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TMCNet:  ARIAD Resumes Marketing and Distribution of Iclusig; FDA Delays Decision on Amarin's Vascepa

[December 20, 2013]

ARIAD Resumes Marketing and Distribution of Iclusig; FDA Delays Decision on Amarin's Vascepa

(BioMed Reports Via Acquire Media NewsEdge) Below is a look at some of the headlines for companies that made news in the healthcare sector on December 20, 2013.

{nfg}Shares of Ariad Pharmaceuticals (NASDAQ: ARIA) responded following an early Friday formal announcement that the company has U.S. approval to bring Inclusig back to the market, and will begin to sell by mid- January. Ariad shares hit $7.75, up 40 percent.Ariad said, "The USPI includes a revised indication statement and boxed warning, updated safety information and recommendations regarding dosing considerations for prescribers."Shares of Ariad significantly moved with the announcement and have halted five times before 11:00 AM. The New York Stock Exchange announced that they will cancel traded in Aria between 09:58:07-10:03:07AM EST and 10:09:55-10:14:55AM.Summer Street analyst Carol Werther commented that this news in “very important” for Ariad and Iclusig. Werther suggested that Ariad management had seemingly indicated it would take "some time" to get the concern which pushed shares lower in October resolved?. The analyst signaled that the news for patients is huge as Iclusig is the last possibility for some kind of treatment. She highlighted that there are currently no competing products for Iclusig?.On October 11, the U.S. Food and Drug Administrations announced that they were investigating “an increasing frequency of reports of serious and life-threatening blood clots and severe narrowing of blood vessels (arteries and veins) of patients taking the leukemia chemotherapy drug Iclusig (ponatinib).” Adverse events with patients taking the drug include “heart attacks resulting in death, worsening coronary artery disease, stroke, narrowing of large arteries of the brain, severe narrowing of blood vessels in the extremities, and the need for urgent surgical procedures to restore blood flow. Other problems occurring with the drug's use include congestive heart failure (CHF) and loss of blood flow to extremities resulting in tissue death requiring amputation. Newly identified serious adverse reactions have also been reported involving the eyes, including decreased vision and clots in blood vessels of the eye.” Shares of Ariad fell 18 percent following the statement on the FDA Bulletin.In a press release on October 18th, Ariad reported the discontinuation of Phase 3 EPIC (Evaluation of Ponatinib in Chronic Myeloid Leukemia) trial of Iclusig in patients with newly diagnosed chronic myeloid leukemia. The company and the FDA agreed on the termination of clinical trials following observed arterial thrombotic events in patients treated with Iclusig. Patients in the EPIC trial were removed from the trial and transferred to the care of their physician. Ariad's Chief Science Officer commented that the company is going to focus on Inclusig in Refractory CML patients and does not expect the frug to be pulled from the market. Despite the announcement, shares of fell 35 percent to approximately $2.83.The U.S. Food and Drug Administration sent a public statement to Ariad requesting that they suspend marketing and sales of Iclusig (ponatinib) on October 31. Ariad spoke with the FDA regarding the marketing suspension, noting that they did not believe suspension was the only strategy. Following the announcement of the temporary suspension of Iclusig marketing, shares continued to take a hit, falling 30 percent in pre-market trading.On November 7, Ariad issued a press release announcing the reduction of 40 percent of staff positions in the United States. The reduction was part of a program to reduce corporate operating expenses following the temporary suspension of marketing and commercial distribution of Iclusig.A week and a half later, the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has made a number of recommendations to help minimize the risk of blood clots obstructing arteries or veins in patients taking Iclusig. The recommendation noted that “Iclusig should not be used in patients who have had a heart attack or stroke in the past, unless the potential benefits to them outweigh the risks. In addition, the cardiovascular risks of all patients should be assessed and measures should be taken to reduce risks before starting and during treatment with Iclusig. Patients who have high blood pressure should have their blood pressure controlled, and treatment with Iclusig should be stopped immediately in any patient with signs of blood clots obstructing arteries or veins.”Shares of Ariad began an upward surge on November 22, following the announcement that European Union regulators announced that they believe Iclusig should stay in the European market. Shares continued to gain entering into December when Ariad confirmed discussions with the FDA regarding lifting the ban on Inclusig in the United States.