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Crazy... But I agree GSK will/has make/made the first move. IMO we get out Bidding war between AZN & GSK.
JZ may announce offer today;). That letter foreshadows intent.
Big time negotiations and dirty play. IMO the letter signifies Interest to negotiate. AZN, MRK, and PFE might be left holding their d!cks in the next couple of weeks.
We agree to disagree then. CP doesn't give any credence to the other 5 Omega 3's that have triglyceride lowering pharmacology. The "mix" should be single and not negate the possible therapeutic characteristics of single concentrated Omega 3 which may have unknown pharmaceutical value. Thoughts?
Very possible...we'll know soon enough
GSK & Provaza(BASF)' s response to Lovaza CP is a BFD
1) "Contrary to the statements made in the Citizen Petition, the designated strength of Lovaza should remain the same, as the active ingredient is not simply the seven omega-3-acid ethyl esters, but the entire mixture. The development and regulatory history of the product clearly indicates that the 1 gram of fish oil concentrate in each Lovaza capsule constitutes the active ingredient. This is consistent with the position that FDA has taken generally for naturally derived, heterogeneous mixtures, where FDA considers the entire mixture to be the active drug substance."
http://www.regulations.gov/contentStreamer?objectId=0900006481391626&disposition=attachment&contentType=pdf
2) directly communicates to the FDA GSK's not going to sue
8-16 might finally be the date!
I think GSK will be the first to make an offer.
Page 502 in the commentary section...sorry
Patel
CP was hand deliverered Feb 6 2013, two weeks to the date MAPP 5021.1 was posted.
The CP requested a change in the OB for Lovaza after the FDA spent 6 months defining the differences between Lovaza and Vascepa, including two RLD's.
MAPP 5021.1 Naming of Drug Products Containing Salt Substances:
PURPOSE
"This MAPP describes how CDER will apply the United States Pharmacopeia (USP)
Monograph Naming Policy for Salt Drug Substances in Drug Products and Compounded Preparations1 (the USP Salt Policy2) to prescription drug products3 to ensure consistent drug product naming when the USP Salt Policy becomes official on May 1, 2013. This MAPP also provides information to help reviewers determine when the USP Salt Policy’s exceptions should be granted."
MAPP 5021.1 has to do with naming the active moiety, the CP requested Lovaza's Active Moiety change from mix of ethyl esters to 900 mg of EPA x mg and DHA x mg.
It's my assertation a former Attorney ,for the FDA, filed a CP with inside knowlege of 5021.2 to further delay the exclusivity of Vascepa. It's well known CP have been used before to manipulate exclusivity and generic entries.
The client of Crowell & Moring has some explaining to do and so does the FDA.
This BS exclusivity delay changed Amarin's whole game plan.
Great, doesn't hurt my feelings you disagree;). How many times have you spoken to the FDA? How many email exchanges? Just guessing, I might have a little more time into the thought process.
Very good. Goldenberg statement:
http://www.nxtbook.com/nxtbooks/medimedia/pt_201209/index.php?startid=499#/21
"The FDA considers Vascepa a NCE"
This is the overhang that hampers a BO or Partnership...Period.
Read about Big Pharma abusing CP to delay generic entry, 2007 laws where updated to include listing conflict of interests. A CP with no name, interest, or motivation is suspect. GSK has a pending lawsuit that's not settle yet. I'll do everything in my power so BP isn't gaming my trades abusing BS loopholes.
It's a card I'm willing to play if BP behind an anonymous petition .
"Several antitrust challenges have arisen in the context of brand name pharmaceutical companies blocking or delaying the introduction of generic pharmaceuticals through manipulation of FDA regulatory processes"
"Moreover, plaintiffs have brought antitrust challenges against branded companies in the context of last minute labeling changes, which have the effect of delaying or impeding the ability of lower-priced generics to enter the market."
"Most recently, however, several antitrust challenges have been brought against branded drug companies allegedly seeking to use the FDA citizen petition process as a tactic to forestall generic entry.10 Often filed on or near the eve of generic entry, citizen petitions can have the effect of delaying final ANDA approval while the FDA sifts through and evaluates if the petitioners’ arguments have merit. While, to date, the FTC has not brought an enforcement action in this area, it has expressed concern regarding the potential for misuse of citizen petitions. According to Commissioner (now-Chairman) Jon Leibowitz, the citizen petition process is “susceptible to systemic abuse. ... It is no coincidence that brand companies often file these petitions at the eleventh hour before generic entry and that the vast majority of citizen petitions are denied.”
