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Halozyme Enters Into Agreement For $150 Million Non-Dilutive Royalty-Backed Debt Financing

On January 4, 2016 Halozyme Therapeutics, Inc. (NASDAQ: HALO) reported that it has entered into a $150 million credit agreement, secured by future royalties of ENHANZE products, received only from Halozyme’s collaborations with Roche and Baxalta (Press release, Halozyme, JAN 4, 2016, View Source [SID:1234508654]).

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"This transaction allows us to continue to execute our two pillar strategy supporting the initiation of our phase 3 study in pancreatic cancer, ongoing studies in non-small cell lung and gastric cancers, and start of our planned trial in breast cancer in collaboration with Eisai," said Dr. Helen Torley, president and chief executive officer of Halozyme. "This opportunity for non-dilutive financing further demonstrates how our ENHANZE platform can drive value, and is additive to the $25 million upfront payment from the recently announced licensing and collaboration agreement with Eli Lilly."

The debt transaction is expected to close in January 2016. The financing will be facilitated through investment funds managed by Pharmakon Advisors and Athyrium Capital Management. "We are pleased to partner with Halozyme in this transaction," said Martin Friedman, managing member of Pharmakon Advisors. "We believe Halozyme’s ENHANZE technology adds tremendous value to biologic products as demonstrated by the strength of Halozyme’s collaborations with Roche and Baxalta." As part of the financing structure, Halozyme formed a wholly-owned subsidiary, Halozyme Royalty LLC ("Halozyme Royalty"), which, subject to satisfaction of certain closing conditions, will borrow $150 million at a per annum interest rate of 8.75 percent plus the three-month LIBOR rate. Under the terms of the loan, the three-month LIBOR rate is subject to a floor of 0.70 percent and a cap of 1.50 percent.

On the closing date, Halozyme will transfer to Halozyme Royalty the right to receive certain royalty payments from the commercial sales of Herceptin SC and MabThera SC under Halozyme’s collaboration agreement with Roche and from the commercial sales of Hyqvia under Halozyme’s collaboration agreement with Baxalta. Halozyme will continue to record and report royalty revenues over the term of the loan, using the payments from the collaboration agreements as the source of funds to repay the principal and interest on the loan. Milestone payments received under any current or future collaboration agreements are excluded from the transaction.

Under the terms of the credit agreement, Halozyme Royalty will not be required to apply any of the royalty payments to repay the loan during 2016. All interest accrued in 2016 will be capitalized and added to the outstanding balance of the loan. Halozyme Royalty will only be required to apply 50 percent of royalty payments received in 2017 to make principal and interest payments subject to quarterly caps set forth in the credit agreement. Thereafter, subject to quarterly caps set forth in the credit agreement, Halozyme Royalty will apply all of the royalty payments received to repay outstanding principal and interest on the loan. If royalty payments available to repay the loan are insufficient to pay accrued interest due on any quarterly payment date, the unpaid interest will be capitalized and added to the outstanding principal balance of the loan. Royalty payments received in excess of the quarterly caps will be retained by Halozyme Royalty and distributed to Halozyme. Loan-related expenses will be deducted from the royalty payments before such amounts are applied to the loan or distributed to Halozyme Royalty.

The final maturity date of the loan will be the earlier of (i) the date when the principal amount and accrued interest are paid in full, (ii) the termination of Halozyme Royalty’s right to receive royalties under the collaboration agreements with Roche and Baxalta and (iii) December 31, 2050. Repayment of the loan is the sole obligation of Halozyme Royalty and is intended to be non-recourse to Halozyme Therapeutics, Inc. and its other subsidiaries.

Baxalta and Symphogen Establish Strategic Collaboration to Accelerate Innovation in Immuno-Oncology

On January 4, 2016 Baxalta Incorporated (NYSE: BXLT), a global biopharmaceutical leader dedicated to delivering transformative therapies to patients with orphan diseases and underserved conditions, and Symphogen, a private biopharmaceutical company developing recombinant antibodies and antibody mixtures, reported a broad strategic immuno-oncology collaboration (Press release, Baxalta, JAN 4, 2016, View Source [SID:1234508653]).

