Prior Approval Supplement Filing Under GDUFA Guidelines is Final Step in Approval Process
NEW YORK, Aug. 20, 2018 /PRNewswire/ -- Q BioMed Inc. (QBIO) (QBIO), a commercial stage biotechnology acceleration development company, and BioNucleonics, licensor of Strontium 89 Chloride, announce submission of a supplemental regulatory filing to the FDA for the approval of a new manufacturing facility. Once cleared by the FDA, the facility will be permitted to manufacture Strontium Chloride Sr89 Injection USP in accordance with cGMP. Strontium Chloride Sr89 Injection USP is an FDA-approved non-opioid injectable radiopharmaceutical indicated to relieve cancer bone pain in patients with painful skeletal metastases.
Oncologic bone pain palliation is an area of increasing unmet need. Advances in cancer treatments and earlier diagnosis have extended survival in patients with breast and prostate cancers, with patients living an average of 2 to 3 years after a diagnosis of bone metastasis. It has been estimated that 65% to 75% of patients with breast or prostate cancer will develop bone metastases; and lung, along with bladder and thyroid cancer frequently metastasize to bone. Data suggest that approximately 75% of patients with bone metastases complain of pain as their main symptom and as the dominant reason for a decreased quality of life.
Sr-89 is an effective, safe, non-narcotic analgesic alternative for the treatment of patients with painful skeletal metastases. Numerous studies have demonstrated significant palliative benefit in the management of painful bone metastases. Treatment with Sr89 has led to a significant improvement in quality of life for patients with metastatic bone disease associated with breast, lung and prostate cancer and has been demonstrated to reduce or eliminate the need for opioids.
Sr89 works by delivering radiation local to the bone metastases that results in pain relief by selectively targeting and accumulating in metastatic bone lesions with minimal risk of toxicity to surrounding normal tissue. Unlike many other therapies that demand that patients make repeated visits to hospitals for a course of treatment, Strontium Chloride Sr89 Injection is administered in a single visit and offers pain relief that can last for 3 months or more. Decades of use have shown it to be safe and tolerable. Sr89 is covered under most insurance plans, including Medicare.
QBioMed CEO, Denis Corin said, "This comprehensive filing required by the FDA is the final step in what has been a long process. Our U.S. based contract manufacturing facility is uniquely equipped for the complex manufacturing of this product, and we will be ready to make the product available on approval. We will be the only commercial manufacturer of this drug in the U.S. and look forward to serving and growing the market for years to come. We believe this proven therapy has been vastly underutilized and can substantially improve the quality of the lives of those afflicted by this very painful cancer metastases. We believe there are approximately 280,000 people currently living with metastatic bone disease in the US alone, in addition to many thousands of cancer patients who will develop skeletal metastases every year as a result of their disease progression. This represents a significant market for us and an opportunity to improve the lives of many people and their families and caregivers."
Please visit www.strontium89.com for more information.
About Q BioMed Inc.
Q BioMed, Inc. is a biomedical acceleration and development company. We are focused on licensing and acquiring biomedical assets across the healthcare spectrum. Q BioMed is dedicated to providing these target assets the strategic resources, developmental support and expansion capital they need to meet their developmental potential so that they can provide products to patients in need.
About Strontium Chloride Sr89 Injection USP
INDICATIONS AND USAGE: Strontium Chloride Sr-89 Injection USP, is indicated for the relief of bone pain in patients with painful skeletal metastases. The presence of bone metastases should be confirmed prior to therapy.
CONTRAINDICATIONS: None known.
WARNINGS: Use of Strontium Chloride Sr89 Injection USP in patients with evidence of seriously compromised bone marrow from previous therapy or disease infiltration is not recommended unless the potential benefit of the treatment outweighs its risks. Bone marrow toxicity is to be expected following the administration of Strontium Chloride Sr89 Injection USP, particularly white blood cells and platelets. The extent of toxicity is variable. It is recommended that the patient's peripheral blood cell counts be monitored at least once every other week. Typically, platelets will be depressed by about 30% compared to pre-administration levels. The nadir of platelet depression in most patients is found between 12 and 16 weeks following administration of Strontium Chloride Sr89 Injection USP. White blood cells are usually depressed to a varying extent compared to pre-administration levels. Thereafter, recovery occurs slowly, typically reaching pre-administration levels six months after treatment unless the patient's disease or additional therapy intervenes. In considering repeat administration of Strontium Chloride Sr89 Injection USP, the patient's hematologic response to the initial dose, current platelet level and other evidence of marrow depletion should be carefully evaluated. Verification of dose and patient identification is necessary prior to administration because Strontium Chloride Sr89 Injection USP delivers a relatively high dose of radioactivity.
This press release may contain "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements include, but are not limited to, any statements relating to our growth strategy and product development programs and any other statements that are not historical facts. Forward-looking statements are based on management's current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from those currently anticipated are: inspection of the proposed third-party manufacturing facility by the FDA or other comments or requests from the FDA in connection with the above mentioned regulatory filing; failure of the proposed third-party manufacturing facility to pass an inspection by the FDA; regulatory risks; risks related to our growth strategy; risks relating to the results of research and development activities; our ability to obtain, perform under and maintain financing and strategic agreements and relationships; uncertainties relating to preclinical and clinical testing; our dependence on third-party suppliers; our ability to attract, integrate, and retain key personnel; the early stage of products under development; our need for substantial additional funds; government regulation; patent and intellectual property matters; competition; as well as other risks described in our SEC filings. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law.
Q BioMed Inc.