(Press release, Inovio, SEP 22, 2014, View Source [SID:1234504553])

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On September 22, 2014 ACCESS PHARMACEUTICALS, INC. (OTCBB: ACCP), reported that it has signed an exclusive, global license agreement with Plasma Technologies LLC ("PlasmaTech") for the development and commercialization of its proprietary plasma fractionation process (Press release, Access, SEP 22, 2014, View Source [SID:1234510400]). Concurrently, the Company announced a new corporate management team and its intention to strategically refocus and rebrand the company as PlasmaTech Biopharmaceuticals, Inc., and its plans to pursue a national listing for its common shares.

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Under the terms of the licensing agreement, the Company will pay a license fee of $5 million in a combination of cash and common stock subject to the achievement of certain events, including, a regulatory approval milestone payment in common shares upon the first FDA regulatory approval of a drug derived from the PlasmaTech fractionation process, and a tiered royalty on annual net sales of plasma fractions produced with the proprietary fractionation process. Upon execution of the agreement, to support the Company’s new strategic positioning, its Board of Directors appointed Mr. Scott Schorer as Chief Executive Officer and Mr. Harrison Wehner as President and Chief Financial Officer of PlasmaTech BioPharmaceuticals, Inc.

"Following the recent completion of the European license agreement for MuGard with Norgine, and receiving FDA Marketing Clearance for ProctiGard, we are pleased to announce the next phase in our corporate development: an important global license agreement and the addition of key senior management to the company," stated Steven Rouhandeh, Chairman of Access Pharmaceuticals, Inc. He continued, "The PlasmaTech novel fractionation process can fundamentally change the economic model for the plasma protein therapeutics market, and provides the opportunity for our company to participate in the high-growth area of plasma biologicals. We are rebranding the Company to better align its image with future product opportunities. We thank Jeffrey Davis for his service and look forward to his continued advice and guidance as a director."

The global market for drugs derived from human blood plasma fractionation is currently greater than US$15 billion, and is growing at a rate close to 10% annually. Despite this significant market opportunity, little innovation in fractionation technology has occurred in decades. PlasmaTech has developed and patented a new extraction process for plasma biologics that may fundamentally change the economics of blood plasma fractionation, and makes possible the extraction of several additional therapeutically useful plasma proteins. The Company believes that PlasmaTech’s proprietary fractionation process is expected to significantly enhance yields of key value blood proteins, including alpha-1 antitrypsin, expanding market opportunities while greatly enhancing margins. The Company obtained rights to utilize and sub-license to other pharmaceuticals firms, the recently patented improved methods for the extraction of therapeutic biologics from human plasma. The Company believes that PlasmaTech’s lead product opportunity, alpha-1 antitrypsin (ATT), will offer a low-risk, high revenue, short time-to-market respiratory product (AAT) for treatment of inherited COPD (pulmonary emphysema), among other indications. Additionally, the ability to extract several additional therapeutically useful and important proteins, due to the process being less destructive than historical fractionation processes, may enable the Company to seek new therapeutic applications and address high-value-added orphan indications.

"I am pleased to be joining PlasmaTech Biopharmaceuticals at this exciting time in its development," stated Scott Schorer, Chief Executive Officer. "The innovative and disruptive fractionation technology can translate into significant value for shareholders, both directly and through multiple partnering and sub-licensing opportunities. I look forward to working with all of the Company’s stakeholders in maximizing this significant opportunity."

"The base technology of the plasma fractionation business has evolved very little since the original Cohn cold ethanol process, developed in the 1940’s," stated Harrison Wehner, President and Chief Financial Officer. "The ability to greatly enhance yields of specific proteins using our technology will enable expanded supplies to meet the growing needs of these types of drugs globally. We look forward to working with global plasma fractionators, contract manufacturers and eventually pharmaceuticals companies to implement this proprietary process, produce proteins and drive value for the Company’s shareholders."

Mr. Scott Schorer has been appointed Chief Executive Officer of PlasmaTech Biopharmaceuticals. He has served over 18 years in a variety of senior management and board positions, including as CEO and President, and has experience in all aspects of operations including research and development, intellectual property, manufacturing, sales and marketing. Additionally, Mr. Schorer has extensive experience as advisor to operating companies, venture capital firms and private equity firms. Previously, he was President, Americas, of Systagenix Wound Management, was President & CEO of Innovative Spinal Technologies, and was Co-Founder, President & CEO of CentriMed. Mr. Schorer served with distinction in the US Army, 82nd Airborne, and holds a B.E and B.A. from Dartmouth College and Thayer School of Engineering.

