As per recent data published in The Lancet , Novartis' ( NVS ) vaccine candidate, Bexsero (meningococcal group B vaccine [rDNA, component, adsorbed]), is safe and provides a strong immune response when administered as a three-dose primary series along with routine vaccines.
The phase III study was conducted with 3,630 infants in the age group of two months and above. On a random basis, infants were administered routine vaccines at two, four and six months alone or with either Bexsero or a serogroup C conjugate vaccine.
Other vaccines that were administered included 7-valent pneumococcal glycoconjugate vaccine and combined diphtheria, tetanus, acellular pertussis, inactivated polio, hepatitis B and hemophilus influenza type b vaccine.
Novartis is currently seeking European approval of Bexsero (2 months of age and older) for protection from meningococcal group B (MenB) disease. If approved, Bexsero will be the first and only broad coverage MenB vaccine for all age groups including infants.
We note that The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) provided a positive opinion on Bexsero in Nov 2012.
Novartis should gain approval for Bexsero as the European Commission generally follows the recommendation of the CHMP - a decision should be out by Feb.
Novartis is already in talks with governments interested in the early adoption of the vaccine and plans to make Bexsero available soon after approval. A part of the ramp up following approval is expected in 2013 while the majority will take place in 2014.
Bexsero's approval will enable Novartis to offer vaccines to help prevent all five of the most common and most virulent meningococcal serogroups.
We are encouraged by Novartis's progress with its pipeline and have a Neutral recommendation on Novartis as of now. Novartis currently carries a Zacks Rank #2 (Buy).