Ligand Partner Verona Pharma Announces FDA Approval of Ohtuvayre™ (ensifentrine), First Inhaled Novel Mechanism for Maintenance Treatment of COPD in More Than 20 Years

By: Ligand Pharmaceuticals Incorporated via Business Wire

June 27, 2024 at 08:00 AM EDT

FDA approval increases Ligand’s key commercial stage portfolio to 11 products

Ligand is entitled to receive a low single-digit royalty on worldwide net sales of Ohtuvayre

Ligand Pharmaceuticals Incorporated (Nasdaq: LGND) today announced that its partner Verona Pharma plc has received approval from the U.S. Food and Drug Administration (FDA) for Ohtuvayre™ (ensifentrine). Ohtuvayre is the first inhaled product with a novel mechanism of action available for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients in more than 20 years. Ligand has earned a $5.8 million milestone payment upon FDA approval of Ohtuvayre and will earn an additional $13.8 million upon its commercial launch which is expected to occur during the third quarter of 2024. Ligand is entitled to a low single-digit royalty on worldwide net sales of Ohtuvayre.

“Verona Pharma has worked tirelessly to bring a new treatment option to the millions of people managing chronic COPD and we are excited to see their efforts come to fruition with this approval,” said Todd Davis, CEO of Ligand. “For Ligand this is an important milestone, as it’s the second FDA approval within our royalty portfolio in two weeks and the eighth regulatory approval since 2023. COPD is a multi-billion-dollar market opportunity in the U.S. alone, and we believe Ohtuvayre will be another key growth driver for Ligand.”

Ohtuvayre is a first-in-class selective dual inhibitor of the enzymes phosphodiesterase 3 and phosphodiesterase 4 (“PDE3 and PDE4”) that combines bronchodilator and non-steroidal anti-inflammatory effects in one molecule. Ohtuvayre is delivered directly to the lungs through a standard jet nebulizer without the need for high inspiratory flow rates or complex hand-breath coordination.

With this FDA approval, Ligand now has 11 key commercial products driving the company’s financial performance and a portfolio of more than 100 additional programs at various stages of development.

About Ohtuvayre^TM (ensifentrine)

Ohtuvayre is the first inhaled therapy for the maintenance treatment of COPD that combines bronchodilator and non-steroidal anti-inflammatory activities in one molecule. Verona has evaluated nebulized Ohtuvayre in its Phase 3 clinical program ENHANCE (“Ensifentrine as a Novel inHAled Nebulized COPD thErapy”) for COPD maintenance treatment. Ohtuvayre met the primary endpoint in both ENHANCE-1 and ENHANCE-2, demonstrating statistically significant and clinically meaningful improvements in lung function. A fixed-dose combination of ensifentrine and glycopyrrolate, a LAMA, is currently under development for the maintenance treatment of COPD. Ensifentrine has potential applications for development in non-cystic fibrosis bronchiectasis, cystic fibrosis, asthma and other respiratory diseases.

About COPD

Chronic obstructive pulmonary disease (“COPD”) refers to a group of diseases that cause airflow blockage and breathing-related problems, such as emphysema and chronic bronchitis. More than 390 million people worldwide are living with COPD, and more than 8.6 million Americans are treated chronically^1-2. Symptoms include increased shortness of breath, frequent coughing (with and without mucus), wheezing, tightness in the chest and unusual tiredness. Approximately 50% of COPD patients experience almost daily symptoms³. There is no cure for COPD and despite available treatment options, it is the third leading cause of death globally.

¹Adeloye D, et al. Lancet Respir Med. 2022;10(5):447-458

²Verona IQVIA Ensifentrine Market Research

³Phreesia 2022 COPD Patient Survey

About Ligand Pharmaceuticals

Ligand is a biopharmaceutical company enabling scientific advancement through supporting the clinical development of high-value medicines. Ligand does this by providing financing, licensing our technologies or both. Its business model seeks to generate value for stockholders by creating a diversified portfolio of biopharmaceutical product revenue streams that are supported by an efficient and low corporate cost structure. Ligand’s goal is to offer investors an opportunity to participate in the promise of the biotech industry in a profitable and diversified manner. Its business model focuses on funding programs in mid- to late-stage drug development in return for economic rights, purchasing royalty rights in development stage or commercial biopharmaceutical products and licensing its technology to help partners discover and develop medicines. Ligand partners with other pharmaceutical companies to leverage what they do best (late-stage development, regulatory management and commercialization) in order to generate its revenue. Ligand’s Captisol® platform technology is a chemically modified cyclodextrin with a structure designed to optimize the solubility and stability of drugs. Ligand has established multiple alliances, licenses and other business relationships with the world’s leading biopharmaceutical companies including Amgen, Merck, Pfizer, Jazz, Takeda, Gilead Sciences and Baxter International. For more information, please visit www.ligand.com. Follow Ligand on X @Ligand_LGND.

We use our investor relations website and X as a means of disclosing material non-public information and for complying with our disclosure obligations under Regulation FD. Investors should monitor our website and our X account, in addition to following our press releases, SEC filings, public conference calls and webcasts.

Forward-Looking Statements

This news release contains forward-looking statements by Ligand that involve risks and uncertainties and reflect Ligand's judgment as of the date of this release. Words such as “plans,” “believes,” “expects,” “anticipates,” “potential,” “will” and similar expressions are intended to identify forward-looking statements. These forward-looking statements include, without limitation, statements regarding: the timing of the anticipated commercial launch of Ohtuvayre by Verona and the potential contribution it is expected to bring to Ligand; the timing and amount of milestone payments Ligand expects; the potential royalties to be paid on sales of Ohtuvayre by Verona; and Ensifentrine’s other potential applications for development. Actual events or results may differ from Ligand’s or its partner’s expectations due to risks and uncertainties inherent in Ligand’s and its partner’s business, including, without limitation: Verona may not be able to successfully commercialize Ohtuvayre which will depend on a number of factors including coverage and reimbursement levels from governmental authorities and health insurers as well as market acceptance by healthcare providers; the market size for Ohtuvayre may be smaller than estimated; Ligand is dependent on Verona for the commercialization of Ohtuvayre; and other risks described in Ligand’s prior press releases and filings with the Securities and Exchange Commission available at www.sec.gov. The failure to meet expectations with respect to any of the foregoing matters may reduce Ligand’s stock price. Ligand disclaims any intent or obligation to update these forward-looking statements beyond the date of this release. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240627518993/en/

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Ligand Partner Verona Pharma Announces FDA Approval of Ohtuvayre™ (ensifentrine), First Inhaled Novel Mechanism for Maintenance Treatment of COPD in More Than 20 Years

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