Human papillomavirus (virus like particle, 9-valent) vaccine is under clinical development by Merck and currently in Phase II for Human Papillomavirus Infections. According to GlobalData, Phase II drugs for Human Papillomavirus Infections have a 19% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how Human papillomavirus (virus like particle, 9-valent) vaccine’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.
GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.
Human papillomavirus (virus like particle, 9-valent) vaccine overview
Human papillomavirus [types 6, 11, 16, 18, 31, 33, 45, 52, 58] (9-valent) vaccine (Gardasil 9/ Silgard 9) is a non-infectious recombinant 9-valent vaccine prepared from the purified virus-like particles, formulated as suspension for intramuscular route of administration. Gardasil 9 is indicated for active immunisation of individuals from the age of 9 years against premalignant lesions and cancers affecting the cervix, vulva, vagina and anus caused by HPV types and genital warts (Condyloma acuminata) caused by specific HPV types. Gardasil 9 indicated following precancerous or dysplastic lesions caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 : cervical intraepithelial neoplasia (CIN) grade 2/3 and cervical adenocarcinoma in situ (AIS), cervical intraepithelial neoplasia (CIN) grade 1, vulvar intraepithelial neoplasia (VIN) grade 2 and grade 3, vaginal intraepithelial neoplasia (VaIN) grade 2 and grade 3, anal intraepithelial neoplasia (AIN) grades 1, 2, and 3, indicated in boys 9 through 15 years of age for the prevention of the following diseases: anal cancer caused by HPV types 16, 18, 31, 33, 45, 52, and 58, genital warts (condyloma acuminata) caused by HPV types 6 and 11 And the following precancerous or dysplastic lesions caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58 : anal intraepithelial neoplasia (AIN) grades 1, 2, and 3. Gardasil 9 is also indicated for use in males 16 through 26 years of age, for the prevention of anal cancer caused by HPV types 16, 18, 31, 33, 45, 52 and 58, precancerous or dysplastic lesions caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58, and genital warts caused by HPV types 6 and 11. Gardasil 9 is approved to include a 2-dose regimen for individuals 9 through 14 years of age, and for the prevention of human papillomavirus (HPV) associated cancers including oropharyngeal cancer, head and neck cancers caused by vaccine-type HPV in females and males 9 through 45 years of age.
The vaccine candidate is under development for the prevention human papillomavirus associated cancer including anal dysplasia, penile cancer and human papillomavirus infections. The drug candidate is administered through intramuscular route. It is a new molecular entity (NME).
Merck overview
Merck is a biopharmaceutical company with focus on the discovery, development, manufacturing and marketing of prescription medicines, biologic therapies, vaccines, and animal health products. It offers prescription products for the treatment of cardiovascular conditions, cancer, immune disorders, infectious and respiratory diseases, and diabetes, among others. The company provides animal health products such as vaccines, poultry products, livestock products and aquaculture products. Merck sells medicines to drug wholesalers, retailers, hospitals, government agencies and managed health care providers; and animal health products to veterinarians, distributors, and animal producers. The company and its subsidiaries operate in the Americas, Europe, the Middle East, Africa, Asia Pacific, and Latin America. Merck is headquartered in Rahway, New Jersey, the US.
For a complete picture of Human papillomavirus (virus like particle, 9-valent) vaccine’s drug-specific PTSR and LoA scores, buy the report here.
Data Insights
From
The gold standard of business intelligence.
Blending expert knowledge with cutting-edge technology, GlobalData’s unrivalled proprietary data will enable you to decode what’s happening in your market. You can make better informed decisions and gain a future-proof advantage over your competitors.
GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.
GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.
