- Vertex Retains all North American Rights -
- Janssen Obtains Exclusive Rights in Europe and Other Regions -
- Vertex to Receive $165 Million Upfront; Tiered Royalty Averaging
mid-20 Percent Range Based on Successful Commercialization -
NEW BRUNSWICK, N.J. and CAMBRIDGE, Mass., June 30
/PRNewswire-FirstCall/ -- Vertex Pharmaceuticals Incorporated (Nasdaq:
VRTX) and Janssen Pharmaceutica, N.V., a Johnson & Johnson (NYSE: JNJ)
company, announced today that they will collaborate to develop and
commercialize Vertex's investigational hepatitis C virus (HCV) protease
inhibitor, VX-950. Under the agreement, Janssen will have exclusive rights
in Europe, South America, the Middle East, Africa and Australia, and Vertex
will retain exclusive commercial rights to VX-950 in North America. Tibotec
Pharmaceuticals, Ltd., another Johnson & Johnson company, will lead the
development and commercialization of VX-950 for Janssen.
"Janssen and Tibotec are committed to developing and commercializing
innovative and transformational products for viral diseases, and will
contribute important capabilities and resources that will strengthen our
global clinical, regulatory, manufacturing and commercial execution for the
VX-950 program," said Joshua Boger, Ph.D, President and Chief Executive
Officer of Vertex. "Our vision for transforming hepatitis C therapy is
closely aligned with that of Janssen and Tibotec, and we look forward to
working with them to ensure VX-950's rapid advancement in Europe and other
territories."
"Vertex shares with us the vision that VX-950 could represent a
significant step forward in treating the growing number of patients with
hepatitis C in the coming years," said Joseph Scodari, Worldwide Chairman,
Pharmaceuticals Group of Johnson & Johnson. "This agreement further
reinforces our established strong commitment to finding innovative
treatments for global viral diseases."
Terms of the Agreement
Under the terms of the agreement, Janssen receives exclusive rights to
commercialize VX-950 in Europe, South America, the Middle East, Africa and
Australia. Vertex will receive an upfront payment of $165 million upon
signing the contract. In addition, Vertex could receive up to $380 million
based on successful development and launch of VX-950 in the territories.
The agreement also includes a royalty on product sales in Europe and other
territories outside of North America and the Far East. Vertex will continue
to lead the global development plan for VX-950.
Vertex and Tibotec also announced today that the companies will
establish a global health initiative to increase the prevention, diagnosis,
treatment and cure of HCV infection to be principally directed toward
developing countries.
Key Financial Terms:
-- Upfront and milestones: Vertex expects to receive a total of $545
million in payments, including an upfront payment of $165 million upon
signing the contract, and a further $380 million in additional
contingent milestone payments based on the successful development and
approval of VX-950, and launch in the regions where Janssen
Pharmaceutica has commercial rights.
-- Royalties: a tiered royalty averaging a mid-20 percent range of net
sales in Janssen's regions and contingent upon successful
commercialization. In addition, Janssen will be responsible for
certain third party royalties in its regions.
-- Drug development costs: reimbursement of 50 percent of drug development
costs incurred by Vertex.
-- Commercial supply responsibilities: Vertex and Janssen will be
responsible for drug supply in their respective territories.
Mitsubishi Pharma holds development and commercial rights to VX-950 in
Japan and certain Far East countries, and is expected to commence clinical
development in its territories in the second half of 2006.
About VX-950
VX-950 is an investigational oral inhibitor of hepatitis C virus
protease, an enzyme essential for viral replication, and is one of the most
advanced investigational agents that specifically targets HCV. In clinical
studies to date, researchers have observed rapid and dramatic antiviral
activity with VX-950. In clinical studies of VX-950 to date, no patients
have discontinued treatment and no serious adverse events have been
reported.
In May 2006, Vertex announced the details of a global Phase 2 program
for VX-950 consisting of three large clinical studies that are expected to
enroll approximately 1000 patients with HCV at clinical centers in the
United States and Europe. Vertex initiated the U.S.-based PROVE 1 study in
May. The PROVE 2 study is being initiated in Europe.
About Hepatitis C
Hepatitis C is a liver disease caused by the infection by hepatitis C
virus (HCV), which is found in the blood of people with the disease. HCV, a
serious public health concern affecting 170 million people worldwide, is
spread through direct contact with the blood of an infected person. Though
many people with hepatitis C may not experience symptoms, others may have
symptoms such as jaundice, abdominal pain, fatigue and fever. Hepatitis C
significantly increases a person's risk of developing chronic liver
disease, cirrhosis, liver cancer and death. The burden of liver disease
associated with HCV infection is increasing, and current therapies only
provide sustained benefit in about 50% of patients with genotype 1 HCV, the
most common strain of the virus. Specifically targeted antiviral therapies
for HCV in clinical development may have the potential to increase the
proportion of patients in who the virus can be eradicated.
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 principally focused on viral
diseases, inflammation, autoimmune diseases and cancer. Vertex co-promotes
the HIV protease inhibitor, Lexiva, with GlaxoSmithKline.
About Johnson & Johnson
Johnson & Johnson is the world's most comprehensive and broadly based
manufacturer of health care products, as well as a provider of related
services, for the consumer, pharmaceutical, and medical devices and
diagnostics markets. The more than 230 Johnson & Johnson operating
companies employ approximately 116,000 men and women in 57 countries and
sell products throughout the world.
