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Merck & Co., Inc. (MRK) Receives Approval to Market GARDASIL(R), ZOLINZA(R) and CUBICIN(R) in Japan


7/1/2011 6:58:47 AM

WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)-- Merck (NYSE:MRK - News), known as MSD outside the United States and Canada, announced today that the Japanese Ministry of Health, Labour and Welfare (MHLW) approved three products - GARDASIL® [Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant], ZOLINZA® (vorinostat) and CUBICIN® (daptomycin for injection) – for use in Japan.

“These three new approvals will enable Merck to bring these new medicines and vaccines to the people of Japan,” said Tony Alvarez, president, MSD Japan. "Doing so will help Merck continue to fulfill its mission and deliver growth."

In Japan, GARDASIL, a quadrivalent human papillomavirus (HPV) vaccine, was approved for the prevention of cervical cancer (squamous cell cancer and adenocarcinoma) and their precursor lesions (cervical intraepithelial neoplasm grade 1/2/3 and cervical adenocarcinoma in situ), vulvar intraepithelial neoplasia grade 1/2/3, vaginal intraepithelial neoplasia grade 1/2/3 and genital warts caused by HPV types 6, 11, 16 and 18 in females 9 years of age and older.

ZOLINZA is an oral anticancer drug and was approved in Japan for the treatment of cutaneous T-cell lymphomas. As the result of a distribution agreement signed in 2011, Taiho Pharmaceutical Co., Ltd. will promote and distribute ZOLINZA in Japan.

CUBICIN is an antibacterial agent with activity against methicillin-resistant Staphylococcus aureus (MRSA) and was approved in Japan for the treatment of MRSA infections. Under a licensing agreement signed in 2007 between Merck and Cubist, MSD obtained the rights for development and distribution of CUBICIN in Japan. CUBICIN is marketed in the United States by Cubist Pharmaceuticals.

Important information about GARDASIL

GARDASIL is approved in the United States for use in girls and young women 9 through 26 years of age for the prevention of cervical, vulvar, vaginal and anal cancers caused by HPV types 16 and 18; genital warts caused by HPV types 6 and 11; and precancerous or dysplastic lesions caused by HPV types 6, 11, 16 and 18. GARDASIL is also approved in the United States for use in boys and men ages 9 through 26 years of age for the prevention of anal cancer caused by HPV types 16 and 18, for the prevention of anal dysplasias and precancerous lesions caused by HPV types 6, 11, 16 and 18, and the prevention of genital warts caused by HPV types 6 and 11.

GARDASIL is not approved in the United States for use in women older than 26 years of age.

GARDASIL does not eliminate the necessity for women to continue to undergo recommended cervical cancer screening. Recipients of GARDASIL should not discontinue anal cancer screening if it has been recommended by a health care provider.

GARDASIL has not been demonstrated to provide protection against diseases from vaccine and non-vaccine HPV types to which a person has previously been exposed through sexual activity.

GARDASIL is not intended to be used for treatment of active external genital lesions; cervical, vulvar, vaginal and anal cancers; cervical intraepithelial neoplasia, vulvar intraepithelial neoplasia, vaginal intraepithelial neoplasia, or anal intraepithelial neoplasia.

GARDASIL has not been demonstrated to protect against disease due to HPV types not contained in the vaccine.

Not all vulvar, vaginal and anal cancers are caused by HPV, and GARDASIL protects only against those vulvar, vaginal and anal cancers caused by HPV Types 16 and 18.

Select safety information for GARDASIL

GARDASIL is contraindicated in individuals with hypersensitivity, including severe allergic reactions to yeast, or after a previous dose of GARDASIL.

Because vaccinees may develop syncope, sometimes resulting in falling with injury, observation for 15 minutes after administration is recommended. Syncope, sometimes associated with tonic-clonic movements and other seizure-like activity, has been reported following vaccination with GARDASIL. When syncope is associated with tonic-clonic movements, the activity is usually transient and typically responds to restoring cerebral perfusion.

GARDASIL is not recommended for use in pregnant women.

