Replies to post #161713 on Biotech Values

[JJM760]

I held Amrn for a long time before cutting my losses a few months ago. Can you explain to me how the NCE decision could be so delayed? For the life of me I can't.

Fwiw I see value here as well.

[DewDiligence]

AMRN faces FDA advisory panel on 10/16/13 for sNDA relating to the ‘ANCHOR’ indication:

http://finance.yahoo.com/news/amarin-informed-fda-october-16th-115900860.html

[DewDiligence]

AMRN selling 25M* shares on unspecified terms:

http://finance.yahoo.com/news/amarin-announces-public-offering-american-204229065.html

The share price is off 8% to $5.69 in AH trading.

*Assuming exercise of underwriter’s option.

[DewDiligence]

AMRN books $5.5M of 2Q13 Vascepa sales:

http://finance.yahoo.com/news/amarin-reports-second-quarter-2013-200200871.html

Not very impressive, IMO.

[DewDiligence]

(AMRN)—FDA approves AZN’s Epanova fish-oil product for high tryglycerides:

http://www.chicagotribune.com/health/sns-rt-us-astrazeneca-pfizer-epanova-20140505,0,7311435.story

Industry analysts, on average, expect Epanova sales to reach a relatively modest $322 million a year by 2018, according to Thomson Reuters Pharma.

The new pill…was originally developed by Omthera Pharmaceuticals, which AstraZeneca acquired last year for up to $443 million [#msg-88369969].

…The new drug will compete with other fish oil-based medicines such as GlaxoSmithKline Plc's Lovaza, which now faces cut-price generic competition, and Amarin Corp Plc's Vascepa.

AstraZeneca also hopes to develop a fixed-dose combination of its cholesterol-lowering drug Crestor and Epanova. The new combination, if successful, would help extend the Crestor franchise beyond 2016, when the drug's U.S. patent ends.

[DewDiligence]

(AMRN)—AZN has no intention of launching Epanova soon, according to AMRN’s 8-K filing today:

http://biz.yahoo.com/e/141114/amrn8-k.html

On November 14, 2014, based on a representation from AstraZeneca Pharmaceuticals LP that the commercial launch of Epanova in the United States is not imminent, the United States District Court for the District of Delaware dismissed, without prejudice (i.e., preserving the ability for Amarin to later re-file the suit), Amarin's complaint against Omthera Pharmaceuticals, Inc., and its parent company, AstraZeneca Pharmaceuticals LP. The complaint sought injunctive relief and monetary damages for infringement of Amarin's U.S. Patent No. 8,663,662… In the complaint, Amarin alleged infringement of the Patent arising from the anticipated launch of Epanova in the United States following the product's FDA approval in May 2014.

…The court was persuaded by the defendants' representation that Epanova would not be launched in 2014 and by the defendants' representation that it would provide notice to Amarin prior to any product launch. The court indicated that it relied on those representations in rendering its decision and noted that they are binding on the defendants as a matter of judicial estoppel. Amarin intends to pursue this litigation vigorously if and when any such notice is received and plans to aggressively protect its intellectual property rights.

Epanova is the Omega-3 fish-oil product AZN picked up in the 2013 acquisition of Omthera for $260M plus contingent rights (#msg-88369969). Epanova was approved by the FDA in May 2014 (#msg-101629554).

AZN apparently hasn’t received much return on its investment.

[DewDiligence]

Epanova is listed on AZN slides 28/29 (#msg-108275963), but there is evidently no intention to launch the product. Curious.