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Mallinckrodt's Roxicodone Reformulation Gets CRL From FDA

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Mallinckrodt plc’s (MNK - Free Report) subsidiary, SpecGx LLC reported that the FDA has issued a complete response letter (“CRL”) for its new drug application (“NDA”) seeking approval of opioid analgesic candidate, MNK-812. The candidate is an abuse-deterrent, immediate-release reformulation of commonly abused opioid painkiller, Roxicodone (oxycodone hydrochloride tablets USP).

The NDA sought approval of MNK-812 for management of pain severe enough to be treated with an opioid analgesic and where alternative treatments have inadequate effect. The company had been developing the reformulation with properties designed to deter intravenous and intranasal abuse under its 505(b)2 NDA.

However, last month, the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee voted in favor of the candidate.

Mallinckrodt’s stock has lost 7.6% in the year so far compared with the industry’s decline of 16.1%.

The letter provides guidance on areas of further evaluation for resubmitting the NDA. The letter from the FDA was unexpected, following the positive outcome at the Advisory Committee meeting held in November. The company is evaluating the agency's guidance and will request a meeting with the FDA in the coming weeks to discuss the path forward.

The news comes as a setback for the company. Acthar, Mallinckrodt’s largest product, is being negatively impacted by the residual impact of the previously reported patient withdrawal issues. Two CRLs – for MNK-812 and stannsoporfin – have also impacted the company’s future prospects unfavorably.

Meanwhile, Mallinckrodt is focused on streamlining its business to focus better on its innovative medicines and therapies. Earlier this month, it announced its intention to spin-off its Specialty Generics/Active Pharmaceutical Ingredients business and Amitiza into a new company.

The company expects to create two independent and publicly-traded companies — one focused on innovative specialty pharmaceutical brands and the other primarily on niche specialty generic products and API manufacturing. The spin-off is expected to be completed by the second half of 2019.

Zacks Rank & Stocks to Consider

Mallinckrodt currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks in the same space are Bristol-Myers Squibb Co. (BMY - Free Report) , Johnson & Johnson (JNJ - Free Report) and Merck & Co. Inc. (MRK - Free Report) . While Bristol-Myers sports a Zacks Rank #1 (Strong Buy), J&J and Merck carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Bristol-Myers’ earnings per share estimates have increased from $3.64 to $3.87 for 2018 and from $3.94 to $4.08 for 2019 over the past 60 days.

J&J’s earnings per share estimates have increased from $8.14 to $8.16 for 2018 and from $8.62 to $8.66 for 2019 over the past 60 days.

Merck’s earnings per share estimates have increased from $4.28 to $4.34 for 2018 and from $4.66 to $4.71 for 2019 over the past 60 days.

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