SEATTLE, Aug. 6, 2015 /PRNewswire/ -- Atossa Genetics
Inc. (NASDAQ: ATOS), the Breast Health Company, announced today
that it has signed manufacturing and quality agreements with
AAIPharma Services Corp. / Cambridge Major Laboratories, Inc.
(AAI/CML) for the manufacturing of a clinical supply for
4-Hydroxytamoxifen, the active pharmaceutical ingredient (API) in
Atossa's leading drug candidate, Afimoxifene Gel. In
May 2015, Atossa acquired from Besins
Healthcare the exclusive rights to Afimoxifene Gel for the
potential treatment of hyperplasia of the
breast.
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Dr. Steven Quay, Chairman, CEO
& President of Atossa Genetics, said, "Securing a manufacturing
source for the API marks important progress of our clinical
program. With the manufacturing and quality agreements in
place, AAI/CML will now begin its work to manufacture a clinical
supply of the API. We expect that the initial production of
the API will be completed by the end of 2015 and once combined with
the proprietary gel to form the clinical drug product we can then
begin clinical studies in 2016."
"We appreciate this opportunity and look forward to working on
Atossa's leading drug candidate. This relationship is an excellent
example of our dedication to delivering reliable, flexible and high
quality service from our Germantown,
WI facility. We look forward to supporting Atossa for its
future clinical and commercial success," stated Dr. Stephan Kutzer, CEO, President and Chairman of
AAIPharma Services Corp. / Cambridge Major Laboratories, Inc.
About Atossa Genetics
Atossa Genetics Inc. is focused on improving breast health
through the development of laboratory services, medical devices and
therapeutics. The laboratory services are being developed by its
subsidiary, The National Reference Laboratory for Breast Health
Inc. The laboratory services and the Company's medical devices are
being developed so they can be used as companions to therapeutics
to treat various breast health conditions. For more information,
please visit www.atossagenetics.com.
About AAIPharma Services Corp. and Cambridge Major
Laboratories, Inc.
AAIPharma Services Corp. and Cambridge Major Laboratories, Inc.
have joined to form a world-class supplier of comprehensive
pharmaceutical development and manufacturing services. With
seven sites across the globe, our combined capabilities include API
development and manufacturing, solid state chemistry, formulation
development, analytical development and testing services, clinical
and commercial finished dosage form manufacturing (solid dose and
parenteral), packaging, and stability services. The family of
companies is in the portfolio of American Capital, Ltd. (NASDAQ:
ACAS). Contact us for all your drug development and manufacturing
needs at www.aaipharma.com and www.c-mlabs.com.
Forward-Looking Statements
Forward-looking statements in this press release are subject to
risks and uncertainties that may cause actual results to differ
materially from the anticipated or estimated future results,
including the risks and uncertainties associated with actions by
the FDA, the outcome or timing of regulatory approvals needed by
Atossa to sell its products, responses to regulatory matters,
Atossa's ability to continue to manufacture and sell its products,
recalls of products, the safety and efficacy of Atossa's products
and services, performance of distributors and manufacturers,
whether Atossa can launch in the United
States and foreign markets the additional tests, devices and
therapeutics in its pipeline in a timely and cost effective manner,
and other risks detailed from time to time in Atossa's filings with
the Securities and Exchange Commission, including without
limitation its periodic reports on Form 10-K and 10-Q, each as
amended and supplemented from time to time.