May 29, 2015
By Alex Keown, BioSpace.com Breaking News Staff
REDWOOD CITY, Calif. – Heron Therapeutics, Inc. ’s stock jumped more 45 percent this morning after the company announced a late stage study of the company’s lead product Sustol, which treats chemotherapy-induced nausea, achieved its primary endpoint.
The news caused Heron’s stock to soar in morning trading. Heron’s stock was trading as high as $18 per share this morning, up more than $5 over its opening price. Market Watch noted this morning that shares were on track to open at the highest level since Jan. 30, 2013.
Heron’s Phase III MAGIC study evaluated the efficacy and safety of Sustol as part of a three-drug regimen with the intravenous neurokinin-1 receptor antagonist fosaprepitant and the IV corticosteroid dexamethasone for the prevention of delayed-onset chemotherapy-induced nausea and vomiting following administration of highly emetogenic chemotherapy agents. The study showed those patients who took the Sustol combination showed a 64 percent reduction in nausea. In a quality of life survey following the treatment, the company noted patients were highly satisfied with their treatment. The primary endpoint was the proportion of patients who achieved a complete response, defined as no emesis and no rescue medications, in the 24 to 120 hours following chemotherapy. Sustol and its companion drugs were tested against a generic 5-HT3 antagonist.
“Symptom management in patients receiving cancer treatment represents a significant unmet medical need, and the results of this study represent another step forward in this important clinical space,” Ian Schnadig, a principal investigator with U.S. Oncology Research, said in a statement.
The MAGIC (Modified Absorption Granisetron In the Prevention of Chemotherapy induced nausea and vomiting (CINV)) involved more than 900 patients from U.S.-based community oncology centers. This was significant because it provided a high representation of what U.S. oncology physicians can expect to see in patients, Jeffrey Vacirca, a principal Investigator with North Shore Hematology/Oncology Associates, said in a statement.
Chemotherapy induced nausea and vomiting (CINV) affects between 70 and 80 percent patients undergoing chemotherapy. CINV is one of the most debilitating side effects of such treatments, often attributed as a leading cause of premature discontinuation of cancer treatment. Some treatments have shown positive results, but Heron said there is an unmet medical need for patients suffering from CINV during the delayed-onset phase, which typically occurs one-to-five days following administration of chemotherapy agents. Sustol contains the 5-HT3 receptor antagonist granisetron, selected due to its broad use by physicians based on a well-established record of safety and efficacy, the company said.
Heron expects to resubmit a new drug application for Sustol to the U.S. Food and Drug Administration (FDA) later this year. This will be Heron’s third attempt at FDA approval for Sustol. The drug was first rejected in 2010 due to the FDA’s questions on data. It was rejected again three years later due to manufacturing problems for the syringes used to deliver the drug. Pending approval, the company expects a commercial launch of the drug shortly thereafter, said Barry D. Quart, Heron’s chief executive officer.
“The results reported today further demonstrate the potential for SUSTOL to be the foundation of the new standard-of-care injectable anti-emetic regimen,” Quart said in a statement.
Earlier this month Heron announced the FDA accepted the company’s proposal to use the 505(b)(2) development pathway for HTX-019, Heron’s proprietary intravenous formulation of aprepitant for the prevention of chemotherapy induced nausea and vomiting. A 505(b)(2) application allows a portion of the information required for a New Drug Application (NDA) approval, such as safety and efficacy data on the active ingredient, to come from previously completed studies conducted by other parties. This pathway can lead to significantly reduced costs and time required for development compared with a traditional development path.
Will PfizerKline Become the Next Pharma Player?
The speculation surrounding a possible bid from Pfizer Inc. for struggling GlaxoSmithKline is heating up, after one closely-watched biotech analyst said in a note last week that Pfizer buying the company would “unlock access to its balance sheet and improve its tax situation.”
Gregg Gilbert, a biotech analyst at Deutsche Bank, wrote in a note to investors “Introducing PfizerKline” that he thinks a deal would be “materially accretive” for both companies. Gilbert estimated that a bid priced at $29.86 a share, via half stock and half cash, which would push up Pfizer’s earnings per share by 10 percent to 16 percent beginning in 2016.
“We believe that the company has a sense of urgency to create value by leveraging the power of its balance sheet to do needle-moving deals,” Gilbert wrote. “Since media reports in the past have pointed to the potential for a Pfizer/GSK combination, we are revisiting that theme.”
We want to know, dear readers, if you agree? Should Glaxo continue going it alone, or might Pfizer buy it and create one of the world’s largest pharma players in history?
