Marinomed Biotech AG

  • Land: Österreich

Nachricht vom 20.10.2021 | 17:45

First Marinosolv(R) platform deal: Marinomed Biotech AG and Luoxin Pharmaceutical Group Stock Co., Ltd. sign agreement on Budesolv to treat allergic rhinitis in Greater China

DGAP-News: Marinomed Biotech AG / Key word(s): Agreement
20.10.2021 / 17:45
The issuer is solely responsible for the content of this announcement.

First Marinosolv(R) platform deal: Marinomed Biotech AG and Luoxin Pharmaceutical Group Stock Co., Ltd. sign agreement on Budesolv to treat allergic rhinitis in Greater China

  • First licensing deal for a drug derived from proprietary Marinosolv(R) solubilization platform
  • Luoxin Pharmaceutical acquires rights for co-development and manufacturing for Budesolv, a Marinosolv(R)-based formulation of the glucocorticoid budesonide for the treatment of allergic rhinitis
  • Marinomed to receive upfront payment and double-digit million US-Dollar milestone payments plus tiered royalties on sales

Korneuburg, Austria, October 20, 2021 - Marinomed Biotech AG (VSE:MARI), a globally operating biopharmaceutical company, announced today a new collaboration and licensing agreement with Luoxin Pharmaceutical Group Stock Co., Ltd. (Stock Code: 002793.SZ, hereinafter referred to as "Luoxin Pharmaceutical"), one of the leading pharmaceutical companies in China. Luoxin Pharmaceutical will further develop and commercialize Budesolv for the treatment of allergic rhinitis in mainland China, Hong Kong, Macau, and Taiwan. Budesolv, a new formulation of the glucocorticoid budesonide, is the first medication originating from Marinomed's proprietary Marinosolv platform. Budesolv has successfully completed a pivotal Phase III clinical study, necessary for marketing authorization in Europe. The agreement to commercialize Budesolv in Greater China, is Marinomed's important next milestone on the communicated development path of the Marinosolv technology platform.

Luoxin Pharmaceutical will co-develop Budesolv for the Chinese markets and will be responsible for clinical development and obtaining the Chinese marketing authorization. This comprises building production capacities, holding the exclusive distribution rights, as well as ultimately being responsible for manufacturing and marketing Budesolv. Under the terms of the agreement, Marinomed will receive an upfront payment of USD 2 million, however, due to legal and corporate finance advisory fees with limited impact on current year's profit and loss statement. Depending on the achievement of specified development, regulatory and commercial milestones, Marinomed is eligible to receive double-digit million US-Dollar milestone payments as well as royalties on Budesolv sales in Greater China.

"We are fortunate to have Luoxin Pharmaceutical as such an outstandingly experienced and knowledgeable partner in China and are proud to have achieved this milestone agreement based on our Marinosolv platform. Budesolv is our first medication developed with the patented platform. Through Budesolv, we aim to revolutionize the treatment of allergic rhinitis. With an 85 % reduced dose and rapid efficacy onset within three hours, our new formulation can even be used for patent extension and further protection," said Dr. Andreas Grassauer, Marinomed's CEO. "The Budesolv example illustrates the immense potential of the Marinosolv platform, facilitating drug delivery and enhancing bioavailability. The Marinosolv platform holds great promise and will further fuel our development pipeline. This first licensing agreement is an important commercial validation and underlines the increasing recognition for our Marinosolv technology."

"We are looking forward to co-developing and marketing Budesolv in the Chinese market. To date, the collaboration with the Marinomed team has been excellent and we are confident that our co-development with their outstanding scientific team will be very fruitful," said Mr. Ryan Liu, Chairman of Luoxin Pharmaceutical.

About Budesolv:
Budesolv is the most advanced product from the Marinosolv(R) platform to date. Budesolv is a novel aqueous and preservative-free formulation containing the corticosteroid Budesonide. The recent pivotal clinical trial was successfully completed, demonstrating non-inferiority of the Budesolv nasal spray when compared to Rhinocort(R) Aqua 64. Furthermore, the trial demonstrated that with Budesolv an 85 % reduced dosage was equally effective and showed a significantly faster onset of action (Zieglmayer P et al., Clin Exp Allergy 2020). Filing for the European marketing authorization application is currently being prepared by Marinomed. For further publications on Budesolv, please visit https://www.marinosolv.com/en/publications.

