Pharmaceutical company Kamada Ltd. (Nasdaq: KMDA); TASE: KMDA) is progressing towards marketing approval for its second product in the US. The company today reported success in its Phase II/III trial of a rabies vaccine used as a preventative treatment in the event of exposure to the disease. Kamada plans to submit a request for US Food and Drug Administration (FDA) approval in mid-2016, and approval by mid-2017 is being predicted.
In the US, there is currently only one dominant supplier in this market. Kamada's product is already being sold in 10 other countries. The Kamada share price jumped 4% in today's trading in Tel Aviv after the successful trial was reported. KamRAB, the vaccine developed by Kamada, contains antibodies for rabies produced from plasma.
The clinical results proved that the treatment using the vaccine is not inferior to the comparison product approved for marketing in this format. The product's safety and tolerance were also tested, and the trial results indicated that the product was safe and tolerable, with no severe side effects.
"We are confident that our product will be a very necessary source of high-quality antibodies for rabies for people at risk of exposure to the disease. We therefore believe that our product will provide competition in the market for the existing product," said Kamada CEO Amir London. "This product will improve Kamada's profit margin, because the expected margin in the US is wider than the margin for the drug in other countries. We are planning to leverage the US trial and future marketing approval to bolster our trailblazing position in our global market with a life-saving treatment,"
In cooperation with Baxalta, Kamada, whose market cap is $152 million, is already marketing Glassia, a drug for treatment of emphysema due to congenital deficiency of alpha1-proteinase inhibitor, which was approved for marketing in the US in 2010. Kamada has set a target of $100 million in sales for 2017, but this target does not take into account any revenue from the rabies vaccine, which now looks like it will reach the market in 2017 and affect Kamada's results in that year. Kamada's revenue in January-September 2015 totaled $44.2 million, down 4.1%, compared with the corresponding period in 2014, and its net loss was $12.3 million, 14.8% less than in the corresponding period in 2014.
Published by Globes [online], Israel business news - www.globes-online.com - on December 23, 2015
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