Novartis Vaccine Wins Approval for Meningitis B

Novartis Vaccine Wins Approval for Meningitis B

November 19th, 2012 // 3:57 pm @ jmpickett

source

In a move that gives Novartis executives hope that they may yet compete in the global vaccines market, the European Medicines Agency has approved the first vaccine that is designed to combat meningitis B, which is the most common strain of meningococcal disease. The approval allows the vaccine to be used in people as young as two months of age.

The move is significant in different ways. For public health officials, the Bexsero vaccine provides a needed weapon against a disease that can kill quickly and leave survivors with severe disabilities, such as brain damage, hearing impairment or limb loss. And the highest rates occur in the first year of life. Until now, vaccines were available only for other strains.

“A licensed vaccine that would protect infants and young children from the B strain of the infection, which is the top of the list cause of bacterial meningitis, could lead to a decreased burden of this devastating disease,” Ulrich Heininger, a pediatrician at the Children’s Hospital in Basel, Switzerland, who specializes in infectious diseases, tells (The Wall Street Journal.

But approval, of course, is only the first step. The Novartis (NVS) vaccine must still be added to recommended vacccination programs by public health officials in various countries to generate widespread usage and, subsequently, become a commercial success. These placements help determine coverage by payers.

“Will Bexsero secure these endorsements from public health agencies or face an easy time with payers? We won’t know for some time yet, but in our view this continues to seem unlikely,” wrote Sanford Bernstein analyst Tim Anderson in an investor note two days before the approval was issued by the EMA’s Committee for Medicinal Products for Human Use (here is the statement).

“While meningitis B is a very serious disease where mortality is high, its incidence has been waning for a number of years now, tilting the risk:benefit equation in the wrong direction. If the disease occurs only rarely, then it may not make sense to administer the vaccine broadly as a preventive measure.”

Meanwhile, in the key US market, Novartis has not yet been approved and Anderson notes that Novartis is deciding whether to mix Bexsero with another vaccine – the drugmaker already sells the Menveo vaccine that combats other strains – instead of as a stand-alone product. He added that the decision has taken longer than planned.

The drugmaker has been hoping that Bexsero will make it possible to compete with Merck (MRK), GlaxoSmithKline (GSK) and Sanofi (SNY) in the global vaccine market. “This is a very important milestone through which we are showing we’re able to deliver on innovation,” Andrin Oswald, who heads the Novartis vaccines division, tells the Journal. “I believe we’re making good progress in building the business.”

But the unit may be sold if further progress does not materialize, accoridng to Anderson, who notes that the business been struggling to break even. For now, he sees EMA approval has a “small win,” and forecasts just $700 million in annual sales by 2020.