AbbVie Goes Alone on Arthritis Pill, Galapagos Dropsby and
Galapagos had agreement with AbbVie on rheumatoid arthritis
Shares of AbbVie partner Galapagos fall most since 2011
AbbVie Inc. said it will move ahead with an experimental rheumatoid arthritis pill the company had been developing internally, and drop a partnership on a similar drug with Galapagos NV, a Belgian biotechnology company.
Galapagos shares fell 19 percent to 44.75 euros, their worst single-day drop since April 2011. AbbVie shares rose less than 1 percent to $56.83 at 1:14 p.m. in New York.
AbbVie said in a statement Friday that its rheumatoid arthritis pill ABT-494 would move into the final stage of testing in humans, phase 3, after successful mid-stage trials. AbbVie won’t go ahead with its partnership with Galapagos on filgotinib. Both drugs belong to a class of treatments called JAK1 inhibitors, which modulate the immune system to combat rheumatoid arthritis.
“We believe ABT-494 has the potential to become a best-in-class therapy for patients,” Michael Severino, AbbVie’s chief scientific officer, said in a statement. “In our view, ABT-494 also offers a faster path to phase 3 development with less uncertainty.”
AbbVie’s mention of "uncertainty" about filgotinib may refer to possible testicular toxicity and questions around lipids and anemia, said Samir Devani, an analyst at Rx Securities in London.
“We completely disagree with AbbVie on that position,” Galapagos Chief Executive Officer Onno van de Stolpe said on a conference call with analysts and investors Friday.
Galapagos is in talks with “multiple” potential partners who have expressed interest in filgotinib, Elizabeth Goodwin, head of investor relations for Galapagos, said in a phone interview. The company will initially begin its late-stage testing program on its own, she said.
Van de Stolpe said AbbVie gave him no prior notice on the decision to opt-out, sending him an e-mail at 1:13 p.m. local time, the same time as AbbVie’s press release.
“We notified Galapagos of our decision shortly before we issued our press releases,” AbbVie spokeswoman Adelle Infante said by e-mail.
Knowing that AbbVie had positive results from mid-stage trials of ABT-494, Galapagos had already started making contingency plans, van de Stolpe said. Had AbbVie moved both ABT-494 and filgotinib into final-stage testing in parallel, it would have been a "horror scenario." Van de Stolpe said he is happy to regain full rights to the drug.
The companies agreed to develop the molecule in 2012, with payments to Galapagos worth as much as $1.35 billion, plus additional royalties if the product was eventually approved and went on the market. As the deal included development of the drug for Crohn’s disease, that partnership will also end, AbbVie’s Infante said. A separate collaboration on cystic fibrosis "is ongoing and progressing well," she said.
AbbVie already sells Humira for rheumatoid arthritis. The injection brought in $12.5 billion last year, and made up 63 percent of the North Chicago, Illinois-based drugmaker’s sales. It has been trying to develop new products to diversify its revenue.
AbbVie’s ABT-494 is being tested in patients for whom existing medicines haven’t worked. Rheumatoid arthritis is typically addressed with treatments that fight inflammation, such as the generic drug methotrexate and a class of therapies known as anti-TNFs, which includes Humira.
In the 576-patient, phase 2 studies, ABT-494 reduced symptoms by an important margin in as many as 82 percent of patients for whom methotrexate hasn’t worked, and in as many as 73 percent of those for whom anti-TNFs haven’t.
Fewer than 5 percent of patients in both studies stopped taking ABT-494 because of serious side effects. The most common side effect was headaches, which happened in less than 5 percent of patients on the drug.
(An earlier version of this report gave the incorrect date of the announcement.)