Bio-Bites!

Amgen buys deCODE for $415 million

Founded in 1996 in Iceland, deCODE holds genetic data, genealogies and medical records from 140,000 Icelanders (about half of Iceland’s population). The ability to correlate genetic information with Iceland’s extensive medical records has enabled deCODE scientists to identify genes and possible disease mechanisms contributing to neurodegeneration, cancer, cardiovascular disease, psychosis and Alzheimer disease.

By becoming part of a much bigger biotech firm in the form of Amgen, deCODE and its CEO, Kári Stefánsson, may finally be able to fulfil a promise made throughout the company’s 16-y history: to use genetic data to benefit patients. Stefánsson says that deCODE can “contribute to more health benefits faster with a company with a proven track record to make therapeutics.”^1,2

First FDA-approved recombinant flu vaccine

Flublock, produced by Protein Sciences Corporation in Meriden, Connecticut, gained FDA approval in mid-January and will be partly released this year to protect people from annual influenza. The vaccine is expected to be fully released next flu season.

It is composed of three influenza hemagglutinins (HA) and protects against two influenza A strains, H1N1and H3N2, and an influenza B strain virus.

It is the first flu vaccine to take advantage of recombinant technologies and is manufactured partly within insect cells, in contrast to previous vaccines based on weakened or inactivated flu viruses that are made in chicken eggs.

In initial trials that included 2,300 people at various sites in the United States, Flublock was 44.6% effective at protecting participants from all types of circulating flu.^3,4

Poland bans GM potato and maize

The crops in question are MON 810, an insect resistant maize of Monsanto, and Amflora, a potato producing only one kind of starch (amylopectin) for the paper industry owned by BASF.

Both genetically modified (GM) crops have gained approval by the European Union science advisory committees as being safe for agriculture.

Poland is one of nine EU members that have sought to impose such bans—despite EU legislation that requires all member states to permit cultivation of approved crops. European courts have ruled against bans in two countries. Many of the bans rely on a legal loophole, with countries claiming that there is new information on harm caused by the crops that is yet to be evaluated.⁵

European Food Safety Agency (EFSA) makes GM maize NK603 data publicly available

Following the example set by EMA (Europen Medicines Agency) which makes public all clinical data it receives after product authorizations, EFSA has announced a project to make data from its risk assessments more available to the broad scientific community and other interested parties.

While the project is still at the early stages, due to the high level of public interest, data for NK603 (a genetically modified maize resistant to the herbicide Glyphosate owned by Monsanto) is already available for download. A widely criticized study published in November 2012 by Séralini et al. had linked NK603 to adverse health effects in rats.^6,7

Large scale production of malaria drug in yeast

Seven years ago, Jay Keasling and his team genetically engineered yeast to produce artemisinic acid, a precursor to the best malaria treatments available: artemisinin-based combination therapies (ACTs). In 2008, Sanofi licensed the yeast and has reportedly produced almost 39 tons of artemisinic acid—the first industrial-scale deployment of synthetic biology for drug production. Until now, the sweet wormwood plant, Artemisia annua, has been the only source of artemisinin. Yeast make ACT production faster and more manageable. For now, artemisinin costs about US$400 per kilogram, and the semi-synthetic version is unlikely to be much cheaper. Sanofi announced that it plans to produce 60 tons of the compound in 2014. Sanofi and its partners are adamant that for the next several years, semi-synthetic artemisinin will be deployed only to smooth out market fluctuations, and will be sold at a „no profit-no loss“ price of $350–400 that is unlikely to undercut other suppliers.^8,9