Astellas har i dag lavet en ret stor aftale med Medivation og et fase 3 prostata stof. Altså samme indikation som Bavarian Nordic Prostvac er rettet mod. Medivations stof MDV3100 er dog ca 1 år foran Prostvas idet MDV3100 startede fase 3 her i sep.
Aftalen mellem de 2 selskaber indeholder følgende.
$110 mio i upfront betaling
$335 mio i udviklings milestones
$320 mio i salgs milestones
50/50 profit split på det amerikanske marked
2-cifrede royalties i resten af verden
De deler alle udviklings udgifter rettet mod det amerikanske marked
Det er hvad jeg kalder en kanon aftale. Og det er i DEN grad noget man skal lægge mærke til i forhold til mulighederne for Bavarian Nordic. Kursen burde faktisk stige på det her
Her er lidt data fra et tidligere fase 1/2 studie som Hya måske også er interesseret i at se nærmere på
http://files.shareholder.com/downloads/MDV/757949698x0x275744/2988792d-3c25-4c64-bb5a-59ffa8e7d66e/GU_ASCO_2009_Poster.pdf
Astellas and Medivation Enter Into Worldwide Agreement to Co-Develop and Co-Commercialize MDV3100 for the Treatment of Prostate Cancer
-- Medivation to Receive $110 Million Upfront Cash Payment and Eligible to Receive $655 Million in Milestone Payments, 50 Percent of U.S. Profits and Double-Digit Royalties on Ex-U.S. Sales --
-- Medivation to Host Conference Call/Webcast Today at 8:30 a.m. Eastern Time --
TOKYO and SAN FRANCISCO, Oct 27, 2009 /PRNewswire-FirstCall via COMTEX News Network/ -- Astellas Pharma Inc. ("Astellas") and Medivation, Inc. (Nasdaq: MDVN) announced today that they have entered into a global agreement to develop and commercialize MDV3100, Medivation's investigational drug for the treatment of prostate cancer. MDV3100 is currently being evaluated in the Phase 3 AFFIRM clinical trial in men with castration-resistant prostate cancer who were previously treated with docetaxel-based chemotherapy.
Under the terms of the agreement, Medivation will receive an up-front cash payment of $110 million. Medivation is also eligible to receive payments of up to $335 million upon the attainment of development and regulatory milestones plus up to an additional $320 million in commercial milestone payments. The companies will collaborate on a comprehensive development program that will include additional studies to develop MDV3100 for both late- and early-stage prostate cancer. Subject to receipt of regulatory approval, the companies will jointly commercialize MDV3100 in the U.S. The companies will share equally all U.S. development costs, commercialization costs, and profits. Astellas will have responsibility for developing and commercializing MDV3100 outside the U.S. and will pay Medivation tiered double-digit royalties on ex-U.S. sales.
"We are pleased to initiate a great partnership with Medivation," stated Masafumi Nogimori, president and chief executive officer of Astellas. "We believe that MDV3100 has the unique potential to establish a new treatment approach for prostate cancer. Astellas already has the global expertise in urology and the strong commitment to focus on oncology. This partnership is a significant milestone to further expand our business in urology and to establish our franchise in oncology."
"We are excited to be working with Astellas to develop MDV3100 for a broad spectrum of prostate cancer disease states," said David Hung, M.D., president and chief executive officer of Medivation. "Astellas is an ideal partner for MDV3100 given its global reach, leading commercial presence in the urology space, and strategic focus on oncology. Astellas is the second major collaboration we have completed in the past year, and we are confident we have the right partners in place for each of our late-stage programs--Astellas for MDV3100 and Pfizer, Inc for dimebon (latrepirdine*)."
According to the American Cancer Society, prostate cancer is the most common non-skin cancer among men in the United States. More than 2 million American men have prostate cancer, and it is the second leading cause of cancer death among men after lung cancer. In 2009, an estimated 192,000 new cases are expected to be diagnosed, and approximately 27,000 men are expected to die from the disease.
MDV3100, a new generation of oral anti-androgen, which shows different pharmacological profiles from current anti-androgens, has been shown in preclinical studies to provide more complete suppression of the androgen receptor pathway than bicalutamide, the most commonly used anti-androgen. MDV3100 slows growth and induces cell death in bicalutamide-resistant cancers via three complementary actions - MDV3100 blocks testosterone binding to the androgen receptor, impedes movement of the androgen receptor to the nucleus of prostate cancer cells (nuclear translocation), and inhibits binding to DNA. Preclinical data published in Science earlier this year demonstrated that MDV3100 is superior to bicalutamide in each of these three actions.
