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Amarin Corporation

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Joseph S. Zakrzewski, CEO, commented on the NCE regulatory situation for the Vascepa. He stated, "As we are all well aware and FDA termination on NCE status is still currently pending. At this time we do not have any further indications from the FDA as to when they will make a determination on Vascepa regulatory exclusivity protection. If Vascepa is not granted five year exclusivity it would be granted three year exclusivity because the MARINE study was a new clinical investigation of a new drug product. "
Source: Q1 2013 earnings conference call, 5/09/13.

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Joseph S. Zakrzewski, CEO, commented on the NCE determination for Vascepa. He stated, "At this time, we do not have any further indication from the FDA as to when they will make a determination on Vascepa’s regulatory exclusivity protection. Given the strengthening of our patent portfolio, as I said before, we see the NCE determination as much less important to the protection of Vascepa that has been historically."
Source: Q4 2012 earnings conference call, 2/28/13.

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Joseph S. Zakrzewski, CEO, commented on the lingering NCE status issue for Vascepa. He stated, "A decision remains overdue on the FDA's determination of 5-year or 3-year regulatory exclusivity for Vascepa. We continue to request that the FDA make a timely determination. I cannot make a prediction as to when that determination will be made. We believe that there are strong arguments to support 5-year regulatory exclusivity of Vascepa as a new chemical entity under the provisions of the Hatch-Waxman Act. However, we cannot make assurances that the FDA will agree with our arguments or provide us with this 5 years of exclusivity."
Source: Q3 2012 earnings conference call, 11/08/12.

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No determination on regulatory exclusivity related to Vascepa™ (icosapent ethyl) Capsules expected in September Orange Book Supplement

The U.S. Food and Drug Administration (“FDA”) typically publishes a determination on the exclusivity of recently approved products in a cumulative supplement to its Approved Drug Products with Therapeutic Equivalence Evaluations , also known as the Orange Book, mid-month in the month following the drug’s approval. Vascepa™ (icosapent ethyl) capsules was approved by the FDA in July 2012.

As previously disclosed, in each of mid-August and mid-September, the FDA communicated to Amarin Corporation plc (“Amarin”) that it had not yet made a determination with respect to Amarin’s pending request for five-year, new chemical entity (“NCE”) exclusivity for Vascepa, and the cumulative supplements to the Orange Book published shortly thereafter, respectively, did not include an entry with respect to the regulatory exclusivity of Vascepa.

Based on information available to Amarin as of the filing of this report, including communication with the FDA on October 9, 2012, the FDA has not yet made a determination with respect to regulatory exclusivity for Vascepa. In mid-October, the FDA is expected to publish the September 2012 cumulative supplement to the Orange Book. Based on communication with the FDA on October 9, 2012, Amarin does not anticipate that the September cumulative Orange Book Supplement will include an entry with respect to the regulatory exclusivity status of Vascepa.

As previously disclosed, since prior to FDA approval of the Vascepa New Drug Application, Amarin has had an active dialogue with the FDA related to its regulatory exclusivity request for Vascepa. In recent months, Amarin has repeatedly followed up with the FDA seeking a determination. While Amarin continues to believe its arguments in support of an NCE determination for Vascepa are strong, the FDA may not agree with Amarin’s arguments. Based on Amarin’s dialogue with the FDA, Amarin does not know what determination the FDA will make on the pending Vascepa exclusivity request or when the FDA will make such determination. Accordingly, Amarin can make no assurance that Vascepa will be granted NCE exclusivity, or that the FDA will make a determination in a timely manner. If Vascepa is not awarded five-year marketing exclusivity, Amarin expects it will be awarded three-year marketing exclusivity.
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Source: Form 8K, 10/10/12. http://investor.amarincorp.com/secfiling.cfm?filingid=1193125-12-419267

