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 multiple sclerosis. GA Depot is currently in clinical studies for both relapsing forms of MS (RRMS) and primery progressive MS (PPMS). We have completed a 24-patient, prospective one-year, open-label Phase II clinical trial in Israel and have submitted an investigational new drug application, to the U.S. Food and Drug Administration, and are about to commence a single pivotal Phase III clinical trial to support a marketing application under the 505(b)(2) regulatory pathway. In addition to the on-going open-label study, we are planning a prospective, multi-center, single arm, open, Phase IIa clinical 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 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 Buspirone ER, GLP-1 Depot and Exenatide Depot. We plan to develop and seek approval for each of our LCM product candidates either as QQ version or 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