Mylan/Theravance’s Yupelri Will Launch Late This Year To Address COPD Niche
Executive Summary
Yupelri was approved by the US FDA as the first nebulized long-acting muscarinic antagonist for once-daily treatment of chronic obstructive pulmonary disease.
Partners Mylan NV and Theravance Biopharma Inc. expect Yupelri (revefenacin) will be an important product for a niche group of chronic obstructive pulmonary disease (COPD) patients who require or prefer nebulized treatment. The long-acting muscarinic antagonist (LAMA) was approved by the FDA Nov. 9 as the first and only once-daily nebulized bronchodilator approved for the treatment of COPD.
"We believe there is a significant and enduring market niche here of 9% of COPD patients that are not well served today," Theravance CEO Rick Winningham said in a same-day conference call.
LAMAs are a cornerstone of treatment for COPD in the inhaled respiratory space and recognized as a gold standard for first-line treatment under the Global Initiative for Chronic Lung Disease (GOLD) guidelines. Yet, there have not been many nebulized LAMA options on the market. Two nebulized products – Mylan's Performist (formoterol fumarate) and Sunovion Pharmaceuticals Inc.'s Brovana (arformoterl tartrate) – are approved for COPD, but they are both long-acting beta2-adrenergic receptor agonists (LABAs). They are also dosed twice a day, in the morning and evening.
Sunovion also won approval last year for a nebulized LAMA, Lonhala Magnair (glycopyrrolate), for COPD but it has limitations. It is dosed twice a day and is approved for use only with the Magnair device. Yupelri has the advantage of being dosed once a day and works with a broader range of nebulizers, including standard jet nebulizers.
Nebulizers are electric or battery-powered machines that turn liquid asthma medicine into a fine mist. Around one in 10 COPD patients in the US relies on a nebulizer, due to dexterity issues, cognition limitations or inability to breathe forcibly enough to aerosolize the drug via the handheld product.
Solid Growth Potential
Theravance and Mylan said they expect to begin shipping the product in December and did not disclose pricing.
Commercially, it is expected to be a new growth-driver for the two companies, despite the niche positioning. (Also see "Are Theravance And Mylan's US COPD Chances Bigger Than First Thought?" - Scrip, 24 Jul, 2017.) Leerink analyst Geoffrey Porges, in an Oct. 29 research note ahead of the approval, forecast that it could generate more than $300m in sales by 2025.
"We believe that a large proportion of the current nebulized LABA population will either incorporate or switch onto a nebulized LAMA therapy," Porges said, pointing out that LAMAs are the preferred treatment over LABAs. Brovana and Performist generated around $450m in 2017, he said.
The FDA approval was based on the positive results of two Phase III trials enrolling 1,250 patients, showing that treatment with revefenacin resulted in improvements in forced expiratory volume at one second (FEV1), as well as the results of 12-month safety study.
Mylan partnered with Theravance on revefenacin in February 2015, paying $45m up front and agreeing to fund Phase III development and US regulatory submissions through the first approval. SC027694 Mylan has full ex-US development and commercialization rights, excluding China, with Theravance eligible to share profits in the US and earn royalties on sales in other geographies. Theravance could also earn up to $220m in milestone payments. [See Deal]
Theravance said it could still receive $160m in milestones related to Yupelri monotherapy, including $150m in sales milestones and $10m related to regulatory actions in Europe.
Mylan will lead US commercialization but Theravance will co-promote the product. Theravance said it would hire a sales force of about 30 reps to sell the product, focusing largely on hospitals with a high incidence of COPD, which are also generally areas with a high historical smoking rate. The company sells the antibiotic Vibativ (telavancin), and receives revenues under its partnership with GlaxoSmithKline PLC on Trelegy Ellipta (fluticasone/umeclidinium/vilanterol) for COPD.
For Mylan, the launch reflects an emphasis on building in respiratory disease. The company already markets Performist, and recently acquired Novartis AG's cystic fibrosis drugs TOBI Podhaler and TOBI solution for $463m. (Also see "Deal Watch: Mylan Clears Up Mystery, Acquires TOBI Cystic Fibrosis Products From Novartis" - Scrip, 6 Sep, 2018.) The company is also hoping to be the first to market with a generic version of GlaxoSmithKline's asthma blockbuster Advair, which is pending at FDA with action anticipated soon.