(Press release, TNI BioTech, AUG 28, 2012, View Source [SID:1234502811])

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On August 11, 2012 Immune Pharmaceuticals Ltd. ("Immune"), a privately held Israeli company, and EpiCept Corporation ("EpiCept") (NASDAQ OMX Stockholm Exchange and OTCQX: EPCT) reported that they have entered into a definitive merger agreement (Press release, Immune Pharmaceuticals, AUG 11, 2012, http://www.immunepharma.com/immune-pharmaceuticals-and-epicept-corporation-agree-to-merge/ [SID:1234508652]). The transaction is anticipated to close during the first quarter of 2013 and is subject to satisfaction of certain customary closing conditions, including the approval of a majority of EpiCept shareholders.

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The combined company, to be named Immune Pharmaceuticals, Inc. ("Immune Pharmaceuticals"), will be primarily focused on developing antibody therapeutics and other targeted drugs for the treatment of inflammatory diseases and cancer. Immune’s lead product candidate, bertilimumab, is a full human monoclonal antibody that targets eotaxin-1, a chemokine involved in eosinophilic inflammation, angiogenesis and neurogenesis. Immune is currently initiating a placebo-controlled, double-blind Phase II clinical trial with bertilimumab for the treatment of ulcerative colitis.

The companies’ collective oncology portfolios comprise: Immune’s NanomAbs, a new generation of antibody drug conjugates, and EpiCept’s vascular disruptive agents. Immune Pharmaceuticals will continue efforts to secure a partner for EpiCept’s Phase III clinical development candidate AmiKet, for which efficacy has been demonstrated for the treatment of chemotherapy-induced neuropathic pain and post-herpetic neuralgia. Daniel Teper, PharmD, CEO of Immune and Robert Cook, Interim President and CEO of EpiCept, jointly commented: "This transaction will create a publicly traded specialty biopharmaceutical company with a portfolio of four clinical-stage drug candidates for the treatment of inflammatory diseases and cancer. Immune’s bertilimumab, a first in class monoclonal antibody, is being evaluated clinically to address unmet medical needs in multiple severe disease indications. EpiCept’s Amiket has clinical data in over 1600 patients in various neuropathies, Fast Track designation and Phase III Special Protocol Assistance from the U.S. Food and Drug Administration as well as a defined clinical path through the European Medicines Agency for the treatment of chemotherapy induced neuropathic pain."

Merger Details

The terms of the merger agreement provide for EpiCept to issue shares of its common stock to Immune shareholders in exchange for all of the outstanding shares of Immune, with EpiCept shareholders retaining approximately 22.5 percent ownership of the combined company and Immune shareholders receiving approximately 77.5 percent, calculated on an adjusted fully diluted basis. Dr. Daniel Teper will become the Chairman and Chief Executive Officer of Immune Pharmaceuticals, which will have dual headquarters in Herzliya-Pituach, Israel and in the New York City area, with research laboratories in Rehovot, Israel. Dr. David Sidransky, Director of Head and Neck Research Division, Professor of Oncology at the Johns Hopkins School of Medicine, and a former Vice Chairman of the Board of Directors of ImClone Systems, will be the Vice Chairman of the Board of Immune Pharmaceuticals. The combined company’s board of directors will consist of not more than six current Immune directors and at least one current EpiCept director. The Immune Pharmaceuticals management team will include Robert Cook, EpiCept’s Interim Chief Executive Officer, who will become the combined company’s Chief Financial Officer, and Stephane Allard, M.D., EpiCept’s Chief Medical Officer, who will become Immune Pharmaceutical’s Chief Medical Officer. Serge Goldner, Chief Financial Officer of Immune will take the new role of Executive Vice President and Chief Operating Officer. Suzy Jones, a former Genentech executive, and Myrtle Potter & Company will continue to advise Immune Pharmaceuticals on business development and the combined company’s Scientific Board will be jointly led by Professor Marc Rothenberg (Cincinnati Children’s Hospital) and Professor Shimon Benita (Hebrew University).

