|Teva R&D Chief Michael Hayden|
Teva ($TEVA) is inching toward an FDA application for reslizumab, touting positive late-stage results for an asthma antibody passed around for years in multiple buyouts.
The drug, which works by blocking the interleukin-5 pathway, met its primary endpoints in two Phase III studies on patients with inadequately controlled asthma and elevated levels of inflammatory white blood cells, Teva said. In 12-month data from more than 950 subjects, reslizumab charted a statistically significant reduction in asthma flare-ups compared with placebo, the company said. The drug demonstrated a positive effect on lung function, a secondary goal, and clocked an adverse event profile in line with the placebo arm, according to Teva.
Now the company is preparing global regulatory submissions for its every-four-weeks treatment, planning to file in the U.S. in the first half of 2015 with applications in the EU and other jurisdictions to follow.
An approval would close the loop on a long journey for reslizumab, which began its life at Schering-Plough before being rescued and revived by the venture-backed Ception Therapeutics in 2004. The drug's potential eventually attracted the interest of Cephalon, which handed over $100 million in 2009 for the right to acquire Ception and then came through with $250 million more to close the deal the following year. Reslizumab landed in Teva's hands in 2011 when the Israeli drugmaker outbid rival Valeant Pharmaceuticals ($VRX) and picked up Cephalon for $6.8 billion.
Teva believes the market for biologics targeting severe asthma could exceed $7.5 billion in the U.S. and Europe, trumpeting reslizumab as a promising new option for a disease that affects more than 300 million people worldwide.
"Asthma that is inadequately controlled by current standard of care therapy continues to present a serious problem for patients, physicians and healthcare systems," Teva Chief Scientific Officer Michael Hayden said in a statement. "The success of these studies gives us confidence that we may have a valuable potential new treatment option for asthma patients with elevated levels of blood eosinophils, who are at risk of exacerbation."
- read the statement