Novartis' Bexsero wins U.K. recommendation in government U-turn

Going into 2014 Novartis ($NVS) said this was the year Bexsero, the great hope of its struggling vaccine unit, would begin to generate significant sales. Exactly how significant depends on whether governments agree to pay for the vaccine, and in this regard Novartis received a big boost this week. Britain could begin vaccinating all babies with Bexsero as early as this summer.

The Joint Committee on Vaccination and Immunisation (JCVI) decision to add the meningitis B vaccine to the childhood vaccination schedule comes 8 months after its interim report rejected the vaccine. In the months following the interim decision, Novartis, meningitis charities and the medical community have all given JCVI further evidence. JCVI says this evidence led it to reverse its previous decision that the benefits of the vaccine wouldn't justify the price, which is $120 a dose in the private sector. The British Department of Health is now trying to negotiate a "cost-effective price" with Novartis.

Assuming the parties can reach an agreement, Britain could begin offering Bexsero to all babies at two months of age from this summer. In 2011-12, 813,200 births were recorded in Britain, a big enough population to put Novartis on track to fulfil its prediction of significant sales this year. The British decision--coupled with the possibility of approval in the U.S.--means Novartis' vaccine unit looks in better health than a few months ago. Whether this results in Novartis retaining the unit or leads to it seeking a higher price from potential buyers remains to be seen.

Novartis could eventually face competition from Pfizer's ($PFE) meningococcal B vaccine--which won FDA breakthrough designation this week--but for now has a chance to build a dominant position. The data that won over JCVI could help Novartis convince other governments to pay for Bexsero, but it might not always have as receptive a political environment as in Britain. The Independent reports the Prime Minister warned the Department of Health that rejecting the vaccine would be politically damaging.

- here's The Guardian's article
- check out The Independent's piece
- read The Telegraph's coverage
- and Reuters' take

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