PCAS press release
April 12th, 2016 - US patent granted for PCAS new Cinacalcet production process
PCAS is committed to the development of its proprietary products catalogue as a way to increase its business performance. In the field of Active Pharmaceutical Ingredients (API), this commitment is put in place by the development of innovative and cost-effective processes for the production of APIs that PCAS will be able to offer to customers in the coming future.
The API, Cinacalcet is a calcimimetic agent used primary for the treatment of hyperparathyroidism primary or secondary. Hyperparathyroidism is a condition in which the parathyroid glands in the neck produce too much parathyroid hormone (PTH), which can lead to bone and joint pain and deformities of the arms and legs. Cinacalcet is sold under the brand Mimpara in Europe and Sensipar in the USA and it is formulated with 30mg, 60mg or 90mg strengths.
Cinacalcet was launched by Amgen in 2004 and has reported worldwide sales of 1 415 M$ in 2015 under the Mimpara/Sensipar brands. The sales figures show an increase of 22% on a year-to-year base.
PCAS has developed an innovative and cost-competitive process for the production of Cinacalcet, taking advantage of its strong know-how on Wittig chemistry but adapted to prepare Cinacalcet on a convergent and direct manner. The process takes advantage of a key product produced in-house at PCAS.
PCAS had filed for patent protection for this process and are pleased to announce that the US Patent Office has granted PCAS' application the US patent number 9,290,439 that has been delivered on March 22nd, 2016.
The equivalent European patent application has a positive review by the European Patent Office, anticipating a smooth delivery of the patent.
PCAS has filed for regulatory approval in major markets, obtaining already the ASMF dossier for entering the European regulated market.
All these actions reinforce PCAS position as a trusted Active Pharmaceutical Ingredients (APIs) supplier, having worldwide regulatory filing capacity to support our customers' product development. This position is confirmed by the regular audits of PCAS production sites by several national authorities in support of the large number of products currently on the market as well as new product launches.
PCAS' multi-client catalogue of APIs lists more than 40 APIs regularly produced in our four GMP-compliant production sites. On the regulatory side, the products of the catalogue are supported by 29 US DMFs, 25 European DMFs, 15 European CEPs, 10 Japanese DMFs, 10 Canadian DMFs, among others successful regulatory filings including several new dossiers in progress in China.