Meditor Pharmaceuticals Ltd. is seeking $20 million to complete the development program of its hypotension (low blood pressure) and migraine drugs, obtain US Food and Drug Administration (FDA) certification, and bring the products to market within 3-4 years.
Meditor will focus its efforts on finding a strategic partner in the industry, as well as private investors. The company has raised $10 million to date.
Investors include Agis Pharmaceuticals (now Perrigo Company (Nasdaq:PRGO; TASE:PRGO)) and PayGea Ltd. owner Nathan Jacobson.
"We're undertaking a large financing round from venture capital funds and private investors. We hope to have a product on the market within four years," Meditor chairman Rafi Barkan said.
Meditor is a case study in the difficulties facing Israeli biomedical companies that are trying to develop and certify innovative drugs for the US market. The company was spun off ten years ago from Aminolab Pharma - Nextar Ltd. (whose CEO is Rafi Barkan), which offers chemical, environmental quality, food, cosmetics, and medical devices outsourcing services. When Aminolab had the chance to buy a molecule with a unique mechanism for treating hypotension, the company saw the business potential and bought it. The company has patented the molecule in several countries.
Development of its MTR105 drug was rapid and all preclinical trials have been completed, including a Phase I safety clinical trial in Germany. Following the success of the trials, the company applied for an Investigational New Drug (IND) application with the US Food and Drug Administration (FDA) to begin a Phase II clinical trial. The drug will be given to patients during cardiac surgery who suffer a drop in blood pressure. The company is about to begin a trial at Yale University.
Meditor's drugs boost blood pressure by compressing the arteries. The mechanism includes an inhibitor of the enzyme that produces nitric oxide (NO). The innovation in Meditor's drugs is that it raises blood pressure precisely to the level needed, and no higher.
Barkan says, "The great promise is in the treatment of migraines. When we prepare the active ingredient as tables given to migraine patients, the effect is felt within an hour. Two-thirds of patients who reported severe headaches, nausea, sensitivity to light and noise, felt significant relief and the pain did not recur even after 24 hours."
Meditor has conducted a Phase II clinical trial of its migraine drug MTR106. It has applied to the FDA for an expanded trial of migraine patients to test the drug's effectiveness and side effects with 50-mg dosages. The results will be the basis for a Phase III clinical trial.
Meditor estimates the market for migraine treatments at $10 billion a year, on the basis of a prevalence of 10% of migraine sufferers in the population. It estimates the market for hypotension, including during surgery, sudden drop in blood pressure, loss of blood, and military purposes at over $1 billion a year.
Published by Globes [online], Israel business news - www.globes-online.com - on August 24, 2010
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