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PERNIX THERAPEUTICS COMPLETES ACQUISITION OF CYPRESS PHARMACEUTICALS, INC. AND HAWTHORN PHARMACEUTICALS, INC.

On January 2, 2013 Pernix Therapeutics Holdings, Inc. ("Pernix" or the "Company") (NYSE MKT: PTX), a specialty pharmaceutical company, reported that it has completed the acquisition of Cypress Pharmaceuticals, Inc. ("Cypress"), a privately-owned generic pharmaceutical company, and Hawthorn Pharmaceuticals, Inc. ("Hawthorn"), a privately-owned branded pharmaceutical company (Press release, Pernix Therapeutics , JUN 2, 2013, View Source;p=irol-newsArticle&ID=2123575 [SID1234517243]). Under the terms of the definitive agreement announced on November 14, 2012 and as amended on December 28, 2012, Pernix will pay up to $102 million, including an up-front payment of $52.0 million in cash and $34.0 million in equity (approximately 4.4 million shares of the Company’s common stock) at closing as well as up to $11 million payable in December 2013 and an additional $5 million in a milestone payment.

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In connection with the closing of the acquisition, the Company completed a $42 million credit facility. MidCap Financial served as Sole Bookrunner, Administrative Agent and Co-Lead Arranger. Cypress and Hawthorn significantly increases and broadens the Company’s branded and generic product portfolio. Cypress and Hawthorn also have clinical and regulatory expertise, receiving approval of more than 10 ANDAs in the last three years and 2 NDAs in 2011. In addition, 15 ANDAs and one 505(b)(2) NDA were filed at the FDA, and Cypress and Hawthorn also have several products in clinical development.

Cooper Collins, President and CEO of Pernix, said, "We are pleased to close on this transaction before the end of the year. We believe the acquisition of Cypress and Hawthorn are an excellent fit for Pernix, and will serve as a key driver for the company’s future growth. We plan to rapidly integrate the branded business of Hawthorn and the generic business of Cypress, and we expect to capitalize on the synergies of the combined companies."

BeiGene and Merck KGaA enter into global co-develop and commercialization agreement for cancer therapy

On May 31, 2013 BeiGene and Merck KGaA reported that they have entered into a global licensing, co-development, and commercialization agreement for BeiGene-283 (Press release BeiGene, MAY 31, 2013, View Source [SID:1234500415]).
The compound is a second-generation BRAF inhibitor for the treatment of cancer. BeiGene-283, which is currently in preclinical development, was discovered and developed in the People’s Republic of China by BeiGene. It is expected to enter clinical development next year. BRAF inhibitors target a protein (BRAF) that is a downstream component of the MAPK pathway, which is thought to promote cancer cell growth and is dysregulated in a number of human cancers.
Under the terms of the collaboration, BeiGene will be responsible for the development and commercialization of BeiGene-283 in the People’s Republic of China and Merck KGaA will be responsible for the development and commercialization of BGB-283 for the rest of the world. BeiGene will receive an undisclosed upfront payment and is eligible to receive further payments of up to US$ 233 million for the achievement of clinical development and potential commercial milestones in both the People’s Republic of China and rest of the world, as well as up to double digit royalties on net sales.

Cancer Research UK launches trial for potential new drug to block cancer cells’ energy supply

On May 31, 2013 Cancer Research UK’s Drug Development Office (DDO) has reported a new clinical trial of a brand new type of experimental drug to treat a range of cancers (Press release, Cancer Research Technology, 31 31, 2013, View Source [SID1234523256]).

The trial of the drug called AZD3965, developed by AstraZeneca, will be undertaken by Cancer Research UK’s National Institute of Health Research (NIHR) Experimental Cancer Medicine Centre, based at the Northern Institute of Cancer Research at Newcastle University, as well as at least one other clinical centre.

Approximately 63 cancer patients will take part in the first clinical trial of the compound to see if it is safe and can benefit cancer patients.*

Cancer Research UK’s DDO have collaborated closely with the trial clinical centres to plan, design and gain regulatory and ethical approval for this exciting first in class, first in man study. The DDO is sponsoring, funding and managing the trial whilst AstraZeneca is providing the drug.

