Pfizer’s Trumenba to challenge GlaxoSmithKline's Bexsero with EU nod

Fresh off a patent settlement with GlaxoSmithKline, Pfizer won EU approval for Trumenba, a rival to GSK’s Bexsero.

Meningococcal group B vaccine Bexsero has been helping drive revenue growth for GlaxoSmithKline, but now, with a European approval, Pfizer’s Trumenba is set to challenge it in that lucrative market.

Tuesday, the European Commission approved Trumenba for the prevention of MenB infection in individuals 10 years or above. The approval came almost three years later than the vaccine’s approval in the U.S. in October 2014 and about four and a half years later than its rival Bexsero’s approval in the EU.

It also came just a month after the two pharma giants had settled all patent disputes surrounding the two vaccines in several markets, including the U.S., Canada, U.K., Italy, Ireland and Austria.

Bexsero, originally a product by Novartis, became GSK’s after an asset swap in March 2015, and it has since become an engine of growth for the British Big Pharma.

For the year 2016, sales of the vaccine more than doubled to reach £390 million ($500 million), making it the fourth-best-selling vaccine of the company’s that year. That momentum continued in the first quarter of 2017, as the vaccine reeled in £126 million revenue worldwide—an 80% expansion at constant exchange rates.

In fact, the growth also came as a surprise for GSK, which ran into shortages for a while. To boost the vaccine’s production, the U.K. pharma is building a $175 million, 9,000-square-meter antigen production plant in Germany. That facility, slated to run in the third quarter of 2020, will allow GSK to move production for three of the four active components of the vaccine there.

RELATED: GSK starts $175M plant to boost production of vaccine star Bexsero

Europe is Bexsero’s major battlefield, representing over 60% of the vaccine’s sales in 2016. Its climbing sales in Spain, Italy, and in the U.K.—after its inclusion in the NHS immunization program—played a critical role in growing the company’s overall vaccines sales, GSK said in its annual earnings report.

Pfizer, though, seems confident that it will snatch share from GSK with similar sales growth, and it's already prepared to meet demand. “We are ... focused on consistent, reliable supply for all the vaccines we manufacture, including a full 36-month shelf life with Trumenba,” Susan Silbermann, president and GM of Pfizer Vaccines, said in a statement.

In the U.S., about 600,000 adolescents and young adults have received Trumenba since its approval, Pfizer said, quoting data from the QuintilesIMS database.

The new EU approval for Trumenba, in a disease field that showed such potential for growth, could compensate for the declining revenues Pfizer has experienced with its blockbuster vaccine Prevnar 13. The company attributed the pneumococcal vaccine’s 8% sales decline in 2016 to “a high initial capture rate of the eligible population following its successful fourth-quarter 2014 launch.”