Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
sts
Currently Provova doesn't produce Vasecpa. BASF owns Equateq, Equateq produces Vascepa API, since BASF owns both Pronova and Equateq I assume Pronova has the patented process for Vascepa.
Highly concentrated fatty acids for the pharmaceutical, nutraceutical and food sectors
When it comes to omega oils, purity is of the essence. At BASF’s cGMP-certified site in Callanish, Scotland, our experts oversee the commercial-scale manufacture of omega-3 and omega-6 products for the pharmaceutical, nutraceutical and food sectors. And for over 20 years, they have been developing novel purification methods for fatty acids, such as the industry-leading Maxomega™ and Crystalpure™ technologies. As a result, customers not only benefit from exceptionally pure products – they can also tap into BASF’s extensive expertise to enhance their own portfolio.
http://www.pharma-ingredients.basf.com/Lipid_APIs/Home.aspx
BASF has no intention on infringing on Amarins 25 listed or NAO patents, they're Amarin's partner. BASF can share the Maxomega and Crystalpure technology with Pronova at will, it theirs.
When Amarin gets Anchor hopefully BASF will need both production faciliticies to supply API to Amarin.
Stang
Pronova can produce crude API 90% or > EPA and ship to Equateq for Vascepa refinement. I want BASF to be the sNDA listed at the FDA 4-12-2013, but it's most likely Chemport. Either way great news for Amarin.
BASF acquired both Pronova and Equateq. Equateq has an API contract with Amarin but it's not list as an API supplier by the FDA, yet.
On 4/12/2013 the FDA has added an API supplier for Amarin.
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.Label_ApprovalHistory#apphist
We don't know who that is, yet. But this is significant news.
It could just be:
1)Equateq
2)Pronova
3)Equateq and Pronova AKA BASF
4)Chemport
http://investor.amarincorp.com/releasedetail.cfm?ReleaseID=581758
Most likely it's Chemport. Expect news soon of this development.
BASF is not competition, there selling both "fish oil" API and only one is patented out until 2030.
Pronova website pure EPA >90%, Patented, API...This is not Lovaza.
http://www.pronova.com/process-for-purity/category156.html
Page updated 1-28-2013 After BASF's takeover.
4-23-2013 is the issue date for 13608744.
It happens to claim a pharmaceudical ingrediate containing >95% EPA with no DHA and claim #8 is the reduction of apolipoprotein B.
APO B are the primary apolipoproteins of chylomicrons and LDL. The significance being Lovaza raises LDL's while Vascepa does not.
It also is currently a difference in the two approved labels. Vascepa lowers APO B by 4% while stats for Lovaza are only included with the combination of Lovaza and Simvastatin.
Without the OB of a Anchor patent this patent separates Lovaza and Vascepa, enough for NCE decision...who knows?4-12-2013 "Manufacturing Change or Addition" on FDA site.
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.Label_ApprovalHistory#labelinfo
4-12-2013 "Manufacturing Change or Addition" on FDA site.
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.Label_ApprovalHistory#labelinfo
Forgot the diabetes link...
Association of an APOC3 promoter variant with type 2 diabetes risk and need for insulin treatment in lean persons
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3088807/
These APO 3 C results, opens Icosapent Ethyl to be studied in depth in the diabetic, pediactric diabetic, and pediactric genetic history of APOC3.
Should children be tested for APOC3 gene?
Could Vascepa prevent the early onset of CV dz?
Do children with onset of DM 1 have the APOC3 gene?
How many billions can be saved in health care costs by reducing CV events in the overall population?
http://ghr.nlm.nih.gov/gene/APOC3
New study BP should read:
Eur Heart J. 2013 February 21; 34(8): 615–624.
