On July 9, 2015 Mylan reported the U.S. launch of Bexarotene 75mg Capsules, which is the generic version of Valeant’s Targretin Capsules (Press release, Mylan, JUL 9, 2015, View Source [SID:1234506195]). This product is indicated for the treatment of cutaneous manifestations of cutaneous t-cell lymphoma in patients who are refractory to at least one prior systemic therapy.(1)

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Mylan CEO Heather Bresch commented: "Mylan’s launch of the first and only generic Targretin is another example of our commitment to expand access to high quality, more affordable medicines. The launch also strengthens Mylan’s growing oncology franchise of more than 30 approved oncology treatments, and associated supportive care and diagnostic products in the U.S. We look forward to continue meeting patient, payor and provider needs in this space."

Bexarotene 75mg Capsules had U.S. sales of approximately $155.5 million for the 12 months ending March 31, 2015, according to IMS Health.

Currently, Mylan has 270 ANDAs pending FDA approval representing $107.2 billion in annual brand sales, according to IMS Health. Forty-seven of these pending ANDAs are potential first-to-file opportunities, representing $33.3 billion in annual brand sales, for the 12 months ending December 31, 2014, according to IMS Health.
Mylan is a global pharmaceutical company committed to setting new standards in healthcare. Working together around the world to provide 7 billion people access to high quality medicine, we innovate to satisfy unmet needs; make reliability and service excellence a habit; do what’s right, not what’s easy; and impact the future through passionate global leadership. We offer a growing portfolio of around 1,400 generic pharmaceuticals and several brand medications. In addition, we offer a wide range of antiretroviral therapies, upon which nearly 50% of HIV/AIDS patients in developing countries depend. We also operate one of the largest active pharmaceutical ingredient manufacturers and currently market products in about 145 countries and territories. Our workforce of approximately 30,000 people is dedicated to creating better health for a better world, one person at a time. Learn more at mylan.com.

This press release includes statements that constitute "forward-looking statements," including with regard to sales of products and the company’s strategy, future growth and performance. These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Because such statements inherently involve risks and uncertainties, actual future results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to: the impacts of competition; changes in economic and financial conditions of the company’s business; strategies by competitors or other third parties to delay or prevent product introductions; risks inherent in legal and regulatory processes; changes in third party relationships; uncertainties and matters beyond the control of management; and the other risks detailed in the company’s filings with the Securities and Exchange Commission. The company undertakes no obligation to update these statements for revisions or changes after the date of this release.
(1) Targretin Capsules are a member of the retinoid class of drugs that is associated with birth defects in humans. Targretin Capsules must not be administered to a pregnant woman.

On July 9, 2015 DelMar Pharmaceuticals reported that the Company will be presenting updated clinical data on its lead product candidate, VAL-083, from its Phase I/II clinical trial in patients with refractory glioblastoma multiforme (GBM), the most common and deadly form of human brain cancer (Press release, DelMar Pharmaceuticals, JUL 9, 2015, View Source [SID:1234506194]).

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DelMar’s abstract entitled, "Update on Phase 1/2 study of VAL-083 (dianhydrogalactitol) in patients with recurrent malignant glioma," will be presented during a poster session at GBM2015, II International Symposium on Clinical and Basic Investigation in Glioblastoma, being held September 9 – 12, 2015, in Toledo, Spain.

In spite of recent advances in cancer care, GBM continues to be the most common and malignant primary brain tumor in adults carrying a dismal prognosis with less than 15 months median survival. The symposium is designed with a focus on clinical and basic research in this devastating disease.

DelMar recently presented interim data from the trial at the American Association of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual meeting. The Company confirmed the completion of the Phase I dose-escalation portion of the trial and presented data supporting a dose response trend: Patients receiving a dose ≥30mg/m2 had a median survival of 9.0 months vs. 4.4 months at doses <10mg/m2. DelMar also confirmed the initiation of a 14-patient Phase II expansion cohort at a dose of 40mg/m2. The purpose of the Phase II expansion cohort is to gain additional information about the safety and efficacy of VAL-083 at the 40mg/m2 dose prior to advancement into registration-directed Phase II/III clinical trials.

DelMar’s multicenter Phase I/II clinical study with VAL-083 is ongoing in patients with recurrent GBM. Eligible GBM patients must have failed both Avastin (bevacizumab) and Temodar (temozolomide) unless either of these therapies was contraindicated. (ClinicalTrials.gov Identifier NCT01478178).

About VAL-083
VAL-083 is a "first-in-class", small-molecule chemotherapeutic. In more than 40 Phase 1 and 2 clinical studies sponsored by the U.S. National Cancer Institute, VAL-083 demonstrated safety and efficacy in treating a number of cancers including lung, brain, cervical, ovarian tumors and leukemia. VAL-083 is approved in China for the treatment of chronic myelogenous leukemia and lung cancer and has received orphan drug designation in Europe and the U.S. for the treatment of gliomas.

