Ildong Pharmaceutical successfully registered a patent on Reyvow Tab. (ingredient: lasmiditan hemisuccinate), a migraine treatment, blocking a possible market entry by a latecomer drugmaker.
On Aug. 5, the Ministry of Food and Drug Safety (MFDS) put Ildong’s Reyvow Tab. 100mg and Reyvow Tab. 50mg on the list of patented medicines. The patent is about Reyvow’s pharmaceutical composition.
With the successful listing of the patented drug, Ildong holds an exclusive right to the composition of lasmiditan hemisuccinate until April 2, 2030. Ildong took the first step to block a latecomer’s attempt to develop a drug using the same ingredient.
CoLucid Pharmaceuticals, a U.S. firm, developed Reyvow as a new migraine treatment.
In 2013, Ildong and CoLucid signed an agreement to give Ildong the right to sell drugs in Korea exclusively. However, after Eil Lilly acquired CoLucid, Ildong’s agreement for the sales right of Reyvow applies to Eli Lilly.
According to Ildong, lasmiditan is a selective serotonin (5-HT) 1F receptor agonist that lowers neuropeptide release and inhibits pain transmission pathways, including the trigeminal nerve.
Existing migraine drugs in the triptan class were limitedly used for patients with cardiovascular diseases, but lasmiditan does not affect the cardiovascular system, Ildong said.
Ildong is preparing to release Reyvow in Korea after scoring regulatory approval in May. In 2019, Lilly obtained FDA approval for Reyvow in the U.S.
However, Ildong will have to get health insurance benefits for Reyvow to raise prescription sales.
Although the Health Insurance Review and Assessment Service’s (HIRA) Drug Reimbursement Evaluation Committee recognized that Reyvow was eligible for reimbursement last month, Ildong did not accept the committee’s proposed reimbursement rate for Reyvow.
Industry watchers said Lilly’s stance could have affected Ildong’s refusal.
Ildong did not disclose any schedule for a market release of Reyvow. However, as Lilly is expected to win reimbursement for another migraine drug Emgality (galcanezumab), Ildong’s Reyvow will have to get insurance benefits to raise prescriptions.
Attention is on whether Ildong will be able to speed up drug price negotiations for Reyvow, after winning the permit and passing the reimbursement review rapidly.