Seqirus wins third FDA flu approval, enters two European distribution agreements

By Eric Sagonowsky Aug 30, 2016 2:11pm

As Seqirus hopes to recover from rocky 2016 financials, the company picked up some steam on both sides of the Atlantic this week. Within the span of a few days, the flu-focused unit of Australia's CSL notched its second quadrivalent vaccine approval from the FDA and signed two marketing and distribution deals in Europe.

On Monday, the FDA gave its thumbs up to Seqirus’ Afluria Quadrivalent, bolstering the company’s offerings following its May regulatory approval for Flucelvax Quadrivalent. The FDA approved Afluria Quadrivalent for people 18 and older.

But it'll be operating in a crowded market. With its quadrivalent offerings, Seqirus will be competing with the likes of Sanofi, GlaxoSmithKline and AstraZeneca.

Both of the quadrivalent approvals followed Seqirus' November FDA nod for Fluad, formerly a Novartis shot that is now the only adjuvanted flu vaccine available in the U.S.

Seqirus also had a busy week in Europe, pairing with vaccine companies Valneva and PaxVax on marketing and distribution agreements. Through the deals, PaxVax will distribute Agrippal, an inactivated trivalent influenza vaccine, and Fluad in Switzerland, while Valneva will distribute Sandovac and Fluad in Austria.

All of the developments come as the budding outfit works to integrate the Novartis flu vaccine assets it picked up for $275 million last summer. Currently the second largest flu vaccine provider, Seqirus has said it’ll aim for “industry leadership” by relying on the launch of Fluad, emerging markets and a switch to quadrivalent flu vaccines for growth.

But in the meantime, execs are looking to cut costs and boost revenue to get Seqirus making money. Earlier this month, CSL reported that the Novartis business posted a $205 million loss for the 2016 fiscal year.

- here's the Afluria Quadrivalent release
- read the PaxVax release
- and the Valneva release

influenza vaccine Pharma