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.

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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.

About Investor1989

Investor in stocks in about 5 years with some very good profits. Focusing on Biotech and Value stocks. Active investor...

 

One Response to Spectrum moves Apaziquone forward and Acquire US and Europe rights

  1. John says:

    good post Andreas

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