In the UK, Specials are prescribed for patients requiring very specific formulations of a drug that is unavailable as a standard licensed medicine.
The licence granted by the UK’s regulatory body MHRA will allow Juniper Pharma Services – previously known as Molecular Profiles – to make and supply such non-sterile drugs in bulk for clients from its facility in Nottingham, England.
“The extension of our currently licenced scope was already planned but it was a request from a client that provided the rationale to prioritise the addition of the Specials licence to our activities,” Claire Madden-Smith, VP commercial services, told Outsourcing-Pharma.com.
Bulking out
One issue that could present a barrier for a contract development and manufacturing organisation (CDMO) entering the Specials business is the generally low batch volumes of products required and therefore the high manufacturing cost.
However, Madden-Smith told us Juniper “only intends to manufacture batch Specials where relatively high/regular volumes are required” and likened the production to producing clinical trial materials.
“Naturally, volumes for Specials tend to be small compared to a licensed product but are similar in scale to the numbers for Phase I or II trials, which we know well given our well established clinical manufacturing services.”
She continued: “Specials are more costly on a unit for unit basis versus say an approved drug, but making bulk volumes is far more cost effective for our clients and potentially the end customer.”
Specials Market
While specialist companies and hospital run units offer significant capacity in the UK to make Specials, these are more aligned with making small batches or one-off named patient supplies, she explained, adding the firm can now off its clients additional options to meet unmet patient needs.
The market for Specials has been relatively stable over the last few years but is being affected by “increasing competition and new entrants to the market,” as well as the UK’s National Health Service’s (NHS) budget pressures and increases in regulation, Madden-Smith explained.
“Generally speaking, the Specials market is evolving with customers looking for ways to become more competitive, hence the launch of our bulk manufacture service.”
The licence is the latest service expansion for Juniper, following additions of hot melt extrusion (HME) and nano-milling capabilities last April, and investments in capsule-filling equipment in September.