Verona touts 'exceptionally strong' launch of blockbuster hopeful COPD treatment Ohtuvayre

Verona Pharma is off to a promising start as it launches its first product, Ohtuvayre, a maintenance treatment for chronic obstructive pulmonary disorder (COPD). In 2024, Ohtuvayre generated sales of $42 million, the company reported on Tuesday.

When it was approved by the FDA in June of last year, Ohtuvayre became the first novel treatment advance in the indication in more than a decade. Then, three months later, the FDA signed off on Dupixent as the first biologic treatment for COPD, expanding its label to six indications and prompting analysts at Evercore ISI to proclaim its peak sales potential at $20 billion.

The newly approved COPD treatments aren't in direct competition as Ohtuvayre is for patients with persistent dyspena, while Dupixent is more for those with persistent excerbations.

Verona, has ginned up strong numbers for its first launch. Of the $42 million in sales, $36 million came in the fourth quarter. Ohtuvayre was prescribed by 3,500 different healthcare professionals, who filled out 16,000 orders in 2024, the company said. Roughly one-third of the prescriptions were patient refills.

“Key metrics showed month over month growth,” Verona CEO David Zaccardelli said in a statement. “Specifically, filled prescriptions increased by over 35% each month in the fourth quarter and physicians continued to prescribe Ohtuvayre across a broad COPD population including those receiving background single, dual and triple therapy.”

Ohtuvayre has a lot going its way. It was approved for use as a monotherapy or as an add-on medicine with current therapies. Additionally, as a selective dual inhibitor of the phosphodiesterase 3 (PDE3) and phosphodiesterase 4 (PDE4) enzymes, it combines two properties in one medicine, setting it apart in COPD for its ability to both open the airways of patients and reduce their inflammation.

“While it is still early in the launch, feedback from HCPs and patients is consistently positive including robust refill rates and increasing prescriber depth with over 150 HCPs prescribing Ohtuvayre to more than 20 patients in their practice,” Zaccardelli said, describing the launch as "exceptionally strong."

Verona expects to report its end-of-year cash and cash equivalents at $400 million, the company said, up from $272 million at the end of 2023. Verona explained that it sold $100 million in shares under an “equity offering program” at an average price of $39.35 per share in the fourth quarter.

Ohtuvayre is administered twice daily by a jet nebulizer, with sessions lasting between five minutes and seven minutes.

Verona charges $2,950 for a monthly dose of Ohtuvayre. The $35,400 annual price exceeds the cost-effectiveness threshold (PDF) of between $7,500 and $12,700 per year established by the Institute for Clinical Economic Review, which assesses the value of pharmaceutical products.

Analysts see the drug achieving blockbuster status quickly, with GlobalData estimating sales to reach $1.05 billion by 2029.

In the wake of the launch update, investors sent the company's share price up by about 11% to $49.72 on Tuesday.

Meanwhile, other companies are rushing to the space with prospective COPD medicines. In September, GSK reported that its respiratory blockbuster Nucala plus inhaled maintenance therapy lowered the rate of moderate or severe exacerbations among COPD patients. Amgen and AstraZeneca have hopes for their asthma drug Tezspire as a potential COPD treatment. Additionally, Regeneron and Sanofi have a second COPD candidate in IL-33 inhibitor itepekimab, which is being tested in two phase 3 trials.