbahn von Celgene folgen, AG (Nasdaq: CELG), die RedChip im Herbst 1998 endeckt.
Wie Sie vielleicht sich erinnern, suchte Celgene und bekam eine FDA-Genehmigung, um den alten, notorischen Droge-thalidomide zu benutzen, um Lepra zu behandeln, obwohl es nur 500 Fälle in den Vereinigten Staaten por Jahr gibt. Es wurde dann endeckt, daß Thalidomide auch in der Behandlung von Krebs, bestimmten HILFE-Zuständen und Crohn`s Krankheit behilflich war. Als der Markt annahm, daß die Droge & dessen Vergangenheit, angesichts seiner neuen Nutzen vergeben werden sollte, wurde der Vorrat von der Anleger-Gemeinde umarmt und beinahe bis zu $200 pro Anteil getradet. Ebenso hat VVUS noch bescheidene Einnahmen und dünne operierende Gewinne, aber es scheint auch, riesige neue Droge-Aussichten zu genießen.
Die Geschichte VVUS ist CELG ähnlich, aber eigentlich mehr verlockend. Seine Marktgelegenheiten sind jedes Stückchen aufregend, wenn nicht größer, als CELG`s wäre. Wie Celgene kommt VVUS der Biotech und wissenschaftlichem Führungsfirmen hinterher. Der Erfolg VVUS hängt von seiner drei bedeutenden Entwicklungen (MUSE/ALIBRA; ALISTA; PE Droge) und könnte die Zukunft von VVUS machen. Wir glauben, daß bedeutungsvolle Rentabilität, verschieden im Fall CELG, ist mehr als ein Jahr entfernt, wenn nicht ein paar Jahre aus. Andererseits spiegeln Aktien wie VVUS beträchtliche Aussichten normalerweise gut vor ihrer Realisierung wider. Unser veröffentlichtes Kursziel von $10 macht jetzt Sinn. Aber wenn Nachrichten über VVUS`s andere Therapien besser verstanden werden, sollten die Anteile sich bis auf $17-19 klettern.
~ ~ ~ ~ ~ ~
Kursziel 12 Monate $17-19!
Für 3Q00, Ende Sept.2000, berichtete VVUS ein netto Einkommen von $208,000, oder $0.01 pro Anteil, auf Einnahmen von $5.0 Million, verglichen mit einem netto Einkommen von $897,000, oder $0.03 pro Anteil, für das gleiche Viertel vor einem Jahr (1999).
Der Rückgang war hauptsächlich wegen der niedrigeren Verwendung von MUSE, nachdem Viagra früher zum Veteranen-Verwaltung-Krankenhäusern dieses Jahr hinzugefügt worden war. Produkt-Einnahmen für 3Q00 war international $256,000 verglichen mit $1.1 Million für das voherige Jahresquartal.
Auframpen von Überseelieferungen
Der neue Übersee-Marketing-Partner, Abbott Laboratories (ABT), fing gerade in spätem September an. VVUS endete das Quartal mit $44.2 Million in Bargeld und andere Gegenstände, während totale Verpflichtungen verringerte sich um $6.4 Million. Mit der klinische Einschränkungen VIAGRA und dessen potentielle Nebenwirkungen, die langsam besser gekannt werden, hat VVUS gute Chancen, Marktanteil als der Versorger der schmackhafteren Alternative zu Viagra zu gewinnen und auch als der Versorger eines nächsten Generation-Kombination ED Therapie, die scheint, noch größere Wirksamkeit zu haben. VVUS führt auch den Weg in der Entwicklung von Produkten für zwei Nische; erstens vorzeitiger Ejeculation und zweitens weibliche sexuelle Funktionsstörung (FSD). Zusätzlich jübelt die Gesellschaft, um die vor kurzem erreicheten Meilenstein vom Unterschreiben einer Marketing-Kooperation mit ABT für die Verteilung von MUSE und Alibra im internationalen Märkten wie Europa, Japan, Australien, Mittelamerika und Südamerika. VVUS hat schon angefangen, ABT für den europäischen Markt zu liefern, und es wird berichtet, daß die Annahme hoch ist. Das sollte VVUS bedeuten, wachsende Umsätze und Gewinne zu erwirtscaften. VVUS hält genauso viel von anderen Gelegenheiten als seine anderen Drogen in der Entwicklungphase, ausdrücklich Alista und das Produkt für vorzeitigen Ejecualtion, mit den sie langsam aber sicher durch die Entwicklungphasen bis zur Kommerzialisierung bringen wird.
Erin Dailey, unsere Analytikerin für dieser Gesellschaft, glaubt, daß ihr Einkommen zunehmend wachsen wird uund 2001 zeigen sollten. Sie schätzte ursprünglich, daß dieser VVUS setzen würde, $0.20 pro Anteil steuerfrei Gewinne erwirtscften wird. Basierte auf den Aussichten von VVUS`s Aktentasche für das Behandlung von sexueller Funktionsstörung, benutzte sie einen 50x KGV, um einen 18 Monats Kursziel von $10.
Ich bin nicht als optimitisch für den Kurs als Erin ist. Aber langfristig bin ich weit über die Aussichten für die Aktien optimistischer. Ich glaube, daß VVUS`s Börsenerfolg sollte der einmaligen Flugbahn von Celgene folgen, AG (Nasdaq: CELG), die RedChip im Herbst 1998 endeckt.
Wie Sie vielleicht sich erinnern, suchte Celgene und bekam eine FDA-Genehmigung, um den alten, notorischen Droge-thalidomide zu benutzen, um Lepra zu behandeln, obwohl es nur 500 Fälle in den Vereinigten Staaten por Jahr gibt. Es wurde dann endeckt, daß Thalidomide auch in der Behandlung von Krebs, bestimmten HILFE-Zuständen und Crohn`s Krankheit behilflich war. Als der Markt annahm, daß die Droge & dessen Vergangenheit, angesichts seiner neuen Nutzen vergeben werden sollte, wurde der Vorrat von der Anleger-Gemeinde umarmt und beinahe bis zu $200 pro Anteil getradet. Ebenso hat VVUS noch bescheidene Einnahmen und dünne operierende Gewinne, aber es scheint auch, riesige neue Droge-Aussichten zu genießen.
