- French pharma giant Sanofi is taking a major step in an effort to land an even bigger leap over rival diabetes drugmakers like Novo Nordisk by redeeming a priority review voucher for its next-gen fixed dose combo LixiLan. Using the voucher will speed up the candidate's review process by four months (meaning the FDA-accepted drug application will only take six months to review).
- LixiLan is an injectable combo which mixes Sanofi's flagship (and now, flagging) insulin Lantus with the investigational GLP-1 boosting compound lixisenatide.
- The review voucher which Sanofi cashed in cost the company a staggering $245 million. It was purchased from Retrophin and is one of the biggest review voucher purposes in history (behind United Therapeutics $350 million pediatric review voucher sale to AbbVie).
Four extra months can prove to be an eternity when it comes to drug marketing. And Sanofi clearly thinks that the lead time will help buoy a once-dominant diabetes franchise that's been hit with accelerating headwinds.
The voucher redemption will give Sanofi a big advantage over Novo Nordisk, whose own GLP-1 combo Xultophy (which includes the long-acting insulin Tresiba and the blockbuster Victoza) until next fall.
Sanofi has been trying to make up for the effects of the insulin Lantus' patent expiration and staring down the advent of biosimilar competition. And the French drugmaker has taken several significant steps in an effort to reverse the trend, including announcing a major restructuring and big layoffs in the core diabetes unit earlier this year.
The company faced another big disappointment after its risky bet on the inhaled insulin product Afrezza, developed by MannKind, turned out to be a flop. Sanofi cut off that co-marketing agreement on the first business day of 2016.
Furthermore, this isn't the first time Sanofi's used a review voucher to jump over a rival in a competitive, potential blockbuster therapeutic space. The firm also used a $67.5 million review voucher to expedite approval of the cholesterol-busting PCSK9 inhibitor Praluent in a race with Amgen's competing Repatha.