Amarin Corp Plc (AMRN)

[sts66]

Ahh.....it all makes sense now....all of those papers from Japanese researchers using Epadel as the drug likely related to increasing visibility and provide free publicity for Epadel, which went OTC earlier this year in Japan. Looks like the scrip version sales were/are > $400M USD, and that's just in Japan - competition for AMRN in the global or non-US market? Or are they content to stay in Japan? If they make a push in the global OTC market, doesn't this have the potential to displace some Vascepa users, especially off-label, if it's cheaper?

Launch of “Epadel T,” Japan’s First Switch-OTC Drug for Lifestyle-Related Diseases

TAISHO PHARMACEUTICAL HOLDINGS News Releases News Releases
April 15, 2013

Launch of “Epadel T,” Japan’s First Switch-OTC Drug for Lifestyle-Related Diseases Taisho Pharmaceutical Co., Ltd.

(“Taisho Pharmaceutical”) [Head Office: Toshima-ku, Tokyo; President: Shigeru Uehara] has announced that it will launch “Epadel T” (Category 1 medicines), a treatment for improving abnormal triglyceride levels, on April 15. The drug marketing approval for “Epadel T” has been obtained by Mochida Pharmaceutical Co., Ltd. (“Mochida Pharmaceutical”) [Head Office: Shinjuku-ku, Tokyo; President: Naoyuki Mochida].

“Epadel T” was developed by converting the ethical drugs “Epadel” into an OTC drug, making it Japan’s first switch-OTC drug for lifestyle-related diseases. “Epadel” is a prescription pharmaceutical treatment for hyperlipidemia and arteriosclerosis obliterans that is manufactured and sold by Mochida Pharmaceutical. The active ingredient is EPA-E (Generic name: ethyl icosapentate). “Epadel T” contains 600 mg of EPA-E per packet, and is indicated for “the treatment of triglyceride levels that are in the borderline region, identified through health check-ups and other means.”

In the run-up to the nationwide launch of “Epadel T,” Taisho Pharmaceutical will conduct a survey on proper use in accordance with the instructions of the Ministry of Health, Labour and Welfare. This survey is designed to confirm whether or not pharmacists are able to determine customers suitable for taking this drug, and to provide proper guidance on drug administration, recommendations to see a doctor, and other services. During the survey period, “Epadel T” will be sold only at drugstores implementing the survey. Furthermore, Taisho Pharmaceutical will provide customers with the information they need to properly take “Epadel T.” Mochida Pharmaceutical will continue to market the prescription pharmaceuticals “Epadel” for medical use.

[Product descriptions]
-Japan’s first switch-OTC drug for lifestyle-related diseases -Administered to treat triglyceride levels that are in the borderline region, identified through health check-ups and other means.

[Edit: product cost is 5500 yen ($55 USD) for 42 packets, 600 mg EPA/packet, would need ~ 6 packets/day to match 4 g of V, monthly cost would be $220 plus tax plus shipping costs - not cost competitive with V even at full retail price. Not coming to America, or outside of Japan, is my guess - good thing too! If they could manage to drop the cost they could go head to head with AMRN, especially with it being OTC.]