Amneal and Impax Merge; Amneal Announces Biosimilar Development Agreement

Earlier this week, Amneal Pharmaceuticals and Impax Laboratories announced the completion of their merger. The newly formed company will be named Amneal Pharmaceuticals, led by Robert Stewart as president and CEO. The finalization of the merger makes Amneal the fifth largest generic drug maker in the United States.

“We are very excited for the future of Amneal, and strongly believe that with our team, differentiated product portfolio, extensive [research and development], and manufacturing infrastructure and expertise, Amneal is well positioned to become an industry leader,” said Chirag Patel and Chintu Patel, co-founders and co-chairmen of Amneal, in a statement.

Stewart offered his own take on the future of the combined company, stating that he believes Amneal will swiftly begin to utilize their merged product portfolio while generating “strong cash flow to support the rapid repayment of debt and further investment in growth opportunities.”

In addition, the new Amneal Pharmaceuticals looks to cut about $200 million in costs over the next 3 years, though exactly where the cuts are going to come from was undisclosed.

However, this is not the only news from the new company this week, as it also announced a deal with Spain-based company mAbxience to be the exclusive US partner for a potential bevacizumab (Avastin) biosimilar.

Exact terms of the deal were not revealed, but this is not the first agreement of its kind for Amneal, who, according to San Francisco Business Times, already has exclusive rights to proposed biosimilar versions of filgrastim (referencing Neupogen) and pegfilgrastim (referencing Neulasta) developed in an agreement with Adello Biologics. However, a representative of Adello Biologics offered clarification to The Center for Biosimilars^® that the agreement struck between the 2 companies was not "tied to Adello's filgrastim or pegfilgrastim programs. Those are being developed solely by Adello without any [research and development] efforts by Amneal, and no terms have been publicly disclosed regarding those assets."

Amneal’s deal with Adello Biologics was based on a cost-sharing agreement made in the first quarter of 2017, for which Adello paid Amneal $10 million for cumulative research and development spending. Though the deal is being terminated, according to an investor presentation made by the company in October 2017, the filgrastim biosimilar has been filed for FDA approval by Adello, and its pegfilgrastim biosimilar candidate could be filed for FDA approval in the second half of 2018.