<i>-HCV: New Drug Application planned for telaprevir in second half of
2010; increasing investment in commercialization and launch preparedness
<i>-CF: Development progress with two compounds in orphan disease of
cystic fibrosis; combination trial planned with VX-770 and VX-809 based
on Phase 2 data for VX-809-</i>
<i>-Pipeline: Proof-of-concept clinical trials planned for 2010 with
novel combination regimens for hepatitis C and cystic fibrosis and with
compounds for rheumatoid arthritis and epilepsy-</i>
<i>-Financial: Vertex enters 2010 with approximately $1.3 billion in
cash, cash equivalents and marketable securities and approximately $32
million in outstanding 2013 convertible debt; 2010 investment to support
long-term business objectives-</i>
<i>-HCV: Rolling submission of New Drug Application for telaprevir
expected to begin in summer of 2010; first Phase 3 SVR data expected in
second quarter 2010 from ADVANCE trial-</i>
<i>-CF: STRIVE, ENVISION and DISCOVER trials dosing patients as part of
Phase 3 registration program for VX-770; data expected in first half of
<i>-Pipeline: Multiple ongoing or planned proof-of-concept clinical
trials with compounds for rheumatoid arthritis and epilepsy and with
novel combination regimens for HCV and CF-</i>
<i>-Financial: Vertex ends first quarter with cash position of
approximately $1.1 billion-</i>
<i>-Hepatitis C: Rolling submission of New Drug Application underway;
data from second pivotal Phase 3 trial - REALIZE - expected in the third
quarter of 2010-</i>
<i>-Cystic Fibrosis: Phase 3 registration program for VX-770 fully
enrolled; data expected in first half of 2011-</i>
<i>-Financial: Vertex ends second quarter with cash position of
approximately $980 million-</i>
<i>-Hepatitis C:</i> <i>New Drug Application submission for telaprevir
on track for fourth quarter 2010-</i>
<i>-Cystic Fibrosis:</i> <i>Phase 3 registration program ongoing for
<i>-Pipeline:</i> <i>Ongoing proof-of-concept clinical trials in
hepatitis C, cystic fibrosis, epilepsy and rheumatoid arthritis-</i>
<i>-Financial:</i> <i>Company ends third quarter with a cash position of
-Hepatitis C: Regulatory agencies in U.S., Europe and Canada to provide accelerated reviews of telaprevir applications- -Cystic Fibrosis: First Phase 3 registration data for VX-770 expected in first quarter 2011; potential regulatory submissions in the U.S. and E.U.
-Hepatitis C: FDA decision on NDA for INCIVEK TM (telaprevir) expected this month- -Cystic Fibrosis: Phase 3 program for VX-770 supports applications for approval in U.S. and E.U., with NDA and MAA planned for second half of 2011- -Financial: Vertex enters second quarter with more than $820 million
-Quarter highlighted by approval and launch of INCIVEK TM for hepatitis C and completion of VX-770 Phase 3 program in cystic fibrosis- -Continued progress in advancing new combinations of medicines for the future treatment of hepatitis C and cystic fibrosis- CAMBRIDGE, Mass.
- $420 million in net product revenues for INCIVEK for the first full quarter since launch- -Continued strength in launch of INCIVEK for hepatitis C; submissions of KALYDECO TM (VX-770, ivacaftor) approval applications complete- CAMBRIDGE, Mass. --(BUSINESS WIRE)-- Vertex Pharmaceuticals
-Successful launch of INCIVEK (telaprevir) for hepatitis C and recent approval of KALYDECO (ivacaftor) for cystic fibrosis position Vertex for continued growth, earnings and cashflow- CAMBRIDGE, Mass. --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today reported consolidated
-Approximately 600 people with cystic fibrosis have started treatment with KALYDECO since approval on January 31 - -Multiple ongoing clinical trials to generate data beginning in second quarter, including study of KALYDECO combined with VX-809 in cystic fibrosis and first data for Alios nucleotides
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