Up To $138 Million in Milestones, Up To Low Double Digit Royalties: Windtree Announces Agreement To Develop And Commercialize Drug Candidates In Greater China

Rhea-AI Summary

Windtree Therapeutics Inc. (NASDAQ:WINT) has entered into a license agreement with Lee's Pharmaceutical (HK) Ltd. to develop and commercialize its product candidate istaroxime for acute heart failure and cardiogenic shock in the greater China region. The deal supports Windtree's pipeline treatments for acute heart failure and cardiogenic shock and has the potential to provide financial support for development of treatment to address an unmet need and a growing problem in China.

Market Research Analyst

The partnership between Windtree Therapeutics and Lee's Pharmaceutical marks a strategic move in the biopharmaceutical industry, particularly within the cardiovascular treatment sector. This collaboration leverages Windtree's clinical advancements in heart failure treatments and Lee's regional expertise to tap into the significant Chinese market. Heart failure is a leading cause of morbidity and mortality worldwide and China represents a large and growing patient population due to its demographic trends and rising prevalence of cardiovascular diseases.

The financial terms of the agreement, with potential milestone payments totaling up to $138.1 million and royalties on sales, indicate a substantial investment in Windtree's pipeline. Such deals can significantly affect a company's financial health and stock performance, often serving as a positive indicator to investors of the company's potential for future revenue growth. Moreover, the structure of the deal, which offloads development and commercialization costs to Lee's Pharmaceutical, provides Windtree with a strategic advantage by minimizing its financial risk and preserving capital.

Financial Analyst

From a financial perspective, the licensing agreement presents a non-dilutive funding opportunity for Windtree Therapeutics. The agreement's structure, which includes milestone payments and royalties, could provide a steady stream of income and reduce the need for Windtree to seek additional capital through equity financing, thereby avoiding shareholder dilution. The deal not only supports the development of istaroxime and other SERCA2a activators but also potentially accelerates their path to market.

The mention of a joint steering committee and joint development and commercialization committees indicates a shared governance approach, which can be instrumental in navigating regulatory pathways and market dynamics in the greater China region. This collaborative model could enhance the efficiency of clinical trials and expedite market entry, thereby potentially leading to earlier revenue generation for Windtree.

Medical Research Analyst

The clinical significance of istaroxime, as a dual-action agent with positive results from phase 2 studies, cannot be understated. Its unique mechanism, which improves both systolic and diastolic functions of the heart, addresses a critical need in acute heart failure treatment. The potential for an oral formulation of SERCA2a activators for chronic heart failure patients also represents an innovation in patient care, as current treatments often require intravenous administration in hospital settings.

The advancement of istaroxime into phase 3 trials by Lee's Pharmaceutical is a pivotal step in the drug's development pathway. The success of these trials could lead to a new treatment option for heart failure patients in China, where the burden of the disease is particularly high. This development is not only significant for patient outcomes but could also set a precedent for future heart failure therapies globally.

WARRINGTON, PA / ACCESSWIRE / January 18, 2024 / Greater China holds a significant, if not the world's largest, acute heart failure patient population. It may be a market where drug treatment innovation can help patients and that's what Windtree Therapeutics Inc. (NASDAQ:WINT) is hoping to accomplish with its new license agreement with Lee's Pharmaceutical (HK) Ltd.

Windtree Therapeutics and Lee's Pharmaceutical are teaming up to develop and commercialize Windtree's product candidate istaroxime for acute heart failure and cardiogenic shock for the greater China region. In addition to istaroxime, the agreement also licenses Windtree's preclinical next-generation dual mechanism SERCA2a activators and rostafuroxin, a phase 2 product candidate for hypertension associated with specific genotypes.

Windtree's Pipeline Supported With Deal As Company Also Potentially Gains Non-Dilutive Development Resources

The deal supports Windtree's pipeline treatments for acute heart failure and cardiogenic shock and has the potential to provide financial support for development of treatment to address an unmet need and a growing problem in China.

