The heparin drug class is estimated to be a $3.0 billion market. Heparin and low molecular weight versions are used to treat a wide range of clotting (thrombosis) disorders, both acute and chronic. Heparin is currently indicated for the treatment and prevention of deep vein thrombosis (DVT) and pulmonary embolisms (PE) as well as for the prevention and treatment of peripheral arterial embolism in acute coronary syndromes (ACS). DVT affects approximately 2.0 million people in the United States each year, approximately 600,000 of whom experience potentially fatal pulmonary embolisms. In addition, more than 20 million people in the United States annually undergo major surgeries or have restricted mobility due to medical illnesses, which place them at risk for DVT. Each year, approximately 1.3 million people in the Unites States are diagnosed with acute coronary syndromes.

M-Enoxaparin

Our most advanced product candidate, M-Enoxaparin, is designed to be a technology-enabled generic version of the most widely-prescribed low molecular weight heparin (LMWH) in the world, Lovenox. Lovenox is a heterogeneous mixture of complex sugar chains that has not been adequately analyzed to date. Under FDA guidelines, a generic product must demonstrate that it has the same active ingredients as the branded version. Our ability to sequence and analyze complex mixtures of sugars has allowed us to analyze the branded low molecular weight heparin, Lovenox, and develop a process that we believe can be used to make a generic version that will meet the FDA requirements for generic approval. We have formed a collaboration with Sandoz, a division of Novartis, to jointly develop, manufacture, and commercialize our generic version of Lovenox.

M-118

M118 is a rationally engineered LMWH that we designed to provide improved efficacy and flexible administration as baseline therapy for patients with ACS. Almost all patients entering emergency rooms with signs of cardiovascular distress are given some kind of heparin therapy. Currently, a physician’s decision of which heparin to provide depends upon the physician’s assessment of the patient’s anticipated treatment path and whether they will require invasive treatment. While LMWHs are easier to administer and have demonstrated superior efficacy in the initial ER setting over unfractionated heparin, selected properties, including LMWHs’ partial reversibility, have limited their use if a patient requires an invasive procedure. We believe potential benefits of M118 over other available therapies include increased efficacy, reversibility, more predictable response, an ability to be monitored, and diminished adverse reaction risk. Due to M118’s beneficial biological activities and flexible administration, we believe M118 could be the baseline heparin of choice to treat patients diagnosed with ACS as well as those patients who may subsequently require angioplasty or bypass surgery. M118 is currently in preclinical development.