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When the Patents update today in the OB, it should update with Amarin's newly issued Patent #:8524698 on 9-3-2013.
By January 2014, Amarin will have over 25 OB'd Patents listed.
Amarin also has a Monopoly on Omega 3 pharmaceutical grade API...this happens to be the reason for a Canadian private company filing a CP to delay exclusivity for Icosapent Ethyl...sad the FDA couldn't see through the shame.
Williams/Bio
Slide 58-60 One of the Authors is on the Anchor Ad Com committee.
ATP 4 lecture notes look favorable for Vascepa
https://www.acli.com/Events/Documents/Tue22812%20-%20Lipidology%20-%20Pamela%20Morris.pdf
Slide 60
Thanks that's the info I wanted.
?About Options?
It would seem to me "shorts" are going to have a huge issue in September. Any thoughts on this?
http://finance.yahoo.com/q/op?s=AMRN&m=2013-09
Study,
You might be right, their arm was twisted...but also at the same time they dropped two encapsulators, and responded quite favorably to C&M CP with respect to Vascepa NCE. Amarin is waiting for the upper hand in negotiations, October through December should be interesting times.
Caution: Lovaza "might" raise bad cholesterol or increase your Afib if you have a history.
Has anyone read through this new site? They should have a link to Vascepa on it.
What are the possible side effects of LOVAZA?
LOVAZA may cause serious side effects, including:
increases in the results of blood tests used to check your liver function (ALT and AST) and your bad cholesterol levels (LDL-C).
increases in the frequency of a heart rhythm problem (atrial fibrillation or flutter) may especially happen in the first few months of taking LOVAZA if you already have that problem.
GSK kicks Lovaza and would be Generic Lovaza square in the nuts!
"New Website"
LOVAZA may cause serious side effects including increases in:
-results of blood tests to check your liver function (ALT and AST) and your bad cholesterol levels (LDL-C)
-frequency of a heart rhythm problem (atrial fibrillation or flutter) that may especially happen in the first few months of taking LOVAZA if you already have that problem.
"Serious side effects" of raising your LDL....
Looks like positioning for an offer...letting supplies dwindle and bad mouthing own drug.
Is there anything here that actually tries to sell you Lovaza?
Vascepa yes, Lovaza...not so much:
Q: What should my target triglyceride level be?
A:
You should work with your doctor to set your personal triglyceride goal. The National Cholesterol Education Program (NCEP) Guidelines for Triglycerides consider less than 150 mg/dL to be a normal triglyceride level.
Before you begin treatment, it's important to continue making healthy diet choices, as well as to know your current triglyceride level and what your doctor’s triglyceride goal is for you. You may also find it helpful to track your progress toward your triglyceride goal throughout treatment and maintain a low fat and low cholesterol diet.
Q: How will I know LOVAZA is working?
A:
Be sure to schedule regular follow-up appointments with your doctor to monitor your triglyceride levels and track your progress.
In some patients, LDL (bad) cholesterol levels may increase when taking LOVAZA. Your healthcare provider should do blood tests before and during treatment to check your cholesterol and triglyceride levels.
Q: Will LOVAZA raise my LDL (bad) cholesterol levels?
A:
In some patients, LDL cholesterol may increase. As LOVAZA works to reduce triglyceride levels, LDL cholesterol levels may increase. It’s important that your doctor gives you regular blood tests before and during treatment.
Q: Can LOVAZA have any serious side effects?
A:
LOVAZA may cause serious side effects including:
increases in the results of blood tests used to check your liver function (ALT and AST) and your bad cholesterol levels (LDL-C)
increases in the frequency of a heart rhythm problem (atrial fibrillation or flutter) may especially happen in the first few months of taking LOVAZA if you already have that problem
Read about the risks and side effects of LOVAZA
Read the Patient Information for LOVAZA
Read the Prescribing Information for LOVAZA
http://www.lovaza.com/
Omthera mailed non-final rejection for 13734846 and 13797557
Claims 1-37 and 65-67 withdrawn while 38-64 rejected for '846
'557 claims 38,39,42,51,56-58,61-64 withdrawn 1-11, 19-23, 28,30, & 34 rejected.
Claims 38-55 for '846 unpatentable over 5502077 Pronova's patent.
