Spectrum Pharma SPPI Stock Research: Apaziquone bladder cancer page
Apaziquone aka Eoquin
- Apaziquone/Eoquin: (prodrug activated by enz that is o/x on bladder cancer cells)
- Formulation patent expires 2022
- partnered w/ Allergan for NA and Europe ($41.5m upfront, up to $304m milestones, co-promote US 50/50, tiered mid-teens+ royalties elsewhere, if opt out of US copromote, get higher royalties than exUS) who pays 65%
- June 2011: filed 8k (click here) announcing that the agreement has been amended. "the parties agreed to change the indication for future planned studies from BCG Refractory to Multiple Instillation, to extend certain milestone dates and to modify certain payment obligations and expense allocation provisions"...more details to come when this is filed with the 2q2011 10q, but I think it is safe to predict that in addition to AGN pushing out it milestone obligations and will be paying a lower share of costs.
- Two p3 trials ongoing w/ FDA SPA and EMEA Scientific Advice for bladder cancer [2.7m pts worldwide, no new tx for 30 yrs, most expensive cancer to tx] (completed 1600 pts at 150 sites enrollment in trials 12/2009 and 1/2010- triggered $1.5m milestone; Single dose instilled locally at surgery, primary endpt is relapse rate at 2 yrs).
- Last pt clinical evaluation will be late 2011, Top-line data from both trials expected 1h2012 and NDA filing guided for 2012.
- meet w/ fda 11/2009 and will initiate a multi-instillation (up to 6) trial in advanced bladder cancer- 11/2010: evaluating study design for this label expansion (not likely by ye2010 - timeline slipping).
- 11/2009 asian parternship w/ Nippon Kayaku ($15m upfront recd 1/2010, they pay for asian trials, $136m milestones, double digit royalties, have met w/ reg's but not promise trial start in 2010)
- Korea partnership w/ Handkok ($1m upfront rec'd 1/2010, $18m milestones; only have to run marketing trial here).
- 1/2011: p1 Asian trial initiated by Handkok (6 pts) - click here for more info.
- peptide agonist of endothelin B receptors. Seen as adjunct to chemoterhapy- selectively increases bloodflow and drug delivery to tumor 3-4 fold)
- phase 1 started in 1q2008 - Click here for details. 9/2011 part one results announced: 30 patients with advanced solid tumors treated by IV in combination with docetaxel. 5 partial responses, including ones of 12 and 18 months. Expect phase 2 in 2012.
- 2010 10k: still enrolling in this trial.
- Licensed from Chicago Labs in 2005. Method of use patents filed in US and EU, other US patents expire 2021-2022
Other pipeline assets
- Unless otherwise indicated, I can find no concrete info on any clinical trials in progress for any of these programs
- 1q2011 10q: "We have several other exciting compounds in earlier stages of development in our portfolio. Based upon a criteria based portfolio review, we are in the process of streamlining our pipeline drugs, allowing for greater focus and integration of our development and commercial goals."
- 1/2011: partnered w/ Viropro to devel biosimilar Rituxan- 1q2011 10q states "nominal upfront fee" plus regulatory and development milestones. Viropro says multimillion dollars paid over 3 yr period, plus royalties. Not listed on pipeline chart 7/2011
- Ortataxel (iv and oral cancer agent listed as being in phase 2 for NSCLC. 2010 10k: Third-gen taxane licensed from Indena (undisclosed milestones and royalties, plus must buy API from them). >350 pts treated in phase 1/2 trials. Working to optimize oral formulation for future studies. COM patents expire 2013, others thru 2021. EU patent expires 2014.
- Elsamitrucin: "dual inhibitor of two key enzymes involved in DNA replication" - phase 1 for cancer. Unsure of details, but two phase 2 trials are listed online that started >5 yrs ago and are complete. No data or mention has ever been made.
- Lucanthone: "Small-molecule which inhibits Topoisomerase II and AP endonuclease" - phase 1 for cancer. 2010 10k: abandoned anti-parasite drug from decades ago. Licensed from inventor in 2005. "Currently working on development plan." US method of use patent expires 2019.
- SPI-1620: peptide agonist of endothelin B receptors Seen as adjunct to chemoterhapy- selectively increases bloodflow and drug delivery to tumor 3-4 fold) - phase 1 started in 1q2008 - Click here for details. 2010 10k: still enrolling in this trial. Licensed from Chicago Labs in 2005. Method of use patents filed in US and EU, other US patents expire 2021-2022
- RenaZorb: acquired all rights 8/2009 from Altair Nanomaterials (limited rights deal was in 2005) for worldwide human and vet use for $0.75m in stock. "a second-generation lanthanum-based nanoparticle phosphate binding agent, has the potential to treat hyperphosphatemia, (high phosphate levels in blood), in patients with stage 5 chronic kidney disease (end-stage renal disease). Hyperphosphatemia affects patients with chronic kidney disease, especially end- stage kidney disease patients on dialysis. It can lead to significant bone disease (including pain and fractures) and cardiovascular disease and is independently associated with increased mortality" (2010 10k). Listed as preclinical in 2/2011 BIO CEO summary. Method of use patent expires 2024.
- Ozarelix: Licensed from Aeterna Zentaris (AEZS). Killed for BPH after mixed p2 data and failure of similar compound by AEZS, "considering for other indications" - not on pipeline chart 7/2011, but a phase 2 trial in prostate cancer is ongoing and was mentioned in the 2010 10k - click here for details. COM patent expires 2020
- 11/2010: acquired early stage asset for shares that will contribute to pipeline of oral cancer drugs if successful
- SPI-205 (chemo-induced neutropenia, preclinical) - not on pipeline chart 7/2011 and no mention in 2010 10k