"In part to deal with the potential anticompetitive abuse of the citizen petition process, Congress passed the FDAAA, which was enacted on September 27, 2007.14 The FDAAA adds new section 505(q) to the Federal Food, Drug, and Cosmetic Act (FDCA) and governs certain citizen petitions and petitions for stay of FDA agency action. Importantly, Section 505(q)(1)(A) provides that the FDA may not delay approval of an ANDA application because of any request to take any form of action related to the pending ANDA unless “a delay is necessary to protect the public health.” 15 Moreover, the FDAAA authorizes the FDA to summarily deny any citizen petition whose primary purpose, as determined by the FDA, is to delay competition."
"An antitrust plaintiff alleging that a branded firm is using the citizen petition process to unlawfully monopolize the market for a particular drug faces a number of challenges, including the establishment of relevant market definition, market power, and antitrust injury"
==============================
If BP did file two weeks before MAPP 5021 with the intent to delay Vascepa NCE Amarin has a lawsuit. Also remember the attorney that filed was one of the FDA's a short year before the filing.
==============================
"While petitioning is generally protected, a party is not entitled to Noerr-Pennington immunity where the petitioning activity “ostensibly directed toward influencing governmental action [ ] is a mere sham to cover ... an attempt to interfere directly with the business relationships of a competitor....” Noerr, 366 U.S. at 144. In other words, when the sole goal of petitioning is to interfere with the business of one’s rival, it is not protected. To prove that the petitioning is a sham, a plaintiff must demonstrate that it is both objectively and subjectively
baseless."
===============================
Suspect timing certainly
“Plus” Factors that Make Monopolization Claims Based on Citizen Petition Theory More Likely to Survive Motion to Dismiss or Summary Judgment
While there is a high standard to prove the sham exception to Noerr-Pennington immunity, as described above, some plaintiffs have successfully survived at the motion to dismiss and/or summary judgment stages. While there is no “formula” for a successful claim for monopolization based on the filing of baseless citizen petition, the courts have discussed certain factors that make the success of these claims more likely.
Suspect Timing
In considering whether the sham exception has been met, courts look to the timing of the filing
"The FDA’s response to citizen petition undoubtedly plays a major role in the determination if a petition is considered objectively baseless. Obviously if the FDA takes action based on the citizen petition, the petition will not be found to be baseless.68 On the other hand, as is present in these cases, the fact that the FDA strongly criticized the requests may tend to show that a petition is objectively baseless and therefore not entitled to Noerr- Pennington immunity. While not expressly called out as a factor, the courts in these cases have recited and quoted extensively from the language contained in the FDA’s letters"
With the FDA excepting a petition from an ex- FDA attorney with recent insight....they'll colluded.
=================================
I have enough skin in the game, it's certainly not a waste of my time.
Williams
Agree, Goldenberg's statement.
Certainly would appear that GSK is willing to concede to a Mix of Omega 3's as the active moiety.
I want to know who filed the original, by law this is required. The FDA should've never accepted a nameless petition without the client posted. Could it have been AZN? If so I have an antitrust allegation which i was prepairing for GSK. Still holding the FDA to collusion with the party that filed....
http://www.wsgr.com/publications/PDFSearch/silber0112.pdf
Next week is going to get interesting.
Williams
NCE chance looks greater than ever IMO.
GSK argues for Lovaza to remain the same. Original petition filer appears not to be GSK.
Comments posted by GSK on Lovaza petition, just posted!
http://www.regulations.gov/contentStreamer?objectId=0900006481391626&disposition=attachment&contentType=pdf
8501225 is the 17 th OB'd patent, updated today
http://www.accessdata.fda.gov/scripts/cder/ob/docs/patexclnew.cfm?Appl_No=202057&Product_No=001&table1=OB_Rx
Expect nothing from the CC. Amarin must report, but no guidance or Anchor plan will be laid out.
-May 22 Amarin PR's '899 AMR102 Vascepa + Crestor
-May 28 AZN PR's Omthera's BO
-May 22 to August 7th Amarin hasn't PR'd anymore patents and crawled under a rock.
Whatever's going on behind the scenes has Amarin being exceptionally quiet, even for them. Anchor plans will made known after, Epanova NDA "snag" or Anchor Ad Com. I don't see Epanova having a survivable 74 day letter. It doesn't mean an AZN deal, but it's a key to the valuation puzzle.
