INDIA — Lupin is set to acquire all rights to two inhalation medicines – Brovana Inhalation Solution and Xopenex Inhalation Aerosol from Sunovion Pharmaceuticals Inc. for a cash consideration US$75 million.
The acquisition of these two brands will expand the company’s inhalation product portfolio in the US and strengthen its presence in the respiratory therapy area while continuing to provide patients access to these important medicines, Lupin said in a statement.
Brovana is indicated for long-term maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease, including chronic bronchitis and emphysema.
Xopenex HFA is a short-acting beta2-adrenergic agonist (SABA), indicated for the treatment or prevention of bronchospasm in adults, adolescents, and children 4 years of age or older.
The acquisitions will expand the company’s portfolio of inhalation products in the US and strengthen its presence in the respiratory therapy area.
The transactions are expected to be accretive to Lupin’s earnings in the first year itself and are likely to be completed over the next 2-3 weeks.
Lupin earned 36 percent of its overall revenue in the financial year 2022 from North America.
Under the regulator’s lens
Lupin is also in focus on Thursday as the USFDA concluded its inspection at the company’s biotech manufacturing facility in Pune. Post the inspection, the regulator issued a form 483 with 17 observations.
However, the company does not see an impact on existing revenues from this facility post the observations.
“We are committed to addressing the concerns raised by the U.S. FDA expeditiously”, the company said in a filing.
It further added, “the Company does not believe that the 483 letter will have an impact on the existing revenues from operations of this facility.”
Lupin has recently been scrutinized by regulators, with the company’s Tarapur plant receiving a warning letter last month for an inspection performed between March and April of this year, as cnbctv18.com reports.
The unit was granted Official Action Initiated (OAI) status in January 2020, and four observations were made during a reinspection in April of this year.
In 2017, the company’s Goa plant received a warning letter, which was lifted in December of last year. In July of this year, its Somerset, New Jersey unit received an Establishment Inspection Report (EIR) with a Voluntary Action Initiated (VAI) status.
Lupin has recently been scrutinized by regulators, with the company’s Tarapur plant receiving a warning letter last month for an inspection performed between March and April of this year.
The unit was granted Official Action Initiated (OAI) status in January 2020, and four observations were made during a reinspection in April of this year.
Among the company’s other outstanding regulatory issues, its Pithampur Unit 2 received a warning letter in November 2017, followed by six observations during the reinspection in January 2019.
Since September 2019, the USFDA has issued a warning letter to Lupin’s Mandideep Unit 1 formulation + API unit.
The management stated that it is still committed to resolving the issues with the regulator as soon as possible.
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