Summary
Regeneron Pharmaceuticals, Inc. (REGN) filed an 8-K on February 13, 2012, primarily to disclose information regarding the commercial performance and safety profile of its drug EYLEA® (aflibercept) Injection. The company provided an update on financial and operating results for the quarter and year ended December 31, 2011, though specific details from these results are not within this 8-K itself but rather in an attached press release. The more significant piece of information for investors in this filing pertains to adverse events related to EYLEA, which was launched in November 2011.
Key Highlights
- 1Regeneron announced financial and operating results for the quarter and year ended December 31, 2011, via an attached press release (Exhibit 99.1).
- 2The company provided an update on adverse events reported for EYLEA® (aflibercept) Injection to the FDA.
- 3Approximately 30,000 EYLEA injections had been administered in the U.S. since its commercial launch in November 2011.
- 4A rate of approximately 0.05% per injection was reported for sterile intraocular inflammation.
- 5This rate was largely influenced by a cluster of events at a single practice; excluding this, the rate was approximately 0.01% per injection.
- 6Regeneron concluded that the incidence of these adverse events is within the expected range for intravitreal injections and clinical development, and factors other than the drug product are likely responsible.
- 7The full letter to the FDA regarding these adverse events is furnished as Exhibit 99.2.
Frequently Asked Questions
This 8-K filing announces that Regeneron released its financial and operating results for the quarter and year ended December 31, 2011. The specific details of these results are contained within the press release furnished as Exhibit 99.1, which is not included in the body of the 8-K but is referenced.
Regeneron reported to the FDA that since EYLEA's commercial launch in November 2011, approximately 30,000 injections had been administered in the U.S. Reports of sterile intraocular inflammation occurred at a rate of about 0.05% per injection, driven mainly by a cluster at one practice. Excluding that practice, the rate was about 0.01%. The company stated this incidence is consistent with other anti-VEGF agents and clinical trial data, suggesting external factors, not the drug itself, are likely the cause.
Regeneron indicated that the reported incidence of sterile intraocular inflammation is within the expected range seen with intravitreal injections of similar drugs and during clinical development. The company also noted the lack of association with any single drug lot and its belief that external factors are responsible, which suggests the issue is manageable and not indicative of a widespread drug defect.
More detailed information regarding the financial and operating results for the period ending December 31, 2011, can be found in the press release attached as Exhibit 99.1. The full details of the company's communication with the FDA concerning EYLEA adverse events are available in the letter furnished as Exhibit 99.2.