After Multiple Failures, Teva Returns Laquinimod Rights to Active Biotech

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Active Biotech, headquartered in Lund, Sweden, regained the global development and commercialization rights to laquinimod from Israel-based Teva Pharmaceutical Industries.

Teva indicates it did not plan on continuing clinical development of the drug, which it has been conducting since 2004. All rights, including data created in its preclinical and clinical programs, will be picked up by Active.

Laquinomid is an orally-available small molecule developed primarily for neurodegenerative diseases like multiple sclerosis (MS) and Huntington’s disease (HD). The drug was in three completed Phase IIII trials in relapsing remitting MS (RRMS) and a single Phase II trial in Huntington’s. The drug showed a consistent effect on endpoints and MRI parameters in RRMS as well as a “pronounced effect on brain trophy” in both RRMS and HD. The drug has a good safety profile.

“We are grateful for the good collaboration with Teva and for the broad development program that has been carried out for laquinimod,” said Helen Tuvesson, chief executive officer of Active Biotech, in a statement. “The pronounced effect of laquinimod on brain atrophy demonstrated in both RRMS and HD patients supports our belief in the potential of laquinomod as a possible treatment for neurodegenerative diseases, a disease area where the medical need remains high. Therefore, we will assess all opportunities for a continuation of the development of laquinimod.”

Laquinimod is an orally-available selective aryl hydrocarbon receptor (AhR) activator that targets neurodegeneration and inflammation. In addition to MS and HD, clinical studies have been performed in Crohn’s disease and Lupus.

It seems a little peculiar that Active is putting a positive spin on this drug. On July 31, Teva and Active announced that the Phase II LEGATO-HD clinical trial in HD failed to meet its primary endpoint of change from baseline after 12 months of treatment. The secondary endpoint, decrease of brain atrophy, was met. The trial was sponsored by Teva in collaboration with the Huntington Study Group and the European Huntington’s Disease Network.

And on December 1, 2017, the two companies announced that the drug’s Phase II proof-of-concept study of the drug in Primary Progressive MS did not meet the primary endpoint of brain atrophy, nor was the secondary endpoint of time to confirmed disability progression. A reduction in new T2 lesions observed in patients treated with 0.6 mg of laquinimod.

Teva originally went after laquinimod as a possible drug to follow Copaxone, Teva’s blockbuster drug for relapsing MS. That clearly isn’t going to happen, and Teva seemed slow to come to the realization, even if most analysts gave up on the drug some time ago.

Teva has struggled in recent years, including having debt ranging from $30 to $35 billion. It acquired Allergan’s generics business for $40.5 billion back in 2015, but the generics business has struggled because of price competition in the U.S. There has been a fairly steady price erosion in company stock as well. Its high was $70.32 on August 7, 2015, which steadily dropped to a low of $11.40 on November 3, 2017. It’s been slowly recovering, currently trading at $22.67 per share.

The company underwent a reorganization and new leadership in late November 2017, which is about the time the stock started its slow recovery. Part of that reorganization included the company no longer having two separate global organizations for generics and specialty medicines. They were integrated into a single commercial organization that operates through three regions—North America, Europe and Growth Markets. The Generic R&D and Specialty R&D groups were combined into a single global group. It formed a new Marketing & Portfolio group to oversee the interface between regions, R&D and operations. Several executives retired and a new group of managers came in, including Mike McClellan as executive vice president and chief financial officer, Hafrun Fridriksdottir as executive vice president, Global R&D and several others.