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Mochida Pharmaceutical Group
Integrated Report 2022

https://www.mochida.co.jp/english/annual/docs/ir2022e_p.pdf

(Page 07) Epadel, launched in 1990, was the world’s first preparation of high purity eicosapentaenoic acid (EPA). EPA is one of the fatty acids found in fish such as sardines.
Furthermore, we improved the formulation of this product aiming at maximizing intestinal absorption and launched Epadel EM in 2022.

(Page 08) Epadel EM
(a self-emulsifying formulation of highly purified EPA)

(Pages 13, 14, 15) Interview with the President
Naoyuki Mochida
Representative Director, President

Q Tell us about the business results and achievements in fiscal year 2021.
A. Looking at our development pipelines, we filed for NDA of MND-2119* for the treatment of hyperlipidemia

Q Tell us about “Vision for 2031,” announced in May 2022.
A. We will also look to expand into overseas markets by offering a lineup of distinctive products that meet the needs in each business segment. Our current aim is to launch highly purified EPA drugs in Vietnam, China, the U.S., and other countries, following their launch in Thailand, however, we will also push ahead with the development of other products such as biomaterials and regenerative medicines with an eye to global expansion.

Q Tell us about the main points of the Medium-term Management Plan (FY2022-2024).
A. The 22-24 Medium-term Management Plan focuses on three issues under the theme of innovation creation and productivity improvement. The first issue is “maximization of profits in targeted areas with a focus on new drugs.” We will concentrate our resources on the targeted areas (cardiovascular medicine, obstetrics and gynecology, psychiatry, and gastroenterology) to maximize earnings from new drugs in our core pharmaceutical business. In particular, we will raise awareness about the value of Lialda, a treatment for ulcerative colitis, Goofice, a treatment for chronic constipation, and Urece, a treatment for gout and hyperuricemia, in a bid to maximize sales. In addition, we will strive to leverage our experience as a leading manufacturer of highly purified EPA drug in marketing activities for Epadel EM, a self-emulsifying formulation of highly purified EPA launched in September 2022. Meanwhile, we will continually work to maintain a stable supply and proper quality of our products based on an end-to-end view of the supply chain, while promoting improvements in our cost structure by reducing procurement costs and reviewing our product lineup.

(Page 18) Development
Looking at our development pipelines, we obtained manufacturing and marketing approval for Epadel EM (development code: MND-2119), for the treatment of hyperlipidemia.

As of August 1, 2022
Code: MND-2119
Name: ethyl icosapentate
Stage: Approved
Indications: Hyperlipidemia
Formulation: Oral
Remarks: in-house development <Japan>

(Page 19) Business Activities

Licensing Activities
Most of our activities are being conducted in alliance with partners including academia-industry cooperation and industry collaboration in Japan and overseas. We promote the in-licensing activity of development programs and developed products in our strong areas and focused fields, the in-licensing and out-licensing of useful products which contribute to the society, including unique drug formulations with additional value which meet customer needs as well as medical needs.

We are also leveraging our alliances to globally expand our EPA drug with high purity in China, Thailand, Vietnam and the United States. In Thailand, the subsidiary of Meiji Seika Pharma Co., Ltd. obtained approval to import and market our EPA drug for the treatment of hypertriglyceridemia in October 2020 and commenced sales in April 2021. In Vietnam, an alliance partner of Meiji Seika Pharma is in the process of applying for approval to import and market our EPA drug.

Intellectual Property (IP) Management
In our business activities, we endeavor to obtain, protect and utilize IP rights, including patents, in anticipation of global commercialization, licensing, collaborative research and other technical alliances. We also regularly conduct searching and evaluation of third-party’s IP rights from the viewpoint of respecting their rights, and work to prevent IP risks in our businesses. We also carry out various IP-related assessments, especially when making important decisions, for example when deciding whether to move to the next stage of drug development.

(pages 21, 22) Four Targeted Areas

Above all, we are currently putting effort into new drugs, concentrating our resources on four targeted areas: cardiovascular medicine, especially treatments for lifestyle diseases such as hyperlipidemia, hypertension, and hyperuricemia; obstetrics and gynecology, including treatments for endometriosis and dysmenorrhea, and pregnancy test kits; psychiatry, with emphasis on antidepressants; and gastroenterology, including treatments for ulcerative colitis and chronic constipation.

Cardiovascular medicine
Urece®, a selective urate reabsorption inhibitor (SURI) released in 2020, is a therapeutic agent for gout and hyperuricemia. Urece® is expected to be more efficient at lowering serum uric acid levels than existing uricosuric agents because it selectively inhibits URAT1, a transporter presents in the proximal tubules of the human kidney which promotes the reabsorption of uric acid, whilst having a small effect on other transporters.

We are also making our presence felt in the cardiovascular field as a leading manufacturer of highly purified EPA drugs. In addition to Epadel, a high-purity EPA drug, which, through various mechanisms, slows atherosclerotic plaque progression, we launched Epadel EM, a new self-emulsifying formulation of Epadel, in September 2022. Epadel EM is a new formulation of Epadel for the treatment of hyperlipidemia. It uses self-emulsifying formulation technology in order to improve gastrointestinal absorption. As the world’s first high-purity EPA drug that can be given in a single daily dose, we expect Epadel EM to be able to help improve the QOL of patients.

With these high-purity EPA drugs and other products such as Atelec®, a calcium channel blocker with a long-acting hypotensive effect, and Treprost®, a therapeutic product for pulmonary arterial hypertension, we are taking on the cardiovascular field.


Product Name
International Nonproprietary Name (INN) Main Indications

Epadel
icosapent

Atelec ®
cilnidipine

Treprost ®
treprostinil
Arteriosclerosis obliterans, Hyperlipidemia (World’s first high purity EPA drug)
Hypertention
Pulmonary arterial hypertension (PAH)

Epadel EM
icosapent
Hyperlipidemia

Urece®
dotinurad
Gout and hyperuricemia

Atedio ®
valsartan/cilnidipine