Alkermes plc (NASDAQ: ALKS) today will present an overview of its proprietary pipeline portfolio at its Research and Development (R&D) Day meeting for analysts and investors. For the first time, the company will discuss three new drug candidates including: a monomethyl fumarate (MMF) prodrug program for the treatment of multiple sclerosis; ALKS 7106 for the treatment of pain; and RDB 1419, a cancer immunotherapy candidate based on interleukin-2 (IL-2) and its receptors, Alkermes’ first proprietary biologic. These drug candidates demonstrate Alkermes’ focus on unmet medical needs in specific patient populations and show the productivity of the company’s expanded R&D capabilities. In addition to the three newly unveiled drug candidates, the company will provide details on its later-stage pipeline candidates, specifically: commercial plans for aripiprazole lauroxil, a once-monthly, long-acting atypical antipsychotic currently in phase 3 development for the treatment of schizophrenia; review of the phase 2 data for ALKS 5461, a proprietary opioid modulator with a novel mechanism for the treatment of major depressive disorder (MDD); and the clinical rationale and development plan, including initiation of a phase 2 clinical study, for ALKS 3831, a proprietary oral compound designed as a broad spectrum antipsychotic treatment for schizophrenia. “During this R&D Day, a more complete picture of our growth strategy will emerge,” commented Richard Pops, Chief Executive Officer of Alkermes. “Today we will be presenting a deeper look into our unique R&D engine that is powering one of the most diverse and exciting pipelines in the biotechnology industry, and bringing to light three innovative product candidates in important therapeutic fields. These new candidates are expected to follow our later-stage CNS product candidates: aripiprazole lauroxil for schizophrenia, ALKS 5461 for major depressive disorder and ALKS 3831 for schizophrenia, which represent growth opportunities over and above our five key commercial products.” “The three new drug candidates that we are unveiling today exemplify the productivity of R&D at Alkermes – which now spans small molecules and biologics – and represent significant opportunities for us to address unmet needs for patients with major, chronic diseases: multiple sclerosis, pain and cancer,” stated Elliot Ehrich, M.D., Chief Medical Officer of Alkermes. “Our distinctive approach is to build on a foundation of known pharmacology and clinical practice, then apply our R&D expertise and novel insights to create proprietary medicines with real value for patients and treatment systems. We will highlight for investors at our R&D Day how Alkermes employs a rigorous clinical development process that incorporates state-of-the-art clinical trial techniques and robust study designs so we can obtain data early in the development process to make rapid decisions about the most promising candidates in our pipeline.”
R&D HighlightsAlkermes today will provide details on the following new proprietary candidates:
- MMF Prodrug Program for the Treatment of Multiple Sclerosis: The company’s MMF prodrug program has resulted in novel, small-molecule prodrugs of monomethyl fumarate for the treatment of multiple sclerosis. Alkermes’ MMF prodrugs are designed to rapidly and efficiently convert to MMF in the body and to offer advantages over the currently marketed dimethyl fumarate prodrug, TECFIDERA®. Alkermes expects to file an Investigational New Drug (IND) application and initiate a phase 1 study in mid calendar 2014.
- ALKS 7106 for the Treatment of Pain: ALKS 7106 is Alkermes’ novel, small-molecule drug candidate derived from the company’s opioid modulator platform. ALKS 7106 is a potent, oral opioid analgesic designed for the treatment of pain with intrinsically low potential for abuse and overdose death, two liabilities associated with other opioid medicines. Alkermes will present preclinical data showing that ALKS 7106 had more potent analgesic properties than morphine and was well tolerated at doses far in excess of those required for analgesic action. Additional preclinical data for ALKS 7106 demonstrated a ceiling effect on neurotransmitter release over a broad concentration range, suggesting low potential for abuse and overdose death. Alkermes expects to file an IND and initiate a phase 1 study of ALKS 7106 in mid calendar 2014.
- RDB 1419, a Cancer Immunotherapy Based on IL-2 and its Receptors: Alkermes will present preclinical data showing that RDB 1419, a novel biologic based on IL-2 and its receptors, preferentially expanded the number of tumor-killing cells involved in immunotherapeutic effects on cancer. Additional preclinical data demonstrated that RDB 1419 inhibited lung metastases in a model of lung cancer. The company will describe how RDB 1419 was engineered using its proprietary fusion protein technology platform to modulate the natural mechanism of action of a biologic and to provide safety and tolerability advantages over existing therapies. Alkermes expects to conduct IND-enabling activities for RDB 1419 in calendar 2014.