Under the terms of the agreement, Baxalta and Symphogen will advance novel therapeutics against six checkpoint targets, with the first program to enter clinical studies in 2017. On a product-by-product basis, following successful completion of Phase 1 clinical trials, Baxalta will have exclusive option rights to complete late-stage development and worldwide commercialization. Symphogen will receive an upfront payment of $175 million (€160 million) from Baxalta in exchange for the exclusive option rights for six checkpoint therapies. Symphogen will be responsible for performing R&D through Phase 1 clinical trials at its own expense. The agreement holds a total potential value up to €1.4 billion ($1.6 billion) in option fees and milestones over the long-term, in addition to royalties on worldwide sales. Additional terms, including therapeutic targets, were not disclosed.

"This exciting partnership aligns well to Baxalta’s strategy to invest in immuno-oncology and build an innovative portfolio of immunotherapies," said David Meek, executive vice president and president, Oncology, Baxalta. "With the expertise Symphogen offers in this category and their broad portfolio of early-stage immuno-oncology programs, this collaboration allows us to actively advance one of the most innovative areas of this field. For Baxalta, this is just the beginning of our focus in building world-class capabilities in immuno-oncology."

"Baxalta’s dedication to delivering transformative therapies and its global commercial presence make it an ideal strategic partner for Symphogen, as we complement Baxalta with R&D competencies within the immuno-oncology area," said Kirsten Drejer, Ph.D., Chief Executive Officer, Symphogen. "We look forward to providing Baxalta with innovative immuno-oncology product candidates under this broad collaboration."

Dr. Göran Ando, Chairman of Symphogen’s Board of Directors added, "This collaboration also provides strong validation for Symphogen’s antibody approach and capabilities within the exciting field of immuno-oncology therapy."

Immuno-oncology, a field focusing on activating and directing a patient’s immune system against tumor growth and proliferation, is a highly attractive area of research that is generating promising new therapeutic advances. Recent research indicates that these immunotherapies, both as single agents and as combination therapies, are likely to significantly improve outcomes for a variety of cancers.

Bevacizumab non-originator biological approved in Russia

On 30 November 2015 Biocad reported that the Russian Ministry of Health had approved the company’s bevacizumab non-originator biological drug, BCD-021 (Press release, Biocad, JAN 1, 2016, View Source [SID1234563674]). The drug is a non-originator biological of Roche’s cancer blockbuster Avastin (bevacizumab).

Bevacizumab is a humanized monoclonal antibody. It inhibits angiogenesis (the formation of new blood vessels) by blocking the action of vascular endothelial growth factor A (VEGF-A). Bevacizumab can therefore slow the growth of new blood vessels in tumours and is used to treat various cancers, including colorectal, lung, breast, glioblastoma, kidney and ovarian.

The Russian Ministry of Health’s positive opinion on BCD-021 is based on the results of international clinical studies comparing the pharmacokinetics, efficacy, safety and immunogenicity of BCD-021 to Avastin. Biocad’s phase III study, which involved centres in Russia, Belarus and Ukraine was completed in December 2014. The design of the clinical trials was developed with the advice of the European Medicines Agency (EMA) for clinical trials of biosimilars of monoclonal antibodies.

Global sales of Avastin in 2014 amounted to US$7.4 billion. While in Russia, Avastin had sales of more than RUB 3.2 billion in 2014.

Bevacizumab is not the only non-originator biological Biocad has in the pipeline. The company received approval for its rituximab non-originator biological AcellBia (BCD-020) in April 2014 [1]. According to ClinTrials.gov the company is also carrying out a phase III clinical trial for another of its biological candidates, BCD-022, which is a non-originator biological of Roche’s blockbuster cancer drug Herceptin (trastuzumab).