These events could trigger action:
1) NCE
2) Epanova snag
3) Ad Com
4) BP bidding war
May 22 Amarin PR's '899 AMR102 Vascepa + Crestor
May 28 AZN PR's Omthera's BO
May 22 to August 7th Amarin hasn't PR'd anymore patents and crawled under a rock. Something behind the scene is going on between AZN and Amarin. Who's gonna give first?
==================================
May 28, 2013AstraZeneca to Acquire Omthera Pharmaceuticals Including NDA-Ready Novel Dyslipidemia Treatment to Complement Cardiovascular Portfolio
PRINCETON, N.J., May 28, 2013 /PRNewswire/ -- AstraZeneca today announced that it has entered into a definitive agreement to acquire Omthera Pharmaceuticals, a specialty pharmaceutical company based in Princeton, New Jersey, focused on the development and commercialization of new therapies for abnormal levels of lipids in the blood, referred to as dyslipidemia.
=================================
May 22, 2013Amarin Announces Notification of Patent Allowance for U.S. Application 13/417,899 Related to Combination Product of Vascepa(R) and Statin Therapy
BEDMINSTER, N.J., and DUBLIN, Ireland, May 22, 2013 (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 United States Patent and Trademark Office (USPTO) has published notification of a Notice of Allowance for Amarin's U.S. Patent Application Serial Number 13/417,899 titled "Pharmaceutical Compositions Comprising EPA and a Cardiovascular Agent and Methods of Using the Same." This application includes claims intended to protect the Vascepa® (icosapent ethyl) indication approved by the U.S. Food and Drug Administration (FDA) based on Amarin's MARINE clinical trial results specifically those results seen in patients on statin therapy.
The claims in this allowed application cover a method to reduce triglycerides in subjects having a triglyceride level of 500mg/dl to 1500mg/dl who are also receiving statin therapy (whether in fixed or non-fixed dose formulation) using an amount of Vascepa effective to reduce triglycerides without substantially increasing low density lipoprotein cholesterol (LDL-C).
"Through our findings from conversations with thought leaders and other clinicians during the launch of Vascepa, we've confirmed that many patients on therapies intended for lowering triglycerides are also on statins. The claims in this allowed application cover the administration of a pharmaceutical composition comprised of EPA in conjunction with a stain, using either a fixed or non-fixed dose, to lower triglycerides without increasing LDL-C, otherwise known as bad-cholesterol," stated Joseph Zakrzewski, Chairman and Chief Executive Officer of Amarin.
A Notice of Allowance is issued after the USPTO makes a determination that a patent can be granted from an application. The issued patent would have a term that expires no earlier than in 2030. Amarin plans to list this patent in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations, or Orange Book, after issuance of the patent.
This application is part of an expanding patent portfolio for Amarin with 23 patent applications now either issued or allowed with the USPTO and over 30 additional applications pending in the United States. Amarin is also pursuing patent applications related to Vascepa in multiple jurisdictions outside the United States, including the application for Amarin's MARINE method of use patent in Europe for which Amarin has announced receipt of an Intention to Grant letter.
Patents in OB not updated today.
Combo patent was the last one Amarin PR'd.
'146 is 8501225 and will be OB'd with the next update.
February 7, 2013Amarin Announces Notification of Patent Allowance for U.S. Application 13/614,146 Related to Vascepa(R) and FDA Approved MARINE Indication
BEDMINSTER, N.J., and DUBLIN, Ireland, Feb. 7, 2013 (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 United States Patent and Trademark Office (USPTO) has published notification of Notice of Allowance for U.S. Patent Application Serial Number 13/614,146. This application includes claims intended to protect the Vascepa® (icosapent ethyl) indication approved by the U.S. Food and Drug Administration (FDA) based on Amarin's MARINE clinical trial results.
A Notice of Allowance is issued after the USPTO makes a determination that a patent can be granted from an application. The issued patent would have a term that expires no earlier than in 2030. After issuance, Amarin plans to list this patent in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations, or Orange Book.
The claims in this allowed application cover a method of use relating to Vascepa's MARINE indication. Specifically, the allowed independent claim covers use of icosapent ethyl, or EPA, including Vascepa, in lowering triglycerides through the daily administration of about 2500 mg to about 5000 mg of EPA, independent of DHA content, present in one or more capsules, effective to lower triglycerides in the subject by at least 25% without increasing LDL-C by more than 5%.
