Almac Pharma Services Retained by MiddleBrook Pharmaceuticals to Produce Physician Samples of MOXATAG
February 5, 2009
The first and only FDA-approved once-daily amoxicillin will be promoted to health care professionals nationwide beginning March 2009
Almac Pharma Services, a product development and commercial manufacture partner to the international pharmaceutical industry, today announced that MiddleBrook Pharmaceuticals, Inc. (Nasdaq: MBRK), a pharmaceutical company committed to developing anti-infective products that fulfill unmet medical needs, has retained Almac to provide packaging services for physician samples of MOXATAG (amoxicillin extended-release) Tablets, 775 mg. Almac Pharma Services will work closely with MiddleBrook’s chosen commercial manufacturer, STADA Production Ireland®.
“MOXATAG samples will be a key element of our nationwide launch to health care professionals in March 2009,” MiddleBrook President and CEO John Thievon said. “Physician samples allow doctors to quickly initiate treatment in conjunction with a patient’s office visit. Almac will provide services integral to the MOXATAG launch, and we’re pleased to have Almac as a partner.”
Almac Pharma Services Vice President of Commercial Operations David Downey said, “Almac is delighted to be working with MiddleBrook to produce sample packs in support of the MOXATAG product launch.”
The Almac Group comprises five closely integrated divisions offering a broad range of services from R&D, translational genomic services, API manufacture, product development, clinical trial supply and technology (IVRS/EDC), to commercial-scale manufacture. Almac provides services to over 600 companies including all the world leaders in the pharmaceutical and biotech sectors.
The company has over 2,200 employees and is headquartered in Craigavon, Northern Ireland. U.S. operations are based in Pennsylvania, North Carolina and California. Construction of the company’s new $100 million North American Headquarters started in July 2008 and is expected to be completed 2010.
Almac Pharma Services is an FDA and EU approved outsourcing partner to the global pharmaceutical and biotechnology industries has over 30 years’ experience in the development and manufacture of solid, oral dosage products. Capabilities include formulation and analytical development, clinical and commercial-scale drug product manufacture, primary and secondary packaging, EU import testing, QP release and supply chain management. To find out more about Almac visit www.almacgroup.com.
About MiddleBrook Pharmaceuticals:
MiddleBrook Pharmaceuticals, Inc. (Nasdaq: MBRK) is a pharmaceutical company focused on developing and commercializing anti-infective products that fulfill unmet medical needs. We are currently developing a portfolio of anti-infective products utilizing our proprietary, once-a-day pulsatile delivery technology called Pulsys. Our near-term corporate strategy is to improve dosing regimens and/or frequency of dosing which we believe will result in improved patient dosing convenience and compliance for antibiotics that have been used and trusted by physicians and patients for decades. The Company currently markets the Keflex brand of cephalexin and has received regulatory approval for Moxatag – the first and only once-daily amoxicillin product approved for marketing in the U.S. For more information about MiddleBrook, please visit www.middlebrookpharma.com.
Moxatag (amoxicillin extended-release) Tablets, 775mg, is a once-a-day extended-release formulation of amoxicillin for oral administration consisting of three components: one immediate-release component and two delayed-release components. The three components of Moxatag are combined in a specific ratio to prolong the release of amoxicillin compared to immediate-release amoxicillin. Moxatag is intended to provide a lower treatment dose, once- daily alternative to currently approved penicillin and amoxicillin regimens for the treatment of adults and pediatric patients 12 years and older with tonsillitis and/or pharyngitis. For more information about Moxatag, please visit www.middlebrookpharma.com.
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For further information contact:
Vice President of Commercial Operations – Almac Pharma Services
T: +44 (0) 28 3836 3363 (Europe)
T: +1 (610) 666 9500 (US)
F: +44 (0) 28 3836 3300