Cardium Therapeutics has agreed to acquire substantially all of Transdel Pharmaceuticals’ business assets, including phase III product candidate Ketotransdel (TDLP-110), a topically-administered analgesic for the treatment of musculoskeletal pain. 

The assets would be acquired in connection with a proposed asset purchase under Section 363 of Chapter 11 of the U.S. Bankruptcy Code, and would also include royalty-bearing license agreements for certain cosmeceutical products marketed by third parties that employ Transdel delivery technology. The completion of the asset acquisition is subject to a number of conditions, including approval of the transaction by the bankruptcy court.

Transdel is a San Diego-based specialty pharmaceutical company that developed topically-administered products, particularly useful for the treatment of acute musculoskeletal pain that occurs with soft tissue injuries and other potential pain indications.  Transdel's innovative drug delivery formulation facilitates penetration of a variety of drugs and other products through the skin barrier, allowing agents to be delivered directly to affected tissues.  Ketotransdel, the company's lead late-stage clinical candidate, is designed as an analgesic prescription product containing ketoprofen, which would be topically administered for the treatment of musculoskeletal pain. 

Ketoprofen is a non-steroidal anti-inflammatory drug that alleviates pain associated with both inflammatory musculoskeletal disorders such as osteoarthritis and rheumatoid arthritis, as well as traumatic pain in patients with soft-tissue injuries or back injuries.   While there are orally administered ketoprofen-based products registered for marketing and sale in the U.S., there are no topical ketoprofen-based products available in the U.S.

Cardium believes with FDA registration, Ketotransdel would offer a new analgesic option within the topical NSAID market, now estimated to exceed $200 million annually in the U.S. Ketotransdel represents a new class of topical NSAID based on an active ingredient, ketoprofen, that is widely used in Europe and is available as a prescription drug in other forms in the U.S.

Cardium would also acquire Transdel's cosmeceutical business rights, which currently include royalty-based licensing arrangements with JH Direct LLC and Jan Marini Skin Research covering the use of Transdel's innovative delivery technology for cosmeceutical products.

 "The proposed purchase of the business assets of Transdel Pharmaceuticals further broadens our technology and late-stage product platform, and provides additional opportunities for potential commercialization, partnering or other monetization, now that our InnerCool Therapies business has been successfully sold to Philips Healthcare," stated Christopher J. Reinhard, Chairman and CEO of Cardium.

Cardium would acquire substantially all of Transdel's business assets for the payment of up to $4.0 million in consideration in the form of unregistered shares of Cardium common stock priced at a minimum of $0.50 per share, including $1.0 million of which that would be a contingent value payment to be held in escrow, released only upon successful registration of Ketotransdel by the FDA within five years of the closing. 

If approved, the assets would be part of a new wholly-owned subsidiary of Cardium responsible for coordinating the clinical development, commercialization, partnering and financing for Ketotransdel and related drug delivery technologies.