Vaccine manufacturer Novartis likely not to benefit from emergency deal with Princeton| Nov 19, 2013
The commercial success of Bexsero — the vaccine made by Swiss pharmaceutical company Novartis that will be offered to Princeton students in December and is not yet licensed for use in the United States — is crucial for the future of the company’s vaccine department, according to a review of financial disclosure forms.
But whether Novartis will reap benefits from the University’s emergency use of Bexsero remains uncertain. Experts said its use will most likely not speed its United States licensing process through the U.S. Food and Drug Administration.
The vaccine is being offered in an emergency effort, at the University’s cost, to curb an outbreak of meningitis that has affected six students and one campus visitor since March. Although state law requires students to be vaccinated against the disease, vaccines licensed in the United States only cover meningitis types A, C, Y and W-135. This outbreak is of type B.
New York-based pharmaceutical company Pfizer currently has a meningitis B vaccination that is in the later stages of FDA approval but has not yet obtained licensure anywhere else. Although Pfizer was included in the Centers for Disease Control's discussions with Princeton, which began over the summer, the fact that the company's vaccine had not yet been licensed anywhere weighed on the minds of health authorities.
"To us, the threshold that seemed reasonable for everybody's comfort level was to have a vaccine that was licensed somewhere," said CDC meningitis branch head Tom Clark. "The Pfizer vaccine isn't licensed anywhere yet."
Bexsero received licensure in the European Union on Jan. 22. Following its approval,Novartis Chief Executive Officer Joseph Jimenez highlighted the achievement in a financial results report for current and future investors.
“Vaccines and diagnostics performance improved [in 2012] and achieved a key approval for Bexsero in the EU,” he was quoted as saying in the quarterly report.
The Vaccines and Diagnostics Division brought in $1.9 billion in income in 2012 and represented 3.3 percent of Novartis’ income, according to the company’s 20-F form, which is submitted annually to the Securities and Exchange Commission by foreign companies publicly traded in the United States.
Still, the Novartis vaccine division reported an operational loss of $250 million that year. The loss was attributed to “lower sales and the manufacturing ramp-up for upcoming launches of Bexsero.”
Currently, vaccines against meningococcal diseases are at the heart of the Novartis’ vaccine division. These include mainly Menveo, a vaccine licensed in the United States that protects against the four other types of meningitis, and Bexsero. Were they not to succeed in the market, they could jeopardize the future of the division, according to the company's 2012 20-F form.
“[Menveo and Bexsero] products are the primary products in the Vaccines and Diagnostics Division's pipeline,” the form reads. “If these efforts by our Alcon and Vaccines and Diagnostics Divisions do not bear significant fruit, they could have a material adverse effect on the medium to long-term success of the divisions, and of the Group as a whole.”
Novartis was already working on getting Bexsero licensed in the United States when the University announced it would offer the vaccine to students on Monday.Novartis spokeswoman Julie Masow said the company has filed an Investigational New Drug application with the FDA, although it has yet to reach an agreement with the agency on a pathway to licensure.
Under the just-announced vaccination plan, thousands of doses will be imported into the United States to be distributed exclusively to Princeton undergraduates, graduate students and other community members with conditions that predispose them to meningitis. But it is unlikely this deal will result in an easier path towards a U.S. license.
“I would be surprised,” said Paul Offit, a professor of vaccinology at the University of Pennsylvania Perelman School of Medicine and a former member of the Advisory Committee on Immunization Practices to the CDC, of the potential licensing benefits. “The FDA sort of answers to its own drum."
Offit explained that Princeton’s case was a “compassionate use response” — which the FDA defines as the use of an investigatory drug outside of a clinical trial for patients with no alternative — and its results would not count as research that the FDA could take into account in Bexsero's existing licensing process.
Similarly, Robert Daum, current chairman of the FDA’s Vaccine Advisory Committee and professor at the University of Chicago's Pritzker School of Medicine, said he thought that the emergency import wouldn’t facilitate licensure.
“I wouldn’t expect that because there is an outbreak on one of many campuses in the United States and because the vaccine has been made available to people on a volunteer basis that it will influence the decision to license it much,” he said.
Daum said that his current position entails three to four advisory meetings a year and that he was not consulted during the decision process regarding Princeton’s case.
While there is currently no licensed meningitis B vaccine in the United States, Novartis’ Bexsero is not the only vaccine seeking licensure from the FDA.
Pfizer's meningitis type B vaccine is currently in phase three of the FDA's licensing process.
Dean Mastrojohn, a Pfizer spokesman, confirmed that the CDC had included Pfizer in the discussions with Princeton, although he did not disclose whether its vaccine had been considered for the emergency vaccination program.
Mastrojohn added that phase two of Pfizer’s vaccine clinical program evaluated more than 6,000 healthy teenagers between the ages of 11 and 18 and said that the “vast majority of participants ... had an immune response" to meningitis B.
But for professor of molecular biology and public affairs Adel Mahmoud, also a former president of Merck Vaccines, the Pfizer product was never an option because the drug being developed has not passed a test of licensure anywhere in the world.
"There is no Pfizer vaccine,” Mahmoud said. “It is a phase-three study. It is basically a candidate vaccine. It has to be proven first that it works."