FDA Play: Cardium Waking Up Print E-mail
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.

The potential licensing deal could be in the several hundreds of millions of dollars based on roughly 500-600k  diabetic foot ulcers per year in the US and $500-600 per treatment. This is also ignoring its broader use as a general wound healer. Once approved, this product could easily do $300 million in revenues per year.

Investors shouldn’t forget that CXM has another potential blockbuster in Generx. Generx is a DNA-based angiogenic growth factor therapeutic being developed for the potential treatment of patients with advanced coronary artery disease. Generx is designed to stimulate the growth of supplemental collateral blood vessels in the heart in order to enhance myocardial blood flow (perfusion) in patients who have insufficient blood flow due to atherosclerotic plaque build up in the coronary arteries. The product has gone through a number of trials and is currently wrapping up Phase 2b/3 trials. They are also aiming this treatment at those who do not have access to expensive, advanced care therapy in developing countries. Investors should read the presentation covering most info about Generx.

As of March 30,2010, CXM had had $11.8 million in cash and cash equivalents and $1.4 million in restricted cash. As of May 6, 2010, 77,852,154 shares of Cardium's common stock were outstanding. They have solid institutional and insider holding for a small-cap biotech. This will be another interesting story to follow over the next couple of months. October is shaping up to be a blockbuster month in biotechs!

Don't forget that you can see a complete list of upcoming FDA decisions and trade to make money by using the information found here.

Disclosure: No positions.

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