Shares of Progenics Pharmaceuticals Inc. (PGNX) have gained 12 percent year-to-date, and trade around $9, as investors await two regulatory catalyst events that are scheduled to occur within the next four months.
For readers who are new to Progenics, here's a brief overview of the company and the upcoming catalysts to keep an eye on...
Tarrytown, New York-based Progenics is a biopharmaceutical company focused on innovative therapeutics for patients suffering from cancer and related conditions. The company has one commercial product - Relistor (methylnaltrexone bromide) subcutaneous injection, approved in the United States for the treatment of opioid-induced constipation, or OIC, in patients with advanced illness who are receiving palliative care, when response to laxative therapy has not been sufficient.
To help alleviate pain, opioids are often prescribed on a continuous basis for patients with late-stage, advanced illness like incurable cancer, end-stage Chronic Obstructive Pulmonary Disease from emphysema, heart failure, Alzheimer's disease with dementia and HIV/AIDS. However, one of the drawbacks with opioids is that they interfere with normal bowel elimination function by relaxing the intestinal smooth muscles and preventing them from contracting and pushing out waste products. Relistor acts by blocking opioid entrance into the cells thus allowing the bowels to continue to function normally.
Relistor is also approved for sale in over 50 countries worldwide, including the European Union, Canada and Australia.
Progenics' original marketing partner for Relistor was Wyeth Pharmaceuticals, now a Pfizer Inc. subsidiary. In December 2010, Progenics assumed full control of future development and commercialization of Relistor. Within two months of regaining the rights, Progenics licensed Relistor to Salix Pharmaceuticals Inc. worldwide except in Japan, where Ono Pharmaceutical Co., Ltd. is developing the subcutaneous formulation of the drug.
Global net sales of Relistor were $12.3 million in 2009 and $16 million in 2010. Salix, Progenics' global partner for Relistor, believes that the drug can generate peak sales of $1 billion, aided by label expansions and focused promotion efforts.
Progenics and Salix are seeking FDA approval of an additional indication for Relistor subcutaneous injection for the treatment of opioid-induced constipation in patients with non-cancer pain. The supplemental New Drug Application for Relistor, which was accepted by the FDA last August, has a decision date set for April 27, 2012.
An oral formulation of Relistor for the treatment of opioid-induced constipation in subjects with chronic, non-cancer pain, successfully completed a phase III trial, late last December. The trial, evaluating three once-daily oral Relistor dosing regimens (150, 300 and 450mg), demonstrated highly statistically significant results for the primary endpoint in two of the three treatment arms when compared to the placebo treatment arm. The efficacy of oral Relistor was also comparable to that reported in clinical studies of subcutaneous Relistor in subjects with chronic, non-cancer pain.
A New Drug Application for the oral formulation of Relistor in the indication of chronic, non-cancer pain subjects with opioid-induced constipation is expected to be submitted in mid-year 2012.
In recent years, there has been a dramatic growth in the use of opioids to treat pain. According to market research firm Wolters Kluwer, opioid analgesics are generating sales in excess of $10 billion a year in the U.S. The pharmaceutical market research firm IMS Health estimates that over 250 million opioid prescriptions are written annually in the U.S. It is estimated that 50 percent of patients treated with opioids for chronic non-cancer pain experience OIC.
Currently, there are no approved oral therapies to treat OIC, although a couple of them are under clinical testing - like Cubist Pharmaceuticals Inc.'s CB-5945, which is expected to enter phase III trial in the second half of 2012; Nektar Therapeutics' NKTR-118, a phase III drug candidate, and Sucampo Pharmaceutical Inc.'s Amitiza, whose sNDA filing in the indication of opioid-induced bowel dysfunction is expected to be submitted in the first half of 2012.
In addition to the Relistor program, Progenics' clinical programs include, a phase 1 trial of a proprietary, fully human monoclonal antibody-drug conjugate, or ADC, directed against prostate-specific membrane antigen for the treatment of prostate cancer, and PRO 140, administered subcutaneously, which is being evaluated in a phase II trial as an adjunct to a new, optimized, oral antiretroviral regimen in HIV-infected injection drug users with viral rebound and documented poor adherence to the previous antiretroviral regimen.
Last February, the company announced positive preliminary results from the ongoing phase 1 trial of its PSMA ADC antibody-drug conjugate for the treatment of prostate cancer.
The company also has novel multiplex phosphoinositide 3-kinase, or PI3K, inhibitors for the treatment of cancer, which are under pre-clinical testing.
A quick look at Progenics' balance sheet...
The company has incurred substantial losses since commencing principal operations in 1988. Revenue is generated from licenses, research grants from the NIH and, to a small extent, from sale of research reagents.
In the third quarter ended September 30, 2011, net loss narrowed to $11.4 million or $0.34 per share from $17.1 million or $0.52 per share in the third quarter of 2010, helped by higher collaboration and royalty revenues. Total revenue for third quarter of 2011 rose to $5.8 million from $2.0 million in the year-ago quarter.
Progenics went public in November 1997, offering its shares at $8 each. Over the last one year, the stock has hit a low of $4.50 and a high of $10.50. Will there be a run-up in stock price ahead of the regulatory catalyst events? Stay tuned...
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