Sticking Point: Novartis Menveo Vaccine Delayed By FDA Request for Info
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Novartis has suffered yet another setback over Menveo, its meningococcal meningitis vaccine, thanks to an FDA request for additional information about unspecified clinical and manufacturing issues
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Novartis has suffered yet another setback over Menveo, its meningococcal meningitis vaccine, thanks to an FDA request for additional information about unspecified clinical and manufacturing issues. In a July 1 announcement, the drug maker expressed confidence that it will be able to respond to all of the agency's questions "fully" in 2009, although the exact timing was not clear. And Novartis also made a point of noting that the FDA did not require any new clinical trials. Nonetheless, the requests made in FDA's "complete response" letter mean that approval for Menveo, which targets four strains of meningococcal meningitis - A, C, W-135 and Y - will be delayed until at least late 2009 or early 2010. Meningococcal meningitis is characterized by bacteria that infect the thin membrane surrounding the brain and spinal cord. Up to 14 percent of cases are believed to be fatal, typically within 24 to 48 hours. Novartis filed a Biologics License Application for Menveo (MenACWY-CRM) in August 2008 for patients ranging from 11 to 55 years old. Studies are also under way in infants and children, which means the novel vaccine may eventually become the first of its kind to cover nearly an entire lifespan. Shortly before its filing, Novartis held presentations for Wall Street in which Menveo was touted as a potential blockbuster. Several analysts promptly agreed and responded by projecting the vaccine, as well as a meningitis B vaccine to come later, would eventually generate anywhere from $1.5 billion to $3.8 billion annually over the next few years (See "Novartis Bets Big on Meningitis: Wall Street Awaits Blockbuster Vaccine Franchise," 1 (Also see "Novartis Bets Big on Meningitis:Wall Street Awaits Blockbuster Vaccine Franchise" - Pink Sheet, 1 Jun, 2008.),). Those big dollars are significant for Novartis, which is working to offset income that will be lost when patents protecting its Diovan (valsartan) heart drug begin to expire in 2012. Equally importantly, the success of Menveo and the meningitis B vaccine will be a test of the big bet Novartis made on the vaccines market three years ago by purchasing Chiron for $5.6 billion. That move catapulted the drug maker into a head-to-head competition with Sanofi-Aventis, which sells the Menactra (meningococcal (groups A, C, Y and W-135 polysaccharide diphtheria toxoid conjugate) vaccine that is also used to prevent meningococcal meningitis. Last year, Menactra generated about $570 million in net sales, an increase of 7.9 percent The looming battle, in fact, may shape up to resemble the rivalry between Merck and GlaxoSmithKline, both of which sell vaccines - Gardasil (human papillomavirus quadrivalent (types 6, 11, 16 and 18) vaccine, recombinant) and Cervarix (human papillomavirus (types 16 & 18) vaccine, recombinant, adjuvanted) , respectively - to combat the human papillomavirus that can cause cervical cancer. Just last week, Novartis planned to challenge Sanofi-Aventis by releasing new data indicating Menveo provides a long-term immune response in more adolescents than Menactra. In a blurb sent to the media, the drug maker described the new data as "significant, because it shows a greater proportion of adolescents maintained a functional immune response lasting up to 2 years in three out of four meningococcal serogroups with Menveo compared with Menactra." Novartis noted that the data had been presented at the June 2009 meeting of the Advisory Committee on Immunization Practices, or ACIP, which issues vaccine recommendations. But the drug maker scuttled the release of the data at the last minute without explanation. For now, though, Novartis must first concentrate on satisfying the FDA. The latest disclosure, in fact, comes just five months after the FDA told Novartis to add 1,500 infants to its safety database in an ongoing Phase III study being used to evaluate the vaccine in infants and children between the ages of two months and 10 years. At the time, Andrin Oswald, the chief executive for the Novartis Vaccines and Diagnostics division, attributed the request to a safety standard that was conveyed by the FDA, but not mentioned in prior discussions. The requirement will delay a U.S. filing for the pediatric population to 2011 (2 (Also see "Novartis Needs A Bigger Safety Database For Menveo, FDA Says" - Pink Sheet, 29 Jan, 2009.)). - Ed Silverman ([email protected]) |