Editor’s Note: Related Tickers: Amarin Corporation plc (ADR) (NASDAQ:AMRN), GlaxoSmithKline plc (ADR) (NYSE:GSK), Abbott Laboratories (NYSE:ABT), Valeant Pharmaceuticals Intl Inc (NYSE:VRX), Obagi Medical Products, Inc. (NASDAQ:OMPI)
Amarin Says FDA Accepts Supplemental New Drug Application for Vascepa (Fox Business)
Amarin Corporation plc (ADR) (NASDAQ:AMRN) said the U.S. Food and Drug Administration accepted its supplemental new drug application for the cholesterol-reducing fish-oil pill Vascepa and has set a Dec. 20 target date to complete its regulatory review. “We are very pleased that the FDA has accepted our sNDA submission for the Anchor indication, which supports the potential expansion of the Vascepa patient population to include adult patients on statin therapy with triglyceride levels ranging from 200 to 499 [micrograms per decilitre] and mixed dyslipidemia,” said Chairman and Chief Executive Joseph S. Zakrzewski.
Glaxo in Drug-Discovery Deal (Wall Street Journal)
GlaxoSmithKline plc (ADR) (NYSE:GSK) will partner with venture capitalists from San Diego in an unusual deal worth up to $495 million to start several drug-discovery firms over the next three years. Under the collaboration, the British drug company will provide financing and technical support to small startups established by Avalon Ventures to explore promising targets for drugs. Glaxo will have to sign off on each startup, and if a technology pans out, Glaxo will have first rights on buying the startup, according to the drug maker and venture-capital firm. Avalon will contribute up to $30 million in funding, while GlaxoSmithKline plc (ADR) (NYSE:GSK) could pay as much as $465 million in seed funding and payments if various development milestones are met.
Russia rejects Abbott Laboratories’ plan to buy Petrovax (Reuters)
Russia’s government commission on foreign investment has turned down U.S. group Abbott Laboratories (NYSE:ABT)’s request to buy Russian vaccine maker Petrovax, the head of Russia’s competition regulator said on Friday. “The commission has reviewed the question about the sale to U.S. company Abbott of Petrovax Pharm. As a result of very lengthy discussion the U.S. company was denied to make this deal,” Igor Artemyev, head of the Federal Anti-Monopoly Service (FAS), told reporters.
Valeant Pharma Gets Antitrust Clearance In U.S For Acquisition Of Obagi Medical (RTT News)
Valeant Pharmaceuticals Intl Inc (NYSE:VRX) announced Monday that it has received antitrust clearance in the United States for its previously announced acquisition of Obagi Medical Products, Inc. (NASDAQ:OMPI) at a price of $24.00 per share. The completion of the tender offer is also conditioned on approval of the transactions by the Antimonopoly Committee of Ukraine or “AMC” for purposes of compliance with applicable Ukrainian antimonopoly law and the tender of a majority of the outstanding shares of common stock of Obagi.
Amarin wins U.S. nod to add S. Korea supplier (Hartford Business)
Irish drug developer Amarin Corporation plc (ADR) (NASDAQ:AMRN), whose research base is Stonington, won the blessing of federal drug regulators to contract with a South Korea company as a second global source of the active ingredient in its patented cardiovascular treatment, Vascepa, authorities say. The U.S. Food & Drug Administration’s approval of Amarin’s supplemental new drug application to bring aboard Korea’s Chemport Inc. to supply Vascepa’s active pharmaceutical ingredient, icosapent ethyl.
Forbes Earnings Preview: GlaxoSmithKline (Forbes)
Analysts have become increasingly bearish on GlaxoSmithKline plc (ADR) (NYSE:GSK) in the month leading up to the company’s first quarter earnings announcement scheduled for Wednesday, April 24, 2013. The consensus analyst estimate has moved from 85 cents a share to…
…the current prediction of earnings of 77 cents a share. Wall Street projections are down 11.5% year-over-year, as the company reported earnings of 87 cents per share. Analysts are expecting earnings of $3.64 per share for the fiscal year. Analysts project revenue to fall 7.7% year-over-year to $9.79 billion for the quarter, after being $10.61 billion a year ago.
New Product from Abbott Labs (Zacks.com)
Abbott Laboratories (NYSE:ABT) recently announced that the company has gained approval from the US Food and Drug Administration (FDA) for its TECNIS Toric 1-Piece intraocular lens (IOL). The company gained approval for treating cataract patients with pre-existing corneal astigmatism. Abbott Labs has launched the product following the approval. Corneal astigmatism results in blurred vision as it prevents light rays from focusing clearly on the retina. We note that the new product from Abbott Laboratories (NYSE:ABT) is superior to conventional IOLs since it has the ability to correct the loss of focus due to pre-existing corneal astigmatism of one diopter or greater.
Amarin’s Fish Oil Pill Faces Even More Exclusivity Risks (TheStreet.com)
More market exclusivity woes for Amarin Corporation plc (ADR) (NASDAQ:AMRN) and its prescription fish oil pill Vascepa. New Molecular Entity (NME) exclusivity is supposed to be the consolation prize awarded by FDA to new drugs refused the preferred New Chemical Entity (NCE) status. But not in this case. If you look at the FDA Orange Book, Vascepa is listed as having “no unexpired exclusivity.” No NCE. No NME.
GlaxoSmithKline suspected of paying to delay release of generics (Europolitics.info)
The UK’s largest pharmaceuticals group, GlaxoSmithKline plc (ADR) (NYSE:GSK), is suspected by the national competition authority, the Office of Fair Trading (OFT), of having paid generic drug manufacturers to delay the release of a generic version of one of its anti-depressants. This is a typical example of a ‘pay for delay’ arrangement, in which an originator pharmaceuticals firm concludes an agreement with one or more generic firms to delay the market release of a generic (a less expensive copy of one of its drugs for which the patent is about to expire or has already expired – see ‘Big pharma’ Insight section in Europolitics 4553). The European and US authorities are investigating several other similar transactions.
Abbott Laboratories PT Raised to $38.00 (ABT) (Daily Political)
Abbott Laboratories (NYSE:ABT) had its price target increased by RBC Capital from $37.00 to $38.00 in a research note released on Friday morning, Stock Ratings Network.com reports. They currently have an outperform rating on the stock. Shares of Abbott Laboratories traded up 0.89% during mid-day trading on Friday, hitting $37.22. Abbott Laboratories has a one year low of $28.4107 and a one year high of $37.55. The stock’s 50-day moving average is currently $35.39. The company has a market cap of $58.461 billion and a P/E ratio of 11.24.