Mr. Harrison Wehner has been appointed President and Chief Financial Officer. Mr. Wehner has over 20 years experience in investment banking advising on equity and debt finance and mergers and acquisitions advisory assignments. Previously, Mr. Wehner held various senior banking roles at Canaccord Genuity, CitiGroup, and UBS where he worked on a variety of banking transactions in the healthcare sector, including advisory and transactional experience in the blood fractionation business. Mr. Wehner holds a BA from The College of William and Mary, and an MBA from the Ross School of Business at the University of Michigan.

The Company is planning to schedule an investor conference call shortly to update investors on the recent developments.

On September 22, 2014 Xenetic Biosciences, Inc. (OTCBB: XBIO), a biopharmaceutical company focused on developing next-generation biologic drugs and novel oncology therapeutics, reported that it will hold a business update conference call on Tuesday, September 23, 2014 at 11:00 a.m. GMT (6:00 a.m. EDT) (Press release, Xenetic Biosciences, SEP 22, 2014, View Source [SID1234537818]). M. Scott Maguire, chief executive officer, and Colin Hill, U.K. chief financial officer and board member, will provide a business update and answer questions.

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To access the conference call, U.K.-based participants should call 0800 368 0649; London-based participants should call 020 3059 8129; and, participants in all other locations should call +44 20 3059 8125. A telephone replay will be available for seven days following the call’s conclusion. Replay dial-in numbers are as follows: United Kingdom 0121 260 4861; United States 866-268-1947; and all other locations + 44 121 260 4861. Please provide conference ID 7591229 when accessing the replay. In addition, a replay of the call will be posted to the Investor Relations section of www.xeneticbio.com in the "Events and Presentations" tab.

On September 18, 2014 Boehringer Ingelheim and CureVac reported jointly announce an exclusive global license and development collaboration (Press release Boehringer Ingelheim, SEP 18, 2014, View Source [SID:1234500827]). The new collaboration focuses on CureVac’s CV9202, a novel investigational therapeutic mRNA vaccine, in early clinical development for the treatment of lung cancer. Boehringer Ingelheim will start clinical investigation of CV9202 in at least two different lung cancer settings, in combination with afatinib in patients with advanced or metastatic epidermal growth factor (EGFR) mutated non-small cell lung cancer (NSCLC) and in combination with chemo-radiation therapy in patients with unresectable stage III NSCLC. Upon signature, CureVac receives EUR 35 million. Further, CureVac can achieve milestone payments of up to EUR 430 million and royalties on sales.

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This new agreement is part of Boehringer Ingelheim’s long-term commitment to delivering tomorrow’s cancer therapies through the discovery of novel treatment options with high therapeutic value for patients. The company’s oncology portfolio includes Giotrif (afatinib)*, an irreversible ErbB family blocker, approved in a number of markets, including the EU, the US and Japan for the treatment of distinct types of EGFR mutation-positive NSCLC. Boehringer Ingelheim’s oncology pipeline covers a broad range of solid tumors and haematologic malignancies (blood cancer), including two investigational compounds in Phase III clinical development: nintedanib in distinct types of NSCLC and colorectal cancer, and volasertib in acute myeloid leukemia.

"At Boehringer Ingelheim we are proud of our commitment to help improve the treatment of cancers with a high medical need. In our collaboration with CureVac, we will investigate combining existing treatments with the approach of sustained activation of the immune system. With this we hope to be able to develop new treatments and further expand our broad pipeline in lung cancer." said Professor Klaus Dugi, Chief Medical Officer, Boehringer Ingelheim.

CureVac’s mRNA-based technology represents a novel approach in cancer treatment. For the first time, mRNA could be optimised to mobilise the patient’s own immune system to fight the tumour with a specific immune response elicited through the RNActive vaccine. Cancer immunotherapy has been chosen as the "Breakthrough of the year 2013" by SCIENCE magazine. CV9202 is a combination of mRNA molecules coding for six antigens overexpressed in lung cancer, designed to induce an immune response against the tumour. CV9202 and the preceding RNActive cancer vaccine CV9201 tested in initial clinical trials by CureVac demonstrated clinical safety and activity in generating immune responses against all anti-tumour antigens.