About Janssen Pharmaceutica
Within the Johnson & Johnson group, Janssen Pharmaceutica is a
worldwide Center of Excellence for integrated R&D, production and general
services. In Belgium, the company has sites in Beerse, Geel and Olen, which
together account for a workforce of 4,350 persons. With more than 80 drugs
to its credit, the company is one of the most innovative in the world and
its products are used worldwide in human and animal medicine, and plant and
material protection.
About Tibotec
Tibotec Pharmaceuticals Ltd., based in Cork, Ireland, is a
pharmaceutical research and development company. The Company's main
research and development facilities are in Mechelen, Belgium with offices
in Yardley, PA. Tibotec is dedicated to the discovery and development of
innovative HIV/AIDS drugs and anti-infectives for diseases of high unmet
medical need.
Conference Call and Webcast
Vertex Pharmaceuticals will host a conference call today, June 30, 2006
at 9:00 a.m. EDT to review the collaboration with Janssen on VX-950. This
call will be broadcast via the Internet at http://www.vrtx.com in the
investor center. Alternatively, to listen to the call on the telephone,
dial (800) 374-0296 (U.S. and Canada) or (706) 634-2224 (International).
Alternatively, Vertex is providing a podcast MP3 file available for
download on the Vertex website, http://www.vrtx.com.
The call will be available for replay via telephone commencing June 30,
2006 at 12:00 p.m. EDT running through 5:00 p.m. EDT on July 7, 2006. The
replay phone number for the US and Canada is (800) 642-1687. The
international replay number is (706) 645-9291 and the conference ID number
is 2582280. Following the live webcast, an archived version will be
available on Vertex's website until 5:00 p.m. EDT on July 14, 2006.
Safe Harbor Statement
This press release contains "forward-looking statements" as defined in
the Private Securities Litigation Reform Act of 1995. Such forward-looking
statements, include the statement that VX-950 could represent a significant
step forward in treating the growing number of patients with hepatitis C in
the coming years; that Tibotec and Janssen will contribute important
capabilities and resources that will strengthen Vertex's global clinical,
regulatory and commercial execution for the VX-950 program; and that upon
successful development, approval and launch of VX-950 in the regions where
Janssen has commercial rights, Vertex could receive up to $380 million
based on successful development and launch of VX-950 in the territories,
and could receive tiered royalties in the mid-20 percent range. These
statements are based on current expectations of future events. If
underlying assumptions prove inaccurate or unknown risks or uncertainties
materialize, actual results could vary materially from Vertex's and Johnson
& Johnson 's expectations and projections. Risks and uncertainties include
general industry conditions and competition; economic conditions, such as
interest rate and currency exchange rate fluctuations; technological
advances and patents attained by competitors; challenges inherent in new
product development, including obtaining regulatory approvals; domestic and
foreign health care reforms and governmental laws and regulations; and
trends toward health care cost containment. These risks and uncertainties
also include the risks that clinical trials for VX-950 may not proceed as
planned due to technical, scientific, or patient enrollment issues, or
disagreements with regulatory authorities over trial design or other
matters; that the scale and scope of future clinical and nonclinical
studies may change and will be determined in significant part by data
collected in ongoing and future trials; that further clinical studies of
VX-950 may not reflect the results obtained in early clinical and
nonclinical studies; that ongoing nonclinical studies, including toxicology
studies, will yield currently unanticipated negative outcomes that could
adversely affect planned clinical trials; that results from the Vertex's
clinical trials commenced during 2006 will be insufficient to support a
Phase III program without additional trials and consequent delay in the
timetable for potential approval; and that any potential product may not
achieve sales in Janssen's territory sufficient to earn the royalties
referenced above. A further list and description of these risks,
uncertainties and other factors can be found in the section entitled "Risk
Factors" in Vertex's Annual Report on Form 10-K for the fiscal year ended
December 31, 2005 and in Exhibit 99 of Johnson & Johnson's Annual Report on
Form 10-K for the fiscal year ended January 1, 2006. Copies of these Form
10-K filings, as well as subsequent filings, are available online at
http://www.sec.gov or on request from the Vertex or Johnson & Johnson.
Neither Vertex nor Johnson & Johnson assumes any obligation to update any
forward-looking statements as a result of new information or future events
or developments.
Lexiva is a registered trademark of the GlaxoSmithKline group of
companies.
Vertex Contacts:
Lynne Brum, Vice President, Strategic Communications, (617) 444-6614
Michael Partridge, Director, Corporate Communications, (617) 444-6108
Lora Pike, Manager, Investor Relations, (617) 444-6755
Zachry Barber, Senior Media Relations Specialist, (617) 444-6470
Johnson & Johnson Contacts:
PR
Ben Plumley 011 32 473554670
Doug Arbesfeld 908-218-7592
Siegfried Marynissen 011 32 14605409
Daniel De Schryver 011 3227492770
IR
Stan Panasewicz 732-524-2524
Louise Mehrotra 732 524-6491
SOURCE Vertex Pharmaceuticals Incorporated
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Related links:
http://www.vrtx.com
http://www.prnewswire.com/comp/938395.html/
CONTACT:
Lynne Brum, Vice President, Strategic
Communications, +1-617-444-6614, Michael Partridge, Director,
Corporate Communications, +1-617-444-6108, Lora Pike, Manager,
Investor Relations, +1-617-444-6755, or Zachry Barber, Senior
Media Relations Specialist, +1-617-444-6470, all of Vertex; or
PR: Ben Plumley +32-473554670, Siegfried Marynissen,
+32-14605409, Daniel De Schryver, +32-27492770, or IR, Stan
Panasewicz, +1-732-524-2524, Louise Mehrotra, +1-732-524-6491,
all of Johnson & Johnson
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