Amgen, Novartis Clinch FDA Nod on Migraine Prevention Drug

Amgen Inc. (AMGN) and Novartis AG (NVS) said late Thursday, May 17, they have obtained approval from the U.S. Food and Drug Administration for Aimovig, a migraine prevention drug for adults.

The drug is the first treatment green-lighted by the agency to prevent migraines by blocking the calcitonin gene-related peptide receptor, thought to play a key role in the disease.

"We believe Amgen will benefit significantly from its first mover advantage and ultimately retain 35-40% market share long term," Leerink Partners LLC analyst Geoffrey C. Porges wrote in a note on Friday.

Other companies looking to enter the anti-CGRP migraine treatment space include Action Alerts PLUS holding Eli Lilly and Co. (LLY) and Teva Pharmaceutical Industries Ltd. (TEVA) .

Around 3.5 million adults in the U.S. receive preventive migraine therapy, and around 10 million qualify for migraine preventives, according to Amgen and Novartis' presentation on Friday.

The drugmakers plan to launch Aimovig next week, according to Anthony Hooper, executive vice president of global commercial operations at Amgen, on a conference call Friday morning. They do not plan to do a television campaign for at least the first six months as they work on creating awareness for the drug among healthcare professionals, Hooper said.

Aimovig 70 mg is self-administered once monthly through Amgen's device, the SureClick autoinjector. Some patients may benefit from a dosage of 140 mg once monthly, the companies said.

The list price in the U.S. is $575 for once-monthly 70- or 140-mg single-use prefilled SureClick autoinjectors, or $6,900 annually. The price is below Wall Street's projections of $7,000 to $10,000, according to Jefferies LLC analyst Michael Yee in a Thursday note.

Yee thinks that net price could fall to around $5,000 to $6,000, noting that Allergan plc's (AGN) Botox, a chronic migraine medicine for adults with at least 15 headache days a month, is around $6,000.

"Overall, we think their pricing strategy fits well into the current reimbursement environment," Yee wrote.

Shares of Amgen were up 1.2% to $176.79 on Friday morning. Novartis' American depository receipts were trading at $77.13, down 0.03%.

Allergan and Eli Lilly are holdings in Jim Cramer's Action Alerts PLUS Charitable Trust Portfolio. Want to be alerted before Cramer and the AAP team buy or sell AGN or LLY? Learn more now.

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