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Advisory Panel Recommends Lutropin Alfa in Follicular Development

ROCKLAND, MD - Sept. 30 /PRNewswire/ -- Serono, Inc. announced today that the Reproductive Health Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) issued a favorable recommendation for Luveris® in Serono's proposed indication of follicular development. Luveris® (lutropin alfa for injection) administered with follitropin alfa for injection, is proposed for the indication of stimulation of follicular development in infertile hypogonadotropic hypogonadal (HH) women with profound luteinizing hormone deficiency (LH

The FDA had previously recommended that Serono study an endpoint of ovulation rates, an endpoint frequently used for products in ovulation induction. However, the Committee agreed that in this rare patient population the endpoint of follicular development was appropriate.

"We are very pleased with the recommendation of the Advisory Committee supporting the efficacy of Luveris® for follicular development in this rare patient population and will continue to work closely with the FDA as it finalizes its review of this important new treatment," said Paul Lammers, MD, Chief Medical Officer, Serono, Inc. "Serono's development of Luveris® is part of our ongoing commitment to reproductive health and our leadership role in this area. Luveris® is the third of three recombinant fertility hormones developed exclusively by Serono."

Luveris® is a recombinant form of luteinizing hormone (LH), a naturally occurring fertility hormone. It is the first and only drug product to contain LH exclusively that can address the unmet medical need for fertility treatment by profoundly LH deficient women. Women whose opportunities for pregnancy are limited by profound LH deficiency have no available treatment approved specifically for their condition. These women lack the ability to produce the hormones needed for full development of follicles in the ovaries, ovulation, and growth of the lining of the uterus sufficient to support implantation of a fertilized egg and early pregnancy.

The Advisory Committee's recommendation was based on a review of the clinical development program conducted in patients with this rare condition, including a phase III confirmatory, double-blind, placebo-controlled, randomized trial. In this trial, patients were treated with either Luveris® or placebo, co-administered with Serono's recombinant follicle stimulating hormone (r-hFSH), Gonal-f® (follitropin alfa for injection). In the Luveris® and Gonal-f® treatment group, 17 patients (65.4%) achieved the primary endpoint of follicular development compared to two patients (15.4%) in the placebo and Gonal-f® group. The four-fold difference between the two groups was both clinically meaningful and statistically significant (p=0.006).

In these studies, Luveris® was well tolerated with reported adverse events similar to those of other currently approved recombinant gonadotropin products.

The Advisory Committee recommendation is considered by the FDA in making its decision regarding Luveris®, which is expected before the end of this year. Luveris® received an Orphan Drug Designation from the FDA and is currently approved for the treatment of women with profound LH deficiency in 46 countries worldwide, including countries of the European Union such as France, Germany and the United Kingdom.

Serono and Infertility Treatment

Serono, the global leader in infertility, is dedicated to providing patient-friendly, innovative products to help couples build families. Serono is the only company to offer a full portfolio of fertility drugs for every stage of the reproductive cycle and recombinant versions of the three hormones needed to treat infertility: Gonal-f® (follitropin alfa for injection), to stimulate the ovaries and produce eggs; Luveris® (lutropin alfa for injection), to stimulate follicular development in women who are profoundly LH deficient; Cetrotide® (cetrorelix acetate for injection) to control hormonal surges; Ovidrel® (choriogonadotropin alfa for injection), to help follicles mature and release eggs; and Crinone® (progesterone gel), to help establish and maintain a pregnancy. (Luveris® is not approved in the US.)

For more information on infertility and full prescribing information for Serono's US marketed fertility products visit http://www.seronofertility.com/.

Source: Serono

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