Q BioMed Inc. (QBIO)

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Q BIOMED TO SCALE UP PRODUCTION OF UTTROSIDE-B, A   NOVEL CHEMOTHERAPEUTIC FOR LIVER CANCER, IN PREPARATION FOR IND FILING

Q BioMed continues its collaboration with Chemveda Life Sciences to prepare for pre-clinical evaluation, Orphan Drug filing and Investigational New Drug (IND) filing of Uttroside-B

 

Novel Therapeutic Shows Remarkable Efficacy in HepG2 Cell Lines

 

New York, NY – July 22, 2020 – Q BioMed, Inc. (OTCQB: QBIO) and Chemveda Life Sciences are very pleased to continue their collaboration on Uttroside-B, a chemotherapeutic that has shown remarkable potential efficacy as a treatment for liver cancer.

 

While focused on its commercial rollout of Strontium89, this drug development program will advance another important asset in the Company’s portfolio towards monetization. The efficacy of Uttroside-B, a potent saponin, against liver cancer was demonstrated in a preclinical study published in the November 2016 issue of Scientific Reports, a Nature journal.

 

In the study, researchers showed that in animal models, Uttroside-B was ten times more cytotoxic to the HepG2 liver cancer cell line than sorafenib, the only drug approved by the Food and Drug Administration for liver cancer at the time, and the current first line treatment for hepatocellular carcinoma. Uttroside-B drastically shrunk tumors in mice bearing human liver cancer xenografts. In addition, in pre-clinical experiments Uttroside-B induced cytotoxicity in all liver cancer cell lines, and researchers were also able to confirm its biological safety, both by in vitro and in vivo studies.

 

Denis Corin, Q BioMed CEO said, “Having successfully completed a very challenging synthesis program, we are pleased to be able to advance this important asset towards the clinic and the patients we hope to treat. Liver cancer incidence rates have more than tripled since 1980, while the death rates have more than doubled during this time. More than 800,000 people are diagnosed with this cancer each year throughout the world and it accounts for more than 700,000 deaths annually. New, more effective treatments for these patients is vital and we are encouraged by the early data we have seen with our molecule.”

 

Q BioMed and its partners in the project, the Oklahoma Medical Research Foundation and The Rajiv Gandhi Centre for Biotechnology (RGCB), will now advance the most promising candidate into preclinical testing and validation over the next few months in anticipation of an Orphan Drug application and an Investigational New Drug (IND) application for a clinical program.

 

The Uttroside B technology is covered by a provisional patent application. To see the full Scientific Reports study, go to: http://www.nature.com/articles/srep36318

 

Please visit www.QBioMed.com for more information on our various pipeline products.

 

About Q BioMed Inc.

 

Q BioMed Inc. is a biotech acceleration and commercial stage company. We are focused on licensing and acquiring undervalued biomedical assets in the healthcare sector. Q BioMed is dedicated to providing these target assets; strategic resources, developmental support, and expansion capital to ensure they meet their developmental potential, enabling them to provide products to patients in need‏.

 

Contact:
Denis Corin CEO Q BioMed Inc. +1(646) 884-7017

Investor Relations:
Keith Ppinder
+1(404) 995-6671 ir@qbiomed.com

 

About Chemveda Life Sciences

Chemveda Life Sciences (http://chemvedals.com) is a chemistry focused, aggressively growing, contract services partner helping global pharmaceutical & biotech companies, and academia improve their cost and timeline efficiencies over internal R&D. Chemveda is headquartered in Hyderabad, India and is creating a niche by providing cutting edge solutions ranging from highly exploratory discovery chemistry to drug product development across multiple chemistry classes. Chemveda’s team of over 200 vastly qualified scientists is supported by its significant investments in client oriented facilities, systems and processes defined on the guiding principles of quality, safety and compliance.

 

For further information, please contact:

 

Piyush Chahar- Corporate Development
piyush.chahar@chemvedals.com

 

About Oklahoma Medical Research Foundation

 

OMRF (omrf.org) is an independent, nonprofit biomedical research institute dedicated to understanding and developing more effective treatments for human diseases. Its scientists focus on such critical research areas as cancer, diseases of aging, lupus and cardiovascular disease.

 

About The Rajiv Gandhi Centre for Biotechnology

 

RGCB is an autonomous national institution fully owned by the Government of India. It does pioneering research in cellular and molecular mechanisms of human animal and plant disease by amalgamating theory, modeling, simulation and experimental science.

 

Forward-Looking Statements

This press release may contain “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements include, but are not limited to, any statements relating to our growth strategy and product development programs and any other statements that are not historical facts. Forward-looking statements are based on management’s current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from those currently anticipated are: risks related to our growth strategy; risks relating to the results of research and development activities; our ability to obtain, perform under and maintain financing and strategic agreements and relationships; uncertainties relating to preclinical and clinical testing; our dependence on third-party suppliers; our ability to attract, integrate, and retain key personnel; the early stage of products under development; our need for substantial additional funds; government regulation; patent and intellectual property matters; competition; as well as other risks described in our SEC filings. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law.

 

Source: Q BioMed Inc.

Q BioMed Initiates Rapid Development of Novel COVID-19 Therapeutics

Artificial Intelligence (AI) and computational biophysics will be deployed to rapidly develop drugs for COVID-19 and other viral infections based on Mannin Research’s Tie2 platform in new joint venture with Cyclica

 

NEW YORK, April 21, 2020 – Q BioMed Inc. (OTCQB: QBIO), a commercial stage biotech company, today announced that together with its technology partner, Mannin Research, they are accelerating the rapid development of novel drugs for the treatment of life-threatening complications caused by COVID-19 and other viral infections. This novel drug program is being evaluated by government programs for funding and accelerated development under various COVID-19 response initiatives. Q BioMed and Mannin hope to have at least one treatment in human trials this year.

 

The accelerated development is the result of a joint venture (JV) between Mannin, with its Tie2 based small molecule platform that addresses vascular leakage, and Cyclica, a Toronto-based biotechnology company that has a proprietary AI-augmented drug discovery platform, Ligand Design and Ligand Express. The JV agreement will deploy Cyclica’s unique AI platform to accelerate the development of new treatments based on Mannin’s Tie2 based platform.

 

Several diseases increase the risk of vascular leakage through blood vessels, including acute respiratory distress syndrome (ARDS), sepsis, malaria, and viral infections. Viral infections do so by causing damage to the cells that make up the inner wall of blood vessels, called the endothelium. This leakage allows a virus to move systemically while also increasing secondary bacterial infections. Independent research has demonstrated that reducing vascular leakage helps prevent organ failure and ameliorate acute infections. By activating the Angiopoietin-Tie2 signaling pathway it is possible to treat the vascular leakage associated with pulmonary edema, addressing the respiratory infection caused by viruses such as COVID-19.

 

Mannin CEO George Nikopoulos said, “Therapeutics based on the Tie2 platform have the potential to offer clinicians an intervention to rapidly stabilize the patient’s vascular endothelium in hospital settings, such as the intensive care unit (ICU) or emergency room (ER), when pulmonary edema is diagnosed. Such an intervention could improve outcomes without waiting for a definitive diagnosis, which has been a bottleneck in the current COVID-19 pandemic in the US and around the world. By targeting Tie2, our therapeutic may also be effective in the treatment of a number of conditions including pulmonary edema, ARDS and severe acute respiratory syndrome (SARS) associated with COVID-19 and the seasonal flu.”

