|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:
- On September 22, 2014, PTBI entered into a global, exclusive license agreement for the Salt Diafiltration (SDF) process, a patented process by which protein biologic drugs are extracted and purified from human blood plasma. The global market for human-derived plasma proteins is estimated to be $15 billion and growing at a rate close to 10% annually. The Company believes that the SDF process will produce higher yields of key high-value proteins, such as alpha-1 protease inhibitor (A1PI) and intravenous immunoglobulin (IVIG), and may enable the extraction of several additional orphan or ultra-orphan proteins which are currently not commercially available due to limitations of current manufacturing methods.
- With respect to its MuGard programs, last year the Company signed additional marketing license agreements to commercialize the product outside of the US. On March 11, 2014, the Company entered into an exclusive license with Hanmi Pharmaceutical for commercialization in South Korea, and Hanmi expects to launch commercially in the near future. On August 7, 2014, the Company entered into an exclusive license with Norgine BV, a leading independent European specialty pharmaceutical company, for the commercialization of MuGard in the Europe. The Norgine agreement was expanded shortly thereafter to include rights to the product in Australia and New Zealand.
- Early in 2014, the Company filed with the FDA for marketing clearance on its second commercial product, ProctiGard, which was developed for symptomatic management of rectal mucositis, a frequent side effect of radiation treatment to the pelvic region for cancers such as cervical, colon and prostate. On July 22, 2014, roughly 90 days after filing the application, the FDA granted 510(k) marketing clearance for ProctiGard. The Company is exploring options for commercialization, including the signing of marketing partners globally.
- From a financial perspective, the Company took steps to effectuate an up listing to the NASDAQ stock exchange, in an effort to enhance shareholder value by increasing visibility and access to institutional investors, and improving access to growth capital. The Company successfully priced a common stock financing of $14 million on December 18, 2014 and began trading on NASDAQ on December 19, 2014.
- In May of 2014, the Company announced the publication of positive MuGard clinical data in Cancer, the journal of the American Cancer Society. The publication, entitled "Multi-Institutional, Randomized, Double-Blind, Placebo-Controlled Trial to Assess the Efficacy of a Mucoadhesive Hydrogel (MuGard) in Mitigating Oral Mucositis Symptoms in Patients Being Treated With Chemoradiation Therapy for Cancers of the Head and Neck," is available to the public at http://onlinelibrary.wiley.com/doi/10.1002/cncr.28553/full.
- Yesterday, the Company announced that MuGard has received marketing approval by the South Korean regulatory authorities, and its partner Hanmi Pharmaceutical Co., Ltd is preparing to import MuGard and commence commercialization efforts shortly.
- On March 5, 2015, PTBI announced that enrollment had begun in a clinical trial at UCLA's Jonsson Comprehensive Cancer Center that is evaluating MuGard in the prevention and treatment of stomatitis in breast cancer patients using everolimus (marketed by Novartis Oncology under the tradename Afinitor®). The title of the trial is "Phase II Randomized Trial of MuGard Compared With Best Supportive Care for Prevention and Treatment of Stomatitis in Women With Hormone Receptor Positive Breast Cancer Initiating Treatment With Everolimus-based Endocrine Therapy" and details on the trial design and enrollment can be found on its clinicaltrials.gov, under the identifier NCT02015559.
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.
Company and Media Contact:
Director of Communications
PlasmaTech Biopharmaceuticals, Inc.
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.