The most common adverse reaction was headache. Common adverse reactions that were observed among recipients of GARDASIL at a frequency of at least 1.0 percent and greater than placebo were: fever, nausea, dizziness; and injection-site pain, swelling, erythema, pruritus and bruising.

Dosage and administration for GARDASIL

GARDASIL is a ready-to-use, three-dose, intramuscular vaccine. GARDASIL should be administered in three separate intramuscular injections in the deltoid region of the upper arm or in the higher anterolateral area of the thigh. 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.

Important information about ZOLINZA

ZOLINZA is indicated in the United States for the treatment of cutaneous manifestations in patients with cutaneous T-cell lymphoma who have progressive, persistent or recurrent disease on or following two systemic therapies.

The recommended dose of vorinostat is 400-mg once daily with food. Dose-related thrombocytopenia and anemia may require dose modification or discontinuation of therapy. Patients intolerant of the full dose may be given a reduced regimen of 300 mg/day, which can be further reduced as needed to 300 mg/day for 5 days/week. The FDA notes that vorinostat capsules should not be opened or crushed; direct contact with the powder should be avoided.

The most common adverse reactions (incidence =20%) are diarrhea, fatigue, nausea, thrombocytopenia, anorexia and dysgeusia. Antiemetics, antidiarrheals, and fluid/electrolyte replacement may be required to prevent dehydration due to gastrointestinal adverse events. Preexisting nausea, vomiting, and diarrhea should be adequately controlled prior to initiation of therapy.

Because of the risks for pulmonary embolism and deep vein thrombosis, patients (particularly those with a prior history of thromboembolic events) should be monitored for pertinent signs and symptoms. Prolongation of prothrombin time and international normalized ratio have been observed in patients receiving concomitant treatment with warfarin-derived anticoagulants; careful monitoring is advised in this setting.

Hyperglycemia has also been observed in vorinostat-treated patients; monitoring of serum glucose is therefore advised, particularly in diabetic or potentially diabetic patients. Adjustments to diet and/or hyperglycemia therapy may be required.

Although vorinostat has not been studied in pregnant women, animal data suggest that gestational use is linked to a risk for fetal harm.

Important information about CUBICIN

CUBICIN is approved in the United States and many other non-US markets as therapy for Staphylococcus aureus bloodstream infections (bacteremia), including right-sided endocarditis, caused by methicillin-resistant S. aureus (MRSA) and methicillin-susceptible S. aureus (MSSA), and complicated skin infections caused by certain Gram-positive bacteria, including MRSA. CUBICIN is not indicated for the treatment of pneumonia. Most adverse events reported in clinical trials were mild to moderate in intensity. The most common were anemia, constipation, diarrhea, nausea, vomiting, injection site reactions, and headache. To reduce the development of drug-resistant bacteria and maintain the effectiveness of CUBICIN, CUBICIN should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria susceptible to CUBICIN.

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 prescription medicines, vaccines, biologic therapies, and consumer care and animal health 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 policies, programs and partnerships. 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 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 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; the impact of pharmaceutical industry regulation and health care legislation; 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 United States 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 2010 Annual Report on Form 10-K and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).

Please see Prescribing Information for GARDASIL® at

http://www.merck.com/product/usa/pi_circulars/g/gardasil/gardasil_pi.pdf and Patient Information for GARDASIL® at

http://www.merck.com/product/usa/pi_circulars/g/gardasil/gardasil_ppi.pdf.

Please see Prescribing Information for ZOLINZA® at

http://www.merck.com/product/usa/pi_circulars/z/zolinza/zolinza_pi.pdf and Patient Information for ZOLINZA® at

http://www.merck.com/product/usa/pi_circulars/z/zolinza/zolinza_ppi.pdf

For full Prescribing Information for CUBICIN®, including important safety information, please visit www.cubicin.com/pdf/PrescribingInformation.pdf.

GARDASIL® and ZOLINZA® are registered trademarks of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Whitehouse Station, N.J., USA

All other brands are trademarks of their respective owners and are not trademarks of Merck & Co., Inc., Whitehouse Station, N.J., USA

Contact:

Merck & Co., Inc.Media:Pam Eisele, 908-423-5042Investors:Carol Ferguson, 908-423-4465




   

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