GW PHARMACEUTICALS PLC (NASDAQ:GWPH) Files An 8-K Entry into a Material Definitive Agreement
Item 1.01.
On March 15, 2019, GW Research Ltd., the principal research subsidiary of GW Pharmaceuticals plc (the “Company”), entered into a definitive agreement to sell its Rare Pediatric Disease Priority Review Voucher (“PRV”) for $105,000,000 to Biohaven Pharmaceutical Holding Ltd. (the “PRV Transfer Agreement”). The Company was awarded the voucher under a U.S. Food and Drug Administration (“FDA”) program intended to encourage the development of treatments for rare pediatric diseases. GW Research Ltd. received the PRV when EPIDIOLEX® (cannabidiol) was approved by the FDA for the treatment of seizures associated with Lennox-Gastaut Syndrome or Dravet syndrome, two rare, severe childhood-onset epilepsies.
The PRV Transfer Agreement contains customary representations, warranties, covenants, and indemnification provisions subject to certain limitations. The transaction remains subject to customary closing conditions, including anti-trust review.
The foregoing summary of the material terms of the PRV Transfer Agreement does not purport to be complete and is qualified in its entirety by the full text of the PRV Transfer Agreement, a copy of which will be filed as an exhibit to the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2019.
| Item 2.01 | Completion of Acquisition or Disposition of Assets. |
The disclosure regarding the PRV Transfer Agreement contained Item 1.01 of this Current Report on Form8-K is incorporated by reference into this Item 2.01.
On March 18, 2019, the Company issued a press release announcing the sale of the PRV. A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference herein.
The information contained in Item 8.01 of this Form 8-K, including Exhibit 99.1 furnished herewith, shall not be deemed “filed” for the purpose of Section 18 of the Securities Exchange Act of 1934, as amended, or the Exchange Act, or otherwise subject to the liability of that section, nor shall it be deemed incorporated by reference in any of the Company’s filings under the Securities Act of 1933, as amended, whether made before or after the date hereof, except as expressly set forth by specific reference in such a filing.
| Item 9.01. | Financial Statements and Exhibits. |
(d) Exhibits
GW PHARMACEUTICALS PLC Exhibit
EX-99.1 2 tv516479_ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 GW Pharmaceuticals plc Announces the Sale of Priority Review Voucher for $105M Carlsbad,…
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About GW PHARMACEUTICALS PLC (NASDAQ:GWPH)
GW Pharmaceuticals plc is involved in the development of cannabinoid prescription medicines using botanical extracts derived from the Cannabis Sativa plant. The Company develops a portfolio of cannabinoid medicines, including Epidiolex, which is an oral medicine for the treatment of refractory childhood epilepsies. The Company operates through three segments: Commercial, Sativex Research and Development (Sativex R&D), and Pipeline Research and Development. The Commercial segment distributes and sells the Company’s commercial products. The Sativex R&D segment seeks to maximize the potential of Sativex through the development of indications. The Sativex R&D segment focuses on the Phase III clinical development program of Sativex for use in the treatment of cancer pain. The Pipeline Research and Development segment seeks to develop cannabinoid medications other than Sativex across a range of therapeutic areas using the Company’s cannabinoid technology platform.
