Regulatory Index News: 23/02/2018

Welcome to your Regulatory Index News digest today. Some promising and not so promising trial data as well as a patent dispute verdict makes for an interesting read, keep up to date here.

Strong phase 3 data for Aimmune’s peanut allergy drug

Aimmune have presented positive results for their phase 3 trial which compared AR101, a peanut allergy treatment, against placebo in almost 500 children intolerant to peanut protein. The participants were given 300mg peanut flour AR101 or placebo over 12 months then given consecutive doses of peanut protein ranging from 3mg to 1000mg to determine their ability to tolerate the allergen. More than two-thirds of the AR101 arm tolerated 600mg of the peanut protein where only 4% of the placebo arm could, leaving a 53% threshold over placebo. However, the safety profile is more troublesome, with 20% of the AR101 participants dropping out due to adverse events. The Biotech Company are now looking to file for FDA approval by the end of 2018, in hope of giving patients protection against accidental peanut exposure. If you would like to read further, please click here to read from a FiercePharma article.

Focal seizure trial failure for GW’s cannabinoid

The top-line data has now been released for GW’s phase 2a placebo-controlled study to evaluate the efficacy and safety of their experimental cannabinoid drug, GWP42006, as an add-on therapy in 162 adults with inadequately controlled focal seizures. Unfortunately, both the active and placebo arms of the trial show similar reductions of focal seizures at around 40% meaning it has failed to hit a key target. However, the placebo response found in this study is considerably greater than that seen in others with similar patient populations, which GW are working to understand. In terms of a safety profile, GWP42006 was found to be generally well tolerated but more emergent adverse events were reported in the active group (73%) than the placebo group (48%). GW, whilst disappointed, still believe in their pipeline drug for addressing unmet needs in the field of autism spectrum disorders as well as epilepsy. Please click here for more from a PharmaTimes article.

Judge reversal of $2.54 billion hepatitis C drug patent verdict

A federal US judge has overturned a jury verdict ordering Gilead to pay $2.54 billion to Merck for an infringement patent dispute over hepatitis C treatments, Sovaldi and Harvoni. Merck believe that the patents for Solvaldi were too closely related to a hepatitis C treatment developed years earlier. However, the judge ruled that the Merck patent was invalid at issue due to the inventions not meeting the disclosing requirement on how to make and use the treatment it covered without undue experimentation. This marks the second Gilead victory over Merck in a patent dispute, with the previous leading to a judge decision that Gilead did not have to pay $200 million in damages. If you would like to read more, please click here for an article from STAT. 



Max Lymbery

Date Published

23rd February 2018

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