SAN DIEGO & STAINES, England—Optimer Pharmaceuticals Inc. and Astellas Pharma Europe Ltd. recently signed an exclusive collaboration and license agreement to develop and commercialize fidaxomicin, an investigational antibiotic for Clostridium difficile infection (CDI), in Europe and certain other countries in the Middle East, Africa and the Commonwealth of Independent States (CIS).
In return for an exclusive license to fidaxomicin in the territory, Astellas is obligated to pay Optimer an upfront cash payment of approximately $68 million. Optimer is also eligible to receive additional cash payments totaling up to approximately $156 million upon the achievement of certain regulatory and commercial milestones. Furthermore, Astellas is obligated to pay tiered double-digit royalty payments on net sales of fidaxomicin in the territory. Astellas will be responsible for all future costs associated with the development, manufacturing, and commercialization of fidaxomicin in the territory including the costs of the ongoing Marketing Authorization Application (MAA) with the European Medicines Agency (EMA).
"We believe the combined strengths of Astellas' world-class anti-infective business capabilities, including established relationships with payers and hospitals in Europe and certain other markets, combined with Optimer's novel therapeutic for CDI, represents the most effective way to address a serious, unmet health need," says Masao Yoshida, president and CEO of Astellas Pharma Europe. "We look forward to bringing fidaxomicin to these markets to help patients and providers address this serious life threatening disease."
"We expect the Astellas collaboration will help Optimer realize the full potential of fidaxomicin and will help position this medication in these countries as the first line of treatment, both for treating CDI and reducing recurrences," says Pedro Lichtinger, Optimer's president and CEO. "CDI poses a significant cost burden on the healthcare system and we believe, if approved, fidaxomicin will provide a cost-savings opportunity for hospitals and payers, especially when used in populations at risk of recurrence such as the elderly, patients with a prior episode, those taking concomitant antibiotics, immune-compromised patients or those with renal impairment."
Fidaxomicin is an orally administered macrocyclic antibiotic with a new mechanism and narrow spectrum of action, and it was developed specifically with the treatment of CDI in mind. In two Phase III trials for the treatment of CDI, fidaxomicin was equally effective in clinical cure when compared to vancomycin, the only FDA-approved product for CDI. Most importantly, fidaxomicin was statistically superior to vancomycin in global cure and in reducing recurrences of CDI by up to 47 percent, according to the companies. Optimer has filed marketing applications in the United States and the European Union for fidaxomicin.
As Luke Timmerman writes at Xconomy.com, "The deal is the latest boon for Optimer, which has had some wind in its sails lately ... The company sought, and the FDA has granted, a faster than usual six-month regulatory review, which the agency sometimes offers to treatments with lifesaving potential. Last week, Optimer got the attention of a key physician audience, when results from one of its pivotal clinical trials for fidaxomicin were published in the New England Journal of Medicine. Since "C.diff" doesn't often make headlines, getting that attention was critical for Optimer, as it lays the groundwork to market the drug on its own in the U.S."
C. difficile has become a significant medical problem in hospitals, long-term care facilities, and in the community and is estimated to afflict more than 700,000 people each year in the United States alone. CDI is a serious illness resulting from infection of the inner lining of the colon by C. difficile bacteria, which produce toxins that cause inflammation of the colon, severe diarrhea and, in the most serious cases, death. Patients typically develop CDI from the use of broad-spectrum antibiotics that disrupt normal gastrointestinal flora, thus allowing C. difficile bacteria to flourish and produce toxins. Current therapeutic options for CDI include the off-label use of metronidazole and oral vancomycin, the latter being the only FDA-approved treatment. However, approximately 20 percent to 30 percent of CDI patients who initially respond to these treatments experience a clinical recurrence following cessation of the CDI treatment.
Astellas Pharma Europe Ltd., based in the United Kingdom, is a European subsidiary of Tokyo-based Astellas Pharma Inc. and is responsible for 21 affiliate offices located across Europe, the Middle East and Africa, a research and development site and three manufacturing plants. The company employs approximately 3,900 staff across these regions.
Optimer Pharmaceuticals is a biopharmaceutical company focused on discovering, developing and commercializing hospital specialty products to treat serious infections and address unmet medical needs. Optimer has two anti-infective product candidates in development, fidaxomicin and Pruvel (prulifloxacin). The FDA granted Optimer's request for a six-month Priority Review of fidaxomicin, and has assigned a Prescription Drug User Fee Act (PDUFA) goal date of May 30, 2011. Optimer has also filed a MAA with the EMA for fidaxomicin. Pruvel is a prodrug in the fluoroquinolone class of antibiotics being developed as a treatment for infectious diarrhea.
