NEW YORK (Reuters) - Vivus Inc., a tiny company whose once-promising anti-impotence product was crushed by Viagra, is preparing to bounce back.
Vivus, based in Mountain View, California, is set to move into late-stage clinical trials for Alista, which could become the first treatment for female sexual arousal disorder. If all goes according to plan, Vivus expects to submit Alista to the U.S. Food and Drug Administration for review in 2006.
Leland Wilson, Vivus’ chief executive since 1991, believes the hunt by many drug makers for a so-called female Viagra will prove elusive because, he says, women are more complicated than men, who rarely require treatment for diminished desire.
“There’s going to be a number of therapies required to treat the majority of women,” Wilson told Reuters. “You will need to treat the desire component and the arousal component.”
Alista, a topical cream, assists arousal in women who, for example, may have suffered damage from surgery or child birth to nerves that trigger increased blood flow to the genitalia.
“The ideal woman for us to treat,” Wilson said, “is someone who has the desire for sexual activity and has had a loss of sensitivity but clearly remembers when it felt good.”
Procter & Gamble is in the late stages of developing a drug to treat desire problems in women.
Ken Trbovich, an analyst for CE Unterberg Towbin, said any drugs for female sexual dysfunction, or FSD, that prove effective in treating arousal, desire or inability to achieve orgasm could garner sales of well over a $1 billion a year.
“There are as many or more women affected with FSD as there are men with erectile dysfunction and the sales of Viagra last year were $1.7 billion,” Trbovich said.
Wilson has been addressing sexual health issues for decades and sees himself as something of a pioneer in the field.
As a graduate student in 1971, Wilson’s bid for grant money for his thesis on the pharmacology of the erectile process fell on deaf ears. All but animal groups, such as dairy and dog breeders, regarded it as unimportant.
“Those were the people who had the first interest in trying to assure reproductive capability,” Wilson recalled.
That all changed with the enormous success of Pfizer’s Inc.'s famous blue pill.
Vivus sells an impotence treatment called Muse -- a suppository pellet that is inserted into the penis -- that has been on the market since 1997. Viagra all but killed it as Muse sales plunged from $130 million in its first year to about $20 million a year with the emergence of Viagra.
Vivus is reloading its slingshot and taking aim at the industry Goliath by developing an erectile dysfunction pill it hopes will have fewer side effects and will be safer for millions of heart patients who should not take Viagra.
The company is conducting mid-stage trials of the drug in an effort to challenge Viagra and new rivals Cialis, from Eli Lilly & Co. and Icos Corp., and Levitra, made by GlaxoSmithKline and Bayer AG.
With its shares trading for less than $4 and revenue of just $13.4 million in the first nine months of this year, Vivus needs new products soon. The company said it has enough funding to conduct phase III trials for Alista and move the new men’s drug into late-stage trials.
However, it will need a deep-pocketed partner to take the products to market, and Wilson said Vivus expects to be able to choose from potential suitors among leading drug companies.
“I believe the ED marketplace is going to prove to be one of the top pharmaceutical markets,” he said. “Everybody in the top tier has their radar out for these products.”
Wilson praised Pfizer for bringing impotence out of the closet and expanding the market to younger men by using athletes as Viagra pitchmen.
It is a measure of how societal views have changed that six years after a Muse commercial Vivus hoped to air during the Super Bowl was rejected as inappropriate, Levitra is now “a proud sponsor of the NFL.”
MeSH Headings:Clinical Trials: Environment and Public Health: Epidemiologic Methods: Evaluation Studies: Health: Health Occupations: Health Services Administration: Medicine: Investigative Techniques: Population Characteristics: Preventive Medicine: Public Health: Quality of Health Care: Specialties, Medical: Drugs, Investigational: Epidemiologic Study Characteristics: Clinical Trials, Phase III: Health Care Quality, Access, and Evaluation: Health Care Evaluation Mechanisms: Analytical, Diagnostic and Therapeutic Techniques and Equipment: Biological Sciences: Health CareCopyright © 2002 Reuters Limited. All rights reserved. Republication or redistribution of Reuters content, including by framing or similar means, is expressly prohibited without the prior written consent of Reuters. Reuters shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon. Reuters and the Reuters sphere logo are registered trademarks and trademarks of the Reuters group of companies around the world.
