-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.
-First data to show potential for viral cure in many patients with a 12-week combination regimen of multiple direct-acting antivirals- CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced interim results from ZENITH, an ongoing Phase 2 study
-INCIVEK was recently approved by the FDA and is now available for people with the most common form of chronic hepatitis C who are new to treatment and those who were treated before but not cured- CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced
-Vertex gains worldwide rights to two distinct nucleotide analogues, ALS-2200 and ALS-2158, that act on hepatitis C polymerase- -Collaboration provides multiple opportunities to develop new "all-oral" combination regimens- CAMBRIDGE, Mass. , & SOUTH SAN FRANCISCO, Calif.
- Complete data presented at ECFS showed improvements in lung function and reductions in sweat chloride observed at week two of treatment were sustained through 48 weeks -
<br><br>
- Vertex also announces that 48-week data from the ENVISION study of VX-770 among children ages 6 to 11 years are consistent with previously announced 24-week results -
-13.17 mmol/L reduction in sweat chloride in one arm supports further evaluation of a combination approach to treating the root cause of cystic fibrosis- CAMBRIDGE, Mass. --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced interim results from the first part of a
-79% of people treated for the first time achieved a SVR (viral cure) with INCIVEK combination treatment- -Vertex launches a comprehensive financial assistance and patient support program- -Conference call today at 11:00 a.m. ET to provide more information on the commercialization of INCIVEK-
CAMBRIDGE, Mass. --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that Terrence C. Kearney has joined its board of directors. The addition of Mr. Kearney brings the number of Vertex board members to nine. Mr. Kearney was appointed to the class of directors
CAMBRIDGE, Mass. --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced results of the voting at its 2011 Annual Meeting of Shareholders. At the meeting, shareholders re-elected director nominees Matthew W. Emmens and Wayne J. Riley , M.D.
-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
CAMBRIDGE, Mass. --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the Antiviral Drugs Advisory Committee to the U.S. Food and Drug Administration (FDA) voted unanimously to recommend FDA approval of telaprevir for people with genotype 1 chronic hepatitis
- Advisory Committee for the Food and Drug Administration reviewing the telaprevir New Drug Application for the treatment of hepatitis C- CAMBRIDGE, Mass. --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (NASDAQ: VRTX) announced that NASDAQ today halted trading of the company's common stock.
-Expanded collaboration supports development of a second corrector, VX-661, and accelerated discovery and development of next-generation correctors- -Phase 2 study of VX-661 planned for 2011 in people with CF who have the F508del mutation- CAMBRIDGE, Mass.
- 90% of people with the ‘CC' variation of IL28B who were new to treatment and received a telaprevir-based regimen achieved a viral cure, 78% of them were eligible to stop all treatment at 24 weeks - - Nearly three-fold improvement in viral cure rates was observed among people with the ‘CT' and
- All major subgroups achieved significantly higher viral cure rates with telaprevir-based therapy compared to pegylated-interferon and ribavirin: 86% vs. 24% in prior relapsers, 57% vs. 15% in prior partial responders and 31% vs. 5% in prior null responders - - No clinical benefit was observed in
BERLIN--(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced interim results from an ongoing Phase 2 study (ZENITH) designed to assess the safety and tolerability of 12-week response-guided treatment regimens with its polymerase inhibitor, VX-222, and its protease
-Mean relative improvement in lung function of 17.4% and mean absolute improvement of 12.5% from baseline compared to placebo in children treated with VX-770- - No discontinuations due to adverse events through 24 weeks - -Vertex on track to submit regulatory applications for the approval of VX-770
-Results support continued development of VX-765 in people with treatment-resistant epilepsy- CAMBRIDGE, Mass. --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced results from a recently completed Phase 2 study of VX-765 in 60 people with treatment-resistant
- Complete results from pivotal Phase 3 REALIZE study of telaprevir in people who had not achieved a viral cure (SVR) with currently available medicines - - First presentation of data from ongoing Phase 2 study evaluating response-guided, 12- and 24-week regimens of telaprevir and VX-222 combined
Early results from ongoing study showed that the hepatitis C virus was undetectable by week 4 in 70% of people treated with telaprevir-based combination therapy
- Relative mean improvement in lung function of approximately 17% from baseline compared to placebo achieved by people treated with VX-770; mean absolute improvement from baseline of approximately 10.5% compared to placebo; both measures through 24 and 48 weeks - - Significant improvements in all
-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.
