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Lannett makes deal for distribution of generic Advair in US

Lannett said that it has signed a US distribution agreement for rights to Respirent Pharmaceuticals’ generic Advair Diskus. The agreement would begin after FDA approval and would continue for 10 years after distribution begins. Lannett said that it would pay an unspecified upfront payment and future milestones and that it would receive a portion of net profits during the term of the agreement.

A Phase 3 trial for the Respirent fluticasone propionate/salmeterol DPI is listed on clinicaltrials.gov as starting in October 2018, with an expected completion date in June 2019. The current recruitment status is listed as “recruiting.”

Lannett CEO Tim Crew commented, “We are pleased to establish a strategic alliance with Respirent, a respiratory focused company developing dry powder inhaled respiratory pharmaceutical products. Moreover, Respirent has substantial capabilities around inhalation products and the distinction of being one of the few companies that have progressed generic Advair Diskus through the clinical stage.  We are working with the Respirent team to complete the product filing, which we expect to submit to the FDA in the second half of our current fiscal year. 

Crew continued: “Generic Advair Diskus represents a potentially large market opportunity, especially for a company of our size.  Over the last 18 months, our strategy for in-licensing products has been focused on near-term opportunities; more recently, we have begun layering in products that have the potential to drive substantial growth to our business over the medium term and beyond.”

Read the Lannett press release.

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published on October 1, 2019

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