Atossa Genetics and AAIPharma / Cambridge Major Laboratories Announce Manufacturing Agreement For Atossa’s Lead Drug Candidate Afimoxifene Gel
SEATTLE – August 5, 2015 – 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.
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.
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.
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 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.
Atossa Genetics Inc.
Steven C. Quay, Ph.D., M.D.
Chairman, CEO and President
Scott Gordon, President
Germantown, Wis. Oct. 7, 2014 /Businesswire/ AAIPharma Services Corp. (“AAIPharma”), a leading global provider of pharmaceutical analytical testing, product development and manufacturing services and Cambridge Major Laboratories, Inc. (“CML”), a global leader in pharmaceutical API development and manufacturing, announce the appointments of Ted Dolan as Vice President, API Operations and Syed T. Husain as Vice President, API Business Unit. Read more >>
Weert, Netherlands. Sept. 30, 2014 /Businesswire/ AAIPharma Services Corp. (“AAIPharma”), a leading global provider of pharmaceutical analytical testing, product development and manufacturing services and Cambridge Major Laboratories, Inc. (“CML”), a global leader in pharmaceutical API development and manufacturing, announce the appointment of Marcel Schreuder Goedheijt, Ph.D. as General Manager, Cambridge Major Laboratories – Europe. Read more >>
WILMINGTON, N.C. July 8, 2014/Businesswire/ AAIPharma Services Corp. (“AAIPharma”), a leading global provider of pharmaceutical analytical testing, product development and manufacturing services, and Cambridge Major Laboratories, Inc (“CML”), a global leader in pharmaceutical API development and manufacturing, announce the appointment of Stephan Kutzer, Ph.D. as Chief Executive Officer (CEO), effective August 1, 2014. Read more >>