ALBANY, N.Y., Jan. 19, 2015 /PRNewswire/ -- AMRI (NASDAQ: AMRI)
today announced it received a 10-year federal contract award from
the National Institutes of Health (NIH) for drug development and
manufacturing services. This NIH/National Institute of Neurological
Disorders and Stroke (NINDS) award will support NIH's Drug
Manufacturing and Formulation Program (DMFP), which is a component
of the Blueprint Neurotherapeutics Network (BPN). AMRI has
supported the NIH BPN since 2011, providing chemistry services and
discovery technologies. Since 2005 AMRI has collaborated with NINDS
in the area of medicinal chemistry on novel treatments for spinal
muscular atrophy, a degenerative neuromuscular disease.
The ultimate goal of the DMFP is to support the NINDS and their
BPN Contributors - drug companies and academic researchers – in the
development and manufacture of dosage forms of small molecule drug
candidates suitable for administration in preclinical and clinical
studies of neurological disease/disorders. This 10-year contract
provides AMRI with funding of up to $37.3
million, based on the number of approved projects and
availability of funds, to advance BPN projects having positive
results in early stage drug discovery into clinical trials.
Services to be provided under this contract will include the
manufacture of active pharmaceutical ingredients (API); drug
product formulation; analytical testing; and clinical trial supply
chain management, including packaging, labeling, storage, and
distribution of the completed drug product.
"AMRI was selected for this contract award because of our proven
track record on projects with NIH and our demonstrated
expertise in drug manufacture and formulation, which is enriched by
our integrated pharmaceutical services platform," said AMRI's
President and CEO, William S. Marth.
"Since our initial NIH BPN award in 2011, AMRI has provided
discovery chemistry services to NINDS and its private sector BPN
members on 15 drug candidate programs, and two of these programs
have advanced to the stage where a pre-clinical candidate has been
declared, with a third candidate pending.
This significant award demonstrates the NIH's continued focus on
addressing high unmet clinical needs for patients with inadequate
treatment options. We are pleased to support NIH/NINDS' efforts and
provide our end-to-end expertise to the neuroscience research
community and to patients who suffer from devastating neurological
and degenerative diseases," added Mr. Marth.
Under the DMFP, AMRI will be responsible for completing
manufacturing, documentation, formulation, fill and finish,
packaging, and labeling required for BPN compounds. AMRI will
leverage its integrated service offering for formulation
development, analytical services and API manufacturing, and
distribution of the completed drug product.
About The National Institutes of Health (NIH)
The
National Institutes of Health (www.nih.gov) includes 27 Institutes
and Centers and is a component of the U.S. Department of Health and
Human Services. It is the primary federal agency for conducting and
supporting basic, clinical and translational medical research, and
it investigates the causes, treatments, and cures for both common
and rare diseases.
About AMRI
Albany Molecular Research Inc. (AMRI) is a
global contract research and manufacturing organization that has
been working with the Life Sciences industry to improve patient
outcomes and the quality of life for more than two decades. With
locations in North America,
Europe and Asia, our key business segments include
Discovery and Development Services (DDS), Active Pharmaceutical
Ingredients (API), and Drug Product Manufacturing. Our DDS segment
provides comprehensive services from hit identification to IND,
including expertise with diverse chemistry, library design and
synthesis, in vitro biology and pharmacology, drug
metabolism and pharmacokinetics, as well as natural products. API
Manufacturing supports the chemical development and cGMP
manufacture of complex API, including potent, controlled
substances, biologics, peptides, steroids, and cytotoxic compounds.
Drug Product Manufacturing supports pre-clinical through commercial
scale production of complex liquid-filled and lyophilized
parenteral formulations. For more information about AMRI, please
visit our website at www.amriglobal.com or follow us on Twitter
(@amriglobal).
About AMRI Drug Product Manufacturing
Albany
Molecular Research Inc.'s (AMRI) Drug Product Manufacturing
business supports the clinical formulation development and cGMP
aseptic formulation and filling of complex Active Pharmaceutical
Ingredients (API), including potent, controlled substances,
biologics, peptides, steroids, and cytotoxic compounds. On the Drug
Product side, we have expertise with supporting formulation through
commercial scale production of complex liquid-filled and
lyophilized parenteral formulations. We specialize in vial and
pre-filled syringe manufacturing and have lyophilization
capabilities for vials. AMRI has the capability to perform small
batch manufacturing, but has the capacity to perform filling for
larger batches to support Phase III, registration batches and
commercial.
AMRI Forward-Looking Statement
Statements in this
press release that are not historical facts are forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995 that involve risks and uncertainties. These
statements may be identified by forward-looking words such as
"may," "could," "should," "would," "will," "intend," "expect,"
"anticipate," "believe" and "continue" or similar words. Readers
should not place undue reliance on our forward-looking statements.
AMRI's actual results may differ materially from such
forward-looking statements as a result of numerous factors, some of
which AMRI may not be able to predict and may not be within the
AMRI's control. Factors that could cause such differences include,
but are not limited to: the quantity, nature and value of projects
or programs selected by the NIH/NINDS to participate in the BPN;
the quantity and value of projects or programs awarded to AMRI by
NIH/NINDS under the contract; AMRI's capacity and ability to
perform the services under the contract; the risk that clients may
terminate or reduce demand under any strategic or multi-year deal;
AMRI's ability to effectively maintain compliance with applicable
FDA and DEA regulations; the ability of AMRI's strategic
investments and acquisitions to perform as expected; as well as
those risks discussed in the company's Annual Report on Form
10-K for the fiscal year ended December 31,
2013 as filed with the Securities and Exchange Commission on
March 17, 2014, and the company's
other SEC filings.
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SOURCE AMRI