"We believe Windtree's pipeline has great potential and we expect this license agreement will progress development in the treatment of heart failure. We see the agreement as validation of the significant heart failure market opportunity for istaroxime and, when coupled with the unique profile and our positive clinical results to date, demonstrates the potential for istaroxime to provide meaningful benefit in heart failure and cardiogenic shock patients. Greater China holds a significant, if not the largest, heart failure patient population. Windtree already studied istaroxime in heart failure patients in China and the results of the Company's positive Phase 2b study have been presented and published. Lee's intends to start Phase 3 for istaroxime in acute heart failure while Windtree continues to advance its global cardiogenic shock program," said Craig Fraser, Windtree's Chief Executive Officer. "Importantly, the agreement also provides support for development of one or more fast follow-on products from our next generation dual mechanism SERCA2a activators that have potential for oral formulation for treatment of chronic heart failure."

Lee's will receive a license to develop and commercialize istaroxime, the dual mechanism SERCA2a activators and rostafuroxin in the greater China region for which Windtree is entitled to receive up to $138.1 million in payments upon the achievement of certain milestones (approximately $100 million of which relate to the heart failure platform of assets) plus up to low double-digit royalties. Lee's will be responsible for funding all development, manufacturing, regulatory and commercial costs for the covered products in the licensed region. This financial support will apply to all indications studied in the region as well as the portion of global clinical trials, such as the cardiogenic shock trial, which take place in the licensed region. The agreement also establishes a joint steering committee and a joint development committee to oversee the regional development (with Windtree retaining final decision rights over clinical protocols) and a joint commercialization committee.

Dual Mechanisms In One Drug

Windtree's istaroxime is a first-in-class, dual-action agent in clinical development for the treatment of acute decompensated heart failure (ADHF) and cardiogenic shock. It increases the force of the heart's contraction with each beat and improves cardiac relaxation in between heart beats. Windtree's data from three phase 2 studies demonstrates that istaroxime both significantly improves cardiac function of a failing heart and blood pressure without increasing heart rate or the incidence of cardiac rhythm disturbances in acute heart failure and cardiogenic shock.

One of the company's goals is to develop several products that can activate SERCA2a in novel manners. Istaroxime represents an important first approach with building positive clinical data. Windtree also has potential follow-on dual mechanism SERCA2a activator drug candidates that are in preclinical development. The idea is to develop one or more dual mechanism SERCA2a activators that are indicated for use in acute heart failure patients in the hospital as well as an oral formulation indicated for use in chronic heart failure patients in the outpatient setting.

​​Image sourced from Shutterstock

Contact:
Matt Epstein
mepstein@kendallir.com

SOURCE: Windtree

View the original press release on accesswire.com

What is the new license agreement about?

Windtree Therapeutics Inc. has entered into a license agreement with Lee's Pharmaceutical (HK) Ltd. to develop and commercialize its product candidate istaroxime for acute heart failure and cardiogenic shock in the greater China region.

What is the ticker symbol for Windtree Therapeutics Inc.?

The ticker symbol for Windtree Therapeutics Inc. is WINT.

What does the deal between Windtree Therapeutics and Lee's Pharmaceutical aim to achieve?

The deal aims to develop and commercialize Windtree's product candidate istaroxime for acute heart failure and cardiogenic shock in the greater China region.

What are the potential benefits of the license agreement for Windtree?

The agreement has the potential to provide financial support for development of treatment to address an unmet need and a growing problem in China.

What is istaroxime and what are its clinical results?

Istaroxime is a first-in-class, dual-action agent in clinical development for the treatment of acute decompensated heart failure (ADHF) and cardiogenic shock. Clinical results demonstrate that istaroxime significantly improves cardiac function of a failing heart and blood pressure without increasing heart rate or the incidence of cardiac rhythm disturbances in acute heart failure and cardiogenic shock.