I must be a masochist. Why else would I be writing another column about the Tarrytown, N.Y., drugmaker, especially after the March 12 announcement of a failed phase III study for the company's bowel drug in surgery patients?
At its current price around $5.85 -- down 57% from the day before news of the disappointing trial -- Progenics is trading near its value in cash. That means investors think bupkis of the bowel drug methylnaltrexone, let alone anything else the company has cooking in its pipeline.
The market may be right. Methylnaltrexone, or MNTX, might be dead and buried. But what if the drug has a pulse and no one is noticing? If that's the case, the stock is priced to buy right now.The ongoing saga of Progenics will become much clearer on April 30. That's when the U.S. Food and Drug Administration is expected to hand down its approval decision on the subcutaneous form of MNTX for the treatment of opioid-induced constipation in patients with acute medical illness, or AMI. This is a different indication than the failed phase III studies. AMI is a catch-all term but generally refers to hospice-care patients who are nearing the end of their lives. These patients are typically offered palliative care that includes large doses of narcotics, which can cause severe constipation. Progenics is seeking FDA approval for a form of MNTX, injected under the skin, that relieves the painful constipation and bloating. Progenics ran two phase III, placebo-controlled studies of MNTX in patients with AMI; both met their primary endpoints of laxation, or bowel movements, within four hours of treatment. In the first study, for instance, 154 constipated patients with advanced medical illness were randomized to receive one of two doses of MNTX or a placebo. Four hours after dosing, 63% and 64% of the MNTX patients had a bowel movement, compared to 34% of placebo patients. The results were statistically significant and there were no serious safety issues associated with MNTX reported. SummerStreet Research Partners, an independent health care research outfit, issued a note to clients March 20 predicting an FDA approval for MNTX in patients with AMI. If MNTX were approved, Progenics shares would be worth $10, the firm stated. "The FDA likely will approve subcutaneous methylnaltrexone by April 30 for the treatment of opioid-induced constipation in patients with advanced medical illness. Two Phase III studies reached their endpoints -- percent of patients who defecated within 4 hours of receiving drug. No significant safety issues have appeared," wrote SummerStreet analyst Carol Werther. She adds, "The biggest risk to a quick approval is that the FDA may require an additional 12 month safety study. The concern is that the drug may cause cardiac adverse events and tumors similar to Adolor's (ADLR) Entereg." The MNTX study that failed earlier this month involved an intravenous form of the drug used to treat patients coming out of abdominal surgery. The study, conducted by Progenics' partner Wyeth (WYE), failed to demonstrate that MNTX was better than placebo in helping patients return to normal gastrointestinal function.