Ariad Pharma: Will It Return To Its Heyday?

(RTTNews) - Shares of Ariad Pharmaceuticals Inc. (ARIA) have soared nearly 64 percent on a year-to-date period, and it looks like the company is slowly getting back in the game.

Here's the story of the fall and recovery of Ariad...

Things were all going well with Ariad until it dropped a bombshell last October when it announced that the FDA is investigating its marketed leukemia drug Iclusig (pronounced eye-CLUE-sig) after increased reports of serious blood clots in arteries and veins.

Iclusig was approved by the FDA to treat adults with chronic myeloid leukemia (CML) and Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL), two rare blood and bone marrow diseases, in December of 2012, based on results from a pivotal phase II trial, named PACE.

The approval was granted under the regulatory agency's accelerated approval program, which provides patients earlier access to promising new drugs while the company conducts additional studies to confirm the drug's clinical benefit and safe use.

In order to provide definitive clinical data to support regulatory approval of Iclusig in treatment-naïve CML patients, the company had initiated a phase III trial of Iclusig, dubbed EPIC, in July 2012 - with a target to enroll approximately 500 patients.

While the FDA approval for Iclusig came faster than many expected - three months ahead of its projected March 27, 2013 decision date - the "black box" warning label alerting patients and health care professionals that the drug can cause blood clots and liver toxicity was unexpected. So Ariad shares fell as much as 20% when Iclusig was approved on December 14, 2012.

The company commercially launched Iclusig in the United States last March, and nearly three months later - in June of 2013 - initiated a phase II trial of the drug in patients with gastrointestinal stromal tumors.

Iclusig received marketing authorization in the European Union last July, and was launched in certain European countries in the second half of 2013.

Just when everything was going the way as planned, Ariad delivered the bad news about Iclusig's safety profile.

On October 9, 2013, the company announced that patient enrollment in all clinical studies of Iclusig is being paused as 24-month follow-up data indicated an increased rate of serious arterial thrombotic events. Accordingly, the FDA placed a partial clinical hold on all new patient enrollment in clinical trials of Iclusig.

In the interest of patient safety, the company also discontinued the EPIC trial of Iclusig in patients with newly diagnosed CML.

Then came another serious blow to Iclusig...

On October 31, 2013, the company announced that it is temporarily suspending marketing of Iclusig in the United States in response to a request by the FDA. Ariad shares, which were trading around $18 in the first week of October 2013, had plunged to $2.20 by the end of that month.

Unlike the FDA, the European Medicines Agency did not suspend sales of Iclusig but allowed the marketing of the drug to be continued in the E.U. The drug was taken up for review by the Pharmacovigilance Risk Assessment Committee or PRAC under the Article 20 procedure.

The PRAC reviews the benefit/risk balance of drugs post-approval in collaboration with the EMA's Committee for Medicinal Products for Human Use (CHMP).

Last November, the European regulatory agency made recommendations to minimize risk of occlusive vascular events in patients taking the drug based on initial review of Iclusig carried out by Pharmacovigilance Risk Assessment Committee, or PRAC.

Ariad started the year 2014 on a positive note - re-launching Iclusig for patients with refractory Philadelphia-positive leukemias in the U.S., but with a revised U.S. Prescribing Information (USPI) and a communications Risk Evaluation and Mitigation Strategy (REMS) on January 17, 2014.

In the first quarter ended March 31, 2014, net product revenues from sales of Iclusig were $8.0 million compared to $6.4 million for the quarter ended March 31, 2013, a 25% increase.

On June 1, 2014, the FDA partial clinical hold to new patient enrollment in Iclusig trials was lifted. Net product revenues from sales of Iclusig were $11.9 million for the quarter ended June 30, 2014.

On October 10, 2014, the Pharmacovigilance Risk Assessment Committee of the European Medicines Agency, after completing its review of Iclusig, recommended that the drug continue to be used in Europe in accordance with its already approved indications.

Toeing the same line as that of PRAC, the EMA's CHMP on October 24, 2014, adopted its final opinion on Iclusig - thereby recommending that the drug continue to be used in accordance with its already approved indications.

According to a Press release issued by the EMA last week, "the available evidence shows that the risk of blood vessel blockage with Iclusig is likely to be dose-related, however the data are insufficient to formally recommend the use of lower doses of Iclusig, and there is a risk that lower doses might not be as effective in all patients and in long-term treatment. Therefore, the recommended starting dose of Iclusig should remain 45 mg once a day".

The EMA has recommended strengthened warnings in the product label aimed at minimizing the risk of blood clots and blockages in the arteries. Additionally, healthcare professionals are requested to stop Iclusig for patients if a complete response has not occurred within three months of treatment, and should monitor patients for high blood pressure or signs of heart problems.

When we first alerted ARIA to our readers in June 2011, it was trading around $9. The stock rallied in succeeding months and touched a high of $25.40 on October 17, 2012. Thereafter, ARIA pared some of its gains and traded in a range of $17.14 to $24.85 between October 18, 2012 and October 8, 2013. The rest is history.

In the past 52 weeks, ARIA has traded in a range of $2.15 to $9.83. The stock is currently trading at $5.70, down 2.23%.

Ariad is scheduled to report third quarter 2014 financial results on November 5, 2014. Keep an eye on Iclusig sales.

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