Updated on 31 October 2014
Pfizer's vaccine will be the first meningitis vaccine to be marketed in the US(PC: free digitalphotos.net)
Singapore: The toe-to-toe battle between Pfizer and Novartis is not new to the pharma industry. The drug giants were racing to win the federal approval to first market their meningitis B vaccines in the US soil. Both the drug makers had won the FDA's coveted ‘breakthrough drug' status for their novel discovery at the beginning of the year. However, Pfizer seems to have won with the battle, with the regulator flashing a green light to its novel vaccine candidate(Trumenba) that provides protection against meningococcal serogroup B.
Earlier in June this year, both the companies had announced the submission of their applications with the FDA. The regulator had also expedited the review process amid two major outbreaks of meningitis in college campuses in the US. Mr Karun Midthun, director of the FDA's Center for Biologics Evaluation and Research, said in a statement, "The recent meningitis outbreaks raised concerns for this deadly disease. The FDA's approval of Trumenba provides a safe and effective way to help prevent this disease in the United States."
Many analysts have considered Pfizer's vaccine as one of the blockbuster drugs in its kitty that can offer the greatest potential profits for the pharmaceutical giant. Novartis's vaccine(Bexsero) was already available in Europe and many other countries. Though not marketed in the US, around 30,000 doses of vaccine was shipped last winter to students at Princeton University and the University of California, Santa Barbara, in response to local meningitis B outbreaks on both campuses. Hence Bexsero already had an advantage with the FDA, as the investigational doses exhibited high safety and tolerability upon administration in an estimated 10,000 people.
Thus, it was expected that Novartis's vaccine will enjoy the market share, however Pfizer's impressive phase II results helped the drug maker sail through the FDA approval. Nevertheless, the news is bad for GlaxoSmithKline who is all set to acquire Novartis's non-flu vaccine business in a whopping $7.1bn deal. The deal is expected to close by mid-2015. Pfizer is strongly working to strengthen its vaccine arm. If reports are to be believed the company has contending with GSK, Sanofi and Novartis to develop a Staphylococcus aureus vaccine that is estimated to be a $4 bn market.