"The claims in this allowed application cover the specified method of administration of a pharmaceutical composition comprising EPA over a broad range of daily EPA doses and amounts of EPA per capsule—including, for example, a daily dosing regimen of 4 capsules with about 625 mg to about 1.25 grams of EPA per capsule," stated Joseph Zakrzewski, Chairman and Chief Executive Officer of Amarin. "The issuance of this Notice of Allowance represents yet another significant step toward Amarin's goal of protecting the commercial potential of Vascepa to beyond 2030 through patent protection, regulatory exclusivity, trade secrets and by taking advantage of manufacturing barriers to entry."
This application is part of an expanding patent portfolio for Amarin with 17 patent applications now either issued or allowed with the USPTO and over 30 additional applications pending in the United States. Amarin is also pursuing patent applications related to Vascepa in multiple jurisdictions outside the United States.
No, Pronova's now BASF...doesn't claim dose, just % of mixtures. 4 gram dose of Lovaza contains less than 2500 mg of EPA. Epanova might want to be concerned though.
5656667 Apr 10, 2017
Fatty acid composition comprising at least 80% by weight of omega-3-fatty acids, salts or derivatives thereof, wherein (all-Z)-5,8,11,14,17-eicosapentaenoic acid (EPA) and (all-Z)-4,7,10,13,16,19-docosahexaenoic acid comprises at least 75% by weight of the total fatty acids. The compositions can be used for the treatment or prophylaxis of multiple risk factors for cardiovascular diseases.
This application is a continuation of application Ser. No. 07/902,500 filed Jun. 23, 1992, now U.S. Pat. No. 5,502,077, which in turn is a continuation of application Ser. No. 07/389,902 filed Aug. 4, 1989, now abandoned.
Claims
What is claimed is:
1. A method for elevating the HDL cholesterol level in the serum of a human patient, which comprises administering to the patient a pharmaceutical composition in which the active ingredients consist essentially of a mixture of fatty acids of which at least 80% by weight is comprised of a combination of (all-Z omega-3)-5,8,11,14,17-eicosapentaenoic acid (EPA) and (all-Z omega-3)-4,7,10,13,16,19-docosahexaenoic acid (DHA) in a weight ratio of EPA:DHA of from 1:2 to 2:1, said composition being administered in amounts providing a daily dosage of 1 to 10 grams of said mixture of fatty acids.
2. The method of claim 1, wherein at least 85% by weight of the mixture of fatty acids is comprised of long chain omega-3 fatty acids.
3. The method of claim 2, wherein the EPA constitutes 40 to 60% by weight of the mixture of fatty acids and the DHA constitutes 25 to 45% by weight of the mixture of fatty acids.
4. The method of claim 3, wherein the EPA and DHA are present in the composition in an EPA:DHA weight ratio of from 1:1 to 2:1.
5. The method of claim 4, wherein at least 3% by weight of the mixture of fatty acids is comprised of omega-3 fatty acids other than EPA and DHA that have 20, 21, or 22 carbon atoms.
6. The method of claim 4, wherein at least 1% by weight of the mixture of fatty acids is comprised of (all-Z omega-3)-6,9,12,15,18-heneicosapentaenoic acid.
7. The method of claim 6, wherein at least 85% by weight of the fatty acid content of the composition is comprised of the combination of EPA and DHA, and the fatty acids are present in the composition in ethyl ester form.
8. The method of claim 4, wherein the composition is administered orally.
9. The method of claim 4, wherein at least 4.5% by weight of the mixture of fatty acids is comprised of fatty acids other than EPA and DHA that have 20, 21, or 22 carbon atoms.
10. The method of any of claims 5, 6, or 9, wherein the fatty acids are present in the composition in esterified form.
11. The method of any of claims 5, 6, or 9, wherein the fatty acids are present in the composition in ethyl ester form.
12. The method of any of claims 5, 6, or 9, wherein the fatty acids are present in the composition in salt form.
13. The method of any of claims 5, 6, or 9, wherein the fatty acids are present in the composition in the free acid form.
14. A pharmaceutical mixed-fatty-acids composition in which
a) at least 80% by weight of the composition is comprised of a combination of (all-Z omega-3)-5,8,11,14,17-eicosapentaenoic acid (EPA) and (all-Z omega-3)-4,7,10,13,16,19-docosahexaenoic acid (DHA) in a weight ratio of EPA:DHA of from 1:2 to 2:1 and
b) (all-Z omega-3)-6,9,12,15,18-heneicosapentaenoic acid is present in an amount of at least one percent by weight.