Die Geschichte VVUS ist CELG ähnlich, aber eigentlich mehr verlockend. Seine Marktgelegenheiten sind jedes Stückchen aufregend, wenn nicht größer, als CELG`s wäre. Wie Celgene kommt VVUS der Biotech und wissenschaftlichem Führungsfirmen hinterher. Der Erfolg VVUS hängt von seiner drei bedeutenden Entwicklungen (MUSE/ALIBRA; ALISTA; PE Droge) und könnte die Zukunft von VVUS machen. Wir glauben, daß bedeutungsvolle Rentabilität, verschieden im Fall CELG, ist mehr als ein Jahr entfernt, wenn nicht ein paar Jahre aus. Andererseits spiegeln Aktien wie VVUS beträchtliche Aussichten normalerweise gut vor ihrer Realisierung wider. Unser veröffentlichtes Kursziel von $10 macht jetzt Sinn. Aber wenn Nachrichten über VVUS`s andere Therapien besser verstanden werden, sollten die Anteile sich bis auf $17-19 klettern.
~ ~ ~ ~ ~ ~
Kursziel 12 Monate $17-19!
Charttechnisch sieht VVUS vielversprechend aus: 
http://139.142.147.18/Charts/V/V/VVUS_3ae4e8c8753egsmC320ac8.gif
http://139.142.147.18/Charts/V/V/VVUS_3ae4e8c8753egsmC320ac8.gif
Trading Spotlight
Eine der renommiertesten US Sex-Dysfunction-forscherin, Jane Bermann wird, Gerüchte zufolge, an die Phase II klinische Tests von ALISTA (FSD) sich beteiligen. Die Firma hat dies noch nicht öffentlich bestätigt, aber vom Investor Relations in den USA ist das Story zu bestätigen:"I called the company this afternoon 650-934-5200. I was able to verify what I heard. You say "you hear wrong". Sorry. I heard right. J. Berman is going to be a paid consultant in conducting Alista trials. The phase 2 Alista clinical trials will be run at several different clinical sights including J Berman`s clinic.
Still dont believe me? Call the company and verify for yourself."
http://messages.yahoo.com/bbs?.mm=FN&action=m&board=7077387&…
Chart sieht auch sehr schön aus und ist seit Anfang des Jahres unter den besten 50 am NASDAQ notierten Aktien (Trendweise). Siehe
http://www.askresearch.com/cgi-bin/chart?symbol=vvus&exchang…
Einstiegsmöglichkeiten!!
Analystengespräch: Vorstand VVUS
CONFERENCE CALL WITH THE MANAGEMENT OF VIVUS Inc. (Nasdaq: VVUS)
Topic:
FOURTH QUARTER FINANCIAL RESULTS (Quartalszahlen Q4 2000)
DATE: January 24, 2001
TIME: 4:30 P.M. EASTERN
Investors can listen to the conference call on the Internet through "VCALL" at www.vcall.com. To listen to the live call, please go to the Web site at least fifteen minutes early to register, download, and install any necessary audio software. For those who cannot listen to the live broadcast, a transcript will be available shortly after the call.
Or you may call the company to access the conference call number, if space allows.
REPLAY AND TRANSCRIPT WILL BE AVAILABLE FOR 90 DAYS AT www.vcall.com
Questions? Please contact Kelly Clyde,
Lippert/Heilshorn & Associates, 212-838-3777
CONFERENCE CALL WITH THE MANAGEMENT OF VIVUS Inc. (Nasdaq: VVUS)
Topic:
FOURTH QUARTER FINANCIAL RESULTS (Quartalszahlen Q4 2000)
DATE: January 24, 2001
TIME: 4:30 P.M. EASTERN
Investors can listen to the conference call on the Internet through "VCALL" at www.vcall.com. To listen to the live call, please go to the Web site at least fifteen minutes early to register, download, and install any necessary audio software. For those who cannot listen to the live broadcast, a transcript will be available shortly after the call.
Or you may call the company to access the conference call number, if space allows.
REPLAY AND TRANSCRIPT WILL BE AVAILABLE FOR 90 DAYS AT www.vcall.com
Questions? Please contact Kelly Clyde,
Lippert/Heilshorn & Associates, 212-838-3777
VIVUS Begins Phase II Study With ALISTA For The Treatment of Female Sexual Dysfunction
MOUNTAIN VIEW, Calif.--(BW HealthWire)--Jan. 23, 2001--VIVUS, Inc. (Nasdaq NM:VVUS - news) today announced enrollment of patients in a Phase II study to evaluate the safety and efficacy of the Company`s female sexual dysfunction (FSD) product, ALISTA(TM). This multi-center, double-blind, placebo-controlled study is intended to evaluate the sexual response with ALISTA in women with a primary diagnosis of Female Sexual Arousal Disorder (FSAD).
"This is an exciting time for VIVUS as we progress to the next phase of clinical development for our lead product intended to treat women with FSAD," said Leland F. Wilson, President and CEO. "Results from this study will provide preliminary data on the efficacy of ALISTA in a population of women with FSAD, and will help us to design the larger pivotal studies that will be required for global regulatory submissions."
Researchers have classified the range of symptoms seen in FSD into four subcategories: desire, arousal, orgasmic and sexual pain disorders. The VIVUS clinical program is designed to evaluate ALISTA in women with a primary complaint of arousal disorder.
ALISTA is a proprietary formulation of alprostadil applied locally to the female genitalia. Alprostadil is a synthetic version of a naturally occurring vasodilating agent. It is the same active ingredient found in the VIVUS product MUSE®, which is used to treat male erectile dysfunction. ALISTA is believed to increase blood flow to the female genitalia, thereby promoting engorgement and other natural processes that occur during sexual stimulation. With both issued and pending patents, the Company believes it has the dominant patent position for the local delivery of prostaglandins, such as alprostadil, in the treatment of women with FSD.
VIVUS, Inc. is a specialty pharmaceutical company engaged in the development of innovative therapies for the treatment of quality-of-life disorders in men and women, with a focus on sexual dysfunction. The Company developed and markets in the U.S. MUSE® (alprostadil) and ACTIS® (recently cleared for OTC marketing), two innovations in the treatment of erectile dysfunction, and has partnered with Abbott Laboratories (NYSE: ABT - news) for the international marketing and distribution of its male transurethral ED products. In Canada, VIVUS has partnered exclusively with Paladin Labs to market and distribute MUSE . VIVUS initiated clinical studies for its female sexual dysfunction product, ALISTA(TM), during the fourth quarter of 2000.
Note to editors and investors: 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).
This news release contains forward-looking statements that involve risks and uncertainties regarding VIVUS Inc.`s operations and future results. Please see the Company`s filings with the Securities and Exchange Commission including, without limitation, the Company`s Form 10-K and Form 10-Qs, which identify specific factors that may cause actual results or events to differ materially from those described in the forward-looking statements.
