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MGI PHARMA Announces Initiation of Aquavan(R) Injection Pivotal Program; Patient Enrollment Expected To Conclude By Year-End |
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21 Mar 2006 |
MINNEAPOLIS, IN, USA | Mar 20, 2006 | MGI PHARMA, INC. (Nasdaq:MOGN), an oncology- and acute care- focused biopharmaceutical company, today announced the initiation of the Aquavan(R) (fospropofol disodium) Injection pivotal program. This program consists of two randomized, double blind, multicenter phase 3 trials and an open label safety study.
The first phase 3 trial is planned to enroll a total of 300 patients undergoing colonoscopy. The second phase 3 study will enroll 250 patients undergoing bronchoscopy. The endpoints of both trials include sedation and treatment success, patient satisfaction, investigator satisfaction, and measures of sedation adequacy, recovery, clinical benefit, and safety.
"The initiation of this pivotal program advances our acute care development pipeline, which will be an important driver of MGI PHARMA's future growth," said Lonnie Moulder, President and Chief Executive Officer of MGI PHARMA. "Aquavan Injection is an excellent companion opportunity to Aloxi(R) Injection for post-operative nausea and vomiting, and together these candidates form the foundation of our acute care franchise. Results from the previously disclosed phase 2 dose ranging study indicated a clear dose response for Aquavan Injection and a promising therapeutic profile. We expect patient enrollment to be completed by the end of 2006, and plan to submit a new drug application in the first half of 2007."
In addition to the two phase 3 trials, an open label, multi-center safety study will be conducted in 150 patients undergoing minor procedures, including arthroscopy, bunionectomy, dilation and curettage, upper endoscopy, hysteroscopy, lithotripsy, arterio-venous shunt placement, and trans-esophageal echocardiograms. The goal of this study is to assess the safety of a single dose of Aquavan Injection in a variety of minor procedures.
About Aquavan(R) Injection
Aquavan (fospropofol disodium) Injection, a water soluble prodrug formulation of propofol, is a product candidate in development for minimal to moderate sedation of patients undergoing short surgical or diagnostic procedures. When administered intravenously, Aquavan Injection is converted to active propofol, a short-acting anesthetic agent. Due to its unique pharmacokinetic profile, Aquavan Injection may have broad utility as a sedative agent for short surgeries and diagnostic procedures such as colonoscopy and bronchoscopy.
About MGI PHARMA
MGI PHARMA, INC. is an oncology- and acute care-focused biopharmaceutical company that acquires, researches, develops and commercializes proprietary products that address the unmet needs of patients. MGI PHARMA markets Aloxi(R) (palonosetron hydrochloride) Injection and Gliadel(R) Wafer (polifeprosan 20 with carmustine implant) in the United States. The company directly markets its products in the U.S. and collaborates with partners to reach international markets. For more information about MGI PHARMA, please visit www.mgipharma.com.
This news release contains certain "forward-looking" statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are typically preceded by words such as "believes," "expects," "anticipates," "intends," "will," "may," "should," or similar expressions. These forward-looking statements are not guarantees of MGI PHARMA's future performance and involve a number of risks and uncertainties that may cause actual results to differ materially from the results discussed in these statements. Factors that might cause MGI PHARMA's results to differ materially from those expressed or implied by such forward-looking statements include, but are not limited to, the ability of MGI PHARMA's product candidates to be proven safe and effective in humans, to receive marketing authorization from regulatory authorities, and to ultimately compete successfully with other therapies; continued sales of MGI PHARMA's marketed products; development or acquisition of additional products; reliance on contract manufacturing; changes in strategic alliances; continued access to capital; ability of MGI PHARMA to successfully complete the integration of Guilford with its existing operations; the risk that the perceived advantages of the Guilford transaction may not be achieved; and other risks and uncertainties detailed from time to time in MGI PHARMA's filings with the Securities and Exchange Commission including its most recently filed Form 10-Q or 10-K. MGI PHARMA undertakes no duty to update any of these forward-looking statements.
CONTACT: MGI PHARMA, INC.
Jennifer Davis, 212-332-4381
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or
Noonan Russo
Brian Ritchie, 212-845-4200
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SOURCE: MGI PHARMA, INC. |
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