In return for an exclusive license to fidaxomicin in the territory, Astellas is obligated to pay Optimer an upfront cash payment of approximately $68 million. Optimer is also eligible to receive additional cash payments totaling up to approximately $156 million upon the achievement of certain regulatory and commercial milestones. Furthermore, Astellas is obligated to pay tiered double-digit royalty payments on net sales of fidaxomicin in the territory. Astellas will be responsible for all future costs associated with the development, manufacturing, and commercialization of fidaxomicin in the territory including the costs of the ongoing Marketing Authorization Application (MAA) with the European Medicines Agency (EMA).
"We believe the combined strengths of Astellas' world-class anti-infective business capabilities, including established relationships with payers and hospitals in Europe and certain other markets, combined with Optimer's novel therapeutic for CDI, represents the most effective way to address a serious, unmet health need," says Masao Yoshida, president and CEO of Astellas Pharma Europe. "We look forward to bringing fidaxomicin to these markets to help patients and providers address this serious life threatening disease."
"We expect the Astellas collaboration will help Optimer realize the full potential of fidaxomicin and will help position this medication in these countries as the first line of treatment, both for treating CDI and reducing recurrences," says Pedro Lichtinger, Optimer's president and CEO. "CDI poses a significant cost burden on the healthcare system and we believe, if approved, fidaxomicin will provide a cost-savings opportunity for hospitals and payers, especially when used in populations at risk of recurrence such as the elderly, patients with a prior episode, those taking concomitant antibiotics, immune-compromised patients or those with renal impairment."
Fidaxomicin is an orally administered macrocyclic antibiotic with a new mechanism and narrow spectrum of action, and it was developed specifically with the treatment of CDI in mind. In two Phase III trials for the treatment of CDI, fidaxomicin was equally effective in clinical cure when compared to vancomycin, the only FDA-approved product for CDI. Most importantly, fidaxomicin was statistically superior to vancomycin in global cure and in reducing recurrences of CDI by up to 47 percent, according to the companies. Optimer has filed marketing applications in the United States and the European Union for fidaxomicin.
As Luke Timmerman writes at Xconomy.com, "The deal is the latest boon for Optimer, which has had some wind in its sails lately ... The company sought, and the FDA has granted, a faster than usual six-month regulatory review, which the agency sometimes offers to treatments with lifesaving potential. Last week, Optimer got the attention of a key physician audience, when results from one of its pivotal clinical trials for fidaxomicin were published in the New England Journal of Medicine. Since "C.diff" doesn't often make headlines, getting that attention was critical for Optimer, as it lays the groundwork to market the drug on its own in the U.S."
C. difficile has become a significant medical problem in hospitals, long-term care facilities, and in the community and is estimated to afflict more than 700,000 people each year in the United States alone. CDI is a serious illness resulting from infection of the inner lining of the colon by C. difficile bacteria, which produce toxins that cause inflammation of the colon, severe diarrhea and, in the most serious cases, death. Patients typically develop CDI from the use of broad-spectrum antibiotics that disrupt normal gastrointestinal flora, thus allowing C. difficile bacteria to flourish and produce toxins. Current therapeutic options for CDI include the off-label use of metronidazole and oral vancomycin, the latter being the only FDA-approved treatment. However, approximately 20 percent to 30 percent of CDI patients who initially respond to these treatments experience a clinical recurrence following cessation of the CDI treatment.
Astellas Pharma Europe Ltd., based in the United Kingdom, is a European subsidiary of Tokyo-based Astellas Pharma Inc. and is responsible for 21 affiliate offices located across Europe, the Middle East and Africa, a research and development site and three manufacturing plants. The company employs approximately 3,900 staff across these regions.
Optimer Pharmaceuticals is a biopharmaceutical company focused on discovering, developing and commercializing hospital specialty products to treat serious infections and address unmet medical needs. Optimer has two anti-infective product candidates in development, fidaxomicin and Pruvel (prulifloxacin). The FDA granted Optimer's request for a six-month Priority Review of fidaxomicin, and has assigned a Prescription Drug User Fee Act (PDUFA) goal date of May 30, 2011. Optimer has also filed a MAA with the EMA for fidaxomicin. Pruvel is a prodrug in the fluoroquinolone class of antibiotics being developed as a treatment for infectious diarrhea.
