Keryx Biopharmaceuticals Inc fka KERX

[califax]

Healthcare Conference Updates: KERX

Written by Mike Havrilla
Friday, 15 January 2010 09:09
http://biomedreports.com/articles/most-popular/24879-healthcare-conference-updates-auxl-ctic-cytx-kerx.html

Below are some updates and developments from the past week, which I spent in San Francisco for the OneMed, JP Morgan, and other healthcare conferences.

I had the opportunity to meet with the CEO (Ron Bentsur) and CFO (James Oliviero) of Keryx Biopharma (NASDAQ: KERX) on Wednesday and was impressed with the Company's focused strategy and upcoming milestones for 2010 and beyond. As outlined in my overview article last week, I have purchased shares of KERX over the past week on weakness at a slightly higher price range ($2.70-2.75) than I originally projected.

Given the Company's history of in-licensing compounds for development and robust cash position, I inquired if anything was on the horizon in this regard. However, for the near to intermediate term, Keryx plans to remain focused on utilizing its resources (cash / personnel) to get the Phase 3 trials well established before considering any new acquisitions, which is a good strategy given that Keryx is well-funded but still a small-cap drug developer that needs to remain focused.

Approximately $10-11 million is the estimated cost to fund both the short and long-term Phase 3 studies of Zerenex while perifosine has estimated funding of $12 million each to fund the Phase 3 studies for multiple myeloma (ongoing) and colorectal cancer (pending), with an estimate of $25,000-$30,000 per patient to fund the Phase 3 cancer trials. Below is a summary of additional details for upcoming catalysts and milestones for Keryx over this year and beyond that were not included in my overview article last week.

During 2010, Keryx expects to report updated data from its Phase 2 colon cancer study, conduct / update additional earlier stage Phase I/II studies, finalize late-stage trial protocol for colon cancer study, and begin additional late-stage studies for colon cancer in addition to the pending pivotal Phase 3 study of perifosine under a SPA agreement with FDA for multiple myeloma. KERX expects to provide an update on Phase 2 colon cancer survival and other data for perifosine next weekend at GI-ASCO 2010 (Jan. 22-24) as it prepares to begin a pivotal Phase 3 trial of perifosine in colon cancer patients with a Special Protocol Assessment (SPA) with the FDA possible for this indication within the next 2-3 months (i.e. mid-April 2010).

The ongoing Zerenex Phase 2 study in Japan by JT Torii is near completion and Keryx expects the Phase 3 trial to begin during 2H10, which will trigger a development milestone payment that is in the mid single-digit million dollar range. An additional $15 million milestone is possible upon regulatory approval in Japan, with approximately $55 million in remaining milestone payments based on the achievement of sales targets upon commercialization.

Zerenex represents a niche market opportunity within well understood / established class of drugs (phosphate binders) that has a key differentiation of being iron-based compared to existing treatments such as PhosLo, Fosrenol, and Renagel/Renvela. Zerenex is expected to offer an improved safety profile / patient acceptance with reduced GI / bloating side effects and approximately 50% less dosing burden (i.e. taking less pills less often) compared to existing phosphate binders.

In addition, a major secondary endpoint being evaluated is the potential ability of Zerenex to decrease the need for IV-iron and blood cell stimulators (EPO agents such as Epogen and Aranesp) since it is iron based and expected to result in long-term accumulation of the mineral. This may result in a first-line phosphate binder indication (with a goal of capturing 20-25% market share) for Zerenex and advantages that include safety (there is a pending FDA Advisory Panel to discuss safety issues of EPO drugs) and economic (dialysis bundling payment issues - Zerenx has potential to save dialysis providers money by reducing need for IV-iron or EPO agents).