Conference Reports
The Joint UK Biotechnology Company Showcase/
Genesis VII, Queen Elizabeth II
Conference Centre, 13th December 2007, London, UK.
As winter gripped the City of London, the 7th annual Genesis conference took place in the Queen Elizabeth II Conference Centre in historic Westminster. As the "UK's largest biotechnology networking conference", the organizers of the event hoped that it would match the success of the previous year, and kept much of the format the same. In the opening address by Ann Crean, Director of Product Development for Genesis sponsors the London Development Agency, the importance of London as a centre for Biotech was highlighted. As an academic centre of excellence, the collaboration between industry and universities is essential for driving innovation. With 70 hospitals, and 200 clinical trials completed per year, London is the UK's largest clinical research centre, and 25% of the government's yearly research expenditure is directed into London. These opening remarks from Ms Crean perfectly set the tone for the conference, with a large representation of UK biotech companies in attendance.
In contrast to the focus on London, Dr Kiran Mazumdar- Shaw, 'the Indian Biotech Queen', spoke about the paradigm shift that is occurring in the Indian drug industry She drew attention to the increasing number of licensing agreements between smaller Indian companies and big pharma as well as highlighting the Indian government's plans to increase its biotech investment from $2 billion to $10 billion over the next five years. Dr Masumdar-Shaw also spoke about some of the potential advantages to biotech companies carrying out their initial research in India. The ease of recruitment into clinical trials and the lower cost of drug development, which in India is only around 30% of that in Europe and the US, are attractive prospects on their own. India also has a regulatory environment that could allow drugs to reach the market more quickly, providing postmarketing data to support submissions to the EMEA and the US FDA.
During the 2nd day's Company Showcase, one company that seemed to spark the delegates' interest was Neuropharm, which is focused on developmental and degenerative central nervous system disorders. NPL-2008, Neuropharm's fast-melt oral wafer formulation of fluoxetine, is under development for the treatment of autism, and the company plans to submit an NDA by the end of 2008, with a view to launching the product in 2009. The outlook for this project seems promising, and it is currently in a Phase III trial (SOFIA) under a Special Protocol Assessment with the US FDA. However, there may still be some difficulties to overcome for this approach; the basis for using fluoxetine, an SSRI used for depression and anxiety, is the observed decrease in serotonin levels in the brains of patients with autism. However, as autism is a brain developmental disorder that typically manifests before a child is three years old, it is likely that administering fluoxetine would be most beneficial if started early in a child's development. But as pointed out by one of the delegates, autism is a spectrum of disorders that range from mild to severe, and the underlying genetics are complex, so it may be difficult to identify candidates for fluoxetine treatment at an early enough stage of development. Neuropharm is confident, however, that administration of fluoxetine from the age of 5 years will provide significant improvements in the repetitive behaviours associated with autism.
As part of the session focusing on infectious diseases, Novabiotics presented its pipeline of novel antifungals and antibiotics, including NP-213, a treatment for the orphan indication of onychomycosis which is expected to enter a Phase I/IIa clinical trial in 2008. Another interesting drug was unveiled by Phico Therapeutics which announced preclinical data for its SASPject treatment for multi-drug resistant Staphylococcus aureus infections. The SASPject technology works by delivering the SASP gene using a vector that is specific for the target organism. Once expressed, the SASP protein binds non-specifically to DNA, including the bacterial chromosome and plasmid DNA, preventing transcription. This non-specific DNA binding means that the bactericidal actions of SASPject should be less likely to encounter bacterial resistance. In preclinical studies, the SASPject product was active against 173 MRSA clinical isolates, and reduced MRSA to undetectable levels in infected human skin samples after 60min. Phico aims to seek partners for Phase II or III clinical development.
Genesis 2007 was an interesting and interactive affair, and we can only hope that Genesis VIII will follow in its footsteps.
Leanne Coyne
Pharmaprojects Analyst