Double patenting over 13889202, Omthera's platelet patent app.
--------
If the patent office thinks Epanova is to similar to Lovaza, I'd expect the FDA see's it the same.
74 day letter for Epanova due mid September.
Generic Lovaza API is not available for a 2015 entry. Did Apotex file the Lovaza CP to try and manipulate a way around Lovaza's patents? I thinks it's highly probable.
C & M filed a comment whining about BASF's acquisition of Pronova. Not only has Amarin's API contracts protected a generic Vascepa but also a generic source for Lovaza.
Apotex is a Canadian pharmaceutical corporation. Founded in 1974, the company is the largest producer of generic drugs in Canada, with sales exceeding $1 billion (CAD) a year.[2] The company produces more than 300 generic pharmaceuticals in approximately 4000 dosages, exporting to over 115 countries around the globe.[2]
http://en.wikipedia.org/wiki/Apotex
Apotex is a private company owned by a Candian Billionaire, Bernard Sherman. They sued Pronova for an early entry for Generic Lovaza.
Now the question: Is generic company using CP to manipulate around patents, delay Vascepa exclusivity, and change the definitions of pharmaceuticals for USP?
Williams
My comments are not posted, guessing after decision is made they will be made public. That's why I posted it here. Comment period for petition is still open. C&M needs to provide motive and client for requested change.
Another CP comment:
The petitioners request to change Lovaza's Active Pharmaceutical to include only EPA and DHA is disingenuous and should be rejected.
Reasons why it should be rejected:
1) The Omega-3-Acid Ethyl Esters USP monograph defines the active pharmaceutical ingredient (API) as composed of seven individual omega-3-acid ethyl ester components, not just EPA and DHA. The petitioner is effectively requesting the FDA and USP change its definition of Lovaza.
2) Other Omega 3 companies, like Omthera consider the mix to be pharmaceutically active.
"Epanova contains EPA and DHA in their free fatty acid form at a total concentration of 50-60% EPA and 15-25% DHA along with other potentially active omega-3 fatty acids"
"The active ingredient of Epanova is a complex mixture of concentrated omega-3 free fatty acids" (1)
Both above statements can be found on Omthera's Website.
3) The petitioners request to change the OB listing circumvents Amarin's request for 5 years of NCE. No pure Omega 3's have previously been listed in the OB before the approval of Vascepa.
The petitioner states, "One notable example is the Agency's recent approval of a related drug product, Vascepa (icosapent ethyl), whose active ingredient is the same as the more prominent of the two major omega-3-acid ethyl esters in Lovaza. For Vascepa, as reflected in the Orange Book, FDA adopted a strength of 1GM, which is the amount of active ingredient in an administration unit as identified in the drug labeling."
This statement is misleading, first the FDA has never before approved a single Omega 3. None of the Omega 3's in the complex mixtures of Lovaza has been listed in the OB before approval of Vascepa. The petitioner is requesting to list the active ingredient in Vascepa under Lovaza before the FDA has determined Vascepa's exclusivity. As previously stated both the FDA and USP have characterized Lovaza's API as a complex mixture.
It's unclear as to the motive of the petition/petitioners client, if granted would likely block exclusivity for Vascepa and also allow earlier Lovaza generic entry.
Changing OB API's, except for public safety concerns, is not warranted. Delay of Vascepa's exclusivity is unjust.
I respectfully request the petition be rejected and exclusivity for Vascepa be made.
Respectfully Amarin Retail Investor,
Williams
(1)http://omthera.com/epanova_overview.html
Even a stopped clock is right more often than my NCE predictions;).
I think the FDA has reprioritized their agenda to get this decision done, today.
Who made the NCE such a BFD?
How about the 6-18-2012 Orange Book Meeting Posted on the FDA website.
Anyone seen those meeting minutes yet?
In the Marine review documents Icosapent Ethyl was listed as "Chemical Type" with the 505b1 application, this is reserved for NME. The 505b1 was changed to a 505b2 because Amarin didn't have the right to reference some Pharmacology data they needed. Changing from a 505b1 to 2 doesn't change the chemical but might have FUBAR'd the "system". Icosapent Ethyl needed a Policy Review...and I can't find documentation that this was done.
