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Mallinckrodt to Pay $35M for Controlled Substances Probe


Mallinckrodt plc MNK recently finalized the agreement which it had reached with the U.S. Drug Enforcement Administration (DEA) and the U.S. Attorneys' Offices (USAOs) for the Eastern District of Michigan and the Northern District of New York.

The agreement will settle the previously disclosed investigations relating to the company's suspicious order monitoring program, reporting, record keeping and security measures related to manufacturing and distribution of controlled substances.

We remind investors that the company received subpoenas from the DEA requesting production of documents relating to its suspicious order monitoring program for controlled substances in Nov 2011 and Oct 2012. The USAO was investigating the possibility of Mallinckrodt failing to report suspicious orders of controlled substances during 2006-2011 in violation of the Controlled Substances Act and its related regulations. The USAO was also investigating whether the company failed to maintain appropriate records and security measures with respect to manufacturing of certain controlled substances at its Hobart facility during 2012-2013.

As part of the settlement, Mallinckrodt will pay $35 million to resolve all potential claims. This, however, will not impact the company’s financials.

Mallinckrodt is currently focused on reshaping its product portfolio through strategic acquisitions and non-core asset divestitures. The company sold its Nuclear Imaging business due to persistent challenging conditions. The company also sold its Intrathecal Therapy business to focus on its key areas. The generic segment continues to face weakness as various product categories are witnessing stiff competition, which is hurting both their volumes and prices. Weakness in shares persists as the company’s shares have lost 13.6% year to date compared with the Zacks categorized Medical – Generics Drugs industry’s decline of 2.5%.

Earlier, Endo International plc ENDP announced that it will withdraw opioid pain medication Opana ER (oxymorphone hydrochloride extended release) from the market following FDA’s request in June over reported misuse. In March, the FDA Drug Safety Risk Management and Anesthetic and Analgesic Drug Products Advisory Committees voted in the ratio of 18 to 8 and consented that reformulated Opana ER did not outweigh public health risks. The FDA asked the Advisory Committees to discuss the pre- and post-marketing data about the abuse of Opana ER as well as the product's overall risk-benefit profile. The abuse of generic oxymorphone ER and oxymorphone immediate-release (IR) products were to be evaluated as well. Few members stated that the benefits are now overshadowed by the continuing public health concerns around the product's misuse, abuse and diversion.

Zacks Rank and Stocks to Consider

Mallinckrodt currently carries a Zacks Rank #4 (Sell). A couple of better-ranked stocks in the sector are Enzo Biochem, Inc. ENZ and AstraZeneca plc AZN. Both stocks sport a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Shares of AstraZeneca have rallied 21.6% so far this year. Also, its earnings estimates for 2017 moved up 0.5%, while the same for 2018 climbed 3.3% in the last 60 days. Its earnings performance has been pretty impressive as well, with consistent positive surprises. The company’s average earnings beat for the last four quarters is 142.6%.

Enzo Biochem’s loss per share estimates narrowed from 12 cents to 7 cents for 2017 and from 11 cents to 3 cents for 2018, over the last 30 days. The company delivered positive earnings surprises in all of the trailing four quarters, with an average beat of 55.83%. The share price of the company has increased 61.1% year to date.

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