Contact:
VIVUS, Inc.
Dick Walliser
650/934-5264
ir@vivus.com
www.vivus.com
MOUNTAIN VIEW, Calif.--(BW HealthWire)--Jan. 23, 2001--VIVUS, Inc. (Nasdaq NM:VVUS - news) today announced enrollment of patients in a Phase II study to evaluate the safety and efficacy of the Company`s female sexual dysfunction (FSD) product, ALISTA(TM). This multi-center, double-blind, placebo-controlled study is intended to evaluate the sexual response with ALISTA in women with a primary diagnosis of Female Sexual Arousal Disorder (FSAD).
"This is an exciting time for VIVUS as we progress to the next phase of clinical development for our lead product intended to treat women with FSAD," said Leland F. Wilson, President and CEO. "Results from this study will provide preliminary data on the efficacy of ALISTA in a population of women with FSAD, and will help us to design the larger pivotal studies that will be required for global regulatory submissions."
Researchers have classified the range of symptoms seen in FSD into four subcategories: desire, arousal, orgasmic and sexual pain disorders. The VIVUS clinical program is designed to evaluate ALISTA in women with a primary complaint of arousal disorder.
ALISTA is a proprietary formulation of alprostadil applied locally to the female genitalia. Alprostadil is a synthetic version of a naturally occurring vasodilating agent. It is the same active ingredient found in the VIVUS product MUSE®, which is used to treat male erectile dysfunction. ALISTA is believed to increase blood flow to the female genitalia, thereby promoting engorgement and other natural processes that occur during sexual stimulation. With both issued and pending patents, the Company believes it has the dominant patent position for the local delivery of prostaglandins, such as alprostadil, in the treatment of women with FSD.
VIVUS, Inc. is a specialty pharmaceutical company engaged in the development of innovative therapies for the treatment of quality-of-life disorders in men and women, with a focus on sexual dysfunction. The Company developed and markets in the U.S. MUSE® (alprostadil) and ACTIS® (recently cleared for OTC marketing), two innovations in the treatment of erectile dysfunction, and has partnered with Abbott Laboratories (NYSE: ABT - news) for the international marketing and distribution of its male transurethral ED products. In Canada, VIVUS has partnered exclusively with Paladin Labs to market and distribute MUSE . VIVUS initiated clinical studies for its female sexual dysfunction product, ALISTA(TM), during the fourth quarter of 2000.
Note to editors and investors: 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).
This news release contains forward-looking statements that involve risks and uncertainties regarding VIVUS Inc.`s operations and future results. Please see the Company`s filings with the Securities and Exchange Commission including, without limitation, the Company`s Form 10-K and Form 10-Qs, which identify specific factors that may cause actual results or events to differ materially from those described in the forward-looking statements.
Contact:
VIVUS, Inc.
Dick Walliser
650/934-5264
ir@vivus.com
www.vivus.com
From: INVESTools Tech Advisory, January 22-26, 2001
www.investools.com
VVUS: KAUFEN!!
Vivus: The Next Viagra? (Der nächste Viagra?)
Pfizer made a killing with Viagra in April 1998, which murdered sales of a then-popular competing product from Vivus (VVUS). But small-cap advisor Marc Robins says Vivus is on the rise again for a number of reasons. For instance, he notes that Viagra only helps about half of men who have problems holding an erection. Pfizer`s wonder drug is also implicated in the deaths of several hundred men.
Vivus` second-generation therapy called Alibra focuses on the large segment of men who are not helped by Viagra. The firm recently sealed a deal with giant Abbott Labs to market Alibra, and it is also hard at work on a third-generation product. "With Viagra`s limitations and potential side effects becoming better known, Vivus is well positioned to gain market share as the provider of a more palatable alternative or a next-generation combination therapy that seems to have greater efficacy," Robins says.
What`s more, Vivus is also developing products for women. "Just as many women, if not more (than men), experience sexual dysfunction," Robins says. Vivus` Alista has shown great promise in Phase II trials. "The success of any one of its three major development opportunities could make the company`s future," he says. "We recommend purchase of Vivus."
www.investools.com
VVUS: KAUFEN!!
Vivus: The Next Viagra? (Der nächste Viagra?)
Pfizer made a killing with Viagra in April 1998, which murdered sales of a then-popular competing product from Vivus (VVUS). But small-cap advisor Marc Robins says Vivus is on the rise again for a number of reasons. For instance, he notes that Viagra only helps about half of men who have problems holding an erection. Pfizer`s wonder drug is also implicated in the deaths of several hundred men.
Vivus` second-generation therapy called Alibra focuses on the large segment of men who are not helped by Viagra. The firm recently sealed a deal with giant Abbott Labs to market Alibra, and it is also hard at work on a third-generation product. "With Viagra`s limitations and potential side effects becoming better known, Vivus is well positioned to gain market share as the provider of a more palatable alternative or a next-generation combination therapy that seems to have greater efficacy," Robins says.
What`s more, Vivus is also developing products for women. "Just as many women, if not more (than men), experience sexual dysfunction," Robins says. Vivus` Alista has shown great promise in Phase II trials. "The success of any one of its three major development opportunities could make the company`s future," he says. "We recommend purchase of Vivus."
Hi rechnung.
Scheinbar sind wir 2 im Moment die einzigen hier.Ich bin seit ca. 1 Jahr in Vivus drin, und an allen Neuigkeiten interressiert.Aber, wie ich schon mal bemerkte, kein englisch-freak.Könntest Du Deine sicherlich guten Neuigkeiten nicht auch mal (wenigstens grob) in deutsch schreiben? wäre Dir sehr dankbar.
Gruß Jack.
Scheinbar sind wir 2 im Moment die einzigen hier.Ich bin seit ca. 1 Jahr in Vivus drin, und an allen Neuigkeiten interressiert.Aber, wie ich schon mal bemerkte, kein englisch-freak.Könntest Du Deine sicherlich guten Neuigkeiten nicht auch mal (wenigstens grob) in deutsch schreiben? wäre Dir sehr dankbar.
Gruß Jack.
Hi Jacky,
leider ist mein Deutsch auch ein bissl wackelig!!
Hab` gerade die neueste Zahlen aus den USA bekommen (Q4 2000).
Sehr gut $0.15c gegenüber die erwartete $0.02c!!
