Medical Device Daily Contributing Writer and Staff Reports

A new industrial biotech age is underway, and the economic case for investing in the field is now equal to that for medical biotech, according to the 2009 Marks and Clerk (London) biotech report, published earlier this week.

The growth in this area over the next 10 years will reflect this potential, in the view of 89% of respondents surveyed for the study. Industrial biotech has drawn in funding from investors ranging from single individuals to traditional oil companies, and the U.S. Defense Advanced Research Project Agency, which recently handed out funding for a project to produce bio-based jet fuel.

The interest is such that industrial biotech looks set to be a continuing area for investment, regardless of the general financial climate, says the report. "The increasing usage of terms such as black biotech and biotech's green gold, indicate that application of microbes and algae to assisting with the world's future energy needs is seen as having immediate promise."

However, there also is concern that industrial biotech could become the next frontline in the battle over genetic engineering and genome modification. In the survey, 76% of respondents believe that for the industrial biotech industry to reach its full potential, public fears about the possible application or misuse of this technology will need to be allayed.

As intellectual property lawyers, Marks and Clerk claim insight into how the field is developing. They say they are handling patent applications on synthetic genomes, which are now reaching prosecution at the European Patent Office. "The fate of these patents may prove defining for the sector," the report says.

Industrial biotech is the brighter spot in the sector as whole. Overall, 93% of respondents believe the climate for biotech deteriorated in the last year, with funding terms becoming increasingly onerous. Investors are asking for more equity or for ownership of the intellectual property. The depth and virulence of the financial crisis means that the funding model will have to change, according to the study, which is based on an international survey of 365 executives across the biotech and pharma industries.

Nine in 10 cited a lack of appetite for risk among investors as the principal problem they face in the current market. As a result, the more speculative, early-stage companies are bearing the brunt of the funding squeeze. While 60% of respondents believe that the outlook will start to improve within the next 12 months, 40% said they believe there is a significant risk of further company failures.

The shortage of capital, combined with cash rich, pipeline poor, pharmaceutical companies lining up to take advantage of low valuations, inevitably will shrink the size of the independent biotechnology sector.

Mike Gilbert, partner at Marks and Clerk, and co-author of the report, said there are clear signals that the next 12 months represent a watershed. "In that time, we can expect to hear some bad news among the biotech's minnows, but also witness much greater consolidation."

Apart from anything else, this could have profound repercussions for patents, Gilbert believes, with important rights being monopolized by a small number of cash-rich companies. "Policymakers need to ask themselves if this scenario best serves society's needs for developing tomorrow's discoveries," he said.

European OK for Qutenza patch

NeurogesX (San Mateo, California), a biopharmaceutical company focused on developing pain-management therapies, said it has received European Commission marketing authorization of Qutenza 179 mg cutaneous patch (formerly NGX-4010) for the treatment of peripheral neuropathic pain in non-diabetic adults either alone or in combination with other medicinal products for pain.

The centralized marketing authorization allows Qutenza to be marketed in all 27 countries of the European Union.

The approval of Qutenza follows a positive opinion recommending approval from the European Medicines Agency's Committee for Medicinal Products for Human Use on March 19.

Qutenza, a dermal patch, is designed to locally deliver a high-concentration (8%) of the active substance capsaicin and to provide sustained relief from peripheral neuropathic pain. Following application to the painful areas on the skin, Qutenza is allowed to remain in place for 30 minutes for the feet and 60 minutes for other locations.

NeurogesX said it anticipates that Qutenza will be marketed in the European Union through a commercial partner.

Merieux Alliance, Pasteur in collboration

The Institut Pasteur and Merieux Alliance (both Paris) have signed a letter of intent for a long-term research partnership.

The Institut Pasteur and Merieux Alliance – which comprises the companies: bioMerieux, Transgene, Shantha Biotechnics, ABL and Silliker – are pooling their resources and efforts to fight infectious diseases through major research projects, spanning the following fields:

– Clinical diagnostics and theranostics (in partnership with bioMerieux and Transgene).

– Food safety and microbiological control, nutrition, health and environment (with bioMerieux and Silliker).

– Immunotherapy (with Transgene and Shantha Biotechnics).

The research projects under consideration must focus on major pathologies calling upon expertise in the fields of virology, bacteriology and immunology. The results of these joint research projects could be utilized by the Merieux Alliance companies and would enhance the Institut Pasteur's patent portfolio, contributing to the valorization of its research efforts.