15. The composition of claim 14, wherein at least 85% by weight of the composition is comprised of long chain omega-3 fatty acids.
16. The composition of claim 15, wherein the EPA constitutes 40 to 60% by weight of the composition and the DHA constitutes 25 to 45% by weight of the composition.
17. The composition of claim 16, wherein C 20:4 omega-6 fatty acid constitutes at least one percent by weight of the composition.
18. The composition of claim 17, wherein C 22:5 omega-3 fatty acid constitutes at least one percent by weight of the composition.
19. The composition of claim 16, wherein the (all-Z omega-3) -6,9,12,15,18-heneicosapentaenoic acid is present in an amount of from 1 to 4% by weight.
20. The composition of any of claims 17, 18, or 19, wherein the EPA and DHA are present in an EPA:DHA weight ratio of from 1:1 to 2:1.
21. The composition of claim 19, wherein C 22:5 omega-3 fatty acid constitutes 1 to 3% by weight of the composition.
22. The composition of claim 21, wherein the EPA and DHA are present in an EPA:DHA weight ratio of from 1:1 to 2:1.
23. The composition of any of claims 14, 15, or 16, wherein the EPA and DHA are present in an EPA:DHA weight ratio of from 1:1 to 2:1.
24. A mixed-fatty-acids composition for the treatment or prophylaxis of multiple risk factors for cardiovascular diseases in which
a) at least 80% by weight of the composition is comprised of omega-3 fatty acids,
b) at least 80% by weight of the total fatty acid content of the composition is comprised of a combination of (all-Z omega-3)-5,8,11,14,17-eicosapentaenoic acid (EPA) and (all-Z omega-3)-4,7,10,13,16,19-docosahexaenoic acid (DHA) in a weight ratio of EPA:DHA of from 1:2 to 2:1, and
c) omega-3 fatty acids other than EPA and DHA are present in an amount of at least 1.5% by weight of the total fatty acids.
25. The composition according to claim 24, wherein other long chain fatty acids present are selected from the group consisting of (all-Z omega-3)-6,9,12,15,18-heneicosapentaenoic acid, (all-Z omega-3)-7,10,13,16,19-docosapentaenoic acid, and (all-Z omega-3)-6,9,12,15-octadecatetraenoic acid.
26. The composition of any of claims 14, 22, or 25, wherein the fatty acids are present in ethyl ester form.
27. The composition of any of claims 14, 22, or 25, wherein the fatty acids are present in the free acid form.
28. A pharmaceutical mixed-fatty-acids composition in which
a) at least 80% by weight of the composition is comprised of a combination of (all-Z omega-3)-5,8,11,14,17-eicosapentaenoic acid (EPA) and (all-Z omega-3)-4,7,10,13,16,19-docosahexaenoic acid (DHA) in a weight ratio of EPA:DHA of from 1:2 to 2:1 and
b) at least 3% by weight of the composition is comprised of omega-3 fatty acids other than EPA and DHA that have 20, 21, or 22 carbon atoms.
29. The composition of claim 28, wherein 3 to 5% by weight of the composition is comprised of omega-3 fatty acids other than EPA and DHA that have 20, 21, or 22 carbon atoms.
30. The composition of claim 28, wherein at least 85% by weight of the composition is comprised of long chain omega-3 fatty acids.
31. The composition of claim 30, wherein the EPA constitutes 40 to 60% by weight of the composition and the DHA constitutes 25 to 45% by weight of the composition.
32. The composition of claim 31, wherein C 20:4 omega-6 fatty acid constitutes at least one percent by weight of the composition.
33. The composition of claim 31, wherein C 22:5 omega-3 fatty acid constitutes at least one percent by weight of the composition.
34. The composition of claim 33, wherein C 22:5 omega-3 fatty acid constitutes 1 to 3% by weight of the composition.
35. The composition of claim 34, wherein the EPA and DHA are present in an EPA:DHA weight ratio of from 1:1 to 2:1.
36. The composition of claim 35, wherein the fatty acids are present in the free acid form.
37. The composition of claim 31, wherein the fatty acids are present in the free acid form.
38. The composition of claim 31, wherein (all-Z omega-3)-6,9,12,15,18-heneicosapentaenoic acid is present in an amount of at least one percent by weight.
