Cycle Pharmaceuticals to use 3D printing to develop 'orphan drugs'
Cambridge-based company signs partnership deal with US firm to develop drugs for rare diseases.
Cycle Pharmaceuticals has signed a partnership agreement to develop and commercialise drugs for rare diseases using three-dimensionally printed technology.
One of the Cambridge-based company’s key focus areas is ‘orphan drugs’ – drugs for rare diseases – which are treatments, not cures. Patients may have to take these medications every day for the rest of their lives, meaning that any improvement in treatment is invaluable.
Cycle’s partnership with US-based Aprecia Pharmaceuticals will deliver quality-of-life improvements over existing approved orphan drugs by utilising Aprecia’s ZipDose 3DP technology platform. ZipDose 3DP can be combined with a variety of active pharmaceutical ingredients to create rapidly-disintegrating oral dosage forms that are easy to take and administer.
Antonio Benedetti, CEO of Cycle, said: “Many rare disease patients do not have a treatment option at all. For those rare diseases where there is an approved pharmaceutical treatment, patients continue to be burdened by sub-optimal drug formulations.
“Aprecia’s ZipDose 3DP technology can formulate fast-melt pharmaceutical products, incorporating significantly higher amounts of active pharmaceutical ingredient than any other fast-melt technology on the market.
“As such, this advanced technology can uniquely overcome both pill burden and dysphagia – swallowing difficulties – both of which are life-long, daily issues for so many rare disease patients.”
Zipdose is the only 3D printing technology used in a pharmaceutical drug product approved by the US Food and Drug Administration.
Don Wetherhold, CEO of Aprecia, said: “We are excited to work with the Cycle team, and we see important synergies in the companies’ shared mission to address unmet needs in patient care. Cycle specialises in orphan drugs – they have proven that they can deliver quality-of-life improvements to rare disease patients around the world.
“Aprecia is fully committed to applying its ZipDose 3DP printing technology to address real-world, daily issues faced by rare disease patients.”
The first drugs from the partnership are expected to reach the market within two or three years.
Cycle’s first orphan drug product, NITYR (nitisinone) tablets, is approved in the US and Canada for the treatment of hereditary tyrosinemia type I, a genetic disorder characterised by disruptions in the process that breaks down the amino acid tyrosine.
Babies with tyrosinemia type I show signs and symptoms in the first few months of life – those affected fail to gain weight or grow at the expected rate. NITYR has an improved formulation aiming to provide patients with greater convenience.
Cycle, founded in 2012, has more than doubled in size to 25 people in the past 18 months. As well as orphan drugs, Cycle focuses on reinstating generic drug products that have been previously marketed, and working with academic and other partners to extend pharmaceuticals to new medical areas where there is clear unmet need.