(Filing, 10-Q, Cleveland BioLabs, AUG 9, 2012, View Source [SID:1234502767])

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On August 6, 2012 Eclipse Therapeutics reported the appointment of Patrick M. O’Connor, Ph.D. to its scientific advisory board (Press release, Eclipse Therapeutics, AUG 6, 2012, View Source [SID1234553008]). "Patrick O’Connor, a leader in the field of oncology drug discovery and development, has brought several highly innovative targeted drugs, such as crizotinib and axitinib from the bench into clinical trials, that have advanced the treatment of cancer," said Jonathan Lim, M.D., co-founder, chairman and CEO of Eclipse Therapeutics.

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Crizotinib (Xalkori) is FDA approved for the treatment of non-small cell lung cancer, and axitinib (Inlyta) is FDA approved for the treatment of kidney cancer.

"We are pleased to welcome Dr. O’Connor to Eclipse’s Scientific Advisory Board," added Peter Chu, Ph.D., president and co-founder of the San Diego based company. "We will benefit from his expertise in designing first-of-a-kind drugs that improve cancer patients’ survival and quality of life."

"The role of stem cells in creating and sustaining tumors is one of the most promising areas of cancer drug research," Dr. O’Connor said. "I am excited about working with Eclipse because of the team’s deep expertise in cancer stem cell biology and therapeutic antibodies, and unwavering dedication to developing novel therapeutics that address unmet needs in cancer patient care."

Dr. O’Connor’s contributions to the field of oncology drug discovery and development include over 100 publications and patents, as well as over 20 compounds brought successfully into development, when he served as the Global Research Therapeutic Area Head for Oncology at Pfizer. Now undergoing clinical trials are four other potential drugs that Dr. O’Connor helped to develop during his tenure at Pfizer.

At Palo Alto-based Ruga Corporation, Dr. O’Connor now serves as Vice President and Head of Oncology. He also is a co-founder of Selexagen Therapeutics, a San Diego biotech which recently licensed its novel B-RAF adaptation inhibitor to Ruga.

One of the senior editors at the journal Cancer Research, Dr. O’Connor is a member of the scientific advisory boards of Molecular Response, located in San Diego, and Deciphera Pharmaceuticals, headquartered in Kansas. Prior to joining the pharmaceutical industry, Dr. O’Connor spent 10 years investigating the molecular underpinnings of chemosensitivity at the National Cancer Institute in Bethesda, MD.

On August 6, 2012 Nanobiotix S.A. reported that it has entered into a strategic partnership with PharmaEngine, Inc. for the rapid development of NBTXR3, the lead product from the NanoXray pipeline of Nanobiotix. Nanobiotix is a nanomedicine company developing novel cancer nanotherapeutics, while PharmaEngine is a specialty pharma company focused on the development of in-licensed oncology drugs (Press release, Nanobiotix, AUG 6, 2012, View Source [SID:1234507494]).

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The partnership aims to accelerate the global clinical development of NBTXR3 as PharmaEngine will add its Asia-based complementary clinical development strengths and will conduct further clinical studies.

Under the terms of the agreement, PharmaEngine will receive exclusive rights to develop and commercialize NBTXR3 in the Asian-Pacific region, including Australia, China, India, Japan, Korea, Taiwan and other countries, while Nanobiotix retains exclusive rights for the rest of the world. Nanobiotix retains an option to re-acquire the rights for the entire Asian-Pacific territory except for China and Taiwan, according to pre-defined conditions in exchange for termination payments and agreed-upon royalties.

Nanobiotix will receive an initial upfront paymentof US$ 1 million and is eligible for further development and commercialization milestone paymentswhich may amount to a total of US$ 56 million plus tiered, up to double-digit royalties on net product salesin the Asian-Pacific region.

PharmaEngine will further fund the clinical development of NBTXR3 in three different indications. The clinical studies will be initiated according to an agreed upon time schedule and development plan with the goal to commence clinical studies in two indications within 18 months. The parties have agreed to share the data to enable an efficient and focused global development in multiple indications.

"With its proven clinical development expertise in Asia, PharmaEngine is an ideal partner to accelerate the development of NBTXR3," said Laurent Levy, CEO of Nanobiotix. "The studies conducted by PharmaEngine in three different indications in Asia will add to the ongoing European Phase I study in soft tissue sarcoma and another Phase I study to be initiated by Nanobiotixin early 2013 – all of this will be closely coordinated between both companies to ensure a broad clinical development. We are happy that we were able to close this very attractive deal for an important and growing market that we address with our NanoXray platform."