LEAD PRODUCTS

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 injectable 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 completed a 24-patient, 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. In addition, we are planning a prospective, multi-center, single arm, open, phase IIa trial for the evaluation of the safety and efficacy of 40 mg long-acting glatiramer acetate (glatiramer acetate depot) administered once per month by intramuscular (IM) injection to patients suffering from 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.

Depot delivery systems are non-digestive formulations containing multiple doses of a drug that are designed to release the drug over a specified, often prolonged, period of time. Depot formulations come in many forms, designed for several different administration routes, including injections and implantations. Depot systems seek to overcome several well-recognized challenges often associated with conventional digestive delivery such as variations in drug plasma levels between doses that can lead to adverse effects or compromised efficacy, poor patient compliance due to frequent dosing, and difficulty localizing exposures to the target organ or tissue.

US Patent number 8,377,885 granted: Depot Systems Comprising Glatiramer or Pharmacologically Acceptable Salt Thereof

 

Lead Products