“In the near-term, Q BioMed Inc.(OTCMKTS: QBIO) has multiple shots on goal with respect to market share, revenue and profit in the multi-billion dollar glaucoma market,” says former Piper Jaffray analyst and mutual fund manager Rob Goldman, who now heads up Goldman Small Cap Research.
Just weeks after the company announced that it had exercised its option to exclusively license GDF15, a diagnostic marker for determining the severity of glaucoma using the expression levels of Growth Differentiation Factor 15 (GDF15) from the Washington University in St. Louis, the firm’s CEO has confirmed that his commercial stage biotechnology acceleration development company is expecting near-term development and approval for both their diagnostic and therapeutic product candidates.
“Strategically combining the GDF15 Biomarker and the kit with our MAN-01 treatment for glaucoma provides a unique product offering for our patients and our clinicians to really combine both the measurement and diagnosis of the disease with an effective therapy,” said CEO Dennis Corin while taping an upcoming video interview with Street Innovators set to be released publicly later this week. “With 70 million people around the world suffering from the disease today and that number expected to grow, having a tool like this to be made available sort of ubiquitously to all of those patients and the physicians that are treating glaucoma represents a very significant opportunity for us. We’re really excited about building this out over the next several months and getting an FDA approval for that over the next year and a half or so.”
Currently, no single examination or diagnostic test is able to accurately predict disease progression and physicians only have surrogate measures to evaluate glaucomatous neurodegeneration.
“We believe that current diagnostic tools like to tonometry- which is that little puff of air that gets blown into your eye when you have an eye exam- don’t really provide a very precise measurement or diagnosis of glaucoma itself at a cellular level,” explained Corin. “And with the discovery of this new biomarker GDF15 and the subsequent kits that we’re developing does do is provide an in-depth a very precise look at the cellular destruction that’s occurring inside the eye as the disease progresses. So this is a really important development and really brings precision medicine into the hands of the clinicians and the physicians treating these patients and allows them to accurately and precisely measure the disease progression by monitoring how those cells are responding or dying within the eye.”
Analysts believe that the emerging biotechnology firm is now a unique player on the path to offering a series of firsts. “QBIO is leading innovation in the lucrative ophthalmology segment, which carries high price/revenue multiples,” says Goldman in a recent analysis of the company.
GDF15 represents an attractive biomarker for glaucoma with distinct advantages including early detection, over conventional clinical tests. It was discovered by Dr. Rajendra Apte, the Paul A. Cibis Distinguished Professor of Ophthalmology and Visual Sciences at Washington University School of Medicine.
Goldman believes that Q BioMed has a good deal of flexibility with respect to its development process and FDA clearance pathway. “It can elect to develop the kit for 510(k) FDA clearance or a PMA (Premarket Approval) designation and each pathway has its own advantages. It has been our experience that the 510(k) process tends to be faster than PMA, which means that revenue could be generated very quickly. The PMA route, while a bit longer, can sometimes provide a greater marketing and deployment boost as the underlying providers can advertise their device as PMA-approved or FDA-approved.”
Dr. George N. Nikopoulos, President & CEO Mannin Research, a Q BioMed partner company, says, “Our team is excited by the potential game-changing impact that Dr. Apte’s invention will have on the practice of treating glaucoma.”
Q BioMed aims to accelerate the monetization of biomedical technologies through rapid innovation and collaborative partnerships with industry leading researchers. Q BioMed believes its assets in oncology, vascular disease, and rare orphan diseases address unmet medical needs and large markets. The Company’s FDA approved, non-opioid drug Metastron, which relieves cancer bone pain, is expected to begin generating revenues in 2019.
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