NEW ENGLAND JOURNAL OF MEDICINE PUBLISHES EFFICACY AND SAFETY DATA FOR GARDASIL® IN MALES

GARDASIL® 90% effective at preventing genital warts

Males' immune response to natural HPV infection weaker than females'

KIRKLAND, QC, Feb. 2 /CNW Telbec/ - The only clinical study to demonstrate the efficacy of an HPV vaccine in males was published in the February 3 issue of the New England Journal of Medicine. In this study, GARDASIL® [Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine] was 90 percent effective at preventing HPV-related external genital lesions1, including genital warts, in males aged 16 to 26. The publication also noted that males have a lesser immune response to natural infection than females, which may partially explain the higher prevalence of HPV infections in males and the constant prevalence and incidence of HPV infection across a wide age range in males.2

"Some may think that HPV is just a girl's problem, but men actually acquire HPV infections as often as women and their natural immune response to HPV is weaker," said Dr. François Coutlée, study investigator, microbiologist at the Centre de Recherche du CHUM and assistant clinical professor, Department of Medicine, Université de Montréal. "These newly published results suggest that prophylactic vaccination of boys and men with the quadrivalent HPV vaccine may reduce the incidence of genital warts, as observed within three years after the introduction of the HPV vaccination program for young women in Australia.3"

Quadrivalent HPV vaccine reported efficacy in sexually active male populations

A total of 4,065 healthy boys and men (3463 heterosexual and 602 who had sex with men), 16 to 26 years of age, from 18 countries were enrolled in this randomized, placebo-controlled, double-blind trial.4 Efficacy analyses were conducted in a "per-protocol" population that approximates a population of young men before sexual debut and an "intention-to-treat" population that represents the general population of unvaccinated boys and men.5

In the per-protocol population, the quadrivalent HPV vaccine was 90.4% efficacious in preventing external genital lesions related to HPV types 6, 11, 16 or 18. In the intention-to-treat population, the quadrivalent HPV vaccine was 65.5% efficacious in preventing external genital lesions related to HPV types 6, 11, 16 or 18.6

No serious adverse events related to vaccination were reported in the study. The majority of adverse events were related to injection-site reactions and were more common in the vaccine group than in the placebo group (69.2% for vaccine group vs. 64.2% for placebo group).

Genital warts are the most common HPV-related disease in young males

It is estimated that 75% of sexually active Canadians will have at least one HPV infection in their lifetime. HPV causes 90% of anal cancers and 50% of penile cancers.7 The most common HPV-related disease in young men is genital warts.8 The lifetime risk for acquiring genital warts has been estimated to exceed 10%.

"The New England Journal of Medicine article supports what I see in my practice. Genital warts have a substantial physical and psychological impact, a high rate of treatment failure and are expensive to treat," said Dr. Charles Lynde, a practising dermatologist, study investigator and Assistant Clinical Professor, University of Toronto. "Genital warts are ugly, distressing and sometimes painful lesions that impact relationships."

In February 2010, Health Canada approved the quadrivalent HPV vaccine for boys and men nine through 26 years of age for the prevention of infection caused by HPV types 6, 11, 16, and 18 and genital warts caused by HPV types 6 and 11.  GARDASIL® is also indicated in girls and women 9 through 26 years of age for the prevention of infection caused by HPV types 6, 11, 16 and 18 and the following diseases associated with these types: cervical cancer, vulvar cancer, vaginal cancer, their precancerous lesions and genital warts.

Visit www.nejm.org to view the entire study: "Efficacy of Quadrivalent HPV Vaccine against HPV Infection and Disease in Males".

About Merck

Today's Merck is a global healthcare leader working to help the world be well.  Merck is known as MSD outside the United States and Canada. 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 healthcare through far-reaching programs that donate and deliver our products to the people who need them. For more information, visit www.merck.com.

Forward Looking Statement

This information 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).

Notes:


  1. External genital lesions were defined as condylomata acuminata (external genital warts); penile, perianal, or perineal intraepithelial neoplasia (PIN); or penile, perianal, or perineal cancer. Giuliano A R et al. "Efficacy of Quadrivalent HPV Vaccine against HPV Infection and Disease in Males". New England Journal of Medicine. February 3, 2011. Volume 364. Number 5. Page 4 (top of page)
  2. Giuliano A R et al. "Efficacy of Quadrivalent HPV Vaccine against HPV Infection and Disease in Males". New England Journal of Medicine. February 3, 2011. Volume 364. Number 5. Page 2 (top of page).
  3. Giuliano A R et al. "Efficacy of Quadrivalent HPV Vaccine against HPV Infection and Disease in Males". New England Journal of Medicine. February 3, 2011. Volume 364. Number 5. Page 8 (bottom of page).
  4. Giuliano A R et al. "Efficacy of Quadrivalent HPV Vaccine against HPV Infection and Disease in Males". New England Journal of Medicine. February 3, 2011. Volume 364. Number 5. Page 1 (under Methods).
  5. Giuliano A R et al. "Efficacy of Quadrivalent HPV Vaccine against HPV Infection and Disease in Males". New England Journal of Medicine. February 3, 2011. Volume 364. Number 5. Page 3 (under Study Population for Analyses).
  6. Giuliano A R et al. "Efficacy of Quadrivalent HPV Vaccine against HPV Infection and Disease in Males". New England Journal of Medicine. February 3, 2011. Volume 364. Number 5. Page 1 (under Results).
  7. American Society for Colposcopy and Cervical Pathology Web site. Accessed at: www.asccp.org/hpv_history.shtml
  8. HPVinfo.ca Web site. Accessed at: http://www.hpvinfo.ca/hpvinfo/adults/men-hpv.aspx

GARDASIL® Registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. Used under license


SOURCE MERCK

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