- Teva's hopes for a follow up to its blockbuster Copaxone (glatiramer) in multiple sclerosis have been blighted by laquinimod’s failure to meet the primary endpoint in the CONCERTO trial in relapsing-remitting multiple sclerosis (RRMS). Laquinimod wasn’t able to delay the time to confirmed disability progression compared with placebo (p = 0.7057) in patients with RRMS.
- The study did meet a number of the secondary endpoints, including improvements in the change in brain volume over time, increasing the time to first relapse, and reducing the annualized relapse rate.
- Teva has confirmed that it is going to drop the development of laquinimod in RRMS, but continue in primary progressive MS (PPMS) and Huntington disease.
The failure of laquinimod in RRMS comes as a blow to Teva, as the company tries to recover from generic and patent attacks to its bestselling drug, Copaxone (glatiramer). Following patent expiry of the original formulation and the launch of a generic 20 mg dose by Novartis’ Sandoz in 2015, Teva has worked hard to extend the life of its flagship drug.
Teva has since developed a higher dose version of the drug that lasts longer. The company has priced that version competitively and managed to transfer a large proportion of patients over to the 40mg formulation. The new formulation has patent protection under five patents, providing protection until 2030.
However, the effort may be for naught; generic giant Mylan has managed to use legal means to undermine the patent coverage of the extended release formulation, overturning four patents and expecting a decision on the fifth this month.
The generic threat could cut as much as $1.3 billion from Teva’s 2017 revenues, said the company during its fourth quarter earnings call in February.
This isn’t the only challenge on Teva’s plate. The beleaguered company doesn’t currently have a CEO, after ousting Erez Vigodman and replacing him with chair of the board Yitzhak Peterburg on an interim basis. Once a new leader is brought in, this would be the fifth CEO in as many years. Teva has also faced charges of price fixing and bribery. The Israeli firm's share price has reflected the constant turmoil at the company, dropping 24% over the last six months.