|ARIAD Resumes Marketing and Distribution of Iclusig; FDA Delays Decision on Amarin's Vascepa|
|By Staff and Wire Reports|
|Friday, 20 December 2013 20:20|
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.
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