Stay up to date with the latest news and standards knowledge.

Blog > The Monday Morning Briefing: Amgen's new cholesterol drug gets green light

The Monday Morning Briefing: Amgen's new cholesterol drug gets green light

31 August 2015

Morning! Did you have fun at the weekend? I did. But now it’s back to the toil - or joy, depending on how you see it - of the working week, and as ever we have the week’s top pharma news stories collected for you. Enjoy, share, and tell us what you think in the comments section below.

The FDA on Thursday approved the second drug in a novel class of powerful cholesterol-lowering medications, the New York Times reported

The new drug, Repatha, made by Amgen, is intended for people with extremely high cholesterol levels and those with heart disease who cannot sufficiently lower their cholesterol levels with statins and other therapies. Repatha will cost $14,100 per year. The two drugs are the first highly effective cholesterol-lowering medications in a generation. Currently, two-thirds of people at high risk for cardiovascular problems like heart attacks and strokes who are treated for high cholesterol levels still do not have them under adequate control, Dr. Sean Harper, Amgen’s executive vice president, estimated.

In other FDA news, the Administration proposed on Thursday identifying cheaper versions of biologic drugs with a suffix to distinguish them from their more expensive, branded counterparts

The FDA said its draft guidance is designed to prevent the inadvertent substitution of non-interchangeable products and to make it easier to monitor and track usage once the products are on the market. Biologic drugs are made from living organisms and, unlike most traditional drugs, cannot be easily replicated. Copies of biologic products are known as biosimilars as they are similar, not identical, to the original. The FDA is proposing that original biologic products and their biosimilars share a core drug substance name. That name would be followed by a unique suffix composed of four lowercase letters with no meaning.

Novo Nordisk is buying two privately-owned biotechs to expand its reach in diabetes and obesity, reports PharmaTimes

The Danish drugmaker said it is acquiring Indiana-based Calibrium LLC and MB2, both of which are working on drugs for diabetes and metabolic diseases. Calibrium is focused on novel peptides and MB2 LLC on first-in-class, mixed agonist drugs. The closing of the transaction is expected during the third quarter of 2015. The news came just a day after Novo announced plans to invest $2 billion over the next five years in ramping up production in Denmark and the US, to meet global demand for its medicines. Close to 700 new production and engineering jobs will be generated in Clayton, NC, where the firm already employs more than 700 people, while a new production facility in Måløv, Denmark, will create around 100 new positions.

Shares of The Medicines Co. surged in premarket trading today (Monday) after the company and its partner Alnylam Pharmaceuticals Inc. reported study results suggesting effectiveness for a potential cholesterol drug, AP reports

The companies said that results from an ongoing Phase 1 clinical trial showed that their experimental treatment ALN-PCSsc lowered bad cholesterol by up to 83 percent compared to published results from studies with anti-PCSK9 MAbs, another class of drugs aimed at treating cholesterol. Both classes of drugs work by blocking a gene related to high cholesterol. Shares of Medicines jumped $5.98, or 17.8 percent, to $39.62 in premarket trading.

“There have long been recruitment battles among academic institutions,” says a New York Times editorial, “but today we’re in the midst of what The Chronicle of Higher Education calls a “boom in academic poaching

Much of the frenzy has been driven by the outsize role of Texas, which has used hundreds of millions of dollars in oil revenue to help its institutions poach talent from other states... New York’s medical schools are feeling the heat. Over the past four years, institutions in Texas have offered almost $40 million in research grants to tempt scientists to leave New York. In New York, a consortium of all 16 medical schools is urging Gov. Andrew Cuomo and the Legislature to invest $100 million a year for the next decade to recruit outstanding scientists from other states and retain top scientists who are already here but might be wooed by other states… At a time when state and federal money for all sorts of worthy projects seems limited, the state would be wise to adopt a more targeted approach by funneling money to upstate schools and aiming the money toward both producing new knowledge and transferring it to private companies.”

Topics: News, Pharma