New injections to prevent migraines with little or no side effects are now being developed to change the lives of people who suffer from intense headaches, industry sources say.
|New injectable migraine prevention therapies are likely to hit the Korean market within the next two years.|
Three such therapies are in clinical trials locally, and Eli Lilly Korea is closest to getting approval.
Migraine headaches cause severe head pain that is characterized by sensitivity to light, sound, or smells. Common symptoms include eye pain, sensitivity to light or sound, nausea, vomiting, and severe headache. Migraines are thought to be caused by the calcitonin gene-related peptide receptor (CGRP-R).
“Pills that block CGRP-R exist but they have painful side effects. Now American, Swiss, and Israeli companies have successfully developed a novel antibody,” said Professor Kim Byung-kun from Eulji Hospital, Department of Neurology and chairman of the Korean Headache Society.
Some of such novel migraine-preventing therapies are being tested here by Eli Lilly Korea, Novartis, and Teva Handok. All three innovative injectable treatments target the CGRP-R and have, unlike existing migraine drugs, fewer side effects.
Kim estimated that Eli Lilly’s galcanezumab would be the first to cross the finish line, with the remaining two being launched within the next two years.
“In Korea, Eli Lilly Korea started their clinical trial for galcanezumab two years ago and finished it recently so there’s a high chance that it will be the first to appear on the market,” Kim continued. “The remaining two by Novartis and Teva Pharmaceutical are in clinical trials in around 10 centers so they will most likely be on the market within the next two years.”
Lilly Korea is almost completing a phase 3, randomized, double-blind, placebo-controlled study of LY2951742 (galanezumab) in patients with episodic migraines in seven sites across the country. The company confirmed it is looking to launch the drug next year.
“Lilly Korea is aiming to get approval from the Ministry of Food and Drug Safety next year although no hard schedule has been set,” a Lilly Korea official said.
Teva Handok also said that it is preparing to get approval considering the clinical trials in process.
“We’re not moving as fast as we are in the U.S., but we do have clinical trials underway, which means that we will be launching the therapy sometime in the future,” said a Teva Handok Korea official.
Novartis Korea said its FDA-approved migraine therapy is in clinical trials and is working to get it to market.
"We are currently conducting a series of clinical trials in Korea, including phase 3 trials involving more than 150 patients to supply domestic patients as soon as possible. Aimovig is the only drug approved by the US FDA that acts on CGRP-R for severe migraine sufferers," a Novartis official said.
Regardless of who would finish first, Professor Kim noted that the hefty price tag would be one of the most significant disadvantages of the therapies.
“These antibodies are all the rage and very expensive. In the U.S. and Europe, you pay around 8 million won ($7,440) a year for the once-monthly injection. The benefits are that these drugs work great and there are no side effects and no pain. The downside? It’s costly,” he said.
In the U.S., the three companies – Novartis/Amgen, Teva Pharmaceutical, and Eli Lilly and Company – have been locked in a fierce competition to get their therapies onto the market with Novartis winning the first approval on May 17.
Novartis and Amgen made a landmark announcement that their migraine therapy Aimovig got approval from the Food and Drug Administration - marking it to be the first preventive therapy for migraines. Estimates placed the promising therapy to reach 1 trillion won in sales, signaling a highly profitable market.
Eli Lilly and Teva are racing to land the second place on the market with Lilly expecting FDA approval by the third quarter of this year. Teva, however, has been facing some roadblocks after its partner Celltrion Healthcare in Korea failed to meet FDA’s requirements for its manufacturing facility.
In its first-quarter earnings report, Teva claimed that the launch would be delayed beyond June. “We do not expect to receive FDA approval on our Biologics License Applications (BLA) for fremanezumab on the mid-June PDUFA date. We expect an FDA pre-approval inspection to take place in the coming months and to receive approval and launch before the end of 2018,” it said.