New breakthrough for CGRP migraine treatments

pharmafile | February 6, 2018 | News story | Research and Development Allergan, Amgen, CGRP, Novartis, biotech, drugs, pharma, pharmaceutical 

Allergan had a rough year in 2017, dropping by close to $80 a share from February 2017 to this month. However, with the financials it has just posted, it may be able to shore up belief that the company has the ability to stop the rot.

One indicator of where the company hopes it can achieve growth was on the announcement of results from its oral CGRP inhibitor, ubrogepant.

The drug was able to achieve ‘pain freedom’ two hours after the first dose in 19.2% of patients in the 50mg group and 21.2% of patients in the 100mg group, against 11.8% in the placebo control

In a separate study, patients achieved a similar level of success on the drug when measured against the absence of their most bothersome symptom, which included photophobia, phonophobia or nausea; with 38.6% and 37.7% of patients achieving absence of these symptoms, on 50mg and 100mg, respectively, against 27.8% of patients on placebo.

The CGRP inhibitor space is becoming increasingly competitive, with Novartis/Amgen currently leading the way through their injectable treatment – after already having posted strong Phase 3 data in November of last year.

The main differentiator for Allergan could offer it a significant advantage – given that the treatment is administered orally and can therefore be taken far more conveniently than Amgen/Novartis’ candidate.

However, Amgen/Novartis are still in the commercialisation driving seat, in terms of being first to market and this may prove a struggle for Allergan to bypass, with their product, Aimovig, set for an approval decision in mid-May.

Another factor counting against Allergan’s treatment was the instance of six cases of aminotransferase at three times the upper limit of normal. The company noted that the liver safety adjudication board did not determine this to be resulting from the treatment, but questions may remain over how safe the treatment is on the liver – after liver toxicity had already proved disastrous in previous development by MSD.

“We are pleased with the favourable results of our ACHIEVE I study, which support the efficacy, safety, and tolerability profile of ubrogepant. We are confident that ubrogepant, an oral calcitonin gene-related peptide (CGRP) receptor antagonist will be an option for the treatment of migraines in adults,” said David Nicholson, Chief Research and Development Officer, Allergan. “Allergan remains committed to identifying, developing and bringing to market therapies that address unmet need for patients suffering from this debilitating disease.”

Shares in Allergan initially rose by $10 a share, before falling to an increase of 1% at the time of reporting.

Its financial displayed total net revenue was up by 9.4% on 2016, to $15.9 billion, with increased sales of Botox (up by 17%) and Restasis (up by 1%) on the previous year.

Ben Hargreaves

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