AllianceRx Walgreens Prime named exclusive distributor for HRA Pharma Rare Diseases FDA approved prescription drugs Lysodren® and Metopirone® in the United States

AllianceRx Walgreens Prime named exclusive distributor for HRA Pharma Rare Diseases

FDA approved prescription drugs Lysodren® and Metopirone® in the United States

Orlando, FL, Morristown, NJ and Chatillon France – Nov. 1, 2020 – HRA Pharma Rare Diseases has named AllianceRx Walgreens Prime – one of the largest specialty and home delivery pharmacies in the United States as the exclusive specialty pharmacy and clinical support provider for two of its rare disease drugs, Lysodren® and Metopirone®. As a result of this agreement, each medication is now available through AllianceRx Walgreens Prime and select Walgreens community-based local specialty pharmacies.

Lysodren® (mitotane) is the only FDA approved drug to treat inoperable, functional or non-functional adrenocortical carcinoma, a rare cancer of the adrenal glands. Metopirone® (metyrapone) is used as a diagnostic test for adrenocorticotropic hormone (ACTH) insufficiency and in the diagnosis of ACTH-dependent Cushing’s syndrome. ACTH is a hormone produced in the pituitary gland in the brain.

“We are very excited to be the exclusive pharmacy to dispense these medicines,” says Tracey James, senior vice president of pharmacy services at AllianceRx Walgreens Prime. “HRA Pharma Rare Diseases recognizes that leveraging our extensive network means more patients with these rare conditions will have access to these essential medicines. Combined with our ability to offer support throughout their treatment, HRA Pharma Rare Diseases and AllianceRx Walgreens Prime share the same goal of providing the best possible outcomes for these patients.”

Evelina Paberze, Chief Operating Officer of HRA Pharma Rare Diseases, says, “At HRA Pharma Rare Diseases, we are dedicated to giving our patients improved access to essential treatments. The decision to make AllianceRx Walgreens Prime our exclusive specialty pharmacy and clinical support provider means that our rare disease patients in the US will get improved access to Lysodren® and Metopirone®”

David Wright, CEO of HRA Pharma, says, “At HRA Pharma we constantly strive to provide accessible and affordable solutions to our patients. I believe making AllianceRx Walgreens the exclusive pharmacy of our Rare Diseases affiliate is a step in the right direction to achieving this goal.”

About AllianceRx Walgreens Prime

AllianceRx Walgreens Prime (alliancerxwp.com) is a specialty and home delivery pharmacy that strives to provide exceptional care throughout a patient’s treatment journey with the medications they need every day. Formed in 2017 through a collaboration between Walgreens, one of the nation’s largest chain drug stores, and Prime Therapeutics, a leading pharmacy benefit manager, the company offers tools and resources for patients, providers and health plans to deliver the optimal health outcomes. The company is headquartered in Orlando, Fla. and its pharmacies are accredited by several national pharmacy accreditation services.

About HRA Pharma Rare Diseases

Established in July 2019, HRA Pharma Rare Diseases was created as a result of HRA Pharma’s heritage in rare diseases and its close partnerships with the community. HRA Pharma Rare Diseases is dedicated to bringing the best care and services to patients and is committed to supporting healthcare professionals all over the world. The company has a personal commitment in tackling current challenges, reducing the time to accurate diagnosis, enabling global access to treatment and optimizing long-term management. HRA Pharma Rare Diseases has a portfolio of medicines that diagnose and treat rare diseases. Now well established in Europe and the USA, the company continues to grow, with future plans to expand its geographical reach worldwide.

www.hra-pharma-rare-diseases.com

About METOPIRONE®

Indication and Important Safety Information

METOPIRONE® is a diagnostic drug for testing hypothalamic-pituitary ACTH function.

METOPIRONE® is contraindicated in patients with adrenal cortical insufficiency, or hypersensitivity to METOPIRONE® or to any of its excipients. Ability of adrenals to respond to exogenous ACTH should be demonstrated before METOPIRONE® is employed as a test. In the presence of hypo- or hyperthyroidism, response to the Metopirone® test may be subnormal.

Since METOPIRONE® may cause dizziness and sedation, patients should exercise caution when driving or operating machinery.

The following adverse reactions have been observed after use of METOPIRONE®: Hypotension, nausea, vomiting, abdominal discomfort or pain, headache, dizziness, sedation, allergic rash, and rarely, decreased white blood cell count or bone marrow depression.

See Full Prescribing Information for METOPIRONE® (metyrapone) capsules.

To report SUSPECTED ADVERSE REACTIONS, contact Direct Success Pharmacy, Inc. at 1-855-M-Pirone (1-855-674-7663) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

About LYSODREN®

Indication and Important Safety Information

LYSODREN® is an adrenal cytotoxic agent indicated for the treatment of inoperable, functional or nonfunctional, adrenal cortical carcinoma.

Warning/Adrenal crisis in the setting of shock or severe trauma: In patients taking LYSODREN®, adrenal crisis occurs in the setting of shock or severe trauma and response to shock is impaired. Administer hydrocortisone, monitor for escalating signs of shock and discontinue LYSODREN® until recovery.

CNS Toxicity: CNS toxicity, including sedation, lethargy, and vertigo, occurs with LYSODREN® treatment. Mitotane plasma concentrations exceeding 20 mcg/mL are associated with a greater incidence of toxicity.

Adrenal Insufficiency: Treatment with LYSODREN® can cause adrenal insufficiency. Institute steroid replacement as clinically indicated. Measure free cortisol and corticotropin (ACTH) levels to achieve optimal steroid replacement.

Embryo-Fetal Toxicity: LYSODREN® can cause fetal harm when administered to a pregnant woman. Abnormal pregnancy outcomes, such as preterm births and early pregnancy loss, can occur in patients exposed to mitotane during pregnancy. Advise females of reproductive potential to use effective contraception during treatment with LYSODREN® and after discontinuation of treatment for as long as mitotane plasma levels are detectable.

Ovarian Macrocysts in Premenopausal Women: Ovarian macrocysts, often bilateral and multiple, have been reported in premenopausal patients receiving LYSODREN®. Complications from these cysts, including adnexal torsion and hemorrhagic cyst rupture, have been reported. In some cases, improvement after mitotane discontinuation has been described.

Lactation: Mitotane is excreted in human milk; however, the effect of LYSODREN® on the breastfed infant, or effect on milk production is unknown. Because of the potential for serious adverse reactions in the breastfed infant, advise nursing women that breastfeeding is not recommended during treatment with LYSODREN® and after discontinuation of treatment for as long as mitotane plasma levels are detectable.

Hepatic Impairment: Administer LYSODREN® with caution to patients with hepatic impairment.

Common adverse reactions (≥ 15%) include: anorexia, nausea, vomiting and diarrhea; depression, dizziness or vertigo; and rash. LYSODREN® is a cytotoxic drug. Follow applicable special handling and disposal procedures. See Full Prescribing Information, including BOXED WARNING, for LYSODREN® (mitotane) tablets. To report SUSPECTED ADVERSE REACTIONS, contact Direct Success Pharmacy, Inc. at 1-844-LYSODREN (1-844-597-6373) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

For more information on HRA Pharma Rare Diseases Products in the United States, visit www.lysodren.com or www.metopirone.us.