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Blog & Resources Camargo Blog February 23rd, 2014

Top Generic CEO’s Confirm Importance of 505(b)(2) in Their Company’s Financial Future

Development stage companies are seeing more opportunities to license their products to generic companies. Recently, generic company CEOs reinforced the importance of 505(b)(2)-developed products to their financial future.

The 2014 Generic Pharmaceutical Association (GPhA) annual meeting concluded this pastweek in Orlando. This is the largest gathering of C-level executives from the generic industry. Camargo has exhibited and I have attended for several years because generic companies are an important clientele of our 505(b)(2) services. As we have relayed over the years, large pharma companies have launched fewer small molecules and are expanding their research on costly biologically derived products. This results in fewer drugs coming off patent – drugs that are the lifeblood of generic companies. Doug Long, VP of Industry Relations, IMS Health, Inc. is a fixture at these annual meetings, presenting statistics on the past and future performance of the generic industry. In his session he pointed out that fewer small molecules were coming off patent in the next 5 years and the value of the products coming off patent was much lower than the past several years. He raised the question about how generic companies could meet revenue forecasts.

Every year a panel of CEOs from the top generic companies is ‘grilled’ by a financial analyst. This year was no different. Ronny Gal, Ph.D. Senior Analyst with Sanford C. Bernstein and Randall Stanicky, Managing Director, Equity Research, RBC Capital Markets quizzed the CEOs of Mylan, Hospira, Teva, Apotex and Momenta. Among the challenges faced by the generic industry, the analysts were interested in how the companies were filling this pending financial revenue gap. Ronny Gal asked if 505(b)(2) products were being considered as a solution. Each of the CEOs responded that 505(b)(2) products were part of the spectrum of solutions. In response to further questioning, a couple of CEOs explained that some of these products could be developed in house, partnered or licensed-in depending on their company’s expertise and strategy. It was pointed out that product differentiation was a key requirement.

Thus, this meeting was a great opportunity to introduce our Ready 4 Action integrated service offering. A large number of people stopped by our booth to learn about how Camargo is offering commercial, scientific, medical and regulatory assessment to gain confidence that their proposed product could meet the in-licensing test of these demanding generic companies.



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Camargo Pharmaceutical Services provides comprehensive drug development solutions, specializing in customized programs including the 505(b)(2) pathway.


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