Upcoming events: Prevnar awaits pneumonia data while serelaxin looks to Europe
Welcome to your weekly digest of approaching regulatory and clinical readouts. Results from Pfizer’s huge Capita trial are expected shortly and will determine whether Prevnar 13 can prevent community-acquired pneumonia in subjects aged 65 and older, an important sales opportunity.
Meanwhile, the first European Medicines Agency human drugs commmittee meeting of 2014 is taking place next week, and could see Novartis’s serelaxin being discussed; if so, this would be the first judgement on the project, whose FDA advisory committee is expected next month. But with mixed clinical results in acute heart failure, approval in either territory is not certain.
Pfizer: Prevnar 13
In the US Prevnar 13 is approved as a vaccine for children between 6 weeks and 17 years of age to prevent invasive disease caused by 13 Streptococcus pneumoniae strains. In adults aged 50 and over it is approved for the prevention of pneumococcal pneumonia and invasive disease. Invasive infections can manifest as bacteraemia and meningitis.
Its approval in adults was based on the surrogate endpoint of immunogenicity. To demonstrate its ability to reduce pneumonia or invasive disease Pfizer conducted the 85,000-patient Capita study.
The readout is important for ex-US markets where Pfizer does not have approval in the adult setting. In its third-quarter conference call the group said Capita results would form the basis for the pneumonia approval application in these countries.
The data are also significant in the US as they will determine whether the US Centers for Disease Control and Prevention’s Advisory Committee for Immunization Practices (ACIP) recommends routine vaccinations for adults over 50. Pfizer has said it will make the data available to the ACIP in time for the committee's June meeting.
Worldwide 2018 sales of Prevnar 13 are forecast to reach $5.8bn, according to EvaluatePharma. Many analysts believe that the Capita outcome will be positive, with Morgan Stanley noting that if they are the sales opportunity could be $2bn.
Prevnar 13, a franchise extension of Pfizer's 7-valent vaccine, is the group's most valuable product. However, sales in the paediatric setting have slowed with a decrease in government purchases cited, leaving the Capita results much needed for growth.
Novartis: Serelaxin (RLX030)
Serelaxin was filed in Europe in December 2012 and could come under scrutiny by the CHMP before it faces an FDA adcom, which is scheduled for February 13. The PDUFA date is expected before the end of that month.
In the US the angiotensin II antagonist is proposed for acute heart failure, an area that lacks treatment options, and was given breakthrough designation. However, questions remain over its approvability given mixed data (Serelaxin continues charmed life with breakthrough designation, June 21, 2013).
It was filed on the results of the Relax-AHF study, a 1,161-patient trial that showed serelaxin to relieve shortness of breath, the most frequent symptom of acute heart failure. However, a reduction in all-cause mortality at 180 days was not reinforced by measures of cardiovascular death or hospital readmission for heart and renal failure.
A second trial called Relax-AHF-2 is recruiting 6,375 patients. The primary endpoint is time to confirmed cardiovascular death during the follow-up period of 180 days. At its investor day last November Novartis said an interim analysis was planned after 60% of events. The first patient entered the study in October and the primary completion date is 2016.
Sales are expected to reach $903m by 2018, according to EvaluatePharma. The project has an NPV of $2.6bn, 1% of the company’s market cap. However, approval based on the first Relax-AHF trial alone is doubtful and a robust mortality claim is needed to drive sales, so the wait for approval could end up being a longer one.