Companies file for a new manufacturing facility for non-opioid injectable radiopharmaceutical, Sr89

Commercial stage biotechnology acceleration development company, Q BioMed, with licensor of Strontium 89 Chloride, BioNucleonics, have announced the submission of a supplemental regulatory filing for a new manufacturing facility.

The filing, which has been made to the US Food and Drug Administration (FDA), is for a facility that will manufacture Strontium Chloride Sr89 Injection USP in accordance with cGMP.

Strontium Chloride Sr89 Injection USP is a non-opioid injectable radiopharmaceutical that is indicated for the relief of cancer bone pain in patients with painful skeletal metastases that has been approved by the FDA. It works by delivering radiation local to the bone metastases that results in pain relief by selectively targeting and accumulating in metastatic bone lesions with minimal risk of toxicity to surrounding normal tissue.

Additionally, Sr89 offers a further benefit as, unlike many other therapies, it is administered in a single visit and offers pain relief that can last for three months or more. Numerous studies have demonstrated significant palliative benefit in the management of painful bone metastases. Treatment with Sr89 has led to a significant improvement in quality of life for patients with metastatic bone disease associated with breast, lung and prostate cancer and has been demonstrated to reduce or eliminate the need for opioids.

“This comprehensive filing required by the FDA is the final step in what has been a long process,” said QBioMed CEO, Denis Corin. “Our US based contract manufacturing facility is uniquely equipped for the complex manufacturing of this product, and we will be ready to make the product available on approval. We will be the only commercial manufacturer of this drug in the US and look forward to serving and growing the market for years to come.

“We believe this proven therapy has been vastly underutilised and can substantially improve the quality of the lives of those afflicted by this very painful cancer metastases. We believe there are approximately 280,000 people currently living with metastatic bone disease in the US alone, in addition to many thousands of cancer patients who will develop skeletal metastases every year as a result of their disease progression. This represents a significant market for us and an opportunity to improve the lives of many people and their families and caregivers.”