TOKYO -- AnGes MG expects to apply in October for approval to manufacture and market a treatment for severe blockage of the arteries in the legs that could become the first commercial gene therapy product in Japan.

The Japanese biopharmaceutical startup grew out of the work of researchers at Osaka University. If the treatment is approved, partnerMitsubishi Tanabe Pharmacould begin sales as soon as next year.

Known as beperminogeneperplasmid,the product is injected directly into the feet, where it promotes the regeneration of blood vessels. It is meant to alleviate the symptoms of critical limb ischemia, a condition marked by reduced blood flow to the extremities, leading to pain and even gangrene.

AnGesestimates that its gene therapy would be suitable for around 10% of the 100,000 to 200,000 people in Japan who suffer from this condition. The alternative is surgery, which places a much heavier burden on the patient.

This will be the second time that AnGessubmits beperminogenefor approval from Japan's health ministry. The company withdrew the first application after more data was found to be needed.

AnGesis more optimistic this time because in November 2014 the health ministry introduced a conditional early approval system for regenerative medicine and gene therapies as part of the government's policy to make Japan a leader in advanced medicine.Under this fast-track system, a company can conditionally release a product and collect additional data while the treatment is in use, later submitting that data to win formal approval.

AnGeshas been conducting domestic clinical trials on beperminogenesince 2014 to take advantage of the new system. The therapy was developed in 1995 by Osaka University'sRyuichi Morishita and his team.

(Nikkei)

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Bioventure AnGes MG tries again to market Japan's first gene therapy - Nikkei Asian Review