 

Q BioMed CEO Denis Corin stated, “Simply put, drugs from Mannin’s Tie2 based platform help to stabilize ‘leaky vessels’ that play a critical part in organ injury, a major determinant of negative outcomes in patients affected by several infectious diseases, including influenza and the current COVID-19 pandemic. While the COVID-19 pandemic has created an urgent need for life saving therapeutics, the Tie2 based platform addresses life threatening complications from a number of infectious diseases including inevitable future novel viral threats. We hope these treatments will be in testing in the clinic by the end of the year.” Mr. Corin continued, “We’re also excited about the potential synergy between virus directed treatments such as remdesivir and Mannin’s host-directed therapeutics.  Mannin’s therapy targets the common physiological pathways that become compromised during any viral infection. Consequently, co-administering an antiviral drug with Mannin’s therapeutic is likely to have a positive synergistic effect on the infected patient.  In addition, because it is not limited to acting on a specific virus, Mannin’s therapeutic wouldn’t be affected by any viral mutation that makes the virus resistant to anti-viral.”

 

About Mannin Research

Mannin is developing therapeutics with mechanism of action involving the Angiopoietin-Tie2 signaling pathway, which is a major regulator of vascular development, vessel remodeling, postnatal angiogenesis, and vessel permeability. Therefore, targeting this pathway has very broad therapeutic applications.

 

Mannin’s core R&D program is based on the Angiopoeitin-Tie2 Mechanism of Action. Mannin’s small molecules and its biologic therapeutic target the endothelium of the patient, stabilizing endothelial barrier integrity by activating Tie2, which in turn reduces lung endothelial vascular leakage, inflammation and cell death that occurs during severe viral infection. This is a novel and promising therapeutic strategy as its mechanism of action is independent of viral replication, but instead focuses on endothelium of the host as the critical target for treatment intervention.

 

 

About Tie2 and its Mechanism of Action

Viral infections can damage the cells that make up the vessels called the endothelium. This damage leads to organ failure and allows the virus to move systemically while also increasing secondary bacterial infections. Independent research has demonstrated that reducing vascular leakage helps prevent organ failure and ameliorate acute infections.

 

The Tie2 receptor and its ligands, Angiopoietin 1 and 2, play an intricate role in maintaining the integrity of the vascular endothelium. This balance has a significant role in several diseases, ranging from glaucoma to infectious disease. Vascular integrity is most essential in the lung, which has the highest level of expression of Tie2 and its ligands. During infection and chronic or acute inflammation, the balance between Angiopoietin 1 and 2 is compromised to favor Angiopoietin 2, which increases vascular permeability. Activating Tie2 receptor either by restoring Angiopoietin 1 levels or through therapeutic interventions targeting its negative regulator VE-PTP has been shown to restore vascular integrity and decrease inflammation by blocking migration of NF-kB to the nucleus and blocking the expression of the adhesion integrins, VCAM1 and ICAM1.

 

About Q BioMed Inc.

Q BioMed Inc. is a biotech acceleration and commercial stage company focused on licensing and acquiring undervalued biomedical assets in the healthcare sector. Q BioMed is dedicated to providing these target assets the strategic resources, developmental support, and expansion capital needed to ensure they meet their developmental potential, enabling them to provide products to patients in need‏.

 

Please visit http://www.QBioMed.com and sign up for regular updates.

 

About Cyclica

Cyclica is a Toronto, Canada based biotechnology company that is decentralizing the discovery of new medicines with its integrated structure-based and AI-augmented drug discovery platform, Ligand Design and Ligand Express. Taken together Ligand Design and Ligand Express design advanced lead-like molecules that minimize unwanted off-target effects, while providing a holistic understanding of a molecule’s activity through integrated systems biology and structural pharmacogenomics. Cyclica’s differentiated platform opens new opportunities for drug discovery, including multi-targeted and multi-objective drug design, lead optimization, ADMET-property prediction, target deconvolution, and drug repurposing for a wide range of indications.

 

Forward-Looking Statements:

This press release may contain “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements include, but are not limited to, any statements relating to our growth strategy and product development programs and any other statements that are not historical facts. Forward-looking statements are based on management’s current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from those currently anticipated are: risks related to our growth strategy; risks relating to the results of research and development activities; our ability to obtain, perform under, and maintain financing and strategic agreements and relationships; uncertainties relating to preclinical and clinical testing; our dependence on third-party suppliers; our ability to attract, integrate, and retain key personnel; the early stage of products under development; our need for substantial additional funds; government regulation; patent and intellectual property matters; competition; as well as other risks described in our SEC filings. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions, or circumstances on which any such statement is based, except as required by law.

 

Q BioMed Media Contact:

Denis Corin

CEO

 

Investor Relations:

Keith Pinder

+1(404) 995-6671

ir@qbiomed.com

 

Q BioMed Enters into a Financial Restructuring of Approximately $7,800,000 Consisting of $4,000,000 New Cash and a minimum of $3,800,000 of Debt Conversion

Sets Roadmap to Uplisting and Provides Cash Runway to 2021 and Beyond

 

New York, NY – April 7, 2020 – Q BioMed Inc. (OTCQB: QBIO), a commercial stage biotech company, announced today the entering of a significant financial transaction with its lead investor, Yorkville Advisors Global (“YA”). Under the agreement, on closing, YA will have converted a minimum of $3,800,000 into common stock and preferred stock and may convert an additional $500,000 which would be the total debt held by them. As part of the agreement, YA will fund an additional $4,000,000 in new capital over the next 2 weeks.

 

This restructuring of the debt and new capital transforms the Company’s balance sheet creating significant positive shareholder equity, a requirement for a Nasdaq listing. The new capital injection will provide enough runway for the Company to implement its full commercial plan as it brings its FDA approved non-opioid, Strontium89 Chloride USP Injection drug to market.

 

Denis Corin, QBioMed CEO said, “In addition to the rollout of our Strontium89 drug, this funding allows us to advance other key pipeline assets such as our infectious disease platform including a potential treatment for COVID-19, influenza and others, liver cancer therapy Uttroside B and our rare disease drug development in non-verbal autism spectrum disorders.”

 

Along with the revenue expected from Strontium89 sales and the significant non-dilutive grant funding available from the Mannin platform, Q BioMed does not anticipate needing more capital until the first quarter of 2021, if not well beyond.

 

For more information on QBioMed, please visit our website www.QBioMed.com.

 

Also, please visit www.strontium89.com for more information on this important cancer pain drug.

 

A current report on Form 8-K detailing the funding translation will be filed with the SEC today.

 

About Q BioMed Inc.

 

Q BioMed Inc. is a biotech acceleration and commercial stage company. We are focused on licensing and acquiring undervalued biomedical assets in the healthcare sector. Q BioMed is dedicated to providing these target assets the strategic resources, developmental support, and expansion capital needed to ensure they meet their developmental potential, enabling them to provide products to patients in need‏.

 

Please visit http://www.QBioMed.com and sign up for regular updates.

 

Q BioMed Media Contact:

Denis Corin

CEO

 

Investor Relations:

Keith Pinder

+1(404) 995-6671

ir@qbiomed.com

 

Forward-Looking Statements:

This press release may contain “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements include, but are not limited to, any statements relating to our growth strategy and product development programs and any other statements that are not historical facts. Forward-looking statements are based on management’s current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from those currently anticipated are: risks related to our growth strategy; risks relating to the results of research and development activities; our ability to obtain, perform under, and maintain financing and strategic agreements and relationships; uncertainties relating to preclinical and clinical testing; our dependence on third-party suppliers; our ability to attract, integrate, and retain key personnel; the early stage of products under development; our need for substantial additional funds; government regulation; patent and intellectual property matters; competition; as well as other risks described in our SEC filings. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions, or circumstances on which any such statement is based, except as required by law.

