Last $88.82 USD
Change Today +1.12 / 1.28%
Volume 3.9M
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As of 8:04 PM 09/19/14 All times are local (Market data is delayed by at least 15 minutes).

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mallinckrodt plc (MNK) Details

Mallinckrodt public limited company develops, manufactures, markets, and distributes branded and generic specialty pharmaceuticals, active pharmaceutical ingredients (API), and diagnostic imaging agents worldwide. The company’s Specialty Pharmaceuticals segment offers EXALGO extended-release tablets to treat chronic pain in opioid-tolerant patients; and GABLOFEN injections indicated for use in the management of spasticity of cerebral or spinal origin in patients age four years and above. This segment also provides generic pharmaceutical products, including acetaminophen products, oxycodone-containing tablets, hydrocodone-containing tablets, and methylphenidate HCl extended-release tablets USP (CII) to treat attention deficit hyperactivity disorder and addiction, as well as API products comprising hydrocodone and oxycodone; and medicinal opioids and synthetic controlled substances. This segment markets its branded products to physicians, including pain specialists, anesthesiologists, orthopedic surgeons, managed care organizations, and neurologists directly; and generic products to wholesalers, retail pharmacy chains, food store chains with pharmacies, mail order pharmacies, and hospital buying groups. Its Global Medical Imaging segment provides contrast media and delivery systems comprising ioversol and gadoversetamide injections for diagnostic imaging applications, such as computed tomography and magnetic resonance imaging under the Optiray and Optimark brands; and pre-filled syringes and proprietary power injectors. This segment also offers nuclear imaging agents consisting of technetium-99m generators under the Ultra-Technekow DTE brand; cold kits; and radiopharmaceuticals, such as Octreoscan kits for localization of tumors. This segment sells its contrast media systems to hospitals and imaging centers; and API products to other pharmaceutical companies directly or through distributors. The company is based in Dublin, Ireland.

5,500 Employees
Last Reported Date: 07/14/14

mallinckrodt plc (MNK) Top Compensated Officers

Chief Executive Officer, President, Director ...
Total Annual Compensation: $823.9K
Chief Financial Officer and Senior Vice Presi...
Total Annual Compensation: $380.6K
Chief Human Resources Officer and Senior Vice...
Total Annual Compensation: $433.3K
Senior Vice President and General Counsel
Total Annual Compensation: $367.4K
Compensation as of Fiscal Year 2013.

mallinckrodt plc (MNK) Key Developments

Mallinckrodt Pharmaceutical's MNK-155, an Extended-Release Hydrocodone/Acetaminophen Combination, Shows Efficacy in Phase 3 Acute Pain Trial

Mallinckrodt Pharmaceutical reported that a Phase 3 efficacy trial of investigational MNK-155 met the study's primary endpoint of improved pain scores vs. placebo over the first 48 hours following bunionectomy (p<0.001). This difference in pain scores was statistically significant in favor of MNK-155. The data is being presented at PAINWeek 2014, a national conference on pain for frontline practitioners, held in Las Vegas, Nevada September 2-6, 2014. MNK-155 is an investigational extended-release oral formulation of hydrocodone and acetaminophen being studied for the management of moderate to moderately severe acute pain where the use of an opioid analgesic is appropriate. MNK-155 is formulated with both immediate- and extended-release components. The release profile of MNK-155 combines Mallinckrodt-proprietary, patented technology and Depomed's advanced Acuform(R) drug delivery technology. The NDA for MNK-155 was accepted for review by the U.S. FDA in May 2014 and included results from this study. In addition to the Phase 3 study, Mallinckrodt will present data at PAINWeek from several other MNK-155 trials, including the pharmacokinetics, safety and subjective effects of abuse-related characteristics. The Phase 3 trial was a multicenter, randomized, double-blind, placebo-controlled, parallel-arm study comparing the efficacy and safety of MNK-155 and placebo in 403 patients with moderate to moderately severe acute pain following a unilateral first metatarsal bunionectomy. Subjects received a single 3-tablet loading dose of MNK-155 (7.5 mg hydrocodone and 325 mg acetaminophen tablets; 22.5 mg/975 mg total dose), followed by 2 tablets every 12 hours (15 mg /650 mg total dose) over 48 hours or placebo. Rescue ibuprofen up to 400 mg every 4 hours was allowed for both the MNK-155 and placebo arms. The primary endpoint was the summed pain intensity difference (change in pain from baseline) over 48 hours (SPID48). Secondary measures included: Cumulative SPID at 0-4, 0-8, 0-12, 0-24, and 0-36 hours; mean PID beginning 15 minutes after dosing, mean total pain relief (TOTPAR) for the time periods 0-4, 0-8, 0-12, 0-24, 0-36, and 0-48 hours; and time to perceptible, confirmed, and meaningful pain relief. The most common adverse events associated with the use of MNK-155 were nausea, dizziness, vomiting, headaches, constipation, pruritus and somnolence (sleepiness).

