New product in development diversifies
portfolio to drive long-term growth
Innovative potential new therapeutic option
for rare/orphan neuropsychiatric disorders with high unmet medical
needs
Zygel™ in pivotal Phase 3 trial for Fragile X
syndrome and has completed Phase 2 proof-of-concept study in
22q11.2 deletion syndrome
PLYMOUTH
MEETING, Pa., Oct. 11,
2023 /PRNewswire/ -- Harmony Biosciences
Holdings, Inc. ("Harmony") (Nasdaq: HRMY), a pharmaceutical company
dedicated to developing and commercializing innovative therapies
for patients with rare neurological diseases, today announced that
it has completed its acquisition of Zynerba Pharmaceuticals, Inc.
("Zynerba") (Nasdaq: ZYNE).
Zynerba is a leader in pharmaceutically produced transdermal
cannabinoid therapies for orphan neuropsychiatric disorders.
Harmony President & CEO
Jeffrey M. Dayno, MD, described its
lead candidate, Zygel, as a 'portfolio in a product' with the
potential to serve 80,000 U.S. patients who are diagnosed with
Fragile X syndrome (FXS) and another 80,000 diagnosed with 22q
deletion syndrome (22q).
"Zygel is a significant market opportunity that advances our
long-term growth strategy of developing a diversified portfolio
beyond sleep/wake therapies," Dayno said. "This acquisition expands
our pipeline with a product candidate in our area of expertise that
could address high unmet medical needs for people living with rare
neuropsychiatric disorders."
Zygel is the first-and-only pharmaceutically manufactured
synthetic cannabidiol. It is a non-euphoric cannabinoid formulated
as a patent-protected permeation-enhanced gel for transdermal
delivery through the skin and into the circulatory system. The
product is manufactured through a synthetic process in a cGMP
facility and is not extracted from the cannabis plant.
Zygel does not contain THC, the compound that causes the
euphoric effect of cannabis, and has the potential to be a
nonscheduled product if approved.
Cannabidiol, the active ingredient in Zygel, has been granted
orphan drug designation by the United States Food and Drug
Administration (FDA) and the European Medicines Agency (EMA) for
the treatment of FXS and for the treatment of 22q. Additionally,
Zygel has received FDA Fast Track designation for the treatment of
behavioral symptoms in patients with FXS.
Harmony's tender offer to acquire all outstanding shares of
Zynerba for a purchase price of $1.1059 per share in cash, or $60 million in the aggregate, plus one
non-tradeable contingent value right (CVR) per share, representing
the right to receive potential additional payments of up to
$140 million or approximately
$2.5444 in additional cash per share,
subject to the achievement of certain clinical, regulatory and
sales milestones, expired at 5:00
p.m. New York City time on
Tuesday, October 10, 2023. The
depositary for the tender offer has advised that, as of the
expiration of the tender offer, a total of 28,236,148 shares of
Zynerba's common stock were validly tendered and not withdrawn in
the tender offer, which represent approximately 52.3% of the total
number of shares of Zynerba's outstanding common stock (not
including 1,072,940 shares delivered through Notices of Guaranteed
Delivery, representing approximately 2.0% of the shares
outstanding).
Following the acceptance of the tendered shares, Harmony
completed the acquisition of Zynerba through the merger of a wholly
owned subsidiary of Harmony with and into Zynerba in which each
share of Zynerba's common stock issued and outstanding immediately
prior to consummation of the merger (other than shares (a) held in
Zynerba's treasury, (b) owned by Harmony at the time the offer
commenced, (c) irrevocably accepted for payment in the tender offer
or (d) shares held by Zynerba stockholders who properly demanded
appraisal for their shares under Delaware law), including shares
granted under Zynerba's equity compensation arrangements that were
not validly tendered in the tender offer, was converted into the
right to receive $1.1059 per share in cash plus one CVR. As a
result of the merger, Zynerba became a wholly owned subsidiary of
Harmony. The common stock of Zynerba will no longer be listed for
trading on the Nasdaq Capital Market.
About Harmony Biosciences
At Harmony Biosciences, we
specialize in developing and delivering treatments for rare
neurological diseases that others often overlook. We believe that
where empathy and innovation meet, a better life can begin for
people living with neurological diseases. Established by Paragon
Biosciences, LLC, in 2017 and headquartered in Plymouth Meeting, PA, our team of experts from
a wide variety of disciplines and experiences is driven by our
shared conviction that innovative science translates into
therapeutic possibilities for our patients, who are at the heart of
everything we do. For more information, please visit
www.harmonybiosciences.com.
