Transgenics - on the cusp of fulfilling promise?

The cloning advances of the mid-1990s prompted a surge in enthusiasm for using transgenic animals to make drugs, as the technology offered low ongoing costs (at least after start-up) and the ability to produce unlimited quantities of the protein.

But since then, the demise of companies such as PPL Therapeutics and Pharming - both of which focused on making transgenic proteins by inserting human DNA into animal cells so that the targeted protein is secreted in the milk of female offspring - have dented enthusiasm for using animals.

But there is a steady stream of new protein-based drugs coming through the clinic and onto the market and there is growing concern about the ability of the pharmaceutical industry to meet production demands, according to Business Communications​.

The introduction of transgenic biopharmaceutical production technologies and transgenically produced human therapeutics will revolutionise the healthcare market, according to the report.

There will be a reduction in the cost of producing existing pharmaceuticals, which can be produced transgenically for as little as one thousandth of the cost of a product manufactured using microbial fermentation or mammalian cell culture systems.

In addition, companies which embrace transgenic production will enjoy markedly higher profits for companies producing biopharmaceuticals using transgenic technology, according to the company.

The report, called Therapeutics from Transgenic Sources​, notes that the current worldwide market for therapeutics from transgenic sources is zero, but is expected to exceed $1 billion in 2008 and to reach $18.6 billion in 2013.

By 2008, between eight and 10 transgenically produced human therapeutics are expected to be on the market. By 2013, there should be at least 30 products on the market or substantially more, depending on how quickly transgenic production methods are adopted and how quickly products now in preclinical trials move into the clinic.

In addition, if regulatory guidelines for the production of generic drugs using transgenic systems are developed, the number of approvals of transgenic products could be two or three times the projection for 2013.

The first transgenic product to reach the market will likely be either GTC Biotherapeutics' (formerly Genzyme Transgenics) antithrombin III agent, which is produced in the milk of transgenic goats, or CaroRx, a topical antibiotic against Streptococcus mutans​ indicated for the treatment and prevention of dental caries, in Phase III development at Planet Biotechnology.

GTC Biotherapeutics projects that its product will be approved in the US before 2005, while Planet Biotechnology expects to launch CaroRx in Europe later this year.

Meanwhile, at the end of 2003, one other transgenic product in development at Medarex - the monoclonal antibody product Osidem for ovarian cancer, was in Phase III trials. Following close behind is a monoclonal antibody in development at Abgenix, ABX-CBL, which is indicated for the treatment of graft-versus-host disease and psoriasis and is in Phase II/III trials. In total, seventeen transgenic products had completed or were involved in Phase II trials.

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