Expands Pfizer’s rare disease portfolio with potential
first-in-class therapy for achondroplasia, a genetic condition and the
most common form of short-limb dwarfism
NEW YORK & BASEL, Switzerland–(BUSINESS WIRE)–Pfizer (NYSE: PFE) today announced that it has entered into a definitive
agreement to acquire all the shares of Therachon Holding AG, a
privately-held clinical-stage biotechnology company focused on rare
diseases, with assets in development for the treatment of achondroplasia
and short bowel syndrome (SBS). Under the terms of the agreement, Pfizer
will acquire Therachon for $340 million upfront with an additional $470
million in additional payments contingent on the achievement of key
milestones in the development and commercialization of TA-46 for the
treatment of achondroplasia, a genetic condition and the most common
form of short-limbed dwarfism. Achondroplasia can result in serious
cardiovascular, neurological and metabolic complications for
approximately 250,000 people worldwide. There are currently no approved
treatments for achondroplasia.
TA-46 is an investigational, soluble recombinant human fibroblast growth
factor receptor 3 (FGFR3) decoy, a mechanism of action that is believed
to normalize the overactive FGFR3 signaling pathways that underlie bone
development abnormalities associated with achondroplasia. Therachon is
developing TA-46 as a weekly subcutaneous injection for children and
adolescents living with the condition. TA-46 has completed Phase 1 and
has received Orphan Drug Designation from the European Medicines Agency
(EMA) and the U.S. Food and Drug Administration (FDA).
Prior to the closing of the transaction with Pfizer, Therachon will
spin-off its apraglutide development program into a separate,
independent company. Apraglutide is a once-weekly, potential
best-in-class GLP-2 analog in Phase 2 development for short bowel
syndrome. Pfizer Ventures, the venture capital arm of Pfizer Inc.,
currently holds a minority stake and will continue to hold an equity
stake in the new company.
“At Pfizer, our strategy is focused on advancing the most promising
science in the world, regardless of whether it is found inside or
outside of our labs,” said Mikael Dolsten, Pfizer Chief Scientific
Officer and President, Worldwide Research, Development, and Medical. “By
acquiring Therachon, we hope to leverage Pfizer’s leading scientific and
development capabilities to more rapidly advance this potentially
promising therapy for people with achondroplasia.”
Therachon Chief Executive Officer Luca Santarelli added, “We are
thrilled that the work we have done to discover and advance a novel and
potentially life-transforming medicine for achondroplasia is now being
continued by Pfizer. With its rare disease expertise and worldwide
reach, Pfizer is well positioned to accelerate the development of TA-46
and fulfill Therachon’s vision of addressing the complications suffered
by children with achondroplasia by targeting the molecular root causes
of this condition.”
The acquisition complements Pfizer’s existing research portfolio in rare
diseases. “Through the acquisition of Therachon, we believe that we have
a significant opportunity to transform the lives of young people with
achondroplasia who courageously endure lifelong complications from
short-limb dwarfism,” said Seng Cheng, Senior Vice President and Chief
Scientific Officer of Pfizer’s Rare Disease Research Unit. “Pfizer’s
existing research programs for pediatric growth disorders provide a
complementary setting for this potential breakthrough therapy.”
“Therachon is a great example of the value that can be built from
cutting edge European science,” said Therachon Chairman Tom Woiwode,
Managing Director at Versant Ventures. “By coupling that research with a
strong group of investors and an exceptional management team, Therachon
developed a highly innovative therapy for a seriously debilitating
condition. We look forward to Pfizer continuing to develop TA-46 in the
hope that it will significantly improve the lives of children suffering
from achondroplasia.”
No other terms of the transaction were disclosed.
Goldman Sachs is acting as exclusive financial advisor and Cooley LLP
and Homburger AG are acting as legal advisors to Therachon. Arnold &
Porter and Lenz & Staehelin are serving as legal advisors to Pfizer.
Pfizer Inc.: Working together for a healthier world®
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About Therachon
Therachon is a clinical-stage global biotechnology company focused on
the discovery and development of innovative treatment for severe, rare
conditions with significant unmet need. The company is currently
advancing a pipeline of therapeutics focused on rare gastrointestinal
and musculoskeletal disorders and conditions, including both
achondroplasia and short bowel syndrome. Therachon is committed to
making a difference in the lives of patients living with serious rare
conditions. For more information, visit www.therachon.com.
Visit us on Twitter.
Visit us on LinkedIn.
Pfizer Disclosure Notice
The information contained in this release is as of May 8, 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
acquisition of Therachon Holding AG (Therachon), TA-46 for the treatment
of achondroplasia and apraglutide for the treatment of for short
bowel syndrome, 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 satisfaction of the conditions to closing the transaction in the
anticipated timeframe or at all and the possibility that the transaction
does not close; 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 within the expected time period; the risk that the businesses
will not be integrated successfully; disruption from the transaction
making it more difficult to maintain business and operational
relationships; unknown liabilities; the risk of litigation and/or
regulatory actions related to the proposed transaction; other business
effects, including the effects of industry, market, economic, political
or regulatory conditions; future business combinations or disposals; 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 TA-46 or apraglutide; 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.
Contacts
Pfizer
Media Relations:
Patricia Kelly
+1 (212)
733-3810
patricia.kelly@pfizer.com
Investor
Relations:
Ryan Crowe
+1 (212) 733-8160
ryan.crowe@pfizer.com
Therachon
Media
Relations:
Morgan Warners
+1 (202) 337-0808
mwarners@gpg.com