Pfizer and Vivet to collaborate on development of potential
breakthrough therapy for Wilson disease
Pfizer acquires 15% ownership stake in Vivet
Vivet Therapeutics (“Vivet”), a privately held gene therapy
biotech company dedicated to developing gene therapy treatments for
inherited liver disorders with high unmet medical need, and Pfizer
Inc. (NYSE: PFE) announced today that Pfizer has acquired a 15%
equity interest in Vivet and secured an exclusive option to acquire
all outstanding shares. Pfizer and Vivet will collaborate on the
development of VTX-801, Vivet’s proprietary treatment for Wilson
disease.
Wilson disease is a devastating, rare, chronic, and potentially
life-threatening liver disorder of impaired copper transport that
causes serious copper poisoning. In patients with Wilson disease, a
monogenetic mutation disables the normal copper biliary excretion
pathway leading to excess copper accumulation in the liver and
other organs including the central nervous system. Untreated,
Wilson disease results in various combinations and severity of
hepatic (fibrosis and cirrhosis), neurologic and psychiatric
symptoms, which can be fatal and that can only be cured by liver
transplantation. Existing therapies for Wilson disease have
sub-optimal efficacy or significant side effects for many
patients.
Jean-Phillippe Combal, Co-Founder & CEO of Vivet, said, “We
welcome Pfizer as a shareholder and partner that can help us
advance our efforts to develop therapies for patients burdened with
inherited liver disorders. This investment demonstrates the clear
value of Vivet’s innovative approaches to gene therapy.”
Mikael Dolsten, Pfizer Chief Scientific Officer and President,
Worldwide Research, Development, and Medical, said, “Pfizer strives
to provide meaningful enhancements to the lives of patients with
rare diseases. Our partnership with Vivet offers an important
expansion of Pfizer’s commitment to collaborate with the scientific
community and to accelerate our leading AAV-directed gene therapy
portfolio.”
Bringing together Pfizer’s and Vivet’s expertise in
liver-directed AAV gene therapy for metabolic diseases creates an
opportunity to develop a breakthrough medicine that can
meaningfully improve the lives of patients with Wilson disease.
“VTX-801 could provide a potentially transformative therapeutic
option for patients with Wilson disease by directly addressing the
underlying cause of the disease—the inability to excrete copper
owing to a mutation in the gene that codes for that function,” said
Seng Cheng, Senior Vice President and Chief Scientific Officer of
Pfizer’s Rare Disease Research Unit.
Under the terms of the transaction, Pfizer paid approximately
€45 million (US$51 million) upon signing and may pay up to €560
million (US$635.8 million) inclusive of the option exercise payment
and subject to certain clinical, regulatory, and commercial
milestones. Pfizer can exercise its option to acquire 100% of Vivet
following the company’s delivery of certain data from the Phase
I/II clinical trial for VTX-801. As part of the transaction, Pfizer
senior executive Monika Vnuk, M.D., Vice President, Worldwide
Business Development, will join Vivet’s Board of Directors. Other
terms of the transaction were not disclosed.
Vivet Co-Founder and Chief Scientific Officer Gloria
Gonzalez-Aseguinolaza said, “The potential of VTX-801 has already
been demonstrated in preclinical models and our partnership with
Pfizer will help accelerate development of VTX-801 and expand our
other innovative technologies.”
In addition to its Wilson disease program, Vivet is also
advancing liver-directed gene therapy programs for progressive
familial intrahepatic cholestasis (PFIC) for bile excretion defects
and citrullinemia for defects in the urea cycle, which leads to the
buildup of ammonia and other toxic substances in the blood.
About Vivet Therapeutics
Vivet Therapeutics is an emerging biotechnology company
developing novel gene therapy treatments for rare, inherited
metabolic diseases.
Vivet is building a diversified gene therapy pipeline based on
novel adeno-associated virus (AAV) technologies developed through
its partnerships with, and exclusive licenses from, the Fundación
para la Investigación Médica Aplicada (FIMA), a not-for-profit
foundation at the Centro de Investigación Medica Aplicada (CIMA),
University of Navarra based in Pamplona, Spain.
