PHARMACY MARKET
Globenewswire | May 16, 2023
Athenex, Inc. a global biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies for the treatment of cancer and related conditions, today announced that, following an ongoing strategic review, it has reached agreement with its lenders to move forward with an expedited sales process of the Company’s assets across its primary businesses: Athenex Pharmaceutical Division (“APD”), Orascovery, and Cell Therapy.
To best facilitate this process, Athenex and certain of its subsidiaries filed voluntary proceedings under Chapter 11 of the U.S. Bankruptcy Code in the U.S. Bankruptcy Court for the Southern District of Texas. This will enable the Company to divest its assets and wind down the Athenex platform in an orderly fashion, while seeking to maximize value for its stakeholders. The Company anticipates concluding the expedited sales process by July 1, 2023, with the Chapter 11 cases continuing thereafter to resolve claims.
Athenex has also reached an agreement with its secured lenders, subject to court approval, for the consensual use of cash collateral, which will enable the Company to, among other things, satisfy certain obligations to its vendors for authorized goods received and services rendered after the filing. Athenex Pharma Solutions (“APS”), which includes the Company’s manufacturing facility in Clarence, New York, is expected to continue its operations for at least the next 90 days, to provide commercial supply of tirbanibulin ointment. In addition, APD is continuing to operate in the ordinary course and fill customer orders with the ample inventory it has on hand.
Dr. Johnson Lau, Chief Executive Officer of Athenex, on behalf of the management team and the Athenex Board of Directors, said, “Throughout our history, we have sought to become a leader in bringing innovative cancer treatments to the market and improving patient health outcomes. Our team was successful in bringing tirbanibulin, through regulatory approvals, to the U.S. market and a number of EU countries, as well as Taiwan. Unfortunately, our oral paclitaxel product candidate received a complete response letter from the U.S. Food and Drug Administration, and this significant regulatory setback, coupled with challenging biotech markets and the difficult economic environment, put tremendous pressure on our ability to continue to fund our businesses.
“Over the past two years, we made considerable progress in refocusing our business around our promising NKT cell therapy platform, monetizing non-core assets to improve our balance sheet and extending our cash runway, paying down $108 million of debt, and undertaking a comprehensive review of strategic alternatives to create value for our stakeholders. While we explored every viable avenue to avoid this outcome, an orderly sales process represents the best path forward at this time.
“Our goal remains to identify purchasers who will continue development of the important drug candidates for which we have established a good foundation, and to bring them to market on behalf of medical practitioners and, most importantly, for patients. We are incredibly thankful to our team for their dedication to Athenex and will look to support our colleagues through this transition period.”
Pachulski Stang Ziehl & Jones LLP is acting as Athenex's legal counsel. MERU is serving as its financial advisor and Cassel Salpeter & Co., LLC as its investment banker.
About Athenex, Inc.
Founded in 2003, Athenex, Inc. is a clinical-stage biopharmaceutical company dedicated to becoming a leader in the discovery, development, and commercialization of next-generation cell therapy products for the treatment of cancer. The Company’s mission is to become a leader in bringing innovative cancer treatments to the market and to improve patient health outcomes. In pursuit of this mission, Athenex leverages years of experience in research and development, clinical trials, regulatory standards, and manufacturing. The Company is focused on its innovative Cell Therapy platform, based on natural killer T (“NKT”) cells.
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PHARMACY MARKET
PRNewswire | May 19, 2023
Asieris Pharmaceuticals a global biopharma company specializing in discovering, developing and commercializing innovative drugs for the treatment of genitourinary tumors and other related diseases, announced a strategic collaboration with UroViu Corporation ("UroViu"). Asieris Pharmaceuticals will obtain exclusive global rights to UroViu's patented technology of portable single-use cystoscope in the field of fluorescent imaging.
Under the agreement, Asieris Pharmaceuticals will use this patented technology in combination with specific optical imaging agents to conduct research on the application of non-white light imaging technology in the diagnosis and postoperative monitoring of None-Muscle Invasive Bladder Cancer (NMBC). At the same time, Asieris Pharmaceuticals will be responsible for the global commercialization of the sterile single-use fluorescent Cystoscope.
