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Biohaven's Nurtec (riluzole) 505(b)2 Application for Amyotrophic Lateral Sclerosis Affected by Issues Related to Apotex Plant: Complete Response Letter (CRL) Received From FDA Related to Isolated Drug Substance Supply Used in Bioequivalence Study

- Biohaven is already engaged with the FDA regarding next steps for a timely resolution of this matter and has submitted additional information to the Agency.

-FDA cited issues with the active pharmaceutical ingredient (API) used in the Biohaven 2017 bioequivalence study that was manufactured between 2014 and 2016 in an Apotex facility.

-Biohaven notes that the API for its commercial supply of Nurtec is sourced from another supplier, with whom there are no current issues.

-Biohaven has not used Apotex material in any of its other development programs. FDA did not cite any other concerns in their CRL.

NEW HAVEN, Conn., July 19, 2019 /PRNewswire/ -- Biohaven Pharmaceutical Holding Company Ltd. (BHVN), a clinical-stage biopharmaceutical company with a portfolio of innovative, late-stage product candidates targeting neurological and neuropsychiatric diseases, today announced that it has received a Complete Response Letter (CRL) from the FDA for the 505(b)2 application seeking approval for NURTEC™ (riluzole) for ALS.

Biohaven Pharmaceuticals Logo (PRNewsfoto/Biohaven Pharmaceutical Holding)

The sole issue identified in the CRL relates to an FDA concern regarding the use of an active pharmaceutical ingredient (API) that was manufactured by Apotex Pharmachem India Private Limited ("Apotex") between 2014 to 2016 and used in the drug product supplies for the bioequivalence study in 2017.  Of note, concerns with Apotex manufacturing recently led to the withdrawal of 31 Apotex drug products from the US market last Wednesday, July 10th 2019 (https://federalregister.gov/d/2019-14660).  

In the CRL, the FDA stated that it provided recommendations to Apotex regarding the information that would be needed to qualify previous API batches manufactured at Apotex during the time period in question. Apotex did not provide Biohaven with notice of the FDA communication, either during the course of its bioequivalence trial or during the submission of its 505(b)2 application for Nurtec (riluzole). Biohaven has been subsequently informed by the manufacturer that they had an exemption from the FDA to supply riluzole to the U.S. market during that time period. Today, Biohaven has been in contact with the FDA's CMC group and Apotex to resolve the matter and Biohaven has already submitted additional information to the FDA regarding this issue.

Biohaven notes that the API for commercial supply of Nurtec (riluzole) is currently sourced from another supplier, with whom no CMC issues have been identified.  Further, the FDA did not cite any other concerns in their CRL regarding Nurtec (riluzole).  Biohaven will be working with the FDA to develop a timely path forward. While timelines are developed to resolve this matter, Biohaven will re-deploy the associated funds for Nurtec (riluzole) commercialization to other commercial needs of the organization.

Robert Berman, M.D., Biohaven CMO and Nurtec (riluzole) Development Lead, commented, "We are doing everything possible to work with the FDA and the API manufacturer to resolve this matter, which we believe to be more technical in nature.  We believe that the quality issues surrounding the Apotex manufacturing facility do not affect the conclusions of our bioequivalence study, but will work collaboratively with the FDA to resolve this matter as quickly as possible." 

John Tilton, Chief Commercial Officer for Rare and Orphan Disease, added, "Biohaven would like to thank the ALS community, including people and caregivers living with ALS, for their participation in our BHV-0223 clinical trials and early access program." Mr. Tilton continued, "Biohaven remains committed to addressing the unmet needs of patients with ALS on multiple fronts including other novel pipeline assets that we will consider pursuing in ALS."

About Nurtec (riluzole)

Nurtec (riluzole) (BHV-0223) is a sublingually administered tablet. While riluzole is FDA-approved for ALS, existing formulations consist only of an oral tablet taken with water or an oral suspension (thickened liquid). Nurtec (riluzole) is designed to be placed under the tongue where it dissolves in seconds and is absorbed by the vasculature, thereby eliminating the need for swallowing.

NURTEC is a trademark of Biohaven Pharmaceutical Holding Company Ltd.

About Biohaven

Biohaven is a clinical-stage biopharmaceutical company with a portfolio of innovative, late-stage product candidates targeting neurological diseases, including rare disorders. Biohaven has combined internal development and research with intellectual property licensed from companies and institutions including Bristol-Myers Squibb Company, AstraZeneca AB, Yale University, Catalent, ALS Biopharma LLC and Massachusetts General Hospital. Currently, Biohaven's lead development programs include multiple compounds across its CGRP receptor antagonist, glutamate modulation and myeloperoxidase inhibition platforms. More information about Biohaven is available at www.biohavenpharma.com.

Forward-Looking Statements

This news release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements involve substantial risks and uncertainties, including statements that are based on the current expectations and assumptions of the Company's management. All statements, other than statements of historical facts, included in this press release regarding the Company's business and product candidate plans and objectives are forward-looking statements. Forward-looking statements include those related to: the effectiveness and safety of Nurtec (riluzole), the expected timing, commencement and outcomes of the Company's planned and ongoing clinical trials, the timeline for receiving FDA approval for Nurtec (riluzole), the timing of planned interactions and filings with the FDA, the timing and outcome of expected regulatory filings, the potential commercialization of the Company's product candidates and the potential for the Company's product candidates to be first-in-class or best-in-class therapies. The use of certain words, including "believe," "continue," "may," "on track," "expects," "will," and similar expressions, are intended to identify forward-looking statements. Various important factors could cause actual results or events to differ materially from those that may be expressed or implied by our forward-looking statements. Additional important factors to be considered in connection with forward-looking statements are described in the "Risk Factors" section of the Company's Annual Report on Form 10-K filed with the Securities and Exchange Commission on February 28, 2019 and the Company's Quarterly Report on Form 10-Q for the quarter ended March 31, 2019, filed with the Securities and Exchange Commission on May 8, 2019. The forward-looking statements are made as of this date and the Company does not undertake any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

For further information, contact:
Dr. Vlad Coric,
Chief Executive Officer,
Vlad.Coric@biohavenpharma.com

Cision

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