Roche gets priority review for Hemlibra's second indication; Orasis gets $13M B round for presbyopia eye drop
→ Roche $RHHBY is now one step closer to realizing its blockbuster ambitions for Hemlibra, securing a priority review for a second, hugely important indication — hemophilia A patients who haven’t developed resistance to factor replacement therapy, more commonly known as patients without factor VIII inhibitors or non-inhibitor patients. The announcement comes days after the pharma giant’s Genentech group rolled out a slate of new Phase III data that backed Hemlibra’s case for reducing treated bleeds: a 97% reduction compared with those with no prophylaxis and 68% compared to previous factor VIII treatment. Hemlibra was originally approved to treat patients with inhibitors. An approval here would make Roche an official rival of Shire, which has built a franchise around factor replacement therapy. The FDA — having already granted the drug breakthrough status — has promised to give a decision by October 4, 2018.
→ Israel’s Orasis Pharmaceuticals has raised a $13 million B round to fuel its work on an eye drop for the treatment of presbyopia symptoms. The financing was led by Visionary Ventures, with participation from Sequoia Capital, SBI (Japan) Innovation Ventures, LifeSci Venture Partners, and “other private investors.”
→ New York’s UroGen Pharma $URGN is losing its CFO Gary Titus, the company announced Tuesday. UroGen is putting its COO Stephen Mullennix in an interim CFO role while the company hunts for his replacement. UroGen also announced the addition of Jason Patel, the former senior director of accounting and finance at Kite, as the company’s new VP of finance.