====================Amarin's (NASDAQ: AMRN) and its controversial cholesterol-controlling drug, Vascepa, was waiting to hear the results of a Food and Drug Administration ruling. The company had appealed the FDA's October decision to rescind support of late-stage trials of Vascepa, a prescription-strength fish oil pill.But instead of a final ruling, it appears the FDA punted. In a press release issued Friday, Amarin said the FDA has delayed its decision, and that “Amarin's request to re-instate the ANCHOR Special Protocol Assessment (SPA) agreement remains under consideration with the FDA.”The FDA, according to Amarin, now views the company's appeals “as separate administration decisions worthy of separate consideration.” It also expects to “convey its decision” by no later than January 15 – although no new action date on that decision has apparently been set.Amarin notes that, while it will continue to pursue resinstatement oof the ANCHOR SPA agreement and approval of the ANCHOR supplemental new drug application (sNDA) for Vascepa, “there can be no assurance that Amarin will be successful in this effort.”Nonetheless, Amarin supporters, some of whom have launched a web site that criticizes the FDA for what they see as “a smear campaign and an arbitrary 'moving of the goal posts', designed to prevent Vascepa from reaching the market at all costs,” appear to be heartened by Friday's news.Bloomberg reports Amarin shares rose 31 percent in early Friday trading, its biggest gain since April of 2011.“Given the low expectations for approval and the fact that Amarin now has a window to at least present their case to FDA, it’s not too surprising to see the stock moving higher,” Akiva Felt, an analyst with Oppenheimer & Co., told Bloomberg.Also Friday:AbbVie (NYSE: ABBV)will participate in the 32nd Annual J.P. Morgan Healthcare Conference on Wednesday, Jan. 15, 2014. Bill Chase, executive vice president and chief financial officer, will make a formal presentation on the company at 11 a.m. Central time.Acceleron Pharma Inc. (NASDAQ:XLRN), a clinical stage biopharmaceutical company focused on the discovery, development and commercialization of novel protein therapeutics for cancer and rare diseases, has been selected for addition to the Russell 2000®, Russell 3000® and Russell Global® Indexes as part of Russell Investments’ quarterly addition of select initial public offering (IPO) companies. Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), a leading RNAi therapeutics company, announced today the publication of a new paper describing a novel technique called circulating Extracellular RNA Detection (cERD). Antares Pharma, Inc. (NASDAQ: ATRS) today announced that it has received a Notice of Allowance from the U.S. Patent Office for application 13/584,317. Atlantic American Corporation (Nasdaq:AAME) today announced that it has closed on its acquisition of Direct Life Insurance Company ("DLIC"), formerly a non-active subsidiary of Direct General Insurance Company.Auxilium Pharmaceuticals, Inc. (NASDAQ: AUXL), a fully integrated specialty biopharmaceutical company, today announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) requesting approval of XIAFLEX (collagenase clostridium histolyticum, or CCH) for the treatment of multiple Dupuytren's contracture (DC) cords concurrently. Baxter International Inc. (NYSE:BAX)today announced completion of CE marking in Europe for the VIVIA hemodialysis (HD) system, designed to deliver more frequent, extended duration, short daily or nocturnal home HD therapy, known as High Dose HD therapyBIND Therapeutics, Inc. (NASDAQ: BIND), a clinical-stage nanomedicine platform company developing targeted and programmable therapeutics called AccurinsTM, announced today that it will be added as a member of the Russell 2000®, Russell 3000®, Russell Global and Russell Microcap Indexes at the close of market today, December 20, 2013, as Russell Investments reconstitutes its comprehensive family of global indexes.BioCryst Pharmaceuticals, Inc.(NASDAQ:BCRX), a pharmaceutical company focused on the development and commercialization of treatments for rare and infectious diseases, today announced that it has submitted a New Drug Application (NDA) filing for intravenous (i.v.) peramivir to the U.S. Food & Drug Administration (FDA). BioTime, Inc. (NYSE MKT: BTX), a biotechnology company that develops and markets products in the field of regenerative medicine reported today the publication of a peer-reviewed scientific paper on the successful generation of human cells with markers of particular cell types in the human brain, potentially useful in the treatment of neurological diseases such as Alzheimer’s disease. Capricor Therapeutics, Inc. (OTCBB: CAPR), a diversified heart failure biotechnology company, today announced that, effective today, the Company’s common stock commences trading on the OTC Markets under the new symbol “CAPR.” CombiMatrix Corporation (Nasdaq:CBMX), a molecular diagnostics company specializing in DNA-based testing services for developmental disorders and cancer diagnostics, today announced that it has closed its previously announced firm commitment underwritten public offering of 12,000 units of Series D convertible preferred stock and warrants at a price to the public of $1,000 per unit for gross proceeds of $12 million, prior to deducting underwriting discounts and commissions and offering expenses payable by the Company. Coronado Biosciences, Inc. (Nasdaq:CNDO), a biopharmaceutical company involved in the development of novel immunotherapy agents for the treatment of autoimmune diseases and cancer, as well as the licensing and acquisition of, and investment in, development stage compounds, biologics and companies, today announced that Dr. Lindsay A. Rosenwald has been appointed Chairman, President, and Chief Executive Officer (CEO) of the Company, effective yesterday. Endologix, Inc. (Nasdaq:ELGX), developer and marketer of innovative treatments for aortic disorders, announced today that it has received Investigational Device Exemption ("IDE") approval from the United States Food and Drug Administration ("FDA") to begin a pivotal clinical trial