39. The composition of any of claims 32, 33, or 38, wherein the EPA and DHA are present in an EPA:DHA weight ratio of from 1:1 to 2:1.
40. The composition of claim 38, wherein the (all-Z omega-3)-6,9,12,15,18-heneicosapentaenoic acid is present in an amount of from 1 to 4% by weight.
41. The composition of any of claims 28, 30, or 31, wherein the EPA and DHA are present in an EPA:DHA weight ratio of from 1:1 to 2:1.
42. The composition of any of claims 28, 31, or 35, wherein the composition is in oral dosage form.
43. The composition of any of claims 28, 31, or 35, wherein the fatty acids are present in esterified form.
44. The composition of any of claims 28, 31, or 35, wherein the fatty acids are present in ethyl ester form.
45. The composition of any of claims 28, 31, or 35, wherein the fatty acids are present in salt form.
46. The composition of claim 28, wherein the fatty acids are present in the free acid form.
47. A mixed-fatty-acids composition for the treatment or prophylaxis of multiple risk factors for cardiovascular diseases in which
a) at least 80% by weight of the composition is comprised of a combination of (all-Z omega-3)-5,8,11,14,17-eicosapentaenoic acid (EPA) and (all-Z omega-3)-4,7,10,13,16,19-docosahexaenoic acid (DHA) in a weight ratio of EPA:DHA of from 1:2 to 2:1 and
b) at least 3% by weight of the composition is comprised of omega-3 fatty acids other than EPA and DHA that have 20, 21, or 22 carbon atoms.
48. The composition of claim 47, wherein 3 to 5% by weight of the composition is comprised of omega-3 fatty acids other than EPA and DHA that have 20, 21, or 22 carbon atoms.
49. A pharmaceutical mixed-fatty-acids composition in which
a) at least 90% by weight of the composition is comprised of long chain, polyunsaturated, omega-3 fatty acids;
b) at least 80% by weight of the composition is comprised of a combination of (all-Z omega-3)-5,8,11,14,17-eicosapentaenoic acid (EPA) and (all-Z omega-3)-4,7,10,13,16,19-docosahexaenoic acid (DHA) in a weight ratio of EPA:DHA of from 1:1 to 2:1, with the EPA constituting 40 to 60% by weight of the composition and the DHA constituting 25 to 45% by weight of the composition;
c) at least 4.5% by weight of the composition is comprised of omega-3 fatty acids other than EPA and DHA that have 20, 21, or 22 carbon atoms;
d) from 1 to 4% by weight of the composition is comprised of (all-Z omega-3)-6,9,12,15,18-heneicosapentaenoic acid; and
e) the composition is in oral dosage form and includes an effective amount of a pharmaceutically acceptable antioxidant.
50. The composition of claim 49, wherein the fatty acids are present in ethyl ester form.
51. The composition of claim 50, wherein at least 85% by weight of the fatty acid content of the composition is comprised of the combination of EPA and DHA.
52. The composition of either of claims 50 or 51, wherein the antioxidant is tocopherol.
53. The composition of any of claims 14, 22, or 24, wherein the composition is in oral dosage form.
54. The composition of any of claims 14, 22, or 25, wherein the fatty acids are present in esterified form.
55. The composition of claim 54, wherein the fatty acids are present in salt form.
56. The composition according to claim 24 or claim 25, wherein the total concentration of long chain omega-3 fatty acids is at least 90% by weight, the combined weight of the EPA and DHA constitutes at least 85% by weight of the total fatty acids, the EPA and DHA are present in a weight ratio of EPA:DHA of from 1:1 to 2:1, and the other long chain omega-3 C 20, C 21 and C 22 acids constitute at least 4.5% by weight of the composition.
57. The composition according to claim 24, wherein the total concentration of long chain omega-3 fatty acids is at least 95% by weight, the combined weight of the EPA and DHA constitutes at least 90% by weight of the total fatty acids, and the other long chain C 20, C 21 and C 22 acids constitute at least 4.5% by weight of the composition.
58. The composition according to claim 57, wherein EPA and DHA are present in a weight ratio of EPA:DHA of from 1:1 to 2:1.
59. The composition according to claim 24 or claim 25, wherein the total concentration of long chain omega-3 fatty acids is at least 85% by weight and the other long chain C 20, C 21 and C 22 acids constitute at least 4.5% by weight of the composition.
60. The composition according to claim 24, wherein the fatty acids are present in the form of pharmaceutically acceptable salts.