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As previously disclosed, Amarin continues to anticipate commercial launch of Vascepa in the first quarter of 2013, and continues to consider three potential paths for the marketing and sale of the product: an acquisition of Amarin, a strategic collaboration, or self-commercialization, the latter of which could include third-party support. As previously disclosed, Amarin is now focused on continued commercial preparations for Vascepa which includes, but is not limited to, finalizing the introduction of Vascepa to managed care plans to gain formulary access, building up inventory levels, hiring key personnel and coordinating other pre-launch marketing activities. oseph S. Zakrzewski, CEO, commented on the NCE status for Vascepa (AMR-101). He stated, "With respect to new chemical entity NCE regulatory exclusivity, Amarin is still on active dialogue with FDA. Since approval, Amarin has had continued discussions with FDA regarding NCE. We are hopeful for a decision and time-frame inclusion in the Orange Book supplement in August, however, due to the uniqueness of the situation, it is also possible that decision may go longer. At this time, FDA has not advised Amarin of a delay or a decision. In the meantime given the active dialogue, we will not be making further additional comments on NCE, nor taking questions on it."
Source: Q2 2012 earnings conference call, 8/08/12.

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Vascepa exclusivity update

A top priority for Amarin in the second quarter of 2012 was, and continues to be, the ongoing prosecution of the company's patent application portfolio. Amarin has made significant progress in its efforts to expand the patent protection for Vascepa in the United States with seven patents "in play," including issued U.S. Patent No. 8,188,146 (a pharmaceutical composition patent), a Notice of Allowance for U.S. Patent Application Serial Number 12/769,885 and published Reasons for Allowance on five other pending U.S. patent applications targeted at methods of using Vascepa to treat patients in the MARINE patient population. Amarin is also prosecuting over 25 additional patent applications in the United States and multiple patent applications outside the United States, including the application for Amarin's MARINE method of use patent in Europe for which Amarin recently announced receipt of an Intention to Grant letter. Amarin is also expecting to receive five-year new chemical entity (NCE) or three-year new product marketing exclusivity under the provisions of the Hatch-Waxman amendments to the Federal Food, Drug, and Cosmetic Act.

Amarin's goal is to protect the commercial potential of Vascepa to beyond 2030 through patent protection, regulatory exclusivity, trade secrets and taking advantage of manufacturing barriers to entry.
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Source: press release, 8/08/12. http://investor.amarincorp.com/releasedetail.cfm?ReleaseID=699335

Compound/DeviceSpecialtyIndicationCompound ClassTarget
Vascepa (AMR-101)CardiovascularHyperlipidemiaOmega-3 fatty acidPlasma lipid

Mechanism of action: Vascepa (AMR-101) is a prescription-grade omega-3 fatty acid, comprising not less than 96% ultra pure EPA (icosapent ethyl) for the treatment of patients with very high triglyceride levels (≥500 mg/dL) and as a potentially first-in-class therapy for patients with high triglyceride levels (≥200 and <500mg/dL) who are also on statin therapy for elevated LDL-cholesterol levels (which we refer to as mixed dyslipidemia).

Phase of Development: Approved in U.S.

Event Type: Regulatory FDA: New chemical entity (NCE)

Dates: 2013-06-01 - 2013-09-30

Results:

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Amarin Announces FDA New Chemical Entity Market Exclusivity Determination for Vascepa(R) (icosapent ethyl) Capsules
BEDMINSTER, NJ and DUBLIN, IRELAND -- (Marketwired) -- 05/31/16 -- Amarin Corporation plc (NASDAQ: AMRN) announced today that the U.S. Food and Drug Administration (FDA) has determined that Vascepa® (icosapent ethyl) capsules are eligible for five-year, new chemical entity (NCE), marketing exclusivity pursuant to the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act. This determination provides Vascepa with the benefits of NCE exclusivity afforded by statute. NCE exclusivity for Vascepa runs from its date of FDA approval on July 26, 2012 and extends until July 26, 2017. The statutory 30-month stay triggered by patent litigation following generic application submissions permitted on July 26, 2016 would expire on January 26, 2020, seven-and-a-half years from FDA approval.

