Active Biotech is back, with one last bid for the failed MS drug Teva discarded
Laquinimod was the drug that was going to save Teva.
Over 14 years, the Israeli pharma started the compound on at least 15 clinical trials, 6 of them Phase III. They wanted it to replace the blockbuster multiple sclerosis drug Copaxone. But it failed late-stage study after late-stage study, not only in MS but also Huntington’s. And in 2018, after the fourth major whiff in 18 months, Teva returned the drug and all its rights back to sender: Sweden’s Active Bio.
Now, Active says they’re trying again: in Crohn’s disease and eye disorders.
After vanishing from headlines for a year and a half following Teva’s withdrawal, Active announced it has been conducting a 6-month long review and is now announcing “a new direction for the company.” The reorientation is an all-but emergency measure to salvage a biotech whose future has been in jeopardy since even before their major partner departed.
It will involve halting two early-stage projects, and another bid to keep laquinimod alive. The company has long shown far greater faith in the asset than outside observers, spotlighting the clinical activity even in trials where the primary and secondary endpoint failed.
When Teva walked away, Active said it would continue exploring the drug as a treatment for neurodegeneration, but now, based in part on a Phase IIa study published in 2014, they say the clearest prospect is Crohn’s disease. They’ll also spend the next 12 months studying results in wet AMD and uveitis preclinically. Any Huntington’s and MS efforts are over, they said.
Two other drugs are in play. Tasquinimod, an immunomodulator, will enter a Phase Ib/IIa trial on multiple myeloma in partnership with the University of Pennsylvania Medical School. Naptumomab, partnered with NeoTX, is in Phase Ia/IIb for solid tumors. Projects for immune-modulating compounds paquinimod and SILC have been abandoned.
Active Biotech first notified the public of its precarious situation in December 2017, after the second major laquinimod MS failure, telling shareholders it “lacks funding to ensure its operations for the coming twelve-month period.” CEO Helén Tuvesson, appointed in mid-2017, moved swiftly after Teva’s departure, most notably selling their property in Lund for 275 million SEK (~$29 million).
Teva, meanwhile, has watched the Copaxone competition they hoped to head off come in full force. Novartis and Mylan each now have copycats on the market. And revenues from the drug have fallen precipitously in the last 2.5 years, from a peak of $842 million in the second quarter of 2017, to $271 million as of Q3 2019. Still, that’s less of a drop-off than some analysts expected and have helped keep the company afloat amid other problems across their business, including a faltering generics business and the lawsuits they face for their role in the opioid abuse epidemic.