Merck & Co., Inc., Medarex, Inc. and Massachusetts Biologic Laboratories Sign Exclusive Licensing Agreement for Investigational Monoclonal Antibody Combination for Clostridium Difficile Infection
WHITEHOUSE STATION, N.J., PRINCETON, N.J. & JAMAICA PLAIN, Mass.--(BUSINESS
WIRE)--Apr. 21, 2009--
Merck & Co., Inc., (through an affiliate), Medarex, Inc. (NASDAQ: MEDX) and Massachusetts Biologic Laboratories (MBL) of the University of Massachusetts Medical School (UMMS) today announced that they have signed an exclusive worldwide license agreement for CDA-1 and CDB-1 (also known as MDX-066/MDX-1388 and MBL-CDA1/MBL-CDB1), an investigational fully human monoclonal antibody combination developed to target and neutralize Clostridium difficile toxins A and B, for the treatment of C. difficile infection (CDI). CDA-1 and CDB-1 were co-developed by Medarex and MBL.
Under the terms of the agreement, Merck gains worldwide rights to
develop and commercialize CDA-1 and CDB-1. Medarex and MBL will receive an upfront payment of $60 million and are potentially eligible to receive additional cash payments up to $165 million upon achievement of certain milestones associated with the development and approval of a drug candidate covered by this agreement. Upon commercialization, Medarex and MBL will also be eligible to receive double-digit royalties on product sales and milestones if certain sales targets are met. In accordance with the co-development agreement between Medarex and MBL, all payments will be divided equally.
The incidence of C. difficile infection (CDI) in the U.S. is
rapidly increasing, with rates doubling from 2000 to 2005. The Centers
for Disease Control and Prevention has projected that there will be as
many as 750,000 cases of CDI per year by 2010.
"C. difficile infection is the primary cause of infectious
diarrhea in hospitalized elderly patients in developed countries," said
Tony Ford-Hutchinson, Ph.D., senior vice president and franchise head, Infectious Diseases and Vaccines, Merck Research Laboratories.
"This agreement underscores Merck's ongoing commitment to infectious disease and our strategy of licensing promising candidates with the potential to address serious unmet medical needs."
“Discovering and developing an effective new treatment for a significant public health threat is the mission of MBL,” said Donna Ambrosino, M.D., executive director of MBL and professor of pediatrics at UMMS. “We are delighted that through this license agreement this candidate will advance towards final clinical studies and thus will potentially be available to patients in the shortest possible time.”
“This agreement exemplifies our ability to execute our corporate
strategy combining creative science with an industry-leading platform to successfully enter into partnerships that are financially attractive and value-enhancing,” said Howard H. Pien, chairman and chief executive officer of Medarex. “We will continue to invest in our growing pipeline of innovative product candidates to address significant unmet medical needs, advance them to proof-of-concept and explore strategic options, either through partnership or by advancing the candidate ourselves, that would create long-term value for Medarex shareholders.”
Top-line results from a Phase II multicenter, randomized, double-blind,
placebo-controlled trial evaluating CDA-1/CDB-1 provided evidence of a statistically significant reduction in the rate of recurrence of CDI
compared with placebo. In the study, 200 patients symptomatic with an acute episode of CDI receiving standard of care antibiotics
(metronidazole or vancomycin) were randomized to receive intravenous CDA-1/CDB-1 or intravenous placebo. An oral presentation of the Phase II data is scheduled at the upcoming Digestive Disease Week (DDW) in Chicago on June 2, 2009 at 2:15 p.m. local time.
.......
MEDX EPV 709 mln USD - heraf 100 mil UDS i Genmabaktier.
60 mln upfront er lig med et halvt kurspoint (kan ikke lige huske samarbejdsaftalen med Massachusetts Medical School - men det er vist et 50/50%)
Mon ikke MEDX vil teste 6-6,2 som er modtanden lige nu ?
WHITEHOUSE STATION, N.J., PRINCETON, N.J. & JAMAICA PLAIN, Mass.--(BUSINESS
WIRE)--Apr. 21, 2009--
Merck & Co., Inc., (through an affiliate), Medarex, Inc. (NASDAQ: MEDX) and Massachusetts Biologic Laboratories (MBL) of the University of Massachusetts Medical School (UMMS) today announced that they have signed an exclusive worldwide license agreement for CDA-1 and CDB-1 (also known as MDX-066/MDX-1388 and MBL-CDA1/MBL-CDB1), an investigational fully human monoclonal antibody combination developed to target and neutralize Clostridium difficile toxins A and B, for the treatment of C. difficile infection (CDI). CDA-1 and CDB-1 were co-developed by Medarex and MBL.
Under the terms of the agreement, Merck gains worldwide rights to
develop and commercialize CDA-1 and CDB-1. Medarex and MBL will receive an upfront payment of $60 million and are potentially eligible to receive additional cash payments up to $165 million upon achievement of certain milestones associated with the development and approval of a drug candidate covered by this agreement. Upon commercialization, Medarex and MBL will also be eligible to receive double-digit royalties on product sales and milestones if certain sales targets are met. In accordance with the co-development agreement between Medarex and MBL, all payments will be divided equally.
The incidence of C. difficile infection (CDI) in the U.S. is
rapidly increasing, with rates doubling from 2000 to 2005. The Centers
for Disease Control and Prevention has projected that there will be as
many as 750,000 cases of CDI per year by 2010.
