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Biopharmaceuticals Oncology FDA

 News Release - June 8, 2006

FDA Approves Merck's GARDASIL(R), the World's First and Only Cervical Cancer Vaccine

GARDASIL Prevents Cervical Cancer, Precancerous and Low-Grade Lesions and Genital Warts Caused by HPV Types 6, 11, 16 and 18

WHITEHOUSE STATION, N.J.--(HSMN NewsFeed)--June 8, 2006--Merck & Co., Inc. announced today that the U.S. Food and Drug Administration (FDA) approved GARDASIL® (Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine), the first and only vaccine to prevent cervical cancer and vulvar and vaginal precancers caused by HPV types 16 and 18 and to prevent low-grade and pre-cancerous lesions and genital warts caused by HPV types 6, 11, 16 and 18. In the United States, approximately 10,000 women are diagnosed with cervical cancer every year, and an average of 10 women die each day from the disease.

The FDA approved GARDASIL for the prevention of cervical cancer; cervical pre-cancers (cervical intraepithelial neoplasia (CIN) 2/3 and adenocarcinoma in situ (AIS)); vulvar pre-cancers (vulvar intraepithelial neoplasia (VIN) 2/3); and vaginal pre-cancers (vaginal intraepithelial neoplasia (VaIN) 2/3)) caused by HPV types 16 and 18. GARDASIL is also approved for the prevention of genital warts and low-grade cervical lesions (CIN 1) caused by HPV types 6, 11, 16 and 18. GARDASIL is approved for 9- to 26-year-old girls and women.

"Merck is proud to be the leader in cervical cancer vaccine research and development," said Richard T. Clark, chief executive officer and president, Merck & Co., Inc. "Bringing forward this life-saving scientific advance is yet another testament to Merck's long-standing mission to research and develop novel vaccines and medicines that can greatly improve public health."

GARDASIL is designed to prevent the majority of HPV-related clinical diseases, those caused by HPV 6, 11, 16 and 18. HPV types 16 and 18 account for approximately 70 percent of cases of cervical cancer, AIS (non-invasive cervical cancer), CIN 3, VIN 2/3 and VaIN 2/3, and account for 50 percent of CIN 2 lesions. HPV 6 and 11 cause approximately 90 percent of genital wart cases. These four types of HPV also cause approximately 35 to 50 percent of all low-grade cervical, vaginal and vulvar lesions (CIN I, VIN I and VaIN I). There are an estimated 4.7 million abnormal Pap results that require follow-up each year in the United States. At least 3 million of these results are caused by some type of HPV. All four types cause abnormal Pap test results; the lesions caused by types 6 and 11 are clinically indistinguishable from pre-cancerous lesions caused by types 16 and 18.

"GARDASIL is a major health breakthrough - the first vaccine specifically designed to prevent cancer - and is approved to prevent not only cervical cancer but also genital warts," said Kevin Ault, MD, associate professor, Department of Gynecology and Obstetrics, Emory University School of Medicine, and clinical study investigator for GARDASIL. "Use of GARDASIL can help significantly reduce the human and economic burden of cervical cancer, precancerous or low-grade lesions and genital warts caused by HPV 6, 11, 16 and 18 in the United States, and the rest of the world, in this generation and future generations." In clinical studies, GARDASIL prevented 100 percent of HPV 16- and 18 -related cervical cancer in women not previously exposed to the relevant HPV types

The efficacy of GARDASIL, which includes results from an HPV-16 prototype of GARDASIL, was evaluated in four placebo-controlled, double-blind, randomized Phase II and Phase III clinical studies. Together, the Phase II and III studies evaluated 20,541 women aged 16 to 26 years. Study participants were followed for up to five years after enrollment.

The studies' primary analyses were conducted in women who received all three vaccinations within one year of enrollment, did not have major deviations from the study protocol and were naive to the relevant HPV type(s) prior to dose one and through one month post-dose three (Month 7). Efficacy was studied in the individual studies and in combined analyses and measured starting after the Month 7 visit. In the combined analyses:
  • Cervical Cancer: GARDASIL prevented 100 percent of HPV 16- and 18- related cervical pre-cancers and non-invasive cervical cancers (CIN 2/3, and AIS, or adenocarcinoma in situ). There were no cases in the 8,487 women who received GARDASIL compared to 53 cases in the 8,460 women who received placebo.

