NEW YORK, November 28, 2018 /PRNewswire/ --
Cancer is one of theleading causes of morbidity and mortality globally. In 2015, cancer was the second leading cause of death worldwide, accounting for 8.8 million deaths. Within the next two decades, cancer-related cases are projected to increase by 70%. The rising number
Cancer therapy treatments have rapidly evolved over time, helping patients effectively combat the ailment. Despite the increasing number of cancer therapies, cancer-related cases are still growing at a swift pace, and this is causing companies to continually conduct R&D initiatives. Currently, there are many cancer therapies commercially available to patients, but there are still many more undergoing clinical trials and awaiting the U.S. Food and Drug Administration's approval. "Precision medicine - tailoring treatments to each patient - will continue to evolve over the next decade. But in order for precision medicine to improve more quickly, widespread sharing of cancer research data is essential to accelerate our collective experience and knowledge. In particular, the cancer field needs accurate progression-free survival data that accounts for all therapy options for each patient's tumor. In addition, researchers need to adopt a standardized approach to analyzing molecular data from patients in clinical trials and share this data widely and in real time. We also need clinical trials that suit each patient's tumor so we can improve on the status quo of clinical outcomes. And, importantly, scientists and cancer patients need to engage in ongoing conversations about the state of cancer care and what more needs to be done," said Wafik El-Deiry, M.D., Ph.D., Fox Chase Cancer Center.
Q BioMed Inc. (OTCQB: QBIO) announced breaking news earlier today that, "it has entered into agreement to acquire the metastatic skeletal cancer palliation drug, Metastron™, from GE Healthcare.
The agreement gives Q BioMed ownership of the brand, trademarks and market authorizations in 22 countries. In addition, all historical and current sales and distribution data related to those market authorizations will be assigned or transferred to Q BioMed to allow for as seamless a transition as possible in all markets.
Q BioMed CEO Denis Corin said of the deal, 'This is a major deal for Q BioMed. Strategically, it affirms our belief in this drug as an effective and underutilized non-opioid therapy for the treatment of debilitating pain associated with skeletal cancer metastases. Importantly, as we enter this market, we will now have access to all information related to Metastron in 22 countries in which the drug is already approved for sale.' Mr. Corin continued, 'This gives us a tremendous springboard to accelerate our revenue potential and establishes a formidable barrier to entry as we grow this market. With regards to the market, it is important to note that our focus is not on the short-term horizon, but rather on the long-term strategic initiative as we look 2 and 5 years down the road at expanding the therapeutic scope for the drug.'
The acquisition agreement with GE Healthcare covers the purchase of the radiopharmaceutical drug Metastron™ and all related intellectual property (IP) including, but not limited to the brand, sales and distribution data, patent, trademark and market authorizations for Metastron in 22 countries in exchange for an undisclosed upfront payment, one milestone payment based on sales and a single digit royalty for 15 years. The first commercial sale of Metastron is expected to occur after the successful transfer or assignment of all IP, material sales and distribution data, technical transfer and establishment of manufacturing capabilities to be made by Q BioMed under the appropriate regulatory filings required by the jurisdictions in which Metastron is sold. The complete transfer and establishment of approved manufacturing facilities will take several months with the relevant international health authorities.
Q BioMed looks forward to updating shareholders and all stakeholders as we advance through the transaction and more importantly, we look forward to providing this drug to the thousands of patients around the world who may depend on it well into the future.
Please visit http://www.QBioMed.com and sign up for regular updates and additional information and see our 8-K filed today."
Merck & Co., Inc. (NYSE: MRK), a leading global biopharmaceutical company known as MSD outside of the United States and Canada, has been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. AstraZeneca and Merck recently announced that the U.S. Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) for priority review for the approval of LYNPARZA tablets as a maintenance treatment in patients with newly-diagnosed, BRCA-mutated (BRCAm) advanced ovarian cancer who were in complete or partial response following first-line standard platinum-based chemotherapy. A Prescription Drug User Fee Act (PDUFA) date is set for the first quarter of 2019. This is the first U.S. regulatory submission acceptance for a poly ADP-ribose polymerase (PARP) inhibitor in the first-line maintenance setting for advanced ovarian cancer, and, if approved, will be the fourth indication for LYNPARZA in the U.S. LYNPARZA is a first-in-class PARP inhibitor approved in the U.S. since 2014. LYNPARZA has a broad clinical development program and AstraZeneca and Merck are working together to deliver LYNPARZA as quickly as possible to more patients across multiple cancer types.
Bristol-Myers Squibb (NYSE: BMY) is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. Bristol-Myers Squibb Company recently announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency adopted a positive opinion recommending approval of the Opdivo (nivolumab) plus low-dose Yervoy (ipilimumab) combination to include first-line treatment for patients with intermediate- and poor-risk advanced renal cell carcinoma (RCC). This recommendation will now be reviewed by the European Commission (EC), which has the authority to approve medicines for the European Union (EU). "There remains a high unmet medical need for patients with advanced renal cell carcinoma," said Arvin Yang, M.D., Ph.D., Development Lead, melanoma and genitourinary cancers, Bristol-Myers Squibb. "We are encouraged by today's positive opinion from the CHMP and look forward to potentially bringing the first Immuno-Oncology combination therapy to appropriate RCC patients across the EU."
Gilead Sciences, Inc. (NASDAQ: GILD) is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. Gilead Sciences, Inc. and Tango Therapeutics, Inc., a company focused on the discovery and development of novel cancer therapies, recently announced a global strategic collaboration to discover, develop and commercialize a pipeline of innovative targeted immuno-oncology treatments for patients with cancer. Under the multi-year collaboration, Tango will perform target discovery and validation and Gilead will have options to worldwide rights on up to five targets emerging from Tango's proprietary functional genomics-based discovery platform. For two programs directed to these targets, Tango will retain the option to co-develop and co-detail in the U.S. The collaboration does not include Tango's lead programs, for which Tango will retain all rights. "Tango has built a unique discovery platform that we hope will help create the next generation of cancer therapies," said John McHutchison, AO, MD, Gilead's Chief Scientific Officer and Head of R&D. "Our collaboration will combine Tango's innovative discovery technology alongside Gilead's drug discovery and development capabilities to build a pipeline of novel immuno-oncology therapies."
Exact Sciences Corp. (NASDAQ: EXAS) is a molecular diagnostics company focused on the early detection and prevention of the deadliest forms of cancer. Exact Sciences Corp. and Pfizer Inc. (NYSE: PFE) recently announced an agreement through 2021 to co-promote Cologuard, the first and only FDA-approved non-invasive stool DNA screening test for colorectal cancer. Pfizer will join Exact Sciences' sales representatives in reaching both physicians and health systems and will also actively participate in extending and deepening the Cologuard marketing campaign. Colorectal cancer is recognized as the most preventable yet least prevented form of cancer and remains the second leading cause of cancer death in the U.S., with more than 50,000 deaths each year. Nine out of 10 people survive more than five years when colorectal cancer is diagnosed in Stages I or II, but only one out of 10 people survive more than five years when the disease is diagnosed in Stage IV. While patient outcomes can be improved through early detection, fewer than two-thirds of people are up-to-date with recommended colorectal cancer screening guidelines. "This partnership marks a turning point in the fight to end colorectal cancer," said Kevin Conroy, chairman and Chief Executive Officer of Exact Sciences. "Pfizer is joining Exact Sciences' mission of eradicating colorectal cancer by helping detect the disease at its earliest, most treatable stages. Together we can help reduce the prevalence of colorectal cancer by combining the power of Cologuard and the talented Exact Sciences team with Pfizer's experience, relationships and resources."
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