Hi and welcome back to the Medical Technology Blog, hope you all had a great weekend, and we’re going to kick off the week with an article from Drug Delivery Insight.
San Diego, CA-based Cardium Therapeutics is making plans to purchase substantially all the business assets of Transdel Pharmaceuticals, also based in San Diego, which specialises in topical pharma products for the treatment of acute musculoskeletal pain. Cardium aims to get hold of Transdel’s assets, including royalty-bearing licence agreements for some cosmeceutical products marketed by third parties that use Transdel technology.
However, Cardium’s main focus is to get its hands on Transdel’s Phase III product candidate, Ketotransdel (TDLP-110), a topical analgesic designed for the treatment of musculoskeletal pain. Transdel’s drug-delivery technology, which is used in Ketotransdel, helps the penetration of a variety of drugs and other products through the skin barrier, allowing agents to be delivered directly to affected tissues. Ketotransdel contains ketoprofen, an NSAID that alleviates pain associated with both inflammatory musculoskeletal disorders like osteoarthritis and rheumatoid arthritis, and traumatic pain in patients with soft-tissue or back injuries. While there are orally-administered ketoprofen-based products registered for sale in the US, the country so far has no topical ketoprofen-based products on offer.
In Cardium’s view, Ketotransdel is capable of offering a new analgesic option within the NSAID market, which is thought to top US$200 million a year in the US alone. Some already-available products for use in the US include third-party products like the Flector patch (sold by King Pharmaceuticals under license from IBSA), Voltaren gel (sold by Endo Pharmaceuticals under license from Novartis) and Pennsaid (sold by Covidien under license from Nuvo Research). All the latter products are based on diclofenac (epolamine or sodium). However, ketroprofen is already widely used in Europe and is available on prescription in the US.
As for the cosmeceutical business rights, Cardium will have royalty-based licensing arrangements with JH Direct and Jan Marini Skin Research, covering the use of Transdel’s delivery technology for cosmeceutical products. The proposed purchase will looks set to broaden Cardium’s technology and late-stage product platform, as well as widening the scope of commercialisation and partnering opportunities now that Cardium’s InnerCool business has been successfully sold to Philips Healthcare.
Cardium is paying US$4.0 million upfront in the form of Cardium shares, of which US$1.0 million would be a contingent value payment to be held in escrow and only be released upon successful registration of Ketotransdel by the FDA within five years of the takeover. Should Transdel accept an alternative offer and terminated the asset purchase with Cardium, Transdel will pay a US$500,000 “break-up fee”, plus certain expenses and costs, to Cardium.
If this deal is approved by the US Bankruptcy Court and goes ahead, the Transdel assets will form part of a new subsidiary of Cardium that would be responsible for co-ordinating the clinical development, commercialisation, partnering and financing for Ketotransdel and related drug-delivery technologies. At the same time, Transdel’s cosmeceutical business would be transferred to Cardium’s MedPodium business, which would be responsible for broadening and expanding these activities and further developing the MedPodium platform, a ‘nutraceutical’ product portfolio and Cardium’s planned Nutra-Apps product line initiative.