Dive Brief:
- The Food and Drug Administration approved Insys' Syndros for use in treating AIDS-related anorexia and chemotherapy-induced nausea or vomiting, the company said Tuesday.
- Syndros is a liquid form of the cannabinoid dronabinol, which is a pharmaceutical version of THC. The drug is still awaiting Drug Enforcement Administration scheduling.
- Insys hopes to "convert a large portion of the market to Syndros" through direct dealings with prescribers, according to their statement. The market for dronabinol has long been led by AbbVie's Marinol. Syndros is the first non-capsule drug on the market.
Dive Insight:
Syndros' approval provides a much needed boon to Insys, whose market performance had been beleaguered by class action lawsuits over the company's off-label marketing of its only other product, Subsys.
NBC News revealed in November that the company had participated in various kickback schemes to encourage healthcare practitioners to prescribe Subsys, a pharmaceutical opiate, as a regular painkiller. The FDA had only approved the drug for late-stage cancer pain.
Days later, Insys' CEO had been replaced and the company was facing numerous costly lawsuits. And in the eight months that followed, the company's stock had plummeted by nearly 50% from $28.83 to $14.40.
And while the green light for Syndros did not revive the shares to their former levels, Insys enjoyed a nearly 7% stock bump in Tuesday trading.
The greater cause for celebration, however, is that the company can finally diversify its portfolio.
The Syndros project had been in the pipeline for years, and was even rejected once already by the FDA in 2014. Now that the drug has been approved, the company must only wait for Drug Enforcement Administration scheduling before it can market the product later this year.
Details have not been released regarding the projected list-price for the new drug, but FierceBiotech reports Syndros could bring in peak annual sales of $200 million to $300 million as a Schedule III drug. As a point for comparison, AbbVie's encapsulated dronabinol Marinol is classified as a Schedule III substance.
But if the DEA schedules the drug as Schedule II, a more strictly controlled designation, FierceBiotech notes that Insys projects 20% to 25% less revenue.
Regardless, Syndros' entry into the market should provide a substantial boost for Insys' financials. Insys' net revenue totaled $330.8 million in 2015, but was primarily gained from the sale of Subsys–the company's flagship Schedule II drug approved in 2012.
Insys expect Syndros to compete with Marinol and generic versions of Marinol, but the company might face new competitors soon. GW Pharma is in late-stage development of Sativex, a cannabinoid drug for treatment of cancer pain.