61. The composition according to claim 24, wherein the fatty acids are present in the form of an ester.
62. The composition according to claim 61, wherein the fatty acids are present in the form of ethyl esters.
63. The composition according to claim 61, wherein the ester is an alkyl ester.
7732488 Jan 30, 2025
Any compound containing EPA 2500 mg to 5000 mg including those with DHA, DPA...or other mixes would fall under the claims. The increasing in LDL is a side effect of a poor generic Vascepa. That's the purpose.
Amarin's new patent today 8501225
1. A method of treating a subject with fasting triglycerides of at least 500 mg/dl comprising, orally administering to the subject daily for a period of 12 weeks a pharmaceutical composition comprising about 2500 mg to 5000 mg of ethyl eicosapentaenoate present in one or more capsules, effective to lower triglycerides in the subject by at least 25% without increasing LDL-C by more than 5%.
2. The method of claim 1 wherein the subject has a fasting baseline LDL-C from about 50 mg/dl to about 300 mg/dl.
3. The method of claim 1, wherein the subject has one or more of: a baseline fasting non-HDL-C of about 200 mg/dl to about 300 mg/dl, a baseline fasting total cholesterol of about 250 mg/dl to about 300 mg/dl, a baseline fasting VLDL-C of about 140 mg/dl to about 200 mg/dl, and/or a baseline fasting HDL-C of about 10 mg/dl to about 80 mg/dl.
4. The method of claim 1, comprising administering to the subject the pharmaceutical composition daily for the period of 12 weeks to effect a reduction in triglycerides of at least about 30% without increasing LDL-C in the subject.
5. The method of claim 1, comprising administering to the subject the pharmaceutical composition daily for the period of 12 weeks to effect a reduction in apolipoprotein B in the subject.
6. The method of claim 1, comprising administering to the subject the pharmaceutical composition daily for the period of 12 weeks to effect a reduction in VLDL-C in the subject.
------------
Important point:
"a pharmaceutical composition comprising about 2500 mg to 5000 mg of ethyl eicosapentaenoate present in one or more capsules"
Regardless of any other component anything over 2500 mg EPA is covered. Should be in the OB by the end of the day.
LOL yes Chess not Chest...thanks for the laugh
Zum
Thanks for sharing your DD. Wow! Amarin's R&D patent team is amazing! We currently have a chest match between AZN and Amarin. This basically demolished Omthera's pat app #13734846. It's likely Amarin will be the first to succeed in approval considering the product, prior patents, and USPTO mojo.
Williams
Regulations Dot Gov is still down... Lovaza petition should be decided by CC next week.
Williams
Rosiglitazone (trade name Avandia, GlaxoSmithKline) is an antidiabetic drug in the thiazolidinedione class of drugs. It works as an insulin sensitizer, by binding to the PPAR receptors in fat cells and making the cells more responsive to insulin. It is marketed by the pharmaceutical company GlaxoSmithKline (GSK) as a stand-alone drug or in combination with metformin (trade name Avandamet) or with glimepiride (trade name Avandaryl). First released in 1999, annual sales peaked at approximately $2.5bn in 2006, but declined after the drug was found to increase risk of heart attacks. The drug's patent expired in 2012.[1]
Concerns about rosiglitazone's adverse effects has reduced its use despite the benefits it offers in treating diabetes.[2] Adverse effects caused by rosiglitazone are currently the subject of over 13,000 lawsuits against GSK.[3] As of July 2010, GSK has agreed to settlements on more than 11,500 of these suits.
----------
Very interesting
https://en.wikipedia.org/wiki/Dipeptidyl_peptidase-4_inhibitor
http://www.diabetovalens.com/lat_news/highlightnews.asp?newsid=14659
Vascepa appears to have DPP-4 inhibitor combo potential.
Current DPP-4's on the market: Sitagliptin - Januvia®, Linagliptin - Tradjenta™, Saxagliptin - Onglyza™
Januvia/Merck http://www.drugs.com/stats/januvia
Lovaza Q2 trend:
http://www.drugs.com/stats/lovaza
Fenofibrate Q2 trend:
http://www.drugs.com/stats/fenofibrate
Big news, Thanks
Right on assessment especially with the offering, however, JZ's been paralyzed by the INCOMPETENCE of the FDA.
The lack of COMMUNICATION from the FDA to Amarin has destroyed WS confidence.
One more attempt at communication with CDER...then I'm giving it to a Judicial Comittee Investigator.
