Cerecor to Acquire Ichorion Therapeutics
25 September 2018 - 8:30PM
Transaction worth approximately $26.6
Million in Stock Plus Potential Milestones Accelerates Cerecor’s
Transformation Strategy; Strengthens Rare Disease
Pipeline and Expands Pediatric Portfolio
Cerecor Inc. (NASDAQ: CERC), a biopharmaceutical company focused on
becoming a leader in development and commercialization of
treatments for orphan disorders, announced today that it has agreed
to acquire Ichorion Therapeutics, Inc. Ichorion is a privately-held
biopharmaceutical company focused on developing treatments and
increasing awareness of inherited metabolic disorders known as
Inborn Errors of Metabolism (IEMs). The terms of the agreement
include the issuance of approximately 5,800,000 shares of Cerecor
common stock at closing, subject to an end of 2019 lock-up, and
development milestones worth up to an additional $15 million,
payable either in Cerecor stock or in cash in certain
circumstances.
The transaction was unanimously approved by the Board of
Directors of both Cerecor and Ichorion and is expected to close
later today.
Ichorion has established a unique pipeline of
genetically-targeted therapies that complement Cerecor’s mission of
developing treatments for pediatric and orphan indications. Their
pipeline augments the existing neurology assets in Cerecor’s
pipeline, adding multiple substrate replacement therapies with the
potential to leverage the 505(b)(2) pathway to accelerate
development and approval. There is the potential for the
first 505(b)(2) program’s New Drug Application (NDA) to be
submitted within calendar year 2020. Ichorion has also expanded a
platform chemistry to address IEMs that are unresponsive to
traditional substrate replacement. The combined pipeline is
exclusively focused on therapeutic approaches that have
demonstrated clinical or genetic validation in neurological and
pediatric orphan disorders with high unmet medical needs.
Peter Greenleaf, Cerecor’s Chief Executive Officer, stated, “We
are extremely excited to complete this acquisition, as these
clinical and preclinical assets solidify our pipeline of rare
disease and orphan drugs. Specifically, these compounds fit
nicely into our Pediatric Portfolio, complementing both our orphan
drug pipeline and commercial footprint in Pediatrics. The bonus is
the potential for expedited development and approval by taking
advantage of the 505(b)(2) hybrid pathway. Two of Ichorion’s
programs have already been granted Rare Pediatric Disease
Designation and are eligible for Priority Review Vouchers upon
approval. We also anticipate potential regulatory designations that
can further accelerate our ability to put these medicines in the
hands of physicians and caregivers to treat children afflicted with
these rare diseases.”
Benefits of the Transaction
- Compelling, non-cash transaction for Cerecor
shareholders: Cerecor continues to build a
commercial footprint that provides non-dilutive cash to fund
pipeline development. This stock transaction accelerates Cerecor’s
transformation towards an organization focused on advancing a
robust pipeline and bringing new therapies to market.
- Value creation through pipeline
assets: The integration of Ichorion’s substrate
replacement therapies enhances the Cerecor rare disease pipeline
and broadens a portfolio of pediatric products in development. Two
of Ichorion’s 505(b)(2) candidates have been granted Rare Pediatric
Disease Designation by the FDA, making them eligible to receive
Priority Review Vouchers upon approval of an NDA. Under
Section 529 to the Federal Food, Drug, and Cosmetic Act (FD&C
Act), FDA awards priority review vouchers to sponsors of rare
pediatric disease product applications that meet certain criteria.
Under this program, a sponsor who receives an approval for a drug
or biologic for a "rare pediatric disease" may qualify for a
voucher that can be redeemed by the sponsor or another company to
receive a priority review of a subsequent marketing
application for a different product. The 505(b)(2) pathway provides
additional flexibility to draw on existing data resources that can
expedite development and approval. Cerecor plans to open INDs for
two of these programs in 2019.Additionally, Ichorion’s chemistry
platform has generated a preclinical candidate for a rare
mitochondrial disorder associated with high pediatric mortality.
The platform utilizes a prodrug approach to overcome limitations of
direct substrate replacement and the lead candidate is preparing to
enter an IND-enabling program.
- Aligns with Cerecor’s Transformation and Innovation
Strategy: Cerecor’s pipeline
strategy is focused on bringing new products to market for orphan
indications in the neurological and pediatric space, two areas ripe
for innovative approaches to unmet medical needs. Ichorion’s
pipeline programs in pediatric rare diseases will supplement
Cerecor’s existing neurology pipeline including CERC-301, an
ongoing clinical development program for neurogenic orthostatic
hypotension, CERC-406 for Parkinson’s and other diseases, and
CERC-611 for rare and more common forms of epileptic seizures. Each
program in Cerecor’s pipeline takes advantage of clinical or
genetic validation of the underlying mechanism-of-action.