In CDER's annual report to congress, showing how great they did their job. They did not have Icosapent Ethyl listed as a NME...it should have obviously been "no decision has been made". But then of course that doesn't look good when you show congress. The FDA declined to comment if they made a clerical error or just lied;)
I'd go with the clerical error since the latter is a crime.
The facts are Vascepa's 505b2 application is incomplete as evidenced by the review document blanks and admissions of exclusivity, policy review, and no comment on NO Ad Com.
By the FDA's own admission, the Omega decisions are "complicated" and not only is the 505b2 Icosapent Ethyl delayed but also a CP for Lovaza delayed. LOL. Brings to question, Does the CP further delay Exclusivity. My opinion is a, Yes. Timing and the filer of the petition is suspect and not up to regulatory standards. First, a CP can't delay a 505b2 application without a "public safety" issue...this is regulation. Second, the filer was an ex FDA attorney who very likely worked on policy that wasn't released yet, MAPP 5021...that specifically dealt with Ethyl Esther exclusivity. Not only the potential for inside information, but it was filed two weeks before MAPP 5021...which would have completely objected to the CP. Lastly, Crowell & Martin, by regulation...should have their client listed to ascertain if this is/was a "sham" CP to serve as a further delay for a competitor. I believe the lack of client is also a violation in regulations.
The FDA should have never excepted the CP which had clear conflict of interest and potential intent to delay Amarin's completion of their 505b2 exclusivity application. A "sham" CP that delayed Amarin's exclusivity further is an Antitrust violation...this I'm fairly certain of, despite those that say otherwise. The potential defendant is the "client" of Crowell & Martin.
The FDA has painted themselves in a corner...if they would like to be accused of collusion in an Antitrust violation then they should continue the game they're playing.
Crowell & Martin's client should consider getting their checkbook out and writing Amarin a check for the damages in the high stakes loan and dilution of stock. Those that sold and lost money due to this "sham" should file a class action against the "client"...if they are guilty of Antitrust laws...they will write you a check too.
For this not go further:
1) FDA needs to rule on exclusivity...no further delay
2) Crowell & Martin's client needs to stop playing games and make an offer or pay damages...
Williams
What's going on at the FDA?
No idea. But.....
I suspect GSK has is back into a corner fighting for Vascepa Exclusivity to avoid Antitrust "issues".
GSK response came from a well respect decent lawyer...hard to put that in the same sentence...
History of Covington in "Vascepa" like NCE arguement is as strong as it gets:
Covington lawyers have been extensively involved in every aspect of the Hatch-Waxman legislation since its passage in 1984, before FDA, in the courts, and before Congress. We give advice on strategies relating to patent listing, generic approval standards, non-patent (regulatory) exclusivity, pediatric exclusivity, settlement of patent litigation, authorized generics, and 180-day generic exclusivity. We have extensive experience with citizen petitions, pursuing formal and informal advocacy at FDA, and engaging in targeted litigation to maximize product lifecycles. We have also represented PhRMA on all issues relating to the Hatch Waxman legislation, including in rulemakings, on amicus briefs, and with respect to legislative proposals. We were deeply involved in the rulemaking and legislative changes in 2003, and we are routinely involved — on behalf of PhRMA and individual biopharmaceutical companies — in legislative proposals in this space.
Covington lawyers were also deeply engaged in the policy discussions and legislative negotiations that culminated in enactment of the Biologics Price Competition and Innovation Act of 2009 (BPCIA), on behalf of a large coalition of biotechnology innovators, many individual biopharmaceutical companies, and PhRMA. Since enactment of this law in March 2010, we have been heavily involved in implementation on behalf of the research-based industry, coordinating advocacy in the United States with advocacy on biosimilar issues worldwide, and assisting numerous companies with development and execution of lifecycle defense strategies for key products. Our work for individual companies in this space includes advocacy at FDA on scientific, regulatory, and legal issues specific to their products (for example, on exclusivity eligibility, the scientific standards governing biosimilar applications, and policy issues connected to naming and labeling). Covington can put together integrated teams of regulatory, patent advisory, and patent litigation lawyers — all steeped in the issues presented by biosimilars — in order to craft coordinated (and, if needed, global) patent and regulatory defense strategies.
Over the years, Covington has represented virtually every major research based pharmaceutical company on product exclusivity and lifecycle issues.