The agreement is not subject to approval under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 and becomes effective immediately. Medivation's legal and financial advisers on the transaction were Cooley Godward Kronish LLP and Aquilo Partners, L.P. Astellas' legal adviser on the transaction was Covington & Burling LLP.
*Latrepirdine is the proposed generic (nonproprietary) name for dimebon.
Conference Call Information
Medivation will hold a conference call today at 8:30 a.m. Eastern Time (5:30 a.m. Pacific Time) to discuss this announcement. To participate in the conference call, please dial 888-280-4443 for domestic callers and 1-719-457-2638 for international callers. In addition, this call is being Webcast and can be accessed at Medivation's website at www.medivation.com.
About MDV3100's Clinical Program
In September 2009, Medivation began enrolling patients in a randomized, placebo-controlled, double-blind, multi-national Phase 3 clinical trial known as AFFIRM. This trial is evaluating MDV3100 at a dose of 160 mg taken orally once daily versus placebo in men with castration-resistant prostate cancer who were previously treated with docetaxel-based chemotherapy. The primary endpoint of the trial is overall survival; secondary endpoints include progression-free survival, safety and tolerability. This trial is expected to enroll approximately 1,200 patients at sites in the United States, Canada, Europe, South America, Australia and South Africa.
Medivation previously announced interim safety and efficacy results from an ongoing Phase 1-2 clinical trial of MDV3100. The interim results showed that MDV3100 was associated with anti-tumor activity in patients who had become resistant to bicalutamide or other standard anti-androgen treatments, including both patients who had failed prior chemotherapy and patients who were chemotherapy naive. Anti-tumor activity was demonstrated by reductions in prostate-specific antigen levels, improvement or stabilization in tumors that had spread to soft tissue or bone, and a decrease in circulating tumor cells, which has been associated in published literature with improved survival in patients with castration-resistant prostate cancer. MDV3100 was generally well tolerated in this trial at doses up to and including 240 mg/day, with fatigue being the most frequently reported adverse event.
About Astellas
Astellas Pharma Inc., located in Tokyo, Japan, is a pharmaceutical company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceuticals. Astellas has approximately 14,000 employees worldwide. The organization is committed to becoming a global category leader in Urology, Immunology and Inflammatory, Diabetes, CNS/Pain, Infectious diseases (virus) and Cancer. For more information on Astellas Pharma Inc., please visit our website at http://www.astellas.com.
About Medivation
Medivation, Inc. is a biopharmaceutical company focused on the rapid development of novel small molecule drugs to treat serious diseases for which there are limited treatment options. Medivation aims to transform the treatment of these diseases and offer hope to critically ill patients and their caregivers. In September 2008, Medivation announced a global agreement with Pfizer, Inc to develop and commercialize dimebon (latrepirdine) for the treatment of Alzheimer's and Huntington diseases. With Pfizer, Medivation is conducting a broad dimebon clinical development program that includes several Phase 3 trials assessing the efficacy and safety of dimebon taken alone or in combination with other Alzheimer's medications in patients with mild, moderate and severe Alzheimer's disease. The companies are also conducting a Phase 3 trial of dimebon in Huntington disease. In October 2009, Medivation entered a global agreement with Astellas Pharma Inc. to develop and commercialize MDV3100 for prostate cancer. The first Phase 3 clinical trial in the MDV3100 development program, known as the AFFIRM trial, is under way in patients with castration-resistant prostate cancer who have previously been treated with docetaxel-based chemotherapy. For more information, please visit us at http://www.medivation.com.
Aftalen mellem de 2 selskaber indeholder følgende.
