FDA Approves Mallinckrodt's Xartemis XR - Analyst Blog
March 13 2014 - 6:00PM
Zacks
Mallinckrodt plc’s (MNK) extended-release oral
formulation, Xartemis XR (oxycodone HCI and acetaminophen) gained
U.S. Food and Drug Administration (FDA) approval for the management
of acute pain in patients requiring opioid treatment and for whom
alternative therapies are inadequate, ineffective or are not
tolerated.
Meanwhile, Mallinckrodt is conducting additional studies and
working closely with the FDA to generate more data on Xartemis XR.
Although the label does not contain abuse-deterrent language,
Mallinckrodt is looking to provide more data on Xartemis XR’s
abuse-deterrence features.
Xartemis XR is the first and only approved extended-release oral
combination of oxycodone HCI and acetaminophen. The company intends
to launch Xartemis XR in the second quarter of fiscal 2014. We
remind investors that Mallinckrodt recently launched another pain
drug, Pennsaid 2%, for the treatment of osteoarthritis pain of the
knees.
Mallinckrodt is actively focusing on strengthening its pipeline
and promoting new products in the pain market. The company expects
to file for approval of another pain candidate, MNK-155, in the
second half of fiscal 2014.
Meanwhile, Mallinckrodt announced its intention to acquire
Cadence Pharmaceuticals, Inc. (CADX) for about
$1.3 billion. With this acquisition, Mallinckrodt is looking to
strengthen its specialty pharma segment. Given Cadence Pharma's
strong presence in the hospital market, this acquisition will add
another potential growth area for Mallinckrodt.
Currently, Mallinckrodt carries a Zacks Rank #1 (Strong Buy).
Other stocks looking equally good in the health care sector are
Dr. Reddy's Laboratories Ltd. (RDY) and
Actavis plc (ACT). While Dr. Reddy's Lab holds a
Zacks Rank #1 (Strong Buy), Actavis carries a Zacks Rank #2
(Buy).
ACTAVIS PLC (ACT): Free Stock Analysis Report
CADENCE PHARMA (CADX): Free Stock Analysis Report
MALLINCKRODT PL (MNK): Free Stock Analysis Report
DOCTOR REDDYS (RDY): Free Stock Analysis Report
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