May 27, 2011
Third quarter 2011
For the treatment of Clostridium difficile-associated diarrhea (CDAD) in adults
Entrée Health (managed markets)
SSCG Media Group (digital)
Considering infectious disease specialists are among the heaviest users of the web during patient consults, a big part of the Dificid launch strategy involves digital promotion. Tactics could include direct-to-physician programs, and online disease awareness to doctors and patients on the incidence and severity of CDAD and the recurrence problem. Currently 20-30% of patients have a relapse, according to Optimer, and that can lead to readmission and additional health costs. Dificid's point of differentiation is that it proved superior to ViroPharma's Vancocin in keeping patients' diarrheal symptoms in check at 25 days post treatment. In mid-July Dificid's combined sales force of 280 US reps (100 from Optimer, 180 from Cubist) will start detailing that message to ID specialists, hospitalists and gastroenterologists. Ads in journals targeting these specialists will support reach. The twice-daily pill will be priced at $2,800 for a 10-day course—significantly more than the roughly $1,000 ViroPharma charges for a course of therapy with Vancocin. Jefferies analyst Eun Yang forecasts US sales of $95 million by 2013, reaching as high as $250 million worldwide.
Also in the Pipeline (courtesy of Adis R&D Insight)
Indication: Clostridium infections
Active ingredient: Rifaximin
Source: Wolters Kluwer Pharma Solutions
Recent MM&M Coverage
The Top 75: CDM New York
Fidaxomicin is a fermentation product obtained from the Actinomycete Dactylosporangium aurantiacum. It is bactericidal against C. difficile in vitro, inhibiting RNA synthesis by RNA polymerases.
In two randomized, double-blinded trials, a non-inferiority design was utilized to demonstrate the efficacy of fidaxomicin (200mg twice daily for 10 days) compared to vancomycin (125mg four times daily for 10 days) in adults with Clostridium difficile-associated diarrhea (CDAD). Enrolled patients received no more than 24 hours of pretreatment with vancomycin or metronidazole. CDAD was defined by >3 unformed bowel movements (or >200mL of unformed stool for subjects having rectal collection devices) in the 24 hours before randomization, and presence of either C. difficile toxin A or B in the stool within 48 hours of randomization. Enrolled patients had either no prior CDAD history or only one prior CDAD episode in the past three months. Subjects with life-threatening/fulminant infection, hypotension, septic shock, peritoneal signs, significant dehydration, or toxic megacolon were excluded.
Nausea, vomiting, abdominal pain, GI hemorrhage, anemia, neutropenia.
200mg twice daily for 10 days.
Not for treating systemic infections (minimal systemic absorption). Pregnancy (Cat. B). Nursing mothers.