$110 mio i upfront betaling
$335 mio i udviklings milestones
$320 mio i salgs milestones
50/50 profit split på det amerikanske marked
2-cifrede royalties i resten af verden
De deler alle udviklings udgifter rettet mod det amerikanske marked
Det er hvad jeg kalder en kanon aftale. Og det er i DEN grad noget man skal lægge mærke til i forhold til mulighederne for Bavarian Nordic. Kursen burde faktisk stige på det her
Her er lidt data fra et tidligere fase 1/2 studie som Hya måske også er interesseret i at se nærmere på
http://files.shareholder.com/downloads/MDV/757949698x0x275744/2988792d-3c25-4c64-bb5a-59ffa8e7d66e/GU_ASCO_2009_Poster.pdf
Astellas and Medivation Enter Into Worldwide Agreement to Co-Develop and Co-Commercialize MDV3100 for the Treatment of Prostate Cancer
-- Medivation to Receive $110 Million Upfront Cash Payment and Eligible to Receive $655 Million in Milestone Payments, 50 Percent of U.S. Profits and Double-Digit Royalties on Ex-U.S. Sales --
-- Medivation to Host Conference Call/Webcast Today at 8:30 a.m. Eastern Time --
TOKYO and SAN FRANCISCO, Oct 27, 2009 /PRNewswire-FirstCall via COMTEX News Network/ -- Astellas Pharma Inc. ("Astellas") and Medivation, Inc. (Nasdaq: MDVN) announced today that they have entered into a global agreement to develop and commercialize MDV3100, Medivation's investigational drug for the treatment of prostate cancer. MDV3100 is currently being evaluated in the Phase 3 AFFIRM clinical trial in men with castration-resistant prostate cancer who were previously treated with docetaxel-based chemotherapy.
Under the terms of the agreement, Medivation will receive an up-front cash payment of $110 million. Medivation is also eligible to receive payments of up to $335 million upon the attainment of development and regulatory milestones plus up to an additional $320 million in commercial milestone payments. The companies will collaborate on a comprehensive development program that will include additional studies to develop MDV3100 for both late- and early-stage prostate cancer. Subject to receipt of regulatory approval, the companies will jointly commercialize MDV3100 in the U.S. The companies will share equally all U.S. development costs, commercialization costs, and profits. Astellas will have responsibility for developing and commercializing MDV3100 outside the U.S. and will pay Medivation tiered double-digit royalties on ex-U.S. sales.
"We are pleased to initiate a great partnership with Medivation," stated Masafumi Nogimori, president and chief executive officer of Astellas. "We believe that MDV3100 has the unique potential to establish a new treatment approach for prostate cancer. Astellas already has the global expertise in urology and the strong commitment to focus on oncology. This partnership is a significant milestone to further expand our business in urology and to establish our franchise in oncology."
"We are excited to be working with Astellas to develop MDV3100 for a broad spectrum of prostate cancer disease states," said David Hung, M.D., president and chief executive officer of Medivation. "Astellas is an ideal partner for MDV3100 given its global reach, leading commercial presence in the urology space, and strategic focus on oncology. Astellas is the second major collaboration we have completed in the past year, and we are confident we have the right partners in place for each of our late-stage programs--Astellas for MDV3100 and Pfizer, Inc for dimebon (latrepirdine*)."
According to the American Cancer Society, prostate cancer is the most common non-skin cancer among men in the United States. More than 2 million American men have prostate cancer, and it is the second leading cause of cancer death among men after lung cancer. In 2009, an estimated 192,000 new cases are expected to be diagnosed, and approximately 27,000 men are expected to die from the disease.
MDV3100, a new generation of oral anti-androgen, which shows different pharmacological profiles from current anti-androgens, has been shown in preclinical studies to provide more complete suppression of the androgen receptor pathway than bicalutamide, the most commonly used anti-androgen. MDV3100 slows growth and induces cell death in bicalutamide-resistant cancers via three complementary actions - MDV3100 blocks testosterone binding to the androgen receptor, impedes movement of the androgen receptor to the nucleus of prostate cancer cells (nuclear translocation), and inhibits binding to DNA. Preclinical data published in Science earlier this year demonstrated that MDV3100 is superior to bicalutamide in each of these three actions.
The agreement is not subject to approval under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 and becomes effective immediately. Medivation's legal and financial advisers on the transaction were Cooley Godward Kronish LLP and Aquilo Partners, L.P. Astellas' legal adviser on the transaction was Covington & Burling LLP.
*Latrepirdine is the proposed generic (nonproprietary) name for dimebon.
Conference Call Information
Medivation will hold a conference call today at 8:30 a.m. Eastern Time (5:30 a.m. Pacific Time) to discuss this announcement. To participate in the conference call, please dial 888-280-4443 for domestic callers and 1-719-457-2638 for international callers. In addition, this call is being Webcast and can be accessed at Medivation's website at www.medivation.com.
