Merck Receives CHMP Positive Opinion for New Fertility Treatment, ELONVA(R)

Saturday, November 21, 2009 General News
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WHITEHOUSE STATION, N.J., Nov. 20 Merck & Co., Inc. today announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) has recommended approval of ELONVAŽ (corifollitropin alfa injection) as a treatment in controlled ovarian stimulation (COS) in combination with a GnRH antagonist for the development of multiple follicles in women participating in an assisted reproductive technology (ART) program. If approved by the European Commission, Merck would receive marketing authorization for ELONVA with unified labeling valid in all European Union Member States.

ELONVA is the first in the class of sustained follicle stimulants (SFS). Due to its ability to initiate and sustain multiple follicular growth for an entire week, a single subcutaneous injection of the recommended dose of ELONVA may replace the first seven injections of any daily recombinant follicle stimulating hormone (rFSH) preparation in a COS treatment cycle.

"ELONVA will reduce the burden of injections for women experiencing difficulty conceiving, and the positive opinion is an important step toward a European approval," said Mirjam Mol-Arts, senior vice president, Merck Research Laboratories. "ELONVA demonstrates Merck's commitment to providing effective patient-focused fertility treatments and extends the company's leadership in this therapy area."

The Phase III development program for ELONVA included the Engage trial, the largest double-blind fertility agent trial ever performed. The ongoing pregnancy rate, the primary endpoint of Engage, in the ELONVA treatment arm (38.9 percent per started cycle) was similar to that achieved in patients receiving a daily dose of rFSH for seven days (38.1 percent per started cycle).(1)

About ELONVA

ELONVA is an investigational product being developed as a potential treatment in COS in combination with a GnRH antagonist for the development of multiple follicles in women participating in an ART program. ELONVA is designed as an SFS with the same pharmacodynamic profile as rFSH, but with a markedly prolonged duration of FSH activity. Due to its ability to initiate and sustain multiple follicular growth for an entire week, a single subcutaneous injection of the recommended dose of ELONVA may replace the first seven injections of any daily rFSH preparation in a COS treatment cycle.

About Engage

Engage was a non-inferiority trial designed to compare ELONVA 150 mcg to 200 IU rFSH. A total of 1,506 patients (with a body weight greater than 60 kg) at 34 in-vitro fertilization (IVF) clinics in North America and Europe were randomized to receive either ELONVA 150 mcg or a daily dose of 200 IU rFSH, followed by rFSH (maximum 200 IU/day) from stimulation day eight onward, when required. Starting on stimulation day five, all patients received 0.25mg gonadotropin-releasing hormone (GnRH) antagonist until triggering of final oocyte maturation by human chorionic gonadotropin (hCG). The primary endpoint was the ongoing pregnancy rate assessed at ten weeks or more after embryo transfer. In the ELONVA treatment arm the ongoing pregnancy rate (38.9 percent per started cycle) was similar to that achieved in patients receiving a daily dose of rFSH for seven days (38.1 percent per started cycle).(1) The number of oocytes retrieved per attempt, the co-primary endpoint, was 13.7 (plus or minus 8.2) for the ELONVA group and 12.5 (plus or minus 6.7) for the rFSH group.(1)

ELONVA Important Safety Information

The most frequently reported adverse drug reactions during treatment with ELONVA in clinical trials are Ovarian Hyperstimulation Syndrome (OHSS) (5.2%), pelvic pain (4.1%) and discomfort (5.5%), headache (3.2%), nausea (1.7%), fatigue (1.4%) and breast complaints (including tenderness) (1.2%). Use with GnRH agonists is not recommended.

About Infertility

Infertility is a disease or condition that impairs the body's ability to perform the basic function of reproduction.(2) It is often diagnosed after a couple has not conceived after one year of unprotected, well-timed intercourse.(3) Women over the age of 35 are encouraged to seek diagnosis and treatment for infertility following six months of unprotected intercourse.(4) Around 15 percent of couples of reproductive age have a fertility problem.(3)

There are many causes of infertility including problems with the production of sperm or eggs, with the fallopian tubes or the uterus, endometriosis, frequent miscarriage, as well as hormonal and autoimmune (antibody) disorders in both men and women.(3)

With infertile couples, the source of infertility lies with the male in 40 percent of cases and 40 percent with the female. The remaining 20 percent is either a joint problem or unknown, because the cause has not been identified. There are a variety of treatments available for infertility; these include surgery, hormone treatments, insemination, IVF and natural treatments, among others.(3)

About Merck

Today's Merck is working to help the world be well. Through our medicines, vaccines, biologic therapies, and consumer and animal products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to health care through far-reaching programs that donate and deliver our products to the people who need them. Merck. Be Well. For more information, visit www.merck.com.

Forward Looking Statement

This news release includes "forward-looking statements" within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Such statements may include, but are not limited to, statements about the benefits of the proposed merger between Merck and Schering-Plough, including future financial and operating results, the combined company's plans, objectives, expectations and intentions and other statements that are not historical facts. Such statements are based upon the current beliefs and expectations of Merck's and Schering-Plough's management and are subject to significant risks and uncertainties. Actual results may differ from those set forth in the forward-looking statements.

The following factors, among others, could cause actual results to differ from those set forth in the forward-looking statements: the possibility that the expected synergies from the merger of Merck and Schering-Plough will not be realized, or will not be realized within the expected time period, due to, among other things, the impact of pharmaceutical industry regulation and pending legislation that could affect the pharmaceutical industry; the risk that the businesses will not be integrated successfully; disruption from the merger making it more difficult to maintain business and operational relationships; Merck's ability to accurately predict future market conditions; dependence on the effectiveness of Merck's patents and other protections for innovative products; the risk of new and changing regulation and health policies in the U.S. and internationally and the exposure to litigation and/or regulatory actions.

Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in Merck's 2008 Annual Report on Form 10-K, Schering-Plough's Quarterly Report on Form 10-Q for the quarterly period ended Sept. 30, 2009, the proxy statement filed by Merck on June 25, 2009 and each company's other filings with the Securities and Exchange Commission (SEC) available at the SEC's Internet site (www.sec.gov).

References:

(1) Devroey P, et al. A double-blind non-inferiority, randomized controlled trial comparing corifollitropin alfa and recombinant FSH during the first seven days of ovarian stimulation using a GnRH antagonist protocol. Hum Reprod 2009; doi: 10.1093/humrep/dep291.

(2) Frequently Asked Questions About Infertility. American Society for Reproductive Medicine Web site. http://www.asrm.org/Patients/faqs.html. Accessed May 14, 2009

(3) http://www.icsi.ws/about_infertility. Accessed May 14, 2009

(4) Frequently Asked Questions; Questions about Infertility. Centre for Fertility and Reproductive Medicine. http://www.csmc.edu/3830.html. Accessed May 14, 2009

SOURCE Merck & Co., Inc.


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