Will big pharma share its APIs for the sake of custom-made drugs?
working on establishing a unique supply agreement with major drug
firms that could serve as a model worldwide for the production of
drugs that meet the specialised medical needs of patients.
Such a partnership would be possible because manufacturers of personalised medicines, referred to as specials, enjoy specific regulatory status in the UK and must have a specials manufacturing licence which regulates their manufacturing processes.
They use this licence to develop formulations that solve the problems of individual patients caused by commercially available drugs.
For example, a patient may be allergic to a pharmaceutical excipient or may not be able to swallow tablets and require a liquid dosage form that a drug company does not produce.
However, to make such specific formulations, specials manufacturers do not start from scratch, as they do not have the raw materials they need, and usually have to work with a company's finished product. This limits the quality and variety of the formulations they can make.
To address this issue, Jonathan Fawdry, chairman of the Association of Commercial Specials Manufacturers (ACSM), spoke to In-PharmaTechnologist.com at the British Pharmaceutical Conference in Manchester about his trade body's efforts to convince big pharma to share ingredients with them.
"A partnership would enable drug companies to provide individual patients, such as babies and young children, with medicines that more closely match their very particular needs," he said.
"Our members are keenly aware of the complexity and concerns surrounding big pharma providing them with raw materials such as active pharmaceutical ingredients (APIs) and intermediates to help them with their formulation but feel that in the climate of increased emphasis on access to medicines the time is right to take the first steps to exploring the potential for cooperation."
Behind much of big pharma's apprehension to this idea is the potential for abuse; pharmacies in most countries are not regulated in their production of specials and just last month the US Food and Drug Administration (FDA) censured three pharmacies for using the traditional practice of compounding as a ruse in order to operate as large-scale drug manufacturers.
Nevertheless, the fact that specials manufacturers in the UK are regulated not only addresses their fears of unlawful competition but also ensures they comply with good manufacturing practice (GMP) standards and ISO 9000 Quality Management.
"Any agreement will absolutely need to protect the intellectual property and patents held by pharma companies and is likely to take a long time to develop," Fawdry said.
"I am glad to say that the response to our approach has been welcoming and I am confident that we are well positioned to explore our options and hopefully to make progress."
The context for the discussion with big pharma is the work that has emerged from the UK government's Medicines for Children initiative launched last year, bringing together practitioners, regulators, academics and industy to work on improving the quality of medicines, for children in particular, but for others as well.
For generically available materials this has already led to the development of a number of liquid products by ACSM members for niche treatment, yet the association claims that much more can be done concerning the APIs currently under patent.
As pressure mounts on drug firms to offer medicines with an unusual formulation or strength, preservative or additive-free, the UK, where the regulatory climate is reassuring, provides fertile ground for a partnership between big pharma and specials manufacturers that could serve as a blueprint for the industry globally.