About Fragile X Syndrome
Fragile X syndrome (FXS) is a
rare genetic disorder that is the leading known cause of both
inherited intellectual disability and autism spectrum disorder,
affecting 1 in 3,600 to 4,000 males and 1 in 4,000 to 6,000
females. The disorder negatively affects synaptic function,
plasticity and neuronal connections, and results in a spectrum of
intellectual disabilities and behavioral symptoms, such as social
avoidance and irritability. There are approximately 80,000 people
in the U.S. and approximately 121,000 people in the European
Union and UK living with FXS. There is a significant unmet medical
need in patients living with FXS as there are currently no FDA
approved treatments for this disorder.
FXS is caused by a mutation in FMR1, a gene which modulates
a number of systems, including the endocannabinoid system, and most
critically, codes for a protein called FMRP.
The FMR1 mutation manifests as multiple repeats of a DNA
segment, known as the CGG triplet repeat, resulting in deficiency
or lack of FMRP. FMRP helps regulate the production of other
proteins and plays a role in the development of synapses, which are
critical for relaying nerve impulses, and in regulating synaptic
plasticity. In people with full mutation of
the FMR1 gene, the CGG segment is repeated more than 200
times, and in most cases causes the gene to not function.
Methylation of the FMR1 gene also plays a role in
determining functionality of the gene. In approximately 60% of
patients with FXS, who have complete methylation of
the FMR1 gene, no FMRP is produced, resulting in
dysregulation of the systems modulated by FMRP.
About 22q11.2 Deletion Syndrome
22q11.2 deletion
syndrome (22q) is a disorder caused by a small missing piece of the
22nd chromosome. The deletion occurs near the middle of
the chromosome at a location designated q11.2. It is considered a
mid-line condition, with physical symptoms including characteristic
palate abnormalities, heart defects, immune dysfunction, and
esophageal / GI issues, as well as debilitating neuropsychiatric
and behavioral symptoms, including anxiety, social withdrawal,
ADHD, cognitive impairment and autism spectrum disorder. It is
estimated that 22q occurs in one in 4,000 live births, suggesting
that there are approximately 80,000 people living with 22q in the
U.S. and 129,000 in the European Union and the UK. Patients with
22q deletion syndrome are managed by multidisciplinary care
providers, and there are currently no FDA approved treatments for
this disorder.
Forward Looking Statements
This press
release contains forward-looking statements within the meaning of
the Private Securities Litigation Reform Act of 1995. All
statements contained in this press release that do not relate to
matters of historical fact should be considered forward-looking
statements. These forward-looking statements, including as they
relate to Harmony and Zynerba, the future development of their
technologies and product candidates, including the development of
and market opportunities for Zynerba's technology and product
candidates, the future value (if any) of the contingent value
rights, Harmony's strategy, and the anticipated synergies and
benefits from the transaction, are neither promises nor guarantees,
but involve known and unknown risks, uncertainties and other
important factors that may cause actual results, performance or
achievements to be materially different from any future results,
performance or achievements expressed or implied by the
forward-looking statements. Potential risks, uncertainties and
other factors to be considered include, among others, problems may
arise in successfully integrating the business and technologies of
Harmony and Zynerba, and Harmony may not realize the expected
benefits of the transaction; the transaction may involve unexpected
costs; the businesses may suffer as a result of uncertainty
surrounding the transaction, including difficulties in maintaining
relationships with third parties or retaining key employees; and no
contingent consideration may become payable. For further
discussion of these and other risks and uncertainties, see
Harmony's and Zynerba's most recent Form 10-K and Form 10-Q filings
with the United States Securities and Exchange Commission (the
"SEC"), including under the headings "Risk Factors." You are
cautioned to not place undue reliance on forward-looking
statements, which speak only as of the date of this document.
Except as required by law, neither Harmony nor Zynerba is under any
duty to update any of the information in this
document.
Harmony Biosciences Investor Contact:
Luis Sanay, CFA
445-235-8386
lsanay@harmonybiosciences.com
Harmony Biosciences Media Contact:
Cate McCanless
202-641-6086
cmccanless@harmonybiosciences.com
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SOURCE Harmony Biosciences
