Just as Active Biotech's big pharma partner Teva ($TEVA) enrolled the first person in its high-stakes gamble on the third big Phase III study for the oral MS drug laquinimod, the Swedish biotech company announced that it had raked in $43 million from a wealthy family. Active says it will use the money to shore up its finances as it prepares for the next step in its evolution. Meanwhile, Teva is scrambling to prove it has a competitive new oral MS drug that can protect its crucial $4 billion franchise for Copaxone, which loses patent protection in 2015.
Laquinimod--seen as a successor to Teva's $4 billion earner Copaxone--has had a troubled history in the clinic. As oral MS drugs like Novartis's approved Gilenya and Biogen Idec's ($BIIB) BG-12--now under review--have advanced, Teva turned to laquinimod as its main hope for a competitive next-gen approach. But it failed to beat out a placebo on a standard measure of efficacy: Reducing the rate of relapses among patients.
Some analysts quickly read the last rites on laquinimod, shaking their heads over any possible commercial value for the drug, especially as new oral drugs were being steered to the marketplace by heavyweight contenders. Rather than bury the program, though, Teva doubled down and came back with a new Phase III study designed to demonstrate that a higher dose of the drug delays the progressive loss of muscle control.
Just days ago Teva--which has been building up its R&D efforts--also filed for a patent on a combination of Copaxone and laquinimod, intrigued by the market potential of a unique combo strategy. That drug, though, would have to be injected, limiting its appeal as new oral drugs promise to scoop up a growing segment of the market.
Teva plans to recruit 1,800 patients for the new Phase III study, CONCERTO, which will compare the old 0.6 mg dose of laquinimod alongside a 1.2 mg dose. Laquinimod is also in Phase II for Crohn's and lupus.
"Previous Phase III studies in more than 2,400 people with RRMS [relapsing-remitting multiple sclerosis] suggest a unique profile of laquinimod, directly affecting the neurodegenerative processes that lead to disability progression, the main concern in the treatment of RRMS," said CONCERTO principal investigator Dr. Timothy Vollmer, a professor of neurology at the University of Colorado, Denver. "We are currently enrolling patients in this third pivotal study to further examine the clinical benefits of laquinimod on disability progression, the primary endpoint of the CONCERTO trial, and brain atrophy.
Active Biotech raised the cash from Investor AB, the investment arm of Sweden's Wallenberg family, which bought 6 million new shares at 45 kronor each. Active is also partnered with Ipsen on the prostate cancer drug TASQ and has other drugs in development as well.
"I am very pleased to see that Active Biotech's project portfolio has obtained additional financing from Investor," says Active CEO Tomas Leanderson. "Active Biotech's portfolio has now matured and, accordingly, our focus over the next 18-month period will be on finding suitable partners and partnering structures for each project. A strong financial position is a prerequisite in order to succeed with this activity in an optimal way."
- here's the release on the laquinimod Phase III
- get the release on Active's $43M raise