Ness Ziona, Israel, May 27, 2014 —- Mapi Pharma Ltd. (“Mapi” or the “Company”), a developer of high-barrier to entry and high value-added generic drugs, announced today that its US patent for the company’s Glatiramer Acetate Depot has been extended until December 2030.
The notice of allowance for US Patent Application No. 13/258,808 entitled Depot Systems Comprising Glatiramer or Pharmacologically Acceptable Salt Thereof, also awarded additional claims to an earlier patent (U.S. Patent 8,377,885), issued to the company in February 2013.
The additional claims include:
- administration from about two weeks to about once-a-month for glatiramer salts, including glatiramer acetate;
- administration from about once-a-week to about six months for salts other than glatiramer acetate; and,
- glatiramer salts Depot, including glatiramer acetate, in combination with at least one additional drug.
The Glatiramer Acetate Depot formulation is a Life Cycle Management product of Copaxone® to be injected between once-a-week and up to once-every-six-months subcutaneously (under the skin) or intramuscularly (into the muscle) for prolonged release of the therapeutic agent, thereby allowing for increased compliance and a reduced burden of treatment.
MS is a chronic, often disabling disease that attacks the central nervous system. Symptoms include numbness in the limbs, paralysis and loss of vision. Symptoms are unpredictable and differ from one person to another. According to Thomson Reuters Cortellis’ website, the global market for MS pharmaceuticals is estimated to be approximately US $15 billion.
Mapi Pharma Ltd. (“Mapi” or the “Company”) is a developer of high-barrier to entry and high value-added generic drugs that include complex active pharmaceutical ingredients (“APIs”), formulations and life cycle management (“LCM”) products that target large markets. Mapi is dedicated to providing generic and innovative intermediates and APIs, as well as developing finished dosage forms, either for Mapi’s internal API program, as a vertically integrated company, or as generics of leading brands. Mapi is headquartered in Israel. It has R&D facilities in Israel, China and Germany and is currently building an API manufacturing site in Neot Hovav, Israel’s designated chemical park. Mapi has filed more than 20 patent applications for APIs and formulations in less than four years of operation. For more information: www.mapi-pharma.com.
Forward Looking Statements
This press release contains “forward-looking statements.” Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward-looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) the adequacy of the Company’s financial and other resources, particularly in light of its history of recurring losses and the uncertainty regarding the adequacy of its liquidity to pursue its complete business objectives; (ii) the Company’s ability to commercialize its pharmaceutical products; (iii) the Company’s ability to obtain and maintain adequate protection of its intellectual property; (iv) the Company’s ability to complete the development of its products; (v) the Company’s ability to find suitable co-development partners; (vi) the Company’s ability to manufacture its products in commercial quantities, at an adequate quality or at an acceptable cost; (vii) the Company’s ability to establish adequate sales, marketing and distribution channels; (viii) acceptance of the Company’s products by healthcare professionals and patients; (ix) the possibility that the Company may face third party claims of intellectual property infringement; (x) the Company’s ability to obtain or maintain regulatory approvals for its products in its target markets and the possibility of adverse regulatory or legal actions relating to its products even if regulatory approval is obtained; (xi) the results of clinical trials that the Company may conduct or that its competitors and others may conduct relating to its or their products; (xii) intense competition in the Company’s industry, with competitors having substantially greater financial, technological, research and development, regulatory and clinical, manufacturing, marketing and sales, distribution and personnel resources than the Company; (xiii) potential product liability claims; (xiv) potential adverse federal, state and local government regulation, in the United States, Europe or Israel and (xv) loss or retirement of key executives and research scientists. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.