Vertex Pharmaceuticals ( VRTX) said Thursday that nearly all patients in three pivotal studies have finished treatment with the company's experimental hepatitis C drug telaprevir. Vertex President Matt Emmens, who joined the company from Shire in February and will replace current CEO Joshua Boger in May, disclosed the telaprevir safety update along with the company's first-quarter financial results. Hepatitis C patients in two phase III studies completed telaprevir dosing in the first quarter, while patients in a third study will finish in May, Vertex said. The milestone is incremental but significant from a safety perspective because it means telaprevir was not associated with any adverse events severe enough to halt the studies. "Our top priority is to execute on the telaprevir phase III program and to prepare for an NDA
New Drug Application filing for telaprevir in the second half of 2010," said Emmens. On the financial front, Vertex CFO Ian Smith said the company will end 2009 with approximately $700 million in cash and will not need to raise any additional cash through stock sales for the remainder of the year. Smith says the $700 million cash guidance for 2009 takes into account expected licensing deals that will bring non-dilutive monies into the company. Smith says Vertex plans to out-license an early stage drug, VX-509 and sign another collaboration deal for telaprevir with its current Japanese partner. Vertex's heavy cash burn and penchant for dilutive financings has been an off-and-on concern for investors, especially as the company nears a commercial launch of telaprevir.