HLS Therapeutics Inc.

HLS Therapeutics Inc.

September 25, 2017 06:00 ET

HLS Therapeutics and Amarin Announce Agreement to Commercialize Vascepa® in Canada

TORONTO, CANADA, BEDMINSTER, N.J., and DUBLIN, IRELAND--(Marketwired - Sept. 25, 2017) -

NOT FOR DISTRIBUTION TO UNITED STATES NEWSWIRE SERVICES OR FOR DISSEMINATION IN THE UNITED STATES.

HLS Therapeutics Inc. ("HLS") and Amarin Corporation plc ("Amarin") announced today an exclusive agreement between the parties to register, commercialize and distribute Vascepa® (icosapent ethyl) capsules in Canada. Amarin and HLS anticipate submitting an application to Canadian regulatory authorities to seek approval to commercialize Vascepa in Canada.

"HLS is delighted to work with Amarin, as we expect Vascepa to be the first highly pure, omega-3 fatty acid product available by prescription in Canada," stated Greg Gubitz, chief executive officer of HLS Therapeutics. "Amarin's $200+ million cardiovascular outcomes study, REDUCE-IT, has a significant number of Canadian key opinion leaders and clinical sites involved. As cardiovascular disease is the number one killer in the world1, HLS is proud to be associated with Amarin's mission to improve cardiovascular health."

"We are excited to enter into a collaboration with HLS to seek regulatory approval and commercialize Vascepa in Canada," stated John F. Thero, president and chief executive officer of Amarin. "The proven track record of HLS's leadership in commercializing pharmaceutical products in Canada, along with our shared vision and commitment, bestow confidence that we will provide Vascepa as a treatment option for millions of Canadians."

Heart disease is a leading cause of death in Canada2. Twenty-five percent of Canadians have high triglycerides3, a key comorbidity associated with cardiovascular disease, and about 2.4 million Canadians live with heart disease2. HLS and Amarin believe Vascepa has the potential to become an important part of the physician's armamentarium in the treatment of the millions of Canadians dealing with these conditions.

Under the agreement, HLS will be responsible for regulatory and commercialization activities and associated costs. Amarin is responsible for providing assistance towards local filings, supplying finished product, maintaining intellectual property and continuing the development and funding of REDUCE-IT. Terms of the agreement include up-front and milestone payments to Amarin, as well as development, regulatory and sale-based milestones. The agreement also provides for HLS to pay Amarin tiered double digit royalties on net sales of Vascepa in Canada. Amarin is obligated to supply finished product to HLS under negotiated supply terms. The agreement for supply and commercialization is for Canada only and includes all Canadian provinces.

About Vascepa® (icosapent ethyl) capsules

Vascepa® (icosapent ethyl) capsules are a single-molecule prescription product consisting of the omega-3 acid commonly known as EPA in ethyl-ester form. Vascepa is not fish oil, but is derived from fish through a stringent and complex FDA-regulated manufacturing process designed to effectively eliminate impurities and isolate and protect the single molecule active ingredient. Vascepa is known in scientific literature as AMR101. Amarin has been issued multiple patents internationally based on the unique clinical profile of Vascepa, including the drug's ability to lower triglyceride levels in relevant patient populations without raising LDL-cholesterol levels.

  • While the safety and efficacy for Canada are still under investigation and the Canadian market authorization has not yet been obtained, the proposed indication would be the same as that approved by the United States Food and Drug Administration, being: Vascepa (icosapent ethyl) is indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia.

FULL VASCEPA UNITED STATES FDA APPROVED PRESCRIBING INFORMATION CAN BE FOUND AT WWW.VASCEPA.COM.

Vascepa is also under various stages of development for potential use in other indications. Vascepa is not approved for use in Canada. Nothing in this press release should be construed as promoting the use of Vascepa where not approved.

About HLS Therapeutics

HLS Therapeutics Inc. is a specialty pharmaceutical company acquiring and distributing commercial stage and legacy, branded pharmaceutical drugs for the North American markets. HLS's management team is comprised of seasoned pharmaceutical executives with a strong track record of success. Building on the expertise of the founders, HLS is focused on treatment products for the central nervous system, and cardiovascular specialties. For more information about HLS, visit www.hlstherapeutics.com.

About Amarin

Amarin Corporation plc is a biopharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular health. Amarin's product development program leverages its extensive experience in lipid science and the potential therapeutic benefits of polyunsaturated fatty acids. Amarin's clinical program includes a commitment to an ongoing outcomes study. Vascepa® (icosapent ethyl), Amarin's first FDA-approved product, is a highly pure omega-3 fatty acid product available by prescription. For more information about Vascepa, visit www.vascepa.com. For more information about Amarin, visit www.amarincorp.com.

Forward-looking statements

This press release contains forward-looking statements, including expectations regarding regulatory submissions and approvals and commercialization of Vascepa in Canada, as well as timing related thereto; future expectation regarding timing and continuation of Amarin's REDUCE-IT cardiovascular outcomes study; statements regarding the potential and therapeutic benefits of Vascepa; and potential milestone and other payments to be paid to Amarin, an obligation of Amarin, under this agreement. These forward-looking statements are not promises or guarantees and involve substantial risks and uncertainties. In particular, as disclosed in filings with the U.S. Securities and Exchange Commission, Amarin's ability to effectively develop and commercialize Vascepa will depend in part on its ability to continue to effectively finance its business, efforts of third parties, its ability to create market demand for Vascepa through education, marketing and sales activities, to achieve increased market acceptance of Vascepa, to receive adequate levels of reimbursement from third-party payers, to develop and maintain a consistent source of commercial supply at a competitive price, to comply with legal and regulatory requirements in connection with the sale and promotion of Vascepa and to maintain patent protection for Vascepa. Among the factors that could cause actual results to differ materially from those described or projected herein include the following: uncertainties associated generally with research and development, clinical trials and related regulatory approvals; the risk that clinical data and regulatory reviews may alter current expectations related to anticipated prospects for approval; the risk that future legal determinations and interactions with regulatory authorities may impact Vascepa marketing and sales rights and efforts; the risk that Vascepa may not show clinically meaningful effects in REDUCE-IT or support regulatory approvals for cardiovascular risk reduction; and the risk that patents may not be obtained or upheld in patent litigation. A further list and description of these risks, uncertainties and other risks associated with an investment in Amarin can be found in Amarin's filings with the U.S. Securities and Exchange Commission, including its most recent Quarterly Report on Form 10-Q. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Amarin undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.

Availability of other information about Amarin

Investors and others should note that Amarin communicates with its investors and the public using Amarin's company website (www.amarincorp.com), Amarin's investor relations website (http://investor.amarincorp.com), including but not limited to investor presentations and investor FAQs, Securities and Exchange Commission filings, press releases, public conference calls and webcasts. The information that Amarin posts on these channels and websites could be deemed to be material information. As a result, Amarin encourages investors, the media, and others interested in Amarin to review the information that Amarin posts on these channels, including our investor relations website, on a regular basis. This list of channels may be updated from time to time on Amarin's investor relations website and may include social media channels. The contents of Amarin's website or these channels, or any other website that may be accessed from Amarin's website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933.

References

1 https://www.medpagetoday.com/PublicHealthPolicy/PublicHealth/67946?xid=nl_mpt_DHE_2017-09-16&eun=g811140d0r&pos=0
2 https://www.canada.ca/en/public-health/services/diseases/heart-disease-heart-health.html
3 http://www.statcan.gc.ca/pub/82-625-x/2010001/article/11136-eng.htm

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