About MDV3100's Clinical Program
In September 2009, Medivation began enrolling patients in a randomized, placebo-controlled, double-blind, multi-national Phase 3 clinical trial known as AFFIRM. This trial is evaluating MDV3100 at a dose of 160 mg taken orally once daily versus placebo in men with castration-resistant prostate cancer who were previously treated with docetaxel-based chemotherapy. The primary endpoint of the trial is overall survival; secondary endpoints include progression-free survival, safety and tolerability. This trial is expected to enroll approximately 1,200 patients at sites in the United States, Canada, Europe, South America, Australia and South Africa.
Medivation previously announced interim safety and efficacy results from an ongoing Phase 1-2 clinical trial of MDV3100. The interim results showed that MDV3100 was associated with anti-tumor activity in patients who had become resistant to bicalutamide or other standard anti-androgen treatments, including both patients who had failed prior chemotherapy and patients who were chemotherapy naive. Anti-tumor activity was demonstrated by reductions in prostate-specific antigen levels, improvement or stabilization in tumors that had spread to soft tissue or bone, and a decrease in circulating tumor cells, which has been associated in published literature with improved survival in patients with castration-resistant prostate cancer. MDV3100 was generally well tolerated in this trial at doses up to and including 240 mg/day, with fatigue being the most frequently reported adverse event.
About Astellas
Astellas Pharma Inc., located in Tokyo, Japan, is a pharmaceutical company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceuticals. Astellas has approximately 14,000 employees worldwide. The organization is committed to becoming a global category leader in Urology, Immunology and Inflammatory, Diabetes, CNS/Pain, Infectious diseases (virus) and Cancer. For more information on Astellas Pharma Inc., please visit our website at http://www.astellas.com.
About Medivation
Medivation, Inc. is a biopharmaceutical company focused on the rapid development of novel small molecule drugs to treat serious diseases for which there are limited treatment options. Medivation aims to transform the treatment of these diseases and offer hope to critically ill patients and their caregivers. In September 2008, Medivation announced a global agreement with Pfizer, Inc to develop and commercialize dimebon (latrepirdine) for the treatment of Alzheimer's and Huntington diseases. With Pfizer, Medivation is conducting a broad dimebon clinical development program that includes several Phase 3 trials assessing the efficacy and safety of dimebon taken alone or in combination with other Alzheimer's medications in patients with mild, moderate and severe Alzheimer's disease. The companies are also conducting a Phase 3 trial of dimebon in Huntington disease. In October 2009, Medivation entered a global agreement with Astellas Pharma Inc. to develop and commercialize MDV3100 for prostate cancer. The first Phase 3 clinical trial in the MDV3100 development program, known as the AFFIRM trial, is under way in patients with castration-resistant prostate cancer who have previously been treated with docetaxel-based chemotherapy. For more information, please visit us at http://www.medivation.com.
27/10 2009 21:52 stengård 0
21003 som sædvanligt gennemarbejdet og godt researchet - thank you Troldman...
Troldmanden
jeg nåede KUN til 1 linje efter overskriften i det her:
Her er lidt data fra et tidligere fase 1/2 studie som Hya måske også er interesseret i at se nærmere på
http://files.shareholder.com/downloads/MDV/757949698x0x275744/2988792d-3c25-4c64-bb5a-59ffa8e7d66e/GU_ASCO_2009_Poster.pdf
hvor jeg læser navnet Howard I. Scher
så står jeg af!
Hr Howard Scher er den største svindler der findes!
som repræsenterer forskning indenfor medicin - og fremstår som expert på prostatacancer.
HAN er/var en stor del af den lægevidenskabelige expertisse, som alle svindlerne brugte til at hikanere DNDN
og var en af experterne der stemte imod på dere s panelmøde i sin tid, samt en af dem der skrev FDA udenom alle kanaler osv
Han har gennem tiden haft ejerandele i diverse USA børsnoterede virksomheder med forskning målrettet mod prostatacancer
ofte firmaer der relaterede til ejerskaber blandt de hegdefonde og camer og rusisk mafia osv
og jeg har utallige gange oplevet news med mega aftaler på de firmaer - hvor det hele har været fake - og hvor firmaerne kort efter at ha modtaget pengene kommer med nye resultater der er meget negative - så firmaet går ned og pengene er pist borte -
du kan læse hele historien i de links jeg tidligere har lagt på alle de kapitler til DNDN's historie og manipulationer i markedet
så desværre gider jeg ik bruge mere tid på den historie - når Hr Howard Scher er involveret - for jeg tror ik en skid på sagen så!
http://www.deepcapture.com/michael-milken-60000-deaths-and-the-story-of-dendreon-chapter-1-of-15/
Hya
jeg nåede KUN til 1 linje efter overskriften i det her:
Her er lidt data fra et tidligere fase 1/2 studie som Hya måske også er interesseret i at se nærmere på
http://files.shareholder.com/downloads/MDV/757949698x0x275744/2988792d-3c25-4c64-bb5a-59ffa8e7d66e/GU_ASCO_2009_Poster.pdf
hvor jeg læser navnet Howard I. Scher
så står jeg af!
