Recro and BioCorRx Expand Development and Manufacturing Relationship to Support BICX104, an Implantable Naltrexone Pellet for the Treatment of Opioid Use Disorder
September 08 2021 - 7:00AM
via NewMediaWire -- Recro Pharma, Inc. (“Recro”; NASD: REPH),
a contract development and manufacturing organization (CDMO)
dedicated to solving complex formulation and manufacturing
challenges in small molecule therapeutic development, and BioCorRx,
Inc. (“BioCorRx”; OTCQB: BICX), a developer and provider of
advanced solutions in the treatment of substance use disorders,
today announced the expansion of the companies' ongoing
relationship with the signing of a new development and
manufacturing agreement. Under terms of the new agreement, Recro
will provide analytical validation services and cGMP manufacturing
of registrational batches of BICX104 to support BioCorRx’s
potential filing of a New Drug Application (NDA) for BICX104 with
the U.S. Food and Drug Administration (FDA).
This new agreement expands the previously signed Master Services
Agreement (MSA) between BioCorRx and IriSys LLC (“IriSys”), the San
Diego-based CDMO that was recently acquired by Recro. Under the
initial MSA signed in 2019, IriSys provided development and
manufacturing services in support of BICX102, the preclinical
precursor to BICX104. Those efforts will now transition to support
BICX104 as it advances toward first-in-human clinical trials. All
activities covered under this new agreement will be conducted at
Recro’s San Diego facility.
BICX104 is a biodegradable, long-acting subcutaneous pellet of
naltrexone for the treatment of opioid use disorder (OUD) being
developed under BioCorRx Pharmaceuticals, Inc., BioCorRx’s
controlled R&D subsidiary. BioCorRx has received clearance from
the FDA to proceed to human trials for BICX104 and expects to
initiate the first-in-human clinical trial of the drug candidate as
soon as scheduling permits. The project has been funded in large
part by the National Institute on Drug Abuse (NIDA), part of the
National Institutes of Health (NIH), under award number UG3DA047925
and is a result of BioCorRx’s application under RFA DA-19-002,
Development of Medications to Prevent and Treat Opioid Use
Disorders and Overdose (UG3/UH3) (Clinical Trial
Optional).
“The legacy IriSys team, now Recro, has had a valued and
productive relationship with BioCorRx in support of the company’s
implantable naltrexone program since 2019 and we are pleased to
expand the scope of the collaboration as BioCorRx prepares to
initiate the first-in-human clinical trial of BICX104,” said David
Enloe, chief executive officer of Recro. “This new agreement is a
testament to the talented team of professionals that was built at
IriSys and offers an immediate demonstration of the impact that our
recent acquisition of IriSys will have on Recro’s ongoing growth
strategy. We look forward to bringing the strength and experience
of the entire Recro organization to the BioCorRx relationship. It
is a privilege to continue to support the important work that
BioCorRx is conducting in an effort to offer a key therapeutic
option in the battle against opioid use disorder.”
“The exceptional service and support provided through our
ongoing CDMO relationship have been critical to BioCorRx’s
successful advancement of our implantable naltrexone program.
Recro’s recent acquisition of IriSys further bolsters our
confidence in our CDMO partnership as we move BICX104 into the
clinical stage and a step closer to market for patients battling
opioid use disorder, as well as alcohol use disorder (AUD),” said
Brady Granier, president and director of BioCorRx, Inc., and chief
executive officer of BioCorRx Pharmaceuticals, Inc.
About Recro
Recro (NASD: REPH) is a bi-coastal contract
development and manufacturing organization (CDMO) with capabilities
spanning pre-Investigational New Drug (IND) development to
commercial manufacturing and packaging for a wide range of small
molecule therapeutic dosage forms. With an expertise in solving
complex manufacturing problems, Recro is a leading CDMO providing
small molecule therapeutic development, end-to-end regulatory
support, clinical and commercial manufacturing, aseptic
fill/finish, lyophilization, packaging and logistics services to
the global pharmaceutical market.
