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United Therapeutics (UTHR) Gains on Tyvaso DPI Approval

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United Therapeutics Corporation (UTHR - Free Report) announced that the FDA has approved the new drug application for the dry powder inhalation (DPI) formulation for its key pulmonary arterial hypertension (PAH) drug, Tyvaso (treprostinil). The NDA also included a device for the administration of the new formulation.

Tyvaso is approved for use as an inhalation solution administered using only the Tyvaso Inhalation System for improving exercise ability in patients with PAH or pulmonary hypertension associated with interstitial lung disease (PH-ILD). The new DPI formulation will be marketed as Tyvaso DPI, targeting both approved indications of Tyvaso.

The DPI formulation of treprostinil will be administered using only a dry powder inhaler approved by the FDA for use in PAH and PH-ILD. United Therapeutics has started launch activities for the drug and expects the availability of the drug-device combination therapy for patients in June.

Shares of United Therapeutics gained 8.8% on May 24, following the FDA approval for Tyvaso DPI. In fact, the company’s shares have gained 1.3% so far this year against the industry’s decline of 25.9%.

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United Therapeutics has developed the new DPI formulation and device of Tyvaso in partnership with MannKind Corporation (MNKD - Free Report) . Tyvaso DPI incorporates the dry powder formulation technology and Dreamboat inhalation device technology used in one of MannKind’s FDA-approved drugs. Per an existing agreement, MannKind is responsible for manufacturing and supplying Tyvaso DPI to United Therapeutics.

United Therapeutics believes that the DPI formulation will provide a treatment option to PAH and PH-ILD patients with easier administration as well as one that has the potential to deliver the proven efficacy of treprostinil through a small inhaler that fits in the palm of the patient’s hand.

The drug-device product offers some benefits over the nebulized Tyvaso Inhalation Solution, which is already approved in the United States to treat PAH and PH-ILD. Tyvaso DPI is expected to be less time-consuming to administer, and more mobile and convenient. If approved, Tyvaso DPI has the potential to expand Tyvaso’s use in both Group 1 and Group 3 pulmonary hypertension

United Therapeutics is evaluating Tyvaso in additional pulmonary hypertension patients. Key phase III programs include Tyvaso in WHO Group 3 pulmonary hypertension patients who have COPD (PERFECT study), Tyvaso in patients with various forms of chronic fibrosing interstitial lung disease (TETON studies) and oral ralinepag (PAH — ADVANCE CAPACITY and ADVANCE OUTCOMES studies). The first TETON study in patients with idiopathic pulmonary fibrosis (IPF) is currently enrolling patients. The second phase III study of Tyvaso in IPF patients, TETON 2 will be conducted in the United States and is expected to commence soon. Enrollment is ongoing in the PERFECT, ADVANCE CAPACITY and ADVANCE OUTCOMES studies.

United Therapeutics has three other products for PAH — Remodulin, Adcirca, and Orenitram, all of which use the PAH drug substance, treprostinil.

Please note that United Therapeutics’ competitor in the PAH field, Liquidia Corporation (LQDA - Free Report) lost 28.3% on May 25, following the approval to Tyvaso DPI. Liquidia has already developed a DPI formulation of treprostinil, Yutrepia, targeting PAH patients. The therapy gained FDA approval in November last year. However, Liquidia is yet to start its commercialization due to a regulatory stay in the United States related to an ongoing patent litigation with United Therapeutics.

United Therapeutics had sued Liquidia for patent infringement in 2020, which led to the regulatory stay on the commercialization of Yutrepia in the U.S. market till Oct 27, 2022. United Therapeutics also sued Liquidia over alleged misappropriations of certain trade secrets in December 2020.

Liquidia believes that the DPI formulation of Treprostinil will provide a market opportunity of more than a billion dollars in the next few years. The launch of Tyvaso DPI earlier than Liquidia’s Yutrepia will certainly hurt the latter’s potential. An early launch of Tyvaso DPI is likely to help it gain market share faster with no competition.

Zacks Rank & Stock to Consider

United Therapeutics currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

ProPhase Labs (PRPH - Free Report) is a better-ranked stock from the same sector. It sports a Zacks Rank #1.

Earnings estimates for ProPhase’s 2022 bottom line have improved from earnings of 27 cents per share to 55 cents per share over the past 30 days. PRPH stock is up 16.4% this year so far.

ProPhase exceeded earnings expectations in two of the last four quarters, while missing the same twice. The company has a negative four-quarter earnings surprise of 130.56%, on average.