About Marinosolv(R):
Marinosolv(R) is an innovative technology platform that enables solubilization of many barely soluble compounds and in consequence, opens new possibilities in treating a multitude of diseases. While organic compounds could previously often only be delivered as a suspension, Marinosolv(R) provides aqueous formulations without preservatives with a faster onset of action and increased local bioavailability. In addition, they can be used without prior shaking, thus improving usability and enabling reliable dosing in sensitive tissues such as eyes or nose. Overall, the use of the Marinosolv(R) technology can facilitate efficient drug delivery with high local availability and low systemic off-target activity. Even off-patent active ingredients can be patented as part of new formulations developed using Marinosolv(R), while keeping production processes cost-efficient. For more information on Marinosolv(R), please visit https://www.marinosolv.com/en, and for a list of scientific publications on Marinosolv(R), https://www.marinosolv.com/en/publications.

About Luoxin Pharmaceutical
Luoxin Pharmaceutical Group Stock Co., Ltd. ("Luoxin Pharmaceutical", stock code: 002793.SZ) is a healthcare conglomerate that is engaged in pharmaceutical research and development, manufacture, sales, and healthcare services. Founded in 1988, Luoxin Pharmaceutical has established R&D centers and manufacturing sites in Shandong, Shanghai and Chengdu, with a total of nearly 6,000 staff members. Luoxin Pharmaceutical is committed to bringing good health to more people and is focused on meeting the unmet medical needs in GI, respiratory and oncology, etc., improving the accessibility of medicines and healthcare services.
Luoxin Pharmaceutical has a rich and competitive portfolio of products and the star products take the lead in GI and respiratory. Many products were listed in major science and technology projects, such as National Major New Product Plan, National Torch Plan as well as Major New Drug R&D. In addition, having been ranking among Top 100 Chinese Pharmaceutical Enterprises since 2006, and among Best Enterprises in Chinese Pharmaceutical R&D Pipelines since 2011, Luoxin Pharmaceutical was recognized as State Key High-tech Enterprise, State Technology Innovation Model Enterprise, National Industrial Quality Model Enterprise, and awarded with the 2nd prize in the State Sci. & Tech Progress many times.
For more information, please visit www.luoxin.cn.

About Marinomed Biotech AG
Marinomed Biotech AG (Korneuburg, Austria) (VSE:MARI) is an Austrian science-based biotech company with globally marketed therapeutics. The company is listed on the Prime Market of the Vienna Stock Exchange. Marinomed focuses on the development of innovative products based on two patent-protected technology platforms. The Marinosolv(R) technology increases the solubility and bioavailability of compounds that are hardly soluble in aqueous formulations. The Carragelose(R) platform comprises innovative patent-protected products targeting viral infections of the respiratory tract and may also reduce the risk of an infection with SARS-CoV-2. Carragelose(R) is used as a virus blocker in nasal sprays, throat sprays, and lozenges, which are sold via international partners in over 40 countries. Marinomed, Marinosolv(R) and Carragelose(R) are registered trademarks of Marinomed Biotech AG. These trademarks may be owned or licensed in select locations only. Further information is available at https://www.marinomed.com.

For further inquiries contact:

Marinomed Biotech AG
Pascal Schmidt
CFO
Hovengasse 25, 2100 Korneuburg, Austria            
T +43 676 603 2478
E-mail: ir@marinomed.com
http://www.marinomed.com
International Media Contact
MC Services AG
Dr. Brigitte Keller, Dr. Regina Lutz
T +49 89 210228 0
UK: Shaun Brown
M: +44 7867 515 918
E-mail: marinomed@mc-services.eu
 

Disclaimer

This press release contains forward-looking statements, which are based on current views, expectations, and projections of the management of Marinomed Biotech AG about future events. These forward-looking statements are subject to risks, uncertainties and assumptions that could cause actual results, performance, or events to differ materially from those described in, or expressed or implied by, such statements. The current views, expectations and projections of the management of Marinomed Biotech AG may be identified by the context of such statements or words such as "anticipate," "believe", "estimate", "expect", "intend", "plan", "project" and "target". Forward-looking statements are only valid as of the date they are made and Marinomed Biotech AG does not assume any obligation to update, review or revise any forward-looking statements contained in this press release whether as a result of new information, future developments or otherwise.



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