Reaxa steps out from Avecia
The spin-out of Reaxa from Avecia will bring new catalyst technologies to the market .
The spin-out of Reaxa from Avecia will bring new catalyst technologies to the market .
Reaxa, the new catalyst technologies company, formally commenced trading in June after a successful spin-out from Avecia. The move is the culmination of 18 months' development since Avecia first launched EnCat, the encapsulated palladium pharma catalyst technology in 2003.Catalyst technologies are used in the manufacture of roughly 30% of new drugs, and Reaxa aims to offer both a new approach to catalyst immobilisation (EnCat) and improved 'clean-up' technologies for conventional homogeneous processes (QuadraPure). Its 'easier, faster, cleaner' chemistry vision is for a new chemical toolkit to help contain the development and production costs of complex new drugs.
innovation in r&d
Reaxa ceo Dr Pete Jackson says the company is ultimately looking towards implementing new technologies and improved synthetic routes to new products at commercial scale, 'though our early priorities are to deliver innovation for our pharma clients in r&d and to advance new catalyst-based programmes'. Reaxa's commercial, r&d and manufacturing operations will continue to be based at Avecia's site in Manchester, UK.
Immobilisation of precious metal catalysts via new EnCat technology is only half the story. Developed in parallel has been the range of QuadraPure metal scavenging resins to remove problematic heavy metal residues remaining in drug products after using conventional catalysts in manufacture. Metals removable by QuadraPure resins include platinum, palladium, ruthenium, rhodium, gold, silver, copper, mercury, lead and cadmium. Additional targets are magnesium, nickel, chromium, iron, cobalt and zinc.
The initial product is QuadraPure TU, a macroporous resin bead with thiourea functionality, specifically developed to have very low levels of extractable impurities for pharma processing in a GMP environment. QuadraPure IDA is a macroporous resin bead with carboxylic acid functionality, while QuadraPure AMPA has a phosphonic acid functionality. Three swellable, microporous products are also available: QuadraPure AEA, QuadraPure IMDAZ and QuadraPure MPA.
Reaxa's chief technology officer, Dr David Pears, believes legislation is driving ever more stringent regulations on Permitted Daily Exposure (PDE) to metal residues in medicines for human use. 'Precious metal catalysis is now such a major feature in pharma production that the issue of trace metal contamination, even at low ppm levels, is an increasingly important challenge,' he says. 'There is almost certain to be further tightening of specifications as improved methods of drug product clean-up are introduced.'
EMEA demands specific routine testing for catalyst metal residues, and may require additional heavy metal testing to embrace all potential sources of contamination. Variations in absorption into the body mean that different PDE limits are applied to topical, oral and parenteral routes of drug administration. Low concentration limits are set to cater for worst-case scenarios.
'Patient safety is the dominant consideration, and the key driver that dictates critical high performance from metal scavenging products and processes,' notes Pears.
Several additions to the EnCat/QuadraPure families are expected in the second half of this year and in 2006. New products in development include Pd EnCat ligand co-encapsulated products, and EnCat variants with other metals included, like osmium, nickel, rhodium, ruthenium and platinum.
In the QuadraPure range, Reaxa expects to introduce macroporous versions of the current microporous products, with improved properties for use in flow-through applications. Also in the pipeline are a number of new scavengers with differentiated function-ality for use in difficult substrate/solvent/pH combinations.
New programmes include nano-particulate metal zero hydrogenation catalysts, chiral catalyst and biocatalyst immobilisation. Reaxa is also talking 'seriously' to several companies on joint venture technology developments.
Reaxa grew from a partnership between industry and academia that set out in the mid-'90s to develop cleaner homogeneous catalysts. This brought together the supported reagent design and development expertise of Professor Steve Ley's Cambridge University group; Syngenta's knowledge of encapsulation methodology and Astra-Zeneca's drug applications for homogeneous catalytic coupling reactions. Avecia brought expertise in resin and polymer chemistry, process development, catalysts and catalyst scale-up.
Elements of that partnership continue as stakeholders in Reaxa - the company being a combined venture between its management team, Steve Ley, Avecia and external investors. Reaxa is also continuing the product distribution relationship with Sigma-Aldrich, piloted by Avecia in summer 2004. Sigma-Aldrich has been additionally retained for the worldwide distribution of the QuadraPure range.
Earlier this year, EnCat technology won the Royal Society of Chemistry's 2005 Teamwork in Innovation award. Now, Jackson hopes that Reaxa will shine commercially, as well as on awards nights.