Mallinckrodt plc (MNK - Free Report) subsidiary, SpecGx LLC, reported the outcome of an FDA joint advisory committee meeting on MNK-812, an abuse-deterrent, immediate-release reformulation of Roxicodone (oxycodone hydrochloride tablets USP).
We note that SpecGx is advancing this reformulation with properties designed to deter intravenous and intranasal abuse under the company's 505(b)2 new drug application for MNK-812.
In a joint meeting, the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee voted in the ratio of 10 to 7 to approve the SpecGx’s experimental abuse-deterrent formulation of immediate-release, single-entity oxycodone tablets for the management of pain severe enough to require an opioid analgesic, and for which alternative treatments are inadequate.
Both the committees also voted in the ratio of 12 to 5 for the drug to be labeled as an abuse-deterrent product by the nasal route of abuse. The committees also voted in 10 to 7 ratio for the drug to be not labeled as an abuse deterrent product by the intravenous route of abuse.
Although the FDA takes the recommendation of the committees in consideration, it is not bound by it.
A tentative approval will boost Mallinckrodt’s diverse portfolio.
Mallinckrodt recently reported strong third-quarter results, beating on both sales and earnings estimates. The hospital franchise (Inomax and Ofirmev) has gained traction, which is positively impacting sales. The company also raised its annual guidance. However, Acthar, Mallinckrodt’s largest product, is being negatively impacted by the residual impact of the previously reported patient withdrawal issues.
Mallinckrodt’s stock has gained 37% in the year so far, against the industry’s decline of 6.8%.
The company has streamlined its business to focus better on its innovative medicines and therapies. The Sucampo buyout will diversify the company’s portfolio, considering Amitiza’s potential.
Zacks Rank & Key Picks
Mallinckrodt carries a Zacks Rank #3 (Hold).
Some top-ranked stocks worth considering are Bristol-Myers Squibb Co. (BMY - Free Report) , Eli Lilly and Co. (LLY - Free Report) and Merck & Co. Inc. (MRK - Free Report) . While Bristol-Myers sports a Zacks Rank #1 (Strong Buy), Lilly 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 $3.62 to $3.84 for 2018 and from $3.82 to $4.07 for 2019 over the past 60 days. The company delivered a positive earnings surprise in all of the trailing four quarters with average of 11.99%.
Lilly’s earnings per share estimates have increased from $5.47 to $5.53 for 2018 and from $5.73 to $5.80 for 2019 over the past 60 days. The company delivered a positive earnings surprise in all of the trailing four quarters with average of 10.03%.
Merck’s earnings per share estimates have increased from $4.27 to $4.34 for 2018 and from $4.62 to $4.71 for 2019 over the past 60 days. The company delivered a positive earnings surprise in all of the trailing four quarters with average of 3.96%.
Wall Street’s Next Amazon
Zacks EVP Kevin Matras believes this familiar stock has only just begun its climb to become one of the greatest investments of all time. It’s a once-in-a-generation opportunity to invest in pure genius.
Click for details >>