Ferrer Will Market Tyvaso for PH-ILD in More Countries

Marta Figueiredo, PhD avatar

by Marta Figueiredo, PhD |

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Ferrer has acquired exclusive rights to commercialize Tyvaso (inhaled treprostinil) for the treatment of pulmonary hypertension associated with interstitial lung disease (PH-ILD) outside North America, Japan, China, and Israel.

The therapy, developed by United Therapeutics, is currently approved for that indication only in the U.S., while PH-ILD patients in other parts of the world remain without an approved treatment.

Under the terms of the agreement between the two companies, United will retain all rights to the therapy in North America, Japan, China, and Israel, as well as for other indications. The company received an upfront payment from Ferrer and will be eligible for additional payments based on future Tyvaso sales by Ferrer.

Ferrer is now working with health authorities in territories included in the deal to determine the appropriate regulatory pathway to obtain Tyvaso’s approval for treating PH-ILD.

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“This is an important milestone for Ferrer, a B Corp company,” Mario Rovirosa, Ferrer’s CEO, said in a press release. Of note, B corp certification is given to businesses meeting high standards of social and environmental performance, transparency, and accountability.

“We aim to deliver the best possible solutions to underserved patients around the globe by promoting a new way of doing business and approaching the world,” Rovirosa added.

Oscar Pérez, Ferrer’s chief business development and global alliances officer, said  “Tyvaso is the perfect fit for Ferrer’s mission to create lasting change by bringing transformative products in this challenging field to market and strengthens our pipeline for the coming years.”

Ferrer is a long-term partner of United, being responsible for providing global access to Remodulin (treprostinil injection) for the treatment of pulmonary arterial hypertension (PAH).

“We’ve found Ferrer to be an excellent partner for the distribution of our treprostinil-based products around the world and are thrilled to expand our collaboration,” Beth Rhodes, vice president of United’s global supply chain and alliance management.

“Without Ferrer, patients outside of our core markets would not have access to these life-sustaining therapies,” Rhodes added.

The agreement takes advantage of Ferrer’s strong capabilities and expertise in pulmonary vascular conditions — diseases affecting the lung’s blood vessels such as PH — and interstitial lung diseases, which are characterized by lung scarring and can lead to PH.

The deal also underscores both companies’ commitment to expanding global access to Tyvaso for the treatment of PH-ILD.

“We’re proud of our strong and lasting relationship with Ferrer, and this distribution agreement has the potential to bring Tyvaso to PH-ILD patients in need worldwide, who currently have no other treatment options,” said Michael Benkowitz, United’s president and chief operating officer.

“Having recently converted into a public benefit corporation ourselves, we applaud and share Ferrer’s patient-driven mission — underscored by its recent B Corp certification,” Benkowitz added.

Treprostinil — sold by United under the brand names Remodulin for injection, Orenitram for oral, and Tyvaso for inhalation — is a molecule that mimics the effects of a natural vasodilator called prostacyclin. It helps blood vessels widen, improving blood flow, preventing blockage in arteries, and lowering blood pressure.

Given as an inhaled solution in a hand-held, portable device, Tyvaso was first approved in the U.S. in July 2009 for PAH. Its 2021 approval for PH-ILD was based on data from the Phase 2/3 INCREASE trial (NCT02630316), which tested Tyvaso (inhaled four times daily, up to 12 breaths per session) against a placebo in 326 adults with PH-ILD.

Results showed that four months of Tyvaso treatment was superior to a placebo at improving patients’ exercise capacity, meeting the study’s main goal. Significant Tyvaso-related benefits also were found for other measures, such as heart health and disease flares.

Notably, such benefits were seen across several patient subgroups, including those based on the cause of PH-ILD, as well as disease severity, age, sex, dose, and blood flow measurements before the trial.

Tyvaso was generally well-tolerated, with a safety profile consistent with that reported in previous trials. The most commonly reported adverse side effects  included cough, headache, shortness of breath, dizziness, nausea, fatigue, and diarrhea.