Teva, Alder ink migraine deal to avoid legal headache
- Teva Pharmaceutical Industries Ltd. is sharing one of its patent portfolios with rival migraine drug developer Alder BioPharmaceuticals Inc. to settle a legal spat between the two companies.
- Alder will pay $25 million upfront for a non-exclusive license to make and sell its drug eptinezumab using Teva's patents for anti-calcitonin gene-related peptide (CGRP) antibodies. The license applies to all countries except Japan and Korea.
- Teva may receive another $25 million if the Food and Drug Administration — or any regulatory agency operating where the company's licensed patents exist — approves the drug. Sales milestones of $150 million and royalty payments of 5% to 7% are on the line as well. Per deal terms, Alder has agreed to end its opposition to a European patent held by Teva.
The list of CGRP candidates in late-stage testing is short: Amgen Inc. and Novartis AG's erenumab, Eli Lilly & Co.'s galcanezumab, Teva's fremanezumab, and Alder's eptinezumab.
Each company expects its migraine drug to serve as a key growth driver. That expectation gets loftier, however, as rival therapies enter the market, and therein lies Alder's disadvantage.
Eptinezumab will be last to reach regulators' desks. Alder intends to file eptinezumab with the FDA in the second half of 2018; whereas Biologics License Applications for the three other CGRPs have already been submitted. Amgen and Novartis are leading the pack, securing a target action date of May 17 for erenumab.
Alder has faced clinical challenges as well. While eptinezumab demonstrates solid efficacy, investors have questioned whether it can beat out other treatments.
In June, for instance, positive Phase 3 results showed treatment with a 300 mg dose of the drug cut the number of days each month that patients experienced migraines by 4.3. Yet a high placebo response made the data less impressive than that seen in trials for erenumab and galcanezumab, leading Alder's stock to fall by more than a fifth.
Investors looked more kindly on Alder following the licensing announcement with Teva. Its stock opened at $15.40 on Monday, up 19% from Friday's close. Alder shares continued to rise into Tuesday, trading at $17.62 by late morning.
"This agreement solidifies Alder’s freedom to operate and provides a clear path for us to commercialize eptinezumab and, if approved, deliver this potential treatment option to the many patients suffering from migraine," Randall Schatzman, Alder's CEO, said in a Monday statement.
Surely helping the share price too was another positive readout from the Phase 3 PROMISE 2 study of eptinezumab. Patients treated with the drug had reduction of 8.2 monthly migraine days from baseline versus 5.6 days for those on placebo, meaning it hit the study's primary endpoint. All key secondary endpoints were also met.
Conversely, Teva stock has gone relatively unchanged since the start of the week.
"This agreement reinforces the broad coverage provided by Teva’s IP in the field of anti-CGRP antibodies therapy. At the same time, it also helps facilitate the ongoing development of additional potential therapies in this exciting field – this can only be good for our increased understanding of the area and ultimately improved patient wellbeing”, said Marcelo Bigal, M.D., Ph.D., Chief Scientific Officer and Head of Specialty R&D at Teva.
- Teva Pharmaceutical Industries Ltd. Statement
- Alder BioPharmaceuticals Inc. Statement
- BioPharma Dive A head above the rest? Drugmakers face off in migraine market
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