Here is a list of upcoming catalysts for the last quarter of 2016
Each event can be a nice price jump for this deeply undervalued pharma
120mil cash and an estimated 1 billion dollar product launched few weeks ago and a market cap of just 400 mil.
Upcoming events
Azedra
What it Does: Azedra is a radiotherapeutic product candidate for the treatment of pheochromocytoma and paraganglioma, very rare tumors that form from neuroendocrine cells. Neuroendocrine cells are primarily in the adrenal glands but are found throughout the body. These cells release hormones into the blood which control heart rate, metabolism, and blood pressure.
Key Differentiator(s): There are currently no approved therapies in the U.S. for these very rare diseases. Existing treatments include adrenergic blockade, surgery, chemotherapy, and radiation which generally fail to produce cure or significant remissions. A product chemically similar to Azedra® with a much lower specific activity and less desirable side effect profile has been used with some success; however, it is not approved by the FDA for the treatment of pheochromocytoma and paraganglioma. Effective alternative therapies are needed, especially in patients who have relapsed. The most recent study saw a more than 50% reduction in anti-hypertensive medications.
Phase / Status / Expected Launch: Azedra is currently in Phase IIb clinical trial under special protocol assessment (enrollment is completed). Top Line Data is expected in late 2016 / early 2017 and NDA submission to the FDA is anticipated in the first half of 2017. The FDA granted Breakthrough Therapy designation, Ultra-Orphan Designation (given the rarity of the cancers), and Fast Track Status and has indicated it would grant a full approval instead of conditional approval based on the positive outcome from the Phase 2b trial (i.e. no need for confirmatory Phase 3 trial). This product has a good chance to hit the market in 2018
Expected Market: pheochromocytoma and paraganglioma's prevalence in the U.S. is 3,000-6,000 patients annual (< 1,000 new cases diagnosed annually). Annual sales can be projected in the $225 million range assuming a cost of $200,000 annually per patient for 25% of the eligible patients. As the diseases are very rare and the target market is small, patients will expect to pay more for the therapy. Azedra is the next significant commercial opportunity for Progenics and the company intends to retain the rights and commercialize the drug independently in the U.S.
Other Considerations: The U.S. market is reachable with a small specialty sales force targeting major centers where these rare tumors are treated. Commercialization of Azedra should not be a major burden and Progenics plans to hire a small commercial team.
EXINI Bone BSI
What it Does: Analytical software that assists physicians and patients with analysis of bone scan index from bone scintigraphy images, expected to assist with Prostate Cancer quantification and tracking.
Key Differentiator(s): removes observer variability and reduces the time to quantify the tumor burden of the skeleton. Over time, this product is expected to enhance the other prostate cancer imaging programs in the pipeline (1404 and PyL).
Phase / Status / Expected Launch: Approved for use in the EU, Japan and the U.S. Progenics' goal is to commercialize this product in the U.S. in 2016.
Expected Market: There are approximately 1,100 hospitals in the U.S. and approximately 7000 in the EU (not counting other types of medical facilities). Prostate cancer is the second most common form of cancer affecting men in the United States: an estimated one in seven men will be diagnosed with prostate cancer in his lifetime. The American Cancer Society estimates that each year approximately 220,800 new cases of prostate cancer will be diagnosed and about 27,540 men will die of the disease. Approximately 2.9 million men in the U.S. currently count themselves among prostate cancer survivors.
Other Considerations: Acquisition of this product brought with it existing relationships with key European partners, clinicians, and researchers to support late-stage pipeline.
1404
What it Does: 1404 is a TC (technetium) 99m labeled small molecule diagnostic imaging agent to diagnose and detect prostate cancer.
Key Differentiator(s): 1404 targets a specific antigen on the surface of >95% of prostate cancer cells and is more sensitive in detecting cancer versus an MRI in the Phase II tests. Per patient, there are multiple opportunities to use this imaging agent (i.e. during diagnoses, surveillance, staging, planning/monitoring…). According to a recent study, 40-50% of men are choosing active surveillance over treatment and this agent will better support that choice.
