|Trading in Amarin Muted After Massacre; Isis Posts Positive Phase 1 Data on Three Drugs in Development|
|By Staff and Wire Reports|
|Friday, 07 December 2012 19:46|
Trading in shares of Amarin (NASDAQ: AMRN) has been muted on Friday despite the expectation for high levels of volatility after the stock plunged 20 percent in Thursday's after hours trading session.
It would appear that the stock has found equilibrium after the big after hours decline, because shares have traded in a fairly tight range, all things considered, on Friday and were last down around 19 percent. Heading into the closing bell, Amarin was sitting at $9.73, which compares to the after hours close of $9.75 on Thursday.
The reason for the move lower in the stock was the announcement that Amarin has raised $100 million in debt financing and is planning on hiring a sales force of 250-300 reps to market its fish-oil drug Vascepa. The announcement of financing and plans to hire a sales force would seem to indicate that Amarin's efforts to find a marketing partner for the drug or reach a buyout deal have failed.
The launch of Vascepa has been delayed since it gained approval on July 26, 2012, as Amarin searched for a Big Pharma marketing partner. Management has also suggested repeatedly that a deal for the entire company is a possibility.
Although Amarin CEO Joe Zakrzewski said on a conference call that "all options are still on the table" and "partner discussions were still active," it is now very likely that the company will be forced to handle the drug launch on its own.
The next catalyst for the stock will likely be an FDA decision on Vascepa's New Chemical Entity (NCE) status. That decision could come at any time and the company has said it has no idea when the FDA will make the ruling.
If the drug were granted NCE status, it would give it a five year window of market exclusivity, which in turn would make Amarin more attractive to a Big Pharma partner.
Isis Pharmaceuticals, Inc. (NASDAQ: ISIS) announced positive results from Phase 1 studies of three drugs, ISIS-PTP1B[Rx], ISIS-GCGR[Rx] and ISIS-GCCR[Rx], in development to treat metabolic disorders, including type 2 diabetes. In all three Phase 1 studies, the drugs were safe and well tolerated with early encouraging data that supports the unique mechanism of each drug. All three drugs are part of Isis' metabolic franchise and are designed to act through distinct mechanisms to improve insulin sensitivity and/or reduce glucose production.
"Our goal is to develop safe, effective drugs with unique mechanisms of action that can provide significant therapeutic benefit for patients with metabolic disorders, including type 2 diabetes. This year we have moved closer to this goal with the completion of our initial clinical studies on three promising drugs from our metabolic franchise. These drugs are uniquely positioned to fill the critical voids in diabetes therapy," said Stanley T. Crooke, M.D., Ph.D., chief executive officer at Isis. "While these drugs may be beneficial as single agents, our goal is to develop them as adjuncts to existing diabetes therapies. We believe that each drug has the potential to address a distinct and significant commercial market in patients with type 2 diabetes."
Abbott (NYSE: ABT) announced today that the Securities and Exchange Commission (SEC) has declared effective the Form 10 Registration Statement filed by AbbVie Inc., its research-based pharmaceuticals business.
Arrowhead Research Corporation (NASDAQ: ARWR) today announced that it has priced a public offering of approximately 1.8 million units at a price to the public of $2.26 per unit.
Auxilium Pharmaceuticals, Inc. (Nasdaq: AUXL) today announced that executive management will participate in the Oppenheimer Annual Growth Conference to be held December 12-13, 2012 at the Waldorf Astoria Hotel in New York City.
BASi (Bioanalytical Systems, Inc.) (NASDAQ: BASI) today announced that it is collaborating with Data Sciences International (DSI), a biomedical research company focused on preclinical systems physiology and pharmacology, to conduct a first-of-its-kind study combining BASi’s Culex®-L automated sampling system with DSI’s newest large animal telemetry technology, PhysioTel™ Digital.
BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) announced today that in response to recent events and an assessment of its assets, the Company is restructuring and implementing a focused strategy to advance its hereditary angioedema (HAE) and antiviral programs.
Celldex Therapeutics, Inc. (NASDAQ: CLDX) announced today that Anthony Marucci, President and Chief Executive Officer, is scheduled to present a corporate overview at the Oppenheimer 23rd Annual Healthcare Conference on Wednesday, December 12, 2012 at 10:00 am ET at the Waldorf=Astoria in New York City.
Cytomedix, Inc. (OTCQX: CMXI) (the "Company"), a regenerative therapies company commercializing and developing innovative platelet and adult stem cell technologies, announced today that positive data on the Angel®cPRP system in a veterinary application -- treatment of persistent mating induced endometritis (PMIE) in mares -- were recently presented at the 3rd annual conference of the North American Veterinary Regenerative Medicine Association (NAVRMA) in Savannah, GA.
EasyMed Services Inc. (CNSX:EZM) (OTCBB:EMYSF) (MUN:EY6) ("EasyMed" or the "Company") is pleased to announce that it has engaged Investor Cubed Inc. to provide investor relations and shareholder communication services, effective November 1, 2012.
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced updated survival results from the Phase III CLEOPATRA study, which showed that the combination of Perjeta® (pertuzumab), Herceptin® (trastuzumab) and docetaxel chemotherapy significantly extended the lives (overall survival) of people with previously untreated HER2-positive metastatic breast cancer (mBC), compared to Herceptin, chemotherapy and placebo.
Genzyme, a Sanofi company (EURONEXT: SAN and NYSE: SNY), today announced it has received European Commission approval of a product label expansion for the use of Thyrogen® (thyrotropin alfa) with a wider irradiation dose range for postoperative thyroid remnant ablation.
OvaScienceSM, (OTC: OVSC), a life sciences company focused on the discovery, development and commercialization of new treatments for infertility, announced today that Michelle Dipp, M.D., Ph.D., Chief Executive Officer of OvaScience, will present at the Oppenheimer 23rd Annual Healthcare Conference at the Waldorf Astoria Hotel in New York City on Wednesday, December 12, 2012 at 1:35 p.m. ET.
PROLOR Biotech, Inc. (NYSE MKT: PBTH), today announced that the company will present preclinical data on its long-acting clotting Factor VIIa (Factor Vlla-CTP) at the 54th Annual Meeting of the American Society of Hematology (ASH).
Simulations Plus, Inc. (NASDAQ: SLP), a leading provider of consulting services and software for pharmaceutical discovery and development, today released preliminary revenues for its first fiscal quarter of fiscal year 2013, ended November 30, 2012 (1QFY13).
Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, today announced key presentations of clinical and scientific data at the 54th Annual Meeting of the American Society of Hematology (ASH), being held in Atlanta, Georgia, from December 8-11, 2012.
Walgreens (NYSE: WAG) (Nasdaq: WAG) and the Cystic Fibrosis Foundation today announced they have completed a transaction giving Walgreens a significant ownership stake in Cystic Fibrosis Foundation Pharmacy LLC, the parent company of Cystic Fibrosis Services Inc.