Vertex
Pharmaceuticals Incorporated (NASDAQ: VRTX) today provided an update
on key 2010 business priorities in conjunction with the 28th Annual J.P.
Morgan Healthcare Conference in San Francisco. The company also
discussed recent progress in its lead development programs in hepatitis
C virus (HCV) infection and cystic fibrosis (CF) and outlined
proof-of-concept clinical trials planned in other serious diseases for
2010.
“Supporting our vision to become a fully-capable biopharmaceutical
company, Vertex is also planning multiple proof-of-concept clinical
trials in other diseases, such as rheumatoid arthritis and epilepsy, and
remains committed to maintaining investment into research to enable
future product opportunities”
"2010 will be a defining year for Vertex as we seek to evolve into a
fully-capable biopharmaceutical company," said Matthew Emmens, Chairman,
President and Chief Executive Officer of Vertex. “With ongoing Phase 3
programs in hepatitis C virus infection and cystic fibrosis, a broad
pipeline of other emerging product candidate opportunities and a strong
capital structure, we believe Vertex today has a unique opportunity to
build a successful company focused on bringing multiple important
therapies to patients. In 2010, we look forward to a series of defining
events from late-stage and proof-of-concept clinical trials that may
support further growth in the years ahead.”
Mr. Emmens will deliver a live webcast presentation from the J.P. Morgan
Healthcare Conference on Tuesday, January 12 at 2:30 p.m. PT (5:30 p.m.
ET) where he will discuss recent clinical progress and provide an
overview of Vertex's 2010 priorities. The webcast will be available on
Vertex's website, www.vrtx.com.
"Phase 3 data for telaprevir, our lead drug candidate for the treatment
of hepatitis C virus infection, will begin to emerge in the spring of
2010 to support the planned submission of a New Drug Application in the
second half of this year. Our more than decade-long commitment to
improving patient care in HCV is unwavering, and the Phase 3 program for
telaprevir will remain our primary focus over the coming year.
Importantly, we also recognize the need for continued innovation in the
treatment of this disease, and we are preparing to initiate the first
clinical trial combining telaprevir with the investigational HCV
polymerase inhibitor VX-222 this quarter,” stated Mr. Emmens.
"Beyond HCV, Vertex is conducting mid-stage and late-stage development
of two novel compounds aimed at addressing, for the first time, the
underlying mechanism of the orphan disease of cystic fibrosis. The
VX-770 Phase 3 registration program is advancing rapidly, and we expect
to obtain Phase 3 data for VX-770 early in 2011. Additionally, we also
expect to obtain clinical data from a Phase 2 trial of VX-809 in the
coming weeks that could potentially support the evaluation of VX-770 and
VX-809 as part of a combination regimen in patients with the most common
mutation of this disease.
“Supporting our vision to become a fully-capable biopharmaceutical
company, Vertex is also planning multiple proof-of-concept clinical
trials in other diseases, such as rheumatoid arthritis and epilepsy, and
remains committed to maintaining investment into research to enable
future product opportunities,” concluded Mr. Emmens.
Phase 3 Registration Program for Telaprevir Nears Completion
Sustained viral response (SVR) data expected from Phase 3 ADVANCE
trial in second quarter 2010 and from Phase 3 ILLUMINATE & REALIZE
trials in third quarter 2010
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The ADVANCE, ILLUMINATE and REALIZE trials are evaluating
telaprevir-based regimens as part of a global Phase 3 registration
program in more than 2,200 genotype 1 treatment-naïve and
treatment-failure patients with HCV infection.
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Vertex today announced that all patients in the ADVANCE and ILLUMINATE
trials, which are evaluating telaprevir in treatment-naïve patients,
have completed dosing of all study drugs, including
pegylated-interferon (peg-IFN) and ribavirin (RBV), and are now in the
post-treatment follow-up period to determine the number of patients
who achieve SVR (defined as undetectable HCV RNA 24 weeks after the
end of treatment). Vertex expects SVR data to become available from
ADVANCE in the second quarter of 2010 and from ILLUMINATE in the third
quarter of 2010.
