On August 24, 2016 ProMetic Life Sciences Inc. (TSX: PLI) (OTCQX: PFSCF) ("ProMetic" or the "Corporation") reported that it has entered into a binding agreement (the "Agreement") for the acquisition of Telesta Therapeutics, Inc, ("Telesta") by way of a plan of arrangement under the Canada Business Corporations Act (the "Acquisition") (Press release, ProMetic Life Sciences, AUG 24, 2016, View Source [SID:1234514710]).

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Under the terms of the Agreement, ProMetic will acquire all of the share capital of Telesta at a share price of $0.14 payable in ProMetic common shares. The number of common shares to be issued by ProMetic will be based on the volume-weighted average closing price ("VWAP") of ProMetic’s common shares for the five (5) trading days prior to the closing date of the Acquisition. Completion of the Acquisition is subject to the approval of Telesta’s shareholders and a number of customary closing conditions for a transaction of this nature, which include court and regulatory approvals (including the approval of the Toronto Stock Exchange). The Acquisition is expected to close in early November, 2016. The Agreement also contains customary deal protection mechanisms, including no shop provisions and a mutual $2.5 million breakup fee payable by Telesta or ProMetic in specified circumstances.

Strategic and Financial Benefits of the Transaction:
Provides the opportunity for further integration of manufacturing capability and longer term capacity expansion in a 150,000 sq. ft. facility in Belleville, Ontario;

Provides approximately $34 million in cash to be deployed towards ProMetic’s drug development and clinical programs and value generating activities;

Does not materially affect ProMetic’s EBITDA and operating cash flows;

Provides up to $50 million in potential tax attributes; and

Provides ProMetic with a significant foothold in Ontario, consolidating its presence as a major player in the Canadian market.
Pierre Laurin, President and CEO of ProMetic stated: "This acquisition opportunity is strategic for ProMetic in many ways, with immediate, mid-term and long-term financial and operational benefits. It allows ProMetic to secure flexibility in its continued objectives of seeking vertical integration from raw material sourcing to distributing finished biopharmaceuticals in North America and abroad. The addition of a central Canada location also fits well with our strategy of facilitating the pursuit of Canadian national self-sufficiency for plasma-derived therapeutic products", added Mr. Laurin.
Commenting on the transaction, Dr. Mike Berendt, Chief Executive Officer of Telesta, said: "We are convinced that ProMetic Life Sciences represents a balanced, low-risk, high reward opportunity for Telesta’s shareholders. ProMetic’s business model combines recurrent and growing revenue from their world-class filtering technology, potential block buster upside from their small molecule fibrosis program, and multiple plasma therapeutic proteins targeting orphan diseases. The premium offered to Telesta’s shareholders by ProMetic is based on their ability to leverage multiple Telesta asset classes".
"The addition of the Belleville, Ontario facility whilst not essential to ProMetic’s current plans and timelines, provides the opportunity to build greater flexibility into our manufacturing capability. The newly refurbished portion of the Belleville, Ontario facility would require minor modifications to fit our purposes", declared Mr. Bruce Pritchard, Chief Operating Officer of ProMetic. "It allows us to consider a vertical integration of fill-finish operations, currently being outsourced, and the creation of further downstream processing lines, adding flexibility to the combination of plasma derived products manufactured simultaneously", added Mr. Pritchard.

On August 24, 2016 TG Therapeutics, Inc. (NASDAQ:TGTX) reported that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for the Company’s oral, next generation PI3K Delta inhibitor, TGR-1202, for the treatment of patients with chronic lymphocytic leukemia (CLL) (Press release, TG Therapeutics, AUG 24, 2016, View Source [SID:1234514703]). TGR-1202 is currently being evaluated in the UNITY-CLL Phase 3 Trial for patients with both frontline and previously treated CLL.

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"We are pleased to receive orphan drug designation for TGR-1202. In addition to our composition of matter patent for TGR-1202 which issued earlier this year, the granting of this orphan drug designation offers an additional level of proprietary protection and also may provide us certain other regulatory and financial benefits," said Michael S. Weiss, Executive Chairman and Interim CEO of TG Therapeutics. "We continue to be excited about the differentiated safety profile of TGR-1202 over other PI3k delta inhibitors and believe the UNITY-CLL Phase 3 Trial will showcase those differences."

Orphan drug designation is granted by the FDA to drugs and biologics which are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases/disorders that affect fewer than 200,000 people in the U.S. Orphan drug designation provides certain incentives which may include tax credits towards the cost of clinical trials and prescription drug user fee waivers. If a product that has orphan drug designation subsequently receives the first FDA approval for the disease for which it has such designation, the product is entitled to orphan product exclusivity.

