News just broke that Toronto based biotech Cynapsus Therapeutics Inc (NASDAQ:CYNA) is set to be bought out by Sunovion Pharmaceuticals, and shares of the former are up more than 112% after hours on Wednesday. The deal will see Sunovion pick up Cynapsus, and it’s pipeline (which we’ll look at in a little more detail shortly) for a little over $40 a share, which values the latter at circa $624 million.
Sunovion is a subsidiary of Japanese drug maker Dainippon Sumitomo Pharma Co., Ltd. (OTCMKTS:DNPUY), so those looking to maintain an exposure to Cynapsus’ pipeline are able to do so OTC, although the exposure is now diluted somewhat based on the scope of Sumitomo’s product portfolio. On the opposite side of the argument, however, it’s also risk mitigated when compared to an all out Cynapsus exposure.
So, with that said, what is Sunovion getting for its money? Let’s take a look.
We’ve covered Cynapsus a number of times across the past six months, and it’s got a very promising pipeline. The primary, and real value driver, is a Parkinson’s indication target called APL-130277. It’s a novel administration version of a currently approved (and well established) Parkinson’s disease drug called Apomorphine.
Parkinson’s disease symptoms come about as a result of a lack of dopamine. Apomorphine is a dopamine agonist. On administration, it induces the production of dopamine, and helps switch patients from OFF to ON; OFF and ON being the terms used to describe the phases of Parkinson’s disease experienced by sufferers daily – bad and good respectively. L-DOPA is the current SOC, but mid to high severity patients that have been been using L-DOPA for a while can suffer from increasing severity dyskinesia. Dyskinesia is an involuntary movement caused by L-DOPA after prolonged use, and so in these patients apomorphine is used as an alternative. In its long history of usage, the drug has been shown to be at least as efficient in converting OFF patients to ON patients.
The problem is, however, it doesn’t work if taken orally. First pass degradation essentially wipes out any efficacy, and so it has to be administered by way of injection. This has the obvious hassle and pain associated with it, and Cynapsus is trying to get round this with an alternative administration version – a sublingual film administration.
The patient unwraps the film, puts it under his or her tongue, and it dissolves for systemic administration. Quick and easy administration, and safety has proven to be no issue so far in trials.
How about efficacy?
Early stage trials have performed very well, and the sublingual administration has been shown to be at least as effective in conversion from OFF to ON as the injection version. It’s upcoming data that is the data to watch, however, and that will form the basis of an application for approval. Specifically, we’ve got a phase III efficacy trial called CTH-300, which is set to report topline at some point during the final quarter of this year. The study is a double-blind, placebo-controlled, study looking at ON/OFF periods in around 126 patients. The primary endpoint is the mean change in the Movement Disorder Society’s Unified Parkinson’s Disease Rating Scale Part III (MDS-UPDRS III) score at 30 minutes after dosing. We’re looking for a stat sig increase in ON time (and a concurrent decrease in OFF time) between the active arm and the control arm.
The second trial is a safety phase III, called CTH-301. This one’s looking at patients who have at least one OFF episode every 24 hours, with total OFF time of at least two hours per day. It’s basically looking at AE rates across more than 200 patients, with most of these being patients from the already discussed CTH-300, rolled over post completion. This one is set to report during the first half of 2017.
These two trials are going to be the make or break for the drug, and if we see some positive data, we expect a pretty smooth ride through to commercialization for the patch in the US. Beyond that, the new controlling interest will likely look to chase an Asian approval.
