Business in Brief
This month’s approvals, acquisitions, revenue reports, regulatory action and trial results
Regeneron reported a Q2 2017 $388 million net income ($3.66 and $3.34 per basic and diluted share, respectively) – which compares well against Q2 2016’s net income of $196 million, or $1.88 per basic share and $1.69 per diluted share. Net product sales were $924 million in Q2 this year, up $90 million over Q2 2016’s figure, and Q2 total revenues increased from $1.213 billion in 2016 to $1.470 billion this year.
Apellis Pharmaceuticals’ APL-2 for geographic atrophy in AMD met its primary endpoint at 12 months in a Phase II trial of the intravitreally-administered complement inhibitor drug, according to a company press release. Allegro Ophthalmics Phase 2b stage 2 DEL MAR study of Luminate (ALG-1001) for the treatment of DME also met its primary endpoint, non-inferiority to bevacizumab at 20 weeks.
Last month, the FDA rejected Valeant’s marketing application for latanoprostene bunod, citing Current Good Manufacturing Practice (CGMP) issues at their manufacturing facility in Tampa, FL. However, the FDA later confirmed that it would issue a Voluntary Action Indicated inspection classification for the Tampa facility, meaning that all products made there are unencumbered by CGMP issues.
SightLife, the Seattle-headquartered Global Health Organization has appointed Claire Bonilla as its new CEO; former CEO, Monty Montoya, will continue as President and CEO of SightLife Surgical.
Bausch + Lomb has launched its Stellaris Elite vitrectomy system for retina surgery in the US.
Carl Zeiss Meditec has acquired Veracity Innovations LLC, which produces a cloud-based platform for cataract surgery planning, according to a company press release. The terms of the acquisition were not disclosed.
Omeros reported a Q2 2017 $14.4 million loss, up $1.8 million from Q2 2016’s figure of $12.6 million. Total Q2 2017 revenues (all from the sale of Omidria) were $17.2 million – a rise of 40 percent from Q1 2017’s revenues, and 71 percent from the last year’s second quarter. However, the company generated $63.6 million of net proceeds from an underwritten public offering of 3 million shares, sold a $22.75 apiece.
The FDA has cleared Optovue epithelial thickness mapping software, used in the company’s iVue and iFusion OCT systems, for the quantitative measurement of epithelial and stromal layers of the cornea.
I spent seven years as a medical writer, writing primary and review manuscripts, congress presentations and marketing materials for numerous – and mostly German – pharmaceutical companies. Prior to my adventures in medical communications, I was a Wellcome Trust PhD student at the University of Edinburgh.
