SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
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| Item 7.01 | Regulation FD Disclosure. |
On September 9, 2020, during a previously announced conference call and webcast, BioMarin Pharmaceutical Inc. (“BioMarin” or the “Company”) is announcing that the Company received the European Medicines Agency (the “EMA”) Joint Assessment Report (the “Report”) related to the EMA’s ongoing review of the Company’s Marketing Authorisation Application (the “MAA”) for valoctocogene roxaparvovec for severe hemophilia A. The Report requests that the Company submit to the EMA the full 52-week results from the 134 patients in the ongoing Phase 3 study of valoctocogene roxaparvovec with the 6e13 vg/kg dose. The Company expects the last patient will reach 52 weeks of follow-up in November 2020, and BioMarin is working with the EMA to enable a potential submission of the requested data by the end of the first quarter of 2021. As a result of the EMA’s request, the review of the Company’s MAA has reverted from an accelerated assessment to a standard review. BioMarin plans to provide additional information about its expectations regarding the timing of the MAA review after the Company has further interactions with the EMA.
Forward-Looking Statements
This Current Report on Form 8-K contains forward-looking statements, including, but not limited to, statements about the timing of BioMarin’s clinical development and regulatory review of valoctocogene roxaparvovec, including (i) the Company’s expectation that it will have full 52-week results from the 134 patients in the ongoing Phase 3 study of valoctocogene roxaparvovec with the 6e13 vg/kg dose in November 2020, (ii) the Company’s expectation that it will submit the full 52-week results from such trial to the EMA by the end of the first quarter of 2021, and (iii) the Company’s plans to provide additional information about its expectations regarding the timing of the MAA review.
These forward-looking statements are predictions and involve risks and uncertainties such that actual results may differ materially from these statements. These risks and uncertainties include, among others: results and timing of the ongoing Phase 3 study of valoctocogene roxaparvovec with the 6e13 vg/kg dose, as well as the potential impact of the COVID-19 pandemic on (i) BioMarin’s ability to continue such clinical trial and (ii) the timing of such clinical trial, and the release of data from such trial; the content and timing of decisions by the EMA concerning the Company’s MAA for valoctocogene roxaparvovec, including the potential impact of the COVID-19 pandemic on the EMA’s abilities to issue such decisions and the timing of such decisions; and those factors detailed in BioMarin’s filings with the Securities and Exchange Commission, including, without limitation, the factors contained under the caption “Risk Factors” in BioMarin’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2020 as such factors may be updated by any subsequent reports. Stockholders are urged not to place undue reliance on forward-looking statements, which speak only as of the date hereof. BioMarin is under no obligation, and expressly disclaims any obligation to update or alter any forward-looking statement, whether as a result of new information, future events or otherwise.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
| BioMarin Pharmaceutical Inc., a Delaware corporation | ||||
| Date: September 9, 2020 | By: | /s/ G. Eric Davis | ||
| G. Eric Davis | ||||
| Executive Vice President, General Counsel | ||||