Auch interessante Diskussion unter www.vcall.com (man muß erst einloggen) unter VVUS vom Vorstand zum Quartal und weitere Highlights.
Hier die PR:
VIVUS Reports Fourth Quarter and Full-year Financial Results
Company Reviews R&D, Clinical and Business Development Programs
MOUNTAIN VIEW, Calif.--(BUSINESS WIRE)--Jan. 24, 2001--VIVUS, Inc. (Nasdaq NM: VVUS - news), a pharmaceutical company developing innovative products to improve quality of life, today reported financial results for the three and 12 months ended December 31, 2000.
For the fourth quarter of 2000, VIVUS reported net income of $5.0 million, or $0.15 per diluted share, compared with net income of $13.8 million, or $0.43 per diluted share, during the fourth quarter of 1999. For the 12 months ended December 31, 2000, net income was $7.7 million, or $0.23 per diluted share, compared with net income of $18.8 million, or $0.58 per diluted share, during the same period of 1999.
U.S. gross product revenue was $5.8 million in the fourth quarter of 2000, an increase of $700,000, or 15%, compared with the third quarter of 2000, and unchanged from the same period in 1999. For the 12 months ended December 31, 2000, U.S. gross product revenue was $22.5 million, compared with $21.2 million for the same period last year. Gross product revenue in the U.S. declined 8% in the last half of 2000 when compared with the first half of the year. Prescriptions for MUSE® continued to decline slightly throughout the year based on information reported by IMS America. In addition, Viagra® was added to the Veterans Administration`s permitted prescription drug list, which is not included in the IMS data, during the year. The Company believes each of these factors contributed to the decline in gross product revenue for the second half of 2000.
International product revenue was $1.8 million for the fourth quarter of 2000, down from $15.6 million for the same period last year. International shipments to Abbott Laboratories (NYSE: ABT - news) to support their re-launch of MUSE in Europe and other international markets account for this quarter`s revenue, while 1999 included $14.9 million associated with the termination of the Company`s distribution agreement with AstraZeneca. For the 12 months ended December 31, 2000, international revenue was $5.2 million, compared with $20.0 million for the same period in 1999. The Company expects that international revenue for 2001 will be comparable to fiscal year 2000.
``It is the goal of the R&D program at VIVUS to have a robust pipeline that consists of drug candidates at various stages of development. Along these lines, we are aggressively evaluating a number of opportunities,`` stated John Dietrich, Ph.D., Vice President of Research and Development at VIVUS.
R&D expenses for the fourth quarter of 2000 were $1.0 million, and included a $320,000 credit related to excess prior-year accruals. Without this adjustment, expenses of $1.3 million were comparable to previous quarters this year. For the 12 months ended December 31, 2000, R&D expenses were $4.7 million, a reduction of $3.2 million compared with the same period last year when the Company was completing its Phase III clinical studies and filing an NDA for ALIBRA®. R&D expenses are expected to increase from this level in 2001 due to clinical studies underway for the Company`s female sexual dysfunction product, ALISTA(TM), and other R&D projects.
Cost of goods in the fourth quarter of 2000 includes a one-time adjustment of $5.1 million, resulting in a credit of $667,000. The Company recorded a $3.1 million write up of its raw material inventory that had been reserved as part of a 1998 restructuring, and reversed an accrual for royalties related to shipments to its previous international distributors due to the termination of those agreements. Without these adjustments, cost of goods would have been $4.5 million and $13.2 million for the fourth quarter and full year, respectively. The increase over 1999 is primarily due to higher international unit shipments.
Selling, general and administrative expenses of $2.1 million for the fourth quarter of 2000 were comparable to previous quarters this year. SG&A for the year ended December 31, 2000 of $8.7 million increased 36% compared with the same period in 1999, primarily due to the Company`s increased investment in its U.S. marketing and sales efforts.
Cash, cash equivalents, restricted cash and available-for-sale securities at December 31, 2000 totaled $45.3 million, up $4.9 million from $40.4 million at December 31, 1999. Working capital at December 31, 2000 was $33 million, an increase of $6.4 million from December 31, 1999.
R&D Update
Female Sexual Dysfunction (FSD)
The recognition of FSD as an emerging market presents a medical and marketing opportunity in which VIVUS intends to be a major player.
As previously reported, during the fourth quarter the Company initiated its first clinical trial with ALISTA, a proprietary formulation of alprostadil applied locally to the female genitalia. The purpose of this trial was to evaluate the safety of and local tolerance to ALISTA. Enrollment has begun in a multi-center Phase II clinical trial, which is designed to assess the safety and efficacy of ALISTA in women with a primary diagnosis of Female Sexual Arousal Disorder, one of four clinical subcategories of FSD. Results from this second study will help in the design of future trials.
The Company believes it enjoys a strong, proprietary position in the treatment of FSD, including multiple issued and pending patents.
Erectile Dysfunction (ED)
As announced in January 2001, the Company is pursuing approval of its second-generation transurethral drug for the treatment of ED, ALIBRA, through discussions with the U.S. Food and Drug Administration and with the European Agency for the Evaluation of Medicinal Products. ALIBRA consists of alprostadil, the active ingredient in MUSE, and prazosin. The goal of the program is to develop ALIBRA for at-home use without the need for titration in the physician`s office.
The Company is also evaluating potential products as a third-generation transurethral formulation, and believes there continues to be a need for safe, effective products that can be used by patients who fail oral therapies or who, for various reasons, are not candidates for oral therapies.
Premature Ejaculation (PE)
Premature ejaculation is reported to be the most common cause of sexual dysfunction in men. As with other types of sexual disorders, PE can cause significant psychological effects and can be disruptive to interpersonal relationships.
VIVUS conducted a proof-of-concept study with an on-demand, oral drug during 2000. In that study, the latency period for ejaculation was increased subsequent to treatment with the VIVUS compound. The Company will be initiating a Phase II study later this year with its novel oral formulation for this product.
Investor Information
VIVUS, Inc. is a pharmaceutical company developing innovative products to improve quality of life disorders in men and women, with a focus on sexual dysfunction. The Company developed and markets in the U.S. MUSE (alprostadil) and ACTIS® (recently cleared for OTC marketing), two innovations in the treatment of erectile dysfunction, and has partnered with Abbott Laboratories (NYSE: ABT - news) for the international marketing and distribution of its male transurethral ED products. In Canada, VIVUS is partnered exclusively with Paladin Labs, Inc. (TSE: PLB - news) to market and distribute MUSE. VIVUS initiated clinical studies for its female sexual dysfunction product, ALISTA, during the fourth quarter of 2000.
