Optimer Pharmaceuticals Inc. (OPTR), said Friday the U.S. Food and Drug Administration has approved its antibiotic Dificid for the treatment of Clostridium difficile infection in adult patients, making it the first drug to be cleared in nearly thirty years to treat the disease.
Shares of Optimer, which until now had no products approved for commercial sale, gained over 5 percent in extended trade, following the news.
The FDA approval for Dificid means CDI patients get to have a better treatment option, compared with standard care Vancocin that comes from ViroPharma Inc.'s stable.
Commenting on the clearance, Optimer Chief Executive Officer Pedro Lichtinger said, "The FDA approval of Dificid is the culmination of Optimer's efforts to develop an innovative therapy for the treatment of CDAD."
Lichtinger said the company is moving into the commercialization stage to ensure the drug's availability.
Clostridium difficile, a gram-positive anaerobic bacterium, is one of the most common hospital infections around the world. The C difficile infection, or CDI, causes inflammation of the colon, severe diarrhea and, in some cases, death, and is a serious problem affecting the U.S. healthcare system.
In the U.S. alone, CDI is said to infect 700,000 people annually. Treatment costs for the infection is huge, with total annual expense for hospital CDI-cases in U.S. estimated at $3.2 billion, and in Europe at about $3.8 billion.
Currently, the only FDA-approved treatment for CDI is ViroPharma Inc.'s (VPHM ) Vancocin, which in 2010 had sales of $260 million, an increase of 22 percent from the prior year.
Nonetheless, treatment with Vancocin has shortcomings of limited efficacy, high recurrence rate, bacterial resistance, and inconvenient dosing regimen. About 20 percent to 30 percent of patients who initially show improvements using Vancocin report a resurgence in the disease after treatment.
Optimer's 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.
According to market research firm Datamonitor, sales of Dificid are expected to reach $265 million across the seven major markets of the U.S., Japan, France, Germany, Spain, and the UK in 2019. In the U.S., Optimer has an exclusive 2-year agreement with Cubist Pharmaceuticals to commercialize the drug.
Today's FDA approval follows the agency's Anti-Infective Drugs Advisory Committee, which in an unanimous vote, found that the clinical evidence submitted by Optimer showed the drug to be efficacious in treating CDI, compared with vancomycin.
Optimer had filed the New Drug Application for Dificid in November last year, after years of research, and nearly $200 million spent in developing the drug.
Dificid also comes with a convenient dosing regimen - twice daily for ten days, while the dosing regimen of Vancocin is every six hours for a minimum of seven days.
For commercializing Dificid in the U.S., Optimer has signed a two-year exclusive agreement with Cubist Pharmaceuticals Inc. (CBST) to co-promote the drug to physicians, hospitals, and healthcare institutions. Optimer will retain ownership of the drug and will oversee manufacturing and distribution of Dificid in the U.S. Cubist on its part will receive quarterly service fees of $3.75 million or $15 million per year over the two years beginning with the first commercial sale of Dificid.
Cubist is also eligible to receive an additional $5 million in the first year after first commercial sale and $12.5 million in the second year of the agreement if mutually agreed upon annual sales targets are met.
Dificid is also under review by the European Medicines Agency. In February 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. In return, Optimer received an upfront cash payment of $69.2 million and is eligible to receive additional cash payments of up to 115 million Euros upon meeting certain milestones.
OPTR closed Friday's regular trade at $12.98, down $1.01 or 7.22%, on a volume of 5.9 million shares on the Nasdaq. In after hours, the stock gained $0.66 or 5.08%.
CBST closed at $38.29, down $0.01 or 0.03%, on a volume of 1.2 million shares.
VPHM is trading at $18.86, down $0.13 or 0.68%. In after hours, the stock gained $0.13 or 0.69%.
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