(Press release, PeptiMed, JUN 23, 2014, View Source;newsId=20140623005412&newsLang=en [SID:1234503455])

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Celsion Corporation Completes Acquisition of EGEN, Inc.

On June 20, 2014 Celsion reported the completion of the acquisition by Celsion of substantially all of the assets of EGEN, Inc. (EGEN), a privately-held biopharmaceutical company focused on the development of nucleic acid-based therapeutics for the treatment of cancer and other difficult to treat diseases (Press release Celsion, JUN 20, 2014, View Source [SID:1234501826]). The acquisition includes EGEN’s Phase Ib DNA-based immunotherapy product candidate EGEN-001 and its therapeutic platform technologies, TheraPlas for delivery of DNA and mRNA, TheraSilence for delivery of RNA, and RAST for Cell Enabled Expression and Secretion of RNA.

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"Completing the acquisition of EGEN marks a defining event for Celsion, as it brings together leading-edge assets and capabilities with the opportunity to not only advance medicine and patient care in cancer and other serious diseases, but create long-term value for our shareholders," said Michael H. Tardugno, Celsion’s President and Chief Executive Officer. "Now, all at once a fully integrated development company with assets and capability from feasibility to commercialization, we look forward to advancing our pipeline of chemotherapies, immunotherapies and DNA or RNA-based therapies in the lab and in ongoing or planned Phase III, II and I studies. Our strong balance sheet provides us with an impressive internal development runway, as well as allows us to develop collaborative partnerships leveraging the power of our multiple platforms."

Under the terms of the agreement, CLSN Laboratories, Inc., a wholly-owned subsidiary of Celsion (CLSN Laboratories), acquired substantially all of the assets and assumed certain specified liabilities of EGEN. At the closing, Celsion issued $8.5 million worth of common stock, representing approximately 15.8% of its outstanding shares, paid approximately $3.0 million in cash to EGEN, and holds back $2.1 million worth of common stock until August 2, 2016 for expense adjustment and certain indemnification claims of Celsion. In addition to the upfront payment, a total of $30.4 million in future milestone obligations are payable to EGEN based on the successful completion of certain clinical development and licensing milestones.

The combination of Celsion and EGEN will create a fully-integrated, oncology-focused research and development company with a multi-phase clinical pipeline, platform technologies for the discovery of novel, nucleic acid-based immunotherapies and other anti-cancer DNA/RNA therapies, and expertise from bench to bedside. The transaction brings to Celsion EGEN’s lead, Phase Ib clinical candidate, EGEN-001, an IL-12 plasmid immunotherapy encased in a nanoparticle delivery system, as well as three technology platforms, TheraPlas, TheraSilence, and RAST for Cell Enabled Expression and Secretion of RNA.

The transaction complements Celsion’s lead development candidate, ThermoDox, a proprietary heat-activated liposomal encapsulation of doxorubicin, currently in a pivotal, double-blind, placebo-controlled, global Phase III trial (the OPTIMA Study) in primary liver cancer.

CLSN Laboratories has retained all EGEN employees and will be based in Huntsville, Alabama, where Celsion also plans to consolidate all of its analytical service and laboratory functions.

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

Vernalis and Servier achieve Research Milestone as BCL-2 inhibitor drug candidate enters Phase I

On June 19, 2014 Vernalis and Servier reported the achievement of a milestone following the treatment of the first patient in a Servier sponsored Phase I trial with a promising new drug candidate, a selectiveBCL-2 inhibitor identified through their joint oncology drug discovery collaboration (Press release, Servier, JUN 19, 2014, View Source [SID:1234508825]).

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This BCL-2 selective inhibitor is the first drug candidate stemming from an on-going collaboration between Vernalis and Servier aimed at discovering anticancer drug candidates selective for individual BCL-2 family members.

Ian Garland, CEO of Vernalis commented: "We are delighted that this new BCL-2 inhibitor candidate has now entered Phase I trials and look forward to further success from our broad, strategic collaboration with Servier."

Jean-Pierre Abastado, Director of the Center of Therapeutic Innovation in Oncology at Servier, said: "Our experience with Vernalis shows that small molecules tailored against specific targets can have very high therapeutic potential. This success was achieved through a comprehensive chemistry and biology research program with our teams identifying and characterizing this promising BCL-2 inhibitor. This new compound further extends Servier’s portfolio beyond kinase inhibitors, HDAC inhibitors and immunotherapeutic products."

About BCL-2 target:

Proteins of the BCL-2 family are crucial regulators of apoptosis. Deregulations of this protein family play a major role in the aberrant survival of tumour cells. Within this protein family, BCL-2 belongs to the pro-survival members and is often overexpressed in tumour cells. Pro-survival BCL-2 family members have been recognized as attractive therapeutic targets in oncology for more than twenty years but drug discovery research on this class of target is particularly challenging and requires innovative chemistry supported by structural biology.

Analyst: GlaxoSmithKline’s Tykerb dead in the water after breast cancer failure

GlaxoSmithKline’s ($GSK) cancer treatment Tykerb took a blow last month when it failed a major late-stage trial in breast cancer. Now, at least one analyst figures the drug is crippled by that data–and that marketing it for breast cancer would be a waste of money (FierceBiotech, Analyst: GlaxoSmithKline’s Tykerb dead in the water after breast cancer failure, JUN 17, 2014, View Source [SID:1234510055]).

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The study that torpedoed Tykerb compared Roche’s Herceptin–the gold standard in HER2-positive breast cancer–against the combination of Herceptin and the GSK drug in patients who had undergone surgery. Obviously, the hope was that adding Tykerb to Herceptin would be a boost for those patients. But it wasn’t; the dual therapy failed to show statistical superiority over Herceptin alone at staving off the disease.

Based on response data from another study, hopes were high for Tykerb in post-surgery patients. Now, with the new trial failure on the one hand–and Roche’s new line-up of HER2-positive cancer therapies, Perjeta and Kadcyla, on the other–Tykerb’s chances look slim, GlobalData analyst Jamie Mallinson figures.

Adding to the uncertainty about Tykerb’s future is the fact that it will go to Novartis as part of Glaxo’s oncology portfolio sale to the Swiss drugmaker in a $16 billion deal. "Tykerb has failed to establish itself as a strong competitor in the HER2-positive market, and its use in the adjuvant setting was the only way it could gain a decent share of the breast cancer therapeutics market after Roche launched Perjeta and Kadcyla," Mallinson said in a recent report.

Coming on top of last year’s Tykerb failure in HER2-positive gastric cancer, the loss in breast cancer is a big disappointment. The upshot? GlobalData figures there is "little more to expect" from the drug. So, the firm says, neither Glaxo nor Novartis is likely to expend much effort–or money–marketing Tykerb.

But after Novartis inked its deal for the GSK cancer portfolio in April, analysts said that the Swiss drugmaker could easily add Tykerb to its marketing lineup. Sales reps working on the Novartis treatment Afinitor, which is approved for breast cancer as well as other forms of the disease, could also tout Tykerb with little additional effort or expense. Whether Novartis can prove the Tykerb naysayers wrong? We’ll have some time to wait and see.

(Press release, CanTx, JUN 17, 2014, View Source [SID:1234505852])

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