Product
Teflaro
Approval Date
October 29, 2010
Release Date
January 2011
Company
Forest Laboratories
Class
Cephalosporin
Indication
For the treatment of adult patients with community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infection (ABSSSI) caused by susceptible strains of indicated pathogens.
Active Ingredient
Ceftaroline
Agency Roster
Scientific Therapeutics Information
Marketing Strategy/Execution
Teflaro (ceftaroline) packs a one-two punch, hailing from an antibiotic class prized for safety and efficacy while bringing expanded activity against MRSA, the most prominent drug-resistant pathogen in the hospital setting. In other words, physicians can prescribe Teflaro if they suspect a patient has one of several different bacterial infections and feel confident the inectable drug will work and be well tolerated. Forest probably will stress these advantages in details and other messaging. The firm said it’s doubling its hospital-based field force, from 110 reps to 220, as it gears up for a January launch. Some are comparing Teflaro to Roche blockbuster antibiotic Rocephin (ceftriaxone), which some have nicknamed “vitamin C” for its high usage in the acute-care setting. Clinical-cure rates with Teflaro rivaled those of ceftriaxone in trials. However, Teflaro does not cover resistant gram-negative organisms, and some analysts feel this, along with the fact that it’s an I.V. antibiotic with generic alternatives, may limit commercial potential. Worldwide annual sales of Teflaro could reach a peak of $650 million, according to Decision Resources.
Also in the Pipeline (courtesy of Adis R&D Insight)
Drug: A-195773
Manufacturer: Advanced Life Sciences (Licensee)
Indication: Community-acquired pneumonia
Active ingredient: Cethromycin
Phase: III
Source: Wolters Kluwer Pharma Solutions
Recent MM&M Coverage
Company News
Company News from the 12/6/09 news brief
Adverse Reactions
GI upset, rash, (+) Coombs test (evaluate for hemolytic anemia if occurs), pseudomembranous colitis, superinfection.
Adults
≥18yrs: Give by IV infusion over 1hr. Treat skin and skin structure for 5–14 days; treat pneumonia for 5–7days. CrCl >50mL/min: 600mg every 12hrs. Renal impairment (CrCl >30–≤50mL/min): 400mg every 12hrs; (CrCl ≥15–≤30mL/min): 300mg every 12hrs; ESRD (including hemodialysis): 200mg every 12hrs (dose after dialysis on dialysis days).
Children
<18yrs: not recommended.
Contradictions
Detailed clinical information withheld for review by MPR’s clinical advisory board and will be added as soon as it becomes available.
Precautions
Penicillin or other allergy. GI disease (esp. colitis). Pregnancy (Cat.B). Nursing mothers.
