Theravance Biopharma, Inc. (TBPH - Free Report) and partner Mylan N.V. (MYL - Free Report) announced positive new data from the phase III program on Yupelri (revefenacin) inhalation solution at the European Respiratory Society (ERS) International Congress 2018 in Paris.
The phase III program on Yupelri comprised three trials. Data from the trials showed that treatment with Yupelri for up to 52 weeks resulted in reduction in the rates of chronic obstructive pulmonary disease (COPD) exacerbations ranging from 15% to 18% in moderate to very severe COPD patients as compared to placebo and Spiriva HandiHaler.
The pooled data from the two replicate 12-week pivotal phase III efficacy trials demonstrated that the mean annualized rate of all COPD exacerbations was 0.47 for Yupelri dosed at 175 mcg/day and 0.45 for Yupelri dosed at 88 mcg/day. Data from the 12-month phase III safety trial demonstrated that the estimated annualized rate of all COPD exacerbations was 0.38 for Yupelri dosed at 175 mcg/day and 0.57 for Yupelri dosed at 88 mcg/day compared to 0.46 for Spiriva HandiHaler dosed at 18 mcg/day.
The researchers were interested in a post-hoc analysis of data from the studies to identify trends in this area.
We remind investors that Yupelri, an investigational long-acting muscarinic antagonist (LAMA), is currently under review by the FDA for the treatment of COPD. The FDA has set an action date of Nov 13, 2018.
Per the company, upon approval, Yupelri would be the first once-daily, long-acting nebulized bronchodilator for the treatment of COPD.
Both the companies had previously reported that Yupelri demonstrated statistically significant and clinically meaningful improvements as compared to placebo in trough forced expiratory volume in one second (FEV1) and in overall treatment effect on trough FEV1 (OTE FEV1), after 12 weeks of dosing in two replicate pivotal phase III efficacy studies. Additionally, the companies completed a 12-month phase III safety study, in which no new safety issues were identified.
Theravance and Mylan have entered into a strategic collaboration to develop and commercialize nebulized revefenacin products for COPD and other respiratory diseases. Per the terms, Theravance is conducting the development program for the revefenacin inhalation solution product in the United States, with all costs related to the registrational program reimbursed by Mylan, up until the approval of the first new drug application, after which costs will be shared.
On the other hand, Mylan is responsible for ex-US development and commercialization. Theravance is entitled to receive up to $220 million in development and sales milestone payments as well as a profit-sharing arrangement with Mylan on sales in the United States and double-digit royalties on ex-US sales.
Additionally, Theravance retains worldwide rights to revefenacin delivered through other dosage forms, such as a metered dose inhaler or dry powder inhaler (MDI/DPI) and the rights to nebulized revefenacin in China.
Theravance’s stock has decreased 2.3% so far this year, lagging the industry’s gain of 0.3%.
A tentative approval of Yupelri will boost Theravance’s growth prospects and reduce its dependence on its sole marketed product, Vibativ.
Glaxo’s (GSK - Free Report) once-daily, single inhaler triple combination therapy, Trelegy Elipta is also approved for the long-term, once-daily, maintenance treatment of COPD patients.
Zacks Rank & Key Pick
Theravance Biopharma carries a Zacks Rank #3 (Hold). A better-ranked stock in the healthcare sector is Gilead Sciences Inc. (GILD - Free Report) which sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Gilead’s earnings per share estimates have increased from $6.15 to $6.58 for 2018 and from $6.33 to $6.48 for 2019 over the past 60 days. The company delivered a positive earnings surprise in three of the trailing four quarters with an average beat of 6.43%.
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