DelMar is currently studying VAL-083 in a multi-center Phase I/II clinical trial for patients with refractory glioblastoma multiforme (GBM) in accordance with the protocol that has been filed with the U.S. Food and Drug Administration (FDA). (ClinicalTrials.gov Identifier NCT01478178). As a potential treatment for glioblastoma, VAL-083’s mechanism of action appears to be unaffected by the expression of MGMT, a DNA repair enzyme that causes chemotherapy resistance to front-line treatment with Temodar (temozolomide).

On July 9, 2015 Cancer Research UK and Cancer Research Technology (CRT) reported they have reached an agreement with Monopar Therapeutics LLC, an emerging biopharmaceutical company focused on developing orphan oncology compounds*, to take forward Monopar’s experimental antibody treatment HuATN-658 into clinical trials in cancer patients with advanced solid tumours (Press release, Cancer Research Technology, JUL 9, 2015, View Source [SID1234523204]).

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HuATN-658 is an antibody that targets the cell surface protein uPAR, which is found in high levels in some of the most deadly cancers.

Under the agreement, Cancer Research UK’s Centre for Drug Development (CDD) will finance and complete preclinical development of HuATN-658 and conduct a Phase 1 clinical trial in cancer patients. Although drug efficacy will be monitored, the trial’s main objective will be to evaluate the safety of the antibody.

The trial will be managed and run by the CDD through the Experimental Cancer Medicine Centre (ECMC) network, a UK-wide initiative funded by Cancer Research UK and the UK’s four Health Departments.

Upon completion of the clinical trial, Monopar has the right to acquire the clinical trial data. If Monopar declines the option, CRT may continue the development and commercialisation of HuATN-658 in exchange for a share to Monopar of any future revenues from the drug.

Dr Chandler D. Robinson, co-founder and CEO of Monopar Therapeutics, said: "While these are still the early days of the company, we have created a very strong team and development strategy.

"HuATN-658, our lead compound, was discovered by our chief scientific officer, Dr Andrew Mazar, one of the world’s experts on the uPAR pathway.

"The development partnership with Cancer Research UK allows Monopar to leverage a strong platform for the clinical advancement of this compound as it brings long established clinical, regulatory, and manufacturing expertise and resources that would be difficult for an emerging company to amass quickly."

Dr Nigel Blackburn, Cancer Research UK’s director of drug development, said, "We’re excited to be working with Monopar Therapeutics to take this promising new treatment a step further on its journey towards the clinic. The collaboration forms part of our Clinical Development Partnerships scheme, which aims to help progress promising treatments from drug company pipelines and bring them into early phase trials sooner. Thanks to this, six new treatments are now in clinical trials that may otherwise never have moved beyond the lab."

On July 9, 2015 Globavir Biosciences, Inc., a specialty biotechnology company developing small molecule drugs to treat cancer and infectious diseases, and Sorrento Therapeutics, Inc. (NASDAQ: SRNE), an oncology company developing new treatments for cancer and associated pain, reported that the companies have entered into an agreement under which Globavir exclusively licensed its novel oncology compound, BC001, to Sorrento Therapeutics (Press release, Globavir, JUL 9, 2015, View Source [SID1234519506]).

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"Our agreement with Sorrento Therapeutics represents the first oncology partnership for Globavir," said Dr. Shalabh Gupta, Globavir’s president and CEO. "Sorrento has a strong background in oncology and proven experience in clinical development advancing drugs to commercial stage. We are excited about the potential of BC001 as a new therapeutic option for patients affected with cancer and look forward to leveraging our computational Globavir Drug Discovery Platform (GDDP) to generate additional oncology compounds in the future."

About the partnership:
Under the terms of the agreement, Sorrento Therapeutics will be responsible for the development and commercialization of BC001 for the treatment of solid tumors. Full details of the partnership were not disclosed, but Sorrento Therapeutics participated as an equity investor in Globavir’s previous round of financing, and under the terms of partnership Globavir is entitled to $80 million in regulatory and sales milestones in addition to multi-tiered royalty payments on global net sales.

About the program:
BC001 is a new chemical entity discovered at The University of Southern California and originally licensed by Globavir. It represents an alternative and a superior approach to targeting angiogenesis, invasion and altered energy metabolism in cancers. BC001 targets hypoxia-inducible factors (HIF)-mediated signaling in a focal point of amplification in response (specifically HIF1a-p300 interaction, downstream of which multiple oncogenic targets are activated). It is known that traditional cancer therapies are often limited in their efficacy because they display toxicity to normal cells and can lead to drug-resistant tumors. Currently, there is no FDA-approved agent to target HIF.

About the compound:
Several companies are currently developing drugs that target traditional signaling and regulatory molecules such as Vascular Endothelial Growth Factors (VEGF), Platelet-Derived Growth Factors (PDGF) and Fibroblast Growth Factors (FGF), as well as transcription factors and receptor tyrosine kinases. BC001 is a different anti-angiogenic molecule, uniquely working by disrupting binding of a transcription factor to its co-factor and thereby controlling tumor growth. BC001 is therefore a highly differentiated compound with potential in oncology as well as outside the cancer setting for treating ophthalmological (macular) diseases and infectious diseases such as hepatitis B virus (HBV) and human papillomavirus (HPV).