Hr Howard Scher er den største svindler der findes!
som repræsenterer forskning indenfor medicin - og fremstår som expert på prostatacancer.
HAN er/var en stor del af den lægevidenskabelige expertisse, som alle svindlerne brugte til at hikanere DNDN
og var en af experterne der stemte imod på dere s panelmøde i sin tid, samt en af dem der skrev FDA udenom alle kanaler osv
Han har gennem tiden haft ejerandele i diverse USA børsnoterede virksomheder med forskning målrettet mod prostatacancer
ofte firmaer der relaterede til ejerskaber blandt de hegdefonde og camer og rusisk mafia osv
og jeg har utallige gange oplevet news med mega aftaler på de firmaer - hvor det hele har været fake - og hvor firmaerne kort efter at ha modtaget pengene kommer med nye resultater der er meget negative - så firmaet går ned og pengene er pist borte -
du kan læse hele historien i de links jeg tidligere har lagt på alle de kapitler til DNDN's historie og manipulationer i markedet
så desværre gider jeg ik bruge mere tid på den historie - når Hr Howard Scher er involveret - for jeg tror ik en skid på sagen så!
http://www.deepcapture.com/michael-milken-60000-deaths-and-the-story-of-dendreon-chapter-1-of-15/
Hya
27/10 2009 23:51 troldmanden 021007 Hej Hya
Helt igennem ufattelig godt spottet.
Jeg er som nævnt mange gange før ikke specielt meget inde i cancer forskning og har derfor ikke fulgt dndn så tæt som du har og kommer nok heller ikke til at læse de 15 kap om sagen. Men har enorm stor respekt for din viden på området.
Jeg ville ellers have svaret dig at når et af de relativ store pharma selskaber laver så stor en aftale, så har de lave en meget dybdeborende DD hvorfor data som sådan bør være vallide nok i forhold til det stadie stoffet befinder sig på. Men kan så forstå på dig at Hr Howard Scher helt konkret har været involveret i flere forskellige selskaber/stoffer som har været gennem flere lignende deals?
Jeg har ikke lige undersøgt Hr Howard Scher forbindelse til Medivation. Men finder det dog lidt interessant at du nævner Rusland/mafia. For Medivation lavede sidste år en anden MEGET stor aftale med Pfizer om deres alzheimers stof som have vist intet mindre end fantastiske resultater. Og måske også lidt FOR fantastiske resultater. Det interessante er at det kliniske forsøg blev udført i Rusland og det har nogle steder vagt lidt snak i krogene. Men Pfizer betalte altså svimlende $225 mio upfront for et fase 2. Umiddelbart det størst upfront beløb nogensinde for et projekt der kun lige har afsluttet fase 2
Helt igennem ufattelig godt spottet.
Jeg er som nævnt mange gange før ikke specielt meget inde i cancer forskning og har derfor ikke fulgt dndn så tæt som du har og kommer nok heller ikke til at læse de 15 kap om sagen. Men har enorm stor respekt for din viden på området.
Jeg ville ellers have svaret dig at når et af de relativ store pharma selskaber laver så stor en aftale, så har de lave en meget dybdeborende DD hvorfor data som sådan bør være vallide nok i forhold til det stadie stoffet befinder sig på. Men kan så forstå på dig at Hr Howard Scher helt konkret har været involveret i flere forskellige selskaber/stoffer som har været gennem flere lignende deals?
Jeg har ikke lige undersøgt Hr Howard Scher forbindelse til Medivation. Men finder det dog lidt interessant at du nævner Rusland/mafia. For Medivation lavede sidste år en anden MEGET stor aftale med Pfizer om deres alzheimers stof som have vist intet mindre end fantastiske resultater. Og måske også lidt FOR fantastiske resultater. Det interessante er at det kliniske forsøg blev udført i Rusland og det har nogle steder vagt lidt snak i krogene. Men Pfizer betalte altså svimlende $225 mio upfront for et fase 2. Umiddelbart det størst upfront beløb nogensinde for et projekt der kun lige har afsluttet fase 2