"C. difficile infection is the primary cause of infectious
diarrhea in hospitalized elderly patients in developed countries," said
Tony Ford-Hutchinson, Ph.D., senior vice president and franchise head, Infectious Diseases and Vaccines, Merck Research Laboratories.
"This agreement underscores Merck's ongoing commitment to infectious disease and our strategy of licensing promising candidates with the potential to address serious unmet medical needs."
“Discovering and developing an effective new treatment for a significant public health threat is the mission of MBL,” said Donna Ambrosino, M.D., executive director of MBL and professor of pediatrics at UMMS. “We are delighted that through this license agreement this candidate will advance towards final clinical studies and thus will potentially be available to patients in the shortest possible time.”
“This agreement exemplifies our ability to execute our corporate
strategy combining creative science with an industry-leading platform to successfully enter into partnerships that are financially attractive and value-enhancing,” said Howard H. Pien, chairman and chief executive officer of Medarex. “We will continue to invest in our growing pipeline of innovative product candidates to address significant unmet medical needs, advance them to proof-of-concept and explore strategic options, either through partnership or by advancing the candidate ourselves, that would create long-term value for Medarex shareholders.”
Top-line results from a Phase II multicenter, randomized, double-blind,
placebo-controlled trial evaluating CDA-1/CDB-1 provided evidence of a statistically significant reduction in the rate of recurrence of CDI
compared with placebo. In the study, 200 patients symptomatic with an acute episode of CDI receiving standard of care antibiotics
(metronidazole or vancomycin) were randomized to receive intravenous CDA-1/CDB-1 or intravenous placebo. An oral presentation of the Phase II data is scheduled at the upcoming Digestive Disease Week (DDW) in Chicago on June 2, 2009 at 2:15 p.m. local time.
.......
MEDX EPV 709 mln USD - heraf 100 mil UDS i Genmabaktier.
60 mln upfront er lig med et halvt kurspoint (kan ikke lige huske samarbejdsaftalen med Massachusetts Medical School - men det er vist et 50/50%)
Mon ikke MEDX vil teste 6-6,2 som er modtanden lige nu ?
21/4 2009 14:19 Hya 0
8432 især 5 års chart - langsigtet - ser utroligt spændende ud på TA
der er en hammer - ligesom der var på DNDN før den brød væsentligt op.
så denne aftale kunne godt være katalysatoren til en længere optur - hvis ellers det overordnede marked tillader det.
Hya
der er en hammer - ligesom der var på DNDN før den brød væsentligt op.
så denne aftale kunne godt være katalysatoren til en længere optur - hvis ellers det overordnede marked tillader det.
Hya
21/4 2009 14:29 Solsen 08435 Ledelsen har også udtalt, at medx vil ligge i en kurs væsentligt fra nuværende om et år (hvis det kan bruges til noget).
Så vidt jeg husker er der PDDFUA dato sidst i måneden hos FDA på deres første stof på det amerikanske marked og indenfor måneder deres andet stof - stoffer der er udlicenseret til JNJ.
Deres væsenligste stof ipilimumab kan være tæt på markedet næste år. Men er pt behæftet med megen usikkerhed - men for mig at se skal det nok gå gennem nåleøjet.
Men clostridium difficile kan godt give en del presseomtale da det er et voldsomt problem mange steder - specielt på sygehuse.
Antisofferne (to stk) neutraliserer de toksiner bakterierne danner !
Så vidt jeg husker er der PDDFUA dato sidst i måneden hos FDA på deres første stof på det amerikanske marked og indenfor måneder deres andet stof - stoffer der er udlicenseret til JNJ.
Deres væsenligste stof ipilimumab kan være tæt på markedet næste år. Men er pt behæftet med megen usikkerhed - men for mig at se skal det nok gå gennem nåleøjet.
Men clostridium difficile kan godt give en del presseomtale da det er et voldsomt problem mange steder - specielt på sygehuse.
Antisofferne (to stk) neutraliserer de toksiner bakterierne danner !
24/4 2009 22:57 Solsen 08759 J&J, Schering-Plough’s Arthritis Treatment Wins U.S. Approval
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By Shannon Pettypiece and Alex Nussbaum
April 24 (Bloomberg) -- Johnson & Johnson and Schering- Plough Corp. won U.S. approval of a rheumatoid arthritis drug designed to be injected less often than their top-selling product, Remicade, for the crippling disease.
The Food and Drug Administration announced its decision on the medicine, golimumab, in an e-mailed statement today. The drug will compete with Amgen Inc.’s Enbrel and Abbott Laboratories’ Humira.
To contact the reporters on this story: Shannon Pettypiece in New York [email protected]; Alex Nussbaum in New York anussbaum
....
Første stof fra MEDX/Genmab teknologien godkendt af FDA !
Forholdsvis lille royalty til MEDX på omkring 2-4%
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By Shannon Pettypiece and Alex Nussbaum
April 24 (Bloomberg) -- Johnson & Johnson and Schering- Plough Corp. won U.S. approval of a rheumatoid arthritis drug designed to be injected less often than their top-selling product, Remicade, for the crippling disease.
The Food and Drug Administration announced its decision on the medicine, golimumab, in an e-mailed statement today. The drug will compete with Amgen Inc.’s Enbrel and Abbott Laboratories’ Humira.
To contact the reporters on this story: Shannon Pettypiece in New York [email protected]; Alex Nussbaum in New York anussbaum
....
Første stof fra MEDX/Genmab teknologien godkendt af FDA !
Forholdsvis lille royalty til MEDX på omkring 2-4%
