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Q Biomed Inc. Announces FDA Filing for Approval of a New Manufacturing Facility for Non-Opioid Strontium Chloride SR89 Injection USP for Relief of Cancer Bone Pain

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NEW YORK, March 16, 2018 /PRNewswire/ —

Q BioMed Inc. (OTCQB: QBIO), a commercial stage biotechnology acceleration development company, and Bio-Nucleonics, licensor of Strontium 89 Chloride, announce submission of a regulatory filing to the FDA for the approval of a new manufacturing facility. Upon approval by the FDA, the facility will be permitted to manufacture Strontium Chloride Sr89 Injection USP (Strontium-89) in accordance with cGMP.

Strontium-89 is a non-opioid injectable radiopharmaceutical to relieve cancer bone pain in patients with painful skeletal metastases. In the body, strontium acts similar to calcium, selectively localizing in bone and is preferentially taken up in osteoblastic lesions. The unabsorbed isotope clears rapidly from the blood and is excreted in the urine the first 2 to 3 days following injection. Uptake of Strontium-89 occurs preferentially in sites of active osteogenesis; thus bone tumors and areas of metastatic involvement (blastic lesions) can accumulate significantly greater concentrations of Strontium-89 than surrounding normal bone.

Strontium-89 is a pure beta emitter, and selectively irradiates sites of primary and metastatic bone involvement with minimal irradiation of soft tissues distant from bone lesions. The presence of bone metastases should be confirmed prior to therapy. When blastic osseous metastases are present, significantly enhanced localization of the radiopharmaceutical will occur with corresponding higher doses to the metastases compared with normal bones and other organs. Although responses can vary, pain relief typically begins 7 to 20 days after injection and lasts for four months or more.

Please visit www.strontium89.com for more information.

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.

About Strontium Chloride Sr89 Injection USP 

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.

CONTRAINDICATIONS:  None known.

WARNINGS: Use of Strontium Chloride Sr89 Injection USP 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 Chloride Sr89 Injection USP, 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 Chloride Sr89 Injection USP. 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 Chloride Sr89 Injection USP, 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 Chloride Sr89 Injection USP delivers a relatively high dose of radioactivity.

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.
+1-888-357-2435

SOURCE Q BioMed Inc.


Q Biomed Inc. to Present at the Microcap Conference Taking Place April 9-10 at the Essex House in New York City

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NEW YORK, April 5, 2018 /PRNewswire/ —

Q BioMed Inc. (OTCQB: QBIO), a commercial stage biotechnology acceleration company, announced today that Denis Corin, Chief Executive Officer, will present at the MicroCap Conference being held at the Essex House in New York City, on Tuesday April 9th and 10th, 2018. In addition to presenting, Mr. Corin will be available for one-on-one investor meetings on Tuesday the 10th.

Details of Q BioMed’s’ participation are as follows:


   
       Event: The Microcap Conference
        Date: Tuesday April 10th, 2018
        Time: 12:00 p.m. Eastern Time
    Location: Essex House - 160 Central Park South, New York, NY

The MicroCap Conference is an exclusive event dedicated to connecting small and micro-cap companies with high-level, institutional and retail investors.

This seventh Microcap Conference is being held at the luxurious Essex House overlooking Central Park. The MicroCap Conference will highlight the 120 of the most attractive companies across various sectors.

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 http://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: 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 Inc Places 2nd in Company Category for Autism Speaks Walk Fundraiser

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Company makes effort to connect with patients and caregivers as it progress its potential treatment for an Autistic Spectrum Nonverbal Developmental Disorder

NEW YORK, June 1, 2018 /PRNewswire/ —

Q BioMed Inc. (OTCQB: QBIO), a biotechnology acceleration company, placed second in the ‘company category’ at this year’s Bay Area Autism Speaks Walk. The fundraiser provided Q BioMed an opportunity to connect with and better understand the autism spectrum disorder (ASD) community as the company progresses with QBM-001, which is being developed to treat pediatric developmental nonverbal disorder in toddlers with ASDs.

“We gave it an all-out team effort to support the autism community, and we are happy to support Autism Speaks’ efforts to raise awareness and educate, fund research, and support patients and caregivers,” explained Denis Corin, CEO of Q BioMed. “Participating in events like the Autism Speaks Walk builds bridges with the community and helps us better understand how to support these individuals and families as we advance our project.”

