|Imminent FDA Decision Prompts the Ignition of Q BioMed's Shares|
|Thursday, 17 January 2019 13:15|
An anticipated key FDA decision is set to transform Q BioMed (OTCMKTS: QBIO) from a biotech developer to a revenue generating manufacturer in what may be record time. That imminent event is already attracting interest from traders and investors, but a game changing plan revealed by the CEO may be an even stronger reason to focus on this emerging biotechnology accelerator.Shares of the low float innovator have been seeing quiet accumulation since the start of the New Year. This, after QBIO shares sold off with the rest of the market during the worst December since the great depression. Part of the reason bulls reportedly started buying at oversold levels may have been that long-awaited, potentially trans-formative pending approval decision announcement from FDA regulators.
In a recent interview, Q BioMed's CEO, Dennis Corin hinted that the FDA decision might be announced any day now and given the way biotech stocks with low-floats move on news and binary decision events, the temptation to own as few shares makes sense. Still, Corin's latest comments about the firm's plans for the metastatic skeletal cancer palliation drug, Metastron™- which the firm entered into agreement to acquire from GE Healthcare late last year- is what may actually end up adding exponential value to the company's shares.
When Corin was asked to acknowledge the "buzz" surrounding upcoming catalysts, he stated: "A lot of the focus over the last year or so has been on the Strontium Chloride Sr-89 Injection or Metastron™ assets because its close to commercialization and I guess the first real commercial catalyst is that we're waiting for FDA approval of the manufacturing facility in South Texas. Once that happens, we'll be in a position to start producing the drug commercially and selling it. So that's a very significant catalyst. I think a lot of people have been waiting for that and we've gone through several rounds of questions and answers with the regulators and that approval could come at any time. So we're really excited about that and looking forward to commercializing the products here and certainly in this quarter. The first quarter of 2019." Corin tempered enthusiasm about the catalyst, stating that he'd "really like to draw attention to the fact that there's so much beyond that as well."
Corin, who cut his teeth working for the sales and marketing divisons at big pharma firms like Novartis and Beckman Coulter, recognized that Metastron™ was basically being ignored by GE Healthcare as an effective and underutilized non-opioid therapy for the treatment of debilitating pain associated with skeletal cancer metastases.
The drug has been on the market for several years, but analysts agree that the global brand which has market authorization in 22 countries has been mostly under marketed and perhaps even under utilized. "The reasoning behind the acquisition of this drug," explains Corin, "is that we beleive that the patient population who are being serviced by this drug are being underserved significantly. Metastron™ is a very effective palliation drug, and as opposed to getting multiple doses of opiates- which lead to all sorts of side effects like brain fog and constipation and literally leaving some of these patients in zombie-like states, a single injection of Metastron™ or Strontium Chloride can soothe pain for up to six months and sometimes even a year. We have data that shows that this drug is being under utilized and we believe there's a huge opportunity for us to re-brand and re-introduce this drug in the market. It hasn't really been marketed for several years and it wasn't part of GE's core portfolio and quite honestly, they kind of ignored it."
Patients with terminal diseases usually need palliation. It's a kind of care that makes you feel better, even though it can't cure you. The Latin root word is palliat, or "cloaked," and palliation does in a sense cloak or mask a person's pain. Pain is the most common sign of bone cancer, and may become more noticable as the tumor grows. The pain can cause a dull deep ache in a bone or bone region (e.g. back, pelvis, legs, ribs, arms).
Corin, who also served as a Management Consultant to the executives and board of TapImmune Inc, saw an opportunity in Metastron™. He had helped transform TapImmune from its early days as a micro-cap OTCBB stock to a Nasdaq listed leader involved in the development of novel immunotherapies for cancer by making carefully calculated moves and helping license novel therapies for cancer patients which harness the patient’s own immune system to fight cancer in a natural way. Prior to announcing the deal with GE Healthcare Corin had already positioned Q BioMed to take a big bite of the Metastron™ market with their own generic version of the drug (the Strontium Chloride Sr-89 Injection), but he saw another big opportunity which could add much more value and which the markets may not have yet fully digested.
"I'd like to add that there are several studies which show overall survival benefits of this drug as well," says Corin. "There are several Phase II studies that have been done that show very significant survival benefits when used in combination with other therapeutics. This is also something that has been ignored and why we see incredible value in Metastron™ and in our program."
One Phase II trial showed a 9-month survival benefit (vs 2 months in a blockbuster competitor). There is already talk of a planned Q BioMed led Phase IV trial to confirm this data. Positive results would exponentially increase potential revenue for the company and its shareholders.
"Our intention here, is to take some of this data from the Phase II clinical trials and reinvigorate them and show them to the FDA in as short a time frame as possible to get the labeling expanded from just a pain palliation drug to an actual cancer theraputic drug. I'm sure you're aware that a cancer therapeutic drug has a significantly larger dollar value attached to it than just a palliation drug. A very similar drug in this space that has a very limited indication for a very small patient population in the prostate cancer sector does about $800M a year in revenue with a very small overall survival benefit. So we see a huge opportunity here to expand the label as a therapeutic drug and because our indication is significantly larger than that other drug, that takes our revenue projections into several hundred million dollars if we can prove that clinical data in a clinical trial or post marketing study. So along with the revenue that comes with Metastron™ and the Strontium Chloride product as palliation drugs, we see a very significant 'Blue Sky' or 'Moonshot' opportunity for this drug at the tip of our pipeline as a commercial opportunity."
"I think what's really important for our shareholders to understand, is that we now have a very deep pipeline of very significant products and value opportunities with catalysts and milestones with each of those assets as we progress into this year."
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