Updates on the regulatory front are eagerly awaited by investors in the pharma/biotech sector as they impact the share price of the concerned company. Regulatory updates include events like filing of investigational new drug applications and marketing applications, acceptance of these applications for review by the regulatory agencies, reviews by advisory panels and, finally, a response from the regulatory agency regarding the approval status.
Late last week, Pfizer Inc. ( PFE ) received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) for its label expansion efforts for pneumonia vaccine, Prevenar 13 (U.S. trade name: Prevnar 13). The company is looking to get Prevenar 13 approved in the EU for the prevention of pneumonia caused by the 13 pneumococcal serotypes in the vaccine in adults aged 18 years and older.
Prevenar 13 is already approved in Europe for the prevention of invasive pneumococcal disease in the same patient population.
The CHMP opinion was based on the results from the Community-Acquired Pneumonia Immunization Trial in Adults (CAPiTA). The favorable opinion of the CHMP will be reviewed by the European Commission with a final decision expected in the next couple of months. With the CHMP issuing a positive opinion, chances of gaining EU approval look high.
We note that Prevenar 13 is currently approved in the EU for use in infants, older children and adolescents (6 to 17 years old) and adults (≥50 years of age and between 18 to 49 years of age).
We are pleased with Pfizer's label expansion efforts. Approval would further increase the drug's sales potential. Pfizer reported global Prevnar family sales of $3.2 billion in the first nine months of 2014, up 10.8% from the year-ago period.
Pfizer is also working to boost its vaccines pipeline. Earlier in the month, Pfizer acquired a controlling interest in Redvax Gmbh, a spin-off from Swiss biopharma company Redbiotec AG. In addition to this, Pfizer acquired Baxter International's Inc. ( BAX ) portfolio of marketed vaccines last year.
Meanwhile, Pfizer is set to report fourth quarter 2014 financial results on Jan 27, 2015.
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