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TICKERS: MNKPF

FDA Grants Approval for Drug Improving Kidney Function
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Shares of Mallinckrodt Plc. traded 28% higher yesterday after the company reported that the U.S. FDA has issued approval for its Terlivaz® (terlipressin) for injection for use in treating hepatorenal syndrome, a serious and life-threatening condition that is accompanied by rapid reduction in kidney function.

Global specialty pharmaceutical firm Mallinckrodt Plc. (MNKPF:OTC), which makes investments in and develops specialty therapeutics for use in treating autoimmune and rare diseases in the areas of nephrology, neurology, rheumatology, ophthalmology, pulmonology, and several additional areas, Wednesday announced that "the U.S. Food and Drug Administration (FDA) approved Terlivaz® (terlipressin) for injection."

The company stated that Terlivaz is currently the only medicine to receive approval from the FDA for use in treating hepatorenal syndrome (HRS) with rapid reduction in kidney function. The firm noted that HRS is an acute, life-threatening condition that requires immediate medical attention and admission to a hospital. The company advised that it expects that Terlivaz will be available in the U.S. in the coming weeks.

Mallinckrodt's Siggi Olafsson, President and CEO Siggi Olafsson commented, "The FDA approval of Terlivaz is a significant milestone for Mallinckrodt as it brings an important treatment option to these critically ill patients requiring hospitalization and to U.S. physicians who historically have had limited treatment interventions."

"We're excited to bring Terlivaz to U.S. patients and physicians and plan to launch the product in the coming weeks," Olafsson added.

The company advised that Terlipressin has been widely studied and has been approved by medical regulatory agencies outside of the U.S. for over 30 years.

The firm indicated that the FDA issued its approval in part based on the data obtained in the Phase 3 CONFIRM trial. The CONFIRM study enrolled a total of 300 HRS type 1 (HRS-1) patient subjects in the U.S. and Canada. The study was designed to evaluate the safety and efficacy of terlipressin and was successful in meeting its primary endpoint, which was identified as verified HRS reversal. The company listed that in the trial verified HRS reversal was defined as "renal function improvement, avoidance of dialysis and short-term survival."

The company's EVP and Chief Scientific Officer Steven Romano, M.D., remarked, "Diagnosing and treating HRS can be challenging, and every minute counts when managing patients who have it. Terlivaz gives U.S. physicians the first FDA-approved option for treating HRS patients with rapid reduction in kidney function that may help them improve kidney function and lessen the associated need for renal replacement therapy, such as dialysis."

The company explained that "HRS involving rapid reduction in kidney function is an acute and life-threatening condition that occurs in people with advanced liver disease." The condition affects 30,000-40,000 people in the U.S. each year. There are two distinct types of HRS, acute and chronic, which are both serious conditions. The company added that "if left untreated, HRS with rapid reduction in kidney function has a median survival time of approximately two weeks and greater than 80 percent mortality within three months."

Mallinckrodt is a specialty pharmaceutical company headquartered in Dublin, Ireland. The firm is engaged in investing in, developing, and commercializing medical treatments for autoimmune and rare diseases.

Mallinckrodt Plc. began yesterday with a market cap of around US$1.19 billion, with approximately 84.78 million shares outstanding. MNKPF shares opened nearly 11% higher yesterday at US$15.50 (+US$1.50, +10.71%) over the previous day's US$14.00 closing price. The stock traded yesterday between US$15.50 and US$18.00 per share and closed for trading at US$17.95 (+US$3.95, +28.21%). It is currently trading at US$17.95.


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