NOTE TO INVESTORS: VIVUS will hold a conference call to discuss the fourth quarter financial results today, January 24, 2001, beginning at 4:30 p.m. Eastern Time. You can listen to this call (live or 90-day replay) via the Internet at the Vcall Web site: www.vcall.com.
leider ist mein Deutsch auch ein bissl wackelig!!
Hab` gerade die neueste Zahlen aus den USA bekommen (Q4 2000).
Sehr gut $0.15c gegenüber die erwartete $0.02c!!
Auch interessante Diskussion unter www.vcall.com (man muß erst einloggen) unter VVUS vom Vorstand zum Quartal und weitere Highlights.
Hier die PR:
VIVUS Reports Fourth Quarter and Full-year Financial Results
Company Reviews R&D, Clinical and Business Development Programs
MOUNTAIN VIEW, Calif.--(BUSINESS WIRE)--Jan. 24, 2001--VIVUS, Inc. (Nasdaq NM: VVUS - news), a pharmaceutical company developing innovative products to improve quality of life, today reported financial results for the three and 12 months ended December 31, 2000.
For the fourth quarter of 2000, VIVUS reported net income of $5.0 million, or $0.15 per diluted share, compared with net income of $13.8 million, or $0.43 per diluted share, during the fourth quarter of 1999. For the 12 months ended December 31, 2000, net income was $7.7 million, or $0.23 per diluted share, compared with net income of $18.8 million, or $0.58 per diluted share, during the same period of 1999.
U.S. gross product revenue was $5.8 million in the fourth quarter of 2000, an increase of $700,000, or 15%, compared with the third quarter of 2000, and unchanged from the same period in 1999. For the 12 months ended December 31, 2000, U.S. gross product revenue was $22.5 million, compared with $21.2 million for the same period last year. Gross product revenue in the U.S. declined 8% in the last half of 2000 when compared with the first half of the year. Prescriptions for MUSE® continued to decline slightly throughout the year based on information reported by IMS America. In addition, Viagra® was added to the Veterans Administration`s permitted prescription drug list, which is not included in the IMS data, during the year. The Company believes each of these factors contributed to the decline in gross product revenue for the second half of 2000.
International product revenue was $1.8 million for the fourth quarter of 2000, down from $15.6 million for the same period last year. International shipments to Abbott Laboratories (NYSE: ABT - news) to support their re-launch of MUSE in Europe and other international markets account for this quarter`s revenue, while 1999 included $14.9 million associated with the termination of the Company`s distribution agreement with AstraZeneca. For the 12 months ended December 31, 2000, international revenue was $5.2 million, compared with $20.0 million for the same period in 1999. The Company expects that international revenue for 2001 will be comparable to fiscal year 2000.
``It is the goal of the R&D program at VIVUS to have a robust pipeline that consists of drug candidates at various stages of development. Along these lines, we are aggressively evaluating a number of opportunities,`` stated John Dietrich, Ph.D., Vice President of Research and Development at VIVUS.
R&D expenses for the fourth quarter of 2000 were $1.0 million, and included a $320,000 credit related to excess prior-year accruals. Without this adjustment, expenses of $1.3 million were comparable to previous quarters this year. For the 12 months ended December 31, 2000, R&D expenses were $4.7 million, a reduction of $3.2 million compared with the same period last year when the Company was completing its Phase III clinical studies and filing an NDA for ALIBRA®. R&D expenses are expected to increase from this level in 2001 due to clinical studies underway for the Company`s female sexual dysfunction product, ALISTA(TM), and other R&D projects.
Cost of goods in the fourth quarter of 2000 includes a one-time adjustment of $5.1 million, resulting in a credit of $667,000. The Company recorded a $3.1 million write up of its raw material inventory that had been reserved as part of a 1998 restructuring, and reversed an accrual for royalties related to shipments to its previous international distributors due to the termination of those agreements. Without these adjustments, cost of goods would have been $4.5 million and $13.2 million for the fourth quarter and full year, respectively. The increase over 1999 is primarily due to higher international unit shipments.
Selling, general and administrative expenses of $2.1 million for the fourth quarter of 2000 were comparable to previous quarters this year. SG&A for the year ended December 31, 2000 of $8.7 million increased 36% compared with the same period in 1999, primarily due to the Company`s increased investment in its U.S. marketing and sales efforts.
Cash, cash equivalents, restricted cash and available-for-sale securities at December 31, 2000 totaled $45.3 million, up $4.9 million from $40.4 million at December 31, 1999. Working capital at December 31, 2000 was $33 million, an increase of $6.4 million from December 31, 1999.
R&D Update
Female Sexual Dysfunction (FSD)
The recognition of FSD as an emerging market presents a medical and marketing opportunity in which VIVUS intends to be a major player.
As previously reported, during the fourth quarter the Company initiated its first clinical trial with ALISTA, a proprietary formulation of alprostadil applied locally to the female genitalia. The purpose of this trial was to evaluate the safety of and local tolerance to ALISTA. Enrollment has begun in a multi-center Phase II clinical trial, which is designed to assess the safety and efficacy of ALISTA in women with a primary diagnosis of Female Sexual Arousal Disorder, one of four clinical subcategories of FSD. Results from this second study will help in the design of future trials.
The Company believes it enjoys a strong, proprietary position in the treatment of FSD, including multiple issued and pending patents.
Erectile Dysfunction (ED)
As announced in January 2001, the Company is pursuing approval of its second-generation transurethral drug for the treatment of ED, ALIBRA, through discussions with the U.S. Food and Drug Administration and with the European Agency for the Evaluation of Medicinal Products. ALIBRA consists of alprostadil, the active ingredient in MUSE, and prazosin. The goal of the program is to develop ALIBRA for at-home use without the need for titration in the physician`s office.
The Company is also evaluating potential products as a third-generation transurethral formulation, and believes there continues to be a need for safe, effective products that can be used by patients who fail oral therapies or who, for various reasons, are not candidates for oral therapies.
Premature Ejaculation (PE)
Premature ejaculation is reported to be the most common cause of sexual dysfunction in men. As with other types of sexual disorders, PE can cause significant psychological effects and can be disruptive to interpersonal relationships.
VIVUS conducted a proof-of-concept study with an on-demand, oral drug during 2000. In that study, the latency period for ejaculation was increased subsequent to treatment with the VIVUS compound. The Company will be initiating a Phase II study later this year with its novel oral formulation for this product.
