Out of Q BioMed’s four drug candidates, Strontium-89 — an injection which treats painful bone metastasis — is the most advanced and is ‘revenue ready,’ with the Food and Drug Administration having already approved it.
Analysts at Brookline Capital Markets expect the commercial launch of the generic drug in the third quarter of this year, claiming there is a “huge clinical/medical need for effective pain palliation.”
In an update on Thursday, Q BioMed said it is "working hard" to commercialize both its Strontium-89 products.
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“In addition to the global exclusive license to generic Strontium-89 from BioNucleonics Inc, we accelerated our global commercial launch by purchasing the Metastron (Strontium-89) brand from GE Healthcare in November of 2018,” said the company.
As a result, the company said it now controls “significant” market share for the injectable non-opioid metastatic cancer palliation drug in North America and much of the world.
The company said Metastron is approved for sale in 22 countries as a non-opioid therapy for acute pain associated with metastatic skeletal cancer.
As part of the Metastron acquisition, the company will move manufacturing to another facility and has selected IsoTherapeutics as the contract manufacturer.
"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," said Q BioMed CEO Denis Corin. "Our Strontium-89 products are our lead revenue opportunities and important for both Q BioMed and the patients that will benefit from having access to the non-opioid palliation treatments.”
Revenue in 2019
Corin said that once the FDA approves IsoTherapeutics Group LLC, it is “well positioned to generate revenues in 2019 and beyond."
The company’s contract manufacturer expects to complete the final site modifications required by the FDA by the end of the month, after which, a follow up review may be required to approve the application.
In anticipation of the approval, the company said it has on-boarded a commercial team which is disseminating medical information, and focusing on government contracting, marketing, contract sales and tele-sales.
Distribution tied up
The company said it had selected a distribution partner with capabilities including warehousing/inventory management, invoicing and customer service/ordering.
“We have completed a reimbursement landscape and set our pricing strategy,” said Corin. “Our scientific platform is complete which is informing a creative advertising campaign to coincide with the commercial launch of our product.”
The company said it is assembling a scientific advisory board to assist with market access and phase four clinical trial planning.
With more than 2 million 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. A single dose of Metastron can provide pain relief for up to six months and reduce or even eliminate the need for opioid therapy.
The company said in a statement that it remains “confident” about bringing a “Strontium-89 product to market this year.”
Contact Uttara Choudhury at [email protected]