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Spectrum Pharmaceuticals yesterday announced that it have acquired the full US and EU rights to Apaziquone from Allergan. SPPI will now have to pay Allergan tiered single digits royalty on global sales of Apaziquone. What was even more important are the consulting Spectrum did with the FDA regarding an approval (NDA) for Apaziquone on the pooled data from the first single installation trials that each missed the primary endpoints in the study. I still have under or around 50 % chance to get an approval for Apaziquone based on the first trials but if approved that would likely be a total gamechanger for SPPI. Apaziquone is against NMIBC, an unmet medical need and target a +500 mio. $ market without any competition.
FDA also reguired SPPI to run a new phase III trial in single installation while we are waiting on the data from multiple installation trial in 2014. An post approval studie fr0m SPPI is nessecary if FDA accepts the NDA.
To me this is a good strategic move. The risk is now much higher but the reward is also. Spectrum now has to pay all development costs for Apaziquone and will not recieve any milestone payments. But Spectrum is a cash flow generating company that can afford such a calculated risk and if the reward from Apaziquone come with an FDA approval in 2014, shares of SPPI could skyrocket.
Spectrum Pharmaceuticals Acquires Rights for Apaziquone in the U.S., Europe and Other Territories from Allergan; Expects to File New Drug Application
- Based on communication with the FDA, Spectrum anticipates an Advisory Committee meeting to review a potential NDA for apaziquone.
- The Company expects to file an NDA, which Spectrum will seek to expedite as part of a plan to achieve potential commercialization of apaziquone in key markets.
- Apaziquone is in development to treat non-muscle invasive bladder cancer (NIMBC) as a single instillation following transurethral resection of bladder tumor (TURBT).
- Approximately 70% of all patients with newly diagnosed bladder cancer have NMIBC, and yet there are no FDA-approved agents for post resection chemotherapy.
HENDERSON, Nev.–(BUSINESS WIRE)– Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, today announced the Company has reacquired development and commercialization rights for apaziquone in the United States, Europe and other territories pursuant to an agreed-upon restructuring of Spectrum’s collaboration with Allergan, Inc. In exchange, Allergan will receive a royalty on future revenue. Apaziquone is an anticancer agent being developed for the treatment of non-muscle invasive bladder cancer (NIMBC) as a single instillation following transurethral resection of bladder tumor (TURBT).
Spectrum also announced that a scheduled meeting with the U.S. Food & Drug Administration (FDA) was held last month to discuss the results from the Company’s Phase 3 clinical trials. Based on the discussions with the FDA, Spectrum understands that the FDA can accept the NDA filing with the current Phase III data and will likely convene an Advisory Committee meeting. Further, based on discussions with the FDA, Spectrum has agreed to conduct one additional Phase III study following consultation with the FDA on its design.
“Regaining apaziquone rights will enable Spectrum to take the steps we believe are essential to advancing apaziquone toward commercialization in the U.S., Europe and other key territories,” stated Rajesh C. Shrotriya, M.D., Chairman, President and Chief Executive Officer of Spectrum Pharmaceuticals, Inc. “Spectrum is committed to expediting our program for apaziquone, with the goal of accelerating potential registration and integrating apaziquone into our plan to expand our footprint in the U.S. and build our presence in the EU. Spectrum is grateful to the FDA for its thoughtful feedback on the apaziquone clinical program. We believe there continues to be a significant unmet need as no drugs have been approved and marketed in the U.S. for more than 20 years for low-grade NMIBC.”
Apaziquone is an anticancer drug that requires activation by bio-reductive enzymes that are over-expressed in bladder cancer cells, to render it a cytotoxic alkylating agent. Spectrum conducted two multi-center, international Phase 3 trials of a single dose of intravesical instillation of apaziquone into the bladder in the immediate post-operative period after surgical resection of low-grade, non-muscle invasive bladder tumors. In April 2012, Spectrum announced that the Phase 3 trials did not meet their primary endpoint of a statistically significant difference in the rate of tumor recurrence at 2 years between treatment and placebo arms. However, analysis of the pooled data from both studies showed a statistically significant treatment effect in favor of apaziquone in the primary endpoint of the rate of tumor recurrence at 2 years (p-value = 0.0174) and in a key secondary endpoint, time to recurrence (p-value = 0.0076).
NMIBC is a form of bladder cancer localized in the surface layers of the bladder that has not spread to the deeper muscle layer. Approximately 70% of all patients newly diagnosed with bladder cancer have NMIBC. More than one million patients in the U.S. and Europe are estimated to be affected by the disease, which is treated predominantly by urologists. Professional urology associations and NCCN Guidelines recommend instillation of a cytotoxic agent following transurethral resection of bladder tumor (TURBT) for NMIBC. However, in the US, there are no FDA-approved agents for this indication.
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