REPRESENTATIVE MATTERS
We assisted sanofi-aventis with a multi-year multi-jurisdiction strategy with respect to ensuring that follow-on versions of Lovenox (enoxaparin sodium), a complex and not fully characterized molecule, contains all pharmacologically active and clinically significant components of Lovenox. This strategy has had legislative, regulatory, and litigation aspects and included, for example, a citizen petition arguing that FDA should refrain from approving any generic drugs citing Lovenox as the reference listed drug absent certain scientific findings by the agency, and litigation against the agency following its approval of an ANDA.
We argued successfully that the DC Circuit should affirm a district court grant of summary judgment in favor of FDA and Shire in a challenge by a generic manufacturer to the agency’s grant of five years of exclusivity to Shire’s drug, Vyvanse (lisdexamfetamine dimesylate). The firm’s regulatory specialists were engaged at FDA on behalf of clients aligned with Shire and worked closely with the firm’s patent and litigation specialists.
In the district court, we challenged FDA’s authority to approve applications for generic versions of Eloxatin (oxaliplatin) before expiration of sanofi-aventis’s 30-month stay, where the Federal Circuit had stayed the District Court’s judgment of non-infringement pending review.
We drafted a citizen petition for Astellas arguing that FDA should refrain from approving any generic version of Prograf (tacrolimus) absent additional bioequivalence studies in transplant patients. We also represented Astellas in challenging FDA’s denial of the citizen petition and the agency’s approval of an ANDA.
We drafted a citizen petition on behalf of Ista Pharmaceuticals arguing that FDA should refrain from approving a generic version of bromfenac ophthalmic solution 0.09% that utilizes discontinued labeling or omits any portion of the new labeling. We then represented Ista in litigation challenging FDA’s denial of the petition.
----------
If...and it's an If...GSK filed the first "sham" CP they could be a Antitrust defendant.
However, if GSK didn't file but intend to acquire Amarin...they may be on the other end of an Antitrust lawsuit against the original filer.
From the FDA''s point of view, they might be best to just make a decision....
History is on the side of Vascepa getting NCE with the Lovenox case and this should have been made 7-25-2012.
Williams
Ad Com meetin calendar updated: took out the regulatory speak...interesting.
http://www.fda.gov/AdvisoryCommittees/Calendar/ucm365571.htm
October 16, 2013: Endocrinologic and Metabolic Drugs Advisory Committee Meeting Announcement
Center Date Time Location
CDER October 16, 2013 8:00 a.m. to 5:00 p.m. FDA White Oak Campus
Building 31
The Great Room (Rm. 1503)
White Oak Conference Center
10903 New Hampshire Avenue
Silver Spring, Maryland
Agenda
The committee will discuss the supplemental new drug application, NDA 202057/S-005, Vascepa (icosapent ethyl) Capsules, submitted by Amarin Pharmaceuticals Ireland Ltd. Vascepa is currently approved as monotherapy for the treatment of severe hypertriglyceridemia. This supplemental application proposes concomitant use with an inhibitor of HMG-CoA reductase (statin) to reduce triglycerides (TG), non-high-density lipoprotein cholesterol (non-HDL-C), apolipoprotein B (Apo B), low-density lipoprotein cholesterol (LDL-C), total cholesterol (TC) and very-low-density lipoprotein cholesterol (VLDL-C) in adults with mixed dyslipidemia and coronary heart disease (CHD) or a CHD risk equivalent.
Meeting Materials
FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting
Background Material
2013 Meeting Materials, Endocrinologic and Metabolic Drugs Advisory Committee
Public Participation Information
Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before September 30, 2013.
Oral presentations from the public will be scheduled between approximately 1:00 p.m. to 2:00 p.m. on October 16, 2013. Those desiring to make formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before September 20, 2013.
Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by September 23, 2013.
Webcast Information
CDER plans to provide a free of charge, live webcast of the October 16, 2013, meeting of the Endocrinologic and Metabolic Drugs Advisory Committee. While CDER is working to make webcasts available to the public for all advisory committee meetings held at the White Oak campus, there are instances where the webcast transmission is not successful; staff will work to re-establish the transmission as soon as possible. Further information regarding the webcast, including the web address for the webcast, will be made available at least 2 days in advance of the meeting at the following website: 2013 Meeting Materials, Endocrinologic and Metabolic Drugs Advisory Committee.