"Amarin's goal is to protect the commercial potential of Vascepa to 2030," stated John F. Thero, president and chief executive officer of Amarin. "NCE regulatory exclusivity complements multiple patents covering Vascepa with expiration dates in 2030."
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Source: press release, 5/31/16. http://investor.amarincorp.com/releasedetail.cfm?ReleaseID=973501

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Amarin Granted Summary Judgment Motion in Suit Against FDA Seeking New Chemical Entity Market Exclusivity for Vascepa(R) (Icosapent Ethyl) Capsules
NCE Supports Extensive Patent Portfolio Toward Vascepa Exclusivity Into 2030
BEDMINSTER, NJ and DUBLIN, IRELAND -- (Marketwired) -- 05/28/15 -- Amarin Corporation plc (NASDAQ: AMRN), announced today that Judge Randolph D. Moss of the federal district court for the District of Columbia has granted Amarin's motion for summary judgment in the company's lawsuit against the United States Food and Drug Administration (FDA) seeking an order requiring FDA to recognize five-year, New Chemical Entity (NCE), marketing exclusivity for Vascepa®(icosapent ethyl) capsules.

Amarin believes based on the court's ruling that Vascepa is entitled to five-year marketing exclusivity starting from FDA's approval of Vascepa in July 2012, thus extending NCE exclusivity through July 25, 2017. The ruling also confirms that acceptance by FDA of abbreviated new drug applications ("ANDAs") for generic versions of Vascepa is not permitted until July 2016. The related statutory 30-month stay triggered by patent litigation following generic application resubmissions in July 2016 would then expire in January 2020. An appeal of the court's decision can be filed within 60 days.

Amarin has multiple patents covering Vascepa that expire in 2030. With this motion granted and FDA's acceptance of ANDAs not permitted, Amarin plans to move to dismiss pending Vascepa patent litigation in connection with ANDA filings previously submitted.

"Congratulations to the extended Amarin team for delivering on this value-enhancing operational goal," stated John Thero, President and Chief Executive Officer of Amarin. "NCE exclusivity helps solidify Vascepa's commercial potential and helps demonstrate Vascepa's status as a significant and novel treatment option in the management of severely high triglycerides. Amarin's goal is to protect the commercial potential of Vascepa to beyond 2030. NCE regulatory exclusivity contributes toward this goal by complementing one of the most extensive patent portfolios covering a single product in the industry and existing manufacturing barriers to entry."
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Source: press release, 5/28/15. http://investor.amarincorp.com/releasedetail.cfm?ReleaseID=915375

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February 21, 2014
Amarin Announces FDA Award of Three-Year Exclusivity for Vascepa(R) (icosapent ethyl) Capsules
BEDMINSTER, N.J. and DUBLIN, Ireland, Feb. 21, 2014 (GLOBE NEWSWIRE) -- Amarin Corporation plc (Nasdaq:AMRN), a biopharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular health, announced today that the U.S. Food and Drug Administration (FDA) has awarded three years of marketing exclusivity to Vascepa® (icosapent ethyl) capsules in connection with the July 26, 2012 approval of Vascepa pursuant to the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act. Such exclusivity extends through July 25, 2015 and is expected to be supplemented by a 30-month stay under the Hatch-Waxman Amendments that would be triggered after patent infringement litigation initiated by Amarin following valid notice to Amarin of the acceptance of an application to the FDA seeking approval of a generic version of Vascepa. FDA marketing exclusivity is separate from, and in addition to, patent protection, trade secrets and manufacturing barriers to entry which also help protect Vascepa against generic competition.

"Amarin is reviewing the FDA's reasoning for granting Vascepa three-year, rather than five-year, exclusivity, and evaluating whether to challenge the decision," stated John Thero, President and Chief Executive Officer of Amarin. "Over the past year, Amarin has significantly bolstered its patent position for Vascepa thereby decreasing the relative value of FDA marketing exclusivity in protecting Vascepa. Amarin now has 40 issued and allowed U.S. patents that provide the primary means to protect the exclusivity of Vascepa to 2030. These patents, all but two of which expire in 2030, are anticipated to protect the exclusivity of Vascepa well beyond the FDA marketing exclusivity period and to augment the protection afforded by Amarin's trade secrets and existing manufacturing barriers to entry."
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Source: press release, 2/22/14. http://investor.amarincorp.com/releasedetail.cfm?ReleaseID=827445

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