Clostridium difficile, a gram-positive anaerobic bacterium, is one of the most common hospital infections around the world. The C difficile infection, or CDI for short, causes inflammation of the colon, severe diarrhea and, in extreme cases, death and is a serious problem facing the U.S. healthcare system.
C. difficile is a multi-drug resistant bacterium. This new superbug has reportedly been on the rise since 2007.
It is estimated that more than 700,000 people are afflicted with CDI each year in the U.S. The total annual costs associated with hospital cases of CDI in United States are estimated at $3.2 billion and the total estimated annual cost for treating the disease in Europe is approximately $3.8 billion.
CDI is currently treated by a generic drug called metronidazole or ViroPharma Inc.'s (VPHM) Vancocin (oral form Vancomycin), and the latter being the only FDA-approved treatment. The dosing regimen of both metronidazole and Vancocin is every six hours for a minimum of seven days.
A new drug may be added to the arsenal of antibiotics if it crosses the final regulatory hurdle, which is scheduled for May 30.
... Yes, you guessed it right. It is Optimer Pharmaceuticals Inc.'s (OPTR) investigational antibiotic , which has been in the works for over a decade, we are referring to.
The FDA decision date for Optimer's investigational antibiotic Fidaxomicin for treating Clostridium difficile infection is just a fortnight away. It will soon be known whether this superbug killer drug will find favor with the regulatory body and hit the drugstore shelves to help counter one of the most menacing emerging health threats.
Fidaxomicin with the proposed trade name of Dificid is the first in a new class of antibiotics called macrocycles, which inhibit the bacterial enzyme RNA polymerase, resulting in the rapid killing of Clostridium difficile.
On April 5, an FDA panel voted unanimously 13-0 recommending approval of Dificid based on its safety and effectiveness in treating Clostridium difficile infection, or CDI for short. The deadly infection of Clostridium difficile, a gram-positive anaerobic bacterium, results in inflammation of the colon, severe diarrhea and, in extreme cases, death and is a serious problem facing the U.S. healthcare system.
The current treatment options of metronidazole and Vancocin have the shortcomings of limited efficacy, high recurrence rate, bacterial resistance and inconvenient dosing and difficult compliance, says Optimer.
According to Optimer, in phase 3 clinical studies, Dificid was proven to be as effective as vancomycin in clinical cure, and was superior to vancomycin in global cure, defined as cure without a recurrence after 4 weeks of therapy. Moreover, Dificid has a convenient twice daily dosing regimen.
Market research firm Datamonitor foresees sales of Fidaxomicin to reach $265 million across the seven major markets of the US, Japan, France, Germany, Spain, and the UK in 2019.
Sales of Vancocin, which were $232.3 million in 2008, declined to $213.1 million in 2009. However in 2010, sales of the drug were up nearly 22% to $260 million even as sales volume were down by 5.8%.
Dificid is also under review by the European Medicines Agency. In February of this year, Optimer entered into an exclusive collaboration and license agreement with Japan-based Astellas Pharma Inc. to develop and commercialize Dificid in Europe and certain other countries in the Middle East, Africa and the CIS (referred to as the Astellas territory). In return for an exclusive license to Dificid in the Astellas territory, Optimer received an upfront cash payment of $69.2 million and is eligible to receive additional cash payments totaling up to 115 million Euros upon the achievement of certain regulatory and commercial milestones. Optimer is also entitled to receive escalating double-digit royalties ranging from the high teens to low twenties on net sales of Dificid in the Astellas territory, if approved.
Last month, Optimer entered into a co-promotion agreement with Cubist Pharmaceuticals Inc. (CBST) to help sell Dificid in the United States. The initial term of the agreement is two years from the date of first commercial sale of Dificid in the United States, subject to renewal or early termination.
Under the terms of the agreement, Optimer will pay a quarterly fee of about $3.8 million to Cubist ($15.0 million per year) beginning as of the first commercial sale of Dificid in the United States for its co-promotion activities and personnel commitments. Cubist is also eligible to receive an additional $17.5 million if mutually agreed upon annual sales targets are achieved, as well as a portion of Optimer's gross profits derived from net sales above the specified annual targets, if any.
Dificid will be the first drug to be cleared in nearly 30 years for treating CDI if it successfully passes FDA muster.
Optimer has no products approved for commercial sale and, to date, has not generated any revenues from product sales. As of March 31, 2011, the company had total cash of $180.1 million and zero debt. Optimer has spent nearly $200 million developing Dificid and it will be the company's first marketed drug if it successfully crosses the regulatory finish line. Stay tuned...
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