Newly Merged Amneal Pharmaceuticals to Push into the Biosimilar Space

Earlier this week Amneal Pharmaceuticals and Impax Laboratories completed their business merger, forming the new Amneal Pharmaceuticals. The combined companies are now the fifth largest generics business in the United States.

At the same time, Amneal acquired Gemini Laboratories, a company focused on branded pharmaceuticals. That deal was for $117 million. Gemini’s lead product is Unithroid to treat hypothyroidism. Amneal also entered into a licensing agreement for the U.S. market with Spanish company MabXience SL for its biosimilar candidate for Roche/Genentech’s Avastin (bevacizumab). It is the third biosimilar licensed by Amneal, suggesting the company plans a significant entrance into the biosimilar market.

BioWorld noted, “With the integration of Impax Laboratories Inc. now complete, one of the first orders of business for Amneal Pharmaceuticals Inc. was to initiate a Phase III trial of IPX-203, an oral sustained-release version of carbidopa-levodopa (CD-LD) in individuals with advanced Parkinson’s disease (PD). The move, combined with Amneal’s disclosure of a biosimilar partnership with MabXience SL, on the day Amneal’s shares began to trade on the New York Stock Exchange as AMRX, signaled the Bridgewater, NJ-based company’s intention to move beyond generics and build a pipeline that is at once profitable and ‘more affordable and accessible’ for patients.”

The company’s merged pipeline will include about 149 abbreviated New Drug Applications (ANDAs) filed with the U.S. Food and Drug Administration (FDA) and 135 projects actively being developed. Almost half of all pipeline products are exclusive first-to-file, first-to-market. The company also stated, it “has a foundation for commercial entry into biosimilars through in-licensed products in various stages of development.”

In addition, it holds the first or second spot for half of its products in its commercial generic portfolio out of more than 200 product families. And its top five products account for about 27 percent of total company revenue.

It is also expecting to create annual double-digit growth in net revenue, adjusted EBITDA and adjusted EPS over the next three years.

BioWorld writes, “Unlike its U.S. branded generics portfolio, where the company will pursue opportunities where it can be ‘first to file and first to market’ or have three or fewer competitors at launch, the company is taking a more calculated approach on biosimilars, where it intends to partner strategically.”

“We’re going to be fast followers,” the company’s president and chief executive officer, Rob Stewart, said in a statement. “We’re going to make sure that we’re minimizing our upfront investment, because I want to see how the marketplace matures and develops before we make any kind of major or significant bet there.”

Although the newly merged company’s headquarters is in Bridgewater, New Jersey, Impax’s has offices and manufacturing facilities in Hayward, California, as well as New Jersey, Pennsylvania and Taiwan. Amneal indicates it expects to create annual double-digit revenue and create annual cost synergies of about $200 million. The company didn’t specify where the cuts would come from. The San Francisco Business Times speculates it will likely come from Impax’s real estate in the Hayward area, where it had offices, labs and manufacturing facilities.

“This is a truly transformative combination that firmly established Amneal as an industry leader, with high-value generic product pipelines and a growing specialty business,” said Paul Bisaro, Amneal’s executive chairman, in a statement. “With our combined resources, we are well-positioned to execute our plans to bring high-quality, affordable medicines to patients and generate long-term returns for our shareholders.”