Solvias AG announces Chemical Development and GMP manufacturing agreement with Rottapharm/Madaus

Solvias AG announces agreement for the manufacturing of the active pharmaceutical ingredient (API) for Rottapharm|Madaus’s phase I candidate, CR4056. Solvias will provide ongoing process R&D support and deliver the CR4056 API, produced in its GMP-approved API manufacturing facility, for use in planned Phase 1 clinical studies.

Rottapharm | Madaus is developing CR 4056 for the treatment of neuropathic pain and acute non-specific pain states. CR 4056 is a novel imidazoline (I2) ligand endowed with potent analgesic activities demonstrated in different animal models related to inflammatory, neurogenic and neuropathic pain during preclinical development.

Solvias has been involved in the development of CR 4056 since 2007, starting with initial lead synthesis and subsequent chemical and analytical development with consequential supply of material for use in preclinical studies. As part of the development program a new manufacturing route was also designed and optimized, which will significantly improve the purity, the ease of synthesis and possibly the cost of this API.

“Over recent years, our collaboration with Rottapharm | Madaus has been very fruitful and we are delighted to be supporting the development and manufacturing of CR 4056 in anticipation of Phase 1 clinical studies,” stated Michael Quirmbach, Product Manager at Solvias. “Our team of chemical and analytical development scientists was able to design an economically feasible process. Our know-how in CX-coupling and heterocyclic chemistry was one of the key factors in this multidisciplinary task.”

 

About Rottapharm/Madaus
Rottapharm|Madaus is a multinational pharmaceutical group of Italian capital with its headquarters and research centre in Monza and branches in over 85 countries. Since its creation, Rottapharm has distinguished itself in its commitment in designing, development and marketing of innovative drugs for the treatment of specific pathologies. Currently, research is focused on gastroenterology; bronco-pneumology, psychiatry, rheumatology, gynecology, cardiology and oncology. Rottapharm|Madaus is also present in the market of personal care products distributed in pharmacies – where it holds a leadership position – and in the field of nutraceutics.

Rottapharm|Madaus finished the year of 2008 with a revenue of 572 millions and an EBITDA of 165 millions.