Vivet’s lead program, VTX-801, is a novel investigational gene
therapy for Wilson disease which has been granted Orphan Drug
Designation (ODD) by the Food and Drug Administration (FDA) and the
European Commission (EC). This rare genetic disorder is caused by
mutations in the gene encoding the ATP7B protein, which reduces the
ability of the liver and other tissues to regulate copper levels
causing severe hepatic damage, neurologic symptoms and potentially
death.
Vivet is supported by international life science investors
including Novartis Venture Fund, Roche Venture Fund, HealthCap,
Columbus Venture Partners, Ysios Capital, Kurma Partners and
Idinvest Partners.
Please visit us on www.vivet-therapeutics.com and follow us on
Twitter at @Vivet_tx and LinkedIn.
Pfizer Inc.: Working together for a healthier
world®
At Pfizer, we apply science and our global resources to bring
therapies to people that extend and significantly improve their
lives. We strive to set the standard for quality, safety and value
in the discovery, development and manufacture of health care
products. Our global portfolio includes medicines and vaccines as
well as many of the world’s best-known consumer health care
products. Every day, Pfizer colleagues work across developed and
emerging markets to advance wellness, prevention, treatments and
cures that challenge the most feared diseases of our time.
Consistent with our responsibility as one of the world’s premier
innovative biopharmaceutical companies, we collaborate with health
care providers, governments and local communities to support and
expand access to reliable, affordable health care around the world.
For more than 150 years, we have worked to make a difference for
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addition, to learn more, please visit us on www.pfizer.com and
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Pfizer Disclosure Notice
The information contained in this release is as of March 20,
2019. Pfizer assumes no obligation to update forward-looking
statements contained in this release as the result of new
information or future events or developments.
This release contains forward-looking information about Pfizer’s
exclusive option to acquire Vivet Therapeutics (Vivet), Pfizer’s
equity investment in Vivet, Pfizer’s collaboration with Vivet on
the development of VTX-801 and Vivet’s gene therapy portfolio,
including their potential benefits, that involves substantial risks
and uncertainties that could cause actual results to differ
materially from those expressed or implied by such statements.
Risks and uncertainties include, among other things, risks related
to the ability to realize the anticipated benefits of the
transaction, including the possibility that the expected benefits
from the transaction will not be realized or will not be realized
in the expected time; the uncertainties inherent in research and
development, including the ability to meet anticipated clinical
endpoints, commencement and/or completion dates for our clinical
trials, regulatory submission dates, regulatory approval dates
and/or launch dates, as well as the possibility of unfavorable new
clinical data and further analyses of existing clinical data; the
risk that clinical trial data are subject to differing
interpretations and assessments by regulatory authorities; whether
regulatory authorities will be satisfied with the design of and
results from the clinical studies; whether and when any
applications may be filed in any jurisdiction for any of Vivet’s
gene therapy product candidates; whether and when any such
applications may be approved by regulatory authorities, which will
depend on myriad factors, including making a determination as to
whether the product’s benefits outweigh its known risks and
determination of the product’s efficacy and, if approved, whether
any such gene therapy product candidate will be commercially
successful; decisions by regulatory authorities impacting labeling,
manufacturing processes, safety and/or other matters that could
affect the availability or commercial potential of any such gene
therapy product candidate; and competitive developments.
A further description of risks and uncertainties can be found in
Pfizer’s Annual Report on Form 10-K for the fiscal year ended
December 31, 2018 and in its subsequent reports on Form 10-Q,
including in the sections thereof captioned “Risk Factors” and
“Forward-Looking Information and Factors That May Affect Future
Results”, as well as in its subsequent reports on Form 8-K, all of
which are filed with the U.S. Securities and Exchange Commission
and available at www.sec.gov and www.pfizer.com.
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