Previously, Asieris Pharmaceuticals entered a cooperation agreement with UroViu in 2021 for the exclusive registration and commercialization rights of its portable single-use flexible white light cystoscopy system in mainland China, Taiwan, Hong Kong and Macau.
"There is still a huge unmet need for more accessible and safer fluorescent cystoscopy in the diagnosis and surveillance of bladder cancer."Dr. Susan Wang, Senior Vice President of Global Business Development & Strategic Partnership of Asieris said, "We are thrilled to deepen and expand our collaboration with UroViu which enabling us not only to broaden our technology portfolio, but also to expedite the implementation of Asieris' integrated strategy for bladder cancer diagnosis and treatment, aiming to provide more effective disease management options for bladder cancer patients."
"We are excited about the possibilities that our expanded Partnership with Asieris will create. Our unique and expanding portfolio of single use endoscopic products are fulfilling UroViu's promise to greatly improve both the patient and provider experience, elevate the standard of care in a field with rapidly advancing technologies," said Bruce OuYang, Founder and CEO of UroViu.
About Asieris
Asieris Pharmaceuticals founded in March 2010, is a global biopharma company specializing in the discovery, development and commercialization of innovative drugs that treat genitourinary tumors and other related diseases. We strive to improve human health and help people live a more dignified life. We aim to become a global pharma leader that integrates R&D, manufacturing, and commercialization in our areas of focus, as we provide best-in-class integrated diagnosis and treatment solutions for patients in China and worldwide.
The company has been developing its proprietary R&D platform and core technologies, exploring new mechanisms of action, and efficiently screening and evaluating drug candidates. With a well-established in-house R&D system and expertise in global drug development, Asieris is committed to launching first-in-class drugs and other innovative products to address huge unmet needs in its areas of focus.
Asieris is also enhancing its pipeline for genitourinary diseases via proprietary R&D and strategic partnerships, while closely following cutting-edge technologies and therapeutics. The company strives to discover and identify unmet medical needs, and adopts a forward-looking approach in product planning and life-cycle management. We aim to establish an outstanding portfolio that covers diagnosis and treatment in a bid to benefit more patients in China and globally.
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BUSINESS INSIGHTS, PHARMA TECH
CONTINUUS Pharmaceuticals | March 15, 2023
On March 14, 2023, ValGenesis, Inc., a leading enterprise validation lifecycle management solutions provider, announced that CONTINUUS Pharmaceuticals has successfully implemented the ValGenesis Validation Lifecycle Management System (VLMS) for efficient management of validation processes across the company in a 100% digital format.
CONTINUUS Pharmaceuticals is a rapidly growing small business specializing in end-to-end integrated continuous manufacturing (ICM) of pharmaceuticals. As a spin-out company resulting from a long-term collaboration between MIT and Novartis, CONTINUUS Pharmaceuticals is committed to enhancing the accessibility and affordability of pharmaceutical products worldwide by exploring advanced manufacturing paradigms that expedite the development of raw materials and APIs to final dosage forms.
Due to the immense validation requirements involved in the production of different drug products, CONTINUUS Pharmaceuticals needed an electronic solution that determines the disposition of their assets while switching amongst product lines. By leveraging the ValGenesis VLMS, CONTINUUS Pharmaceuticals has successfully implemented facilities, equipment validation, computer system and utility validation.
The ValGenesis VLMS is the system of record for CONTINUUS Pharmaceuticals' engineering team and will be expanded to other teams in the future. The highly automated, real-time, and compliant system provided by ValGenesis minimizes the potential for Good Manufacturing Practice (GMP) non-compliance while accelerating time to market.
About CONTINUUS Pharmaceuticals
CONTINUUS Pharmaceuticals is an end-to-end integrated continuous manufacturing (ICM) company specializing in pharmaceutical production. The company is committed to enhancing the accessibility and affordability of pharmaceutical products worldwide by exploring advanced manufacturing paradigms that expedite the development of APIs and raw materials to final dosage forms. It leverages a novel continuous manufacturing platform called Integrated Continuous Manufacturing (ICM), initially developed through a $65 million joint research project between Novartis and MIT. With ICM, it aims to transform and streamline the supply chain of pharmaceuticals by delivering high-quality, lower-cost drugs "on-demand."
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