Bentley hives-off CPEX delivery division

By Gareth Macdonald

- Last updated on GMT

Related tags: Pharmacology, Pharmaceutical drug

USA-based Bentley Pharmaceuticals is moving forward with plans to
spin-off its drug delivery division as a publicly-traded entity
under the name CPEX Pharmaceuticals.

The new company will focus on the CPE-215 excipient drug delivery technology,​ownership of which will be split between CPEX and Bentley, via a series of development deals and licensing agreements with other pharmaceutical manufacturers. Speaking at Bentley's fourth quarter earnings call in March, company president John Sedor identified key growth drivers for CPEX in the next few years, including two in-house developed products based on CPE-215. The first is Testim (testosterone gel), which has been sold in the US since 2003 by licensee Auxillium Pharmaceuticals, and Bentley's nasal insulin candidate Nasulin. ​ At present the market for novel delivery solutions is experiencing strong growth as pharmaceutical firms seek to develop needle-free solutions that enhance treatment compliance. A recent study by the Freedonia group predicted that the US demand for innovative drug delivery systems will increase by more than 10 per cent a year over the next few years, reaching $132bn (€83.7bn) by 2012. The CPEX spin-off, which was first mooted in October last year, comes ahead of Bentley's anticipated $360m (€234m) acquisition by Teva Pharmaceuticals. Bentley's strength in the Spanish generics market is thought to be driving that deal. CPEX shares are expected to begin trading on the New York Stock Exchange on July 1. CPE-215 permeation technology ​The CPE-215 excipient enhances the permeation, absorption and bioavailability of active pharmaceutical ingredients across a variety of biological membranes including the skin, mouth, nose and eye. The compound, which occurs naturally in the plant Angelica archangelica​, has been a widely used food and cosmetics additive for many years and is 'generally recognised as safe' (GRAS) by the Food and Drug Administration (FDA). While CPE-215 was initially developed to improve the delivery of relatively small molecules like the hormone testosterone, recent research efforts have focused on using it to improve the mucosal permeation of more complex molecules weighing up to 1,000 Daltons. Use of the technology in such applications is likely to attract the interest of pharmaceutical firms looking to improve the delivery of drugs belonging to the growing biologics class. During the development of Nasulin, which is currently in Phase II clinical trials, CPE-215 has been shown to improve the bioavailability of the drug two hours post-administration by between 20 and 30 per cent, compared with injectable insulin. The market for needle-free insulin products, which Bentley's research suggests is worth $8bn (€5.2bn) a year, is currently wide open due to the failure of various inhalable insulin technologies in recent months and the increasing incidence of diabetes worldwide. Bentley had not responded to in-PharmaTechnologist's questions at the time of going to press.

Related topics: Ingredients, Delivery technologies

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