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Press Release 01/27/2020

Vyera Responds to U.S. Federal Trade Commission Civil Action Related to Daraprim®

NEW YORK, Jan. 27, 2020 /PRNewswire/ -- Vyera Pharmaceuticals, LLC (Vyera) acknowledges the decision announced today by the U.S. Federal Trade Commission ("FTC") and the New York State Office of the Attorney General ("NYAG") to file a civil action against Vyera, its parent company, and certain former members of its management relating to Daraprim® (pyrimethamine), which is a prescription drug used in combination with sulfonamide for the treatment of toxoplasmosis.

Vyera believes the claims brought by the FTC and the NYAG are without merit and will vigorously defend these claims in court. The FTC and the NYAG allege in their complaint that certain activities undertaken by Vyera with respect to Daraprim constituted anticompetitive conduct that was unlawful. These allegations are unsupported by the facts and overlooks the realities in the marketplace. Robust competition from other products for the treatment of toxoplasmosis already exists and no action taken by Vyera has prevented additional potential competitors from entering the market.

Vyera shares the FTC's and the NYAG's focus on consumers and getting prescription drugs to patients who need them. As such, Vyera has invested, and is continuing to invest, significant time and expense in establishing and maintaining its patient assistance programs and pricing discounts, and in optimizing its distribution system in order to get the drug to patients in an affordable, timely and efficient manner. Additionally, since its acquisition of Daraprim®, Vyera has devoted substantial resources to the development of new therapies and is now successfully growing and diversifying its business under new management. Vyera is deeply disappointed that, despite all of these efforts and its full cooperation with an investigation that has lasted over four years, the FTC and the NYAG have chosen to pursue an action in this case.

About Vyera

Vyera is a United States based biopharmaceutical company committed to developing and commercializing treatments that address serious and rare diseases with high unmet medical needs. Vyera supports programs that offer financial assistance to patients in need and gives discounts to organizations that provide care to underserved populations. Vyera's research and development efforts focus on novel treatment options for toxoplasmosis and other rare or serious health conditions.

Forward Looking Statements

Statements in this press release that are not historical facts, including statements about future prospects of Vyera's business, are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and as that term is defined in the Private Securities Litigation Reform Act of 1995. Vyera intends that such forward-looking statements be subject to the safe harbors created thereby. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that could cause Vyera's actual results to be materially different from its historical results or from any results expressed or implied by said statements. Vyera's actual results may differ materially from those discussed in the forward-looking statements for reasons including, but not limited to, results of clinical trials, regulatory actions and the need for regulatory approvals, Vyera's ability to fund development of its technology and to successfully complete clinical trials, the length of time and costs required to complete clinical trials and to submit applications for regulatory approvals, products developed by competing companies, commercial acceptance of Vyera's products, and other factors. Vyera is not responsible for updating events occurring after the date of this press release.

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