Nov. 9 /PRNewswire/ -- Penwest Pharmaceuticals Co. (Nasdaq: PPCO - news) today announced that as part of its alliance with Celltech Group plc (NYSE: CLL; LSE: CCH), the companies have brought together Penwest's oral drug delivery expertise and Celltech's chiral chemistry competency, to create a patented formulation platform designed to release chiral isomers at differential rates. Their lead candidate, D6428, a centrally acting synthetic analgesic, is expected to be among the next generation pain medications and may surpass current market leaders in therapeutic performance.
The companies have successfully completed Phase 1A clinical trials, validating that chiral isomers can be released at different rates from a tablet using Penwest's proprietary TIMERxr controlled release drug delivery technology in healthy volunteers.
Previously, pharmaceutical products containing stereoisomers, mirror image molecules, were treated as single entities. The isomers were either released in tandem or, utilizing chiral chemistry, only the active stereoisomer would be included in the product. Celltech discovered that the isomers within D6428 are both active and have different and complementary profiles, and that by releasing both of them at the desired rates, there may be a reduction in the side effects. The challenge then became formulating these isomers to be delivered at differential release rates.
Tod R. Hamachek, Chairman and Chief Executive Officer, said, ``By isolating the isomers and applying the strength of our controlled release drug delivery technology, we believe that it is possible to design an entirely new pain management product. Creative innovations, such as this one, can be developed when two market-leading companies come together to focus their expertise on clearly defined market needs. Penwest's novel drug delivery products are now not only proven to generate faster time to market and provide therapeutic enhancements, but also to be fundamental to the development of ground-breaking drug formulations. We are proud of our success in applying our technologies in pioneering ways.''
As part of the Phase 1A trials, the companies jointly developed the optimal release profiles for the chiral isomer combination. Celltech then successfully isolated and produced the single isomers, which, when joined with a TIMERx formulation, achieved the optimized release profile target and confirmed that -- for the first time -- chiral isomers could successfully be differentially released within the body. The results were supported by TIMERx's ability to minimize design experiments and reduce the cost and time of formulation development.
Anand R. Baichwal, Senior Vice President, Research & Development, said, ``We are very pleased that our TIMERx technology has demonstrated its predictability and flexibility by taking a very difficult release profile and developing it into a simple tablet formulation. In working with Celltech, we were able to deliver chiral isomers with differentiated release rates in large part because of our fundamental competency in tabletting and drug delivery. This enabled the partnership to develop an original formulation that we anticipate will have expanded therapeutic advantages.''
Penwest and Celltech have already begun Phase 1B clinical trials, which are designed to confirm the therapeutic benefits of the product, while minimizing side effects such as nausea that are commonly associated with branded pain medications. These results are expected around year-end.
In December 1998, the two companies signed an agreement to develop novel isomer product opportunities in combination with drug delivery technologies. |
