Saturday, August 31, 2013

Celsion definitive signs of the asset purchase agreement to acquire VMMR

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Celsion definitive signs of the asset purchase agreement to acquire VMMR -

Celsion Corporation (Celsion) (NASDAQ: CLSN), a drug development company oncology, and EGEN, Inc. (EGEN), a private biopharmaceutical company focused on the development of therapeutic products based on nucleic acids for the treatment of cancer and other difficult to treat diseases, announced today the signing a definitive purchase agreement in which assets Celsion will acquire substantially all the assets of VMMR, including its candidate based phase Ib DNA product EGEN-001 immunotherapy and therapeutic technologies, TheraPlas ™ for delivery of DNA and mRNA, TheraSilence ™ for delivery of RNA, and RAST ™ mobile Enabled expression and secretion of RNA.

Under the terms of the agreement, a wholly owned subsidiary of Celsion will acquire the assets of VMMR and assume certain liabilities in exchange for cash and shares of Celsion totaling $ 14 million. The initial payment consists of $ 10.6 million in Celsion common shares representing approximately 16.4% of the outstanding shares of Celsion, including $ 2.1 million in Celsion common shares are subject to a deduction of 24 months for Celsion adjustment expenses and certain claims of Celsion, and $ 3.4 million in cash.

in addition to the initial payment, a total of $ 30.4 million in future milestone obligations are payable VMMR based on the success of certain development and clinical milestones license. The acquisition is expected to close in June 2014, subject to customary closing conditions. The boards of both Celsion and VMMR have unanimously approved the transaction. The transaction is not subject to shareholder approval Celsion.

The combination of Celsion and VMMR will create a research and development company in oncology fully integrated focus with a multi-phase clinical pipeline, the platform technology for the discovery of novel immunotherapies based nucleic acid and other anti-cancer therapies DNA / RNA, and expertise of the laboratory to the bedside. The transaction brings to advance Celsion VMMR, clinical phase Ib candidate, EGEN-001, a plasmid IL-12 immunotherapy enclosed in a nanoparticle delivery system, and three technology platforms, TheraPlas ™, ™ and TheraSilence RAST ™ Enabled mobile Expression and secretion of RNA.

The complete transaction lead development candidate Celsion, ThermoDox®, a proprietary liposomal encapsulation heat activated doxorubicin, now advancing in a double-blind pivotal, global Phase III placebo-controlled trial (the OPTIMA study) in primary liver cancer.

"This transaction provides a strategic fit well defined immediately, bringing the discovery and preclinical expertise with the clinical and operational excellence, breakthrough technologies with clinical assets with high value added, to form a company whose synergy provides much more than its parts, "said Michael H. Tardugno, Celsion President and CEO. "As a combined company, Celsion-VMMR will focus on the cutting edge of cancer treatment, with assets in directed chemotherapies, immunotherapies and DNA- or RNA-based therapies. With clinical programs in Phases III, II and I, and a broad product pipeline preclinical candidates, Celsion-VMMR will be well positioned to offer new innovative therapies to address areas of unmet medical needs pressing in oncology. "

Khursheed Anwer, Ph.D. . .D, President and Chief scientific Officer VMMR, said: "since VMMR was founded twelve years ago, our team has been working to develop technologies that overcome the delivery challenges that have kept therapies nucleic acid base to realize their potential and promise complete significant. by joining Celsion now, we add not only the operational and management expertise to accelerate the development of these assets and technologies, but have access to financial resources additional an established public company. "

key strategic benefits of the transaction include:

  • A high-value, multi-line with pipeline programs Spanning Discovery Through Phase III. After completion of the acquisition, Celsion portfolio include two clinical stage candidates targeting various oncology indications, and three platform technologies for developing new immunotherapies based nucleic acid and . other therapies DNA / RNA anti-cancer These include:
    • ThermoDox ® - ThermoDox® Celsion of liposomal encapsulation is a proprietary heat activated doxorubicin This. liposomal technology allows for the provision of high concentrations of doxorubicin, an anthracycline chemotherapy widely used in a region specifically for the localized application of heat, for example in radiofrequency ablation (RFA). Celsion recently received FDA authorization to initiate a 550 patient Phase III pivotal study of ThermoDox® in combination with RFA in primary liver cancer. ThermoDox® is also being evaluated in a Phase II study courses in breast cancer wall of recurrent chest
    • TheraPlas ™ -. TheraPlas ™ is a versatile platform technology for the delivery of DNA and mRNA of the therapeutic through synthetic nonviral carriers and is only capable of providing a transfection ability of cells to DNA double strand plasmids and large segments of therapeutic RNAs, such as messenger RNA. The first clinical candidate on TheraPlas platform is VMMR-001.
      • VMMR-001 - VMMR of EGEN-001 is a DNA-based immunotherapy for the localized treatment of cancer. VMMR-001, designed using the technology TheraPlas ™ platform is a vector IL-12 plasmid DNA enclosed in a nanoparticle delivery system which allows the transfection of cells followed by persistence, local secretion of IL-12 protein. IL-12 is one of the most active cytokine for the induction of potent anticancer immunity acting by induction of T cells and natural killer (NK) cells, cell proliferation. As a recombinant protein, however, IL-12 has poor pharmacokinetic properties and has historically been associated with severe toxicity. The Company believes that these problems can be effectively treated with a unique mechanism of action VMMR-001 and method of administration
      • EGEN-001 for ovarian and brain cancer -. positive safety and encouraging Phase I results with EGEN-001 monotherapy in patients with peritoneal cancer metastasized ovarian strongly support a trial of combination of planned phase II. A Phase Ib EGEN-001 in combination with pegylated doxorubicin in patients with ovarian cancer resistant to platinum is currently underway. EGEN-001 has also demonstrated preclinical activity in glioblastoma (brain cancer) and the Company plans to initiate a Phase I study in this indication
    • TheraSilence ™ . - TheraSilence ™ is a versatile technology platform focused on delivering synthetically generated by small inhibitory RNA (siRNA), microRNA, and microRNA mimics and related molecules that can regulate the expression of proteins by exploiting endogenous cellular mechanisms. VMMR developed several classes of pharmaceutical carriers that can efficiently deliver the siRNA in the cytoplasm of many types of cells both in vitro and in vivo. The TheraSilence ™ platform has generated its first drug candidate, EGEN-ARN-002, which is currently in preclinical development
    • RAST ™ -. VMMR developing a new technology that allows cells to express and secrete RNA (microRNA, mRNA, shRNA, aptamers) called RAST ™ (RNA Amplification and Secretion Technology). VMMR got broad intellectual property rights on this technology and is currently evaluating new opportunities for therapeutic products and life sciences.
  • fully integrated research and development organization with a wide range of scientific and clinical expertise. combined organization will draw on the experienced group of scientists, physicians, employees and managers of both companies to create a wide range of abilities and skills from early discovery and validation, clinical development , regulatory, quality control and assurance, manufacturing on a commercial scale, business development and corporate strategy.
  • potential for significant value creation. as a combined company, the organization has a potential value higher than any single company, combining the recording potential of a pivotal Phase III study with near term milestones earlier clinical stage, and additional opportunities for strategic partnerships leveraging the ThermoDox®, TheraPlas ™, TheraSilence ™ and RAST ™ platforms.
  • Financial arrangements to preserve capital and investment risks. The structure of the negotiated acquisition transaction provides Celsion investors with a "risk shared mutual trust" approach, capital preservation for oncology research with strong potential while establishing an earn out based program value creating steps. These characteristics of friendly investors are designed to strengthen the alignment of Celsion with shareholders and the commitment to pay for performance.

The combined company will retain all Egen employees and will be headquartered in Lawrenceville, NJ discovery and preclinical operations will be based on current, leased Egen facilities in Huntsville, Alabama, where Celsion also considering consolidate all of its functions and service analytical laboratory.

Cantor Fitzgerald & Co. acted as financial advisor to Celsion. Sidley Austin LLP and O'Melveny & Myers LLP acted as legal advisor to Celsion this transaction.

Information on the conference call

Celsion Corporation will hold a conference call to discuss the acquisition of VMMR 11:00 AM EDT Tuesday, June 10, 2014. For participate in the call, interested parties may dial 1-888-510-1765 (toll free / North America) or 1-719-325- 2428 (International / toll) and ask for the Celsion Corporation Acquisition VMMR (code the conference: 5633593) to save ten minutes before the call is scheduled to begin. The call will also be broadcast live on the Internet at http://www.celsion.com.

The call will be archived for replay Tuesday, June 10, 2014 and will remain available until June 24, 2014. the replay is accessible at 1-888-203-1112 (Toll Free / North America) or 1-719-457-0820 (International / Toll) using the conference code: 5633593. A replay of the call will also available on the Company's website, http://www.celsion.com for 30 days after 14:00 EDT Tuesday, June 10, 2014.


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