Product
Rotarix
Approval Date
April 3rd, 2008
Release Date
Second Half of 2008
Company
GlaxoSmithKline
Indication
Rotavirus Gastroenteritis
Active Ingredient
Live attenuated human rotavirus RIX4414 strain
Marketing Strategy/Execution
Rotarix is late to a market dominated by another, but theGlaxoSmithKline vaccine for preventing the rotavirus in infants may have a legup. Rotarix requires two doses, enabling the oral regimen to be completed bythe fourth month after birth. Merck’s rival vaccine RotaTeq, on the marketsince 2006, requires three, with the final dose not given until the sixthmonth. Fewer trips to the doctor’s office could make Rotarix more convenient.GSK aims to launch in time for the fall rotavirus season, and managed carecoverage could ramp up this summer after a Centers for Disease Control andPrevention vaccine panel reviews the product. By way of comparison, RotaTeq had2007 sales of $525 million, making it Merck’s second-best selling vaccine.
The Market
| Rotavirus (Rotateq) US sales ($000s) last 5 years | |
| 2007 | $369,787 |
| 2006 | $98,124 |
| 2005 | ***** |
| 2004 | ***** |
| 2003 | ***** |
| Source: IMS Health, Apr. 2008 |
|
Also in the Pipeline(courtesy of Adis R&D Insight)
No competitor compounds in phase III or pre-registration, US
Recent MM&MCoverage
Product News
Adverse Reactions
Fussiness/irritability, cough/runny nose, fever, loss of appetite, vomiting, diarrhea, dehydration, pneumonia; rare: Kawasaki disease.
Adults
Not applicable.
Children
<6 weeks or >24 weeks of age: not recommended. Each oral dose is 1mL. Give 1st dose beginning at 6 weeks of age, 2nd dose at least 4 weeks later; complete 2-dose series by 24th week of age. May give a replacement dose at same vaccination visit if dosing is incomplete or regurgitated.
Contraindications
Uncorrected congenital GI tract malformation (eg, Meckel’s diverticulum) (increased risk of intussusception).
Precautions
Acute diarrhea or vomiting (delay immunization). Chronic GI disorders. Immunodeficiency or immunosuppressed close contacts (live virus shedding may allow transmission to others). Latex allergy. Pregnancy (Cat.C): not applicable.
Interactions
May give with concomitant vaccines (eg, DTaP, Hep B, Inactivated Poliovirus Vaccine Combined, Hib conjugate). Immunosuppressants (eg, irradiation, chemotherapy, high-dose steroids): may get suboptimal response.