Q BioMed dedicated its walk to a subgroup of ASDs that QBM-001 is being developed to treat within the nonverbal or minimally verbal spectrum. “We want to be a positive force for this group, not only with our potential treatment, but also with everything we do. This is just the start of many good things to come,” Corin continued.

QBM-001 has been developed to target multiple mechanisms of action that will help address chemical imbalances that have been correlated with impaired language development at elevated levels. Q BioMed intends to initiate a registration trial with the treatment by the beginning of 2019.

About Pediatric Nonverbal Developmental Disorder in the Autism Spectrum Disorder 

There are approximately 20,000 new cases of pediatric developmental nonverbal disorder in the United States (US) each year and a similar amount in Europe. The majority of the affected children are diagnosed as toddlers and are diagnosed with autism. Individually, the economic costs for toddlers that become non- or minimally verbal is ten million on average per person over their average life of 40 years. Collectively, an estimated 200 billion dollars is spent yearly on individuals who have become nonverbal in the US alone. While not all individuals who become nonverbal may benefit from QBM-001, testing by trained specialists along with blood tests and genetic testing, could identify a targeted population that may respond to treatment.

About Q BioMed Inc. 

Q BioMed Inc. is a biomedical acceleration and development 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.

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 Inc. Provides Important Update on Mannin Research Tie2 Technology Platform Development

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NEW YORK, June 6, 2018 /PRNewswire/ —

Q BioMed Inc. (OTCQB: QBIO), a commercial stage biotechnology acceleration development company, provides the following update on its exclusively licensed platform technology asset from Mannin Research Inc.

Together with Mannin Research, the company has made significant progress on their Tie2 activating molecule – currently being optimized for a topical eye drop for the treatment of open angle glaucoma. They recently filed patents with the United States Patent and Trademark Office disclosing novel compounds capable of activating Tie2 receptor-mediated signaling. This is a tremendous achievement and involved significant and detailed work, giving them broad coverage of the platform from an intellectual property standpoint.

They have also completed initial proof-of-concept work on a novel biologic targeting Tie2 (MAN-11). This project provides them a completely different approach – i.e. a biologic vs. a small molecule, from which to build a biologic-based therapeutic platform targeting Tie2 receptor for the treatment of glaucoma and other vascular diseases.

The MAN-01 Program for primary open angle glaucoma is progressing well. Q BioMed Inc. iteratively optimized and refined new compounds for use in treating Primary Open Angle Glaucoma as an eye-drop.

The patients with primary open angle glaucoma, and their physicians, are seeking new medications to treat glaucoma, by slowing down or stopping the progressive loss of vision. There is a long standing, and demonstrated need to increase both adherence and compliance in new glaucoma therapeutics (Glaucoma Today, August 2006). Their MAN-01 program is designed to address both issues by employing improved drug delivery profiles. The company will continue optimization of its lead candidates for planned phase I clinical trials in 2019.

Mannin Research representatives and CSO, Dr. Susan Quaggin will attend the International Vascular Biology Meeting 2018 (IVBM 2018), organized in Helsinki, Finland, June 3-7, 2018, by the European Vascular Biology Organisation, University of Helsinki & Wihuri Research Institute. The IVBM2018 will bring together researchers, executives, and investigators from all fields of vascular biology for the exchange of new ideas and discussions of burning issues. Dr. Quaggin will be presenting during the first Plenary session on June 3 discussing: ‘Stolen identities – new vascular phenotypes Tie’d to disease’.

Q BioMed and Mannin representatives are also attending The BIO International Convention (BIO 2018) on June 4-7, 2018 in Boston, MA. The BIO International Convention is hosted by the Biotechnology Innovation Organization (BIO). The key benefits of attending the 2018 BIO International Convention are access to global biotech and pharma leaders via BIO One-on-One Partnering, exposure to industry thought-leaders with over 500 education sessions, and unparalleled networking opportunities with 16,000+ attendees from 74 countries.

BIO 2018 will provide Mannin Research with the opportunity to connect with key industry partners, develop new relationships, and continue discussions with key pharmaceutical and biotechnology partners with specific expertise in commercializing novel therapeutics for ophthalmology, glaucoma, and vascular diseases. The goal is to identify and engage with partners to explore research partnerships, or commercial partnership to drive new therapeutics for treating patients with primary open angle glaucoma.

