- Vertex holds rights to earn up to $250 million in milestones
associated with filing, approval and launch of telaprevir in Europe -
Vertex
Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced its
intention to sell the rights to certain milestone payments tied to the
future regulatory filing, approval and market launch of its hepatitis C
virus (HCV) protease inhibitor drug candidate, telaprevir, in Europe. As
part of a collaboration signed in June 2006 to develop and commercialize
telaprevir for the treatment of HCV, Janssen Pharmaceutica N.V., a
Johnson & Johnson company, agreed to pay Vertex a total of $250 million
in aggregate milestone payments for successful development and launch of
telaprevir in the European Union.
The milestones anticipated for telaprevir in Europe include $100 million
related to regulatory filing and approval and $150 million related to
launch of telaprevir.
Vertex anticipates, based on projected development and commercial
timelines for telaprevir, and assuming successful development, that it
will earn these milestones prior to April 2012. If the intended sale of
the future milestone payments announced today is successful, Vertex
would receive a one-time cash payment that reflects a substantial
percentage of these future milestones payable by Janssen.
Telaprevir is being evaluated in three Phase 3 studies that have
enrolled more than 2,200 patients in the United States and Europe. The
telaprevir dosing portion of all of these studies has been completed,
and sustained viral response (SVR) data from all three Phase 3 studies
are expected to be available in mid-2010, supporting planned New Drug
Application (NDA) and Marketing Authorization Application (MAA) filings
in the United States and Europe, respectively, in the second half of
2010. Vertex retains commercial rights to telaprevir in North America.
Morgan Stanley is acting as a structural advisor to Vertex in connection
with this transaction.
About Vertex
Vertex Pharmaceuticals Incorporated is a global biotechnology company
committed to the discovery and development of breakthrough small
molecule drugs for serious diseases. The Company's strategy is to
commercialize its products both independently and in collaboration with
major pharmaceutical companies. Vertex's product pipeline is focused on
viral diseases, cystic fibrosis, inflammation, autoimmune diseases,
cancer, and pain. Vertex co-discovered the HIV protease inhibitor,
Lexiva, with GlaxoSmithKline.
Lexiva is a registered trademark of the GlaxoSmithKline group of
companies.
Special Note Regarding Forward-looking Statements
This press release contains forward-looking statements, including
statements of our expectations regarding the intended sale of the
telaprevir milestone payments and the anticipated timing of receipt of
these milestone payments assuming the successful development and
commercial launch of telaprevir. While Vertex believes those
forward-looking statements are accurate, the statements are subject to
risks and uncertainties that could cause actual outcomes to vary
materially from the outcomes described. Those risks and uncertainties
include, among other things, the risk that telaprevir development could
be significantly delayed due to regulatory approval issues that are
currently unanticipated, that telaprevir might not be approved as a
result of unfavorable Phase 3 clinical trial results, that market
conditions will not support the sale of the telaprevir milestone
payments at a price acceptable to Vertex, and other factors set forth in
Vertex’s annual report and quarterly reports filed with the Securities
and Exchange Commission and available through the Company’s website at www.vrtx.com.
Vertex disclaims any obligation to update the information contained in
this press release.
Vertex’s press releases are available at www.vrtx.com
(VRTX-GEN)
Vertex Contacts:
Investors
Michael Partridge,
617-444-6108
Lora Pike, 617-444-6755
or
Media
Jane
A. Kramer, 617-444-6924
Zachry Barber, 617-444-6470