BioTime Completes Distribution of Approximately 4.75 Million Shares of OncoCyte Corporation Common Stock

On December 31, 2015 BioTime, Inc. (NYSE MKT: BTX), a clinical-stage regenerative medicine company with a focus on pluripotent stem cell technology, has completed its previously reported distribution of approximately 4.75 million shares of common stock of its subsidiary OncoCyte Corporation ("OncoCyte") to BioTime shareholders (Press release, BioTime, DEC 31, 2015, View Source;p=RssLanding&cat=news&id=2125490 [SID:1234508648]). Regular way trading of OncoCyte common stock on the NYSE MKT is expected to begin on January 4, 2016 under the symbol OCX. The distributed shares represent approximately 18.69% of the outstanding shares of OncoCyte. As a result of the distribution of the shares, BioTime’s ownership of OncoCyte has been reduced from approximately 76.4% to approximately 58.55%.

OncoCyte is primarily focused on the development of novel, non-invasive liquid biopsy diagnostic tests for the early detection of cancer. BioTime shareholders receiving OncoCyte stock will receive an Information Statement containing details regarding the distribution of OncoCyte common stock and OncoCyte’s business and management. The Information Statement is part of a Form 10 filed by OncoCyte with the Securities and Exchange Commission that may be found at the Commission’s website www.sec.gov or at OncoCyte’s website at www.oncocyte.com.

"This distribution is another example of the BioTime’s Board of Directors strategy to provide shareholder value from our assets while we focus our operations on the Company’s clinical-stage regenerative therapeutic candidates based on pluripotent stem cell technology," said Adi Mohanty, BioTime’s Co-Chief Executive Officer. "We look forward to participating as a major shareholder in the progress of OncoCyte as the Company’s management advances development of its molecular diagnostic products toward commercialization."

Any BioTime shareholder who sells their BioTime shares on or before December 31, 2015 will be selling their entitlement to receive OncoCyte shares to the buyer of their BioTime shares. BioTime shareholders are encouraged to speak to their financial advisor before making any financial decisions.

H2Biologics Licenses Worldwide, Exclusive Rights to Develop SD1-Granzyme B Drug Conjugate for Treatment of Mesothelin-Expressing Tumors

On December 31, 2015 H2Biologics reported that it has been granted a worldwide, exclusive license by the Research Development Foundation (RDF) for the use of human granzyme B (GrB), a naturally occurring serine protease, in developing an immunoconjugate with a human single domain antibody (SD1) that targets mesothelin-expressing tumors. Under this agreement and a license agreement with NIH for SD1, H2Biologics can target mesothelioma, pancreatic cancer, ovarian cancer, breast cancer, and lung adenocarcinoma (Press release, H2Biologics, DEC 31, 2015, View Source [SID:1234508651]).

This group has generated a number of targeted anticancer therapeutic proteins using granzyme B as the payload and demonstrated potent anti-tumor killing in preclinical studies. The many, distinct advantages of using human GrB over conventional toxins are lower systemic toxicity and, therefore, a greater therapeutic index compared to other targeted therapeutic agents, and impressive biological activity without release of GrB from the antibody. The GrB payload has three distinct mechanisms of action resulting in cell death at nanomolar concentrations in cell culture. In vivo studies with GrB-based therapeutics show excellent antitumor efficacy in tumor xenograft models. H2Biologics has entered into a Sponsored Research Agreement with the Clayton Foundation to sponsor additional pre-clinical research under the direction of Dr. Rosenblum. Manufacturing of the designed constructs is expected to begin in January 2016.

H2Biologics will initially evaluate mesotheliomas in preclinical and clinical studies and later expand this evaluation to pancreatic, lung, and ovarian cancers that also express the target mesothelin. The anticipated safety and therapeutic advantages of this human antibody – human serine protease conjugate over other antibody-drug agents in development are minimal or no immunogenicity and toxicity and additive or synergistic effect of its multiple mechanisms of action when used in combination with other immunotherapeutics.

About H2Biologics Inc.
H2Biologics is a startup biotechnology company focusing on the in-licensing, development, and manufacture of targeted immunotherapeutics for the treatment of cancers with unmet needs. It leverages the experience of its team in design, manufacture, and development of improved therapeutic biologics.

About Research Development Corporation
Research Development Foundation is a non-profit supporting organization of the Clayton Foundation for Research and is responsible for filing patents and licensing intellectual property arising from medical discoveries made by the Clayton Foundation. The Foundation conducts or funds medical research programs at leading universities, hospitals and research institutions such as the University of Texas M.D. Anderson Cancer Center.