Cimzia

Certolizumab pegol (CDP870) is a PEGylated Fab' fragment of a humanized anti-TNF-alpha monoclonal antibody. It is the subject of phase III clinical trials in both Crohn's disease and rheumatoid arthritis. Significant positive results have been demonstrated for two pivotal phase III trials (PRECiSE 1 and 2) of certolizumab pegol in moderate to severe active Crohn's disease. In addition, data from both trials suggest it is well-tolerated.

Analysts reckon Cimzia has blockbuster potential. What other Crohn's disease drugs are on the market, and how is Cimzia different?
The biggest rivals are Remicade from Johnson & Johnson and Abbott's Humira, a drug currently approved for use in rheumatoid arthritis that's expected to gain additional approval for use in Crohn's.

Both of these drugs are monoclonal antibodies, which are derived from very large molecules. These drugs require a lengthy, complex, and expensive manufacturing process. Because they're large molecules, they tend to penetrate tissues poorly, so they must be administered by injection. Also, these larger antibodies can often trigger unwanted immune responses.

In contrast, Cimzia is the next generation of antibodies. We use the smallest possible fragment of an antibody, called a nanobody. As these nanobodies are much smaller, they're able to penetrate tissue in the body more easily. The big advantage with nanobodies, we believe, is that it requires a much simpler manufacturing process, which means that over time it will be a lot less expensive than monoclonal antibodies to produce.

The way Cimzia is administered is also unique. While Remicade is given by an intravenous infusion at the doctor's office or hospital, Cimzia is the first Crohn's drug that is able to be given by injection through the skin. It's similar to the way diabetics are able to self-inject insulin.

Of course, what really matters is efficacy. And we're very happy with the significantly positive late-stage clinical results, which is why we submitted a biologics license application with the U.S. Food & Drug Administration in February.

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Carrageenan: a harmful food additive

During the latter half of the twentieth century, inflammatory bowel disease and gastrointestinal malignancy have been major causes of morbidity and mortality in the United States. Even with improvements in treatment and cancer screening, colorectal cancer remains the second leading cause of cancer mortality in the United States. The Western diet has been considered a possible source of inflammatory bowel disease and colorectal malignancy, and intensive efforts have been undertaken to study the impact of specific constituents of the Western diet, such as fiber and fat.

One food additive, carrageenan, has been associated with induction and promotion of intestinal neoplasms and ulcerations in numerous animal experiments; however, carrageenan remains a widely used food additive. In 1982, the International Agency for Research on Cancer (IARC) designated degraded carrageenan as Group 2B, noting sufficient evidence for the carcinogenicity of degraded carrageenan in animal models to infer that "in the absence of adequate data on humans, it is reasonable, for practical purposes, to regard chemicals for which there is sufficient evidence of carcinogenicity in animals as if they presented a carcinogenic risk to humans". The National Research Council has noted this designation for degraded carrageenan in their 1996 monograph. Recognizing the impact of carrageenan in animal models, several European and British investigators have advised against the continued use of carrageenan in food. Several reports have called attention to the problems associated with carrageenan consumption.

Extracted from red seaweed, carrageenan has been used in food products for centuries and was patented as a food additive for use in the United States in the 1930s. It has been used widely as a food additive, contributing to the texture of a variety of processed foods. It has also been used as a laxative, as treatment for peptic ulcer disease, and as a component of pharmaceuticals, toothpaste, aerosol sprays, and other products. In 1959, carrageenan was granted GRAS (Generally Regarded as Safe) status in the United States. GRAS substances are permitted to be incorporated into food products as long as good manufacturing processes are used and the substance is used only in sufficient quantity to achieve the desired effect.

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Nothomyrmecia macrops

These beautiful honey-colored insects, endemic to old-growth mallee scrub in southern Australia, have long been regarded as "living fossils." The single species N. macrops is the only living representative of an ancient lineage (the Prionomyrmecini) that occurred worldwide in the Cretaceous. Although a few other extant lineages such as Amblyoponeare actually older than the dinosaur ants, Nothomyrmecia holds a special place in myrmecological history for the fortuitous story of its rediscovery.

Nothomyrmecia ants are only rarely seen, not because they are uncommon, but because they only forage on cold nights during some parts of the year and because they are restricted to a particular type of mallee habitat. Colonies are small, with a simple social structure, and the ants forage singly usuing visual cues. It is possible that the cold-weather ecological niche and the relictual distribution of N. macrops have allowed it to escape competition with the more modern ant lineages that may have driven the extinction of other Prionomyrmecini.

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Genesis - Land of Confusion