Alder BioPharma Migraine Drug Scores In Trial; Stock Spikes
Small biotech Alder BioPharmaceuticals ( ALDR ) soared more than 50% to a two-month high in early trading Monday after its migraine drug candidate succeeded in a mid-stage trial, positioning it to compete with some giant rivals. Alder said that a single intravenous infusion of its monoclonal antibody, ALD403, had significantly reduced migraine days over a 12-week period compared to a placebo. Depending on the dose, between 44% and 57% of patients experienced a 50% reduction in migraine days, while 27% to 33% experienced a 75% reduction. “Evaluation of ALD403 continues to exhibit a potential best-in-class profile, which includes immediate, significant and durable migraine prevention with infrequent quarterly dosing,” Alder CEO Randall Schatzman said in a statement. “With our commitment to the accelerated development of ALD403 reinforced by today’s positive results, we look forward to advancing our development plan, and assuming FDA approval, independently marketing ALD403 in the U.S. to meet the critical medical needs of the 13 million patients nationwide who are candidates for migraine prevention therapy.” Alder’s decision to market its drug without a big-pharma partner, unusual for a small biotech, could pit it against some very big competitors developing similar drugs. ALD403 is an anti-calcitonin gene-related peptide (CGRP) antibody, similar to migraine candidates being developed by Amgen ( AMGN ), Teva Pharmaceutical Industries ( TEVA ) and Eli Lilly ( LLY ). Alder’s drug is distinguished by its infrequent dosing: Amgen and Teva’s drugs are injected once a month, while Lilly’s is biweekly. It would also be competing against Allergan ‘s ( AGN ) Botox, which is also quarterly but involves 31 separate shots. Credit Suisse analyst Vamil Divan wrote that ALD403’s results seem roughly equivalent to Teva’s in terms of effectiveness, but he did note that there was no significant improvement over the placebo in the number of patients who experienced a 100% reduction in migraine days. Between 4% and 8% of patients on the drug achieved this, which was rather lower than the 16% who had been headache-free in a previous trial. Alder stock, like so many other biotech stocks, had lost more than half its value since touching its all-time peak of 54.90 in July. But in early trading on the stock market today , shares were was up some 52% near 26. Image provided by Shutterstock .