CDER plans to post archived webcasts after the meeting, however, in cases where transmission was not successful, archived webcasts will not be available.
Contact Information
Stephanie L. Begansky, PharmD.
Center for Drug Evaluation and Research
Food and Drug Administration
10903 New Hampshire Avenue
WO31-2417
Silver Spring, MD 20993
Phone: 301-796-9001
Fax: 301-847-8533
E-mail: EMDAC@fda.hhs.gov
FDA Advisory Committee Information Line
1-800-741-8138
(301-443-0572 in the Washington DC area)- follow the prompts to the desired center or product area
Please call the Information Line for up-to-date information on this meeting.
A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the agency’s Web site and call the FDA Advisory Committee Information Line to learn about possible modifications before coming to the meeting.
No OB update:
Orange Book Data - Monthly
Generic Drug Product Information & Patent Information - Daily
Orange Book Data Updated Through June 01, 2013
Patent and Generic Drug Product Data Last Updated: August 19, 2013
No Ad Com Calendar update with Friday's agenda posting indicating it was to be posted today.
Briefing Documents due to Amarin this week if the Oct 16 th Ad Com is still on, "to discuss regulatory issues".
Akanz...when REDUCEIT is over, will he apologize to his dead patients who could have spent more time with their grandchildren...or question the results...or design?
The 53% reduction in events with the 900 sub population, in my opinion, is Evidence enough to warrant the risk of a placebo. In the Overall JELIS population a 19 % decrease in "Chest Pain" would save $millions$ in healthcare costs.
Evidence based medicine is only ethical when risk/benefit is cloudy, IMO. JELIS isn't a hunch.
JMO
Williams
Vascepa isn't going to help pad the invasive cards pocket.
http://articles.baltimoresun.com/2010-07-03/health/bs-md-stent-data-20100703_1_unneeded-stents-three-hospitals-procedures
Akanz
The JELIS sub group:
957 Japanese TG>150 & HDL<40
53% reduction in "Major Coronary Events" with the RX group taking 1.8 Gram of Epadel vs Placebo
---------------------
REDUCEIT patients are arguably "sicker" and taking 4 grams of Vascepa. The study population is in high risk ethnic groups like Russia. This is a no brainer.
Your Kaiser Cards are not impressive, but they do have a good (high) stent rate, probably something that would take a huge hit (>53% reduction in income) if they put all Cards patients on Vascepa.
http://www.calhospitalcompare.org/profile.aspx?c=1&h=155
For a small biotech with one product NCE is very important short term. ( Next 3 yrs). Amarin can focus all resources on Offense (sales) and IP.
Long term Amarin has build a solid patent wall.
After 3 years, 2016 REDUCEIT rolls in. If BP hasn't picked small Amarin off by then it'll be a Warner-Lambert like deal, I'll hold.
It unusually that the OB didn't update Friday, especially since they updated the OB' d patents. I really hope they update it this week with Amarin exclusivity so I don't have to waste my time....
JL---not a great story but all I have time for.
If the CP was filed by an Amarin competitor and the FDA delayed exclusivity for the decision...Amarin has good cause to make an allegation.
http://www.wsgr.com/publications/PDFSearch/silber0112.pdf
-------------------
First, I've had numerous emails with CDER Ombudsman, Virgina Behr and two phone conversions all related to NCE delay. Ms. Behr also put me in touch with a CDER official I will not name at this time. After a brief search on this individuals background she appeared to have contact with GSK's Marketing Director. I confronted her on this connection and she stammered around it....and then gave me the Amarin stonewall, "a decision regarding exclusivity for Vascepa is still under review".
At this point I decided to make a formal complaint, and notified Ms. Behr....
In a very round about way, I will not get into, I was put in touch with a Senate Judicial Investigator.
This is a copy of my last e-mail with Ms. Behr, it was also CC'd to the CDER contact that appeared to "know" GSK's Marketing Director:
Williams,
Thanks for letting me know.
