Merck & Co’s bid to market its human papillovirus vaccine Gardasil for older women has received another setback after US regulators demanded longer-term clinical data.
The US Food and Drug Administration has issued a second complete response letter regarding the New Jersey-based major’s supplemental biologics license application for the use of Gardasil in women ages 27 through to 45. The vaccine is currently approved for the prevention of cervical cancer and genital warts in females aged between nine and 26.
The FDA has completed its review of the response that Merck provided in July to the first letter and has now recommended that the company submit additional data when a 48-month study has been completed. The initial sBLA included data collected through an average of 24 months from enrollment into the study.
Merck, which anticipates providing a response to the agency in the fourth quarter of this year, stressed that the FDA letter does not affect the use of Gardasil in the approved age group, or the application filed with the agency in December to expand use to men. The company also reiterated its 2009 group sales forecast of $23.7-$24.2 billion.
Commenting on the FDA’s decision, Sanford Bernstein analyst Tim Anderson issued an investor note saying that “Gardasil’s efficacy drops sharply once females have been exposed to HPV and this is probably the genesis of the problem with the older female population that Merck has been pushing for in this new application”. He added that even if the jab is approved for older women, insurers may not be prepared to cover it.
Galapagos deal could be worth over 230 million euros
Meantime, Merck has signed a deal with Belgium’s Galapagos to develop new treatments for obesity and diabetes. Under the terms of the multi-year alliance, Merck is making an upfront payment of just 1.5 million euros, but Galapagos will be eligible to receive discovery, development and regulatory milestones that could potentially exceed 170 million euros.
Galapagos chief executive Onno van de Stolpe, said that the agreement demonstrates his firm’s ability to expand into new therapeutic areas. He added that the company “has a proven track record of delivering on its alliance programs, making us attractive to potential pharma partners seeking to fill their pipelines with medicines based on novel modes of action”.
Mr van de Stolpe went to say that “this early stage alliance with Merck fits nicely into our alliance infrastructure as other programmes advance into later stages”. Investors seemed impressed and Galapagos shares were up nearly 5% to 4.85 euros.
