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Theravance Pipeline Strong, Plans Yupelri Launch by Year End

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On Nov 28, we issued an updated research report on Theravance Biopharma, Inc. (TBPH - Free Report) . The company had only one marketed product, Vibativ in its portfolio.

Vibativ is a once-daily dual-mechanism antibiotic approved in the United States, Europe and certain other countries for specifically difficult-to-treat infections. However, in November, Theravance announced that it has signed an agreement with specialty pharma Cumberland Pharmaceuticals to sell Vibativ. Per the deal, Cumberland is entitled to pay $25 million to Theravance besides tiered royalties of up to 20% on the product’s future net sales in the United States.

Earlier this month, Theravance received a huge boost when the FDA approved its investigational product Yupelri (revefenacin) for the maintenance treatment of adults with chronic obstructive pulmonary disease (COPD). Theravance and Mylan are collaborating on the development and commercialization of the drug with a launch expected before 2018 end.

Following the approval, Yupelri became the first once-daily nebulized long-acting muscarinic antagonist (LAMA) option for COPD patients to be approved by the FDA.

Shares of Theravance have lost 4.2% year to date narrower than the industry’s decline of 9.9%.


Apart from this, Theravance has a promising pipeline portfolio to focus on. The company has collaboration agreement with Johnson & Johnson’s (JNJ - Free Report) subsidiary Janssen for developing its JAK inhibitors, TD-1473 and TD-0714, for the treatment of inflammatory intestinal diseases.

Earlier this month, Theravance announced that it has dosed the first patient in a phase II study on its gut-selective pan-JAK inhibitor TD-1473 for the treatment of patients with Crohn's disease. The candidate is also being evaluated in phase Ib study for the treatment of ulcerative colitis.

Also, during the same month, the company dosed the first patient in a phase I study on its novel, inhaled, lung-selective pan-Janus kinase (JAK) inhibitor, TD-8236. The candidate is currently being developed to evaluate its potential for the treatment of various serious respiratory diseases.

Other early to mid-stage pipeline candidates include TD-9855 (neurogenic orthostatic hypotension), TD-6450 (hepatitis C virus/HCV genotype 1 and genotype 4), and TD-8954 (selective 5-HT4 receptor agonist for gastrointestinal motility disorders).

Successful development and subsequent approval of these candidates will be a huge boost to the company.

However, with the potential sale of Vibativ, Theravance is now solely dependent on Yupelri for future revenues. However, the drug is yet to launch and it will take some time to generate revenues. Hence, any kind of regulatory setback for Yupelri could affect the company’s growth prospects.

Zacks Rank & Stock to Consider

Theravance currently carries a Zacks Rank #3 (Hold).

A better-ranked stock in the same sector is BioSpecifics Technologies Corp. , which sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

BioSpecifics’ earnings estimates have been revised 9.6% upward for 2018 and 16.8% for 2019 over the past 60 days. The stock has surged 36.4% year to date.

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