Thank you for reading our latest newsletter! There is a definite ‘vaccine flavour’ to this issue. When the founding members of the Eden team worked at Medeva (in what seems like another life now!), vaccines were almost a commodity product which attracted little pharma industry interest. In these days of ‘the perfect storm’ of pharma pricing pressures, generics, etc plus exciting science breakthroughs in therapeutic vaccines, allied to the threats of bioterrorism and the stalking menace of rampant strains of killer bird flu - the story couldn’t be more different.


The last two months have been rich in news, scientific innovations, and thoughts over the vaccine business. To start with, the recent announcement of the acquisition of MedImmune by Astra Zeneca in an all-cash transaction worth $15.2 billion has literally shaken the industry. AZ signs here its biggest buyout since the company was formed in 1999 with the merger of Astra and Zeneca.  For the Anglo-Swedish drugmaker which is facing loss of patent protection for its own drugs, this operation is aligned with the 2006 purchase of CAT, in its aim to establish a fully integrated biologics and vaccines business. The merger gives AZ an access to 45 new products in development at MedImmune, including: Synagis for lower respiratory tract disease; Ethyol, a drug to reduce toxic effects of chemotherapy; and what is seen by many as the key product in this deal: FluMist, the nasal spray flu vaccine manufactured in Liverpool.

Whilst Glaxo Biologicals predicts the global vaccines market will double in size by 2010 and triple by 2015, The Scientist published an insightful article showing that currently, too many companies cannot afford the high risks and low profits that accompany the development of vaccines. Improving government funding and expanding public-private partnerships are some of the solutions the authors discuss in order to address funding issues.

Also this month, the first vaccine to protect humans against the H5N1 influenza (bird flu) virus won U.S. FDA approval. The vaccine made by French company Sanofi-Aventis will not be sold commercially but has been purchased for inclusion within the U.S. Strategic National Stockpile as an interim measure in case an influenza pandemic strikes. The decision arises less than two months after the World Health Organization (WHO) voiced again its concerns about the ability of the global community to produce enough vaccine to protect populations in the event of a pandemic.

In this sensitive context, researchers work harder to discover new technologies that will permit the achievement of vaccines mass-production. An US study involving the use of an insect virus, baculovirus, has been reported by the Journal of the American Medical Association (JAMA) as a potential alternative method to produce flu virus proteins in cells taken from caterpillars. Proved to be as effective as conventional egg-based techniques, this new expression system possesses several advantages in terms of speed (taking weeks rather than months to produce high levels of protein), cost, glycosylation, and folding.

Novartis’ answer to the growing demand for seasonal influenza vaccines is Optaflu. The Swiss Company said it is the most advanced cell-based vaccine - and now the first one to receive support from the Committee for Medicinal Products for Human Use (CMPH). The European drug regulator has recently given positive backing for this new process, which makes it possible to devise vaccines that are better at protecting people from new strains of the flu.



Following on from the announcement of our manufacturing license from the MHRA, work is now underway on our first GMP projects for Onyvax Ltd and SR Pharma plc.

In other news we are pleased to announce we have commenced work with a new client, ImmBio (Cambridge, UK), to provide a range of development and manufacturing services for their leading influenza vaccine programme. The press release for this deal attracted a lot of press coverage including this from in-Pharma Technologist.

We have had something of a reorganisation now that we have successfully achieved our manufacturing license and are now completely focused on client work. Richard Dennett has been promoted to lead Eden Biodesign’s consultancy business, Philip Ball will take on Purification Development in addition to Analytical Development and Dave Simpson moves from Molecular Biologist to head Upstream Development. Mark Rayner will take Richard’s previous role as Technical Transfer Manager.

In what is really just a pretext to show a photograph of grown men crying, we are pleased to report that we raised an impressive £360 for Comic Relief through baking cakes, wearing red for the day, a sponsored silence (we aren’t saying who for!) and of course the obligatory leg waxing of the Hochtief and Eden’s facility management team!



We held a family open day last Saturday, 28 April, to show our children and relatives the National Biomanufacturing Centre. Amongst the balloons, sweets and pictures of yucky bugs, we hope we have managed to encourage some budding scientists to follow in mum and dad’s footsteps.





Richard Dennett was interviewed by Pharmaceutical Technology Europe regarding our decision to design the NBC around the use of disposables in biopharmaceutical production. It includes an incredible, immortal line from Rik which will probably end up as his epitaph - so take a look.



This newsletter is prepared by Eden Biodesign and comments and suggestions are most welcome.

Please address them to: Johanne Tabern (Tel: 0151 728 1750)

Eden Biodesign
National Biomanufacturing Centre, Estuary Banks
Estuary Commerce Park, Speke Road, Liverpool L24 8RB
www.edenbiodesign.com

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