Statins suppress apolipoprotein CIII-induced vascular endothelial cell activation and monocyte adhesion
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3578265/
Amarin's newly published results:
In Amarin's MARINE and ANCHOR trials, the 4 gram dose of Vascepa achieved reductions in Apo C-III levels of 25.1% (p < 0.0001) and 19.2% (p < 0.0001) compared to placebo, respectively.
http://finance.yahoo.com/news/amarin-announces-clinical-data-showing-100000785.http
The Apo C 3 topic is heating up:
-------------------------
Research Shows Antisense Inhibition of ApoC-III and Triglycerides in Multiple Species Including Humans
CARLSBAD, Calif., April 1, 2013 /PRNewswire/ -- Isis Pharmaceuticals, Inc. (NASDAQ: ISIS) announced today the publication of new data in the journal Circulation Research [doi:10.1161/CIRCRESAHA.111.300367] demonstrating that antisense targeting of apolipoprotein C-III (apoC-III)
http://ir.isispharm.com/phoenix.zhtml?c=222170&p=irol-newsArticle&id=1801803
APOC3 apolipoprotein C-III [ Homo sapiens (human) ]
Gene ID: 345, updated on 7-Apr-2013
http://www.ncbi.nlm.nih.gov/gene/345
------------------------
APOC3 is a good indication in which direction we see REDUCE-IT heading.
Keep us posted Livin, you know your stuff.
I do like to see the March supp out before I give up hope completely. It's still Feb.
As per protocol, the FDA hasn't updated Vascepa's NCE again.
OB has two listings for Vascepa
Exclusivity is not updated, yet.
This could however be an exceptace of Anchor flat out. It was a SPA. (Speculative but possible)
Keep an eye on this new development.
This seems to be an increasing institutional interest moving into Anchor PDUFA cycle
April 12, 2013
07:24 EDT AMRN Leerink to host a conference
Subscribe for More Information
April 9, 2013
12:54 EDT AMRN Amarin management to meet with Jefferies
Meetings to be held in San Francisco on April 9-10 hosted by Jefferies.
April 8, 2013
06:03 EDT AMRN Amarin announces additional positive data from clinical trials of Vescepa
Subscribe for More Information
April 1, 2013
15:19 EDT AMRN Amarin management to meet with JPMorgan
Subscribe for More Information
11:19 EDT AMRN Amarin Vascepa prescriptions tracking well, says Leerink
Subscribe for More Information
Sign up for a free trial to see the rest of the stories you've been missing.
http://www.theflyonthewall.com/permalinks/entry.php/AMRN;SINAid1440907/AMRN;SINA-Stocks-with-call-strike-movement-SINA-AMRN?symbol=AMRN
Livin
http://www.theflyonthewall.com/permalinks/entry.php/AMRN;SINAid1440907/AMRN;SINA-Stocks-with-call-strike-movement-SINA-AMRN
http://www.leerink.com/default.aspx
Next Leerink conference is Boston, so it's more of an educated guess on my part.
Found some interesting pediatric information r/t Apo C III and potential Peds indication for Vascepa
http://www.ncbi.nlm.nih.gov/pubmed/3128878
Hope alls well;)
Williams
Mitch
Amarin has been invited to Leerink Swann's Therapeutics Conference, Boston, MA, July 10, 2013
Invitation only.
You heard it here first;)
Leerink Swann meeting with AMRN flyonthewall 4-12-13
Last encounter:
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 that John F. Thero, Amarin's President, is scheduled to present a general company update at the Leerink Swann Global Healthcare Conference 2013 on Wednesday, February 13, 2013, at 4:00 p.m. ET. This conference will be held at the Waldorf Astoria in New York City.
The importance of IP protection: Abilify example
Abilify 2012 generated about $6 Billion dollars, no generic available. It was approved by the FDA 2002, obviously it's five years are up.
Abilify has two patent listed in OB 5006528 and 5006528 Peds. First patent expiring Oct 2014.
It's not the 5 yr that held of generics of this multi $Billion drug, it's one patent number...ONE.
It's a coin toss each time, the complexity of the issues are becoming more clear. However, more MAPP's may still be in the process of release before a decision is made. Vascepa has cleared the RLD bar and is now listed instead of TBD. More information doesn't mean ALL the information though. Nothing I've seen in the past 9 months leads me to believe Vascepa doesn't get 5 yrs, but the FDA could make that decision today or 2017.
Ultimately, patents will fend off generic Icosapent and by this time next year Vascepa is likely to have 25 to 30 booked in the OB. Try to find another prescription drug with that kind of IP protection.
"RLD (Reference Listed Drug) Status To Be Determined (TBD)
FDA has not yet determined Reference Listed Drug status for this recently approved product."
