|
By Catherine Hollingsworth
Staff Writer
BioSante Pharmaceuticals Inc. has entered an agreement with Azur Pharma Ltd. to market Elestrin (estradiol gel) in the U.S. to treat moderate-to-severe hot flashes in menopausal women, a deal that could bring in up to $144.5 million for BioSante plus double-digit royalties.
The deal includes an up-front payment of $3.325 million, comprised of a $500,000 product licensing fee and $2.825 million for transfer of the Elestrin trademark and inventories, among other items.
The additional payments are contingent on BioSante achieving certain sales-based milestones. In addition, Azur has agreed to pay to BioSante royalties on sales of Elestrin ranging from 10 percent to 20 percent depending on the annual sales level.
Dublin, Ireland-based Azur has agreed to market Elestrin using its women's health and urology sales force of about 50 sales people who target estrogen prescribing physicians in the U.S., comprised mostly of gynecologists. The U.S. estrogen therapy market currently is estimated to be about $1.4 billion in annual sales, of which the transdermal segment - mostly patches - is about $260 million, according to BioSante.
The leading estrogen patches such as Bayer HealthCare Pharmaceuticals' Menostar represent a $300 million a year market, but oral contraceptives led by Wyeth's Premarin pill hold the biggest chunk of the market for estrogen, Oppenheimer analyst Kevin DeGeeter, told BioWorld Today. Evamist, another estrogen gel by KV Pharmaceutical, was launched in the last six months, he said.
When male and female patients are given a choice between the three formulations - pill, patch or gel - they consistently chose the pill, DeGeeter said. But he said the message to physicians should not focus on the formulation, rather on "the amount of estrogen delivered to a woman . . . Most physicians have never really heard the message yet." He said he will be waiting to see the marketing message to physicians, how the product is positioned by Azur, and Elestrin's pricing. DeGeeter estimated that, at launch, Elestrin would generate $125 million in peak sales, though, he said, he would be more conservative today with an estimate of $100 million.
Seamus Mulligan, chairman and CEO of Azur, said in a statement that, "we believe Elestrin and its approved ultra-low dose regimen will be an attractive alternative for physicians who treat and for women who suffer from menopausal symptoms."
Elestrin is administered using a metered dose applicator that delivers 12.5 micrograms of estradiol, one of the two lowest estradiol doses and 67 percent lower than the lowest dose estrogen patch approved by the FDA for the treatment of hot flashes. The gel, which is applied to upper arm, dries in one to two minutes.
Much of BioSante's attention is focused on one of its lead products, LibiGel, (transdermal testosterone gel) in Phase III development under an FDA special protocol assessment (SPA) for the treatment of female sexual dysfunction.
"BioSante's primary focus and spending today is for the Phase III development of LibiGel . . . for which there is no [prescription] product approved in the U.S," Stephen M. Simes, president & CEO of BioSante, told BioWorld Today.
Currently, BioSante has two Phase III trials in progress covered by an SPA, to demonstrate the safety and efficacy of LibiGel, in the treatment of hypoactive sexual desire disorder.
In addition to the two LibiGel Phase III safety and efficacy trials, BioSante is enrolling women in a Phase III cardiovascular and breast cancer safety study of LibiGel. Under a written agreement with the FDA, the safety study will serve as the basis of safety for both surgically and naturally menopausal women.
As previously announced, the safety study is a cardiovascular events-driven study of between 2,400 and 3,100 women exposed to LibiGel or placebo for 12 months. At the end of the 12 months, BioSante intends to submit a LibiGel new drug application (NDA) for FDA review and possible approval by the FDA. BioSante will continue to follow the women enrolled in the safety study for an additional four years after the NDA submission and possible approval of LibiGel.
The two SPAs for LibiGel for the treatment of female sexual dysfunction are for "surgically" and "naturally" menopausal women. | 
