Vertex Pharma Backs FY10 Outlook; Prepares To Launch Hepatitis C Drug Telaprevir

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Vertex Pharma Backs FY10 Outlook; Prepares To Launch Hepatitis C Drug Telaprevir

1/9/2011

(RTTNews) - Vertex Pharmaceuticals Inc. (VRTX: News ) on Sunday reiterated its

earnings outlook for fiscal year 2010 and announced its business objectives for

2011, including the planned launch of its lead investigational drug telaprevir

for the treatment of Hepatitis C.

Cambridge, Massachusetts-based Vertex reiterated its earnings outlook for fiscal

year 2010. The company continues to anticipate a non-GAAP loss for the year of

about $600 million as provided on February 4, and GAAP net loss of about $750

million, as provided on July 28.

On average, analysts polled by Thomson Reuters expect the company to report a

loss of $3.65 per share for the year.

The company will report its full-year 2010 financial results on February 3,

2011.

As at December 31, 2010, Vertex had more than $1 billion in cash, cash

equivalents and marketable securities. The company also recently entered into a

$100 million commercial line of credit from Bank of America for a term of 18

months.

The company, which completed the submission of its new drug application or NDA

for its hepatitis drug telaprevir to the U.S. Food and Drug Administration in

November 2009, said it expects a response from the FDA regarding its request for

priority review of the telaprevir NDA by January 2011. Vertex said that it has

hired more than 200 new employees to support the planned launch of telaprevir.

The company noted that planned enrollment is currently ongoing for a Phase 3b

study of twice-daily dosing of telaprevir to support the submission of a

supplemental NDA by the end of 2012.

Telaprevir, a hepatitis C-specific protease inhibitor drug, is being developed

by Vertex in collaboration with & 's (JNJ) Tibotec unit and

Japan-based Mitsubishi Tanabe Pharma. Hepatitis C is a disease that affects the

liver and can cause scarring of liver tissue, resulting in liver failure or

cancer. It is estimated that in the U.S. alone, about 3.9 people suffer from the

malady.

Regarding cystic Fibrosis, Vertex said that the phase 3 registration program for

VX-770 is nearing completion and the first data for the drug is expected in the

first quarter of 2011. The company noted that the results from the Phase 3

program for VX-770, if positive, could support the submission of an NDA for

VX-770 in the second half of 2011.

Emmens, Chairman, President and Chief Executive Officer of Vertex, said,

" 2011 will be a landmark year for Vertex as we prepare for the expected launch

of telaprevir in hepatitis C and advance other new therapies in development. "

Emmens added, " We are in a unique position, as just behind telaprevir is VX-770,

a medicine in development that aims to treat the underlying cause of cystic

fibrosis. We will soon obtain data from the Phase 3 registration program of

VX-770 that may support the planned submission of a New Drug Application to the

FDA in the second half of this year. "

Vertex said it was looking at opportunities to further advance future treatment

of hepatitis C and cystic fibrosis. The company is conducting a Phase 2 clinical

trial evaluating multiple 12-week, response-guided regimens of telaprevir dosed

in combination with its lead investigational HCV polymerase inhibitor, VX-222.

Interim data from both of the four-drug treatment arms are expected in the first

quarter of 2011.

In November 2010, Vertex announced the planned addition of a three-drug

treatment arm to evaluate the potential of an all-oral, interferon-free regimen

of telaprevir, VX-222, and ribavirin dosed twice daily. The company expects

enrollment in this new treatment arm to begin in the first quarter of 2011.

Vertex and Tibotec also plan to conduct several additional clinical trials of

telaprevir in 2011 that aim to expand the future patient population for

telaprevir-based regimens.