SEOUL - Dong-A ST has signed a licensing out contract with Brazil's Eurofarma Laboratorios Ltda. to sell the new diabetes drug evogliptin (DA-1229) in 17 Latin American countries including Mexico. The latest deal follows Dong-A ST's licensing agreement with Eurofarma in July last year for the marketing of the drug in Brazil.

Under the latest contract, Eurofarma will proceed with development and sales of evogliptin in the new countries, while Dong-A ST will receive up front and milestone payments. After the product is launched, the South Korean firm will export raw materials to Eurofarma, but Dong-A ST declined to comment on any of the financial terms of the deal.

Evogliptin, a DPP-4 inhibitor, was developed in-house by the South Korean firm, which received support from the health ministry for two years after the molecule was selected as an innovative new drug research project in 2008.

The company said the Latin American drug market has been rapidly growing each year and is now estimated to be worth KRW70 trillion ($64.4 billion). The region’s oral diabetes therapeutics sector has also been rising sharply each year and stood at about KRW1.3 trillion in 2014, of which the DPP-4 inhibitor market is estimated to be KRW540 billion.

In 2012, Dong-A ST also licensed out evogliptin to China's Luye Pharma Group Ltd. and India's Alkem Laboratories Ltd. The drug is currently in clinical trials in China after receiving approval from the China FDA in July last year, while in India it is gearing up to enter the clinic.

Other South Korean pharma firms have also been accelerating their efforts to advance into the diabetes market, including LG Life Sciences Ltd with another DPP-4 inhibitor Zemiglo (gemigliptin) and Chong Kun Dang Pharmaceutical Corp. with the thiazolidinedione Duvie (lobeglitazone; CKD-501).

According to the Korea Health Industry Development Institute (KHIDI), the global diabetes therapeutics market, which has been rising at an average of 10% annually from 2003 to 2010, is expected to grow by an average of 7% from 2010 to 2017.

Neuropathy Candidate

Separately, Dong-A ST said it had successfully completed a Phase II clinical study with its herbal-derived diabetic neuropathy pain drug DA-9801 in the U.S. The 12-week trial was conducted in 128 type 1 and 2 diabetes patients with neuropathy pain for at least three months prior to the study across 14 sites including Johns Hopkins University, and marks the first time for a South Korean herbal medicine to complete such a study after U.S. FDA approval.

The company cited a doctor at Albany Medical Center, which also participated in the placebo-controlled study, as saying that it is hard to find an effective drug for diabetic neuropathic pain, but that the outcome of the DA-9801 trial had shown that 50% of the patients who took the medication for 12 weeks experienced a more than 50% reduction in pain.

DA-9801's main ingredients are extracts of the flowering plant Chinese Dioscorea and Dioscorea nipponica Makino, which have established use in Asian herbal medicine, and the trial looked at 300mg, 600mg and 900mg daily doses.

The 300mg and 600mg arms showed a statistically significant more than three point reduction in mean pain score (11-point NRS) at week 12 versus baseline (p<0.05). a="" two="" point="" reduction="" is="" considered="" clinically="">

Improvements of at least 50% were observed in 46.9% of patients in the 300mg group, 50% in the 600mg group and 43.8% in the 900mg group, Dong-A ST said. One subject from each of the 300mg, 600mg and placebo discontinued due to adverse events.

Dr. Roy Freeman, distinguished professor of neurology at the Harvard Medical School and a member of the Data Safety Monitoring Board for the trial, pointed to the similar or greater efficacy and good side-effect profile of DA-9801 in the trial compared with other available therapies.

“Compared to currently FDA-approved treatments for diabetic neuropathic pain such as pregabalin, duloxetine and tapentadol ER, the favorable adverse event profile is a major strength of the drug,” Dong-A ST quoted him as saying.

"We also plan to do the Phase III clinical study in the U.S., but the timing hasn't been determined yet," said a company official. The U.S. herbal drug pathway allows the skipping of Phase I studies if the product's natural ingredient has been used sufficiently and its safety has been proven.

Dong-A ST said the global diabetic neuropathy treatment market is estimated to be worth about $2.5 billion, with the U.S. accounting for more than 80% of the total. Currently, the main FDA-approved treatments for diabetic neuropathic pain are anticonvulsants and antidepressants, but because of their possible side-effects, the need for new therapies has been growing.

Dong-A Progresses In Diabetes With Lat Am Deal, New Study

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