Kamada Plunges By Record as Trial Flops: Tel Aviv Mover
Kamada, which on May 16 announced results for a mid-stage trial of its inhalatory treatment for the Alpha-1 Antitrypsin Deficiency, slumped 36 percent to 29.86 shekels ($8.63) in Tel Aviv at 2.31 p.m., the biggest drop on record. The decline tracked a 34 percent drop to $9.08 for U.S. traded shares on May 16.
Data for the primary endpoint in the trial, which measured “time to first moderate or severe exacerbation,” failed to show differences between the group taking the inhaled therapy and the group taking a placebo, according to a Business Wire statement by Kamada on May 16.
The company said it observed an approximate 50 percent reduction in severe exacerbation rates versus placebo, and continues to plan on filing for European approval by the fourth quarter.
The company did not disclose key statistics, making it difficult for investors to interpret the results, said Ori Hershkovitz, a managing partner at Sphera Funds Management Ltd. in Tel Aviv.
“Kamada did not mention whether the results were statistically significant, something that is not common in this industry, to put it mildly,” said Hershkovitz. “Because very partial data was published, our initial estimate is of a 25 percent chance of approval in Europe with even lower chances in the U.S. based on the current results.”
Kamada said it will continue to analyze the data in “accordance with the statistical plan” and release expanded results in third quarter. The shares were downgraded to Market Perform from Outperform at Oppenheimer & Co. on May 16.
Kamada and competitors such as Barcelona-based Grifols SA (GRF) market intravenous treatments for Alpha-1 Antitrypsin deficiency, a disease that RBC Capital Markets says is still largely under served, with about 7,000 patients globally being treated out of as many as 200,000 with the illness. Kamada sells Glassia, its intravenous drug, in the U.S. with Baxter International Inc. It is seeking to boost sales by securing approval for an inhalatory version of the drug.
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