Chronic lymphocytic leukemia (CLL) is a type of cancer in which the bone marrow makes too many lymphocytes (a type of white blood cell). CLL usually gets worse slowly and is one of the most common types of leukemia in adults. It often occurs during or after middle age. It is estimated that there are approximately 20,000 new cases of CLL diagnosed each year in the United States.

On August 24, 2016 Cell Medica, a leader in developing, marketing and manufacturing cellular therapeutics for cancer and infections, reported that it has signed a research collaboration with UCL (University College London) aiming to utilize UCL’s novel T cell receptor (TCR) technology to generate leading-edge modified TCR products for the treatment of cancer (Press release, UCLB, AUG 24, 2016, View Source [SID:1234514681]).

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The collaboration also provides Cell Medica with an exclusive worldwide option and license agreement for these technologies as well as TCR gene sequences for the development and commercialisation of specific products. The collaboration will build on the research of Professor Hans Stauss and Professor Emma Morris of UCL, global leaders in developing modified TCRs for cancer treatments.
T cell receptors are molecules found on the surface of T cells which recognise antigens expressed by cancer cells. TCR technology exploits the ability of TCRs to target both intracellular and cell surface antigens, providing an important mechanism to engineer immune cells to target tumors. The UCL TCR technology has the potential to produce strong expression of TCRs by the engineered T cells which is expected to improve their efficacy in fighting tumors.

Collaboration structure
The collaboration will accelerate the pioneering work performed at the UCL Institute of Immunity and Transplantation (IIT) with grant support from Bloodwise, Medical Research Council and National Institute for Health Research (NIHR). The work is led by Professor Hans Stauss, Director of the IIT, and Professor Emma Morris, Director of the Infection, Immunity and Inflammation research theme at the NIHR University College London Hospitals Biomedical Research Centre, both based at the Royal Free Hospital, a UCL Partners academic health science center.

UCL will conduct the preclinical and early clinical research under the guidance of a Joint Steering Committee. Cell Medica will support the product development work with its substantial experience in manufacturing clinical-grade cell therapies and establishing robust production processes suitable for industrial scale-up. Following completion of successful first-in-man studies, the products will transfer to Cell Medica for later-stage clinical development and commercialization.

License, option and sponsored research agreement
Cell Medica has entered into an exclusive license and option agreement with UCL Business, the technology commercialisation company of UCL, for the dominant TCR platform patent and two target antigens. As part of this agreement, both parties can bring targets or platform technologies to the collaboration, aiming to generate leading-edge modified TCR products. In addition, UCL and Cell Medica have signed a Sponsored Research Agreement under which Cell Medica will fund all research and development with an exclusive option to license all products developed within the collaboration.

Cell Medica has paid an up-front fee and will make additional payments to exercise its exclusive option to license future products. UCL is eligible to receive further payments related to clinical, regulatory and sales milestones, as well as single digit royalties.

Gregg Sando, CEO of Cell Medica said:
"This collaboration adds the modified TCR technology platform to our strategy to develop breakthrough treatments for cancer using cellular immunotherapy products. The partnership with Profs Hans Stauss and Emma Morris, leading researchers in this field, should enable us to generate a pipeline of new TCR products with increased efficacy and safety for patients."

Professor Hans Stauss, Director of the Institute of Immunity and Transplantation at the Royal Free Hospital, a UCL Partners academic health science centre, said:
"This collaboration provides an exciting opportunity to move our TCR gene therapy technologies more effectively towards clinical application. We are grateful to the blood cancer charity Bloodwise, who have provided important long-term support for our work. The new collaboration with Cell Medica enables us to take full advantage of our pre-clinical research and rapidly develop novel TCRs for the treatment of patients with cancer"

Professor Emma Morris, Director of the Infection, Immunity and Inflammation research theme at the National Institute for Health Research University College London Hospitals Biomedical Research Centre, and Professor of Clinical Cell and Gene Therapy said:
"As a clinician treating patients with blood cancers, I am aware of the urgent need to develop more effective and less toxic therapies. Immunotherapy with gene-modified immune cells has enormous potential to transform the lives of cancer patients. It is truly exciting to be supported by Cell Medica to accelerate our progress in developing new therapies."

Dr Alasdair Rankin, Research Director at Bloodwise, said:
"Having supported the UCL team’s work for many years, it is exciting to see their hugely promising research reach this stage. This important collaboration is a vital step in the development of new treatments that could have a significant impact on outlook for many patients."