Immune Pharmaceuticals provides update on plan to implement a spin-off of Cytovia into a separate publicly traded oncology company.

Immune Pharmaceuticals on Wednesday confirmed it is continuing to structure and pursue a spin-off of Cytovia, Inc., its subsidiary dedicated to the development and commercialization of oncology drugs and drug candidates, into a separate, stand-alone publicly-traded company. It is contemplated that a pro rata distribution of shares in Cytovia would be issued to Immune shareholders as a dividend.

The spin-off is expected to create two independent publicly traded companies with distinct strategic plans, leadership, growth strategies, and operational and development priorities.

The new Cytovia, will focus on the development and commercialization of novel immuno-oncology and hematology therapeutics to meaningfully improve cancer patients’ lives. Cytovia aims to grow into a global specialty biopharmaceuticals company through potential acquisitions and rejuvenation of late-stage development or commercial-stage products. 

The initial core asset of Cytovia will be Ceplene (histamine dihydrochloride), an immunotherapy treatment approved in Europe in combination with low-dose IL2 for remission maintenance in patients with acute myeloid leukemia (AML).

Cytovia Update

As previously disclosed in a press release and current report on Form 8-K filed with Securities and Exchange Commission (SEC) on June 15, 2017, Immune signed, on behalf of its subsidiary Cytovia, a definitive asset purchase agreement with Mylan to acquire the rights to Ceplene in the territories that Immune did not previously own; namely Asia, Europe, Middle East, and Africa.

The European Marketing Authorization allows the company to commercialize in 30 EU countries and serves as the basis for approval in Latin America, Russia and other Eastern European countries and countries in the Middle East, Africa, and Asia. The addressable market for remission maintenance of AML patients that could be treated with Celine exceeds 10,000 patients in Europe, Russia, and other Eastern European countries. The current reimbursement in Europe is $25,000 for a full course of treatment.

On July 11, 2017, Cytovia entered into a definitive licensing and commercialization agreement with Pint Pharma Int’l Ltd. for all the markets in Latin America. Pint will implement Early Market Access programs until full registration in those countries. The addressable Latin American market for Ceplene is estimated at 4,000 patients.

Under the Pint agreement, Cytovia is eligible to receive 35 percent of net sales in Latin America subject to the terms contained therein. Additionally, Pint has committed to make a $4 million equity investment in Cytovia.

Cytovia is committed to further development of Ceplene in additional indications such as Myelo-Displasic Syndrome (MDS), also known as CMML ( chronic mono-myelocytic leukemia) for which a pilot clinical study has been initiated in Sweden.

Cytovia Strategic Plan

Cytovia expects that it will be well-positioned to establish itself as a “pure play” commercial stage specialty pharmaceutical company in the highly attractive immuno-oncology field, with an integrated pipeline portfolio.

Cytovia’s strategic plan includes the following initiatives:

• Commercialize Ceplene in select territories directly and through partnerships with leading regional companies in other territories following the business model being implemented with Pint Pharma in Latin America
   
• Focus development resources toward an approval of Ceplene in the United States for remission maintenance in patients with AML as well as the extension of the use of Ceplene to new indications;
   
• Consider potential acquisitions and rejuvenation of synergistic late-stage development or commercial-stage immuno-oncology drugs;
   
• Realize the strategic potential of its pipeline, including through potential collaborative partnerships of its Phase 2 drug candidates, Azixa and crolibulin, its bi-specific antibody platform technology and other early-stage drug candidates.

Additional Information

The spin-off transaction is intended to take the form of a tax-free distribution to Immune’s shareholders of common stock of a new publicly traded Cytovia; however, as the proposed transaction progresses, the structure may be revised accordingly.

The transaction will allow Immune to become a pure play immuno-inflammation, clinical stage. development company with all resources being allocated to its lead assets, bertilimumab and nano-cyclosporin, with a special interest in immuno-dermatology.

Immune’s core assets are bertilimumab, a first-in-class human monoclonal antibody targeted at eotaxin-1, currently in Phase 2 development in bullous pemphigoid and ulcerative colitis, with a planned Phase 2 in severe atopic dermatitis, and a proprietary topical nano-cyclosporine for the treatment of atopic dermatitis and of moderate psoriasis.

(Source: Business Wire)