Merck's investigational, 9-valent HPV vaccine has the potential to block about 90% of invasive cervical cancer cases worldwide, new research shows. But getting there will be no walk in the park. First, the company will have to solve some uptake problems that have been plaguing the candidate's predecessor, Gardasil, since it rolled out in 2006.
The debate around use of Merck's Gardasil in the United Kingdom is ratcheting up ahead of a meeting of the Joint Committee on Vaccinations and Immunisation (JCVI) in October.
Using a gene-editing method, investigators were able to delete certain genes in the human papillomavirus, prompting cancer-causing cells to self-destruct. The antiviral technique could be replicated to target other DNA-based viruses like hepatitis B and herpes simplex, researchers say.
Though Merck's Gardasil tops the company's best-selling vaccines list and has already achieved blockbuster sales, the drug giant has a long way to go if it wants to boost U.S. immunization rates against human papillomavirus.
Worries over Gardasil's safety are just one of the issues that have hampered uptake of Merck's best-selling vaccine for HPV. But now, a study published in JAMA says patients need not worry about an increased risk of deadly blood clots.
Gardasil may be the No. 2-selling vaccine in the world, but its marketers have struggled against a variety of barriers to get it where they want it in terms of uptake. Now, a new anal cancer indication in Europe may help with that goal.
Back in 2012, the GAVI Alliance announced plans to help immunize 30 million girls in 40 countries with HPV vaccines by 2020. Wednesday, the Children's Investment Fund Foundation chipped in toward that goal with a $25 million investment that will be matched through the U.K.'s Department of International Development.
New York's Provista Diagnostics expanded a licensing deal for biomarker and autoantibody technology developed at Arizona State University--concepts first spotted at Harvard Medical School and the Dana-Farber Cancer Institute.
Roche has won FDA approval for its HPV test used for primary screening of cervical cancer. The regulatory nod is expected to increase the company's profile in the U.S. and grow its 20% share of the global diagnostics markets.
Cepheid booked much higher sales during its fiscal 2014 first quarter and successfully launched new HPV and norovirus molecular diagnostic tests outside of the U.S. But the California company faced a net loss as it dealt with higher overall costs and continued to work through restructuring.