NEW YORK, Nov. 20, 2019 /PRNewswire/ -- In 2019, the American Cancer Society is estimating a total of 1.76 million new cancer cases and 606,880 cancer-related deaths in the U.S. The National Cancer Institute expects prostate, lung, breast, and colon/rectal cancer to account for the majority of the new estimated cases. Generally, most cancer patients undergo some type of therapy, whether it is chemotherapy or immunotherapy, and while these therapies can increase the survivability of a patient, there are several drawbacks. One of the most common symptoms associated with cancer therapy is chronic pain. Additionally, pain can also result from the cancerous tumor itself by pushing onto bones, nerves, or other organs. And according to Cancer Research UK, typically 30% to 60% of cancer patients deal with some sort of pain. Meanwhile, up to 90% of patients suffering from advanced cancer face similar pain management issues. Overall, the pain resulting from cancer can severely impact daily life activities such as typical day-to-day jobs, eating, and even sleeping. Most patients are also typically prescribed some sort of opioid-based painkillers, which is used to suppress the pain. However, opioids can also cause adverse effects; opioid painkillers such as morphine and oxycodone are commonly prescribed to cancer patients dealing with pain. Consequently, many patients tend to develop a dependency on opioids. Moreover, side effects associated with opioids includes dizziness, respiratory issues, and depression. And long-term effects can cause life-threatening issues to internal organs such as kidney failure. As a result, pharmaceutical companies have manufactured non-opioid or non-narcotics to help control or suppress pain. Some non-opioid medications can be purchased over-the-counter, however, stronger dosages may require a prescription. And according to data compiled by Mordor Intelligence, the global cancer therapy market was valued at USD 136.25 Billion in 2018. By 2024, the market is expected to reach USD 220.70 Billion while expanding at a CAGR of 8.37%. Q BioMed Inc. QBIO, Bayer A.G. BAYRY, Novartis AG NVS, Eli Lilly and Company LLY, AbbVie Inc. ABBV
The American Cancer Society mentioned that patients should never accept pain as a normal part of having cancer. The organization said that patients should work with their medical physicians in order to control or lessen the pain as much as possible. Generally, the most common forms of pain are spinal cord compression and bone pain. Spinal cord compression is when a tumor spreads to the spine and presses onto the nerves of the spinal cord. Mild symptoms associated with spinal cord compression are usually back or neck pains. In severe instances, the matter can cause excruciating pain, numbness, or weakness in the arms and legs. The American Cancer Society stated that patients should immediately treat spinal cord compression because it can result in the loss of control over the bladder and bowels or ultimately even lead to paralyzation. On the other hand, bone pain is caused when cancer starts or spreads into the bones. Typically, treatment is aimed towards regulating cancer from affecting other parts of the body. Patients are often prescribed opioids as a common painkiller, but the adverse effects have prompted many to turn against the use of opioids. In fact, the National Cancer Institute highlighted that many oncology care providers relied heavily on opioids. Now, some primary care doctors no longer prescribe opioids, while some insurance companies have made it increasingly more difficult to obtain these medications. And as a result, more and more prescribers have been reluctant to introduce opioids and are now exploring different alternatives such as therapy or non-opioid drugs. "We providers have to educate our patients to help them understand that the role of opioids and other pain medications is to allow them to move and function better," said the National Cancer Institute. "For some people, that may mean being able to walk around the block. For some, controlling the pain will allow them to return to work. And for those patients who are more fragile, the goal of pain medications may be to make them sufficiently comfortable to be able to hold their grandkids, or to sit comfortably on a hard chair in a church or restaurant."
Q BioMed Inc. QBIO announced breaking news this morning that, "FDA approval of its contract manufacturer IsoTherapeutics Group LLC (ITG). ITG is now cleared to manufacture the Company's FDA approved non-opioid cancer bone pain drug Strontium-89 Chloride USP.
The long-awaited approval of the facility means that this important oncologic pain drug will soon be available to patients in the US and the rest of the world. Q BioMed is now the only FDA-approved source for this drug in the western world. The Company is activating its planned commercial operations to support marketing, sales, and distribution in the US and, soon, in the rest of the world.
Strontium-89 is an FDA-approved non-opioid radiopharmaceutical indicated for the treatment of painful skeletal metastases caused by cancer. The product is administered intravenously once every three months as an alternative to opioid analgesics and plays a critical role in the treatment of metastatic bone pain. The product has a long history of providing well-documented and significant pain relief for patients suffering from the excruciating pain associated with primary cancers that have spread to the bone, including breast, prostate, lung and others. This is the ideal time to be launching Strontium-89 given the current concerns with the over-use of opioid drugs. In addition, as more therapies come to market for the treatment of primary cancers, more people are living longer with metastatic disease. It is estimated that approximately two million patients experience debilitating bone pain from metastatic disease. The opportunity to provide significant pain relief to this group is substantial.
