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Cell Genesys, Inc. (Nasdaq: CEGE ) (Mon, March 31, 2008) Cell Genesys, Inc. ("Cell Genesys") and Takeda Pharmaceutical Company Limited ("Takeda") announced that the companies have formed a global alliance for the development and commercialization of GVAX immunotherapy for prostate cancer, Cell Genesys' lead product candidate currently in Phase 3 clinical development.
Under the agreement, in exchange for exclusive worldwide commercial rights to GVAX immunotherapy for prostate cancer, Takeda will pay Cell Genesys an upfront payment of $50 million and additional milestone payments totaling up to $270 million relating to regulatory approval and commercialization of GVAX immunotherapy for prostate cancer in the United States, European Union and Japan. Takeda will pay Cell Genesys tiered, double-digit royalties based on net sales of GVAX immunotherapy for prostate cancer in the United States and flat double-digit royalties based on net sales of the product in all other regions. From this point forward, Takeda will pay for all external development costs associated with the ongoing Phase 3 clinical development of GVAX immunotherapy for prostate cancer and will also pay for all additional development costs and all commercialization costs. Cell Genesys will maintain responsibility for the worldwide manufacture and supply of the product and will retain rights to co-promote GVAX immunotherapy for prostate cancer in the United States.
"We are very pleased to have entered into this agreement with Takeda for the development and commercialization of GVAX immunotherapy for prostate cancer and look forward to benefiting from Takeda's impressive record of success as a global pharmaceutical business and clear commitment to become a leader in the field of oncology," stated Stephen A. Sherwin, M.D., chairman and chief executive officer of Cell Genesys. "In particular, we are very glad to have the opportunity to work with the company that pioneered the global development and commercialization of the world's leading prostate cancer drug, Lupron , and hope to build on that success with GVAX immunotherapy for prostate cancer, a potential new treatment option for men with this disease."
"We are excited to have added GVAX immunotherapy for prostate cancer to our growing oncology pipeline and are eager to do all that we can to ensure its commercial success in the United States and globally," said Yasuchika Hasegawa, president of Takeda. "Our extensive experience in the prostate cancer market, coupled with our global infrastructure of development and marketing makes us well-suited to work in partnership with Cell Genesys in the effort to make GVAX immunotherapy for prostate cancer a reality for patients in need."
GVAX immunotherapy for prostate cancer is currently being evaluated in two Phase 3 clinical trials, VITAL-1 and VITAL-2, in patients with advanced prostate cancer. The U.S. Food and Drug Administration has granted Cell Genesys Fast Track status for the GVAX prostate cancer program and both trials have completed Special Protocol Assessment agreements. In 2007, the VITAL-1 trial completed enrollment with 626 patients and in January 2008, Cell Genesys announced that the Independent Data Monitoring Committee (IDMC) had completed a pre-planned interim analysis for VITAL-1 and recommended that the study continue. The IDMC provided no information to the company other than the recommendation to continue the trial. The company currently estimates that there will be sufficient events to trigger the final analysis for VITAL-1 in the second half of 2009. Patients are continuing to be enrolled in the VITAL-2 trial at approximately 100 clinical trial sites located in North America and Europe. Cell Genesys is targeting the completion of enrollment for VITAL-2 with approximately 600 patients in the first half of 2009 and expects that there will be sufficient events to trigger the pre-planned interim analysis in the same time frame.
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Acusphere Inc. (NASDAQ: ACUS ) (Mon, March 31, 2008) Acusphere Inc. announced that it has signed an agreement to license the intellectual property rights to its Hydrophobic Drug Delivery System (HDDS) for oncology applications, along with the rights to AI-850, its formulation of paclitaxel, to Cephalon, Inc., in exchange for a cash payment of $10 million.
"We are very pleased with the terms of this transaction, which establishes a strong value for part of our technology platform that is at an early stage of development," said Sherri C. Oberg, President and CEO of Acusphere. "We are confident that Cephalon is the right partner for one application of this important technology, given its strong focus on oncology. Just six months ago, we announced that AI-850 was a potential bio-equivalent to the one of the fast-growing anti-cancer drugs, Abraxane . This transaction confirms the potential for our technology in the oncology arena, which is one of many potential applications for our HDDS technology."
Frank Baldino, Jr., Chairman and CEO of Cephalon, stated, "Cephalon has a growing oncology business with a deep and diverse portfolio of marketed products and pipeline compounds. The addition of the HDDS technology, and AI-850 in particular, will build on our expertise and expand our oncology portfolio."
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mPhase/AlwaysReady, Inc. (OTCBB: XDSL) (Mon, March 31, 2008) mPhase/AlwaysReady, Inc. stated that it is set to make battery history on Thursday, April 3rd at 9:00am ET, by demonstrating for the first time a significant breakthrough in battery technology enabled by microfluidics -- the science that deals with the behavior, control and manipulation of fluids geometrically constrained to a small, typically sub-milimeter, scale. The event will be held at AJ Maxwells located at 57 W. 48th Street in New York City and will be hosted by mPhase/AlwaysReady, Inc. The mPhase/AlwaysReady Smart NanoBattery uses microfluidics to transfer liquid electrolyte through a nanostructured separator known as a membrane which makes contact with the solid electrodes, enabling activation of an electrical device. The membrane is designed to keep the electrolyte separate from the electrodes until activation is initiated.
"This microfluidic phenomenon serves as the basis for a new type of battery with unlimited shelf life that can be used to provide power in portable electronic devices for commercial and military applications," said Ronald A. Durando, CEO of mPhase Technologies Inc.
The mPhase/AlwaysReady Smart NanoBattery was recently mentioned by Credit Suisse, a global research and investment banking firm, in a report entitled "Nanotechnology for Energy Systems of the Future."
To view the full Nano Circle report please visit www.Credit-Suisse.com and search mPhase or visit the following link: https://entry.credit-suisse.ch/csfs/p/b2c/en/privatebanking/services/nanotech/media/pdf/newslett er0208_en.pdf. mPhase is mentioned on page 5 under "Nanotechnology for the Energy Systems of the Future."
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