5-year contract makes Strontium89 available to over 9 million VA beneficiaries
NEW YORK, March 2, 2021 - Q BioMed Inc. (OTCQB: QBIO), a commercial stage biotech company, announced today that it has signed an agreement for Strontium89 (Strontium Chloride Sr-89 Injection, USP) to be included on the Federal Supply Schedule ("FSS"). The agreement provides U.S. veterans and other federal government agencies access to Strontium89 for eligible patients. The final FSS contract is effective March 1, 2021 and has a five-year term. The FSS contract will extend access to Strontium89 to over nine million VA beneficiaries and others within the federal system.
Veterans are at higher risk for prostate, breast, and lung cancer, the three most common cancers treated with Strontium89 if they become painfully metastatic to the bone. In fact, prostate cancer rates in the military are twice those in the general population[1] and military personnel were found to be nearly 40 percent more likely to develop breast cancer[2]. Now these patients will be able to benefit from Strontium89 treatment for their metastatic bone pain.
In the Strontium89 pivotal trial, as many as 79% of patients had pain relief with Strontium89, and twice as many patients treated with Strontium89 had no pain for 3 months compared with placebo. Further, new pain sites were less frequent in patients treated with Strontium89[3] [4]. Strontium89 is administered once every 3 months via injection, and patients can be re-treated if needed. Please see Important Safety Information below.
Q BioMed is preparing commercially to serve the U.S. Department of Veterans Affairs (VA) and Department of Defense (DoD) with activities that include a VA sales force, formulary and market access, medical education, and marketing. Efforts will begin in March 2021 and build throughout the year as the FSS agreement is translated to clinical use.
“Q BioMed is very encouraged by this important milestone. This agreement further extends the commercial reach of Strontium89 to eligible adult patients suffering pain from metastatic bone cancer in the VA and other federal agencies," said Q BioMed CEO Denis Corin. "Q BioMed is committed to helping those who serve and have served their country and their families. It is our hope that, through this agreement, we can make a positive impact on the lives of veterans affected by cancer."
Learn more at www.Strontium89.com
[1] https://zerocancer.org/get-support/zero-prostate-cancer-veterans/
[1] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2780333/pdf/nihms158630.pdf
[1] STRONTIUM CHLORIDE Sr-89 INJECTION, USP THERAPEUTIC [PI]. Angleton, TX: IsoTherapeutics Group, LLC; 2020.
[1] Porter AT, McEwan AJB, Powe JE, et al. Results of a randomized phase-III trial to evaluate the efficacy of strontium-89 adjuvant to local field external beam irradiation in the management of endocrine resistant metastatic prostate cancer. Int J Radiat Oncol Biol Phys. 1993;25(5):805-813.
INDICATIONS AND IMPORTANT SAFETY INFORMATION:
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.
WARNINGS
Use of Strontium-89 Chloride Injection 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-89 Chloride Injection, 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-89 Chloride Injection. 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-89 Chloride Injection, 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-89 Chloride Injection delivers a relatively high dose of radioactivity.
Strontium-89 Chloride Injection may cause fetal harm when administered to a pregnant woman. There are no adequate and well-controlled studies in pregnant women. If this drug is used during pregnancy, or if the patient becomes pregnant while receiving this drug, the patient should be apprised of the potential hazard to the fetus. Women of childbearing potential should be advised to avoid becoming pregnant.
PRECAUTIONS
Strontium-89 Chloride Injection is not indicated for use in patients with cancer not involving bone.
Strontium-89 Chloride Injection should be used with caution in patients with platelet counts below 60,000 and white cell counts below 2,400.
Radiopharmaceuticals should only be used by physicians who are qualified by training and experience in the safe use and handling of radionuclides and whose experience and training have been approved by the appropriate government agency authorized to license the use of radionuclides.
Strontium-89 Chloride Injection, like other radioactive drugs, must be handled with care and appropriate safety measures taken to minimize radiation to clinical personnel.
In view of the delayed onset of pain relief, typically 7 to 20 days post injection, administration of Strontium-89 Chloride Injection to patients with very short life expectancy is not recommended.
A calcium-like flushing sensation has been observed in patients following a rapid (less than 30 second injection) administration.
Special precautions, such as urinary catheterization, should be taken following administration to patients who are incontinent to minimize the risk of radioactive contamination of clothing, bed linens and the patient’s environment.
Strontium-89 Chloride Injection is excreted primarily by the kidneys. In patients with renal dysfunction, the possible risks of administering Strontium-89 Chloride Injection should be weighed against the possible benefits.
PREGNANCY
Teratogenic effects. Pregnancy Category D. See Warnings section.
NURSING MOTHERS
Because Strontium-89 Chloride Injection acts as a calcium analog, secretion of Strontium-89 Chloride Injection into human milk is likely. It is recommended that nursing be discontinued by mothers about to receive intravenous Strontium-89 Chloride Injection. It is not known whether this drug is excreted in human milk.
PEDIATRIC USE
Safety and effectiveness in children below the age of 18 years have not been established.
ADVERSE REACTIONS
A single case of fatal septicemia following leukopenia was reported during clinical trials. Most severe reactions of marrow toxicity can be managed by conventional means.
A small number of patients have reported a transient increase in bone pain at 36 to 72 hours after injection. This is usually mild and self-limiting, and controllable with analgesics. A single patient reported chills and fever 12 hours after injection without long-term sequelae.
You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.FDA.gov/medwatch or call (800) FDA-1088.
Please see full Prescribing Information for Strontium-89 Chloride Injection.
About Q BioMed Inc.
Q BioMed Inc is a biotech acceleration and commercial stage company. Q BioMed is focused on licensing and acquiring undervalued biomedical assets in the healthcare sector. Q BioMed is dedicated to providing these target assets the strategic resources, developmental support, and expansion capital needed to ensure they meet their developmental potential, enabling them to provide products to patients in need.
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Forward-Looking Statements:
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: 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.
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