Novartis boosts vaccine pipeline
pharmafile | January 8, 2009 | News story | Research and Development, Sales and Marketing | Novartis, recruitment, vaccines
Novartis has added an investigational vaccine to its pipeline through a $20 million deal with AlphaVax.
The North Carolina-based biotech company's investigational Cytomegalovirus (CMV) vaccine programme is expected to enter phase II clinical trials later this year.
There are currently no approved treatments for CMV, which can be passed from mothers to their unborn child – for whom it is potentially fatal.
Established manufacturers have invested heavily in biotech products over the past few years in a bid to beat the twin pressures of dwindling pipelines and generic competition.
The move strengthens Novartis' vaccines pipeline and the pharma company retains an option to make an equity investment in return for four million shares at the end of phase II trials.
AlphaVax will in turn be eligible for milestone payments and royalties as the vaccine's development continues.
CMV infects approximately 86,000 newborns in the US and EU each year causing 700 deaths and 17,500 cases of severe disability.
AlphaVax's vaccine candidate is based on an alphavirus replicon particle encoding CMV phosphoprotein 65, IE1 (immediate early protein 1) and soluble gB protein.
Under the terms of its agreement with Novartis, AlphaVax is responsible for finalising phase I clinical trials and will also provide the clinical trial material for the phase II trials later this year.
Novartis will be responsible for these trials, as well as registration and global commercialisation of the product.
"We are happy to gain access to a promising vaccine candidate for the prevention of cytomegalovirus infections, which are particularly problematic during pregnancy as they can cause permanent disability in newborns," said Dr Andrin Oswald, chief executive of Novartis Vaccines and Diagnostics.
The deal also gives Novartis the first look at AlphaVax's preclinical respiratory syncytial virus programme.
Novartis said the AlphaVax product joins its promising early-stage pipeline of novel vaccines focusing on significant unmet needs for the prevention of fatal diseases.
These include meningococcal infections and other hospital and community-acquired infections.
The company is currently working on vaccines to prevent Helicobacter pylori infections, a major cause of gastritis that can lead to gastric cancer.
It is also developing a Group B Streptococcus vaccine candidate with the potential to protect against 85% of neonatal sepsis and meningitis.
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