- Commercial Fit: Ichorion’s pipeline aligns
with Cerecor’s existing commercial efforts focused in Pediatrics.
Cerecor’s Pediatric Franchise provides a leading commercial
position in an established market and the platform to introduce new
products that are transformational for patients. This foothold
should help identify patients by increasing awareness through
patient advocacy and by educating pediatric healthcare providers on
solutions available for patients that can help facilitate diagnosis
and treatment.
- Extends Cerecor’s geographic and commercial
reach: The current focus of Cerecor is primarily the
U.S., however the addition of the Ichorion assets and the
ultra-rare nature of these disorders could provide the opportunity
for expansion of the commercial and medical footprint with academic
collaborators abroad.
Patrick J. Crutcher, former Chairman of the Board and President
of Ichorion, along with Stephen Thomas, PhD, former Chief
Scientific Officer of Ichorion, will be joining the Cerecor
leadership team. Mr. Crutcher will serve as Vice President,
Business Development. Mr. Crutcher brings strategic expertise
in corporate and business development, regulatory strategy,
competitive intelligence, market analysis, and new business
evaluation with a focus orphan drug development. He holds a BSc in
Mathematics from University of Illinois and a MSc & CPhil in
Statistics from UCLA.
Dr. Stephen Thomas, former Chief Scientific Officer and
co-founder of Ichorion, will serve as Vice President, Head of
Discovery at Cerecor, overseeing early-stage development and
portfolio management of Cerecor's R&D pipeline. Dr. Thomas has
extensive experience in drug development for rare and orphan
diseases, from discovery to clinical development and regulatory
strategy. Dr. Thomas obtained his Ph.D. in Chemistry and Chemical
Biology from Columbia University.
Mr. Crutcher commented, “Both Boards unanimously supported this
acquisition based on the potential to build one of the most
exciting pipelines in the orphan space while addressing significant
medical needs. The strategic fit is evident and the leadership at
Cerecor know how to build impactful biopharmaceutical
organizations. We are truly excited to join Cerecor in their
efforts to develop and commercialize therapies for patients with
orphan disorders where we believe we can make an impact,
particularly on children and their families.”
About Cerecor
Cerecor is a biopharmaceutical company focused on becoming a
leader in the development of neurologic and pediatric therapies
that make a difference in the lives of patients. The Company’s
pipeline is led by CERC-301, which Cerecor is currently exploring
as a novel treatment for orphan neurological indications. Cerecor
is also developing two pre-clinical stage compounds, CERC-611 and
CERC-406. The Company’s R&D efforts are supported by revenue
from its franchise of commercial medications led by Poly-Vi-Flor®
(multivitamin and fluoride supplement tablet, chewable) and
Tri-Vi-Flor® (multivitamin and fluoride supplement
suspension/drops). In February 2018, the Company added to its
marketed product portfolio by acquiring Karbinal™ ER, AcipHex®
Sprinkle™, Cefaclor for Oral Suspension, and Flexichamber™.
For more information about Cerecor, please visit
www.cerecor.com.
Forward-Looking Statements
This press release may include forward-looking statements made
pursuant to the Private Securities Litigation Reform Act of 1995.
Forward-looking statements are statements that are not historical
facts. Such forward-looking statements are subject to significant
risks and uncertainties that are subject to change based on various
factors (many of which are beyond Cerecor’s control), which could
cause actual results to differ from the forward-looking statements.
Such statements may include, without limitation, statements with
respect to Cerecor’s plans, objectives, projections, expectations
and intentions and other statements identified by words such as
“projects,” “may,” “will,” “could,” “would,” “should,” “continue,”
“seeks,” “aims,” “predicts,” “believes,” “expects,” “anticipates,”
“estimates,” “intends,” “plans,” “potential,” or similar
expressions (including their use in the negative), or by
discussions of future matters such as: the development of product
candidates or products; timing and success of trial results and
regulatory review, potential attributes and benefits of product
candidates; the expansion of Cerecor’s drug portfolio; and other
statements that are not historical. These statements are based upon
the current beliefs and expectations of Cerecor’s management but
are subject to significant risks and uncertainties, including: drug
development costs, timing and other risks; Cerecor’s cash position
and the potential need for it to raise additional capital; risks
associated with acquisitions, including the need to quickly and
successfully integrate acquired assets and personnel; and those
other risks detailed in Cerecor’s filings with the Securities and
Exchange Commission. Actual results may differ from those set forth
in the forward-looking statements. Except as required by applicable
law, Cerecor expressly disclaims any obligations or undertaking to
release publicly any updates or revisions to any forward-looking
statements contained herein to reflect any change in Cerecor’s
expectations with respect thereto or any change in events,
conditions or circumstances on which any statement is based.
For media and investor inquiriesJohn Woolford
Westwicke Partnersjohn.woolford@westwicke.com443-213-0506
office410-375-3658 mobile
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