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Following Friday’s announcement that Teva’s prophylactic migraine treatment, fremanezumab, received FDA approval,

Rahael Maladwala, Pharma Analyst at GlobalData, a leading data and analytics company, offers his view on why fortunes are starting to brighten for a company which has experienced its fair share of problems recently:

‘‘Teva will breathe a sigh of relief after the FDA approval for fremanezumab, which was thought to be touch and go; while the efficacy and safety profile of the calcitonin gene-related peptide (CGRP) monoclonal antibody (mAb) was not to be questioned, manufacturing issues with Teva’s South Korean plant were valid FDA concerns. This will go down as positive step after a problematic few years and the company are expected to launch the drug as soon as possible. The goal now is to establish fremanezumab in the migraine market before the launch of Eli Lilly’s galcanezumab and Alder Biopharmaceuticals’ eptinezumab, while trying to catch up to Amgen/Novartis’ erenumab.

“The FDA approval is a timely morale booster to the pharmaceutical company which has seen its fair share of setbacks over the last few years. Teva had been in a downwards slope since they bought out Allergan’s generics unit for $40.5bn in 2016; this saddled the company with huge debt that it is still struggling to pay off. Further to this, job cuts, factory closures, biosimilar entry to one of the company’s leading assets, Copaxone, and Phase III failure of promising late stage pipeline drug, laquinimod, means Teva have seen issues arise across the whole business. The approval and subsequent launch of migraine treatment fremanezumab will act as a much needed revenue boost for the company for the last quarter of 2018. Indeed, according to GloblData’s PharmaPoint: Migraine report, the migraine market is predicted to reach up to $8.7bn by 2026, and fremanezumab is set to become one of the top selling drugs in the indication.

“Any delay in launching fremanezumab would have been a huge blow due to the current state of the migraine market. There are three other CGRP monoclonal antibodies, with extremely similar efficacy and safety profiles that are launching, or close to it, and any hiccup would have allowed Amgen, Eli Lilly, and potentially even Alder Biopharmaceuticals, extra time to help establish their drugs in the market. However, the approval means that Teva are now second-to-market in a highly lucrative therapy area and have the luxury of a quarterly dosing regimen, compared to the monthly regime of erenumab, which is the only other CGRP mAb that is currently approved, which is likely to gain favour with physicians.

“The next few months will be pivotal for Teva, with two biosimilars and a medical device also facing FDA decision days. The approval of fremanezumab has got this crucial time off to the best start and will significantly ease the pressure on the company.”

ENDS

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