String Of Positives For Lupin Lifts Outlook
Regulatory clearances for some key sites awaited
Tentative FDA approval for Lupin’s arformoterol tartrate inhalation solution and a potential EC nod for etanercept are seen aiding the company’s prospects in FY2021. Besides, success in a Phase III trial for secnidazole to treat trichomoniasis bodes well, though manufacturing clearances and continuity will also be closely watched.
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Lupin CEO Vinita Gupta shares plans to shift manufacture of albuterol and some other products to its US facilities, with a rollout of a generic to Teva’s ProAir expected soon. Enthused by Lupin’s first biosimilar introduction In Europe with etanercept and looking to up the company’s digital game, the executive says Amazon’s entry into India’s e-pharmacy space is not a near-term worry
Despite plans to launch a biosimilar to Enbrel in August and a generic to ProAir in September, Lupin cut its FY21 EBITDA forecast to 17% from 19-20%, as first-quarter revenues were hit by COVID-19 and a recall of metformin in the US. Meanwhile, it sees the US “Buy American” order for some essential medicines as a near-term opportunity
Lupin hopes a surge in demand for albuterol sulphate due to increased off-label use in COVID-19 patients will help its generic version, which is likely to be launched in the first half of FY21. But the Indian firm may recall a batch of metformin after the US FDA recently asked a few companies to retract extended-release versions due to NDMA concerns.