FDA Approves Exaglo

FDA Approves Exaglo (hydromorphone HCl) Extended-Release Tablets

ST. LOUIS--(BUSINESS WIRE)--Mar 2, 2010 - Covidien today announced that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application 21-217 for Exalgo (hydromorphone HCl) Extended-Release Tablets, (CII).

The indication for Exalgo is once daily administration for the management of moderate to severe pain in opioid-tolerant patients requiring continuous, around-the-clock opioid analgesia for an extended period of time.

Currently, many people suffer from moderate to severe chronic pain such as low-back pain, even with the medications that are already available. In fact, physicians frequently try many types of opioids before finding a regimen that provides adequate pain relief for a patient. Exalgo tablets provide a well known therapy in hydromorphone HCl, which has been used in the treatment of chronic pain for more than 80 years – now in an extended-release formulation. FDA approval of Exalgo tablets offers an important new treatment for physicians treating opioid-tolerant patients for moderate to severe chronic pain.

Exalgo utilizes the OROS® Push-Pull osmotic delivery system designed to release the opioid at a controlled rate. By providing a steady release of hydromorphone throughout the day, the drug is formulated to help minimize the peaks and troughs that are sometimes experienced by chronic pain patients who rely on products that are dosed at more frequent intervals.

Covidien is the largest supplier of controlled pain medications in the United States based on number of prescriptions. Its development partner, CombinatoRx, Incorporated, develops novel drug candidates with a focus on the treatment of pain and inflammation.

"We are excited that our collaboration with CombinatoRx provides physicians and patients with the only extended-release hydromorophone treatment that will be available for this type of pain relief," said Timothy R. Wright, President, Pharmaceuticals, Covidien. "Building on more than a century of pain treatment experience, Covidien is focused on providing patients with access to advanced medications that expand the limits of pain therapy by combining proven drugs with innovative delivery systems.

In June 2009, the companies announced that Mallinckrodt Inc., a Covidien company, had entered into an asset purchase agreement with Neuromed for the U.S. commercialization rights to Exalgo. Under the agreement, Covidien is responsible for all commercialization activities for Exalgo, including marketing, sales and all post-approval FDA regulatory filings.

"Reflecting our commitment to pain management, we will be significantly increasing our branded pharmaceutical sales force in 2010 as a result of the approval of Exalgo," said Wright.

The launch of Exalgo tablets, which Covidien anticipates in the first half of calendar year 2010, will include a comprehensive Risk Evaluation and Mitigation Strategy (REMS) that is designed to ensure that the benefits of Exalgo outweigh the potential risks. The REMS for Exalgo includes a medication guide and a robust set of educational programs and materials as part of the company's focused effort to help ensure that prescribers, pharmacists and patients have the needed information regarding appropriate prescribing, dispensing and use of Exalgo tablets. Under the program, healthcare provider education is required as an important element to assure safe use with a focus on appropriate patient selection and dosing. As part of Covidien's ongoing commitment to be a responsible advocate for patients, the company has also voluntarily developed a broad range of safe use tools for Exalgo that will be provided to healthcare professionals, pharmacists, patients and caregivers and will be continually reviewed for improvement.

PLEASE SEE IMPORTANT RISK INFORMATION, INCLUDING BOXED WARNING BELOW

Exalgo is contraindicated in opioid non-tolerant patients, in management of mild pain or pain not expected to persist, in patients with compromised respiratory function or in patients with narrowed or obstructed gastrointestinal tract or with known hypersensitivity to any components including hydromorphone hydrochloride and sulfites. Concurrent use of Exalgo with CNS depressants, including alcohol, increases risk of respiratory depression, hypotension, and profound sedation, potentially resulting in coma or death. Not recommended in patients who have received MAO inhibitors within 14 days of starting Exalgo.

See full package insert for full prescribing information.

