Welcome to your weekly roundup of EP Vantage’s snippets – short takes on smaller news items.
This week, March 6 to March 10, 2017, we had thoughts on the following: Acorda wins one case but another looms; Zoll’s hospital shocker comes to the US; Tryton branches out; Ionis can’t dismiss safety questions.
These snippets were previously published daily via twitter.
Acorda wins one case but another looms
March 10, 2017
Acorda is over the first hurdle, but the bigger challenge remains. Yesterday the US Patent and Trademark Office upheld all four of the patents covering its multiple sclerosis drug Ampyra, rejecting the argument that they should be invalidated as the molecule has been known since the 1920s. The drug is expected to hit peak sales of more than half a billion dollars in 2018, so the company is fighting hard to protect its IP, but an upcoming district court decision might still imperil Ampyra. The inter partes review decision won yesterday stated that Acorda’s S-1 filing could not be used to invalidate the patents as the authors of the S-1’s clinical sections were the same inventors named on the patents. The district court case, however, concerns different intellectual property with different authors, and Acorda might find it tougher to argue that someone else did not get there first. A district court decision is expected in the summer. Until then, at least, Acorda will be able to enjoy the revenue stream from Ampyra, and its shares closed up 7% yesterday.
Zoll’s hospital shocker comes to the US
March 10, 2017
Zoll Medical has obtained US premarket approval for a wearable defibrillator designed for the temporary use of patients in hospital. The device continuously protects patients at risk of ventricular tachycardia or ventricular fibrillation, automatically detecting such events and delivering a shock to steady the heartbeat and prevent cardiac arrest. If a life-threatening rhythm is detected the device alerts the patient before delivering a shock; if the patient is conscious they can delay the treatment. Zoll, a subsidiary of Asahi Kasei, also makes a wearable defibrillator to be used outside hospital, the LifeVest, and the in-hospital version uses the same detection algorithm and defibrillation waveform. Patients wearing the LifeVest have a 98% first shock success rate, Zoll says, and a 92% event survival rate.
Tryton branches out
March 7, 2017
The FDA has approved another medical device that failed its pivotal trial. The Tryton side branch stent, a device to prop open the coronary arteries at the point where they bifurcate, is the sole product developed by Tryton Medical and the first such product to be approved in the US. In its US approval study, which reported in October 2013, the Tryton stent failed to show non-inferiority to balloon angioplasty. Two years later a single-arm “confirmatory study” intended to back up a post hoc analysis of the failed trial showed reduced target vessel failure compared with provisional stenting – the placement of a stent in the main branch, which can lead to side branch occlusion and bailout stenting. Two years further on, doubtless much to Tryton’s relief, these data seem to have done the trick for the FDA. The stent will be distributed in the US by Cordis, the interventional cardiology unit Johnson & Johnson sold to Cardinal Health last year.
Ionis can’t dismiss safety questions
March 6, 2017
With the risk of thrombocytopenia overshadowing efficacy Ionis needed to restore confidence with volanesorsen in its Approach study. While the trial met its primary endpoint niggling safety issues remain and shares are down 6% in early trading. The trial in 66 patients with familial chylomicronemia syndrome showed a statistically significant 77% mean reduction in triglycerides from baseline after three months of treatment, compared with a mean increase of 18% in placebo. There were also reductions in pancreatitis and abdominal pain. The company said the previously disclosed grade 4 thrombocytopenia events occurred in three treated patients, and in total five patients discontinued owing to declines in platelets, but none was in the last six months of the study after platelet monitoring was fully implemented. Five patients also discontinued because of injection site reactions. Thrombocytopenia has also been seen with another one of Ionis's projects, Ionis-TTRRx in amyloidosis, and when the phase III Neuro-TTR trial reports in the second quarter safety will again be closely watched.