Sanofi and Regeneron offered results of their Phase-III trials for LDL-cholesterol lowering treatment and PCSK9 antibody, alirocumab, at the European Society of Cardiology Congress in Barcelona over the weekend. At 24 weeks of treatment, patients with hypercholesterolemia—as well as those with the genetic disorder heterozygous familial hypercholesterolemia (HeFH)—observed a 61% reduction from baseline LDL cholesterol levels. Eighty-one percent of patients achieved their LDL cholesterol goal, the drugmakers reported. All four reported trials met their primary efficacy endpoint. Sanofi/Regeneron plan to submit the drug to US and EU regulatory authorities by the end of 2014, and will use a Priority Review voucher for their alirocumab submission to FDA. Amgen announced today that it has submitted its PCSK9, evolocumab, to the European Medicines Agency—following its submission to FDA last week.
Merck announced today it will present detailed data on oncology drug pembrolizumab, the company’s investigational anti-PD-1 antibody, on September 26-30 for the European Society of Medical Oncology Conference in Madrid. The drugmaker will unveil data for five solid-tumor types: advanced melanoma, non-small cell lung cancer carcinoma, advanced urothelial tract cancer, advanced gastric cancer as well as patients who are positive for HPV and negative head and neck cancer. The drug is slated to receive a decision from FDA by the end of October.
The US should spearhead an immediate effort to assist African nations hit by the growing Ebola epidemic, urge co-authors of an op/ed in today’s Wall Street Journal. While standard infection controls used in Western nations can curtail the spread of non-airborne diseases, write Scott Gottlieb and Tevi Troy, “our ability to prevent an epidemic here doesn’t reduce our obligations abroad.” Efforts have included quarantines, but as the New York Times reported last week, one in Monrovia, Liberia, touched off local anger and may, in fact, be enhancing Ebola’s spread. Better procedures to contain new cases are what’s needed. First, they argue, FDA and the CDC should work together with private sponsors to create a program to advance promising treatments, similar to the way the Bush administration worked with industry to be ready to quickly ramp up vaccine development in case of the flu pandemic in the mid-2000s. President Obama should also lead a “major charitable effort” to raise the approximately $489 million that the WHO estimates will be needed to corral the outbreak. Finally, the government must help countries adjacent to those hardest hit with screening and track-and-trace procedures for those thought to be infected.
Four hundred Novo Nordisk employees may be packing up their desks. PharmaTimes reports that the Danish drugmaker is closing up its inflammatory disease business to focus on diabetes and obesity. The decision follows a Phase II failure of the monoclonal antibody NN8226, an experimental rheumatoid arthritis treatment. The manufacturer tells PT some of the 400 affected employees may be shifted to new projects.
GlaxoSmithKline may be experiencing a slow respiratory business rebuild, but its lapsed patent items present a major opportunity for generic drugmaker Cipla. Bloomberg reports that the Indian firm, which “shot to prominence a decade ago by selling AIDS drugs for $1 a day in Africa,” plans to send its Advair (fluticasone propionate) generic to the FDA for approval this year. “If Cipla gets it through—it will change the face of Cipla,” company chairman Yusuf Hamied tells Bloomberg. The CEO says Cipla’s goal is to have the US account for 20% of its overall sales by 2020.