Drug Name
Active Ingredients
Strength
Dosage Form/Route
Marketing
Status
RLD
TE
Code
VASCEPA ICOSAPENT ETHYL 1GM CAPSULE; ORAL Prescription Yes None
Your both on timeout! Go to your rooms and when you come out you better get a long.
Who cares what SR said or didn't say, or if ST exaggerated.....it has nothing to do with anything. Can't you two bicker in private?
Do not waste MB responding to me please.
As JL confirmed yesterday, Vascepa is odder less...the fishy smel is from oxidation. PlusEPA, Lovaza, and OTC supplements are oxidized. Amarin has a patented process of preventing oxidation and it's also a requirement for would be generics of Icosapent with the new BE FDA document.
Vascepa has no competition.
Williams
Anyone taking Vascepa for RA?
The role of fish oils in the treatment of rheumatoid arthritis.
http://www.ncbi.nlm.nih.gov/pubmed/12678571
Effects of high-dose fish oil on rheumatoid arthritis after stopping nonsteroidal antiinflammatory drugs. Clinical and immune correlates.
http://www.ncbi.nlm.nih.gov/pubmed/7639807
How about Depression? Or IBS/Chron's Dz.?
Icosapent Ethyl may be a single drug with many OFFLABEL indications that have been previously studied with "fish oil", but with the lack of a pharmaceutical medication, popular treatment failed to gain traction.
PlusEPA is oxidized and smells like fish, Vascepa is orderless. It certainly wouldn't pass for Vascepa API.
Effects have worn off for the sinus, but my left eye is not dry.
Lama
Your "wild" fish oil may through off your LDL numbers if it has DHA or other oils in it. Also you may be consuming more than the recommend dose of EPA. LD 50 for EPA is 20g/kg for mice, so I doubt you'll drop over, but you should go through all your medication and supplements with your primary.
Williams
JL
I'm most impressed with my left sinus decongestion! The results have been dramatic and still in effect. It happened soon after draining down my nasolacrimal duct, I could smell the PlusEPI only through my left nostril.
Trying to think of a mechanism of action, do you suppose it could increase sinus lymphatic drainage, thus decongesting the left side? I can't wait to try it on the other side, however, I'm waiting a few days to rule out longer term side effects. My ENT friends are gonna love this;)
PlusEPA doesn't give me the fish burps, but it sure does stink when capsule punctured. Does Vascepa have any smell to it?
Thanks JL
Williams
Zip
Thanks. However, Lacri-lube eye ointment "contains white soft paraffin, liquid paraffin (also known as mineral oil) and lanolin alcohols (also known as wool alcohols). These ingredients produce a transparent, lubricating and moistening film on the surface of the eyeball."
Mineral oil Is a light mixtures of alkanes in the C15 to C40 range.
"EPA-lube" is not painful on the sclera even at 100% concentration. It does need to be cut otherwise you will have haze from the mixture of oil and normal 0.9% NaCl tear mixture.
Still don't try this at home, I'm professionally educated and skilled to recognize and treat reactions/infections
-----------
My experience: left eye one gtt with a few 0.9 normal saline gtts after to clear "oil" vision
1) 100% must be cut with 0.9% Normal Saline
2) PlusEPA is somewhat oxidized...smells like fish, although when I injest PO I don't have fish Eructation
3) clears nasolacrimal duct within minutes, you can smell and taste oil
4) seems to have cleared left nasal passage also
5) throughout the day no irritation, no redness, no oily vision
6) left eye has felt significantly more lubricated over day, especially noted outside
Plan to take 5 days off and watch for s/s of Longer term reactions then repeat again.
This is NOT advisable to try.
Bravo
Let me make it crystal clear I have no guess as to when "the" decision will be made. We can see that over the past 3 months the FDA has posted numerous MAPP documents that relate to difficult decisions being made to best match historical decisions while also providing wiggle room for exceptions.
MAPP documents have an effective date, all that are posted now are effective at the date of posting.
Here's the link: http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ManualofPoliciesProcedures/default.htm
If both the generic guidelines for Icosapent Ethyl and Omega 3 Ethyl Esters used the same vocabulary my opinion would be the FDA is leaning towards rejecting 5 yr exclusivity. Clearly this is NOT what the USP and FDA have done in both the BE documents and MAPP 5021.1. This Manual of Policies and Procedures on pg. 9 changes the guidelines related to "an active moiety so that it will no longer include "esters"..." We all have to look at the facts and draw our own conclusions.