 

Source:  Q BioMed Inc.

Q BioMed Treats its First Patient in Commercial Setting Following Product Launch
  • Full commercial launch expected in the coming weeks of March
  • An estimated 10 million people are living worldwide with pain from bone metastases

 

New York, NY –  March 12, 2020 – Q BioMed Inc. (OTCQB: QBIO), a commercial stage biotech company,  announced today the first patient has been dosed in a commercial setting with its U.S. FDA approved non-opioid drug Strontium89  (Strontium Chloride Sr-89 Injection, USP) for patients with pain from metastatic bone cancer.

 

The Company completed its initial commercial production run and shipment in February and is pleased to have dosed the first of what it expects to be thousands of patients in the coming years. Due to the opioid crisis, clinicians and patients are looking for pain management alternatives. Strontium89, which can be administered every 3 months, was shown in numerous clinical trials to relieve pain in over 70% of patients who received the treatment.

 

“With an estimated 10 million people living with bone metastases, we expect that even a small penetration in this market will have dramatic effects on QBioMed’s future. We believe this drug has a very important role to play as clinicians move toward proven non-opioid therapeutics for pain palliation for patients with painful bone metastases,” stated Q BioMed CEO Denis Corin.

 

Q BioMed plans to launch the drug in global markets, including Europe, in late 2020.

 

To learn more please visit www.Strontium89.com.

 

INDICATIONS AND IMPORTANT SAFETY INFORMATION:

 

INDICATIONS AND USAGE

 

Strontium Chloride Sr-89 Injection, USP is indicated for the relief of bone pain in patients with painful skeletal metastases. The presence of bone metastases should be confirmed prior to therapy.

 

WARNINGS

 

Use of Strontium-89 Chloride Injection in patients with evidence of seriously compromised bone marrow from previous therapy or disease infiltration is not recommended unless the potential benefit of the treatment outweighs its risks. Bone marrow toxicity is to be expected following the administration of Strontium-89 Chloride Injection, particularly white blood cells and platelets. The extent of toxicity is variable. It is recommended that the patient’s peripheral blood cell counts be monitored at least once every other week. Typically, platelets will be depressed by about 30% compared to pre-administration levels. The nadir of platelet depression in most patients is found between 12 and 16 weeks following administration of Strontium-89 Chloride Injection. White blood cells are usually depressed to a varying extent compared to pre-administration levels. Thereafter, recovery occurs slowly, typically reaching pre-administration levels six months after treatment unless the patient’s disease or additional therapy intervenes. In considering repeat administration of Strontium-89 Chloride Injection, the patient’s hematologic response to the initial dose, current platelet level and other evidence of marrow depletion should be carefully evaluated. Verification of dose and patient identification is necessary prior to administration because Strontium-89 Chloride Injection delivers a relatively high dose of radioactivity.

 

Strontium-89 Chloride Injection may cause fetal harm when administered to a pregnant woman. There are no adequate and well-controlled studies in pregnant women. If this drug is used during pregnancy, or if the patient becomes pregnant while receiving this drug, the patient should be apprised of the potential hazard to the fetus. Women of childbearing potential should be advised to avoid becoming pregnant.

 

PRECAUTIONS

 

Strontium-89 Chloride Injection is not indicated for use in patients with cancer not involving bone. Strontium-89 Chloride Injection should be used with caution in patients with platelet counts below 60,000 and white cell counts below 2,400.

 

Radiopharmaceuticals should only be used by physicians who are qualified by training and experience in the safe use and handling of radionuclides and whose experience and training have been approved by the appropriate government agency authorized to license the use of radionuclides.

 

Strontium-89 Chloride Injection, like other radioactive drugs, must be handled with care and appropriate safety measures taken to minimize radiation to clinical personnel.

 

In view of the delayed onset of pain relief, typically 7 to 20 days post injection, administration of Strontium-89 Chloride Injection to patients with very short life expectancy is not recommended.

 

A calcium-like flushing sensation has been observed in patients following a rapid (less than 30 second injection) administration.

 

Special precautions, such as urinary catheterization, should be taken following administration to patients who are incontinent to minimize the risk of radioactive contamination of clothing, bed linens and the patient’s environment.

 

Strontium-89 Chloride Injection is excreted primarily by the kidneys. In patients with renal dysfunction, the possible risks of administering Strontium-89 Chloride Injection should be weighed against the possible benefits.

 

PREGNANCY

 

Teratogenic effects. Pregnancy Category D. See Warnings section.

 

NURSING MOTHERS

 

Because Strontium-89 Chloride Injection acts as a calcium analog, secretion of Strontium-89 Chloride Injection into human milk is likely. It is recommended that nursing be discontinued by mothers about to receive intravenous Strontium-89 Chloride Injection. It is not known whether this drug is excreted in human milk.

 

PEDIATRIC USE

 

Safety and effectiveness in children below the age of 18 years have not been established.

 

ADVERSE REACTIONS

 

A single case of fatal septicemia following leukopenia was reported during clinical trials. Most severe reactions of marrow toxicity can be managed by conventional means.

 

A small number of patients have reported a transient increase in bone pain at 36 to 72 hours after injection. This is usually mild and self-limiting, and controllable with analgesics. A single patient reported chills and fever 12 hours after injection without long-term sequelae.

 

You are encouraged to report negative side effects of prescription drugs to the FDA.

 

Visit www.FDA.gov/medwatch or call (800) FDA-1088.

 

Please see full Prescribing Information for Strontium-89 Chloride Injection.

 

About Q BioMed Inc.

Q BioMed Inc. is a biotech acceleration and commercial stage company. We are focused on licensing and acquiring undervalued biomedical assets in the healthcare sector. Q BioMed is dedicated to providing these target assets the strategic resources, developmental support, and expansion capital needed to ensure they meet their developmental potential, enabling them to provide products to patients in need‏.

 

Please visit http://www.QBioMed.com and sign up for regular updates.

 

Q BioMed Media Contact:

Denis Corin

CEO

 

Investor Relations:

Keith Pinder

+1(404) 995-6671

ir@qbiomed.com

 

Forward-Looking Statements:

This press release may contain “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements include, but are not limited to, any statements relating to our growth strategy and product development programs and any other statements that are not historical facts. Forward-looking statements are based on management’s current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from those currently anticipated are: risks related to our growth strategy; risks relating to the results of research and development activities; our ability to obtain, perform under, and maintain financing and strategic agreements and relationships; uncertainties relating to preclinical and clinical testing; our dependence on third-party suppliers; our ability to attract, integrate, and retain key personnel; the early stage of products under development; our need for substantial additional funds; government regulation; patent and intellectual property matters; competition; as well as other risks described in our SEC filings. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions, or circumstances on which any such statement is based, except as required by law.

 

 

Source:   Q BioMed Inc.

