Yesterday after close, the small cap pharmaceutical reformulation specialists Adamas Pharmaceuticals announced that the US FDA has approved the company’s New Drug Application for Gocovri. The drug will be used for the treatment of Parkinson’s disease, an area not typically included in the Arctic Aurora LifeScienece portfolio. Chief Biotech analyst Daniel Bolanowski explains.
Adamas Pharmaceuticals now US FDA approved Gocovri will be used to treat Parkinson’s patients suffering from dyskinesia, probably better known as the severe involuntary movements that are a hallmark symptom of Parkinson’s disease.
Arctic Aurora LifeScience typically does not invest in reformulation approaches as they typically do little in terms of patient benefit compared to the original drug and mostly serves pharmaceutical companies’ product life cycle management strategies. However, Adamas’ approach in Parkinson’s has shown to be entirely different. Gocovri is based on an old drug amantadine, previously approved for Parkinson’s, but it is today very rarely used due to its severly limited efficacy. The new drug is a high dose capsule of amantadine to be taken once a day before bedtime and is designed to release the active substance in an even manner during the course of the next day.
Clinical study results of Gocovri have shown significant reductions in off time and reductions in levels of dyskinesia while maintaining an acceptable safety and tolerability profile. Long-term extension studies have further shown that the effect is maintained with continuous Gocovri use. Thus given the patient data and large unmet medical need in this patient group, the approval comes as no surprise to us and the fund has gradually increased its position in Adamas during the summer. Friday pre-market trading sees the share soar more than 50% up.
Also during Thursday, Genmab announced additional good clinical trial results with their multiple myeloma success drug Darzalex (marketed by Johnson & Johnson). Genmab showed that Darzalex in combination with traditional first-line treatment was considerably more efficacious in stopping the progression of the blood cancer disease compared to the control group that did not receive Darzalex. The drug is already approved in later treatment lines where patients have progressed from initial therapy and it is now likely that Darzalex label will be extended to an ever wider myeloma population. Genmab shares closed up 11.3% yesterday, corresponding to a market cap increase of nearly DKK 10 billion.
Arctic Aurora LifeScience is an equity fund investing in global biotechnology and pharmaceutical companies. The fund is run by former portfolio manager in the Swedish AP Fonder, Ulrica Bjerke, and Dr. Torbjørn Bjerke, both with 20 years of experience from the industry. Daniel Bolanowski fills the role as anlyst on the team with a MSc in both Biotech and Economics. Aurora LifeScience was launched in May 2016 with both hedged and un-hedged share classes.
Past performance in Arctic Aurora LifeScience s no guarantee for future returns. Future returns depend on the market, fund manager skill, fund risk level, costs, among others. Performance in the fund may at times be negative and may for this fund vary considerably within periods.