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|PlasmaTech Biopharmaceuticals Provides Strategic Update for 2015 and Review of 2014 Acheivements|
ANNOUNCES FILING OF ITS ANNUAL REPORT ON FORM 10-K
DALLAS and NEW YORK, April 1, 2015 /PRNewswire/ -- PlasmaTech Biopharmaceuticals, Inc. (NASDAQ: PTBI), a biopharmaceutical company advancing protein biologic therapies and oncology supportive care products, today provided an overview of the Company's 2014 achievements and a strategic update for 2015. The highlighted achievements below demonstrate the progress the Company has made in the areas of business development with multiple corporate partnerships for its MuGard programs, the FDA clearance of the ProctiGard product, and the in-licensing of the SDF Plasma technology platform, culminating in the successful recapitalization, financing and up listing to NASDAQ in the fourth quarter of last year. Additionally, today the Company announces that it has filed its Annual Report on Form 10-K for the year ended December 31, 2014, with the Securities and Exchange Commission.
"2014 was a year of significant developments for the Company. We in-licensed the innovative, and potentially disruptive, human plasma purification technology platform called Salt Diafiltration, finalized three marketing partnerships on our polymer hydrogel program, and secured our second FDA marketing clearance for a product positioned to address a large unmet medical need," stated Steven H. Rouhandeh, Executive Chairman. "We are moving forward aggressively with the validation and scale-up of the proprietary SDF plasma process and with the first protein, our Alpha-1 Protease Inhibitor, and we continue to evaluate new and interesting products and technologies which we feel are synergistic with our vision for the Company and that could create additional shareholder value."
Recent 2014/2015 Achievements Include:
About Plasma Proteins and the SDF Process: The global market for drugs derived from human blood plasma fractionation is currently greater than US$15 billion, and is growing at a rate close to 10% annually. Despite this significant market opportunity, limited innovation in fractionation technology has occurred in decades. PTBI has developed and patented a new extraction process for plasma biologics that may fundamentally change the economics of blood plasma fractionation, and makes possible the extraction of several additional therapeutically useful plasma proteins. The Company believes that PlasmaTech's proprietary fractionation process is expected to significantly enhance yields of key value blood proteins, including alpha-1 antitrypsin, expanding market opportunities while greatly enhancing margins. The Company obtained rights to utilize and sub license to other pharmaceuticals firms, the recently patented improved methods for the extraction of therapeutic biologics from human plasma. The Company believes that PlasmaTech's lead product opportunity, alpha-1 antitrypsin (ATT), will offer a potentially high revenue, short time-to-market respiratory product (AAT) for treatment of inherited COPD (pulmonary emphysema), among other indications. Additionally, the ability to extract several additional therapeutically useful and important proteins, due to the process being less destructive than historical fractionation processes, may enable the Company to seek new therapeutic applications and address high-value-added orphan indications.
About MuGard: MuGard® Mucoadhesive Oral Wound Rinse is indicated for the management of oral mucositis/stomatitis (that may be caused by radiotherapy and/or chemotherapy) and all types of oral wounds (mouth sores and injuries), including aphthous ulcers/canker sores and traumatic ulcers, such as those caused by oral surgery or ill-fitting dentures or braces. MuGard is available by prescription only and is contraindicated in patients with known hypersensitivity to any of the ingredients in the formulation. MuGard received 510(k) clearance from the U.S. Food and Drug Administration and is marketed by AMAG Pharmaceuticals, Inc. in the United States. MuGard is licensed in Korea through Hanmi Pharmaceuticals and in Europe, Australia and New Zealand through Norgine, B.V.
About PlasmaTech: PlasmaTech is a biopharmaceutical company focused on advancing protein biologic therapies and oncology supportive care products. Exploiting two proprietary platforms, Salt Diafiltration (SDF™) Process and Polymer Hydrogel Technology (PHT™), PlasmaTech is active in the development and commercialization of human plasma-derived therapeutics, including its proprietary alpha-1 protease inhibitor, SDF Alpha™. The company has a robust product pipeline that includes two commercial stage products, MuGard® and ProctiGard™, and follow-on products in development. For more information, visit www.plasmatechbio.com.
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This press release contains certain statements that are forward-looking within the meaning of Section 27a of the Securities Act of 1933, as amended, and that involve risks and uncertainties. These statements include those relating to: our cash burn rate, clinical trial plans and timelines and clinical results for MuGard and ProctiGard, our ability to achieve clinical and commercial success and our ability to successfully develop marketed products. These statements are subject to numerous risks, including but not limited to PlasmaTech's need to obtain additional financing in order to continue the clinical trial and operations and to the risks detailed in PlasmaTech's Annual Reports on Form 10-K and other reports filed by the Company with the Securities and Exchange Commission.