Q BioMed Launches Non-Opioid Treatment for Metastatic Bone Pain
  • First orders for product received, with initial doses to ship in February
  • Full commercial production and availability starting in March

 

New York, NY –  February 13, 2020 – Q BioMed Inc. (OTCQB: QBIO), a commercial stage biotech company, announced today the launch of its FDA approved non-opioid drug Strontium89  (Strontium Chloride Sr-89 Injection, USP), which has been shown in clinical studies to help relieve persistent pain associated with cancer that has metastasized to bone. In several multicenter, placebo-controlled trials in cancer patients with persistent pain after external beam radiation therapy for bone metastases, pain relief occurred in more patients treated with a single injection of Strontium89 than in patients treated with an injection of placebo*, with a greater percentage of patients experiencing pain scores of zero without any need for opioid or non-opioid rescue analgesics.2† Duration of pain palliation has been shown to range from 2 to 5 months in most patients.1,2 Strontium89 can be redosed every 90 days.2

 

An estimated 10 million people are living with bone metastases. Due to the opioid crisis, clinicians and patients are looking for pain management alternatives. Strontium89, which is administered every 3 months, has been shown to relieve pain in over 70% of patients who received the treatment. Q BioMed is hopeful that broad market reacceptance will be swift.

 

Use of Strontium-89 Chloride Injection in patients with evidence of seriously compromised bone marrow from previous therapy or disease infiltration is not recommended unless the potential benefit of the treatment outweighs its risks. Bone marrow toxicity is to be expected following the administration of Strontium-89 Chloride Injection, particularly white blood cells and platelets. The extent of toxicity is variable.

 

Q BioMed has already received U.S. hospital orders and will begin delivering doses in February. Q BioMed’s contract manufacturing facility is manufacturing initial commercial-scale quantities now; manufacturing will reach full production quantities in March. Under its distribution relationship with Jubilant Radiopharma, Q BioMed has the capability to reach patients in all 50 states. Orders can be placed by calling Jubilant Radiopharma at (901) 345-3434. Commercial and marketing activities, including conferences and sales, will begin concurrently with commercial availability. Strontium89 is reimbursed by Medicare and most insurance companies.

 

“This is a major milestone for Q BioMed. We are now a revenue-generating entity. This was a goal we set for ourselves when we founded the company almost 5 years ago. The journey to producing this critically important drug has not been easy, but we are now here. It’s a great achievement and a testament to all those who have helped get us to this point. We look forward to being able to help serve the unmet needs of the millions of patients suffering from debilitating bone pain associated with metastatic cancer. Years of well-documented data show that Strontium89 can help alleviate the pain suffered by most patients with painful bone metastases. We believe this drug has a very important role to play as clinicians move toward proven non-opioid therapeutics for pain palliation,” stated Q BioMed CEO Denis Corin.

 

Q BioMed plans to launch the drug in global markets, including Europe, in the coming quarters. Q BioMed is also planning further research for Strontium89 for potential label extension into therapeutic use for survival benefit in metastatic bone cancer through a Phase IV study.

 

Learn more at www.Strontium89.com

 

INDICATIONS AND IMPORTANT SAFETY INFORMATION:

 

INDICATIONS AND USAGE

 

Strontium Chloride Sr-89 Injection, USP is indicated for the relief of bone pain in patients with painful skeletal metastases. The presence of bone metastases should be confirmed prior to therapy.

 

WARNINGS

Use of Strontium-89 Chloride Injection in patients with evidence of seriously compromised bone marrow from previous therapy or disease infiltration is not recommended unless the potential benefit of the treatment outweighs its risks. Bone marrow toxicity is to be expected following the administration of Strontium-89 Chloride Injection, particularly white blood cells and platelets. The extent of toxicity is variable. It is recommended that the patient’s peripheral blood cell counts be monitored at least once every other week. Typically, platelets will be depressed by about 30% compared to pre-administration levels. The nadir of platelet depression in most patients is found between 12 and 16 weeks following administration of Strontium-89 Chloride Injection. White blood cells are usually depressed to a varying extent compared to pre-administration levels. Thereafter, recovery occurs slowly, typically reaching pre-administration levels six months after treatment unless the patient’s disease or additional therapy intervenes. In considering repeat administration of Strontium-89 Chloride Injection, the patient’s hematologic response to the initial dose, current platelet level and other evidence of marrow depletion should be carefully evaluated. Verification of dose and patient identification is necessary prior to administration because Strontium-89 Chloride Injection delivers a relatively high dose of radioactivity.

 

Strontium-89 Chloride Injection may cause fetal harm when administered to a pregnant woman. There are no adequate and well-controlled studies in pregnant women. If this drug is used during pregnancy, or if the patient becomes pregnant while receiving this drug, the patient should be apprised of the potential hazard to the fetus. Women of childbearing potential should be advised to avoid becoming pregnant.

 

PRECAUTIONS

Strontium-89 Chloride Injection is not indicated for use in patients with cancer not involving bone. Strontium-89 Chloride Injection should be used with caution in patients with platelet counts below 60,000 and white cell counts below 2,400.

 

Radiopharmaceuticals should only be used by physicians who are qualified by training and experience in the safe use and handling of radionuclides and whose experience and training have been approved by the appropriate government agency authorized to license the use of radionuclides.

 

Strontium-89 Chloride Injection, like other radioactive drugs, must be handled with care and appropriate safety measures taken to minimize radiation to clinical personnel.

 

In view of the delayed onset of pain relief, typically 7 to 20 days post injection, administration of Strontium-89 Chloride Injection to patients with very short life expectancy is not recommended.

 

A calcium-like flushing sensation has been observed in patients following a rapid (less than 30 second injection) administration.

 

Special precautions, such as urinary catheterization, should be taken following administration to patients who are incontinent to minimize the risk of radioactive contamination of clothing, bed linens and the patient’s environment.

 

Strontium-89 Chloride Injection is excreted primarily by the kidneys. In patients with renal dysfunction, the possible risks of administering Strontium-89 Chloride Injection should be weighed against the possible benefits.

 

PREGNANCY

Teratogenic effects. Pregnancy Category D. See Warnings section.

 

NURSING MOTHERS

Because Strontium-89 Chloride Injection acts as a calcium analog, secretion of Strontium-89 Chloride Injection into human milk is likely. It is recommended that nursing be discontinued by mothers about to receive intravenous Strontium-89 Chloride Injection. It is not known whether this drug is excreted in human milk.

 

PEDIATRIC USE

Safety and effectiveness in children below the age of 18 years have not been established.

 

ADVERSE REACTIONS

A single case of fatal septicemia following leukopenia was reported during clinical trials. Most severe reactions of marrow toxicity can be managed by conventional means.

A small number of patients have reported a transient increase in bone pain at 36 to 72 hours after injection. This is usually mild and self-limiting, and controllable with analgesics. A single patient reported chills and fever 12 hours after injection without long-term sequelae.

 

You are encouraged to report negative side effects of prescription drugs to the FDA.

Visit www.FDA.gov/medwatch or call (800) FDA-1088.

 

Please see full Prescribing Information for Strontium-89 Chloride Injection.

 

About Q BioMed Inc.

Q BioMed Inc. is a biotech acceleration and commercial stage company. We are focused on licensing and acquiring undervalued biomedical assets in the healthcare sector. Q BioMed is dedicated to providing these target assets the strategic resources, developmental support, and expansion capital needed to ensure they meet their developmental potential, enabling them to provide products to patients in need‏.

 

Please visit http://www.QBioMed.com and sign up for regular updates.

 

Q BioMed Media Contact:

Denis Corin

CEO

 

Investor Relations:

Keith Pinder

+1(404) 995-6671

ir@qbiomed.com

 

Forward-Looking Statements:

This press release may contain “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements include, but are not limited to, any statements relating to our growth strategy and product development programs and any other statements that are not historical facts. Forward-looking statements are based on management’s current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from those currently anticipated are: risks related to our growth strategy; risks relating to the results of research and development activities; our ability to obtain, perform under, and maintain financing and strategic agreements and relationships; uncertainties relating to preclinical and clinical testing; our dependence on third-party suppliers; our ability to attract, integrate, and retain key personnel; the early stage of products under development; our need for substantial additional funds; government regulation; patent and intellectual property matters; competition; as well as other risks described in our SEC filings. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions, or circumstances on which any such statement is based, except as required by law.

