Bulletin: Alkermes PLC Ratings Unaffected By FDA Refusal-To-File Letter

NEW YORK (S&P Global Ratings) April 3, 2018--S&P Global Ratings said today that its ratings and outlook on Alkermes PLC (BB-/Stable/--) are not affected by the pharmaceutical company's announcement that it has received a Refusal to File letter from the U.S. Food and Drug Administration (FDA) regarding the company's New Drug Application (NDA) for ALKS 5461. The FDA stated that it was unable to complete a substantive review of the regulatory package because of insufficient evidence of overall effectiveness for the proposed indication, and that the resubmission of the NDA for ALKS 5461 would require additional clinical trials. We view the news as credit negative, as ALKS 5461 was expected to be a significant near-term launch for Alkermes. However, our

...NEW YORK (S&P Global Ratings) April 3, 2018--S&P Global Ratings said today that its ratings and outlook on Alkermes PLC (##-/Stable/--) are not affected by the pharmaceutical company's announcement that it has received a Refusal to File letter from the U.S. Food and Drug Administration (FDA) regarding the company's New Drug Application (NDA) for ALKS 5461. The FDA stated that it was unable to complete a substantive review of the regulatory package because of insufficient evidence of overall effectiveness for the proposed indication, and that the resubmission of the NDA for ALKS 5461 would require additional clinical trials. We view the news as credit negative, as ALKS 5461 was expected to be a significant near-term launch for Alkermes. However, our ratings and the outlook on the company are unchanged because we expect Alkermes' other key products to continue growing at a double-digit rate, resulting in improved profitability. We project that the company's leverage will improve to a sustainable...

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