Glenmark’s Lonhala Version Hits ‘Intriguing’ Indian Nebulizer Market
Executive Summary
Glenmark’s nebulized, long-acting muscarinic antagonist for COPD has hit the Indian market. Delivered via a novel mesh nebulizer, it is seen as likely catering to a relatively small patient group.
Glenmark Pharmaceuticals Ltd. has introduced glycopyrronium inhalation solution 25mcg (nebulization) on the Indian market, providing additional treatment delivery options for a niche chronic obstructive pulmonary disease (COPD) patient group but potentially more as an add-on therapy, at least going by some early physician speak.
Glenmark’s product, a generic version of Sunovion Pharmaceuticals Inc.'s Lonhala Magnair (glycopyrrolate), is delivered via the Nebzmart nebulization inhalation device, which has been in-licensed from Taiwan’s MicroBase Technologies. Like Lonhala Magnair, Glenmark’s nebulized long-acting muscarinic antagonist (LAMA) has also been approved for COPD and is dosed twice a day.
Last month a subject expert committee (SEC), which advises the Indian regulator on trial-related clearances, recommended glycopyrronium inhalation solution 25mcg (nebulization) for grant of permission to manufacture the product “for the same indication as approved in the US”. (Also see "FDA's NDA And BLA Approvals: Lonhala Magnair, Ozempic" - Pink Sheet, 8 Dec, 2017.)
Lonhala Magnair was approved by the US FDA in Dec. 2017, for the long-term, maintenance treatment of airflow obstruction in people with COPD and was, at the time, the first nebulized LAMA approved for the treatment of COPD in the US; the product has been available in the US since April this year.
Last month, the FDA approved Theravance Biopharma Inc. and Mylan NV’s Yupelri (revefenacin) inhalation solution, a once-daily nebulized LAMA for the maintenance treatment of COPD. (Also see "Mylan/Theravance’s Yupelri Will Launch Late This Year To Address COPD Niche " - Scrip, 12 Nov, 2018.)
The Indian SEC (pulmonary) said that the data presented by Glenmark in support of safety and efficacy of its formulation were “acceptable”. Glenmark, which has been expanding its play in the respiratory segment, had presented in vitro comparative data on particle size distribution, “published reports of clinical trials carried out in other country with glycopyrronium inhalation solution”, among other data, details of the SEC meeting said. Specifics around the exact data provided could not be immediately ascertained.
Improvement Over Conventional Jet Nebulizers
While details around the launch were not immediately clear, the indications are that Glenmark’s glycopyrronium respule is priced at around INR30 each, while the Nebzmart nebulization kit is available at around INR4,500 ($62.80).
Glenmark, in its latest annual report, maintained that the Nebzmart’s active vibrating mesh technology platform is an improvement over conventional jet nebulizers as it is “quieter and enables quicker, more efficient delivery” of the medication. The technology allows children, the elderly and the physically challenged to correctly administer inhaled therapies for asthma and COPD to improve outcomes.
An average 50% of patients are estimated to incorrectly use their MDI (metered dose inhalers)or DPI (dry powder inhaler) devices, leading to poor drug delivery, which results in uncontrolled disease.
The Nebzmart complete nebulization care kit has been launched in India, Brazil, Mexico, Kenya and South Africa, with launches planned in more countries, details in the annual report added.
Nebulizer Solution/Suspension Market Continues To 'Intrigue'
The valuable niche notwithstanding, some key opinion leaders appeared to suggest that Glenmark’s nebulized LAMA would in all probability find its place as an add-on therapy, noting that the nebulized "long-acting solo bronchodilator market never really took off” in India.
Dr Sujeet Rajan, consultant respiratory physician, Bombay Hospital Institute of Medical Sciences and also of Bhatia Hospital, told Scrip that basically most COPD patients don't need regular medication through a nebulizer - they do pretty well with single and dual bronchodilator MDIs with a spacer, or the same drugs through a DPI.
Rajan, though, maintained that the Indian nebulizer solution/suspension market continues to “intrigue” him and that “unbelievably high” usage exists for reasons ranging from novelty to just sheer laziness to use an MDI/DPI effectively and correctly.
“Of course there is a patient population that needs regular nebulized drug delivery (those unable to use other devices) - but that is a small proportion realistically,” Rajan told Scrip.
Add-On Therapy?
The physician also noted how nebulized formoterol alone was “hardly ever used when available”, and is seemingly off the market currently; however, the formoterol plus budesonide combination respule (with little major indication) seems to be used frequently.
“I would see the key role of nebulized glycopyrronium as an add-on to this combination in the maintenance treatment of severe COPD patients who need triple therapy. I do not see this ever (or rarely) being used alone,” Rajan maintained.
He explained that even mild to moderate COPD patients who present to physicians are usually prescribed dual long-acting bronchodilators today. “So the case for a single nebulized LAMA being used alone is very small,” he added.
Rajan also observed that the studies with nebulized glycopyrollate had been done with a mesh-type nebulizer – one that, he believes, is more expensive, and difficult to maintain well.
“This is not the nebulizer frequently used in India, though most certainly a more effective nebulizer. Most doctors and patients in India use only jet nebulizers, where actual drug delivery to the airways could be reduced from label claims, ” he noted.