Sanofi Pasteur MSD GmbH

GARDASIL® 9, New HPV Vaccine from Sanofi Pasteur MSD Granted Positive Opinion by European Committee for Medicinal Products for Human Use

Lyon, France (ots/PRNewswire) - European Committee for Medicinal Products for Human Use (CHMP) granted

positive opinion for GARDASIL 9, the first 9-valent HPV vaccine

Sanofi Pasteur MSD today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted this week a positive opinion recommending the marketing authorisation for GARDASIL 9, a 9-valent HPV vaccine, for active immunization of females and males from the age of 9 years against premalignant lesions and cancers affecting the cervix, vulva, vagina and anus caused by vaccine HPV types and genital warts (Condyloma acuminata) caused by specific HPV types.

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The CHMP's positive opinion comes after the recent approval of GARDASIL 9 granted by the Food and Drug Administration (FDA, USA).

"We anticipate that, if approved, GARDASIL 9 will represent a major step forward in HPV prevention. GARDASIL 9 has the potential to help prevent over 80% of genital cancers caused by HPV and to reduce the transmission of the 9 HPV types" said Dr Jean-Paul Kress, President of Sanofi Pasteur MSD. "We are delighted that the CHMP has recommended marketing authorisation for GARDASIL 9 and we are looking forward to the European Commission decision," he concluded.

GARDASIL 9 includes the greatest number of HPV types in any available HPV vaccine. The seven high-risk HPV types in GARDASIL 9 (HPV 16, 18, 31, 33, 45, 52 and 58) cause approximately 90% of cervical cancer cases and approximately 80% of high-grade cervical lesions (cervical precancers, defined as CIN 2, CIN 3 and AIS) worldwide. The 2 remaining types, HPV 6 and 11, cause 90% of genital wart cases.

The CHMP opinion was granted following review of the results from a comprehensive clinical program that began in 2007 and included seven trials that evaluated more than 15,000 individuals in more than 11 countries.



Contact: Sylvia Martin-Jarrand, Sanofi Pasteur MSD, Tel:
+33-4-37-28-40-55, Mob: +33-6-74-85-19-63,

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