DSM accelerates anti-infective activity
accelerating its activity in the anti-infective arena and targeting
new active pharmaceutical ingredients (APIs) that it can develop
into cost-competitive generic versions.
The company has developed a unique environmentally-friendly enzymatic processing technology that doesn't use any solvents or chemical processes.
According to the firm, the process also results in a very high purity products, therefore requiring less ingredients to make and as a result is cheaper.
"This enzymatic process is revolutionary, we are the only company to have it," Hans van Nistelrooij, director of business development in DSM anti-infectives, told In-PharmaTechnologist.com at the recent CPhI show in Paris.
DSM has used this process to produce DSMPureActives - a range of generic antibiotics that are made with up to 90 per cent less waste production and over 50 per cent less greenhouse gas emissions and water consumption.
Now the company is looking to take this technology further and apply it to a much broader range of products.
"Until now we have only used this processing competence in anti-fungals but now we are expanding our portfolio to include other APIs," said van Nistelrooij.
"The aim is to use these enzymatic process to improve the manufacturing efficiency of the APIs, produce the finished generic API products and them sell them to pharma companies at competitive prices so they can then make finished dosage forms."
van Nistelrooij said the company has taken the top 600 drugs on the market that have, or are due to come off patent in the next few years and evaluated the molecules that best fit with its competence base.
"If we can't offer a substantial decrease in costs then there is no point in us to be the number ten API producer in an overcrowded market," he said.
"Therefore we only selected molecules that we see having a clear cost advantage."
"Of course, we will also choose molecules where new technology in process routes can signal a major manufacturing breakthrough for companies and offer them large time and cost savings," he added.
The implementation of this new plan will be carried out in waves. The first phase, planned for the second quarter of 2007, will be mainly based on fermentation development competencies and will focus on big-name drugs such as Pravachol (pravastatin) and Prograf (tacrolimus).
"The pravastatin molecule for example is today produced by two different fermentation steps and we have developed a new micro-organism that can be used to cut this down to one step," said van Nistelrooij.
The second phase, which will also take place around the same time as the first, will focus on developing improved processes for chemicals, that aren't ß-lactam intermediates, that currently need either chemical- or biocatalysis synthesis.
"Unlike the fermentation processes that require extra-special attention and will be carried out within the EU, these chemical- or biocatalysis processes will be performed in our manufacturing facilities in Toansa, India, as we already have a large knowledge base in this area there," said van Nistelrooij.
"So for these molecules we will be able to offer the benefit of our improved process technology, in addition to the benefit of the Indian cost structure."
The molecules will be transferred to India from DSM's R&D labs in The Netherlands and will include blockbusters such as Lipitor (atorvastatin) and Altace (ramipril).
The third phase will also involve DSM's Indian plant and is also earmarked for the second quarter of 2007 and will include the compounds atomoxetine and dorzolamide.
For the fourth and final phase, planned for the second quarter of 2008, DSM is now screening all compounds that were launched in 2001 that will come off-patent in 2014 in order to build up a complete new portfolio for the future.