Mallinckrodt Pharmaceuticals Releases Human Abuse Liability (HAL) Data for Investigational MNK-155, an Extended-Release Hydrocodone/Acetaminophen Combination

Mallinckrodt plc reported data from a Human Abuse Liability study in which both intact and crushed MNK-155 showed lower subjective abuse-related effects than an immediate-release hydrocodone bitartrate/acetaminophen formulation (a generic form of Vicodin(R)). In the HAL study, intact and crushed MNK-155 demonstrated statistically significant (p <0.001) lower measures of drug liking, drug high and good drug effects compared with comparable doses of intact immediate-release hydrocodone bitartrate/acetaminophen when measured at the peak drug effect (E(max)). It also took significantly longer for intact and crushed MNK-155 to reach peak drug effect compared with intact immediate-release hydrocodone bitartrate/acetaminophen for each of these three measures (p <=0.029). MNK-155 is an investigational extended-release oral formulation of hydrocodone and acetaminophen being studied for the management of moderate to moderately severe acute pain where the use of an opioid analgesic is appropriate. MNK-155 is formulated with both immediate- and extended-release components and was recently awarded patent protection covering its unique design, formulation, pharmacokinetic, and release characteristics. The NDA for MNK-155 was accepted for review by the U.S. Food and Drug Administration (FDA) in May 2014. The HAL study was a single-center, randomized, double-blind, double-dummy, active- and placebo-controlled 7-way crossover study assessing the abuse potential of orally-administered MNK-155 in 52 healthy male and female non-dependent recreational opioid users. During the seven treatment periods, subjects received a single treatment with one of the seven study drugs: -- Placebo; -- 22.5 mg/975 mg MNK-155 (low dose, intact); -- 22.5 mg/975 mg immediate-release hydrocodone bitartrate/acetaminophen formulation (low dose, intact); -- 45 mg/1950mg MNK-155 (high dose, intact); -- 45 mg/1950mg immediate-release hydrocodone bitartrate/acetaminophen formulation (high dose, intact); -- Crushed, encapsulated high dose MNK-155; and -- Crushed, encapsulated high dose immediate-release hydrocodone bitartrate/acetaminophen formulation.

Mallinckrodt Announces Executive Changes

Mallinckrodt plc announced that Gary Phillips has been appointed to serve as Senior Vice President and President of the company's Autoimmune and Rare Disease business, which includes the commercial organization supporting H.P. Acthar(R) Gel. Additionally, Ray Furey, formerly Senior Vice President and Chief Compliance Officer at Questcor Pharmaceuticals, has been appointed as Senior Vice President and the Chief Compliance Officer at Mallinckrodt. The appointments are effective immediately. In his new role, Dr. Phillips will assume responsibility for the Acthar franchise and all of its sales, support and service activities. Both executives will report directly to Mark Trudeau, Chief Executive Officer of Mallinckrodt.


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Price/Sales 2.3x
Price/Book 3.9x
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