Plastic Surgery for Men QT: Any new drugs for men's health?

Eli Lilly and Co., which helped turn impotence drug Cialis into a household name, is moving aggressively to put other products in men's medicine cabinets.It's a move that could yet again broaden Lilly's reach beyond its traditional role of developing drugs for diabetes and mental illness.

Prompted by an aging male population, the Indianapolis drug maker is gearing up to develop and sell new treatments for enlarged prostate, low testosterone and other ailments that affect millions of men.


On Thursday, Lilly said it had advanced an experimental drug for treating enlarged prostate from early-stage to middle-stage clinical trials, a sign that the drug has worked safely in healthy volunteers. The company is enrolling men with enlarged prostates in a 24-week test to see how well the drug, known as LY500307, can treat the ailment.


That follows Lilly's announcement in March that it signed a worldwide license agreement with an Australian biotech firm, Acrux, to sell an experimental gel for treatment of testosterone deficiency, which affects up to 39 percent of men older than 45.

The gel, called Axiron, is applied over a small area of the body with an underarm applicator. The product is now under federal review, and Lilly hopes to get approval by next year.


If these moves work out as planned, Lilly could become a more significant player in men's health. It's a fragmented but growing market worth billions of dollars a year in sales.

"There are a lot of companies with lots of different products that touch men's health, but no one really is a clear leader," said Linda Bannister, a drug analyst at Edward Jones & Co. in St. Louis. "There's an opportunity for Lilly here."

Developing new drugs takes years, and some analysts doubt that Lilly will be able to make a huge impact immediately. But if successful, Lilly could reap untold billions in new sales, which could help the company as it struggles to cope with a steep falloff in sales from other leading products, which are about to lose their patent exclusivity and face low-cost generic rivals.

Lilly has a good foothold in this area already. Cialis, a popular treatment for erectile dysfunction, is still selling briskly after seven years on the market. On Thursday, Lilly said second-quarter sales of Cialis climbed 15 percent to $418.7 million, putting it on pace to trounce last year's sales of $1.6 billion.In addition to owning the Cialis brand, Lilly has amassed something else just as valuable: contacts with thousands of urologists around the world who have prescribed Cialis millions of times.

"If you go to most urologists, they know Lilly pretty well," said John Bamforth, a Lilly executive who oversees men's health. "So it seemed logical for us to see if there were any other opportunities in this area where we could use contacts and teams we already have."

Already, Lilly is using the compound behind Cialis for other purposes. A few years ago, Lilly received approval to market the drug under another name, Adcirca, to treat high blood pressure. And it is studying the drug as another treatment for enlarged prostates. That test is in late-stage clinical trials. How Lilly got to this position is a mixture of chance, good timing and a bit of catch-up.  In 1998, rival Pfizer launched a revolutionary drug, Viagra, the first oral treatment for erectile dysfunction. It quickly became a success, ringing up $1 billion in annual sales within just a few years.


Other drug makers, including Lilly, recognized the opportunity and began looking for ways to capitalize on it.

Lilly struck a joint venture in 1998 with Icos Corp., a Seattle biotech that was developing its own treatment for erectile dysfunction. The drug, Cialis, hit the U.S. market in 2003. The company hit the national stage with a memorable TV commercial for Cialis during the 2004 Super Bowl. The ad showed middle-aged couples relaxing in side-by-side bathtubs at sunset.


The product quickly became a top seller, eventually overtaking Viagra in more than a dozen countries, including France, where it became known as "le weekend," because a single dose can last as long as 36 hours. It remains the only ED drug that works for that long, rather than wearing off in just a few hours, so there's less pressure for men to watch the clock.

In 2007, Lilly bought out its partner, Icos, for $2.3 billion, taking full control of Cialis and ending a partnership that lasted nearly a decade."Back in 1998, when we originally did that deal, we saw it as a bit of an opportunistic play," Bamforth said. "I don't think we planned it necessarily as a path beyond the one asset (in men's health)."He added: "But now it's something we can build on, and leverage our experience and expertise in this growing area."

Meanwhile, Lilly faces new challenges to keep sales robust.Several other companies are developing new ED drugs. And Viagra will lose its patent exclusivity in 2012, allowing competitors to introduce generic versions that could pull down prices for the entire category.


Some analysts say Lilly's effort to broaden its portfolio in men's health is worth a try. Other drug companies have only a handful of products in this area, including GlaxoSmithKline, which sells drugs for erectile dysfunction, overactive bladder and enlarged prostate.

"It's an area where Lilly won't have much competition," said Les Funtleyder, a drug analyst at Miller Tabak & Co. "If they're successful at this, they'll do pretty well."

resource:   http://www.indystar.com/article/20100723/BUSINESS/7230356/1003/BUSINESS/At-
Lilly-the-success-of-Cialis-is-fueling-a-push-for-new-male-health-drugs  July 23, 2010