Phase / Status / Expected Launch: Phase II testing has been completed detecting cancer in the Prostate gland with 94% sensitivity (versus 86% for an MRI). The Company's goal for this product is to release interim analysis for the pivotal Phase III trial in 2016.
Expected Market: Refer to the prostate cancer statistics above.
Other Considerations: This product will be enhanced by EXINI BSI in the future.
PSMA Antibody Radiolabeled With Alpha Emitter
What it Does: This product candidate is a prostate specific membrane antigen (PSMA)-targeted Iodine-131 labeled small radiopharmaceutical molecule which treats metastatic castration resistant prostate cancer.
Key Differentiator(s): The company maintains that it has a leadership position in PSMA targeted therapeutics which have the potential to transform clinical practice with improved detection and monitoring of prostate cancer. On May 2nd, the Company announced it had granted Bayer (OTCPK:BAYRY) exclusive World-Wide rights to develop and commercialize products using Progenics' PSMA Antibody Technology in combination with Bayer's Alpha-Emitting Radionuclides.
Phase / Status / Expected Launch: In Phase III testing with interim results expected soon in the second half of 2016.
Expected Market: Refer to the prostate cancer statistics above. The recent Progenics/Bayer agreement included an upfront payment of $4M, up to additional $49M in potential clinical and regulatory development milestones, potential net sales milestone payments up to $230M, and single digit royalties on net sales.
Other Considerations: Licensed to buyer.
PSMA ADC
What it Does: PSMA ADC is an antibody-drug conjugate therapeutic for the treatment of prostate cancer. It binds to a known cancer marker known as prostrate specific membrane antigen (PSMA) along with a potent toxin.
Key Differentiator(s): According to Progenics, this therapeutic has the potential to transform clinical practice in prostate cancer by selectively attacking tumor cells while sparing healthy tissues. Progenics boasts a leadership position in PSMA targeted therapeutics.
Phase / Status / Expected Launch: PSMA ADC has completed Phase II testing in chemotherapy-experienced patients (demonstrating activity and tolerability) and there is an ongoing second PII test in chemotherapy-naive patients.
Expected Market: Refer to the prostate cancer statistics above.
PYL
What it Does: PYL is a PET Radiopharmaceutical imaging agent product candidate targeting a known prostate cancer antigen (PSMA).
Key Differentiator(s): The completed pilot study data indicates; high uptake even in small lesions, identification of more lesions than the current standard of care, detection of lesions as small as 3mm, tolerance with no serious adverse effects to date, and a few mild adverse effects. This agent has the potential to detect minimal levels of cancer (including some undetectable today such as during early stages) and sites of relapse non-invasively. It finds prostate cancer cells, and is not confounded by degenerative or inflammatory conditions (including recent surgery). Per patient, there are multiple opportunities to use the agent (i.e. during diagnoses, surveillance, staging, planning/monitoring).
Phase / Status / Expected Launch: after positive results from the initial study, the next steps are several clinical trials including 2 Phase II studies. The company aims to initiate the trials in 2016.
Expected Market: Refer to the prostate cancer statistics above.
Other Considerations: In-licensed from Johns Hopkins University. This agent will likely also be enhanced by EXINI BSI over time. Over the course of this year, the company plans to further explore how to leverage PyL to support further development of promising therapies in prostate cancer.
1095
What it Does: 1095 is a targeted small molecule radiotherapeutic which (treats metastatic castration resistant prostate cancer), and selectively binds to PSMA.
Key Differentiator(s): This product candidate delivers a lethal dose of radiation direction to prostate cancer cells with minimal impact on healthy tissue.
Phase / Status / Expected Launch: This product is in the clinical stage, early results of the best 25 show reduced PSA levels and bone pain, with potent activity in advanced cancer. The company's goal is to initiate a Phase I trial in 2016.
Additionally, the company is developing PRO 140, an HIV treatment viral entry inhibitor currently in Phase II testing, and PRO 391, antibodies targeting C. Diff Toxins currently in the pre-clinical stage. These are not expected to impact market valuation of Progenics any time soon