Ingmar Hoerr, co-founder and CEO of CureVac GmbH commented: "This collaboration is extremely relevant for CureVac because, as a biotech enterprise, we rely on collaboration with strong partners for the clinical development and commercialisation of our compounds. Cancer immunotherapy represents one of the biggest innovations in cancer treatment of recent times and we are delighted to now be working with Boehringer Ingelheim. The out-licensing and clinical development of our promising therapeutic vaccine CV9202 represents the logical next step in developing this novel treatment for cancer patients and the significant commitment from Boehringer Ingelheim underscores the relevance of the mRNA technology."

On September 18, 2014 Spectrum Pharmaceuticals, Inc. (Nasdaq: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, and CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a biopharmaceutical company dedicated to the acquisition, development and commercialization of innovative therapeutics addressing cancer and other unmet medical needs for the global market with a primary focus on China, reported the signing of license agreements whereby CASI has been granted exclusive rights to two of Spectrum Pharmaceuticals’ commercial oncology drugs, Zevalin (ibritumomab tiuxetan) Injection for intravenous use and Marqibo (vinCRIStine sulfate LIPOSOME injection) for intravenous infusion, and a Phase 3 drug candidate, Captisol-EnabledTM Melphalan (CE melphalan), for development and commercialization in China, including Taiwan, Hong Kong and Macau (Press release, Spectrum Pharmaceuticals, SEP 18, 2014, View Source [SID1234533645]).

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ZEVALIN is used in the treatment of non-Hodgkin’s lymphoma (NHL) and MARQIBO is used in the treatment of acute lymphoblastic leukemia (ALL). CE melphalan has met the endpoints in a pivotal trial for use as a conditioning treatment prior to autologous stem cell transplant for patients with multiple myeloma. Spectrum plans to file a New Drug Application with the U.S. Food and Drug Administration (FDA) for CE melphalan in the second half of 2014.

CASI will be responsible for the development and commercialization of the three drugs, including the submission of import drug registration applications to regulatory authorities and conducting any confirmatory clinical studies in greater China, if and as required.

"We are delighted to see our anticancer drugs to be developed and marketed in greater China through CASI, a NASDAQ-listed Company focused on China," said Rajesh C. Shrotriya, MD, Chairman and Chief Executive Officer of Spectrum Pharmaceuticals. "The management of CASI has a track record of successfully developing anticancer drugs in China. We are pleased to be a shareholder of CASI at this early stage of their development and look forward to CASI creating value for our shareholders as they grow. China’s pharmaceutical market is growing at a rapid pace and is already approaching second place to only the United States in the world. The greater China drug market for anticancer drugs is projected to become the world’s largest in the next decade and CASI has the opportunity to take a leading position to address these significant unmet medical needs. We are impressed with the management team at CASI and their expertise in China, and look forward to sharing in the success of our drugs in this important market."

Commenting on the transaction, Ken K. Ren, Ph.D., CASI’s Chief Executive Officer, said, "We are very excited to have entered into this transaction with Spectrum, a Company with a successful track record of developing and commercializing drugs expeditiously in the U.S. The addition of these three drugs transforms our pipeline and significantly expands our market share potential in China. Our transaction is structured rather uniquely in that the shares and note represent the purchase price to Spectrum and is in lieu of royalties and milestones normally associated with traditional licenses, thereby aligning Spectrum’s interest with our shareholders. We look forward to a productive relationship with Spectrum."

Dr. Ren added, "These drug products come with strong intellectual property protection and significant technology barriers. We are currently preparing the import drug registration applications in greater China, initially for ZEVALIN and MARQIBO, and since both drugs are approved for sale in the U.S., we anticipate that confirmatory clinical trials will be required for marketing approval in our territory. The submission of the import drug registration for CE melphalan will follow immediately after its approval by the U.S. FDA. The annual incidence in China for NHL, ALL and multiple myeloma is increasing each year with high mortality rates, it is our goal to have these innovative products available to patients in greater China as soon as possible to address these unmet medical needs, and as Spectrum expands these drugs into additional indications in the U.S., we too will apply for expanded labels in our territory."

In addition to its initial stake in CASI, Spectrum Pharmaceuticals will have certain rights to maintain its post-transaction ownership position. Spectrum Pharmaceuticals also will have the opportunity to designate a member to CASI’s board of directors. Detailed information on the transaction can be found in CASI’s Report on Form 8-K, which will be filed with the Securities and Exchange Commission.

H.C. Wainwright & Co., LLC acted as Spectrum’s advisor.