Investor Information
VIVUS, Inc. is a pharmaceutical company developing innovative products to improve quality of life disorders in men and women, with a focus on sexual dysfunction. The Company developed and markets in the U.S. MUSE (alprostadil) and ACTIS® (recently cleared for OTC marketing), two innovations in the treatment of erectile dysfunction, and has partnered with Abbott Laboratories (NYSE: ABT - news) for the international marketing and distribution of its male transurethral ED products. In Canada, VIVUS is partnered exclusively with Paladin Labs, Inc. (TSE: PLB - news) to market and distribute MUSE. VIVUS initiated clinical studies for its female sexual dysfunction product, ALISTA, during the fourth quarter of 2000.
NOTE TO INVESTORS: VIVUS will hold a conference call to discuss the fourth quarter financial results today, January 24, 2001, beginning at 4:30 p.m. Eastern Time. You can listen to this call (live or 90-day replay) via the Internet at the Vcall Web site: www.vcall.com.
29.01.2001
Vivus kaufen
INVESTools
Pfizer habe im April 1998 mit Viagra den großen Coup gelandet, schreibt Marc Robins in Dick Davis’ „The Technology Digest“ von INVESTools. Dadurch sei das damals populäre Konkurrenzprodukt von Vivus (WKN 893380) unter die Räder gekommen. Robins ist aber aus einer Reihe von Gründen der Ansicht, Vivus sei dabei, sich wieder zu erholen. So helfe Viagra z.B. nur ca. der Hälfte aller Männer, die Erektionsprobleme hätten. Außerdem gebe es mehrere hundert Todesfälle von Männern, bei denen die Wunderdroge von Pfizer einer Rolle gespielt haben könnte.
Vivus’ Medikament der 2. Generation namens Alibra ziele auf jene große Gruppe von Männern ab, denen durch Viagra nicht geholfen werde. Vivus habe vor kurzem ein Vermarktungsabkommen mit Abbott Labs geschlossen und arbeite außerdem hart daran, ein Medikament der dritten Generation zu entwickeln. In dem Maße, in dem die Begrenzungen und Nebenwirkungen von Viagra mehr bekannt würden, meint Robins, werde Vivus wieder in der Lage sein, als Anbieter einer verträglicheren Alternative oder einer wirksameren Kombinationstherapie der nächsten Generation Marktanteile zu erringen.
Zusätzlich entwickle Vivus auch Produkte für Frauen, die noch häufiger als Männer unter sexuellen Funktionsstörungen litten. Das von Vivus entwickelte Medikament Alista habe in der klinischen Testungsphase 3 vielversprechende Ergebnisse geliefert. Wenn nur eines der drei entwickelten Medikamente ein Erfolg werde, wäre die Zukunft des Unternehmens damit gesichert. Deshalb empfehle Robins die Aktie von Vivus zum Kauf.
Vivus kaufen
INVESTools
Pfizer habe im April 1998 mit Viagra den großen Coup gelandet, schreibt Marc Robins in Dick Davis’ „The Technology Digest“ von INVESTools. Dadurch sei das damals populäre Konkurrenzprodukt von Vivus (WKN 893380) unter die Räder gekommen. Robins ist aber aus einer Reihe von Gründen der Ansicht, Vivus sei dabei, sich wieder zu erholen. So helfe Viagra z.B. nur ca. der Hälfte aller Männer, die Erektionsprobleme hätten. Außerdem gebe es mehrere hundert Todesfälle von Männern, bei denen die Wunderdroge von Pfizer einer Rolle gespielt haben könnte.
Vivus’ Medikament der 2. Generation namens Alibra ziele auf jene große Gruppe von Männern ab, denen durch Viagra nicht geholfen werde. Vivus habe vor kurzem ein Vermarktungsabkommen mit Abbott Labs geschlossen und arbeite außerdem hart daran, ein Medikament der dritten Generation zu entwickeln. In dem Maße, in dem die Begrenzungen und Nebenwirkungen von Viagra mehr bekannt würden, meint Robins, werde Vivus wieder in der Lage sein, als Anbieter einer verträglicheren Alternative oder einer wirksameren Kombinationstherapie der nächsten Generation Marktanteile zu erringen.
Zusätzlich entwickle Vivus auch Produkte für Frauen, die noch häufiger als Männer unter sexuellen Funktionsstörungen litten. Das von Vivus entwickelte Medikament Alista habe in der klinischen Testungsphase 3 vielversprechende Ergebnisse geliefert. Wenn nur eines der drei entwickelten Medikamente ein Erfolg werde, wäre die Zukunft des Unternehmens damit gesichert. Deshalb empfehle Robins die Aktie von Vivus zum Kauf.
mal wieder ein Lebenszeichen von VVUS
Tuesday February 27, 3:59 am Eastern Time
Press ReleaseResearch On Local Delivery of Type 5 Phosphodiesterase Inhibitors Published by VIVUS and Tulane University Medical School
MOUNTAIN VIEW, Calif.--(BW HealthWire)--Feb. 27, 2001--VIVUS Inc. (Nasdaq:VVUS - news), a pharmaceutical company developing innovative products to improve quality of life, and Tulane University Health Sciences Center, New Orleans, Louisiana, today announced publication of research in the March, 2001 edition of the Journal of Urology, conducted to determine the effects of selective type 5 phosphodiesterase (PDE5) inhibitors when given alone or in combination with a nitric oxide donor or alprostadil (PGE1).
Data from the studies conducted in a well accepted in vivo model demonstrated that intracavernosal injection of a selective PDE5 inhibitor combined with PGE1 produced erectile responses that were greater than when the PDE5 inhibitor was administered alone or in combination with a nitric oxide donor.
Further, the response was equivalent to responses obtained with the control drug combination of papaverine, phentolamine and alprostadil (also known as triple mix, the ``Gold Standard`` against which all treatments of erectile dysfunction are compared).
``These data suggest that combining a selective type 5 phosphodiesterase inhibitor with PGE1 may be a highly effective local therapy for men suffering from erectile dysfunction and an acceptable alternative to other current forms of treatment,`` stated Dr. Wayne Hellstrom, Professor of Urology, Tulane University School of Medicine.
While data presented in this study demonstrated that intracavernosal injection of the combination was highly effective, additional studies using transurethral administration showed similar results.
