United Therapeutics Corporation UTHR announced that it has enrolled the first patient in the phase III TETON study which is evaluating Tyvaso for the treatment of adult patients with idiopathic pulmonary fibrosis (“IPF”).
The double-blind, placebo-controlled phase III registration study will evaluate the safety and efficacy of Tyvaso in patients with IPF over a period of 52 weeks. The study will investigate the impact of Tyvaso in approximately 396 adult patients on a key prognostic indicator for IPF known as forced vital capacity (“FVC”).
The primary endpoint of the study is to see the change in FVC from baseline at week 52 of treatment.
Shares of United Therapeutics have rallied 15.4% so far this year against the industry’s decline of 12.6%.
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We note that, Tyvaso, an inhaled version of treprostinil, is already approved to treat pulmonary arterial hypertension (“PAH”) and pulmonary hypertension associated with interstitial lung disease (PH-ILD; WHO Group 3).
PH-ILD is a serious, life-threatening lung disease for which Tyvaso is currently the only FDA-approved treatment.
Tyvaso is one of the key drugs in United Therapeutics’ commercial portfolio, generating almost a third of total revenues. In the first quarter of 2021, Tyvaso sales totaled $123 million, up 20% year over year, gaining from higher volumes as a result of patient growth.
Per the company, an estimated 100,000 people are affected by IPF in the United States. Hence if successfully developed and upon potential label update to include the IPF indication, Tyvaso's eligible customer base in the United States will increase, thus driving sales of the drug higher.
Notably, in April 2021, United Therapeutics submitted a new drug application (“NDA”) seeking approval of Tyvaso dry powder inhaler/Tyvaso DPI for both PAH and PH-ILD indications with a priority review voucher (“PRV”). The PRV was redeemed upon submission of the Tyvaso DPI NDA.
The NDA filing was based on data from the BREEZE study, which met its primary objective of demonstrating safety and tolerability of Tyvaso DPI in PAH patients who transitioned from Tyvaso Inhalation Solution.
Other than Tyvaso, United Therapeutics markets three other PAH medicines in the United States – Remodulin, an injectable formulation of treprostinil; Orenitram, an oral version of treprostinil; and Adcirca tablets. Please note that Eli Lilly LLY markets Adcirca as Cialis and the drug has lost patent protection, resulting in several generic versions being available.
Zacks Rank & Stocks to Consider
United Therapeutics currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the healthcare sector include Catalent, Inc. CTLT and Xencor, Inc. XNCR, both carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Catalent’s earnings estimates have been revised 1.7% upward for 2021 and 2.4% upward for 2022 over the past 60 days.
Xencor’s loss per share estimates have narrowed 34% for 2021 and 12.2% for 2022 over the past 60 days.
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