FDA rejects Kala's dry eye drug; Troubled Insys finds a buyer (of some assets) in Hikma
→ Kala Pharmaceuticals, one of the plethora of biotechs that trace their roots to the prolific lab at MIT led by Bob Langer, on Thursday disclosed that its experimental drug for short-term dry eye relief did not pass muster with the FDA. Last year, the company posted mixed data from two studies — STRIDE 1 and STRIDE 2. Kala $KALA is now banking on the ongoing STRIDE 3 study to reverse its fortunes. It expects STRIDE 3 to read out by the end of the year, and to resubmit its marketing application the first half of 2020.
While disappointing, the CRL is not completely unexpected, COO Todd Bazemore said. The company had initiated STRIDE 3 last year at the advice of the FDA, and is confident that they have now gotten the inclusion/exclusion criteria right by screening out patients with unstable symptoms. Once they have the data, he added, they can refile an NDA under a type 2 submission, which entails a 6-month instead of 12-month review.
Pointing to Novartis‘ recent $5.3 billion purchase of Shire’s Xiidra — whose approval process inspired Kala to take its chances the first time — Bazemore emphasized the potential of KPI-121: “There’s so few products in this category, it’s a huge untapped category in which only about a million and a half of the 30 million patients are currently being treated with a prescription product.”
→ Embattled Insys, engulfed in litigation and financially starved, has found a buyer for its unit-dose nasal and sublingual spray manufacturing equipment, as well as two pipeline products — naloxone nasal spray and epinephrine nasal spray — in UK-based Hikma. “Hikma is the largest supplier of generic nasal sprays in the US and we have been looking for ways to build upon our strong manufacturing platform and expand our product portfolio,” said Hikma’s president of generics Brian Hoffmann in a statement.
→ Los Angeles biotech BioVie, which in April posted positive data from a small study testing its infusion therapy for serious complication of advanced liver cirrhosis, on Thursday amended the terms of its impending IPO. The company now plans to raise $15 million by offering 1.3 million shares for $11.44/share, the as-converted last close of its shares on the over-the-counter market. The company, which plans to list under the symbol BIVI, had previously filed to offer 1.3 million priced at $11.88/share.