Indian pharmaceutical firm Cipla is sharpening its aim to become a leader in respiratory medications in the United States. During its third quarter earnings conference call, Cipla's management highlighted the company's increasing focus on building its respiratory portfolio to drive future growth in the US market.
Cipla announced that it filed two generic respiratory drug applications with the US FDA in the last quarter, including a generic version of Symbicort and one other undisclosed inhalation product. Symbicort is an asthma and COPD medication with over $3 billion in annual sales, presenting a major market opportunity for Cipla's respiratory pipeline.
The company has invested heavily in respiratory drug development over the last few years, with "high single digit" number of assets currently in its pipeline according to MD & Global CEO Umang Vohra. Cipla is also working on several peptide-based respiratory products as part of its specialty drug focus in the US.
Vohra stressed Cipla's aim to maintain lung leadership by continuously building its respiratory portfolio. The company owns a substantial portion of the manufacturing and development value chain for its respiratory products, which provides cost and quality control advantages.
Cipla's respiratory products already account for the dominant share of its US generics business. Its Albuterol inhalation product continues to maintain market share despite recent regulatory challenges, underscoring the strength of Cipla's position.
The company is also making progress on resolving previous US regulatory observations around its manufacturing facilities related to respiratory drug production, which have prevented key drug approvals so far.
Looking ahead, Cipla aims to file its generic Advair product application from an alternative site by mid-FY 2025, which could gain approval towards end of next fiscal year if everything goes according to plan, according to the company. The original Advair filing faced approval delays due to unresolved facility compliance issues.
Cipla is hoping that its respiratory focus will set it up well for the long term even if near term headwinds like price erosion in the US generics market continue to pose challenges. The company aims to launch up to five more peptide products in FY2025, further bolstering its US respiratory leadership credentials.