Immune Pharmaceuticals Ltd., a developer of treatments for inflammatory diseases and cancer expects to close within days a reverse merger with US pain and cancer treatment developer EpiCept Corporation (Nasdaq; OMX: EPCT) . The merged company will be called Immune Pharmaceuticals Inc., and will continue to be listed on Nasdaq and in Stockholm, after EpiCept shareholders approved the merger and a 1:40 reverse stock split last week.
EpiCept's share price fell 5.2% on Friday to $0.09, giving a market cap of $10.1 million, and a combined company valuation of over $56 million
Immune Pharmaceuticals' shareholders will receive 81% of the merged company, and EpiCept shareholders will receive 19%. Immune Pharmaceuticals has also raised $4,125,000, so its current and new shareholders will receive 84% of the merged company.
Immune Pharmaceuticals chairman and CEO Daniel Teper, who will manage the merged company, declined to provide "Globes" with details of future financing plans, but said that it would be much larger than the $4.13 million recently raised, and that the proceeds would be enough for two years.
Immune Pharmaceuticals' lead product is an antibody for the treatment of inflammatory diseases, bertilimumab, which it licensed from Canada's iCo Therapeutics Inc. (TSX: ICO) in June 2011 for the treatment of inflammatory diseases and cancer. It bought the rights for oral and direct delivery into the bloodstream versions of the drug, which is similar to blockbuster drugs Humira (made by AbbVie Inc. (Nasdaq: ABBV) for the treatment of rheumatoid arthritis, chronic plaque psoriasis, and Crohn's disease) and Remicade (made by Janssen Biotech Inc. for treatment of Crohn's Disease and rheumatoid arthritis).
The company has also leased from Yissum Technology Transfer Company of the Hebrew University of Jerusalem injectable applications of NanomAb antibody nanoparticle conjugate technology developed by Prof. Shimon Benita.
Immune Pharmaceuticals plans to begin enrolling patients in a Phase II clinical trial of bertilimumab for the treatment of moderate-to-severe ulcerative colitis, and later this year commence a second study to that will evaluate bertilimumab for treating bullous pemphigoid, a rare auto-immune condition that affects the skin and causes the formation of blisters. Both studies will examine bertilimumab's suitability for patients on the basis of their biomarker profile. If the studies are successful, bertilimumab could become the first personalized anti-inflammatory drug. Currently, such patient profiling is only conducted on cancer drug candidates.
The study will begin in Israel and Europe, and Immune Pharmaceuticals is in talks with the US Food and Drug Administration (FDA) to expand the study to the US. The Israeli centers of the study are due to open in 2013, and the results on 90 patients (including 30 patients in the control group) are due by the end of the year. There will be no interim results report.
If the study results are positive, which Teper defines as a difference of at least 20% in the immune response in the treatment group, a combined Phase II/III clinical trial may be held. "Big pharma and biotech companies are showing great interest in the product, and are waiting for the results," he says.
Teper says that Immune Pharmaceuticals has raised $8.5 million to date from private investors, mostly Israelis or people with an Israeli connection and prior experience in investment in the life sciences.
"Globes": What caused you to merge with a US company instead of holding an IPO in Israel or the US, or merging with an Israeli company?
Tepper: "The Israeli capital market does not sufficiently value life sciences companies, unless they are also listed in the US. A Wall Street offering could have been an option, but when we planned the merger, the IPO option was closed, and we're now deep in the present process. Since we merged with an active company, not a stock market shell, immediately upon the closing of the merger and a financing, we can apply to a national US securities exchange."
Does EpiCept have interesting products?
"It has a cream for the treatment of chemotherapy-induced neuropathic pain which is ready for a Phase III clinical trial, with fast track designation from the FDA. It's an attractive product, but we decided to focus resources on Immune Pharmaceuticals' anti-inflammatory antibody, and we want to commercialize the pain product to finance Immune's activities."
Immune Pharmaceuticals hopes to a portion of the proceeds from the US offering to expand its R&D laboratory in Jerusalem. "We hope to operate out of the Hadassah campus to create synergy with Hebrew University," says Teper.
Published by Globes [online], Israel business news - www.globes-online.com - on August 11, 2013
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