Drug Development and Manufacturing

Developer of Treatment Drugs for Serious Diseases
Compiled & Translated by | Fan Dongdong
Novartis and Amgen were the first pharmaceutical companies to enter the CGRP space with the migraine drug Aimovig, but shortly after its launch, the two companies filed lawsuits against each other. Meanwhile, fierce competition immediately emerged with the market entry of drugs in the same class. Now, as the migraine market becomes increasingly crowded, Novartis has recently decided to transfer its U.S. Aimovig business to Amgen.
On Tuesday, a Novartis spokesperson announced that Novartis will transfer its previously shared U.S. commercial operations for Aimovig to Amgen, including, but not limited to, sales, marketing, and medical support functions. Consequently, Novartis has decided to eliminate 186 existing positions within the company that support Aimovig. The affected roles include brand marketing and field sales positions reporting to Novartis’s U.S. headquarters in East Hanover, New Jersey.
The layoffs, initially filed on the state's Worker Adjustment and Retraining Notification (WARN) website, will take effect this September. A Novartis spokesperson stated that the workforce reduction will "improve operational efficiency in the increasingly competitive migraine therapeutic area." The financial terms of the Aimovig collaboration in the United States, including "sharing commercialization costs and receiving sales royalties," will remain unchanged. Novartis will also retain the rights to commercialize Aimovig outside the United States (excluding Japan).
Aimovig is a fully humanized monoclonal antibody that targets and blocks the calcitonin gene-related peptide (CGRP) receptor, and it is the first approved medication for the preventive treatment of migraine. The drug generated $119 million in sales revenue for Amgen in 2018. Regarded as a key blockbuster by Amgen, Aimovig has now been approved in over 30 countries. The dispute between the two pharmaceutical companies dates back to litigation initiated in early 2019. Novartis first filed a lawsuit against Amgen in the U.S. Federal Court in Manhattan, seeking to terminate the collaboration between the two companies. The complaint alleged that although Amgen initially held the rights to the drug, Novartis partnered on Aimovig in 2015 and has since invested over $800 million in its development and commercialization.
Amgen promptly filed a lawsuit, alleging that Novartis violated the collaboration agreement by helping bring a potential competitor to Aimovig to market. Specifically, Novartis' generics division, Sandoz, collaborated with Alder BioPharmaceuticals to develop a CGRP-targeting drug named eptinezumab. In late 2019, Lundbeck acquired Alder BioPharmaceuticals for $2 billion, thereby obtaining the drug, which has since received FDA approval and is marketed as Vyepti.
Regarding this adjustment, a Novartis spokesperson stated that the company's latest move aims to improve efficiency and "does not resolve the ongoing litigation between Novartis and Amgen." The Swiss pharmaceutical company noted that in the lawsuit filed against Amgen in the United States, two claims related to commercialization expenses and the drug's market launch will be resolved, while the remaining claims remain pending.
Although Aimovig was likely the first FDA-approved preventive CGRP-targeted migraine therapy in 2018, a series of competing therapies have since emerged in this field. In the injectable monoclonal antibody market, Aimovig has faced competition from Teva’s Ajovy and Eli Lilly’s Emgality. While Aimovig secured a first-mover advantage in time to market, Lilly’s competing product has already surpassed it in quarterly sales. Emgality generated $119 million in the first quarter, compared to just $66 million for Aimovig.
Meanwhile, Biohaven Pharmaceutical's oral Nurtec ODT became the first FDA-approved option for both the prevention and treatment of migraines in late May. Additionally, the FDA is reviewing AbbVie's oral medication atogepant for migraine prevention, and AbbVie's Ubrelvy was also approved by the FDA in late 2019 as an acute treatment option.
These layoffs may also be part of a four-year restructuring process initiated by Novartis CEO Vas Narasimhan in 2018. At the time, Narasimhan outlined a streamlining plan to reduce the company's overall workforce by at least 19% by 2022, cutting the headcount from 124,000 to under 100,000 employees. Currently, the pharmaceutical company employs approximately 110,000 people globally.
Source: Slashing 186 jobs, Novartis hands off U.S. sales, marketing duties for migraine med Aimovig to Amgen
*Disclaimer: This article was written by a contributing author to Sina Pharma News. The views expressed are solely those of the author and do not represent the position of Sina Pharma News.