Hot-flash cream at Novavax is OK'd

Estrasorb approved for short-term use during menopause

`It's just an amazing story'

October 11, 2003|By William Patalon III | William Patalon III,SUN STAFF

Novavax Inc., aiming for a piece of the $1.6 billion domestic estrogen-replacement market, has won government approval for a prescription estrogen formulation that is absorbed after being rubbed into the skin like a lotion, the Columbia-based firm announced yesterday.

The product, called Estrasorb, received U.S. Food and Drug Administration approval for short-term use by women suffering from the effects of menopause, the company said. In development for nine years, Estrasorb is the first drug developed by Novavax. The company will market it jointly with its partner, King Pharmaceuticals Inc., of Bristol, Tenn.

The two firms expect Estrasorb to hit the market late in the first quarter.

"It's just an amazing story that a small Maryland company can make a difference in such a huge market that's so important to women," said Nelson M. Sims, president and chief executive officer of Novavax. "We're extremely excited" about the product's potential.

Estrasorb's billing as a short-term solution for such discomforting menopausal symptoms as hot flashes is indicative of the medical profession's recent about-face on the hormone-replacement therapies. For years, the medical profession has championed long-term estrogen treatment as a means of protecting women from such maladies as Alzheimer's and heart problems.

But recent research has found the opposite. Long-term estrogen use now appears to increase the risk of many forms of dementia, as well as heart attacks. It also can make breast tumors more difficult to locate, which can delay diagnosis and increase the risk that breast cancer can spread before it's discovered.

Novavax makes no claims that Estrasorb reduces the risks of estrogen usage, Sims said.

"The key [to being safe] is in following the directions," he said. "It's for short-term use, and it's just for women who are experiencing ... hot flashes" and related menopause side-effects.

During clinical trials and some accompanying studies, Novavax found that many women preferred the topical application to patches or even pills, the company said. Some women experience stomach woes from pills, and some who have tried estrogen patches found that they irritated their skin, the company said.

"During our marketing studies, we found that women use lotions or creams every day," Sims said. "It was a natural follow-on for them to use [Estrasorb]; it's a small amount of a lotion-like emulsion, and it even has great moisturizing properties to it."

Although Novavax declined to make any sales forecasts for Estrasorb, "it should create significant revenue for us," Sims said.

With a combined sales force of 120 representatives, King and Novavax will jointly market the drug in the United States and Puerto Rico. King has an exclusive license to market Estrasorb everywhere else worldwide, with Novavax receiving royalties from those overseas sales.

According to Novavax, Estrasorb's underlying transdermal technology has the potential to deliver other kinds of drugs: analgesics, anti-inflammatory agents, steroids, and central-nervous system drugs, for instance. Novavax is already working on a topical testosterone formulation that has been through several clinical trials, Sims said.

The announcement of Estrasorb should increase Novavax's credibility in the financial markets, making it easier to raise money needed to finance new products, the company said. Novavax recently filed documents announcing its intention to raise as much as $50 million, probably by selling additional shares in the company.

Novavax shares closed yesterday at $7.63, down 37 cents, after spiking as high as $8.62 during the session.

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