April 12, 2016
By Alex Keown, BioSpace.com Breaking News Staff
CAMBRIDGE, Mass. – Could the struggling fortunes of Ariad Pharmaceuticals be turning around? With a new streamlined workforce and executive leadership, the company is moving into a Phase III trial for its lung cancer drug brigatinib, an investigational anaplastic lymphoma kinase (ALK) inhibitor. The head-to-head study will directly test brigatinib against Pfizer s lung cancer drug, crizotinib, which was approved by the U.S. Food and Drug Administration (FDA) in 2011. Brigatinib received Breakthrough Therapy designation from the FDA in October 2014.
An ALK inhibitor is an oncology treatment developed to inhibit production of an “enzyme produced from a gene called the ALK gene, which is known to be responsible for certain fusions to other genes, and in turn, oncogenic cell production,” Market Exclusive noted. In addition to Pfizer’s crizotinib, which is marketed as Xalkori, there is one other ALK inhibitor on the market, Alectinib, which is sold in Japan by Chugai.
If Ariad’s Phase III trial goes well, it could challenge Pfizer’s Xalkori, which netted that company $500 million last year. Ariad could file a New Drug Application with the FDA by the end of 2016, Market Exclusive said.
Ariad has had a few tough years. Most recently Ariad Pharmaceuticals slashed 25 percent of employees in the U.S. and Europe as part of a strategic review aimed at increasing patient and shareholder value. Paris Panayiotopoulos, Ariad’s new president and chief executive officer, said the layoffs will allow the company to “invest in the promising growth potential of both Iclusig and brigatinib,” as well as enabling orphan oncology medicines to reach cancer patients.
In late 2012, Ariad’s blood cancer drug, Iclusig, was approved for use by the FDA. But in 2013, the company halted marketing it after the FDA warned about dangerous side effects. At this point, the company laid off 160 people, reevaluated its plans for a new headquarters at Cambridge’s Kendall Square, and its stock plunged. In 2014, Ariad inked a $77.5 million deal with Japanese firm Otsuka Pharmaceutical, giving Otsuka the rights in 10 Asian countries to Iclusig.
Iclusig is also involved in several clinical trials to expand its clinical indications. Those include the OPTIC-2L trial, a Phase III study in patients with chronic-phase chronic myeloid leukemia (CP-CML) who did not respond to imatinib. It is also currently enrolling patients in the OPTIC trial of Iclusig to evaluate three different doses of the drug in patients with refractory CP-CML.
Ariad has been in the midst of an executive shuffle, tapping a new CEO and chief financial officer over the past few months. On March 11, the company announced former Pharmacyclics executive Manmeet S. Soni would take on the CFO spot. In December, Panayiotopoulos took over the top spot at Ariad after leaving a position as president of EMD Serono, Inc., a division of Germany-based Merck KgaA . Ariad also tapped a new chairman for its board of directors, Alexander J. Denner, who led the search committee for the company’s new CEO. Denner was the head of hedge fund Sarissa Capital, the largest shareholder of Ariad stock. Denner was widely thought to be behind the company’s former CEO Harvey Berger, who Panayiotopoulos replaced.
