(Reuters) – Mylan NV has reached a tentative agreement to pay $30 million to resolve a probe by the U.S. Securities and Exchange Commission related to its emergency allergy shot EpiPen, which became the center of a firestorm over price increases.
The drugmaker in a regulatory filing on Monday disclosed that it had reached an agreement-in-principle with the SEC’s enforcement staff to resolve the investigation that dated back to 2016. Mylan said it will neither admit nor deny wrongdoing as part of the accord. (bit.ly/2ym0CaO)
The EpiPen, which Mylan acquired in 2007, is a handheld device that treats life-threatening allergic reactions by automatically injecting a dose of epinephrine.
Mylan came under fire in 2016 after raising the price of a pair of EpiPens to $600, from $100 in 2008, enraging consumers and putting it in the center of the ongoing U.S. debate over the high cost of prescription medicines.
In 2017, the drugmaker finalized a $465 million settlement resolving U.S. Justice Department claims it overcharged the government for EpiPen.
The deal resolved claims that Mylan avoided higher rebates to state Medicaid programs by misclassifying EpiPen as a generic product, even though it was marketed and priced as a brand-name product.
In 2016, Mylan revealed the SEC had launched its own investigation related to EpiPen and sought copies of its communications with the U.S. Centers for Medicare and Medicaid Services and documents related to the Medicaid rebate program.
Mylan said the settlement with the SEC is subject to approval by the agency’s commissioners.
Separately on Monday, Mylan confirmed that it would merge with Pfizer Inc’s off-patent branded drugs unit, a move that will help it diversify its business as it continues to be pressured by falling prices of generic drugs in the United States.
Shares of generic drugmakers have suffered over the past several years and, this year alone, Mylan shares had lost one-third of their value through Friday, before news broke of the Pfizer tie-up.
The companies are also in talks to transfer a Pfizer manufacturing unit that makes EpiPen to the newly created business, although it remains unclear whether this will address an ongoing shortage of the product.
Reporting by Tamara Mathias in Bengaluru and Nate Raymond in Boston; Editing by Shailesh Kuber