Amarin Corp Plc (AMRN)

[Biobillionair]

Oh... I started that already;)

August 9, 2013.



Attention: Laurie Lenkel, Virgina Behr, Janet Woodcock, M.D., Margaret A. Hamburg, M.D., Kati Johnson, & CDER exclusivity Board
-Retaliation Policy
At the FDA, our mission is to protect, promote, and enhance the public health. We also have important responsibilities to the industries we regulate, including working to bring new products to the market and minimizing regulatory burdens.

In carrying out this mission, FDA employees are required to make many decisions and take many actions involving complex clinical, scientific, legal, and factual issues. In this context, questions can be, and have been, raised about the fairness of agency proceedings and retaliatory actions-against companies which challenge or criticize the agency.

We take such concerns and allegations very seriously. Without question, companies are free to vigorously challenge agency positions and requirements, and to freely voice their views to the agency, the press, the public, and the Congress. One of our fundamental duties is to be scrupulously fair, even-handed and objective. We can accept no less. Fear of retaliation among those we regulate may chill scientific, legal and policy discourse, depriving the agency of information crucial to sound judgments and decisions. Given our special responsibilities, all FDA employees must make every effort to avoid even the appearance of unfairness or retaliatory action.

Because of the critical importance of these issues, any allegation of retaliation should be reported immediately to the Office of the Ombudsman. In addition, anyone with concerns about retaliation or related issues should contact that office. Such matters will be treated in confidence, and the office will work with other agency offices to address all relevant issues.



Ms. Lenkel,
I have exchanged many e-mails and have had two phone conversations with Ms. Behr, she suggested I forward you my concerns regarding CDER's exclusivity delay for Amarin's Vascepa.


It's my opinion CDER played Regulatory Favoritism with the respect to Amarin's Vascepa/Icosapent Ethyl application exclusivity delay. I also allege CDER has retaliated against Amarin investors and Amarin Pharmaceuticals by further delaying the decision after complaints to CDER were communicated. Also delays may have been extended by the acceptance of a Citizen Petition, with likely conflict of interests. Citizen Petition FDA-2013-P-0148-0001 drafted by and ex-FDA Attorney now a partner at Crowell & Moring LLP. I also fear CDER will retaliate against Amarin for current sNDA and future NDA after formal complaints have been made to the Senate Judiciary Committee Investigators, which is my intention after another delay. I request Ms. Laurie Lenkel and Ms. Virgina Behr closely follow the current review of Vascepa's sNDA to assure fairness in this process.


History of Amarin's Vascepa/Icosapent review:
Icosapent Ethyl was approved for the treatment of very high triglycerides on July 26, 2012. Vascepa is Amarin's only approved product and at this time Amarin's revenue stream was Amarin stock holders. Upon approval, neither NME or NCE was applied to Vascepa by CDER for undisclosed reasons. Amarin and Amarin shareholders clearly communicated to CDER that an exclusivity decision was paramount to Amarin's business plan. After 12 consecutive delays Amarin's Market Value has collapse from $2.4 Billion to $820 Million, and Amarin was forced to take out a very high stakes loan leveraging all it's IP on default. Today, after 13 Months CDER was failed to rule on a very strait forward decision. The continued delay is perceived as punitive.




Example of Regulatory Favoritism:
Biogen Idec received NCE for Dimethyl Fumarate, after it's 505B1 application was approved. Like Icosapent Ethyl, Dimethyl Fumarate was previously approved as a "mix" in Novartis's Aliskiren Hemifumarte. The following links lead to the approvals and Pubchem sites clearly showing the compounds. I can find no FDA delay's or confusion regarding the approval of and designation of NCE for Dimethyl Fumarate.

Dimethyl Fumarate's OB Exclusivity:
http://www.accessdata.fda.gov/scripts/cder/ob/docs/patexclnew.cfm?Appl_No=204063&Product_No=001&table1=OB_Rx

Dimethyl Fumarate's chemical structure can be viewed here:
http://pubchem.ncbi.nlm.nih.gov/summary/summary.cgi?cid=637568&loc=ec_rcs
Aliskiren Hemifumarate's OB Exclusivity:
http://www.accessdata.fda.gov/scripts/cder/ob/docs/patexclnew.cfm?Appl_No=022217&Product_No=001&table1=OB_Rx

The mix containing Biogen's Dimethyl Fumarate can be viewed here at PubChem under Novartis's Aliskiren Hemifumarate:
http://pubchem.ncbi.nlm.nih.gov/summary/summary.cgi?cid=9939627&loc=ec_rcs



Vascepa and Dimethyl Fumarate share the same mix/NCE parodox:
As GSK has recently stated in the response to Crowell & Moring LLP- CP (FDA-2013-P-0148-0001), "the active ingredient (In Lovaza) is not simply the seven omega-3-acid ethyl esters, but the entire mixture", the Icosapent Ethyl should be considered a single agent separate from the mixture. Clearly CDER came to this conclusion with Biogen's Dimethyl Fumarate.
http://www.regulations.gov/#!documentDetail;D=FDA-2013-P-0148-0003

Dr. Goldenberg came to this very conclusion in a fall of 2012 Pharmaceutical Approval Update . "The active moiety in GlaxoSmithKline’s Lovaza, a similar agent for the treatment of hypertriglyceridemia, is a mixture of omega-3-acid ethyl esters that includes icosapent ethyl (EPA), docosahexaenoic acid (DHA), and a few others. Without requiring GlaxoSmithKline to specify which ester helps to lower triglycerides, the FDA considered the mixture of EPA and DHA as the active moiety that is responsible for the physiological and pharmacological action of Lovaza. Vascepa might have an advantage over Lovaza; it does not increase LDL-C levels, which has sometimes been observed with Lovaza.

The FDA considers Vascepa to be a new chemical entity. It contains only EPA but not DHA, and it does not contain any appended portions of both EPA and DHA that cause them to be an ester, salt, or other non-covalent derivative. Therefore, its active moiety has not been previously approved by the FDA in any other application submitted under Section 505(b) of the Federal Food, Drug, and Cosmetic Act."
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3462608/




Resolution:


CDER immediatly contact Amarin and inform them of a decision and when the OB will be updated. Please forward my request to Dr. Hamburg as she's ultimatly responsible for the actions of CDER.