Q BioMed Inc (OTCMKTS:QBIO) announced Wednesday that the US Food and Drug Administration has cleared its contract manufacturer IsoTherapeutics Group LLC to produce the company’s non-opioid cancer bone pain drug Strontium-89 Chloride USP.
The long-awaited approval of the facility means that this important oncologic pain drug will soon be available to patients in the US and the rest of the world, according to a statement.
Following the milestone announcement, the company's stock rocketed 343% higher to close at $1.62 a share on the over-the-counter markets.
Q BioMed is now the only FDA-approved source for this drug in the western world. The company meanwhile is activating its planned commercial operations to support marketing, sales, and distribution in the US and, soon, in the rest of the world.
Strontium-89 is a non-opioid radiopharmaceutical indicated for the treatment of painful skeletal metastases caused by cancer. The product is administered intravenously once every three months as an alternative to opioid analgesics and plays a critical role in the treatment of metastatic bone pain.
The product has a long history of providing well-documented and significant pain relief for patients suffering from the excruciating pain associated with primary cancers that have spread to the bone, including breast, prostate, lung and others.
Q BioMed said now is an ideal time to be launching Strontium-89, given the current concerns with the over-use of opioid drugs. In addition, as more therapies come to market for the treatment of primary cancers, more people are living longer with metastatic disease.
It is estimated that about 2 million patients experience debilitating bone pain from metastatic disease. The opportunity to provide significant pain relief to this group is substantial.
"We have been anticipating this critical regulatory step for a long time, certainly longer than we hoped, but we are thrilled that we can now move forward with certainty,” said CEO Denis Corin. “This is the start of a new chapter in the evolution of our company, and we are looking forward to serving the needs of thousands of patients suffering from metastatic bone pain, providing them the chance to minimize their pain and positively impact life with metastatic disease.
"With millions of potential patients around the world, this is a major market opportunity for our company. In addition, we are investigating and planning expansion trials to provide additional indications for the drug and entry into an even larger therapeutic market."
The New York City-based company will provide shareholders and those awaiting the drug's availability an update in the next 60 days.
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