Key Developments: Covidien PLC (COV)

Covidien PLC To Shutter South Carolina Plant, Lay Off 595-Reuters
Thursday, 13 Sep 2012 04:42pm EDT 

Reuters reported that Covidien PLC said it would close a South Carolina facility where it manufactures vascular products, laying off about 595 full-time employees as it looks to improve efficiency across its global operations. The Company have been closing or consolidating manufacturing facilities as they look to cut costs to cope with lower reimbursements and pricing pressures. Covidien, which employs about 41,000 people worldwide, said it would provide full severance to the affected employees and assist them with applying to jobs at its other plants.  Full Article

Covidien PLC Comments On FY 2013 Revenue Guidance-Conference Call
Thursday, 13 Sep 2012 04:00am EDT 

Covidien PLC announced that for fiscal 2013 it expects net sales to increase 3% to 6% versus fiscal 2012 net sales. According to I/B/E/S Estimates, analysts were expecting the Company to report revenue of $12.272 billion for fiscal 2013.  Full Article

Covidien PLC Announces FDA 510(k) Clearance Of LigaSure Small Jaw Instrument For Ear, Nose And Throat Surgical Procedures
Tuesday, 11 Sep 2012 07:01am EDT 

Covidien PLC announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the LigaSure curved, small jaw, open sealer/divider surgical instrument to be used in ear, nose and throat (ENT) procedures. When working in confined surgical spaces, the LigaSure device addresses surgeons’ needs by offering a low-temperature profile and minimal thermal spread to surrounding tissues. The new clearance, for the device’s use in head and neck procedures, will allow for additional uses such as thyroidectomies, parotidectomies and additional open ENT procedures. There are more than 160,000 of these procedures performed each year in the United States.  Full Article

Covidien PLC Receives FDA 510(k) Clearance For Groundbreaking iDrive Ultra Powered Stapling System
Tuesday, 28 Aug 2012 07:00am EDT 

Covidien PLC announced that it has obtained 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the iDrive Ultra powered stapling system. The new stapling system is the only fully powered, reusable, battery-operated endoscopic surgical stapler in the world. Featuring one-handed push-button operation and unlimited articulation, the system eliminates the need for manual firing force and improves maneuverability, compared with traditional endomechanical staplers. The iDrive Ultra powered stapling system is designed for multi-patient use, thus streamlining operating room inventory management, and offers an environmentally friendly benefit by reducing medical waste. The system will be available In the U.S. beginning in the fourth quarter of 2012.  Full Article

Covidien PLC Announces FDA Approves Mallinckrodt’s EXALGO
Monday, 27 Aug 2012 08:30am EDT 

Covidien PLC announced that the .S. Food and Drug Administration (FDA) has notified Mallinckrodt, the pharmaceuticals business of the Company, that it has approved a 32 mg tablet strength of EXALGO (hydromorphone HCI) Extended-Release Tablets (CII) for opioid-tolerant patients with moderate-to-severe chronic pain requiring continuous around-the-clock opioid analgesia for an extended period of time. The FDA approved the 8, 12 and 16 mg tablets of EXALGO in March 2010 and the Supplemental New Drug Application (sNDA) for the 32 mg tablet was submitted in January 2012 with post-marketing data to support the original application’s compendium of clinical trials demonstrating efficacy and tolerability. The EXALGO 32 mg tablet strength will be available in the next few weeks. All EXALGO dosage strengths, including the new 32 mg tablet, are subject to the recently approved Risk Evaluation and Mitigation Strategy (REMS) program for all long-acting and extended-release opioids. The three primary components of this REMS program are: training for prescribers in the form of continuing medical education (CME) initiatives, which will be available by March 2013; updated medication guides for each opioid and a patient counseling document; and assessment and auditing to ensure the reach and effectiveness of prescriber training.  Full Article

Covidien PLC's Mallinckrodt Announces Agreement With Xanodyne Pharmaceuticals To Purchase Roxicodone
Thursday, 23 Aug 2012 08:00am EDT 

Mallinckrodt, the Pharmaceuticals business of Covidien announced that it has entered into an agreement with Xanodyne Pharmaceuticals to purchase Roxicodone (oxycodone hydrochloride tablets USP) in 5, 15 and 30 mg dosage strengths. Roxicodone, currently marketed in the United States, is an immediate release formulation of oxycodone indicated for the management of moderate to severe pain where the use of an opioid analgesic is appropriate. With this agreement, Mallinckrodt acquires all rights to the Roxicodone New Drug Application (NDA). No financial details were disclosed.  Full Article

Covidien PLC Recalls Surgical Tools-Reuters
Wednesday, 22 Aug 2012 04:35am EDT 

Reuters reported that Covidien PLC has recalled tools used to reinforce tissues after stapling during surgery and will stop manufacturing the products.  Full Article

Covidien PLC Declares Quarterly Cash Dividend
Wednesday, 18 Jul 2012 04:00pm EDT 

Covidien PLC announced that its Board of Directors has declared a quarterly cash dividend of $0.225 per ordinary share. The dividend is payable on August 16, 2012, to shareholders of record on July 30, 2012.  Full Article

FDA Warns Covidien PLC On Violations Related To Patient Deaths-Reuters
Tuesday, 26 Jun 2012 02:28pm EDT 

Reuters reported that U.S. health regulators censured Covidien PLC for failing to promptly address complaints related to deaths and serious injuries linked to its devices used in thoracic surgery. Covidien in January said it would recall all production lots of its Duet TRS units, after it received reports of 13 serious injuries and three deaths. The U.S. Food and Drug Administration said the Company had received numerous complaints related to the use of the product since May 2009. Covidien, however, did not initiate a corrective and preventative action until Jan 19 this year, when an FDA inspection team sought to review data related to the complaints, the regulator said in a warning letter. The Company also failed to document investigations into the deaths and serious injuries, the FDA said in the letter dated June 14. 'Failure to promptly correct these violations may result in regulatory action being initiated by the FDA without further notice', the FDA wrote. Covidien should investigate and determine the causes of the violations, and take prompt actions to correct the violations and bring the products into compliance, the regulator said.  Full Article

Covidien PLC Completes Acquisition Of Oridion Systems Ltd.
Tuesday, 26 Jun 2012 07:00am EDT 

Covidien PLC announced that it has completed the previously announced acquisition of Oridion Systems Ltd. for an aggregate consideration of approximately $310 million, net of cash and investments acquired. Pursuant to the terms of the acquisition agreement, Covidien has acquired all of the outstanding capital stock of Oridion Systems, based in Jerusalem, Israel. Oridion develops Microstream capnography monitors and modules, in conjunction with specialized algorithms, as well as etCO2 breath sampling lines. Covidien will report the Oridion Systems business as part of its Oximetry & Monitoring product line in the Medical Devices segment.  Full Article

Covidien to acquire CV Ingenuity