Trial lead, Professor Ruth Plummer, Cancer Research UK clinician at the Northern Institute of Cancer Research at Newcastle University, said: "I’m excited to open this trial of a completely new type of cancer treatment, which continues our drive for the most effective new treatments to give patients the best chance of surviving this dreadful disease.

"It’s heartbreaking for cancer patients when the drugs have stopped working and they have run out of options. But we hope new drugs will be able to save their lives in the future."

AZD3965 targets monocarboxylate transporter 1 (MCT1) which is essential in cell metabolism. Blocking this transporter limits cancer cells’ ability to generate energy, and decreases their capacity to survive.

Susan Galbraith, head of the oncology innovative medicines unit at AstraZeneca, said: "Targeting tumour cell metabolism represents a novel and exciting approach to potentially treat cancer. AstraZeneca is delighted to be working with Cancer Research UK to investigate the utility of AZD3965 which is aimed to address the needs of cancer sufferers."

The drug has been developed through Cancer Research UK’s Clinical Development Partnerships (CDP) scheme.**

CDP is a joint initiative between Cancer Research UK’s DDO and Cancer Research Technology, to progress promising anti-cancer agents which pharmaceutical companies do not have the resources to progress, through early phase clinical trials. This is the fifth drug from the scheme to enter clinical trials.

Dr Nigel Blackburn, director of drug development at the DDO, said: "We’re delighted to open this clinical trial of such a promising new drug which cuts off the energy supply to tumour cells and kills them.

"This is the fifth drug from our CDP programme to reach clinical trials – without the scheme it simply might not have been possible to provide this drug to patients. We’ll continue to build on these successes to accelerate the development of further treatments though new trials of drugs which otherwise may not have reached patients for many years."

10-K – Annual report [Section 13 and 15(d), not S-K Item 405]

Burzynski Research Institute has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission .

Alethia Biotherapeutics and IBC Generium sign agreements

On May 29, 2013 Alethia Biotherapeutics Inc., a privately held biotechnology company focused on developing therapeutic monoclonal antibodies (mAb) reported that it has entered into a global strategic alliance with the International Biotechnology Center (IBC) Generium to jointly develop AB-16B5, a mAB inhibitor of epithelial-to-mesenchymal transition (EMT) (Company Pipeline, Alethia Biotherapeutics, MAY 29, 2013, View Source [SID1234518222]).

Under the terms of the alliance, Alethia and IBC Generium will collaborate for the ongoing development of AB-16B5 and, upon completion of the initial clinical study, share equally in the downstream economics in territories outside Russia and the CIS states. Alethia will receive an upfront cash payment and R&D funding to conduct the initial clinical study in Canada. In addition, to an exclusive license granted to IBC Generium for other territories, IBC Generium has also been granted the right to an exclusive license for Russia and the CIS states for which development milestones and royalties would be payable to Alethia. Further financial terms were not disclosed.

"We are very excited to conclude this global strategic alliance with IBC Generium," said Yves Cornellier, President and CEO of Alethia. "Like Alethia, IBC Generium is dedicated to improving the treatments available to cancer patients and is committing significant resources to develop innovative biological therapeutics including AB-16B5"

Mr. Daniil Talyanskiy, Chief Business Officer at IBC Generium commented: "We are very pleased to have formed this global strategic alliance with Alethia. EMT is a key contributor to both tumor invasion and the emergence of resistance to many cancer therapies. The excellent EMT inhibitor program developed at Alethia represents a unique opportunity for our company to accelerate the development of a novel therapy with potential applications in multiple cancer indications."

"This transaction with IBC Generium represents an important milestone for Alethia" commented Mrs. Ela Borenstein from BDC Capital. "It serves as recognition of the excellent preclinical development performed at Alethia to date, added Mr. Louis Lacasse of Agechem Venture Fund. Progressing to a clinical stage company through the advancement of AB-16B5 contributes to the potential for material value creation for Alethia’s shareholders."