to evaluate the safety and effectiveness of the Nellix® EndoVascular Aneurysm Sealing System ("EVAS") for the endovascular repair of infrarenal abdominal aortic aneurysms. Epizyme, Inc. (NASDAQ: EPZM), a clinical stage biopharmaceutical company creating innovative personalized therapeutics for patients with genetically defined cancers, today announced that it has been selected for addition to the NASDAQ Biotechnology Index (Nasdaq: NBI), which will become effective before market open on December 23, 2013. GreeneStone Healthcare Corporation (OTCBB:GRST), a provider of healthcare services including Addiction and Mental Health has signed a non-binding Letter of Intent ("Addiction LOI") to merge the assets of its addiction and mental health business with other addiction and mental health assets for a cash and equity consideration of up to $7.75 million. GW Pharmaceuticals plc (Nasdaq: GWPH, AIM: GWP, "GW"), a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform, announced today that it has filed a registration statement with the U.S. Securities and Exchange Commission ("SEC") for a proposed public offering of American Depositary Shares ("ADSs") on the NASDAQ Global Market. iCo Therapeutics (TSXV: ICO) (OTCQX: ICOTF), announced that its common shares will begin trading today on OTCQX International, a segment of the OTCQX marketplace in the U.S., under the symbol "ICOTF." Intrexon Corporation (NYSE:XON), a leader in synthetic biology, today announced that it has entered into a definitive agreement to acquire, for approximately $26 million, San Diego-based Medistem, Inc. (OTCQB:MEDS) a pioneer in the development of Endometrial Regenerative Cells ("ERC" or "ERCs"), universal donor adult stem cells that stimulate new blood vessel formation and are capable of generating different tissues including heart, brain, pancreas, liver, bone, cartilage and lung. Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a clinical-stage pharmaceutical company focused on the discovery and development of novel first-in-class drugs directed against nuclear transport targets for the treatment of cancer and other major diseases, today announced that it has been added to the Russell 3000® and Russell 2000®Indexes as part of Russell Investments' fourth quarter IPO additions, to be effective at the close of the U.S. markets today.Life Technologies Corporation (NASDAQ: LIFE) today announced that five new American, five European and two Asia Pacific sites joined the Ion AmpliSeq™ Exome Certified Service Provider program.Oramed Pharmaceuticals Inc. (NASDAQCM: ORMP), a clinical-stage pharmaceutical company focused on the development of oral drug delivery systems, announced today successful results in a clinical trial testing the pharmacokinetic dose response of its oral insulin capsule (ORMD-0801) in type 1 diabetes patients. Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced the launch of a new business focused on providing comprehensive, evidence-based weight management interventions for employers, hospitals, medical groups, health plans and patients. Merrimack Pharmaceuticals, Inc. (Nasdaq:MACK)today announced that Robert Mulroy, President & CEO, is scheduled to present at the 32ndAnnual J.P. Morgan Healthcare Conference on Wednesday, January 15, 2014 at 3:00 p.m. (PT) at the Westin St. Francis Hotel in San Francisco.Osiris Therapeutics, Inc. (NASDAQ: OSIR), the leading stem cell company focused on developing and marketing products to treat conditions in orthopedic, sports medicine and wound care markets announced that it has received a $15 million milestone payment from Mesoblast for successful completion of the transfer of assets relating to the Prochymal business.RegeneRx Biopharmaceuticals, Inc. (OTC: RGRX) today announced that it has received a Notice of Allowance of a Canadian patent application for using Thymosin beta 4 (Tß4) and various fragments and other related peptides for inhibiting or reversing skin aging. The patent will expire in 2021.Roche (SIX: RO, ROG; OTCQX: RHHBY) and Kapa Biosystems announced today a partnership to provide an optimized NGS target enrichment workflow solution. Kapa Biosystems will custom manufacture NGS library preparation products for Roche NimbleGen to distribute to its customers.Synta Pharmaceuticals Corp. (NASDAQ: SNTA) today announced the appointment of Steven Bernitz as Senior Vice President, Corporate Development. Tribute Pharmaceuticals Canada Inc. (OTCQB:TBUFF) (OTCBB:TBUFF) (PINKSHEETS:TBUFF), a specialty pharmaceutical company with a primary focus on the acquisition, licensing, development and promotion of healthcare products in Canada, today commented on the recent acquisition of CAMBIA® (diclofenac potassium for oral solution) by Depomed, Inc. (NASDAQ:DEPO). Walgreen Co. (NYSE: WAG) (Nasdaq: WAG) today announced earnings and sales results for the first quarter of fiscal year 2014 ended Nov. 30.Zoetis Inc. (NYSE:ZTS) will host a webcast and conference call at 8:30 a.m. (EST) on Tuesday, Feb. 11, 2014. Chief Executive Officer Juan Ramón Alaix and Executive Vice President and Chief Financial Officer Rick Passov will review fourth quarter and full year 2013 financial results, discuss 2014 financial guidance, and respond to questions from financial analysts during the call.Zynex, Inc. (OTCQB: ZYXI), a provider and developer of non-invasive medical devices for electrotherapy, stroke rehabilitation, and neurological diagnosis, announced today that it has enabled Level 2 quote visibility for investors though the OTC Markets Group.


2013 BioMed Reports All rights reserved.

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