QBioMed CEO Denis Corin said, "We have been anticipating this critical regulatory step for a long time, certainly longer than we hoped, but we are thrilled that we can now move forward with certainty. This is the start of a new chapter in the evolution of our company, and we are looking forward to serving the needs of thousands of patients suffering from metastatic bone pain, providing them the chance to minimize their pain and positively impact life with metastatic disease. With millions of potential patients around the world, this is a major market opportunity for our company. In addition, we are investigating and planning expansion trials to provide additional indications for the drug and entry into an even larger therapeutic market."
We look forward to updating our shareholders and those awaiting the drug availability in the next 60 days."
About Q BioMed Inc: Q BioMed Inc. is a biotech acceleration and commercial stage company. We are focused on licensing and acquiring undervalued biomedical assets in the healthcare sector. Q BioMed is dedicated to providing these target assets with strategic resources, developmental support, and expansion capital to ensure they meet their developmental potential, enabling them to provide products to patients in need. Please visit http://www.QBioMed.com and sign up for regular updates."
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Bayer A.G. BAYRY is a global enterprise with core competencies in the life science fields of health care and nutrition. Its products and services are designed to benefit people by supporting efforts to overcome the major challenges presented by a growing and aging global population. Of Bayer's products, the drug Xofigo™ (active ingredient: radium-223 dichloride) is approved in the E.U. and the United States for the treatment of adult patients with castration-resistant prostate cancer (CRPC) with symptomatic bone metastases but no known visceral metastases. In March 2016, the Japanese MHLW granted marketing authorization for Xofigo™ (radium‑223 dichloride) for the treatment of adult patients with castration-resistant prostate cancer and bone metastases.
Novartis AG NVS is reimagining medicine to improve and extend people's lives. Novartis recently announced the US Food and Drug Administration has approved Piqray® in combination with fulvestrant for the treatment of postmenopausal women, and men, with hormone receptor positive, human epidermal growth factor receptor-2 negative, PIK3CA-mutated, advanced or metastatic breast cancer, as detected by an FDA-approved test following progression on or after an endocrine-based regimen. PIK3CA is the most commonly mutated gene in HR+/HER2- breast cancer; approximately 40% of patients living with HR+/HER2- breast cancer have this mutation. PIK3CA mutations are associated with tumor growth, resistance to endocrine treatment and a poor overall prognosis. Piqray targets the effect of PIK3CA mutations and may help overcome endocrine resistance in HR+ advanced breast cancer. "The FDA approval of Piqray, which was discovered at the Novartis Institutes for BioMedical Research, marks the first ever treatment specifically for HR+/HER2- advanced breast cancer with a PIK3CA mutation. We are proud to offer a new treatment option that specifically addresses the needs of the patients living with this mutation," said Susanne Schaffert, PhD, Chief Executive Officer, Novartis Oncology. "We are grateful to our researchers' bold and unrelenting pursuit of a first-in-class treatment for this incurable disease, and to the patients, investigators and administrators who participated in the clinical trials leading to this remarkable milestone."
Eli Lilly and Company LLY is a global healthcare leader that unites caring with discovery to create medicines that make life better for people around the world. Eli Lilly and Company recently announced that results from the global Phase 3 RELAY trial of CYRAMZA® in previously untreated patients with metastatic EGFR-mutated non-small cell lung cancer were published in The Lancet Oncology. In the RELAY study, treatment with CYRAMZA in combination with erlotinib demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) – the time patients lived without their cancer growing or spreading after starting treatment – compared to erlotinib alone. The CYRAMZA-erlotinib combination achieved a median PFS of 19.4 months, corresponding to a seven-month improvement over erlotinib alone. There were no new safety signals and the safety profile observed in the trial was consistent with what has been previously observed for CYRAMZA in other Phase 3 clinical trials and the established safety profile of erlotinib. "The RELAY data are the strongest clinical evidence to date for targeting both the EGFR and VEGFR pathways to treat this type of cancer. We're excited by these results and the promise they may hold for metastatic non-small cell lung cancer patients with an EGFR mutation," said Maura Dickler, M.D., Vice President of late phase development, Lilly Oncology. "The RELAY trial is another example of Lilly's deep commitment to providing new treatment options to people with lung cancer, and the value that CYRAMZA can provide in advanced or metastatic cancers."
AbbVie Inc. ABBV is a global, research and development-based biopharmaceutical company committed to developing innovative advanced therapies for some of the world's most complex and critical conditions. AbbVie recently announced that it had acquired Seattle-based Mavupharma, a privately held biopharmaceutical company focused on novel approaches to target the STING (STimulator of INterferon Genes) pathway for the treatment of cancer. STING pathway signaling plays an important role in the generation of an immune response directed at tumors, and enhancing STING signaling has shown promise in a variety of tumor models. STING pathway stimulation has the potential to increase the susceptibility of tumors and broaden treatment options for patients. "AbbVie's vision in oncology is to advance breakthrough areas of science leading to a strong pipeline of innovative cancer therapies," said Steve Davidsen, Ph.D., Vice President of oncology discovery, AbbVie. "Mavupharma's platform has the potential to further our immuno-oncology portfolio and assist in the development of transformative medicines for patients."
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