 

References:

  1. Kraeber-Bodéré F, Campion L, Rousseau C, Bourdin S, Chatal JF, Resche I. Treatment of bone metastases of prostate cancer with strontium-89 chloride: efficacy in relation to the degree of bone involvement. Eur J Nucl Med. 2000;27(10):1487-1493; 2. STRONTIUM CHLORIDE Sr-89 INJECTION, USP THERAPEUTIC [package insert]. Angleton, TX: IsoTherapeutics Group, LLC; 2020.

 

*71.4%, 78.9%, and 60.6% of patients receiving a single injection of Strontium Chloride Sr-89 reported a reduction in pain score without any increase in analgesic intake and without supplementary radiotherapy at the index site at months 1, 2, and 3, respectively, versus 61.4%, 57.1%, and 55.9% of patients receiving placebo at the same time points.

 

†14.3%, 13.2%, and 15.2% of patients receiving Strontium Chloride Sr-89 Injection, USP were pain free (pain score of zero) with no use of supplementary analgesics at months 1, 2, and 3, respectively, versus 6.8%, 8.6%, and 5.9% of patients receiving placebo at the same time points.

 

Source:  Q BioMed Inc.

Q BioMed Announces FDA Approval

Company Gets Green Light for Manufacturing FDA Approved Non-Opioid Cancer Palliation Drug

 

New York, NY – November 20, 2019 – Q BioMed Inc. (OTCQB: QBIO) announces FDA approval of its contract manufacturer IsoTherapeutics Group LLC (ITG). ITG is now cleared to manufacture the Company’s FDA approved 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. Q BioMed is now the only FDA-approved source for this drug in the western world. The Company 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 an FDA-approved 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. This is the 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 approximately two million patients experience debilitating bone pain from metastatic disease. The opportunity to provide significant pain relief to this group is substantial.

 

QBioMed CEO Denis Corin said, “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. 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.”

 

We look forward to updating our shareholders and those awaiting the drug availability in the next 60 days.

 

About Q BioMed Inc.

Q BioMed Inc. is a biotech acceleration and commercial stage company. We are focused on licensing and acquiring undervalued biomedical assets in the healthcare sector. Q BioMed is dedicated to providing these target assets with strategic resources, developmental support, and expansion capital to ensure they meet their developmental potential, enabling them to provide products to patients in need‏.

 

Please visit http://www.QBioMed.com and sign up for regular updates.

 

Media Contact Q BioMed:

Denis Corin

CEO

 

+1(404) 995-6671

ir@qbiomed.com

 

Source:  Q BioMed Inc.

In a Major Breakthrough Q BioMed Discovers First Biomarkers for Pediatric Nonverbal Autism Subgroup
  • Marks the first time a company has identified biomarkers that hold the potential to stratify this subset of patients

 

  • Study examined 1,953 significant autistic biomarkers, resulting in 2 significant markers tied to expressed genes and pathways responsible for speech development

 

  • Biomarkers in the nonverbal subset were distinct from children with typical speech development with or without autism

 

  • Biomarkers will help homogenize clinical trial participants and will be studied as possible diagnostic and prognostic indicators during trials

 

New York, NY – April 10, 2019 – Q BioMed Inc. (OTCQB: QBIO), a commercial stage biotech company, announced today the discovery of two novel biomarkers for pediatric nonverbal autism, identified in a subset of children with Autism Spectrum Disorder (ASD). This marks the first time a company has been able to identify biomarkers that hold the potential to stratify this subset of children. The study took into consideration 1,953 potential biomarkers and used Vineland II scores to stratify 240 children into three groups: verbal, semi-verbal, and nonverbal autism.

 

Q BioMed CEO, Denis Corin highlighted, “This is a major breakthrough for these children and their families. To date, very little attention and research has been focused on these nonverbal autistic children. In partnership with the clinical and advocacy community, QBioMed is leading the effort to better stratify this group, while also pursuing a treatment.”

 

Children of this subset typically never develop the ability to speak, or commence with language progression between 9-14 months and then regress. Most psychologists and physicians feel comfortable providing a diagnosis of nonverbal around the age of 7 years. Each year, an estimated 18,000-20,000 newborns will go on to become autistic and nonverbal in the U.S.

 

Speaking to the benefit of the biomarker work completed to date by Q BioMed, Corin explained, “Children with ASD need safe, effective and targeted treatments that are tested under conditions that take their best interests into consideration. Today’s announcement ensures we continue to take a tailored and patient-centric approach to find those children who will benefit the most from our efforts.”

 

One of the highlights of the biomarker study was the identification of known genes and pathways that are directly implicated in speech impairment. The studies also revealed comorbidities that manifest serologically as early as 18 months (the lower limit of detection to date) even though the children do not yet manifest clinical symptoms of these diseases.

 

To date, the results would allow for the development of diagnostic capabilities for children as young as 18 months and as old as 6 years. Further studies are needed for children older than 6 years.

 

Q BioMed will continue to enrich its data set for these biomarkers over time and work with its advisory committee, regulators and partners to incorporate these biomarkers into the QBM-001 trial design. In parallel, Q BioMed is finishing the formulation of QBM-001. The completion of formulation over the next couple months will then lead to subsequent regulatory filings and ongoing IND enabling studies.

 

QBM-001 targets toddlers with pediatric nonverbal autism, where underlying commonalities – as further reinforced by this current biomarker study – lead to developmental delay, an autism diagnosis, and eventual nonverbal or very minimally verbal capability for the rest of their lives.

 

About Pediatric Nonverbal Autism

There are approximately 18,000-20,000 new cases of pediatric nonverbal autism in the U.S. each year and a similar amount in Europe. The majority of the children are diagnosed by the age of seven and fall within the autism spectrum. Individually, the economic costs for toddlers that become non- or minimally verbal is $10 million dollars on average per child over a lifetime. Collectively, an estimated $200 billion is spent yearly on individuals who are nonverbal in the U.S. Not all individuals who are nonverbal will benefit from QBM-001. However, with validated biomarkers, testing from trained specialists and genetic testing, children who fall in this targeted population can be identified, and will have a higher likelihood of responding to an approved treatment.

 

About Q BioMed Inc.

Q BioMed Inc. is a biotech acceleration and commercial stage company. We are focused on licensing and acquiring undervalued biomedical assets in the healthcare sector. Q BioMed is dedicated to providing these target assets; strategic resources, developmental support, and expansion capital to ensure they meet their developmental potential, enabling them to provide products to patients in need‏.

 

Please visit http://www.QBioMed.com and sign up for regular updates

 

Forward-Looking Statements:

This press release may contain “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements include, but are not limited to, any statements relating to our growth strategy and product development programs and any other statements that are not historical facts. Forward-looking statements are based on management’s current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from those currently anticipated are: risks related to our growth strategy; risks relating to the results of research and development activities; our ability to obtain, perform under and maintain financing and strategic agreements and relationships; uncertainties relating to preclinical and clinical testing; our dependence on third-party suppliers; our ability to attract, integrate, and retain key personnel; the early stage of products under development; our need for substantial additional funds; government regulation; patent and intellectual property matters; competition; as well as other risks described in our SEC filings. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law.

 

Contact
Denis Corin
CEO
Q BioMed Inc.
+1(646)884-7017

 

Investor Relations
+1(404) 995-6671

ir@qbiomed.com

 

Source: Q BioMed Inc.

