The three formulation projects will be supported by Rottendorf’s 40 formulation scientists and their ability to work with multi-layer, delayed-release tablets or hot melt granulates. All of that work will be done at the Ennigerloh, Germany-based Rottendorf Development Center, which is in line with GMP and FDA standards for the development of solid oral dose pharmaceuticals. Built in 2009, it is capable of producing drug batches from 2 kg to 150 kg for clinical trials, stability studies, or small commercial batches.
Rottendorf Pharmaceuticals CEO Gordon Haines told Outsourcing-Pharma.com that although the he can’t offer any specifics on the deals because of client sensitivity, nearly all of them involved companies that previously worked with Rottendorf, found the work and expertise to be sufficient, and have continued on with other projects.
“The commercial transfers are the same story – companies like what we did and they added to our plate,” Haines told us. “We’re finding that here in US, the majority of growth has been new small molecule projects – frankly we did not set out to target big pharma but we cultivated those relationships and have multiple projects with small and virtual companies as well.”
The five new projects capped a strong year of growth for the US-based subsidiary of Rottendorf Pharma GmbH, which Haines told us has been growing at about 10% since 2009.
“The new projects signed in the last quarter reflect the industry’s positive response to our business model,” said Haines.
Haines noted that a significant number of new clients come to the company as a result of word-of-mouth referrals from satisfied clients who have benefited from the proactive approach Rottendorf takes to process improvement. But over the past six months the company has made a more proactive marketing push, Haines added.
Under these contracts, Rottendorf assumes a high degree of process responsibility and ownership. Benefits to clients include reduced management oversight; lower costs due to reduced complexity; and supply chain improvements.
Clients also seem to appreciate the CDMO’s unique corporate structure. “We are owned by a charitable foundation, which allows us to focus more on long-term success of our business and the goals of our customers, rather than needing to satisfy shareholders on a quarter-by-quarter basis,” Haines added.
All of the shareholders have also signed a charter agreeing that the company cannot be sold and nearly all of the profits stay in the company for re-investment, Haines said.