Drug production is a dirty business. In 1997 researchers in the Netherlands developed a scale that assigns chemical processes an environmental impact - or E number - based on the energy and material inputs required and the amount of waste produced.
As examples, crude oil has an E value of 0.1, meaning 0.1kg of waste is made per kg of product. Bulk chemicals typically have E values in the 1 to 5 range.
Both of these are much lower than active pharmaceutical ingredients (APIs), which usually have E values of between 50 and 200.
There is considerable drug industry interest in ‘green chemistry’ processes that improve efficiency and cut waste – at least that is according to the corporate social responsibility reports issued by firms like Pfizer, GSK and Roche.
Whether these efforts are PR – so called greenwashing - or genuine is difficult to judge, although a study published in January by US Environmental Protection Agency (EPA) researchers suggested that drug industry production of toxic waste products fell 60% between 2002 and 2011.
Biotech slow to be green
Dhileepkumar Krishnamurthy from Piramal takes the view that while some drugmakers are investing to try and be environmentally-friendly others, particularly smaller biotechs, have yet to commit to greener manufacturing.
“Big pharma innovators are already using a GCbD approach to design routes that are more practical, scalable, and that reduce cost and waste” Krishnamurthy said, adding that “this involves R&D investment, which not everyone can afford, in particular cash starved, biotech innovators.”
The situation does not usually improve after biotechs license their molecules to partners because at that point “commercializing the molecules becomes highest business priority for the licensor - not green chemistry- due to the tight timelines associated with such licensing contracts” Krishnamurthy said.
But Krishnamurthy thinks biotechs are missing out on tangible benefits of being green, particularly those that have completed pivotal Phase II studies.
“A drug post phase II has typically demonstrated clinical efficacy and significantly improved its odds towards commercialization. An R&D investment in atom efficient green manufacture, improves the cost position for both, the larger Ph III trial coming up, and if successful, manufacturing the drug for a number of years post NDA.”
Market share
Similarly, green chemistry can benefit firms with drugs at the end of their patents according to Krishnamurthy who argues that: “A drug post patent expiry would face significant head winds and pricing pressure due to generic entry.
“Therefore an investment in a cost effective, green route, can reward both the innovator and the generic firm. For the innovator, a new route can offer a way to better compete against the generic competition, so long as the regulatory costs in filing for the new route are offset by its financial attractiveness.
“For a generic firm, the new route can be readily incorporated into its DMF filing, and if cost effective, can provide increased market share at the expense of both, the innovator and other competing generic firms.”