Medexus has acquired the exclusive right to commercialize Gleolan in the United States.
Complements Medexus’ existing rights to Gleolan, Canada
Gleolan is an optical imaging agent currently indicated for glioma patients in the United States.
As an aid for visualization of malignant or tumor tissue during surgery
Gleolan generated US net sales of $ 3-4 million in the fourth quarter of 2021.
Toronto and Chicago, March 1, 2022 (GLOBE NEWSWIRE) — Medexus Pharmaceuticals (Medexus) (TSX: MDP) (OTCQX: MEDXF) is a US subsidiary of Medexus Pharma (OTCQX: MEDXF).Medexus US) Has acquired the exclusive right to commercialize Gleolan in the United States from NX Development Corp. ().NXDC), Photonamic GmbH & Co. US subsidiary (Photonamic). The transaction extends the strong relationship between Medexus and Photonamic and complements Medexus’ existing commercialization rights to Greoran, Canada, where Medexus recently launched its product. Medexus estimates that using information provided by NXDC, Gleolan generated US net sales of $ 3-4 million in the fourth quarter of 2021. And we look forward to strong sales and institutional uptake in both markets. Medexus and NXDC will work closely together to ensure a seamless migration for existing customers.
Under the terms of Medexus’ new license, supply, and distribution agreement, Medexus commercializes Gleolan in the United States to NXDC’s annual royalty payments (net sales to minimum annual baseline and net supply price paid). Pay on a regular basis). Low to medium single digit million dollar milestone payments (including prepayments, two payments triggered by the passage of time, and three payments triggered by reaching the net sales threshold) .. NXDC will supply Gleolan to Medexus and continue to sponsor Gleolan’s New Drug Application filed with the US Food and Drug Administration (FDA). The transaction will allow NXDC to continue its important R & D activities as a sponsor, including the pursuit of additional indications for Gleolan. Medexus US’s exclusive commercialization rights extend to one additional indication, meningioma, and there is an opportunity to negotiate commercialization rights for future indications. The first period of the agreement between the parties will be extended until March 31, 2028, followed by a two-year extension.
Kend’Entremont, Chief Executive Officer of Medexus, said: “We believe that Gleolan has a bright future and is currently being tested for use in meningiomas, which will be a new indication,” said Dentremont. I’m continuing. Given the successful launch of the product in Canada early last year, we are already familiar with Gleolan. By expanding Gleolan’s marketing rights to the United States, we can continue to develop our business in the United States. We expect this product to be able to deploy infrastructure to support the upcoming launch of Treosulfan in the United States later this year, assuming increased revenue in the United States and FDA approval. doing. “
(Note: Dollar figures in this press release are expressed in US dollars unless otherwise stated.)
Greoran (aminolevulinic acid hydrochloride or ALA HCl) is shown as an aid to the visualization of malignant tissue during surgery in patients with glioma (World Health Organization grade III or IV suspected on preoperative images). Approved optical imaging agent. The FDA permits the designation of Gleolan orphan drugs until June 2024.
Gleolan fluoresces high-grade gliomas (malignant, rapidly progressing brain tumors) under certain forms of fluorescent blue light. Greoran is a powder and is given to patients as an oral solution. After administration, when the brain is exposed to blue light during surgery, the area within the tumor glows pink or red, as opposed to healthy brain tissue that appears blue. This helps neurosurgeons better visualize these gliomas and promote more complete removal.
Surgeons using fluorescent-guided surgery with Gleolan showed a significant improvement in resection range when compared to procedures using white light. NXDC estimates that ALA HCl has been used in more than 100,000 patients worldwide in more than 42 countries to date.
The American Society of Clinical Oncology estimated that in 2021, approximately 24,500 adults in the United States would be diagnosed with primary cancerous tumors of the brain and spinal cord. According to the American Association of Neurological Surgeons, glioblastoma is the most common malignant central nervous system tumor, accounting for 47.7% of all diagnosed cases and presenting an incidence of 3.21 per 100,000 population.
Medexus is a leader in innovative rare disease treatment solutions with a powerful North American commercial platform and a proven portfolio of best-in-class products. Our current focus is on the treatment of hematology, autoimmune diseases, and allergies. We will continue to expand our portfolio of innovative, high-value orphan and rare disease products and build highly differentiated companies that will support growth over the next decade.
Our current flagship products are Rasuvo ™ and Metoject®, proprietary formulations of methotrexate (automatic pens and prefilled syringes) designed to treat rheumatoid arthritis and other autoimmune diseases. IXINITY®, Intravenous Recombinant for use in patients 12 years and older with hemophilia B, a hereditary bleeding disorder characterized by a deficiency of factor IX in the blood needed to control bleeding. Factor IX treatment. Rupall® is an innovative prescription allergic drug with a unique mechanism of action.
It is also licensed for Treosulfan, a preparatory regimen for allogeneic hematopoietic stem cell transplantation used in combination with fludarabine for commercialization in the United States and Canada. Treosulfan was approved by Health Canada in June 2021 and is marketed in Canada as Trecondyv®. Treosulfan is currently being reviewed by the US Food and Drug Administration.
Our mission is to provide the best medical products to medical professionals and patients. We strive to fulfill this mission by acting on the core values of quality, innovation, customer service and collaboration.
For more information, please contact one of the following:
Ken d’Entremont, CEO
Medexus Pharmaceuticals Inc.
Chief Financial Officer, Marcel Konrad
Medexus Pharmaceuticals Inc.
Investor public relations
Description of future prospects
The specific statements contained in this press release contain information about the future outlook within the meaning of applicable securities law (Description of future prospects). Words and expressions such as “expect”, “believe”, “expect”, “do”, “plan”, and “potential” often identify forward-looking statements. Although intended, not all forward-looking statements include these. Word identification. The specific forward-looking statements contained in this news release include statements regarding future net annual sales, future indications for Gleolan, when Treosulfan will be launched in the United States and related FDA approvals. However, it is not limited to these. These statements are based on factors or assumptions applied in drawing conclusions, making predictions or forecasts, including assumptions based on past trends, current circumstances, and expected future developments. .. Forward-looking statements are related to future events and circumstances and, by their very nature, require assumptions and carry inherent risks and uncertainties. Medexus believes that this assumption is reasonable in some circumstances, but these risks and uncertainties may cause actual results to differ materially from the expectations set forth in the forward-looking statements. I warn you that there is. Key risk factors include those listed in Medexus’s materials, which are submitted from time to time to Canadian securities regulators, including the latest Medexus annual information form and management discussions and analysis. Future capital requirements and dilution. Intellectual property protection and risk of infringement. Competition (including the possibility of generic competition); Reliance on key managers. Ability to implement Medexus business plans. Medexus’ ability to leverage US and Canadian infrastructure to drive further growth. Regulatory approval by relevant health authorities, including the FDA. Refund of the product by a third party payer. Proceedings or expiration of patents or other intellectual property rights. Litigation risk; Stock price volatility; Government regulation; and potential third party claims. Given these risks, we should not place excessive reliance on these forward-looking statements. These statements have been made only as of the date of this document. Medexus undertakes no obligation to update any forward-looking statement to reflect new information, unless otherwise required by law.
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Medexus Pharmaceuticals Announces Gleolan Transactions in the US, Canadian Business Journal
Source link Medexus Pharmaceuticals Announces Gleolan Transactions in the US, Canadian Business Journal