Knobias Clip Report (10-15-2007)

Sumbmited From Knobias ClipReport

PGNX: To Begin Ph II Trial of Oral Methylnaltrexone in Opioid Constipation

Progenics Pharmaceuticals, Inc. (PGNX) got a modest boost at Monday's open after announcing plans with Wyeth (WYE) to begin two Phase 2 clinical trials to evaluate daily dosing of oral methylnaltrexone in patients with chronic, non-malignant pain who are being treated with opioids and are experiencing opioid-induced constipation. Each study will separately evaluate a different oral formulations of methylnaltrexone. Both studies are expected to take approximately six months to complete.

Methylnaltrexone, an investigational drug, is being studied as a treatment for the peripheral side effects of opioid analgesics. It is designed to mitigate the effect of opioids on peripheral receptors without interfering with central nervous system pain relief. Methylnaltrexone is being developed in subcutaneous and oral forms to treat opioid-induced constipation. Currently, there is no approved medication that specifically targets the underlying cause of opioid-induced constipation.

Wyeth and Progenics have an exclusive, worldwide agreement for the joint development and commercialization of methylnaltrexone for the treatment of opioid-induced side effects, including constipation and post-operative ileus (POI), a prolonged dysfunction of the gastrointestinal (GI) tract following surgery. Wyeth received worldwide rights to methylnaltrexone, and Progenics retained an option to co-promote the product in the United States.

Adolor Corporation (ADLR), in collaboration with GlaxoSmithKline plc (GSK), is developing an opioid antagonist, Entereg(TM) (alvimopan), for post-operative ileus, which has completed phase 3 clinical trials, and for opioid-induced bowel dysfunction, which is in phase 3 clinical trials. Entereg is further along in the clinical development process than methylnaltrexone, and Adolor has received an approvable letter from the FDA for Entereg regarding the treatment of post-operative ileus.

Mundipharma International Ltd, an independent company associated with Purdue Pharma, has an oral PR oxycodone/naloxone combination tablet that has been licensed in Germany under the trade name TARGIN(R) for adult patients with severe chronic pain and opioid-induced constipation. Oral naloxone reduces the impact of opioid-induced constipation, while having no effect on the analgesic efficacy of oxycodone and minimal central effects. The drug will also be submitted for registration in other European countries.

In addition to the development of methylnaltrexone, Progenics is developing a novel viral-entry inhibitor for HIV. This molecule is designed to inhibit the virus' ability to enter certain types of immune system cells. The Company has successfully completed a phase 1a study with PRO 140.

The Company is also developing immunotherapies for prostate cancer, including monoclonal antibodies directed against prostate specific membrane antigen ("PSMA"), a protein found on the surface of prostate cancer cells. Vaccines designed to stimulate an immune response to PSMA are conducted through a joint venture with Cytogen Corporation (CYTO). Recent findings on PSMA structure and biology may have important implications for other cancers as well. According to the Prostate Cancer Research Institute, "Monoclonal antibodies are the closest thing we have found so far to 'magic bullets,' which can be carefully targeted to reach specific sites."

A substantial portion of revenues to date has been derived from federal government grants and research contracts. As of June 30, 2007, the Company had an accumulated deficit of $223.2 million and cash on hand of $139.1 million.

In September, Wellington Management Company, LLP, on behalf of its clients, reported an 11.8% ownership in the Company's stock. This was increase of 7.06% beneficial ownership on June 30, 2007.

Bank of America recently initiated coverage of PGNX at a Buy rating with a price target of $31.


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