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Vertex today also announced that all patients in the REALIZE trial,
which is being conducted by Vertex’s collaborator Tibotec and is
evaluating telaprevir in patients who did not achieve SVR with a prior
pegylated interferon-based treatment, are expected to complete dosing
of all study drugs, including pegylated-interferon and ribavirin, by
the end of January. Vertex expects SVR data to become available from
REALIZE in the third quarter of 2010.
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Vertex plans to submit a New Drug Application (NDA) for telaprevir in
the second half of 2010 for both treatment-naïve and treatment-failure
patients.
Twice-daily dosing of telaprevir
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In November 2009, Vertex announced SVR results from Study C208, an
exploratory Phase 2, open-label clinical study of telaprevir. The
study was conducted by Tibotec in Europe and evaluated a twice-daily
(1125mg q12h) dosing schedule of telaprevir in combination with
peg-IFN-alfa-2a (PEGASYS(R)) or peg-IFN-alfa-2b (PEGINTRON(R))
and RBV, as compared to the three-times-daily (750mg q8h) telaprevir
dosing schedule used in telaprevir clinical trials to date. The C208
trial enrolled 161 treatment-naïve patients with genotype 1 HCV
infection. The C208 data included the first SVR data for
telaprevir-based regimens in treatment-naïve patients as part of a
response-guided therapy trial design, similar to that being used in
the ADVANCE and ILLUMINATE Phase 3 trials of telaprevir.
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Vertex has submitted the Study C208 clinical data to the U.S. FDA, and
Vertex and Tibotec have initiated discussions with regulatory
authorities in the U.S. and E.U. regarding future development plans
for telaprevir as part of an every-12-hour (q12h) dosing regimen.
Vertex collaborator completes dosing of telaprevir in Phase 3
trials in Japan
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Vertex today announced that its collaborator, Mitsubishi Tanabe Pharma
Corporation, has completed the dosing portion for telaprevir in three
ongoing Phase 3 trials of telaprevir-based combination therapy in
approximately 300 treatment-naïve and treatment-failure HCV patients
in Japan.
New capabilities to support potential launch of telaprevir
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Vertex continues to build its commercial infrastructure in preparation
for the potential launch of telaprevir and has begun to develop and
implement internal systems and processes to support the company’s
commercial operation and the potential future sale of telaprevir.
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The company expects to establish key elements of its customer-facing
operation in 2010, including the hiring of the sales management team
to be charged with the implementation of a fully-functioning
commercial sales force in 2011.
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To inform launch preparedness activities, Vertex continues to conduct
extensive HCV market research and is in discussions with key managed
markets organizations and specialty pharmacies to generate additional
insights on the HCV patient population, HCV patient care and flow,
market communication strategies, and reimbursement processes for the
HCV market.
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Vertex has assembled a global supply chain network to support the
potential launch of telaprevir and is currently manufacturing
telaprevir at a commercial (metric ton) scale. The company has
successfully completed all registration campaigns as well as
validation campaigns of the active pharmaceutical ingredient (API) and
is prepared to complete drug product validation in advance of the
potential launch of telaprevir.
Potential Future Combination Regimens for HCV with Telaprevir and the
HCV Polymerase Inhibitor VX-222
Initiation of first clinical trial of telaprevir combined with
VX-222 planned for first quarter 2010
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Vertex recently completed a multiple-dose Phase 1b viral kinetic study
of the investigational oral HCV polymerase inhibitor VX-222. Interim
results from the trial are consistent with the findings of a
previously-conducted three-day viral kinetic study and support future
clinical evaluation of VX-222, including the initiation of the first
clinical trial of VX-222 in combination with telaprevir. Additional
results from this Phase 1b study of VX-222 are planned for
presentation at a medical meeting in 2010.
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Upon completion of ongoing discussions with regulatory authorities,
Vertex plans to initiate a combination trial of telaprevir and VX-222
in the first quarter of 2010. This trial is expected to evaluate SVR
rates using multiple regimens of telaprevir/VX-222-based therapy in
HCV patients.
Addressing the Underlying Defect of Cystic Fibrosis
VX-770 Phase 3 registration program progressing; STRIVE trial
completes planned enrollment