|FDA Play: Cardium Waking Up|
|By Patrick Crutcher|
|Tuesday, 03 August 2010 00:03|
Cardium Therapeutics, Inc. (AMEX: CXM) appears to be finally waking up from the slump it has been in for the past month.CXM currently has a 510(k) currently under review with the FDA for their Excellagen(TM) product. This was filed in December 2009. (Since this is a 510(k) application, be aware no specific action date from the FDA can be guaranteed.) The Excellagen(TM) product line covers ExcellagenXL(TM) and ExcellagenFX(TM), advanced wound care management medical devices comprising customized collagen protein-based topical gels designed for patients with dermal wounds. Their Phase 2b study specifically looked at diabetic foot ulcers(DFU). This market has a current unmet need for first in-class therapies.
The market for the Excellagen product is quite substantial. With an estimated 25-30+ million diabetics, CXM estimates about 1.26 million annual foot ulcers. This market is estimated to be in the $1.5-2.4 billion in the US alone. The main product on the market for diabetic foot ulcers is Regranex. In CXM’s Phase 2b study, they found complete wound closure by 12 weeks at 34% with Regranex. Excellagen had complete wound closure by 12 weeks at 45%; that’s more than 30% better than Regranex with no side effects. Also noteworthy is that Regranex currently carries a warning label about the risk to develop cancer. Excellagen could become the first line treatment given those issues. The June 2010 presentation on Excellagen can be found here.
With regard to Excellagen, as part of the final steps required by the FDA for regulatory clearance for Excellagen, CXM expects to have final market-ready product material and process testing completed and submitted to the FDA sometime during the third quarter(3Q ends September 30 since our fiscal year-end is December 31).
Once this crucial step has been completed, CXM could see approval somewhere in the next 1-3 months. Hopefully by then we have heard word of a potential partnership for Excellagen. CXM’s management has made it very clear they plan to license the Excellagen product line. Cardium is focused on late stage product development opportunities and is not a fully integrated sales and marketing organization. Based on their business model and long-term strategy, they plan to place their product candidates into larger organizations or with partners having existing commercialization, sales and marketing resources.