Fully integrated commercialization model and newly appointed leadership to accelerate U.S. business
NEW YORK & CHICAGO – November 8, 2021 – Q BioMed Inc. (OTCQB: QBIO) a biotech acceleration and commercial stage company focused on licensing and acquiring undervalued biomedical assets in the healthcare sector, today announced it has engaged EVERSANA™, the pioneer of next generation commercial services to the global life sciences industry, to immediately support the commercialization of Strontium89, an FDA-approved cancer bone palliation radiotherapy.
Strontium89 (Strontium Chloride Sr-89 Injection, USP) is the only approved radiotherapy currently available in the U.S. indicated for metastatic cancer bone pain palliation. 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 three months compared with a placebo. Further, new pain sites were less frequent in patients treated with Strontium89. Strontium89 is administered once every three months via injection, and patients can be re-treated if needed. Please see Important Safety Information below.
To support and accelerate the product’s rollout in the U.S., Q BioMed will leverage the EVERSANA COMPLETE Commercialization model which fully integrates services for: market access, agency services, clinical and commercial field teams, health economics and outcomes research and compliance. Each service is optimized by data and predictive analytics.
“We are pleased to have a partner like EVERSANA leading our commercialization efforts going forward, and I believe this adds tremendous value to what we had already established. The team is passionate about obtaining deep insights into the patient journey and using this knowledge to shape the strategic and creative process needed to maximize commercial successes,” said Denis Corin, Chief Executive Officer of Q BioMed.
“Millions of patients are bearing the burden of devastating pain. We are immediately activating our commercial model to create more awareness, faster access and optimized product support for Strontium89 and its potential to change lives,” said Jim Lang, CEO of EVERSANA.
The ready-to-deploy commercial platform is complemented by more than 5,500 EVERSANA employees and a dedicated commercialization leadership team, replacing Kristin Keller who is leaving Q BioMed. The EVERSANA field force and commercial team will augment an in-place contract sales force focused on the U.S. Department of Veterans Affairs (VA) and Department of Defense (DoD).
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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 provides 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. Please visit http://www.QBioMed.com and sign up for regular updates.
EVERSANA™ is the leading provider of global services to the life sciences industry. The company’s integrated solutions are rooted in the patient experience and span all stages of the product life cycle to deliver long-term, sustainable value for patients, prescribers, channel partners and payers. The company serves more than 500 organizations, including innovative start-ups and established pharmaceutical companies, to advance life sciences solutions for a healthier world. To learn more about EVERSANA, visit eversana.com or connect through LinkedIn and Twitter.
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.
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 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.
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.
Radio pharmaceuticals 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 managed 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.
Teratogenic effects. Pregnancy Category D. See Warnings section.
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.
Safety and effectiveness in children below the age of 18 years have not been established.
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.
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.