VIVUS Inc. is a pharmaceutical company developing innovative products to improve quality of life disorders in men and women, with a focus on sexual dysfunction. The Company developed and markets in the U.S. MUSE (alprostadil) and ACTIS® (recently cleared for OTC marketing), two innovations in the treatment of erectile dysfunction, and has partnered with Abbott Laboratories (NYSE:ABT - news) for the international marketing and distribution of its male transurethral ED products. In Canada, VIVUS is partnered exclusively with Paladin Labs (to market and distribute MUSE). VIVUS initiated clinical studies for its female sexual dysfunction product, ALISTA, during the fourth quarter of 2000.
This news release contains forward-looking statements that involve risks and uncertainties regarding VIVUS Inc.`s operations and future results. See the Company`s filings with the Securities and Exchange Commission including, without limitation, the Company`s Form 10-K and Form 10-Qs, which identify specific factors that may cause actual results or events to differ materially from those described in the forward-looking statements.
Note to editors and investors: 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
Tuesday February 27, 3:59 am Eastern Time
Press ReleaseResearch On Local Delivery of Type 5 Phosphodiesterase Inhibitors Published by VIVUS and Tulane University Medical School
MOUNTAIN VIEW, Calif.--(BW HealthWire)--Feb. 27, 2001--VIVUS Inc. (Nasdaq:VVUS - news), a pharmaceutical company developing innovative products to improve quality of life, and Tulane University Health Sciences Center, New Orleans, Louisiana, today announced publication of research in the March, 2001 edition of the Journal of Urology, conducted to determine the effects of selective type 5 phosphodiesterase (PDE5) inhibitors when given alone or in combination with a nitric oxide donor or alprostadil (PGE1).
Data from the studies conducted in a well accepted in vivo model demonstrated that intracavernosal injection of a selective PDE5 inhibitor combined with PGE1 produced erectile responses that were greater than when the PDE5 inhibitor was administered alone or in combination with a nitric oxide donor.
Further, the response was equivalent to responses obtained with the control drug combination of papaverine, phentolamine and alprostadil (also known as triple mix, the ``Gold Standard`` against which all treatments of erectile dysfunction are compared).
``These data suggest that combining a selective type 5 phosphodiesterase inhibitor with PGE1 may be a highly effective local therapy for men suffering from erectile dysfunction and an acceptable alternative to other current forms of treatment,`` stated Dr. Wayne Hellstrom, Professor of Urology, Tulane University School of Medicine.
While data presented in this study demonstrated that intracavernosal injection of the combination was highly effective, additional studies using transurethral administration showed similar results.
VIVUS Inc. is a pharmaceutical company developing innovative products to improve quality of life disorders in men and women, with a focus on sexual dysfunction. The Company developed and markets in the U.S. MUSE (alprostadil) and ACTIS® (recently cleared for OTC marketing), two innovations in the treatment of erectile dysfunction, and has partnered with Abbott Laboratories (NYSE:ABT - news) for the international marketing and distribution of its male transurethral ED products. In Canada, VIVUS is partnered exclusively with Paladin Labs (to market and distribute MUSE). VIVUS initiated clinical studies for its female sexual dysfunction product, ALISTA, during the fourth quarter of 2000.
This news release contains forward-looking statements that involve risks and uncertainties regarding VIVUS Inc.`s operations and future results. See the Company`s filings with the Securities and Exchange Commission including, without limitation, the Company`s Form 10-K and Form 10-Qs, which identify specific factors that may cause actual results or events to differ materially from those described in the forward-looking statements.
Note to editors and investors: 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
Gestern +5.4% Umsatz steigend 508,000+++
Hier der Grund für den Anstiegn gestern (+18.7%) und heute:
VIVUS Announces Clinical Safety Data for ALISTA, Its Treatment for Female Sexual Arousal Disorder
ALISTA is Safe and Well Tolerated in Initial Clinical Study
MOUNTAIN VIEW, Calif.--(BW HealthWire)--May 22, 2001--VIVUS Inc. (Nasdaq:VVUS - news) today announced the clinical results of its safety study for ALISTA(TM), a proprietary topical formulation of alprostadil for the treatment of female sexual arousal disorder.
This study, conducted in healthy volunteers, was designed to evaluate the local and systemic safety and tolerance of ALISTA.
Subjects in the study were treated with placebo and one of four doses of ALISTA in a double-blind manner; all treatments were applied topically to the clitoris and surrounding genital tissues. Clinical end-points included assessment of local irritation and/or inflammation as well as systemic effects on blood pressure and heart rate. All four dose levels of ALISTA were well tolerated both locally and systemically.
``This is an exciting time for VIVUS as we successfully advance the clinical development of ALISTA for the treatment of women with female sexual arousal disorder,`` commented Dr. John Dietrich, vice president of Research and Development. ``This study has demonstrated the safety of a single dose of ALISTA, applied topically, in healthy women, and has enabled VIVUS to initiate a study to evaluate the safety and efficacy of ALISTA in a population of women with female sexual arousal disorder.``
In February 2001, VIVUS began enrolling patients in a multi-center, double-blind, placebo controlled Phase II safety and efficacy study of ALISTA. This study will evaluate the response to topically applied ALISTA in women with female sexual arousal disorder.
ALISTA is a proprietary formulation of alprostadil applied locally to the female genitalia. Alprostadil is a synthetic version of a naturally occurring vasodilating agent found in the body and is the same active ingredient found in VIVUS` product, MUSE®, used to treat erectile dysfunction. ALISTA is believed to increase blood flow to the female genitalia, thereby promoting engorgement and other natural processes that occur during sexual stimulation.
It is estimated that over 40 percent of women report some form of female sexual dysfunction, caused by both organic and psychogenic causes. Researchers have classified the range of symptoms seen in female sexual dysfunction into four subcategories: desire, arousal, orgasmic and sexual pain disorders. The VIVUS clinical program is designed to evaluate ALISTA in women with a primary complaint of sexual arousal disorder.
VIVUS received the first patent ever issued in the United States for the treatment of female sexual dysfunction, has several patents pending and has also acquired rights to additional patents in this area.
In March 1999, VIVUS was issued U.S. patent number 5,877,216 for the ``Treatment of Female Sexual Dysfunction,`` which provides broad patent protection for the local delivery of vasodilating agents, including alprostadil, for the treatment of female sexual dysfunction. The company`s intellectual property provides a solid foundation for commercializing ALISTA.
VIVUS Inc. is a pharmaceutical company developing innovative products to improve quality of life disorders in men and women, with a focus on sexual dysfunction. The company developed and markets in the U.S. MUSE® (alprostadil) and ACTIS®, two innovations in the treatment of erectile dysfunction, and has partnered with Abbott Laboratories (NYSE:ABT - news) for the international marketing and distribution of its male transurethral erectile dysfunction products.
