1. What is the Chemxpert database?

Chemxpert database is a techno-commercial information platform developed and operated by Lifescience Intellipedia Pvt. Ltd. Our data provides valuable insights regarding sourcing, marketing, development, and regulatory functions for the entire Lifescience industry. The different industries covered by our data encompass APIs, FDFs, pharma intermediates, paints, dyes, polymers, biotechnology, biochemical, food additives, nutraceuticals, etc.

2. How can I subscribe to the Chemxpert database?

You can gain access to the Chemxpert database after subscribing to it by visiting this link: - https://chemxpert.com/pricing

3. How many countries' data is available on your portal?

The Chemxpert database covers more than 200 countries. We are working in the direction of expanding our data coverage in more countries.

4. What are the different sources you use for obtaining information?

The different sources we use for data collection are as follows: - • Primary researc • DMF, ANDA, & CEP list • Conferences, Exhibitions, & Tradeshow • Company annual reports • DMF, ANDA, & CEP list • Subject matter experts & KOL survey. Apart from these, our other valuable sources include application-wise manufacturers list, subscribed and non-subscribed databases, corporate partners, US FDA Orange book, publicly available sources, industry associates, national statistics, regulatory websites, etc. You can gain access to the Chemxpert database after subscribing to it by visiting this link: -https://chemxpert.com/sources

5. What is the expected time for account activation?

Your Chemxpert account will be activated instantly if the payment is made through our website. If you choose to use RTGS, NEFT, or IMPS systems for payment, your account will be activated within 24 hours.

14 Mar 2024
Admin
News Article

Merck Plans to Begins Trial for HPV Vaccine & Gardasil 9

Merck to conduct trials of novel investigational multi-valent HPV vaccine and single-dose regimen for Gardasil 9

Merck, known as MSD outside of the United States and Canada, at the EUROGIN 2024 HPV Congress, announced plans to initiate clinical development of a new investigational multi-valent HPV vaccine designed to provide broader protection against multiple HPV types. Separately, the company also plans to conduct clinical trials in both females and males to evaluate the efficacy and safety of a single-dose regimen of Gardasil 9 (Human Papillomavirus 9-valent, recombinant), compared to the approved three-dose regimen.

Words from Merck

“Evidence continues to emerge showing the importance of Gardasil and Gardasil 9 to public health,” said Dr. Eliav Barr, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories. “These significant investments build upon our leadership and importantly provide the opportunity to further impact the global burden of certain HPV-related cancers and disease.”

Gardasil 9 Indicatcions

In the US, Gardasil 9 is indicated for use in females 9 through 45 years of age for the prevention of cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers caused by HPV Types 16, 18, 31, 33, 45, 52, and 58; cervical, vulvar, vaginal, and anal 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 also indicated for use in males 9 through 45 years of age for the prevention of anal, oropharyngeal and other head and neck cancers caused by HPV Types 16, 18, 31, 33, 45, 52, and 58; anal 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. The oropharyngeal and head and neck cancer indication is approved under accelerated approval based on effectiveness in preventing HPV-related anogenital disease. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. The confirmatory trial is ongoing.
Gardasil 9 is contraindicated in individuals with hypersensitivity, including severe allergic reactions to yeast, or after a previous dose of Gardasil 9 or Gardasil [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant].

Further Development

Merck vaccine researchers continue to build on the development of Gardasil and Gardasil 9 to identify new candidates with the potential to extend protection against a broader array of HPV types.
The latest addition to the pipeline employs the company’s proprietary virus-like particle (VLP) technology to incorporate additional VLPs for expanded HPV type coverage.
This includes several types known to have more impact in African and Asian populations and individuals of African and Asian descent.
First-in-human studies (phase 1) are scheduled to start in the fourth quarter of 2024.
Future trials for more clinical data
In response to calls from scientific leaders for more clinical data concerning alternative dosing regimens for Gardasil 9, Merck, pending regulatory input, plans to conduct two prospective clinical trials, one in females (16-26 years old) and one in males (ages 16-26 years old).
These randomized, double-blind, multi-year clinical trials will examine the short and long-term efficacy and immunogenicity of a single-dose of Gardasil 9 versus the currently approved three-dose regimen.
The goal of these large, randomized trials is to generate data that clearly determines whether or not a single dose of Gardasil 9 provides comparable long-term protection to the approved three-dose regimen, while also satisfying the high standards required by regulatory authorities.
The clinical trials are anticipated to start enrolling participants in the fourth quarter of 2024.
Investments for increased supply
To address the increasing global demand for Gardasil and Gardasil 9 and support broader and equitable access, Merck has made significant investments in manufacturing to help increase supply.
Starting in 2019, the company committed to expand manufacturing capacity by increasing production at existing plants as well as constructing new facilities.
Between 2017 and 2020 this resulted in a near doubling of supply which has subsequently been doubled again between 2020 and 2024.
Merck expects to supply sufficient quantities of HPV vaccines to meet anticipated demand for 2025 and will continue to expand our supply capacity in the future.

About Gardasil 9

Gardasil 9 is a vaccine indicated in females 9 through 45 years of age. Gardasil is a vaccine indicated in females 9 through 26 years of age.
Gardasil 9 is indicated for the prevention of cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers caused by human papillomavirus (HPV) Types 16, 18, 31, 33, 45, 52, and 58; and precancerous or dysplastic lesions caused by HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58.
Gardasil is indicated for the prevention of cervical, vulvar, vaginal, and anal cancers caused by HPV Types 16 and 18, and precancerous or dysplastic lesions caused by HPV Types 6, 11, 16, and 18. Both are indicated for the prevention of genital warts caused by HPV Types 6 and 11.
Gardasil 9 is indicated in males 9 through 45 years of age. Gardasil is indicated in males 9 through 26 years of age.
Gardasil 9 is indicated for the prevention of anal, oropharyngeal and other head and neck cancers caused by HPV Types 16, 18, 31, 33, 45, 52, and 58; and precancerous or dysplastic lesions caused by HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58.
Gardasil is indicated for the prevention of anal cancer caused by HPV Types 16 and 18, and precancerous or dysplastic lesions caused by HPV Types 6, 11, 16, and 18. Both are indicated for the prevention of genital warts caused by HPV Types 6 and 11.

The Gardasil 9 oropharyngeal and head and neck cancer indication is approved under accelerated approval based on effectiveness in preventing HPV-related anogenital disease. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.