It is required to start a new PIII not PI. FDA is still going to review the pooled PIII data from the earlier trials. Spectrum has another PIII for multiple instillation ongoing.
Allegran getting out of the commitment indicates the likelihood of getting an approval is less than 30%, but you can hope for the best.
Spectrum acquired the rights for the drug
Simply put, it's good news. The FDA could have nixed the idea. The fact that the U.S. FDA are even considering it(accepting an NDA) means something and Raj has already stated the pooled data was highly stat sig. AGN may not be as interested as they once were about going forward into that particular cancer territory AND they prolly now don't have to worry about incurring extremely high milestone payments....Biotechs change their "game-plan", focus and direction ALL the time....APAZ is a potential blockbuster and SPPI now owns a whole heck of a lot more it's worldwide opportunity....
Spectrum Pharmaceuticals Announces Initiation of a Required Phase 1 Study of Apaziquone in Japan by Nippon Kayaku
•Apaziquone is in Pivotal Registrational Trials in the United States; NDA Expected to be Filed in 2012
IRVINE, Calif.--(BUSINESS WIRE)--Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in oncology, announced today that the first patient has been dosed in Japan in a Nippon Kayaku sponsored Phase 1 study of apaziquone in bladder cancer. The Phase 1 study is required by the local regulatory authorities and is designed to enroll up to 6 patients and determine the safety and pharmacokinetics of an immediate instillation of apaziquone in the bladder following transurethral resection of bladder tumor (TURBT), followed by 6 weekly instillations of apaziquone in the bladder, starting week 4.
“We are excited that Nippon Kayaku has begun required studies of apaziquone in Japan, a major market for oncology drugs”
“We are excited that Nippon Kayaku has begun required studies of apaziquone in Japan, a major market for oncology drugs,” said Rajesh C. Shrotriya, MD, Chairman of the Board of Directors, Chief Executive Officer, and President of Spectrum Pharmaceuticals.
In December 2009, Spectrum Pharmaceuticals licensed to Nippon Kayaku exclusive rights to apaziquone for the treatment of non-muscle invasive bladder cancer in Asia, including Japan and China, for an upfront licensing fee of $15 million, plus up to $136 million in milestones, and royalties. Nippon Kayaku will conduct the apaziquone clinical trials pursuant to a development plan. Nippon Kayaku will be responsible for all expenses relating to the development and commercialization of apaziquone in the Nippon Kayaku territory.
good thread- thanks........ hopefully tonite i get time to read all these press releases and posts and can sort out all this news and the apparent intricacies w/r to nda to fda versus japanese trials on A.