Did anyone send me contact info to the "Investigative Counsel, Senate Judiciary Committee"? It's very tempting.
Williams
What % of the prescribers of Lovaza know it significantly bumps LDL?
I bet it's low,very low. When anchor is added to Vascepa label and reps start seeing PCP this will change...fast. Will it spill over to the primary's that recommend fish oils to millions of others? Yes, very likely and this will drive the Anchor market. Switch overs from "OTC fish oil" that bumps LDL.
If I have time I'll post some of the review... I do not buy the cancer BS. A NDA must file the appropriate cancer studies...Lovaza's didn't go long enough or use a high enough dose...this is in the review.
"Reality"
Vascepa market potential
Marine: 4,000,000 currently we have 2.5% of this market (after 6 mo)
Anchor: 40,000,000
REDUCE-IT: 80,000,000
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now let's add ROW market
a very conservative 200,000,000....this is ON LABEL.
2.5% of 200M is $10 billion per year in revenues.
World statin market is $32 Billion
Amarin didn't put API suppliers together for the US Marine market.
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Once Anchor's approved, restrictions on Lovaza's gives Amarin the market...period...game over.
History of last meeting.
Fall of 2012 :AMRN, GSK Amarin Vascepa has blockbuster potential, says Roth Capital
Roth Capital believes that Amarin's (AMRN) Vascepa for patients with elevated triglycerides has a differentiated profile from GlaxoSmithKline's (GSK) Lovaza. The firm thinks that Vascepa has a very benign adverse event profile but it lowered its target on Amarin to $17 from $26 to reflect greater commercial and competitive risks. However, the firm maintains a Buy rating on the stock.
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Roth's basis of today's meeting was IP, it was scheduled after Vascepa's Epanova Patent test FAILURE.
Expect analysts to start to include anchor in projections soon. Just multiple by 10;)
It's likely whatever moves the PPS will move it into a range of true valuation, you forgot a zero.
It's not a suggestion, it's protocol.
First read the Lovaza review, the carcinogenic study was documented as inadequate. This is not my opinion, it is stated as such in the review. So yes I do believe the FDA will require Epanova to have the proper carcinogenetic studies. Despite the lower DHA content, blood DHA levels are higher with Epanova compared to Lovaza.
At the site of action, Lovaza and Epanova are the same the blood levels of EPA & DHA may very but the clinical results are similar.
"Amarin has also granted the underwriters a 30-day option to purchase an additional 3,255,000 ADSs." Another possible cause for the late day action.
"They had an SPA. Clearly the fda is on board with the trial."
Omthera's SPA was designed before the September 2012 RLD draft was drawn up for Lovaza. Lovaza's RLD covers Fatty Acids of both EPA and DHA. This changed Epanova's destiny... Unless you can tell me how Epanova and Lovaza can have the same RLD, same clinical results, Epanova not original enought for IP, and not be consider "generic".
"I doubt the NDA will be rejected" As you file a NDA, RLD must be searched for compounds containing the same active ingrediates.
This is Lovaza and the active ingrediates are 1) EPA total lipids in plasma 2) Basline adjusted EPA total lipids in plasma 3) DHA total lipids in plasma 4) Baseline adjusted DHA total in plasma 5) EPA free fatty acids in plasma 6) Baseline adjusted EPA free fatty acids in plasma 7) DHA free fatty acids in plasma 8) Baseline adjusted DHA free fatty acids in plasma
The same tests have to apply for a generic Lovaza, as a NDA for Epanova. Regardless of the increase levels of both DHA & EPA with Epanova compaired to Lovaza, clinically the both drop Trigs and raise Bad cholesterol at equal levels.
Epanova is a generic end around Lovaza...period. Both have the same Free fatty acids "available at the site of drug action".
You have to perform both Bioavailability and Bioequalivance. Bioequalivance is defined in 320.1 as "the absence if a significant difference in the rate and extent to which the active ingredient or active moiety in pharmaceutical equivalent or pharmaceutical alternative becomes available at the site of drug action when administered at the same molar dose under similar conditions in an appropriately designed study."
How could the application be accepted?
In addition to this, Epanova must complete a 2 year rat study done on the carcinogenesis, especially since Lovaza approval was lacking this data and the EPA/DHA levels are higher. I bet they over looked this.
AZN's 74 day Epanova letter is due 9-23 to 9-27 week. If the NDA is a bust we might see some action heat up.
Consider this a timed event, IMO.