Industry News Bytes: Delcath, Amylin and Access Pharma

by: Mike Havrilla

Potash (NYSE:POT) is poised to open trading at new highs after posting strong earnings and upping its guidance. Meanwhile, Yara International (OTCPK:YARIY) has withdrawn its bid for Terra Industries (TRA), which will be acquired by CF Industries (NYSE:CF). In addition, Agrium (NYSE:AGU) has dropped its hostile bid for CF.

Delcath Systems (NASDAQ:DCTH) is an emerging, small-cap medical device innovator that is developing a regional treatment system for cancer in the liver. Delcath's Percutaneous Hepatic Perfusion (PHP) technology allows physicians to deliver significantly higher doses of existing chemotherapy drugs to the liver without exposing each patient's entire body to the anti-cancer drugs, representing an elegant solution that promises to increase the effectiveness of approved anti-cancer drugs while reducing systemic side effects.

DCTH conducted an update conference call Friday and still expects pivotal study results in April. The pending FDA filing will be based on these results with Fast Track status and rolling submission to expedite the process, while a filing for CE Mark (Europe) clearance as a Class III medical device is now expected by year-end.

Amylin Pharma (AMLN), Eli Lilly (NYSE:LLY), and Alkermes (NASDAQ:ALKS) have a financial stake in a pending FDA decision that was expected Friday for a new once-weekly formulation of the diabetes drug Byetta (exenatide LAR).

Access Pharma (OTCQB:ACCP-OLD) has developed a nano-polymer drug delivery system for the oral administration of large molecules that are currently administered as injections (e.g. insulin, human growth hormone or hGH, erythropoietin or EPO, fertility drugs, parathyroid hormone/PTH, RNA-based therapeutics (sRNAi), and monoclonal antibodies).

On Thursday, Access announced that it received reports from its two bio-pharmaceutical collaborators for oral insulin, which independently confirmed previous results by the Company for oral bio-availability in preclinical animal models of greater than 80% as compared to subcutaneous injections of insulin.

Access reported several ongoing negotiations with additional companies that are interested in its Cobalamin Oral Drug Delivery Technology while simultaneously evaluating options for advancing oral insulin to proof-of-concept studies in humans as soon as possible. Based upon previous guidance, Access may initiate proof-of-concept (Phase 1 equivalent) studies for oral insulin in humans in Eastern Europe or India during 2H10 (with expected duration of 3-5 months and cost of $250-300,000).

Earlier Friday morning, Eisai Inc. (OTCPK:ESALY) announced FDA approval for a five-day dosing regimen for anti-cancer drug Dacogen (decitabine) to treat patients with myelodysplastic syndromes (MDS). Dacogen was approved by the FDA in May 2006 for a three-day regimen and developed by SuperGen (SUPG) and MGI Pharma (which was since acquired by Eisai).

Disclosure: Author long ACCP.OB and DCTH