Monday, March 10, 2008

Pear Tree aims for FDA OK of hormone treatment

By Ryan McBride

A Cambridge biotech startup wants to gain U.S. approval of a menopause treatment that combines two female hormones. The startup, Pear Tree Pharmaceuticals Inc., plans to combine estrogen and progesterone into one treatment for vaginal dryness, or atrophic vaginitis, a common symptom of menopause, and is seeking clearance from the U.S. Food and Drug Administration.

Formed in July 2007, the biotech in recent weeks has closed on just under $2.8 million in Series A venture capital financing to fund efforts to bring its experimental drugs to market, according to company executives and public filings.

From prescribed pills to kava root, there are a variety of conventional and homeopathic treatments for hot flashes, insomnia, and other symptoms of menopause. Increasingly, gynecologists tell women to take hormones not approved by the FDA but considered effective by physicians, Pear Tree CEO Martin Driscoll said.

A combination of estriol, a form of estrogen, and progesterone is one of those unapproved remedies taken by women with vaginal dryness from menopause, Driscoll said. His startup aims to put a set dose of each hormone in a vaginal capsule and test the treatment in clinical trials needed to gain FDA approval.

Some drug distributors have drawn the ire of pharmaceutical companies for marketing estriol and other unsanctioned treatments for symptoms of menopause. In fact, the FDA reported in January that it had warned some operations about making faulty claims about their menopause treatments, following up on a complaint about the practice from New Jersey drug major Wyeth, which is developing and marketing several drugs to treat menopause symptoms.

"The FDA may want to see an approved product on the market with estriol," said Driscoll, who said he thinks the FDA warning would neither help nor hinder his firm's efforts to develop estriol as an approved drug.

Pear Tree has attracted investments from angel investors and from Wexford Capital LLC, a Greenwich, Conn., investment firm, said Driscoll. The founders of the startup include Driscoll, a drug industry veteran from New Jersey; Janet Chollet, a gynecologist who serves as the firm's director of clinical affairs; and Fred Mermelstein, president of Javelin Pharmaceuticals Inc. of Cambridge.

Driscoll said he serves on the board of Javelin, a developer of pain medicines, with Mermelstein. Chollet, who practices medicine at Beth Israel Deaconess Medical Center in Boston, had tested the estriol and progesterone treatment in her patients at her former practice in Pennsylvania before the formation of Pear Tree. The firm plans to discuss the design of a Phase 2 clinical trial of the treatment with the FDA this year.

The biotech now employs five people and is expected to grow to seven workers shortly, Driscoll said.

To give an estimate of the market his firm pursues, Driscoll said the annual U.S. market for vaginal estrogen is about $375 million.