NEW YORK, July 11, 2019 (GLOBE NEWSWIRE) — Q BioMed Inc. (OTCQB: QBIO), a commercial stage biotech company, is pleased to announce the latest updates on its non-opioid therapy for the debilitating pain associated with metastatic skeletal cancer. ™
We have been working hard to commercialize both our Strontium-89 products. In addition to the global exclusive license to generic Strontium-89 from BioNucleonics Inc. (“BNI”), we accelerated our global commercial launch by purchasing the MetastronTM brand from GE Healthcare in November of 2018. As a result, we now control significant market share for this injectable non-opioid metastatic cancer palliation drug in North America and much of the world. MetastronTM is approved for sale in 22 countries as a non-opioid therapy for the debilitating pain associated with metastatic skeletal cancer. As part of the MetastronTM acquisition, we agreed to transition manufacturing to another facility and chose IsoTherapeutics to be that manufacturer in parallel with our Strontium-89 product.
“The FDA approval of IsoTherapeutics to produce a commercial drug product is one of several milestone catalysts we expect to positively impact our business over the next few months,” stated Q BioMed CEO Denis Corin. “Our Strontium-89 products are our lead revenue opportunities and an important step for both Q BioMed and the many patients that will benefit from finally having access to the non-opioid palliation treatments. Once the FDA approves IsoTherapeutics Group LLC, this radiopharmaceutical is well positioned to generate revenues in 2019 and beyond.”
Although the commercial manufacturing approval process has taken longer than anticipated, we are now more confident than ever in the timing around the commercial launch. Our contract manufacturer expects to complete the final site modifications required by the FDA after its recent inspection by the end of the month, after which, a follow up review may be required to approve the application.
In anticipation of the approval, we have on-boarded our commercial team tasked with infrastructure set-up, including: medical information and pharmacovigilance, government contracting, marketing, contract sales and telesales. Our distribution partner has been identified with capabilities including warehousing/inventory management, invoicing and customer service/ordering. It also has a sales team that calls on major providers, a national network of nuclear pharmacies in the U.S. and distribution and coverage throughout the U.S. We have completed a reimbursement landscape and set our pricing strategy. Our scientific platform is complete which is informing a creative advertising campaign to coincide with the commercial launch of our product. We are assembling a world class scientific advisory board specific to this product to assist in market access and phase 4 clinical trial planning.
With more than 2,000,000 people affected by painful metastatic disease and over 100,000 new incidences a year, Metastron is a substantial opportunity for Q BioMed. There are very few treatment options for patients suffering from severe pain associated with metastatic cancer in the bone and particularly those with multiple lesions. These patients are often treated with multiple doses of opioids every day. A single dose of Metastron (Strontium-89) can provide pain relief for up to six months and reduce or even eliminate the need for opioid therapy. We believe this drug is an important, but somewhat neglected tool in the hands of oncologists and radio-oncologists and we believe the availability and marketing of these products will be well-received and supported, especially those that have had previous successful outcomes.
As disclosed earlier this year, the licensor, BioNucleonics Inc. (“BNI”), of our generic Strontium-89 product refused to transfer outright ownership of the amended new drug application after we performed fully on our obligations. We determined that only a court order would successfully compel BNI to perform and we are confident that will occur in 2019. Thankfully, the BNI legal activity has had no material impact on the timing around the approval of our contract manufacturer, IsoTherapeutics Group LLC to be a producer of a commercial drug product. We expect that process to be completed shortly. Thus, we remain confident in bringing a Strontium-89 product to market this year.
Our Strontium-89 radiopharmaceutical drug products are expected to begin generating revenue this year in the cancer pain palliation market, with a significant opportunity to expand into a much larger market through our planned phase IV clinical trial designed to expand the label from a pain palliation to a cancer therapeutic. A similar radiopharmaceutical with a much narrower indication in metastatic disease, but with survival benefits (two months), was acquired by Bayer for $2.9 billion in 2013 and will have sales exceeding $700,000,000 this year.
The acquisition of Metastron has given Q BioMed access to a global market much sooner than expected and we continue to be extremely excited about its prospects to re-establish a deserved niche in the late stage cancer treatment landscape.
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; strategic resources, developmental support, and expansion capital to ensure they meet their developmental potential, enabling them to provide products to patients in need.
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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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