-Six-month review date of May 23, 2011 set by FDA- CAMBRIDGE, Mass., Jan 20, 2011 (BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced today that the U.S. Food and Drug Administration ( FDA) has accepted the New Drug Application (NDA) for telaprevir and granted the
-Hepatitis C: Submission of New Drug Application complete for telaprevir- -Cystic Fibrosis: First Phase 3 data for VX-770 expected in first quarter 2011- -Additional ongoing trials in HCV, CF, epilepsy and rheumatoid arthritis- -Vertex enters 2011 with cash and cash equivalents position of more
-Two-drug treatment arm of telaprevir and VX-222 alone discontinued- -Study continues with three arms, including all-oral combination of Vertex's lead protease and polymerase inhibitors with ribavirin- -Both of the four-drug treatment arms are fully enrolled; the majority of patients in these arms
-Treatment with VX-770 resulted in improvements in lung function and markers of disease- -There were no discontinuations of treatment due to adverse events- -Late-stage Phase 3 clinical trials for VX-770 ongoing- CAMBRIDGE, Mass., Nov 17, 2010 (BUSINESS WIRE)-- In a study published in this week's
-New treatment arm to evaluate all oral, triple combination regimen of telaprevir, VX-222, and ribavirin- CAMBRIDGE, Mass., Nov 10, 2010 (BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced plans to enroll an additional treatment arm as part of its ongoing Phase 2
<i>-75% of people treated in the Phase 3 ADVANCE study achieved a viral
cure with telaprevir; majority of people treated for a total of 24 weeks-</i>
<br />
<i>-62% of African Americans/Blacks in the ADVANCE study achieved a
viral cure with telaprevir-</i>
<br />
<i>-Low discontinuation rates of all drugs due to adverse events-</i>
<br />
<i>-Hepatitis C:</i> <i>New Drug Application submission for telaprevir
on track for fourth quarter 2010-</i>
<br />
<i>-Cystic Fibrosis:</i> <i>Phase 3 registration program ongoing for
VX-770-</i>
<br />
<i>-Pipeline:</i> <i>Ongoing proof-of-concept clinical trials in
hepatitis C, cystic fibrosis, epilepsy and rheumatoid arthritis-</i>
<br />
<i>-Financial:</i> <i>Company ends third quarter with a cash position of
$1.2 billion-</i>
<br />
<i>- First Phase 3 study to evaluate twice-daily (BID) dosing of a
protease inhibitor for hepatitis C -</i>
<br />
<i>- All patients will receive telaprevir-based combination therapy -</i>
<br />
<i><b>-Primary endpoints of safety, tolerability and effect on CFTR
function as measured by sweat chloride-</b></i>
<br />
<i><b>-Phase 2a proof of mechanism clinical trial to enroll people with
the most common mutation of cystic fibrosis, known as F508del-</b></i>
<br />
CAMBRIDGE, Mass., Sep 24, 2010 (BUSINESS WIRE) -- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the underwriter for its offering of 3.35% convertible senior subordinated notes due 2015 has exercised in full its option to purchase an additional $25 million aggregate
CAMBRIDGE, Mass., Sep 23, 2010 (BUSINESS WIRE) -- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that it has entered into an agreement to sell $375.0 million aggregate principal amount of 3.35% convertible senior subordinated notes due 2015.
CAMBRIDGE, Mass., Sep 22, 2010 (BUSINESS WIRE) -- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that intends to offer, subject to market and other conditions, $375.0 million aggregate principal amount of convertible senior subordinated notes due 2015 in an underwritten public
<i>-17% of people achieved SVR with pegylated-interferon and ribavirin
alone in the control arm-</i>
<br />
<i>-Safety and tolerability results were consistent with prior Phase 3
studies-</i>
<br />
<i>-Completion of rolling New Drug Application submission on track for
the fourth quarter 2010-</i>
<br />
<i>-Viral cure rates of 92% and 88% with 24 and 48-week regimens,
respectively, in people who met certain response criteria-</i>
<br />
<i>-Safety and tolerability results were similar to those seen in the
Phase 3 ADVANCE study</i>-
<br />
<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>
<br />
<i>-Cystic Fibrosis: Phase 3 registration program for VX-770 fully
enrolled; data expected in first half of 2011-</i>
<br />
<i>-Financial: Vertex ends second quarter with cash position of
approximately $980 million-</i>
<br />
CAMBRIDGE, Mass., Jul 13, 2010 (BUSINESS WIRE) -- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that Wayne J. Riley, M.D., M.B.A., joined its board of directors as an independent director. The addition of Dr. Riley brings the number of Vertex board members to 10. Dr.
