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.
Vertex sold 10 million share raising $320 million in February. A portion of that money was used by Vertex to acquire Canadian hepatitis C drug maker ViroChem in early March. Vertex ended 2008 with $832 million in cash. In other telaprevir news, Vertex said a phase II study testing whether the drug could be dosed twice a day, instead of three-times daily, will be completed by the end of the year. Based on data collected to date, Vertex reiterated its confidence that telaprevir can be just as effective dosed twice daily. Telaprevir is far ahead of most of its hepatitis C competitors in terms of completing clinical trials needs for approval. But the drug's current requirement that it be taken three times a day is a competitive disadvantage to earlier-stage rivals that can be taken once daily. Away from hepatitis C, Vertex said it has reached agreement on a phase III program for its cystic fibrosis drug VX-770. Those studies will start later this quarter. Vertex reported a first-quarter net loss of $161.5 million, or $1.04 a share, compared to a net loss of $96.2 million, or 72 cents a share, in the year-ago quarter. On an adjusted basis, Vertex lost 82 cents a share, matching Wall Street's consensus estimate. The company revised its 2009 net loss forecast to a range of $500 million to $535 million from its previous estimate of a net loss in the range of $495 million to $530 million.