Q BioMed Inc Announces Acquisition of Cancer Pain Drug Metastron™ from GE Healthcare

Strategic Acquisition Gives Company Ownership of Brand Name Drug and Related Market Authorizations in 22 Countries in Which Metastron™ is Already Registered and Approved for Sale

 

NEW YORK, November 28, 2018 — Q BioMed Inc. (OTCQB: QBIO), a biotechnology acceleration company, is pleased to announce that it has entered into agreement to acquire the metastatic skeletal cancer palliation drug, Metastron™, from GE Healthcare.

 

The agreement gives Q BioMed ownership of the brand, trademarks and market authorizations in 22 countries. In addition, all historical and current sales and distribution data related to those market authorisations will be assigned or transferred to Q BioMed to allow for as seamless a transition as possible in all markets.

 

Q BioMed CEO Denis Corin said of the deal, “This is a major deal for Q BioMed. Strategically, it affirms our belief in this drug as an effective and underutilized non-opioid therapy for the treatment of debilitating pain associated with skeletal cancer metastases. Importantly, as we enter this market, we will now have access to all information related to Metastron in 22 countries in which the drug is already approved for sale.” Mr. Corin continued, “This gives us a tremendous springboard to accelerate our revenue potential and establishes a formidable barrier to entry as we grow this market. With regards to the market, it is important to note that our focus is not on the short-term horizon, but rather on the long-term strategic initiative as we look 2 and 5 years down the road at expanding the therapeutic scope for the drug.”

 

The acquisition agreement with GE Healthcare covers the purchase of the radiopharmaceutical drug Metastron™ and all related intellectual property (IP) including, but not limited to the brand, sales and distribution data, patent, trademark and market authorizations for Metastron in 22 countries in exchange for an undisclosed upfront payment, one milestone payment based on sales and a single digit royalty for 15 years. The first commercial sale of Metastron is expected to occur after the successful transfer or assignment of all IP, material sales and distribution data, technical transfer and establishment of manufacturing capabilities to be made by Q BioMed under the appropriate regulatory filings required by the jurisdictions in which Metastron is sold.  The complete transfer and establishment of approved manufacturing facilities will take several months with the relevant international health authorities.

 

Q BioMed looks forward to updating shareholders and all stakeholders as we advance through the transaction and more importantly, we look forward to providing this drug to the thousands of patients around the world who may depend on it well into the future.

 

Please visit www.QBioMed.com and sign up for regular updates and additional information and see our 8K filed today.

 

Follow us on Social Media @QBioMed

 

 

About Q BioMed Inc.

 

Q BioMed, Inc. is a biomedical acceleration and development company. We are focused on licensing and acquiring biomedical assets across the healthcare spectrum. Q BioMed is dedicated to providing these target assets the strategic resources, developmental support and expansion capital they need to meet their developmental potential so that they can provide products to patients in need.

 

Please visit www.qbiomed.com and sign up to receive regular updates. Follow us on social media @QBioMed.

 

Forward-Looking Statements

 

This press release may contain “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements include, but are not limited to, any statements relating to our growth strategy and product development programs and any other statements that are not historical facts. Forward-looking statements are based on management’s current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from those currently anticipated are: inspection of the proposed third-party manufacturing facility by the FDA or other comments or requests from the FDA in connection with the above mentioned regulatory filing; failure of the proposed third-party manufacturing facility to pass an inspection by the FDA; regulatory risks; risks related to our growth strategy; risks relating to the results of research and development activities; our ability to obtain, perform under and maintain financing and strategic agreements and relationships; uncertainties relating to preclinical and clinical testing; our dependence on third-party suppliers; our ability to attract, integrate, and retain key personnel; the early stage of products under development; our need for substantial additional funds; government regulation; patent and intellectual property matters; competition; as well as other risks described in our SEC filings. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law.

 

Contact:
Denis Corin
CEO
Q BioMed Inc.
+1 (646) 884-7017

Source:  Q BioMed Inc.

Q BioMed Provides Important Update on QBM001 Developmental Drug Targeting a Non-Verbal and Minimally Verbal Patient Subset on the Autism Spectrum

Company Further Develops Its Autistic Spectrum Disorder (ASD) Drug Technology and Expects Several Development Partnerships In Anticipation of Clinical Program in 2019

 

NEW YORK, October 9, 2018 /PRNewswire/ — Q BioMed Inc. (OTCQB: QBIO), a biotechnology acceleration company, is pleased to provide an update on QBM001, its Autistic Spectrum Disorder (ASD) drug development program for non-verbal or minimally verbal autistic children.

 

Q BioMed continues to develop its intellectual property including its patent pending QBM-001 drug technology, which is being tested for pediatric developmental nonverbal disorder in toddlers within the autism spectrum disorders. Working with its medical and scientific advisors, Q BioMed is focusing on QBM001 candidate formulations that seek to provide an improved safety profile in preclinical studies. Q BioMed has visited with many potential trial sites in the U.S. and Europe over the last 9 months in preparation for the planned clinical trial of its drug candidate.

 

Denis Corin, CEO of Q BioMed Inc. stated, “We are grateful for the feedback from clinicians, patients and their families and medical and scientific advisors. All are excited about the roadmap for QBM-001 over the next 6 months and look forward to reporting on our progress.”

 

QBM-001 targets toddlers with pediatric developmental nonverbal disorder, where an underlying commonality of this subgroup is elevated blood markers that lead to developmental delay, an autism diagnosis and eventual nonverbal or very minimally verbal capability for the rest of their lives.

 

Although the nonverbal or very minimally verbal subgroup is definable by the lack of language development, there is no diagnostic tool to identify the children at risk at an early age. As such, Q BioMed has vetted diagnostic options over the last 9 months that could offer a way to diagnose these children as early as two years of age. These tools will be a part of the upcoming clinical trial in order to help validate them as potential biomarkers. Q BioMed is looking forward to announcing these partnerships in the coming months as we complete and submit the regulatory filings required for orphan drug designation and an IND to initiate the planned clinical trial.

 

In preparation for the clinical trial, Q BioMed is preparing partnerships with a Contract and Development Manufacturing Organization (CDMO) to start manufacturing, and Contract Research Organizations (CROs) to finish preclinical studies, submit a pre-IND, orphan drug designation filing and continue to secure its intellectual property through patent filings.

 

About Pediatric Development Nonverbal Disorder 

There are approximately 18,000 new cases of pediatric developmental nonverbal disorder in the US each year and a similar amount in Europe. The majority of the children are diagnosed as young children and fall within the autism and epilepsy spectrum disorders. Individually, the economic costs for toddlers that become non- or minimally verbal is ten million dollars on average per person over their life. Collectively, an estimated 200 billion dollars is spent yearly on individuals who have become nonverbal in the US. Not all individuals who become nonverbal will benefit from QBM-001. However, with validated biomarkers, testing from trained specialists and genetic testing, children who fall in this targeted population can be identified, and will have a higher likelihood of responding to treatment.

 

About Q BioMed Inc. 

Q BioMed Inc. “Q” is a biomedical acceleration and development company. We are focused on licensing and acquiring undervalued biomedical assets in the healthcare sector. Q is dedicated to providing these target assets, strategic resources, developmental support, and expansion capital to ensure they meet their developmental potential, enabling them to provide products to patients in need.

