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Theravance (TBPH) Submits NDA for COPD Candidate Revefenacin

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Theravance Biopharma, Inc. (TBPH - Free Report) and partner Mylan (MYL - Free Report) announced that the new drug application for the combined entity’s key pipeline candidate, revefenacin (TD-4208), has been submitted to the FDA for treatment of adults with chronic obstructive pulmonary disease (“COPD”).

Notably, revefenacin is an experimental once-daily nebulized long-acting muscarinic antagonist (“LAMA”) to treat COPD.

We remind investors that Theravance and Mylan entered into a development and commercialization agreement for revefenacin in February 2015. Under the terms of the agreement, the companies will codevelop revefenacin for COPD and other respiratory diseases. While Theravance will lead the U.S. registration development program, Mylan will be responsible for the product’s commercial manufacture.

Shares of Theravance have underperformed the industry so far this year. The stock has lost 11.3% while the broader industry has remained flat during the period.


The NDA submission was supported by positive data from two replicate pivotal phase III efficacy studies and a single 12-month, open-label, active comparator safety trial. In October 2016, the company reported positive data from both the phase III studies. The programs met their primary endpoints demonstrating statistically significant improvements over placebo after 12 weeks of dosing for each of the doses of revefenacin comprising 88 mcg once daily and 175 mcg once daily, respectively.

Earlier in July, the company had announced positive data from the 12-month safety study. Findings from the study demonstrated that both the doses of revefenacin were generally well-tolerated with low rates of adverse events and serious adverse events, respectively.

Significantly, the company initiated a phase IIIb study, evaluating revefenacin on patients with low peak inspiratory flow rate in March 2017. Data from the study is expected in early 2018.

Per the company’s press release, COPD is the third leading cause for death in the United States. The grim picture suggests that while 12.7 million Americans are diagnosed with the disease, almost an equal number of patients remain undiagnosed. An approval will be a huge boost as patients who prefer nebulized therapy, have no access to a nebulized LAMA. Hence, there is a large commercial countrywide opportunity for revefenacin in the COPD area.

Zacks Rank & Key Picks

Theravance carries a Zacks Rank #3 (Hold). A few better-ranked stocks in the health care sector include Ligand Pharmaceuticals Inc. (LGND - Free Report) and Achillion Pharmaceuticals, Inc. (ACHN - Free Report) , both carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Ligand’s earnings per share estimates have moved up from $3.68 to $3.70 for 2018 over the last 30 days. The company delivered positive earnings surprises in two of the trailing four quarters with an average beat of 8.22%. Share price of the company has surged 40.5% year to date.

Achillion’s loss per share estimates have narrowed from 65 cents to 63 cents for 2017 and from 74 cents to 67 cents for 2018 over the last 30 days. The company came up with positive earnings surprises in two of the trailing four quarters with an average beat of 4.51%.

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