Amgen and Novartis inaugurated a highly anticipated new class of migraine on Wednesday with FDA approval for Aimovig, an injectable drug with blockbuster hopes. But Aimovig still has some hurdles to overcome before he can achieve these high goals.
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With a rival drug from Eli Lilly just months later, Amgen and Novartis have a limited amount of time to take advantage of the first-time adopter. A representative from Express Scripts has already said that the company will have a prior approval program to manage access to Aimovig.
The approval is probably more important for Amgen, which is preparing for new biosimilar competition for some key products such as the anemia drug Neupogen. But Novartis has its own financial challenges, including generic competition for its large-scale leukemia drug Gleevec, and with a political scandal it can use this dose of good news.
The race continues with the nod of Wednesday. Amgen had a chance to put the starting prizes in the class, said Vice President of Development Rob Lenz before approval, and now he can work to capture what he called "pent-up demand" for better migraine medicines. "There is a lot of excitement in the field," he said of the excitement of patients and doctors for the drug. "This is the first preventive therapy ever developed specifically for migraine."
As Lenz pointed out, older migraine drugs were reused from other applications. This lack of specially-designed treatments is one of the reasons why the cGRP class is so crowded that other participants from Teva and Allergan as well as Lilly are expected. But Teva's drug, which may have been approved next month, will be delayed due to manufacturing issues, the company said in February, giving Amgen and Novartis a bit more runway for their launch than previously expected. Allergan, which is expected to be the first oral CGRP drug, is further behind, with a possible FDA approval next year.
RELATED: The Top 15 Patent Breaks of 2018 – Neulasta-Epogen-Sensipar  Patients will appreciate a tolerability profile that is "similar to a sugar tablet" and has efficacy seen within days is, said Lenz. The once-monthly self-injection allows patients "built-in compliance" because they do not have to remember to take a pill every day, he said. Lilly's injection is also monthly, while Tevas was tested monthly and quarterly.
Payers could be a tougher crowd, but Amgen may be able to apply a few lessons learned from the introduction of Repatha, a blockbuster-priced PCSK9 cholesterol drug. However, Payer Resistance quickly came along and the recording is still not as strong as expected.
In an effort to gain favorable coverage, Amgen and his rivals, Regeneron and Sanofi's great results, ran trials hoping to show the drugs could provide cardiovascular benefits. But even with data showing that the drugs can reduce CV risks, PCSK9 drug companies discounted their medications by 40% or more to get coverage. The momentum has led to sales far below initial forecasts.
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Against this background, analysts have raised questions about the inclusion of new migraine medicines. In a note this week, Wells Fargo analyst David Maris said it remains to be seen whether CGRP Meds will be "the next PCSK9-like category – a major advance that needs to be low to gain access."
Aimovig's approval closely follows a discount offer from Praluent, which sees Maris as a potential harbinger of trouble for the new migraine drugs. Regeneron and Sanofi offered large price reductions for an exclusive seat in the PBM formulary – and access to millions of patients it covers. The deal "does not bode well for the anti-CGRP drug class," Maris wrote this week. At the time of the transaction, Bernstein analyst Ronny Gal called a "capitulation" because it tacitly admitted that the class would never be a commercial success.
"When classes become exclusive, the payers win," Gal said video about the deal.
Payers have already targeted CGRP drugs. In a recent Reuters interview, Express Scripts' Chief Medical Officer, Steve Miller, suggested avoiding the usual approach of setting a high list price and offering big discounts and discounts. The company might try instead to downsize the "gross-to-grid" gap, he suggested.
In a statement, an Express Scripts spokesman said Amgen was "responsible" for his Aimovig awards. While citing "serious unmet needs" for migraineurs, she said that not all patients need Aimovig. Express Scripts believes the drug is suitable for patients who have failed previous preventive therapy.
In light of this, the company will have "a prior approval program to help payers spend the most money on their money." She added.
Amgen and Novartis are marketing Aimovig as part of a partnership that was first launched in 2015 and expanded last April. After the last agreement, the companies will jointly market the drug in the US. Amgen will book the sale in the US and pay Novartis royalties while Novartis ex-US. Sell and pay Amgen royalties on revenue elsewhere. Amgen has exclusive rights in Japan and Novartis has exclusive rights in Canada.
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The approval comes on Thursday of a serious competition for other Amgen drugs. This week, Pfizer received approval for its biosimilar anemia blockbuster Epogen to start plans this year. On Neulasta and Calcium Sensipar, Amgen could also face new challenges this year.
Together, these drugs generate billions of sales, and Amgen knows that Aimovig will be a key driver for growth when these drugs fall off the patent cliff. Analysts predict that Aimovig will generate $ 1.2 billion in revenue by 2022.