Sanofi, Principia agree to develop multiple sclerosis drug candidate
(Thomson Reuters ONE) -
Sanofi, Principia agree to develop
multiple sclerosis drug candidate
* Clinical-stage oral drug candidate (PRN2246)
with the potential to treat multiple sclerosis
* Principia to receive $40 million upfront payment,
future milestone payments could total $765 million
Paris, France and South San Francisco, Calif - November 9, 2017 - Sanofi
will develop Principia Biopharma Inc.'s experimental oral treatment that
shows promise in multiple sclerosis (MS) and, potentially, other central
nervous system (CNS) diseases.
Under the license agreement signed this week, Sanofi will develop
Principia's Bruton's tyrosine kinase (BTK) inhibitor (PRN2246), which was
designed to access the brain and spinal cord by crossing the blood-brain
barrier and impact immune cell and brain cell signalling. PRN2246 is
currently in clinical development.
"Our agreement with Principia is an example of Sanofi's strategic commitment
to build our drug discovery and development pipeline in MS and neurological
diseases," says Rita Balice-Gordon, PhD, Global Head of MS/Neuroscience
Therapeutic Research Area at Sanofi. "Complementing our own internal R&D
expertise, external relationships like this may accelerate delivery of new
treatments to patients living with these serious diseases."
"Sanofi is an ideal partner for PRN2246. The agreement allows Principia to
maximize the BTK opportunity in neurology with a strong partner for PRN2246
while focusing internal resources on our lead BTK inhibitor in another
therapeutic area," said Martin Babler, Chief Executive Officer of Principia
Biopharma. "PRN2246 is a blood brain barrier crossing, highly potent BTK
inhibitor, that we believe is especially well suited for the treatment of MS
and other neurological disorders."
Sanofi to receive exclusive, worldwide license
Under the terms of the agreement, Principia will grant Sanofi an exclusive,
worldwide license to develop and commercialize PRN2246. Sanofi will pay
Principia a $40 million upfront payment, future milestone payments that
could total $765 million and royalties on product sales. Principia has the
option to co-fund Phase 3 development, in exchange for either increased
royalties on worldwide product sales or a profit and loss sharing
arrangement in the United States.
The transaction is expected to close in the fourth quarter of 2017, subject
to customary regulatory approvals.
Sanofi is a leader in MS
Sanofi Genzyme, the specialty care global business unit of Sanofi, currently
has two marketed MS medicines available around the world, and programs in
research and development to address MS, potentially through neuroprotection
and remyelination in addition to anti-inflammatory mechanisms. Sanofi is
committed to discovering and developing new treatment options for people
living with MS.
About Principia Biopharma
Principia Biopharma Inc., a private, clinical-stage biopharmaceutical
company, has created a revolutionary new way to design and develop oral
small molecule therapies that are more potent, selective, durable and safer
than currently available drugs. The Company has utilized its proprietary
Tailored Covalency(TM) technology to develop a portfolio of drug candidates
that exhibit antibody-like specificity to benefit patients with autoimmune
and inflammatory diseases and cancer. PRN1008, a reversible covalent BTK
inhibitor, is currently being evaluated in a Phase 2 clinical trial in
patients with pemphigus, an orphan autoimmune disease. PRN1371, a covalent
FGFR1-4 inhibitor, is currently being evaluated in a Phase 1 clinical trial
in cancer patients with various solid tumors. PRN2246, a low dose covalent
BTK inhibitor which crosses the blood brain barrier, recently has initiated
a Phase 1 clinical trial in healthy volunteers. For more information,
please visit the Company's website at www.principiabio.com.
About Sanofi
Sanofi is dedicated to supporting people through their health challenges. We
are a global biopharmaceutical company focused on human health. We prevent
illness with vaccines, provide innovative treatments to fight pain and ease
suffering. We stand by the few who suffer from rare diseases and the
millions with long-term chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is transforming
scientific innovation into healthcare solutions around the globe.
Sanofi, Empowering Life
Sanofi Media Relations Contact Sanofi Investor Relations Contact
Jack Cox George Grofik
Tel.: +33 (0)1 53 77 46 46 Tel.: +33 (0)1 53 77 45 45
mr(at)sanofi.com ir(at)sanofi.com
Principia Media Contact: Principia Investor Contact:
Kelly Boothe Christopher Chai, Principia
Pure Communications Tel: +1 (650) 416-7730
Tel: +1 (415) 946-1076
kboothe(at)purecommunications.com
Sanofi Forward-Looking Statements
This press release contains forward-looking statements as defined in the
Private Securities Litigation Reform Act of 1995, as amended. Forward-
looking statements are statements that are not historical facts. These
statements include projections and estimates regarding the clinical
development of and potential marketing approvals for the product. Forward-
looking statements are generally identified by the words "expects",
"anticipates", "believes", "intends", "estimates", "plans", "would be" and
similar expressions. Although Sanofi's management believes that the
expectations reflected in such forward-looking statements are reasonable,
investors are cautioned that forward-looking information and statements are
subject to various risks and uncertainties, many of which are difficult to
predict and generally beyond the control of Sanofi, that could cause actual
results and developments to differ materially from those expressed in, or
implied or projected by, the forward-looking information and statements.
These risks and uncertainties include among other things, the uncertainties
inherent in research and development of the product, future clinical data
and analysis, including post marketing, decisions by regulatory authorities,
such as the FDA or the EMA, regarding whether and when to approve the
product or biological application that may be filed for the product as well
as their decisions regarding labeling and other matters that could affect
the availability or commercial potential of the product, the absence of
guarantee that the product if approved will be commercially successful,
risks associated with intellectual property, future litigation, the future
approval and commercial success of therapeutic alternatives, and volatile
economic conditions, as well as those risks discussed or identified in the
public filings with the SEC and the AMF made by Sanofi, including those
listed under "Risk Factors" and "Cautionary Statement Regarding Forward-
Looking Statements" in Sanofi's annual report on Form 20-F for the year
ended December 31, 2016. Other than as required by applicable law, Sanofi
does not undertake any obligation to update or revise any forward-looking
information or statements.
PDF Version:
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The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Sanofi via GlobeNewswire
Unternehmensinformation / Kurzprofil:
Datum: 09.11.2017 - 12:59 Uhr
Sprache: Deutsch
News-ID 567490
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