Virginia
From: Williams (changed)
Sent: Thursday, August 01, 2013 11:51 AM
To: Behr, Virginia L; Khatri, (unnamed CDER contact)
Subject: Formal Investigation Request
Ms. Behr
August 19 th 2013 I will request a formal investigation by Investigative Counsel Senate Judiciary Committee into the exclusivity delay for Vascepa based on Lovaza Citizen Petition Suspect Timing" and source of filing.
Under section 505(q)(1)(B) a 502(b)(2) -application can be delay only due for safety reasons
-the FDA is required to provide to the applicant not later than 30 days after making the determination: 1) that a determination to delay has been made 2) request additional information from the applicant 3) brief summary of issues
The CP is unrelated to public safety and filed by a competitor of Amarin Pharmaceuticals. Under 505(q)(1)(B), the CP should not have delayed the completion of Amarin's 505(B)(2) 5 yr exclusivity request.
In addition, an application filed by a competitor and former FDA Attorney intended to delay exclusivity, should be rejected outright by the FDA.
Thank You,
Williams
I also sent an email to the FDA Ombudsman to express my concerns of CDER's retalitory behaviors, Ms. Behr suggested this in our last phone conversation:
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.
Respectfully,
Williams
---------------------------------------
At this point, my goal is for Amarin to get a fair Anchor review. In my opinion this may not happen with the current CDER administration.
Crazy Azz Retail Investor,
Williams/BioBill
8-15 Amarin's TD accepted for '291 moving very close to NOA. Epanova like patent covering "about" 20% DHA fatty acid compositions.
This likely ends Astra's hopes for a viable drug candidate. Unless they would either licenses the patent from Amarin or acquire Amarin.
In my opinion we're looking at a GSK/AZN bidding war or joint BO. Timing is after Anchor approval, unless 3 party forces an earlier deal.
Epanova: from Omthera's web site
Epanova contains EPA and DHA in their free fatty acid form at a total concentration of 50-60% EPA and 15-25% DHA along with other potentially active omega-3 fatty acids stored in a patent-protected capsule with a patent-protected coating designed to maximize bioavailability and tolerability. Free fatty acids are the chemical form in which essential fatty acids, such as EPA and DHA, are absorbed in the digestive tract. The active ingredient of Epanova is a complex mixture of concentrated omega-3 free fatty acids purified from crude marine fish oil and are, therefore, of natural origin. Our strategy is to initially develop and commercialize Epanova in the United States as a prescription monotherapy as an adjunct to low-fat diet in patients for the reduction of triglyceride levels greater than or equal to 500 mg/dL, or severe hypertriglyceridemia.
The present Epanova formulation is the result of the further development of a drug originally intended to serve as treatment of Crohn’s disease, which ultimately proved safe but ineffective for treatment of Crohn’s disease. Before halting internal development and licensing its rights to the drug formulation to us, Tillotts Pharma AG (the predecessor entity to Chrysalis) conducted two large pivotal Phase III trials in 762 randomized patients with Crohn’s disease in both the European Union and North America.
I've got some thoughts on Omthera's patents and our 281 and 291 patents that hopefully I can post tomorrow. Nothing earth shattering but may add to some of Williams comments he has made on 291. Night all.
I'd love to hear them study.
Time to wake up.
Read the whole post STS...
You know in basketball and the refs really F'k up a call....it's the make-up call.
We must be the only ones seeing it this way;)
Read: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM358301.pdf
This is new as of 6-25-2013 and it does apply to Vascepa!
I might go and sit next to Adam...kinda of a Hannity and Colmes thing... (I would be Hannity/with blond hair though)
I'll see if Adumbs up for it...he has no hair;(
Expedited Programs for Serious Conditions––Drugs and Biologics
Amarin might be the trial run:
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM358301.pdf
"Restriction" wouldn't contain "CHD or CHD risk equivalent"
What is a CHD risk equivalent? Sound like another way to state CAD risk factors.
"This sup ap proposes concomitant use with an inhibitor of HMG-CoA to reduce trigs, non HDL, APO B, LDL, VLDL in mixed dys, CHD, or
CHD risk equivalent."
No mention of 200-499 clearly states the FDA is considering taking this label further than just Labs.
"or CHD risk equivalent" ....like treating CHD wouldn't be enough... They go further to "risk".
I agree to disagree, and believe the FDA is doing the only right thing by granting full label approval for the "potential" benefit of reducing cardiac events.