WARNING: POTENTIAL FOR ABUSE, IMPORTANCE OF PROPER PATIENT SELECTION AND LIMITATIONS OF USE

Potential for Abuse

Exalgo contains hydromorphone, an opioid agonist and a Schedule II controlled substance with an abuse liability similar to other opioid analgesics. Exalgo can be abused in a manner similar to other opioid agonists, legal or illicit. These risks should be considered when administering, prescribing, or dispensing Exalgo in situations where the healthcare professional is concerned about increased risk of misuse, abuse, or diversion. Schedule II opioid substances which include hydromorphone, morphine, oxycodone, fentanyl, oxymorphone and methadone have the highest potential for abuse and risk of fatal overdose due to respiratory depression [see Drug Abuse and Dependence (9)].

Proper Patient Selection

Exalgo is an extended-release formulation of hydromorphone hydrochloride indicated for the management of moderate to severe pain in opioid tolerant patients when a continuous around-the-clock opioid analgesic is needed for an extended period of time. Patients considered opioid tolerant are those who are taking at least 60 mg oral morphine per day, 25 mcg transdermal fentanyl/hour, 30 mg of oral oxycodone/day, 8 mg oral hydromorphone/day, 25 mg of oral oxymorphone/day or an equianalgesic dose of another opioid, for a week or longer [see Indications and Usage (1) and Dosage and Administration (2)].

Exalgo is for use in opioid tolerant patients only [see Indications and Usage (1) and Dosage and Administration (2)].

Fatal respiratory depression could occur in patients who are not opioid tolerant.

Accidental consumption of Exalgo, especially in children, can result in a fatal overdose of hydromorphone [see Warnings and Precautions (5.1)].

Limitations of Use

Exalgo is not indicated for the management of acute or postoperative pain [see Indications and Usage (1)].

Exalgo is not intended for use as an as needed analgesic [see Indications and Usage (1)].

Exalgo tablets are to be swallowed whole and are not to be broken, chewed, dissolved,

crushed or injected. Taking broken, chewed, dissolved or crushed Exalgo or its contents leads to rapid release and absorption of a potentially fatal dose of hydromorphone [see Warnings and Precautions (5)].

OROS® and Push-Pull™ are trademarks of ALZA Corporation.

About Covidien

Covidien is a leading global healthcare products company that creates innovative medical solutions for better patient outcomes and delivers value through clinical leadership and excellence. Covidien manufactures, distributes and services a diverse range of industry-leading product lines in three segments: Medical Devices, Pharmaceuticals and Medical Supplies. With 2009 revenue of $10.7 billion, Covidien has 42,000 employees worldwide in more than 60 countries, and its products are sold in over 140 countries. Please visit www.covidien.com to learn more about our business.

Forward-Looking Statements

Any statements contained in this communication that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. Any forward-looking statements contained herein are based on our management's current beliefs and expectations, but are subject to a number of risks, uncertainties and changes in circumstances, which may cause actual results or Company actions to differ materially from what is expressed or implied by these statements. The factors that could cause actual future results to differ materially from current expectations include, but are not limited to, our ability to effectively introduce and market new products or keep pace with advances in technology, the reimbursement practices of a small number of large public and private insurers, cost-containment efforts of customers, purchasing groups, third-party payers and governmental organizations, intellectual property rights disputes, complex and costly regulation, including healthcare fraud and abuse regulations, manufacturing or supply chain problems or disruptions, rising commodity costs, recalls or safety alerts and negative publicity relating to Covidien or its products, product liability losses and other litigation liability, including legacy Tyco-related litigation, divestitures of some of our businesses or product lines, our ability to execute strategic acquisitions of, investments in or alliances with other companies and businesses, competition, risks associated with doing business outside of the United States, foreign currency exchange rates or potential environmental liabilities. These and other factors are identified and described in more detail in our filings with the SEC. We disclaim any obligation to update these forward-looking statements other than as required by law.

Contact: Covidien
John Gillespie, 314-654-3263
Manager, Media Relations
Pharmaceuticals
john.gillespie@covidien.com
or
Coleman Lannum, CFA, 508-452-4343
Vice President
Investor Relations
cole.lannum@covidien.com
or
Bruce Farmer, 508-452-4372
Vice President
Public Relations
bruce.farmer@covidien.com
or
Brian Nameth, 508-452-4363
Director
Investor Relations
brian.nameth@covidien.com

Posted: March 2010

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Exalgo (hydromorphone) FDA Approval History

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