  • Cervical Intraepithelial Neoplasia (CIN): GARDASIL prevented 95 percent of low-grade cervical dysplasia (low grade lesions) and pre-cancers (CIN 2/3 or AIS) caused by HPV 6, 11, 16 or 18. There were 4 cases in the 7,858 women who received GARDASIL compared to 83 cases in the 7,861 women who received placebo.

  • Genital Warts: GARDASIL prevented 99 percent of cases of genital warts caused by HPV 6 or 11. There was one case in the 7,897 women who received GARDASIL compared to 91 cases in the 7,899 women who received placebo.
GARDASIL also prevented 100 percent of HPV 16- and 18-related vulvar and vaginal pre-cancers (VIN 2/3 or VaIN 2/3) in women not previously exposed to the relevant HPV types. There were no cases in the 8,641 women who received GARDASIL compared to 24 cases in 8,667 women who received placebo. VIN 2/3 and VaIN 2/3 are the immediate precursors to vulvar and vaginal cancers.

These studies also showed that administration of GARDASIL to women who are already infected with one or more vaccine related HPV types prior to vaccination protects them from clinical disease caused by the remaining vaccine types but may not alter the course of an infection that is already present.

GARDASIL was generally well tolerated

In all studies, GARDASIL was generally well tolerated and few subjects (0.1 percent) discontinued due to adverse events. Vaccine-related adverse experiences that were observed in clinical trials at a frequency of at least 1.0 percent among recipients of GARDASIL and also greater than those observed among recipients of placebo, respectively, were pain (83.9 percent vs. 75.4 percent), swelling (25.4 percent vs. 15.8 percent), erythema (24.6 percent vs. 18.4 percent), fever (10.3 percent vs. 8.6 percent), and pruritis (3.1 percent vs. 2.8 percent). Most injection-site reactions were reported to be mild to moderate in intensity.

Bridging the efficacy of GARDASIL from young adults to young adolescents

Prior vaccination strategies have shown that the ideal time to administer any vaccine is before exposure to the infection. Adolescents are an important group to vaccinate against HPV - one in four people ages 15 to 24 are infected with HPV. In addition, in a survey of 525 mothers with children as young as 11 years, up to 80 percent of mothers said they would allow their daughters to receive a vaccine that helps protect against cervical cancer.

Merck studied the anti-HPV 6, -11, -16 and -18 immune responses for GARDASIL in 10-to 15-year-old girls compared to those in 16- to 23-year-old adolescent and young adult women. Among the study participants who received GARDASIL, the immune responses (geometric mean titers, GMTs) in 10- to 15-year-old girls were similar to those in 16- to 23-year-old women. Similar outcomes were observed in a comparison of immune responses among 9- to 15-year- old girls to immune responses in 16- to 26-year-old adolescents and females. Based on these analyses, the FDA approved GARDASIL for use in adolescent girls ages 9 to 15.

Studies examine impact of GARDASIL in the general population

A secondary analysis to assess the potential impact of GARDASIL on rates of cervical cancer and other HPV-related diseases on the general population was also conducted. This analysis included all women regardless of whether they were infected with HPV prior to vaccination, developed an infection after the start of vaccination and those who may not have completed the 3-dose vaccination. In this analysis, GARDASIL reduced the risk for development of cervical pre-cancerous lesions and cervical cancer caused by HPV types 16 and 18 by approximately 40 percent in just two to four years. Genital warts (related to type 6, 11, 16 and 18), which develop more quickly than cervical cancer and pre-cancerous lesions, were reduced by almost 70 percent. Virtually all of the cases of CIN and genital warts seen in subjects who received GARDASIL resulted from infections that were present when the women received their vaccination.

Dosage and administration for GARDASIL

GARDASIL should be administered in three separate intramuscular injections in the upper arm over a six-month period. The following dosage schedule is recommended: first dose at elected date, second dose two months after the first dose and the third dose six months after the first dose.

Selected important information about GARDASIL

GARDASIL is contraindicated in individuals who are hypersensitive to the active substances or to any of the excipients of the vaccine.

As with any vaccine, vaccination with GARDASIL may not result in protection in all vaccine recipients. GARDASIL is not intended to be used for treatment of active genital warts; cervical cancer; CIN, VIN, or VaIN. GARDASIL has not been shown to protect against disease due to non-vaccine HPV types. The health-care provider should inform the patient, parent, or guardian that vaccination does not substitute for routine cervical cancer screening. Women who receive GARDASIL should continue to undergo cervical cancer screening per standard of care.

