Proprietary Feasibility Assessment Helps Generic Drug Companies Overcome Patent Cliff

Camargo Pharmaceutical Services’s Ready 4 Action assessment enables drug developers — generic companies in particular — to identify viable products to bring to market. Camargo will be exhibiting at the Generic Pharmaceutical Association (GPhA) Annual Meeting, 19–20 February, JW Marriott Orlando Grande Lakes, Florida, where attendees can learn more about this four-step process.

“The patent cliff that rocked big pharma is starting to reverberate in companies developing generic alternatives,” said Ken Phelps, President and CEO of Camargo. “One way generic companies are looking to add more value to their product lines is through the 505(b)(2) application process, which allows companies to file NDAs.”

The success of developing a product using the 505(b)(2) pathway hinges on identifying products that have documented market differentiation, low development risk and high profit potential.

By using its Ready 4 Action assessment, Camargo helps companies developing pharmaceutical products identify candidates for possible development by assessing the four essential areas of drug viability: scientific, medical, regulatory and commercial. This process aids generic companies to identify a differentiated product, setting the cornerstone of a cost-effective product development plan to advance from concept to commercialisation.

“Because generic companies have historically produced copies of other products, they often need guidance to evaluate these four aspects to fully understand the unique requirements that come with the 505(b)(2) development process,” Phelps said. “With Ready 4 Action, we help all pharmaceutical companies evaluate candidate criteria that are vital to market success and ROI.”

GPhA attendees can visit Camargo on booth 17 to learn more about Ready 4 Action as well as Camargo’s expertise in the 505(b)(2) process and other service offerings.

Camargo Pharmaceutical Services, www.camargopharma.com.