Hope this helps...
JL
I would also like to keep the forum factual, if asked to speculate I will not.
Are you taking RESTASIS gtt for your eyes? Have you stop other treatment for your eyes?
I'm gonna experiment today and directly EPA one eye topically and take a picture...I also have issues with my eyes...(others don't start putting stuff in your eyes!)
Williams
FDA posted new MAPP policy re Outside Speaking Events
It's worth a read, an attempt at culling the flow of inside information.
http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ManualofPoliciesProcedures/ucm078813.pdf
It would seem like the FDA has all the duck's in a row....but I thought that last month.
Of course the BE is new now...
I have no further guesses as to when, just leaning towards a yes.
Mr. Beverlyhills
Vascepa is the "black gold, Texas tea" of the sea;)
Hope we get some FDA action this week.
Williams
To add to SR, Amarin has specific patents related to non active ingredients in capsule preserving the active form. The "generic" document DEMANDS the same inactive ingredients thus validating the Patent until 2030. So it's more like a 17 yr NCE designation if capsule patent holds. Also note the separation between Lovaza's alpha-tocopherol and Amarins just "tocopherol". The USP also changed Icosapent Ethyl to Icosapent Ethyl CAPSULE.
Good luck defeating a patent that both the USP and FDA support.
Study
Also my understanding with NME, 3 yrs starts basically with filing (30 vs. 36).
Amarin will have 24 patents before June. This tells us two things, one...they have a great team with a plan, and two the unexpected results in the CV markers where unexpected and significant.
I expect 5 yrs of exclusivity, otherwise BE guidance for Lovaza and Vascepa would use EXACT terms "icosapent ethyl" and EPAee. Also new MAPP salt policy wouldn't exclude Esters...
Williams
Yahoo MB is horrible
Biobillionair is Williams4076...excuse the name...we all have goals.
The current patent fence:
NOA:
13608744 issue date 4-23-2013
12815569
13040977
13198221
13266085
13266374
13359114
13403699
13404666
13404686
13417899
13418591
Twelve NOA so far
Marine issued Patents
8293727
8293728
8298554
8314086
8318715
8324195
8357677
8377920
8399446
8415335
Anchor
8410086 or '520 not OB until after Anchor approval
12 NOA & 12 issued
4-9 USPTO issued patent #8415335, or '157 Marine patent.
Should be OB's today with patent updates. Patent updates last updated 4-5 at FDA.
Why I think the FDA is leaning to a YES to NCE:
Draft guidance on Omega-3 Acid Ethyl Esters: Lovaza
No mention of Icosapent Ethyl, EPA is refered to as "EPAee", the ee is a designation to ethyl esters of a natural source.
From Appendix 1 API Equivalence:
"The Omega-3-Acid Ethyl Esters Capsules USP monograph (official 8-1-2012) establishes ranges for the two most abundant components (EPAee and DHAee) of the active pharmaceutical ingredient (API) and ranges for the sum of the two components."
Analyses to measure (in appropriate biological fluid):
For Icosapent Ethyl "3) Free (unesterified) EPA lipids in Plasma"
For Lovaza "(5) EPA free fatty acids in plasma (6) Basline-adjusted EPA free fatty acid in plasma"
-----
Icosapent Ethyl from a synthesized process (EPA)
Lovaza (Omega 3 Acid Ethyl Esters) API (EPAee and DHAee) from fish oil
In my opinion the FDA has every intention of granting NCE to Icosapent Ethyl, when is anyone's guess....
Look at this for two views, one NCE two can I build a patent around the definition.
NCE
-USP has two separate categories/names for Lovaza vs. Vascepa. I believe they plan on granting NCE.
Patents
-multiple patents would have to be breached
1)all pure EPA patents
2)capsule patent with exact preservation technique would also have to be breached, the generics for Vascepa has to contain the same inactive ingredients. Amarin's patent this.
3)No DHE
4)unesterfied EPA levels
We need a yes or a no. 5 yrs of exclusivity is nothing compared to the 10 OB'd patents.
"Unesterified EPA" ...I love it.
It's out. Looks good, mirors patent capsule technology.
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm075207.htm
This is the link to BE update, nothing yet. Note it also links to the OB, you can check exclusivity from this page;)