Progenics Pharmaceuticals (PGNX)
Progenics engages in the research and development of biotechnology product candidates in the areas of oncology and therapeutics worldwide. The company offers Relistor* (methylnaltrexone bromide), a subcutaneous injection for the treatment of opioid induced constipation (OIC) in patients with advanced illnesses such as cancer, as well as for the treatment of OIC in patients with noncancer pain. It also offers Relistor-Oral, which has completed Phase III testing for the treatment of OIC in patients with noncancer pain. It also provides oncology medicines including PSMA ADC that is in Phase II testing for treatment of prostate and other cancers.
The first drug we want to talk about in more detail is Relistor, which is the only prescription medicine approved in the United States to treat this form of constipation. Relistor is now approved in the U.S. and over 50 other countries around the world. In the U.S., Relistor is marketed by its commercial partner Salix Pharma (SLXP), a leading specialty pharmaceutical company focusing on gastrointestinal diseases. It is sold outside the U.S. by sublicenses of Salix and Ono Pharmaceutical in Japan.
The interesting thing that Progenics is doing with this drug is that it's trying to increase the patient population that the company can treat with it. Salixa and Progenics has an advisory panel meeting (ADCOM) coming up in March of this year to review the supplemental new drug application (SNDA) for Relistor expanded usage in OIC chronic pain. If approved, this additional form of Relistor would now treat patients taking opioids for noncancer pain who suffer from OIC as a result. This population includes patients taking opioids for conditions such as back pain or joint pain.
In July of 2012, Salix and Progenics Pharmaceuticals received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) following its review of the sNDA for the Relistor injection for subcutaneous use for the treatment of opioid-induced constipation in adult patients with chronic, noncancer pain—the CRL requested additional clinical data.
Sources tell us the reason for the CRL was because according to the FDA, Salix submitted incomplete safety data. It has been over one-and-a-half years since the CRL, and both companies, after extensive meetings with the FDA, engaged the new FDA appeals process believing they have the complete safety data to ensure the FDA approves the sNDA. As a result of the appeals process and meetings with the regulatory body, the FDA assigned the ADCOM.
We believe come March, the ADCOM will recommend approval for the sNDA to the FDA, and the FDA will likely accept this recommendation and approve Relistor for this chronic pain indication.
- Progenics is set to receive $50M for sNDA approval, and $200M in milestone payments from Salix.
1. Up to $50.0 million upon U.S. marketing approval of an oral formulation of Relistor.
2. Up to $200.0 million of commercialization milestone payments upon achievement of specified U.S. sales targets.
- Progenics' proprietary drug candidate, if eventually approved, should warrant a market cap well north of $1B.
Sucampo Pharma’s (SCMP) Amitiza is the top approved treatment for OIC in patients with chronic pain. In July 2013, Amitiza was launched in the U.S. for the treatment of OIC in adults with chronic, noncancer pain. As stated, we expect ADCOM to give a positive recommendation for Relistor's sNDA, which would boost sales significantly of the drug and should give Amitiza a run for its money.