Product
Azasite

Release Date
August 24, 2007
 
Company
Inspire
 
Class
Antibiotic (macrolide)

Indication
Susceptible bacterial conjunctivitis
 
Active Ingredient
Azithromycin 1%; oph. soln; contains benzalkonium chloride.
 
Agency Roster
S&R Communications (professional)
MedThink Communications (publication planning)
BMC Communications (PR)
 
MarketingStrategy/Execution
Inspire’s sales force of about 100 representativesis detailing three main groups of physicians—pediatric, primary care andeye care professionals—for Azasite. The firm hopes to takeshare from Alcon, marketer of category frontrunners Vigamox and Zymar. Inspire’seye drop for bacterial conjunctivitis has more favorable dosing than currentproducts; think of it as a “Z-pack” for the eye, referring to Pfizer’s brandname for azithromycin, the same active ingredient in Azasite. In addition topersonal selling, the launch employs a typical mix of CME, speaker training andads in pediatric and ophthalmology journals, said Jeff Sampere, Inspire VP ofmarketing and program head for AzaSite. Inspire is considering studying AzaSitefor use in refractive surgery, such as PRK and Lasik, as well as forblephiritis and corneal abrasion. There is already a fair amount of off-labelprescribing for these uses, Sampere said. Inspireforecasts 2008 USsales of between $30 million and $45 million.

The Market

Opthalmologic broad/med spec US sales ($000s) last 5 years
2006 $363,463
2005 $320,763
2004 $315,152
2003 $301,264
2002 $234,170
Source: IMS Health, Oct. 2007

 

Top 5 opthalmologic broad/med spec
  Jan.-July ’07 US sales ($000s) % sales growth over Jan.-July ‘06
VIGAMOX  (Alcon) 130,536 17
ZYMAR(Alcon) 60,142 2
CILOXAN   (Alcon) 6,848 -8
TOBREX    (Alcon) 6,456 0
CIPROFLOXACIN HCL 5,310 8
Source: IMS Health, Oct. 2007

Physician Outlook
AzaSite (azithromycin ophthalmic) is a macrolide antiobioticto treat bacterial conjunctivitis. Like other azithromycin products, AzaSitehas a shortened dosing schedule: twice a day for the first two days, then oncedaily for the next five days. AzaSite takes advantage of topical,sustained-release technology developed by InSite Vision. Fewer doses per dayand a shorter course of treatment are advantages. AzaSite still provides thebroad spectrum of coverage typically required for treatment of bacterialconjunctivitis. No pediatric dose (for patients less than one year old) hasbeen established.


—Sally Davis, senior consultant, GfK Strategic Marketing,Oct. 2007

Also in the Pipeline(according to Adis R&D Insight)

No competitor compounds in phase III or pre-registration, US


Recent MM&MCoverage
Product News

S&RCommunications Group

TheTop 60: S&R Communications Group

Triesence


Pharmacology
AzaSite is an ophthalmic solution formulation of themacrolide antibiotic, azithromycin, for the topical treatment of bacterialconjunctivitis caused by CDC coryneform group G, Haemophilus influenzae,Staphylococcus aureus, Streptococcus mitis group, and Streptococcus pneumoniae.

AzaSite offers an advantage in that it is dosed less frequently thanother products used to treat bacterial conjunctivitis. Like other macrolides,azithromycin exerts its antibacterial effect by binding to the 50S ribosomalsubunits of susceptible bacteria.

AzaSite is indicated for topical ophthalmic use only, and should notbe administered systemically, injected subconjunctivally, or introduceddirectly into the anterior chamber of the eye.

Clinical Trials
The results of a randomized, placebo-controlled, double-blind, multi-centerclinical study indicated that AzaSite was more effective than placebo intreating bacterial conjunctivitis. In this study, 685 patients (aged 1–96years) were dosed twice daily for the first two days, then once daily on days3, 4, and 5. In patients who had a confirmed clinical diagnosis of bacterialconjunctivitis, treatment with AzaSite was superior to treatment with vehicleon days 6–7. Clinical resolution was attained in 63% of patients treated withAzaSite compared to 50% of patients treated with vehicle. The microbiological successrate for the eradication of baseline pathogens was about 88%, compared to 66%of patients treated with vehicle.

A randomized, double-blind study conducted in the US and Latin Americainvolving 743 patients (aged 1–87 years) with presumed bacterial conjunctivitiscompared treatment with AzaSite to treatment with tobramycin 0.3% ophthalmicsolution. Positive bacterial cultures were established for 316 of theenrollees. AzaSite was dosed twice daily for the first 2 days, then once dailyfor the next 3 days. Tobramycin was dosed at four times daily for 5 days. Theresults of this study showed that treatment with AzaSite was equivalent totreatment with tobramycin, with clinical resolution rates of 80% and 78%,respectively.

Adverse Reactions
Eye irritation, super-infection; rare: contact dermatitis,corneal erosion, dysgeusia, dry eye, punctate keratitis, others.


Adults and children
<1yr: not recommended. =1yr: 1 drop in affected eye(s)twice daily (8–12 hrs apart) for 2 days then once daily for the next 5 days.


Precautions
Remove contact lenses during therapy. Pregnancy (Cat.B).Nursing mothers.