Marvel Biosciences Corp. to Commence cGMP Manufacturing of Its Lead Asset MB-204
Calgary, Alberta--(Newsfile Corp. - July 21, 2021) - Marvel Biosciences Corp. (TSXV: MRVL) (the "Company" or "Marvel") is pleased to announce that the Company's wholly owned subsidiary, Marvel Biotechnology Inc., has achieved a significant science milestone in the development of its lead compound MB-204. Marvel Biotechnology Inc. has entered into a current good manufacturing process (cGMP) manufacturing agreement (the "Agreement") with Zhejiang Ausun Pharmaceutical Co., Ltd. ("Ausun") for the supply of its lead asset MB-204 for toxicology studies and clinical trials. MB-204 is the Company's lead compound with potential application to the neurological diseases of depression & anxiety, Alzheimer's, ADHD and non-neurological diseases such as cancer and non-alcoholic steatohepatitis.
Ausun was chosen and the Agreement entered into as a result of an extensive Request for Proposal ("RFP") process and negotiations undertaken by Marvel Biotechnology Inc. for the pilot manufacturing of its lead compound, MB-204. The Company believes that Ausun possesses the expertise in process development and custom manufacturing of active pharmaceutical ingredients, intermediates and formulated products; and will develop the chemical process and manufacture of Marvel's MB-204 active pharmaceutical ingredient ("API") formulation.
"This is a major science milestone event for the Company as we work to achieve and develop our lead asset MB-204 for clinical testing and commercialization," stated Dr. Mark Williams, President and Chief Science Officer of Marvel. "This program has now commenced and follows after the completion of our reverse take-over and amalgamation transaction with our partners at Alphanco, and the recommencement of trading on the TSXV last week as Marvel Biosciences Corp. We look forward to updating the market on our progress and the lead asset, MB-204".
About Zhejiang Ausun Pharmaceutical Co., Ltd.
Ausun was established in 2010 as a China-based contract development and manufacturing ("CDMO") and is a public pharmaceutical company listed on the Shanghai Stock Exchange since May 2017. Ausun is a custom manufacturer and principally engaged and specialized in the research, development and production of formulations, APIs, pharmaceutical intermediates and fine and bulk chemicals. The manufacturing site is United States Food and Drug Administration ("US-FDA") registered and quality assurance US-FDA inspected facility located in Linhai, Taizhou, Zhejian Province, China.
Ausun has successfully passed all inspections by the US, European, Japanese and Russian Health authorities. In addition, Ausun has filed 16 Drug Master Files ("DMF") in these markets. A DMF is a submission to the US-FDA that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drugs. The last inspection by the US-FDA in May 2018 was passed with zero US-FDA Form 483 observations and Ausun received an NAI rating. An US-FDA Form 483 is issued to management at the conclusion of an US-FDA inspection when an investigator(s) has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.
About Marvel Biosciences Corp.
Marvel Biosciences Corp., and its wholly owned subsidiary, Marvel Biotechnology Inc., is a Calgary-based biotechnology company that utilizes a "drug redevelopment" approach to drug development. Historically, when a new class of drug is developed, it is optimized for a particular target, but typically only approved for a specific disease. Often, a new disease is identified which involves the same target, however, pending the remaining patent life, the originally approved drug may not have sufficient time left for it to be commercially viable to be developed for the new disease indication. Marvel develops new synthetic chemical derivatives of the original approved drug for the new disease indication. Patent protection is sought as the new potential asset is developed by the Company The Company believes the business model results in significantly less risk, cost and time to develop its assets compared to traditional biotechnology companies.
Marvel Biotechnology Inc. has currently developed several new chemical entities, using synthetic chemical derivatives of known, off-patent drugs, that inhibit the A2a adenosine receptor with application to neurological diseases (depression & anxiety, Alzheimer's, ADHD), and the non-neurological conditions of cancer and non-alcoholic steatohepatitis. Marvel is also exploring additional undisclosed targets to expand its asset pipeline.
Dr. Mark Williams, President and Chief Science Officer
Marvel Biosciences Corp.
Phone: 403 770-2469
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All information contained in this news release with respect to the Company and its subsidiary, (collectively, the "Parties") were supplied by Marvel, respectively, for inclusion herein and each parties' directors and officers have relied on each other for any information concerning such Party.
This news release may contain forward-looking statements and other statements that are not historical facts. Forward-looking statements are often identified by terms such as "will", "may", "should", "anticipate", "expects" and similar expressions. All statements other than statements of historical fact, included in this release, including, without limitation, statements regarding the future plans and objectives of the Company are forward-looking statements that involve risks and uncertainties. There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those anticipated in such statements. Important factors that could cause actual results to differ materially from the expectations of the Company and include other risks detailed from time to time in the filings made by the Company under securities regulations.
The reader is cautioned that assumptions used in the preparation of any forward-looking information may prove to be incorrect. Events or circumstances may cause actual results to differ materially from those predicted, as a result of numerous known and unknown risks, uncertainties, and other factors, many of which are beyond the control of the Company. As a result, the Company cannot guarantee that the above events on the terms will occur and within the time disclosed herein or at all. The reader is cautioned not to place undue reliance on any forward-looking information. Such information, although considered reasonable by management at the time of preparation, may prove to be incorrect and actual results may differ materially from those anticipated. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement. The forward-looking statements contained in this news release are made as of the date of this news release and the Company will update or revise publicly any of the included forward-looking statements as expressly required by Canadian securities law.
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