This is what I base my opinion on:
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM358301.pdf
Vascepa has clear benefit to reduce cardiac risk factor labs...Fact
CAD is the number one killer...Fact
Vascepa is highly suspected to reduce cardiac events by reviewing JELIS...Fact
Vascepa is over 1/2 enrolled in a Cardiac outcomes study...Fact
Vascepa seems to have side effects at the same rate as placebo...Fact
Vascepa is a perfect trial drug for the FDA to model the "Expedited Programs for Serious Conditions––Drugs and Biologics"
This was a wise choice for the FDA for many reasons.
Williams
After review other Ad Com calendar documents Amarin's Agenda doesn't include Safety or Efficasy. That's very odd for an advisory committee.
This Ad Com is about a very wide label the FDA is considering. Wider than REDUCEIT with " CHD risk equivalent"...leaving it to risk factors....age, sex, smoker, family hx, diabetes...
Williams
The Ad Com appears not to just cover Anchor's primary of reduction of trigs but also secondary's. in addition to mix lips 200-500 it IS including treatment of "CHD and CHD risk equivalent". This is VERY broad...more than REDUCEIT Broad!
That's what it looks like to me, I have to find the source of the Doc.
Appears to be linked off of www.ofr.gov.
It clearly states CHD and CHD risk equivalent.... To me this is REDUCEIT wording.
New MAPPs have passed, to approve drugs before outcome studies are finished, we may benefit from those.
I'll post them later.
Agree with all that, however:
"This sup ap proposes concomitant use with an inhibitor of HMG-CoA to reduce trigs, non HDL, APO B, LDL, very low LDL in mixed dys, CHD, or
CHD risk equivalent"
Mixed dys, CHD or CHD equivalent.
CHD or CHD equivalent on the label with mixed dys.
That's was not requested or expected.
What indication did Amarin ask for?
This document claims we will be discussing Anchor, combination use ie. AMR 102, and treatment of CV disease. Anchor 200-500 is not specifically mentioned.
Docket # FDA 2013 N 0001
General Function of the meeting:
To provide advice and recommendations to the Agency on FDA's regulatory issues.
Agenda: To discuss the supplemental new drug application 202057/S-005
This supplemental ap proposes concomitant use with an inhibitor of HMG-CoA to reduce trigs, non HDL, APO B, LDL, very low LDL in mixed dys, CHD, or
CHD risk equivalent.
----------
What exactly is the FDA up to here?
Missing....seems to the question on 3rd party support/partnership. John clearly stated they weren't going to make a deal just to make news headlines. Talked about building share value long term and not to just increase revs as fast as possible by doing a deal that Amarin would just carry a partner on it coat tails....paraphrased of coarse.
John did a great job yesterday.
Call Joe at Amarin and ask if the FDA was pissy about NCE. That should set it straight for you.
I do believe you are correct....and this is why MAPP 5021 was instrumental in the approval of NCE for Vascepa as it excluded Ethyl Esters. The Lovaza CP manipulated the MAPP 5021 angle and snuck the CP in two weeks before being posted and active. It was almost like the CP filer new about MAPP 5021...but that couldn't be the case;)
John Fuson Author of Lovaza CP and Ex FDA Attorney, last date of FDA employment May 2012.
John likely happened to work on the draft of 5021 when employed at the FDA 10 short months prior...I bet numerous FDA documents could support that statement.
http://www.linkedin.com/profile/view?id=39380015&authType=NAME_SEARCH&authToken=1sKk&locale=en_US&srchid=2121059301376651147378&srchindex=1&srchtotal=3&trk=vsrp_people_res_name&trkInfo=VSRPsearchId%3A2121059301376651147378%2CVSRPtargetId%3A39380015%2CVSRPcmpt%3Aprimary&_mSplash=1
If GSK hired Mr. Fuson and then responded to their own CP we're looking at violations that dawf their China issues.
Stang
Thanks for the Biogen example! I saw it was left out...guessing it was intensional.
John T I thought did a great job today. Especially with the no approval question and the Co-promoting deals that have been "offered". Amarin's not taking anyone for a ride that's not going to buy the car. Tried to test drive a Shelby 500GT one day, and got the same treatment from a Ford dealer....kinda funny considering the car I drove to the lot was nicer;)
Please provide all the other that listen.