In addition to our experience in handling DEA controlled
substances and developing and manufacturing modified release dosage
forms, Recro has the expertise to deliver on our clients’
pharmaceutical development and manufacturing projects, regardless
of complexity level. We do all of this in our best-in-class
facilities, which total 145,000 square feet, in Gainesville,
Georgia and San Diego, California.
For more information about Recro’s CDMO solutions,
visit recrocdmo.com.
About BioCorRx Inc.
BioCorRx Inc. (OTCQB: BICX) is an addiction
treatment solutions company offering a unique approach to the
treatment of substance use and other related disorders. Beat
Addiction Recovery is a substance use disorder recovery program
that typically includes BioCorRx’s proprietary Cognitive Behavioral
Therapy (CBT) modules along with peer support via mobile app along
with medication prescribed by an independent treating physician
under their discretion. The UnCraveRx™ Weight Loss Program is also
a medication assisted weight loss program; please
visit www.uncraverx.com for more information on
UnCraveRx™. BioCorRx also conducts R&D under its controlled
subsidiary, BioCorRx Pharmaceuticals. For more information on BICX
and product pipeline, please visit www.BioCorRx.com.
Forward-Looking Statements
This press release includes forward-looking
statements within the meaning of Section 27A of the Securities Act
of 1933 and Section 21E of the Securities Exchange Act of 1934.
These statements, among other things, Recro’s and BioCorRx’s
expectations regarding their relationship, the new agreement with
respect to BICX104 and the development of BICX104 and other
statements. The words “anticipate”, “believe”, “could”, “estimate”,
“upcoming”, “expect”, “intend”, “may”, “plan”, “predict”,
“project”, “will” and similar terms and phrases may be used to
identify forward-looking statements in this press release. Recro’s
operations involve risks and uncertainties, many of which are
outside Recro’s control, and any one of which, or a combination of
which, could materially affect Recro’s results of operations and
whether the forward-looking statements ultimately prove to be
correct. Factors that could cause the Recro’s actual outcomes to
differ materially from those expressed in or underlying these
forward-looking statements include risks and uncertainties
associated with the ongoing economic and social consequences of the
COVID-19 pandemic, including any adverse impact on the customer
ordering patterns or inventory rebalancing or disruption in raw
materials or supply chain; demand for services, which depends in
part on customers’ research and development and the clinical plans
and market success of their products; customers’ changing inventory
requirements and manufacturing plans; customers and prospective
customers decisions to move forward with the company’s
manufacturing services; the average profitability, or mix, of the
products Recro manufactures; Recro’s ability to enhance existing or
introduce new services in a timely manner; fluctuations in the
costs, availability, and suitability of the components of the
products Recro manufactures, including active pharmaceutical
ingredients, excipients, purchased components and raw materials, or
Recro’s customers facing increasing or new competition. These
forward-looking statements should be considered together with the
risks and uncertainties that may affect Recro’s or BioCorRx’s
business and future results presented herein along with those risks
and uncertainties discussed in Recro’s or BioCorRx’s filings with
the Securities and Exchange Commission at www.sec.gov. These
forward-looking statements are based on information currently
available to Recro’s or BioCorRx’s, and neither Recro nor BioCorRx
assume any obligation to update any forward-looking statements
except as required by applicable law.
The content presented in this release is solely the
responsibility of the authors and does not necessarily represent
the official views of the National Institutes of Health.
Contacts:
Stephanie Diaz (Investors) Vida Strategic Partners
(for Recro) 415-675-7401 sdiaz@vidasp.com
Tim Brons (Media) Vida Strategic Partners (for Recro)
415-675-7402 tbrons@vidasp.com
Ryan D. Lake (CFO) Recro 770-531-8365
ryan.lake@recroCDMO.com
BioCorRx Inc. Investor Relations: Crescendo Communications, LLC
(212) 671-1020 x304 bicx@crescendo-ir.com
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