Pricing and CPT information

The catalog price for GARDASIL is $120 per dose. Health economic models that Merck has presented show that vaccination with GARDASIL to reduce the incidence of cervical cancer, cervical intraepithelial neoplasia (CIN) and genital warts caused by HPV types 6, 11, 16 and 18 is likely to be cost-saving in the approved age ranges. Used in conjunction with screening, GARDASIL can help significantly reduce the human and economic burden of cervical cancer and other HPV-related diseases in the United States.

GARDASIL is available for ordering. The American Medical Association has established a Current Procedural Terminology (CPT)® code of "90649". CPT codes allow for the identification and potential reimbursement of existing common procedures, services and products' new and emerging technologies, as well as the collection of data to facilitate performance measures.

Merck has created a new patient assistance program for vaccines. Through this new program, Merck will provide free vaccines to adults who are uninsured and who are unable to afford vaccines. Merck vaccines, including GARDASIL, will become available through this program in the third quarter of 2006.

Worldwide Availability of GARDASIL

On June 1, GARDASIL was approved in Mexico. Applications for GARDASIL are currently under review with regulatory agencies on five continents, including but not limited to agencies in Argentina, Australia, Brazil, the European Union, New Zealand, Singapore and Taiwan. Additionally, Merck is actively working to accelerate the availability of GARDASIL in the developing world: in December, Merck announced a partnership with India's Council of Medical Research to study GARDASIL. Merck is also working with PATH and the Gates Foundation to develop HPV vaccination programs that will facilitate introduction of GARDASIL to the most impoverished nations.

Other Information

In 1995, Merck entered into a license agreement and collaboration with CSL Limited relating to technology used in GARDASIL. GARDASIL also is the subject of other third-party licensing agreements.

GARDASIL is the third new Merck vaccine to be approved by the FDA in 2006: ROTATEQ® received FDA approval in February to prevent rotavirus gastroenteritis, a leading cause of severe infant diarrhea, and ZOSTAVAX® was approved by the FDA and in the European Union in May to prevent shingles in adults 60 and older. Other regulatory agencies around the world are reviewing applications for GARDASIL, ROTATEQ and ZOSTAVAX.

About HPV Disease

In the United States, approximately 20 million people are infected with HPV, and approximately 80 percent of females will have acquired HPV by age 50. For most people, HPV goes away on its own; however in some, certain high-risk types of HPV, if unrecognized and untreated, can lead to cervical cancer. In the United States, approximately 10,000 women are diagnosed with cervical cancer every year, and an average of 10 women die each day from the disease. Cervical cancer is the second most common cause of cancer death in women worldwide, resulting in nearly a half-million diagnoses and 240,000 deaths each year. In addition, certain low-risk types of HPV cause genital warts and can lead to abnormal Pap results. Approximately 1 million cases of genital warts occur each year in the United States and an estimated 32 million cases occur worldwide. Additionally, there are an estimated 4.7 million abnormal Pap results that require follow-up each year in the United States. At least 3 million of these results are caused by some type of HPV. HPV related disease, including screening, follow-up and treatment, costs about $5 billion per year in the U.S. Used in conjunction with screening, GARDASIL can help significantly reduce the human and economic burden of cervical cancer and other HPV-related diseases in the United States.

About Merck

Merck & Co., Inc. is a global research-driven pharmaceutical company dedicated to putting patients first. Established in 1891, Merck currently discovers, develops, manufactures and markets vaccines and medicines to address unmet medical needs. The Company devotes extensive efforts to increase access to medicines through far-reaching programs that not only donate Merck medicines but help deliver them to the people who need them. Merck also publishes unbiased health information as a not-for-profit service. For more information, visit www.merck.com.

Forward-Looking Statement

This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements are based on management's current expectations and involve risks and uncertainties, which may cause results to differ materially from those set forth in the statements. The forward-looking statements may include statements regarding product development, product potential or financial performance. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Merck's business, particularly those mentioned in the cautionary statements in Item 1 of Merck's Form 10-K for the year ended Dec. 31, 2005, and in its periodic reports on Form 10-Q and Form 8-K, which the Company incorporates by reference.

Full prescribing information and patient product information for GARDASIL® will be available at www.GARDASIL.com.

GARDASIL®is a registered trademark of Merck & Co., Inc., Whitehouse Station, N.J., U.S.A.


Source: Merck

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