As previously disclosed, on December 12, 2018, the Company completed a merger, whereby Keryx Biopharmaceuticals, Inc. (Keryx) became a wholly
owned subsidiary of the Company (the Merger). At the consummation of the Merger, each issued and outstanding share of common stock of Keryx, $0.001 par value per share, was converted into 0.37433 of a share of common stock of the
Company, $0.00001 par value per share (Common Stock), and cash in lieu of fractional shares. At December 31, 2018, the Company had 116,887,518 shares of Common Stock outstanding.
As previously disclosed, on October 31, 2018 and November 6, 2018, Keryx received Paragraph IV certification notice letters regarding Abbreviated
New Drug Applications (ANDAs) submitted to the U.S. Food and Drug Administration (FDA) by Lupin Atlantis Holdings SA (Lupin) and Teva Pharmaceuticals USA, Inc. (Teva), respectively, requesting approval
for generic versions of Auryxia
®
(ferric citrate) tablets (210 mg iron per tablet). On December 13, 2018, Keryx and its licensors, Panion & BF Biotech, Inc. (Panion)
and Chen Hsing Hsu, M.D., filed a complaint for patent infringement against Lupin and Lupin Ltd. (the Lupin Defendants) in the United States District Court for the District of Delaware (the Delaware Court) arising from
Lupins ANDA filing with the FDA, and on December 19, 2018, Keryx and Panion filed a complaint for patent infringement against Teva and Teva Pharmaceutical Industries Limited (the Teva Defendants) in the Delaware Court arising
from Tevas ANDA filing with the FDA. As a result of the timely filing of these lawsuits in accordance with statute, a
30-month
stay of approval will be imposed by the FDA on Lupins and Tevas
ANDAs, which stays are expected to remain in effect until April 2021 and May 2021, respectively, absent an earlier judgment by the Delaware Court in each of these lawsuits finding the patents at issue invalid, unenforceable or not infringed. The
plaintiffs in each of these lawsuits seek, among other relief, an order that the effective date of FDA approval of the ANDA be a date no earlier than the expiration of each of the patents at issue, equitable relief enjoining the Lupin Defendants and
Teva Defendants from infringing these patents, and monetary relief as a result of any such infringement.
On December 24, 2018, Keryx received a
Paragraph IV certification notice letter regarding an ANDA submitted to the FDA by Chemo Research S.L. (Chemo) requesting approval to market, sell and use a generic version of the Auryxia tablets (210 mg iron per tablet). In its notice
letter, Chemo alleges that Keryxs U.S. Patents Nos. 9,387,191; 5,753,706; 7,767,851; 8,093,423; 8,299,298; 8,338,642; 8,609,896; 8,754,257; 8,754,258; 8,846,976; 8,901,349; 9,050,316; 9,328,133; and 9,757,416 (the Patents), which
cover the approved drug substance, drug product and/or methods of using Auryxia, are invalid, unenforceable and/or will not be infringed by Chemos manufacture, use or sale of the product described in its ANDA. Keryx is currently reviewing
the notice letter and intends to vigorously enforce its intellectual property rights relating to Auryxia. By statute, Keryx has 45 days from receipt of the notice letter to initiate a patent infringement lawsuit against Chemo. Such a lawsuit would
automatically preclude the FDA from approving Chemos ANDA until the earlier of 30 months from December 24, 2018 or entry of a district court decision finding the Patents invalid, unenforceable or not infringed.
Going forward, the Company plans to provide updates on any additional Paragraph IV certification notices that Keryx may receive and about patent litigation
against ANDA filers through the Companys Quarterly Reports on Form
10-Q
and Annual Reports on Form
10-K
filed with the SEC.