Please visit http://www.qbiomed.com and http://www.mannin.ca for more information.

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 http://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.
+1-888-357-2435

SOURCE Q BioMed Inc.

Q Biomed Inc. Extends its Exclusive Option Agreement With Washington University in St. Louis for a Novel Companion Biomarker for Monitoring Glaucoma and Initiates a Clinical Study

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NEW YORK, July 25, 2018 /PRNewswire/ —

Q BioMed Inc. (OTCQB: QBIO), a commercial stage biotechnology acceleration development company, is pleased to announce that it is extending its option agreement with Washington University in St. Louis. Under the agreement granting the exclusive right to license the technology, Q BioMed will continue to evaluate the feasibility and usability of GDF15, a novel biomarker for monitoring glaucoma, as a companion diagnostic to the MAN-01 small molecule currently being optimized for the topical treatment of glaucoma.

The extension allows for more extensive evaluation to be conducted on the feasibility and usability of GDF15 as a novel biomarker for glaucoma and companion diagnostic to, Q BioMed’s exclusively licensed technology, MAN-01. Dr. Arsham Sheybani, Assistant Professor of Ophthalmology and Dr. Rajendra S. Apte, the Paul A. Cibis Distinguished Professor of Ophthalmology and Visual Sciences at Washington University in St. Louis, will conduct a study planned to take place at Washington University in St. Louis using GDF-15 to gather more clinical data on its feasibility and usability as a biomarker for monitoring glaucoma.

In the clinical study, the investigators will examine whether GDF-15 levels correlate with glaucoma severity and with adequate therapeutic response in patients undergoing glaucoma surgery. A primary goal of glaucoma surgeries is reducing IOP, as elevated IOP contributes to RGC death and vision loss. Therefore, in addition to measuring GDF-15 levels, they will also record IOP measured before surgery and at the follow-up. IOP measurement is done at each visit as part of usual care of the patient. These independent studies will provide valuable insights regarding the role of GDF-15 that can inform future clinical studies.

Denis Corin, QBioMed CEO, said, “We are very pleased to be taking this project one step further. We believe that Q BioMed is uniquely positioned to address the marketable demand for novel, breakthrough, precision medicine tools to treat glaucoma. This GDF-15 diagnostic, combined with our MAN-01 drug to treat glaucoma, will be a powerful combination: improving the decision-making tools for clinicians, while making a positive impact on the health of glaucoma patients.”

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 http://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.
+1-888-357-2435

SOURCE Q BioMed Inc.

Q BioMed Inc. Announces FDA Filing for Strontium Chloride Sr89 Injection USP for Relief of Metastatic Cancer Bone Pain

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Prior Approval Supplement Filing Under GDUFA Guidelines is Final Step in Approval Process

NEW YORK, Aug. 20, 2018 /PRNewswire/ — Q BioMed Inc. (OTCQB: QBIO) (OtherOTC: QBIO), a commercial stage biotechnology acceleration development company, and BioNucleonics, licensor of Strontium 89 Chloride, announce submission of a supplemental regulatory filing to the FDA for the approval of a new manufacturing facility. Once cleared by the FDA, the facility will be permitted to manufacture Strontium Chloride Sr89 Injection USP in accordance with cGMP. Strontium Chloride Sr89 Injection USP is an FDA-approved non-opioid injectable radiopharmaceutical indicated to relieve cancer bone pain in patients with painful skeletal metastases.

Oncologic bone pain palliation is an area of increasing unmet need. Advances in cancer treatments and earlier diagnosis have extended survival in patients with breast and prostate cancers, with patients living an average of 2 to 3 years after a diagnosis of bone metastasis. It has been estimated that 65% to 75% of patients with breast or prostate cancer will develop bone metastases; and lung, along with bladder and thyroid cancer frequently metastasize to bone. Data suggest that approximately 75% of patients with bone metastases complain of pain as their main symptom and as the dominant reason for a decreased quality of life.

Sr-89 is an effective, safe, non-narcotic analgesic alternative for the treatment of patients with painful skeletal metastases. 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.