 

Please visit http://www.qbiomed.com for more information and signup for regular updates. Also, follow us on Social Media @QbioMed #QbioMed $QBIO

 

Forward-Looking Statements:

This press release may contain “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements include, but are not limited to, any statements relating to our growth strategy and product development programs and any other statements that are not historical facts. Forward-looking statements are based on management’s current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from those currently anticipated are: risks related to our growth strategy; risks relating to the results of research and development activities; our ability to obtain, perform under and maintain financing and strategic agreements and relationships; uncertainties relating to preclinical and clinical testing; our dependence on third-party suppliers; our ability to attract, integrate, and retain key personnel; the early stage of products under development; our need for substantial additional funds; government regulation; patent and intellectual property matters; competition; as well as other risks described in our SEC filings. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law.

 

Contact:
Denis Corin
CEO
Q BioMed Inc.
+1-888-357-2435

SOURCE Q BioMed Inc.

Q BioMed Takes the Stage in the Expanded Access Debate at European Early and Managed Access Program Conference

Q BioMed Orphan Drug VP, who started the first Expanded Access Program Database asked to Speak on Panels and run Roundtable at the Early and Managed Access Program Conference in the UK from October 22nd to 24th 2018

 

NEW YORK, October 26, 2018 /PRNewswire/ — Q BioMed Inc. (OTCQB: QBIO), a biotechnology acceleration company, is pleased to announce that Robert Derham, a member of the Q BioMed team and founder of CheckOrphan and architect of the world’s first access program database, hosted a roundtable discussion on how companies can compliantly communicate their expanded access program and participated on a panel discussion about how to more effectively work with patients and patient organizations when executing an expanded access program.

 

Expanded access programs are highly regulated programs that provide people with medicine that has not yet been approved on the market. Expanded access programs are receiving more attention as legislation known as “The Right to Try” bill passed in March of this year in the USA. FDA is responsible for regulating requests for expanded access use and most cases are handled over the phone within 24 hours when it is a matter of life of death.

 

Denis Corin, CEO of Q BioMed Inc. stated, “We live in an exciting time, where talk about gene therapy, stem cells and other cutting edge therapies is becoming reality. Thus we can now treat very difficult diseases that have no current treatment, which makes expanded access programs an avenue of hope for patients and their families. However, it is imperative for companies to plan early and engage regulators, health care professionals and advocates to ensure all stakeholders are prepared and can act in the best interest of the patient.”

 

The conference also discussed the augmenting role that expanded access programs play in Europe and the rest of the world. In Europe, expanded access programs are regulated by EMA and then approved and governed at the national level by the respective country’s health administrators. Some have governing bodies that regulate an expanded access program, while other countries handle each request on a case by case basis.

 

About Expanded Access Programs

Expanded access programs are regulated programs put in place to through coordination between regulators and pharmaceutical manufacturers to allow physicians to request access to specific medicines where their patient is unable to access that medicine through clinical trials or via the usual commercial route. The decision to treat a patient as part of an access program is based on the clinical judgment of their physician, and is applicable where there is a genuine unmet medical need and no alternative treatments available.

 

CheckOrphan Access Program Database

CheckOrphan launched the database in 2015, in collaboration with Idis (now Clinigen), to create a resource for the rare disease community who wish to access a specific medicine, but find that it is currently unavailable to them. The listings include information about the therapeutic areas and specific indications where such access programs have been put in place by pharmaceutical manufacturers. Due to regulations governing unlicensed medicines, entries submitted to CheckOrphan for review and publication will not be mentioning product names. Where product names are mentioned on any detail pages, this information is taken from other publicly available sources.

 

About Q BioMed Inc.

Q BioMed Inc. “Q” is a biomedical acceleration and development company. We are focused on licensing and acquiring undervalued biomedical assets in the healthcare sector. Q is dedicated to providing these target assets, strategic resources, developmental support, and expansion capital to ensure they meet their developmental potential, enabling them to provide products to patients in need.

 

Please visit http://www.qbiomed.com for more information and signup for regular updates. Also, follow us on Social Media @QbioMed #QbioMed $QBIO

 

Forward-Looking Statements:

This press release may contain “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements include, but are not limited to, any statements relating to our growth strategy and product development programs and any other statements that are not historical facts. Forward-looking statements are based on management’s current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from those currently anticipated are: risks related to our growth strategy; risks relating to the results of research and development activities; our ability to obtain, perform under and maintain financing and strategic agreements and relationships; uncertainties relating to preclinical and clinical testing; our dependence on third-party suppliers; our ability to attract, integrate, and retain key personnel; the early stage of products under development; our need for substantial additional funds; government regulation; patent and intellectual property matters; competition; as well as other risks described in our SEC filings. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law.

 

Contact:
Denis Corin
CEO
Q BioMed Inc.
+1-888-357-2435

SOURCE Q BioMed Inc.

About Q BioMed

Our vision is to create a pipeline of innovative biomedical assets in various stages of development in multiple therapeutic areas. Our strategy will minimize risk, share success and accelerate our technologies from incubation to monetization.

 

We are dedicated to acquiring and providing strategic resources and expansion capital to innovative healthcare companies that strive to provide much needed healthcare and related products to patients in need. By partnering with exceptional entrepreneurs we aim to help to create market-leading products in the biomedical and healthcare sector. As entrepreneurs and investors with operational and technical expertise we embrace a collaborative approach to capital formation and business development.

 

  • identify
    Criteria match and fit

 

Preliminary scientific and commercial criteria review. Determining management’s expectations and flexibility moves the asset to the next step.

 

  • analyze
    Asset and development plan

 

Due diligence is combined with a validation of management’s
development and capital requirements.

 

  • invest
    Capital attached to goals

 

Performance-based capital is deployed to meet specific and mutually agreed goals in each stage

 

  • accelerate
    Increase investment and ownership

 

Additional resources are infused to move the asset through development stages and to a value-creating inflection point.

 

  • monetize
    Operate, partner, license, IPO or sell

 

Assets can be sold, licensed, joint-ventured or operated as cash flow positive product lines. QBIO’s goal is to maximize value for its shareholders.

 

THE RIGHT FIRM

 

Focuses exclusively in the biotechnology and healthcare sectors, targeting a broad spectrum of biomedical products and healthcare solutions. Q’s expertise is in business & product development and the capital formation required for phased advancement of products.

 

 

THE RIGHT SOLUTION

 

Our team assists companies by utilizing our strategic partners and network of experts to provide public market access for private company assets. 80% of biomedical start ups lack capital and resources to transition from incubation to development and beyond.

 

 

THE RIGHT STRATEGY

 

Q expects to maximize risk-adjusted returns by focusing on value-driven assets from early stage to near-revenue businesses where the technical, regulatory, and commercial risks have been mitigated or where major valuation inflections are imminent.

 

PIPELINE

 

 

Strontium Chloride Sr89 Injection, USP

 

Following intravenous injection, soluble strontium compounds behave like their calcium analogs, clearing rapidly from the blood and selectively localizing in bone mineral. Uptake of strontium by bone occurs preferentially in sites of active osteogenesis, thus primary bone tumors and areas of metastatic involvement (blastic lesions) can accumulate significantly greater concentrations of strontium than surrounding normal bone. Strontium-89 Chloride is retained in metastatic bone lesions much longer than in normal bone, where turnover is about 14 days. In patients with extensive skeletal metastases, well over half of the injected dose is retained in the bones. Excretion pathways are two-thirds urinary and one-third fecal in patients with bone metastases. Urinary excretion is higher in people without bone lesions. Urinary excretion is greatest in the first two days following injection. Strontium-89 is a pure beta emitter and Strontium-89 Chloride selectively irradiates sites of primary and metastatic bone involvement with minimal irradiation of soft tissues distant from the bone lesions. (The maximum range in tissue is 8 mm; maximum energy is 1.463 MeV.) Clinical trials have examined relief of pain in cancer patients who have received therapy for bone metastases (external radiation to indexed sites) but in whom persistent pain recurred.

