AbbVie, Allergan sell 3 drugs to win U.S. antitrust clearance—and send AZ, Nestlé into new realms

AbbVie and Allergan is selling Zenpep and Viokace to Nestlé and returning brazikumab to AstraZeneca as the pair looks to seal their $63 billion merger. (Kritchanut/iStock/Getty Images Plus/Getty Images)

AbbVie and Allergan may actually win U.S. antitrust clearance for their $63 billion tie-up soon, thanks to three product selloffs that will propel buyers AstraZeneca and Nestlé into relatively new territories.

AstraZeneca is taking back brazikumab, an IL-23 inhibitor currently under testing in Crohn’s disease and ulcerative colitis. And Nestlé is purchasing two Allergan pancreatic replacement enzymes, Zenpep and Viokace.

Brazikumab and Zenpep landed on the chopping board awhile ago as Allergan voluntarily offered them up in hopes of a smooth antitrust review. But the Federal Trade Commission (FTC) hit the pair with a “second request” anyway as part of a more detailed evaluation of the deal. Now, adding Viokace to the selloff mix might just have satisfied the U.S. antitrust watchdog.

“These definitive agreements represent significant progress toward the completion of our acquisition of Allergan,” AbbVie Chairman and CEO Richard Gonzalez said in a statement Monday, as Allergan chief Brent Saunders concurred.

Zenpep and Viokace will be offloaded because they overlap with AbbVie’s Creon in treating exocrine pancreatic insufficiency (EPI) patients who suffer from the inability to digest food properly due to missing enzymes.

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Their buyer, Nestlé, exited all prescription drugs—marketed or in R&D—after spinning off skin health specialist Galderma and gastrointestinal disease diagnostics and treatment developer Prometheus Laboratories in 2019. Is the Swiss food giant taking a U-turn?

“[T]he fact that it is a prescription drug was secondary to the fact that it is a nutrition-enabling solution” for patients with EPI, a Nestlé spokeswoman said in a written statement to FiercePharma. “Zenpep is a natural fit within our gastrointestinal medical nutrition portfolio. It complements other products and is aligned with our approach of nutritional support for ingestion, digestion and absorption.”

Nestlé’s medical nutrition business—which sells popular nutritional drinks such as Boost and Resource—has been working with healthcare professionals on its over-the-counter products also used in hospitals and clinics. The range covers therapeutic areas including cystic fibrosis, gastrointestinal and oncology, she added.

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About 90 Zenpep employees are expected to join Nestlé Health Science as part of the transaction. In the first nine months of 2019, Zenpep brought in $207.9 million, up 21.9% year over year. Still, it was no match for AbbVie’s Creon, with a $749 million haul during the same period that marked a 12.4% increase over the previous year.

As for AstraZeneca, the British drugmaker originally licensed out brazikumab to Allergan in 2016 because its inflammatory bowel disease (IBD) indications fall outside the company's three main therapy areas, namely respiratory, cardiovascular and metabolic disease, and oncology.

But this time around, Mene Pangalos, AZ’s executive vice president of biopharmaceutical R&D, said: “We’re pleased to bring brazikumab back into the AstraZeneca pipeline.” The lack of a GI pipeline begs the question: Is AZ simply holding onto the drug as a transition plan before finding it a new home?

According to an AstraZeneca spokesman, it previously transferred brazikumab because it was striving to return to growth. “Now that we have returned to growth, the company is now in a position to competitively commercialize a potential new medicine like brazikumab,” he said.

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Brazikumab’s being let go as AbbVie’s own newly approved IL-23 inhibitor Skyrizi’s also eyeing the IBD market. Carrying blockbuster hopes, Skyrizi recently topped Novartis’ IL-17A antagonist Cosentyx at clearing psoriasis patients’ skin in a phase 3 trial.

While inflammatory GI disease is a relatively new area for AZ, the drugmaker boasts a growing presence in immunology in general. Its IL-5 inhibitor Fasenra is rapidly stealing market share in asthma and is being evaluated in seven eosinophil-driven diseases beyond respiratory. AZ also has some history in other GI maladies, given its years of blockbuster sales for now-off-patent acid reflux med Nexium.

With these three planned selloffs, AbbVie and Allergan look on track to win FTC approval after winning a European green light a few days ago. The pair continues to expect to wrap up the deal in the first quarter.