Sr89 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. Unlike many other therapies that demand that patients make repeated visits to hospitals for a course of treatment, Strontium Chloride Sr89 Injection is administered in a single visit and offers pain relief that can last for 3 months or more. Decades of use have shown it to be safe and tolerable. Sr89 is covered under most insurance plans, including Medicare.

QBioMed CEO, Denis Corin said, “This comprehensive filing required by the FDA is the final step in what has been a long process. Our U.S. 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 U.S. and look forward to serving and growing the market for years to come. We believe this proven therapy has been vastly underutilized 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.”

Please visit www.strontium89.com for more information.

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.

About Strontium Chloride Sr89 Injection USP

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.

CONTRAINDICATIONS:  None known.

WARNINGS: Use of Strontium Chloride Sr89 Injection USP 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 Chloride Sr89 Injection USP, 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 Chloride Sr89 Injection USP. 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 Chloride Sr89 Injection USP, 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 Chloride Sr89 Injection USP delivers a relatively high dose of radioactivity.

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.
+1-888-357-2435

 

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SOURCE Q BioMed Inc

Q Biomed Inc. Announces Dr. Rajendra Apte Joins Advisory Board

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Distinguished Ophthalmology Specialist Brings Wealth of Experience

NEW YORK, Sept. 17, 2018 /PRNewswire/ — Q BioMed Inc. (OTCQB: QBIO), a commercial stage biotechnology acceleration development company, is pleased to announce that Rajendra Apte, MD, PhD has joined its Advisory Board contributing his extensive experience in the field of ophthalmology (https://wuphysicians.wustl.edu/for-patients/featured-physicians/rajendra-apte-md-phd).

Dr. Rajendra Apte Joins Advisory Board of Q Biomed Inc.

Dr. Apte is the Paul A. Cibis Distinguished Professor of Ophthalmology and Visual Sciences at Washington University in St. Louis. His areas of specialty include age-related macular degeneration, diabetic retinopathy and vascular diseases, retinal surgery, macular holes, retinal detachments, aging, retinal neurodegeneration, inflammation and metabolism.

Dr. Apte is currently running a human study to investigate the correlation of GDF-15 levels with glaucoma disease severity and progression. Success in this program will provide a new and valuable tool for physicians to monitor disease treatment and progression.

“We are honored to have Dr. Apte join our distinguished team of scientific advisors,” said Denis Corin, CEO of Q BioMed. “His experience in the field of ophthalmology will add significant value to our portfolio technologies such as MAN-01, a small molecule for treatment of Primary Open Angle Glaucoma and our potential companion diagnostic, GDF-15, a biomarker to detect severity of glaucoma in patients.”

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.
+1-888-357-2435

 

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SOURCE Q Biomed Inc.

Q Biomed Inc. Announces Entry Into Definitive Funding Agreement for $4,000,000

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Financing Provides Necessary Capital to Reach Important Milestones

NEW YORK, September 24, 2018 /PRNewswire/ —

Q BioMed Inc. (OTCQB: QBIO), is pleased to announce that it has entered into a definitive agreement with Yorkville Advisors Global (‘Yorkville‘) for $4,000,000.

Q BioMed has closed on the initial tranche of $2,000,000 and expects to close on the balance pending the filing of a registration statement with the U.S. Securities and Exchange Commission for the underlying shares.

Q BioMed Inc. CEO, Denis Corin said, “We are very pleased to once again partner with Yorkville as we enter a very milestone intensive period for Q BioMed. Yorkville has participated in every company financing since 2016. Yorkville’s continued support is indicative of our mutually beneficial relationship. We are confident that this capital will provide a meaningful return to Yorkville, and the necessary runway to reach some important milestones for QBIO.” These include:

  • Drug launch for Strontium Chloride 89 USP Injection for Bone Cancer Palliation
  • Orphan Drug Application and Pre-IND filings for QBM-001 (Autism Spectrum Disorder Drug)
  • Final synthesis data on Uttroside B (Liver Cancer) and
  • Molecule selection for Man01 (Glaucoma)

The $4,000,000 debentures have a conversion price of the lower of $4.00 or a 7% discount to market with a $2 floor price – see the Q BioMed 8-K filing today for further details.

Please visit http://www.qbiomed.com and sign up to receive regular updates. Follow us on social media @QBioMed,  #QBioMed,  $QBIO.

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.

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.
+1-888-357-2435

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

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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

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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.





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