 

 

About QBM – 001

 

QBM-001 is given to high-risk genetically identified children during the second year of life to regulate faulty membrane channels that are known to cause migraines and/or seizures. This drug acts as an allosteric regulator of these faulty channels in the brain to potentially alleviate the condition and allow toddlers to actively develop language and speech and avoid life-long speech and intellectual disability of being non-verbal. QBM-001 also reduces inflammation in the brain and by so doing can reduce the amount of long-term nerve loss.

 

 

About UTTROSIDE-B Chemotherapeutic

 

P Uttroside-B appears to affect phosphorylated JNK (pro survival signaling) and capcase activity (apoptosis inliver cancer)

 

> A natural compound
> Fractionated Saponin derived from S. nigrum
> Small molecule
> Steroid Glycoside

 

Uttroside B increases the cytotoxicity of a variety of liver cancer cell types

> Up to 10x more potent than Sorafenib in pre clinical studies

 

 

About MAN-01
Topical Eyedrops for Glaucoma

 

First in class drug for Intraocular Eye Pressure. No new drugs in”IOP” for 20 years Only drug targeting the critical ‘Schlemms’ Canal. The Schlemms Canal is responsible for 70%-90% of fluid drainage in the eye.

 

We are developing a unique set of molecules to treat vascular related diseases, such as Primary Open Angle Glaucoma, Pediatric Glaucoma, Cystic Kidney Disease, and Inflammation via our proprietary research platform.

 

MAN-01 faciltiates the drainage of liquid through the Schlemm’s Canal testing on mice as consistently delivered positive results in relieving IOP.

 

TEAM

 

Denis D Corin
CEO and Chairman

 

Mr. Denis D. Corin is Chief Executive Officer and Chairman of the Board. Mr. Corin is an experienced public company executive and management consultant. He has worked almost exclusively in the biomedical field for over 13 years from large pharma and diagnostic companies to small innovative biotech. He has served in various senior executive roles and has been instrumental in building and restructuring businesses. Mr. Corin has raised millions of dollars in development capital to advance businesses. Mr. Corin also served as a Management Consultant to the executives and board of TapImmune Inc. (NASD:TPIV), a clinical stage immune-oncology company through 2014, He holds a Bachelors Degree majoring in both Economics and Marketing & Advertising Management from the University of Natal, South Africa.

 

 

William Rosenstadt
General Counsel and Director

 

Mr. William Rosenstadt is a partner and a co-founder of Ortoli Rosenstadt LLP and head of the firm’s capital markets and securities practice and co-chair of the firm’s Asian practice. He has been practicing corporate and securities law since 1995. He represents entrepreneurs, public companies, hedge funds, private equity funds and other corporate entities on complex international and corporate transactions. He has represented public companies in the U.S., Europe and Asia. William is proud to be given the opportunity to help Q BioMed create value for its shareholders and bring life changing solutions to as many patients as possible.

 

David Laskow-Pooley
VP Product Development

 

Mr. Laskow-Pooley has 30 years of experience in all aspects of the discovery, development and commercialization of pharmaceutical products, diagnostics and devices. He is an industry veteran and has a distinguished career working for numerous pharmaceutical and life sciences companies. He has held director, executive officer and general management posts in both small and major multinational companies including GSK, Abbott, Amersham plc, Life technologies, OSI, Bilcare and Surface Therapeutics.

 

 

Ari Jatwes
Business Development Analyst

 

Mr. Ari Jatwes is an analyst and a banker, with over twenty years of experience. He began his career in a large accounting firm, progressing to a reputable investment bank, where he gained his experience in mergers and acquisitions. Over the last decade Mr. Jatwes interest and focus has been in the biotech and pharma sector, which included trading biotech stocks from start up to late stage biotech companies, advising management and raising capital for their needs. He has played a role in several successful contracts and transactions in the healthcare space – with emphasis on the life sciences and immunotherapy. Mr. Jatwes holds two Master degrees and a Bachelor Degree from the University of South Africa and the University of Natal.

 

 

Robert Derham
VP Orphan Products

 

Robert Derham has focused the majority of his career working with rare diseases and orphan products. For the past seven years he has focused on driving corporate change within medium and large pharmaceutical companies to transition their corporate strategy to an orphan drug development approach. In addition to driving corporate change, he conducted business development for companies looking for partnering, licensing or acquisition opportunities in the orphan drug space. Prior to that, he worked for Mondobiotech, Novartis, Syngenta Biopharma and Alexis Biopharma, always focused on orphan indications and corporate development. Robert is also the founder of CheckOrphan, a comprehensive media and information source for all news, videos, clinical trials, research, treatments and more about rare diseases and orphan products. He also has degrees in medical immunology and biochemistry and thoroughly enjoys diving into the science and research of the rare diseases, with which he is working.

 

 

Dr. Rick Paniccucci
Director and Advisor Pharmaceutical Development

 

Dr. Rick Panicucci is the Vice President of Pharmaceutical Development at WuXi AppTec. He is responsible for providing scientific leadership in the areas of Developability, Formulation Development and GMP Manufacturing.Dr. Panicucci plays an important role in the early stages of drug discovery for various companies. His responsibilities include solid state chemistry and formulation development of all small molecule therapeutics in early development, and developing novel drug delivery technologies for small molecules and large molecules including siRNA.Prior to WuXi he held the position of Global Head of Chemical and Pharmaceutical Profiling (CPP) at Novartis from 2004 to 2015, where he led the development and implementation of innovative dosage form designs and continuous manufacturing paradigms. He has also held positions as the Director of Formulation Development at Vertex Pharmaceuticals and Senior Scientist at Biogen.Dr. Panicucci received his Ph.D. in Physical Organic Chemistry at the University of Toronto, and has two post doctoral fellowships at University of California at Santa Barbara and the Ontario Cancer Institute. Dr. Panicucci will advise our technology partner, Mannin Research Inc.’s development both scientifically and commercially.

 

 

Amy Ripka
Advisor Medicinal Chemistry

 

Dr. Amy Ripka is Executive Director of Medicinal Chemistry at WuXi AppTec. She started her career at Bristol Myers Squibb and over 17 years has worked in various capacities in medicinal chemistry with many small companies, including EnVivo (FORUM) Pharmaceuticals as Head of Chemistry, Infinity, Daiamed, HydraBiosciences and FoldRx. Her current responsibilities include strategic planning in medicinal chemistry, early library drug design utilizing multiple in silico methods, hit optimization and overall screening architectures to advance early stage compounds through Phase I-II clinical development. Dr. Ripka’s therapeutic specialties include Neuroscience, Oncology, Thrombosis and Anti-Infective Disease areas. She has led multiple early stage programs resulting in four clinical candidates, two of which are marketed drugs. Her career has spanned big pharma, biotech and CROs where she has made significant contributions to each of these.Dr. Ripka, was elected by her peers to Chair the prestigious Medicinal Chemistry Gordon Research Conference and is currently serving a second elected term as the Industrial Councilor for the MEDI Division of the American Chemical Society.Dr. Ripka, received her Ph.D. in Chemistry from the University of Wisconsin-Madison with a double concentration in organic and medicinal chemistry, and did her post-doctoral studies with Nobel Laureate K. Barry Sharpless from The Scripps Research Institute. Dr. Ripka will advise Mannin’s scientific development and growth.

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