In Canada, VIVUS is partnered exclusively with Paladin Labs Inc. (TSE:PLB - news) to market and distribute MUSE. The company also has development programs for TA-1790, a highly selective PDE5 inhibitor compound for both oral and local treatment of sexual dysfunction in men and women. VIVUS is also working on products for premature ejaculation.
VIVUS Announces Clinical Safety Data for ALISTA, Its Treatment for Female Sexual Arousal Disorder
ALISTA is Safe and Well Tolerated in Initial Clinical Study
MOUNTAIN VIEW, Calif.--(BW HealthWire)--May 22, 2001--VIVUS Inc. (Nasdaq:VVUS - news) today announced the clinical results of its safety study for ALISTA(TM), a proprietary topical formulation of alprostadil for the treatment of female sexual arousal disorder.
This study, conducted in healthy volunteers, was designed to evaluate the local and systemic safety and tolerance of ALISTA.
Subjects in the study were treated with placebo and one of four doses of ALISTA in a double-blind manner; all treatments were applied topically to the clitoris and surrounding genital tissues. Clinical end-points included assessment of local irritation and/or inflammation as well as systemic effects on blood pressure and heart rate. All four dose levels of ALISTA were well tolerated both locally and systemically.
``This is an exciting time for VIVUS as we successfully advance the clinical development of ALISTA for the treatment of women with female sexual arousal disorder,`` commented Dr. John Dietrich, vice president of Research and Development. ``This study has demonstrated the safety of a single dose of ALISTA, applied topically, in healthy women, and has enabled VIVUS to initiate a study to evaluate the safety and efficacy of ALISTA in a population of women with female sexual arousal disorder.``
In February 2001, VIVUS began enrolling patients in a multi-center, double-blind, placebo controlled Phase II safety and efficacy study of ALISTA. This study will evaluate the response to topically applied ALISTA in women with female sexual arousal disorder.
ALISTA is a proprietary formulation of alprostadil applied locally to the female genitalia. Alprostadil is a synthetic version of a naturally occurring vasodilating agent found in the body and is the same active ingredient found in VIVUS` product, MUSE®, used to treat erectile dysfunction. ALISTA is believed to increase blood flow to the female genitalia, thereby promoting engorgement and other natural processes that occur during sexual stimulation.
It is estimated that over 40 percent of women report some form of female sexual dysfunction, caused by both organic and psychogenic causes. Researchers have classified the range of symptoms seen in female sexual dysfunction into four subcategories: desire, arousal, orgasmic and sexual pain disorders. The VIVUS clinical program is designed to evaluate ALISTA in women with a primary complaint of sexual arousal disorder.
VIVUS received the first patent ever issued in the United States for the treatment of female sexual dysfunction, has several patents pending and has also acquired rights to additional patents in this area.
In March 1999, VIVUS was issued U.S. patent number 5,877,216 for the ``Treatment of Female Sexual Dysfunction,`` which provides broad patent protection for the local delivery of vasodilating agents, including alprostadil, for the treatment of female sexual dysfunction. The company`s intellectual property provides a solid foundation for commercializing ALISTA.
VIVUS Inc. is a pharmaceutical company developing innovative products to improve quality of life disorders in men and women, with a focus on sexual dysfunction. The company developed and markets in the U.S. MUSE® (alprostadil) and ACTIS®, two innovations in the treatment of erectile dysfunction, and has partnered with Abbott Laboratories (NYSE:ABT - news) for the international marketing and distribution of its male transurethral erectile dysfunction products.
In Canada, VIVUS is partnered exclusively with Paladin Labs Inc. (TSE:PLB - news) to market and distribute MUSE. The company also has development programs for TA-1790, a highly selective PDE5 inhibitor compound for both oral and local treatment of sexual dysfunction in men and women. VIVUS is also working on products for premature ejaculation.
Hallo,
+33% in USA ,gibt`s was Neues.
Gruß
+33% in USA ,gibt`s was Neues.
Gruß
Schon 45%
ON24, 12/14/2001 09:51
Audio:Spotlight: Vivus
ON24/Briefing.com: A small biotech with big potential.
http://vuwin.on24.com/vuwindow/scripts/vuwin.asp?ref=quot&cb…
JS200
ON24, 12/14/2001 09:51
Audio:Spotlight: Vivus
ON24/Briefing.com: A small biotech with big potential.
http://vuwin.on24.com/vuwindow/scripts/vuwin.asp?ref=quot&cb…
JS200
Hallo,
schon komisch.Ich kann nichts außergewöhnliches finden?
Nur auf eine Empfehlung ,einen Anstieg von 45 %zu verzeichnen.
Alle Achtung.
Habe diese Aktie selber nicht.Beobachte sie nur ab und zu.
Hätte doch mal zuschlagen sollen.???
Geht bestimmt wieder runter.
Gruß
schon komisch.Ich kann nichts außergewöhnliches finden?
Nur auf eine Empfehlung ,einen Anstieg von 45 %zu verzeichnen.
Alle Achtung.
Habe diese Aktie selber nicht.Beobachte sie nur ab und zu.
Hätte doch mal zuschlagen sollen.???
Geht bestimmt wieder runter.
Gruß
In zwei Wochen kann man sie wieder für 4,5$ bekommen!!!
Dann ist der Schreck verflogen.
JS200
Dann ist der Schreck verflogen.
JS200
13:31 ET Vivus climbs to new 52-week high; institutional buying, rumors cited (VVUS) 8.30 +0.55 (+7%): Hearing that Dow Jones is reporting that stock is being accumulated by institutional investors and that co is expected to release positive news soon. Also in the market is a trading floor rumor that Pfizer (PFE) is considered a potential bidder for the company. However, there is skepticism about a deal occurring.
In zwei Wochen bekommen Sie VVUS nicht unter €10.
Gute Nachrichten und neue Media-Interesse (AUA Konferenz in US) wird es zeigen.
Gute Nachrichten und neue Media-Interesse (AUA Konferenz in US) wird es zeigen.
Hi rechnung.
Wie kommst du auf diese Annahme? Im Moment gehts ja ziemlich bergab.Hast du neue Erkenntnisse?
Gruß Jack.
Wie kommst du auf diese Annahme? Im Moment gehts ja ziemlich bergab.Hast du neue Erkenntnisse?
Gruß Jack.
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