EntreMed Inc, a clinical-stage biopharmaceutical company developing therapeutics primarily for the treatment of cancer, has entered into a Clinical Supply Agreement with Elan Drug Delivery Inc to reformulate and manufacture EntreMed's Panzem in an oral liquid product format, according to a company release.
This supply of reformulated Panzem will support EntreMed's clinical oncology programme that is planned to begin in early 2005. Elan is manufacturing the reformulated Panzem using its proprietary NanoCrystal technology that enhances product bioavailability and absorption and produces particles that are fifty times smaller than conventional processes. A number of products using NanoCrystal technology have been commercialized successfully, including Wyeth's Rapmune and Merck's Emend.
EntreMed president and CEO James S Burns commented, "We remain on schedule with our plan to initiate clinical trials with reformulated Panzem in cancer patients in early 2005. Using Elan's NanoCrystal technology, we believe we have developed a robust formulation of Panzem that will improve product bioavailability and provide patients with a convenient orally administrated liquid product. EntreMed and Elan are working together closely to ensure that internal timelines continue to be met."
Elan's NanoCrystal technology may enhance the clinical performance of poorly water-soluble drugs by transforming them into nanometer-sized particles. An increasing number of the drug candidates synthesized each year by pharmaceutical companies are poorly water-soluble. Many of these potentially innovative drug candidates are often abandoned because of poor pharmacokinetic properties including absorption, distribution, metabolism, and excretion.
NanoCrystal technology has the potential to rescue a significant percentage of these chemical compounds. The drug in nano-form can be incorporated into common dosage forms, including tablets, capsules, inhalation devices, sterile forms for injection, with the potential for substantial improvements to clinical performance.
There are currently two pharmaceutical products that have been commercialized incorporating NanoCrystal technology, with several additional product launches anticipated over the next two years. The NanoCrystal technology is protected by 85 issued US patents and 48 pending patents.