Pfizer, Celgene's ​Brazilian subsidiaries, others, queried about substitutes in AbbVie-Allergan deal

23 October 2019 2:16pm
prescription drug substitutes

21 October 2019. By Ana Paula Candil.

Brazilian subsidiaries of Pfizer, Celgene, Bristol-Myers Squibb, Eli Lilly, Johnson & Johnson and UCB were asked by the national competition authority reviewing the AbbVie-Allergan deal whether there are close substitutes for medicines to treat Crohn’s disease, noninfectious uveitis and ulcerative colitis.

Chicago-based AbbVie is planning to acquire Dublin-based Allergan for $63 billion.

The drugmakers told the Administrative Council for Economic Defense, or CADE, in initial filings that their deal will result in “potential overlaps” concerning pipelines in the market for treating Crohn’s disease and ulcerative colitis, but those treatments don’t compete because they're at different stages of clinical testing and undergo distinct biochemical reactions.

In questionnaires sent Oct. 17 to Eli Lilly do Brasil, Janssen do Brasil, UCB-Biopharma Brasil, Laboratórios Pfizer, Brstol-Myers Squibb Farmacêutica, Celgene Brasil and UCB-Biopharma Brasil, CADE asked whether medicines to treat Crohn’s disease compete and can be substituted by each other, regardless of disease stage and the medicines’ biochemical reactions. The agency had the same questions concerning treatment of noninfectious uveitis and ulcerative colitis.

Crohn's disease is a chronic inflammatory condition of the gastrointestinal tract, and ulcerative colitis is a chronic disease that affects only the colon. Noninfectious uveitis is a sight-threatening intraocular inflammatory condition characterized by inflammation of the uvea.

CADE also asked for rivals’ opinion about whether the deal could affect market investment in research and development of treatments for those diseases.

The companies queried have until Oct. 25 to respond.

— Notification form —

AbbVie and Allergan notified their deal to CADE using the fast-track procedure – meaning the parties’ combined shares in overlapping markets are below 20 percent, and the agency has a 30-day deadline to issue a decision.

The parties told CADE their deal will result in overlaps concerning pipelines in the market for Crohn’s disease, where AbbVie markets Humira, and Allergan is developing a treatment. AbbVie is also developing a new medicine to treat Crohn’s disease.

Their deal will also result in potential overlaps in pipelines in the market for treating moderate to severe ulcerative colitis, AbbVie and Allergan said.

Deal overlaps, however, won’t affect competition because they involve medicines with distinct biochemical reactions that will be used in different disease stages, AbbVie and Allergan said.

They also said market competition is high. “There is intense development activity of new products in this area, involving many of the world’s industry leaders such as Johnson & Johnson/Janssen, Celgene, Gilead/Galapagos, Eli Lilly and BMS,” AbbVie and Allergan said in their initial filings.

Drugmakers suffer pressure from imports, as most medicines for Crohn’s disease and ulcerative colitis sold in Brazil are imported to the country. That’s the case of AbbVie’s Humira, the parties said.

AbbVie and Allergan’s submissions are partially confidential, and it isn’t clear whether they overlap in the pipeline market for treating noninfectious uveitis or why CADE queried companies about that specific market.

AbbVie and Allergan submitted merger paperwork on Aug. 22, but amended their notification form, pushing the review deadline to Nov. 14.

AbbVie and Allergan are listed on the New York Stock Exchange.