Novartis lands EU approval of Bexsero – By Alison Bryant

Novartis (NVS) nabbed EU (European Union)  approval of  Bexsero, a meningitis B vaccine the company has been banking on to bolster its lagging vaccine unit.

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Novartis dropped $7.5 billion to acquire Chiron and its vaccine candidates to create the unit. But since then, sales have fallen far below expectations, and years of delays raised concerns that Bexsero would flop.  

Analysts put the European Bexsero market between $600 million and $700 million, Reuters reports, which may help offset coming patent losses. Zometa, with estimated global sales of $1.26 billion last year, and Reclast, with estimated global sales of $612 million last year, both fall off patent in March. Novartis will likely take the biggest hit, though, from Diovan, which went off patent in September. Diovan and Diovan HCT together brought in $5.67 billion in 2011.

„We are proud of the major advance that Novartis MenB vaccine represents within the field of vaccine development against what up until now has been a very challenging disease target,“ Rino Rappuoli, global head of vaccines research, Novartis Vaccines and Diagnostics, told FierceVaccines. „The CHMP positive opinion has been an incredible step forward in the fight against meningitis.“

Bexsero is the first vaccine to combat meningococcus B bacteria, which can cause brain damage, hearing loss and death. The World Health Organization estimates that 170,000 people die worldwide each year from meningitis.

„Each year, thousands of parents see their children die or left with severe disabilities as a result of this devastating disease,“ Andrin Oswald, division head of Novartis Vaccines and Diagnostics, said in a statement. „Through the combined efforts of many people over two decades, we are closer than ever to seeing an end to this suffering. Our vision is a world without meningitis, and our priority is to work with decision makers across Europe to ensure there is broad and timely access to vaccination.“

Of the big 5 vaccine players–GlaxoSmithKline  ($GSK), Sanofi ($SNY), Pfizer (PFE), Merck (MRK) and Novartis–Novartis is expected to experience the largest growth through 2018, according to EvaluatePharma. Bexsero and Menveo will contribute to a boost estimated to land Novartis vaccine sales at $3.14 billion by 2018.


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