Product
Makena
Approval Date
February 4, 2011
Release Date
March 2011
Company
Hologic/K-V Pharmaceutical/Ther-Rx Corp.
Class
Hormone (progestin)
Indication
To reduce the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth
Active Ingredient
Hydroxyprogesterone caproate injection
Agency Roster
AbelsonTaylor (professional)
GolinHarris (PR)
Marketing Strategy/Execution
Now that women prone to pre-term labor have an FDA-approved treatment, marketing will seek to educate HCPs and Makena-eligible moms. K-V Pharmaceutical’s branded drug subsidiary Ther-Rx, which is promoting the drug to certain obstetricians using 150 reps, estimates the number of patients at about 140,000. Makena will cost $1,500 per weekly injection, with patients averaging anywhere from 15-20 injections. Given that preterm birth can be costly to a health plan, the firm anticipates little resistance among commercial and government payers. Makena is indicated in a certain subset of women—those who have a history of delivering prematurely (prior to 37 weeks gestation) and who are currently carrying one baby. While Makena reduced the proportion of women who delivered preterm (to 37% vs. 55% among those who did not get the drug), any effects on neonatal mortality and morbidity have not been shown. Marketing channels used during launch will reflect Makena’s orphan drug designation, Ther-Rx said. A specialty distribution network has been developed to facilitate access, called Makena Care Connection. K-V bought global marketing rights to Makena, formerly called Gestiva, from Hologic for a total price of $199.5 million.
Also in the Pipeline (courtesy of Adis R&D Insight)
Drug: Prochieve 4%
Manufacturer:Watson Pharmaceuticals
Indication: Preterm labor (Prevention)
Active ingredient: Progesterone gel
Phase: III
Source: Wolters Kluwer Pharma Solutions
Pharmacology
Detailed clinical information withheld for review by MPR’s clinical advisory board and will be added as soon as it becomes available.
Clinical Trials
Detailed clinical information withheld for review by MPR’s clinical advisory board and will be added as soon as it becomes available.
Adverse Reactions
Detailed clinical information withheld for review by MPR’s clinical advisory board and will be added as soon as it becomes available.
Adults
Detailed clinical information withheld for review by MPR’s clinical advisory board and will be added as soon as it becomes available.
Children
Detailed clinical information withheld for review by MPR’s clinical advisory board and will be added as soon as it becomes available.
Precautions
Detailed clinical information withheld for review by MPR’s clinical advisory board and will be added as soon as it becomes available.
Interactions
Detailed clinical information withheld for review by MPR’s clinical advisory board and will be added as soon as it becomes available.
