We are a clinical stage pharmaceutical company, engaged in the development of improved extended-release versions of existing commercially successful products, which we refer to as life cycle management, or LCM products, that target large markets, as well as high-barrier to entry and high-added value generic drugs.
Our LCM products are new forms of marketed drugs which we believe may offer advantages over existing formulations, such as improved patient compliance and reduced side effects and allow extended patent and regulatory exclusivity due to different formulations of product components, for example through depot or extended-release formulations. Our depot drugs are non-oral formulations containing multiple doses of a drug and are designed to release the drug over specified, often prolonged, periods of time. Our LCM product candidates seek to add value to drugs that are expected to go off-patent by integrating off-patent active pharmaceutical ingredients, or APIs, with our formulations, resulting in a new final combination that we believe to be patentable.
Our lead product candidate is Glatiramer Acetate Depot, a once-monthly injection for the treatment of patients with relapsing-remitting multiple sclerosis, or RRMS, in contrast to the daily 20 mg and the thrice-weekly 40 mg dosage of Copaxone®, Teva Pharmaceutical Industries Ltd.’s approved product for the same indication. We have successfully completed a prospective one-year, open-label Phase II clinical trial in Israel and are planning to submit an investigational new drug application, to the U.S. Food and Drug Administration, and commence a single pivotal Phase III clinical trial to support a marketing application under the 505(b)(2) regulatory pathway. We have partnered with Mylan N.V. (NASDAQ: MYL) for GA Depot injection in an agreement under which Mylan was granted an exclusive license to commercialize the GA Depot injection product for relapsing multiple sclerosis. Concurrently, we are planning to initiate a Phase II trial in primary progressive multiple sclerosis (PPMS).
We are developing two other LCM products targeting large markets. We are developing Pregabalin ER, an extended release oral form of Lyrica®, Pfizer, Inc.’s Pregabalin-based drug, for the treatment of neuropathic pain and epilepsy. We are also developing Risperidone LAI+, a once-monthly depot formulation of Johnson & Johnson’s Risperdal Consta® for the treatment of schizophrenia and bipolar disorder. We plan to develop and seek approval for each of our LCM product candidates under the 505(b)(2) regulatory pathway in the United States. We are also developing Paliperidone Palmitate and Buspirone ER for the treatment of Schizophrenia.
In addition to our LCM product platform, we are also developing finished dosage formulations, or FDFs, and a portfolio of complex APIs for the development, manufacture and sale of generic pharmaceuticals. We specifically intend to develop FDFs for generic versions of branded drugs that are scheduled to come off patent between 2015 and 2030, including generic versions of the daily 20 mg dosage and thrice-weekly 40 mg dosage of Copaxone® and the every two week formulation of Risperdal Consta®, which we expect to develop under abbreviated new drug applications, or ANDAs. Some of the FDFs we intend to develop will utilize complex APIs owned and developed by us. We intend to commercialize our LCM products, APIs and FDFs through forming co-development and marketing partnerships with large pharmaceutical companies. Our lead programs include a generic form of Teva’s Copaxone®, Johnson & Johnson’s Risperdal Consta®, Johnson & Johnson’s Prezista®, and Novartis’ Gilenya®.