<i><b>-Majority of patients treated with telaprevir received a 24-week
regimen-</b></i>
<br />
<i><b>-6.9% and 7.7% treatment discontinuation rates due to adverse
events in 12- and 8-week telaprevir-based treatment arms -- lower than
previous telaprevir trials-</b></i>
<br />
<i><b>-First Phase 3 trial results for a direct acting antiviral therapy
in hepatitis C-</b></i>
<br />
CAMBRIDGE, Mass., May 13, 2010 (BUSINESS WIRE) -- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced results of the voting at its 2010 Annual Meeting of Shareholders. At the meeting, shareholders re-elected director nominees Dr. Joshua Boger, Dr. Charles A. Sanders and Elaine S.
<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>
<br />
<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
2011-</i>
<br />
<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>
<br />
<i>-Financial: Vertex ends first quarter with cash position of
approximately $1.1 billion-</i>
<br />
<i>-VX-222 was well-tolerated across all four dose groups through three
days of dosing, with all adverse events being mild to moderate in
severity-</i>
<br />
<i>-Greater than 3 log</i><sub><i>10 </i></sub><i>reduction in HCV RNA
observed across all four VX-222 dose groups-</i>
<br />
<i>-Results support previously announced Phase 2 proof-of-concept
clinical trial evaluating VX-222 in combination with Vertex's lead HCV
protease inhibitor telaprevir-</i>
<br />
<i>-56% of prior treatment null responder patients achieved SVR with a
48-week telaprevir-based regimen-</i>
<br />
<i>-97% of prior treatment relapsers and 55% of prior treatment partial
responders achieved SVR with 24-week or 48-week telaprevir-based
regimens-</i>
<br />
<i><b>-51% and 53% SVR rates when telaprevir was dosed in combination
with pegylated-interferon and ribavirin in treatment-failure patients,
compared to 14% SVR rate with pegylated-interferon and ribavirin alone-</b></i>
<br />
<i><b>-Telaprevir Phase 3 SVR data expected in second quarter 2010 for
treatment-naïve patients and third quarter 2010 for treatment-failure
patients-</b></i>
<br />
<i><b>-New Drug Application submission planned for second half of 2010
in treatment-naïve and treatment-failure HCV patients-</b></i>
<br />
CAMBRIDGE, Mass., Mar 16, 2010 (BUSINESS WIRE) -- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that multiple abstracts related to the hepatitis C virus (HCV) protease inhibitor telaprevir and the HCV polymerase inhibitor VX-222 were accepted for presentation at the 45 th
<i>-Trial will evaluate safety and SVR rates with multiple 12-week
response-guided regimens of telaprevir/VX-222-based combination therapy,
including two-drug regimens of telaprevir and VX-222-</i>
<br />
<i>-Interim clinical data expected in the second half of 2010-</i>
<br />
<i>-Multiple clinical trial sites in the U.S. to enroll patients-</i>
<br />
CAMBRIDGE, Mass., Feb 16, 2010 (BUSINESS WIRE) -- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced that on March 19, 2010 it will redeem the outstanding $32.1 million aggregate principal amount of 4.75% Convertible Senior Subordinated Notes due 2013, in accordance with the terms of the
<i>-HCV: New Drug Application planned for telaprevir in second half of
2010; increasing investment in commercialization and launch preparedness
activities-</i>
<br />
<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>
<br />
<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>
<br />
<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>
<br />
<i>-VX-809 was well-tolerated at all dose levels when dosed once daily
for 28 days-</i>
<br />
<i>-Statistically significant changes observed in measurement of sweat
chloride suggest increased CFTR activity-</i>
<br />
<i>-Data support planned combination trial of VX-809 and VX-770 in
second half of 2010 for CF patients with the F508del mutation-</i>
<br />
