Healthcare Industry News: Aloxi
News Release - December 14, 2006
MGI PHARMA and HELSINN Announce Positive Phase 3 Results for Aloxi(R) (Palonosetron Hydrochloride) Injection for the Prevention of Post Operative Nausea & Vomiting
Pre-NDA Meeting Held; sNDA Submission Remains on Track for 1H07MINNEAPOLIS & LUGANO, Switzerland--(HSMN NewsFeed)--MGI PHARMA, INC. (Nasdaq: MOGN ), a biopharmaceutical company focused in oncology and acute care, and its partner HELSINN HEALTHCARE SA, a privately owned Swiss pharmaceutical group, today announced the successful completion of two phase 3 trials of Aloxi® (palonosetron hydrochloride) Injection for the prevention of post-operative nausea and vomiting (PONV). Both clinical trials successfully met the primary efficacy endpoint of complete response for the 0-24 hour time period following surgery for the selected dose of 0.075 mg. In addition, both trials achieved the secondary endpoints of complete response for the 0-48 and 0-72 hour time periods. The incidence, pattern, and intensity of adverse events were similar among treatment groups, and the most frequently observed side effects were headache and constipation.
Two randomized, multi-center phase 3 clinical trials were conducted to evaluate the safety and efficacy of three doses of Aloxi compared to placebo for the prevention of PONV. Based on these results, HELSINN and MGI PHARMA plan for the submission of a Supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration during the first half of 2007. Aloxi is approved by the U.S. FDA for the prevention of acute nausea and vomiting associated with initial and repeat courses of moderately and highly emetogenic cancer chemotherapy and for the prevention of delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy.
"We and our partner HELSINN are pleased with the results of these phase 3 trials of Aloxi and believe that they describe a product profile with an extended period of activity," said Lonnie Moulder, President and Chief Executive Officer of MGI PHARMA. "Following our recent pre-NDA meeting with the FDA, we remain on track for the submission of the sNDA for Aloxi in this new indication during the first half of 2007."
"HELSINN is pleased with the completion of the phase 3 trials and we look forward to full presentation of these data at future medical meetings," said Enrico Braglia, Managing Director of HELSINN. "We are enthusiastic about working together with our partner MGI PHARMA to bring this new indication to the medical community and to patients."
Phase 3 Program Design
Two randomized, multi-center phase 3 clinical trials were conducted to evaluate the safety and efficacy of Aloxi compared to placebo for the prevention of PONV following elective outpatient abdominal or gynecological laparoscopic surgery (Study PALO-04-06) or elective inpatient gynecological or breast surgery (Study PALO-04-07). In these two trials, a total of 1,219 patients were randomized to receive one of three single intravenous doses of Aloxi or placebo prior to administration of anesthesia.
The co-primary endpoints of both trials were complete response, defined as no emesis or use of rescue medication, for the 0-24 hour and 24-72 hour time periods following surgery. According to the prospectively defined statistical analysis plan, achievement of the 0-24 hour endpoint determined a successful trial and allowed for the testing of the 24-72 hour endpoint. Secondary endpoints included complete response for both the 0-48 and 0-72 hour time periods, complete control (defined as complete response and no more than mild nausea), number of emetic episodes, incidence and severity of nausea, and impact of PONV on patient functioning.
About Post-Operative Nausea and Vomiting (PONV)
Post-operative nausea and vomiting, or PONV, is a common consequence of anesthetic and surgical procedures. In the United States, nearly 30 million doses of 5-HT3 receptor antagonists are used annually for the management of PONV. Patients undergoing abdominal, gynecological, ear/nose/throat, or optical procedures are at highest risk for PONV. Additional factors that can increase the risk for PONV include female gender, non-smoking status, prior history of PONV or motion sickness, length of surgery and the use of volatile anesthetics and opioids. If not prevented, PONV can result in hospital re-admissions and increased healthcare costs in approximately 58% of patients who undergo surgery.
About Aloxi® Injection
Aloxi is currently being evaluated in a clinical program designed to evaluate its safety and efficacy in post-operative nausea and vomiting, but it is not approved for this indication. Aloxi is approved by the U.S. FDA for the prevention of acute nausea and vomiting associated with initial and repeat courses of moderately and highly emetogenic cancer chemotherapy and for the prevention of delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy. Aloxi is the first and only 5-HT3 receptor antagonist to be indicated for the prevention of delayed chemotherapy-induced nausea and vomiting (CINV) caused by moderately emetogenic cancer chemotherapy. The most common adverse reactions related to Aloxi were headache (9%) and constipation (5%). Aloxi is contraindicated in patients known to have hypersensitivity to the drug or any of its components. Please see the Aloxi package insert, available at www.mgipharma.com and www.Aloxi.com, for important additional details.
About HELSINN HEALTHCARE
HELSINN HEALTHCARE SA is a privately owned pharmaceutical group with headquarters in Switzerland and is the worldwide licensor of palonosetron. HELSINN's core business is the licensing of pharmaceuticals in therapeutic niche areas. The company's business strategy is to in-license early-stage new chemical entities and complete their development from the performance of pre-clinical/clinical studies and CMC development to the attainment of market approvals in strategic markets (U.S. and Europe). HELSINN's products are eventually out-licensed to its marketing partners for distribution. The active pharmaceutical ingredients and the finished dosage forms are manufactured at HELSINN's cGMP facilities and supplied worldwide to its customers. For more information about HELSINN, please visit the company's Web site at www.helsinn.com.
About MGI PHARMA
MGI PHARMA, INC. is a biopharmaceutical company focused in oncology and acute care that acquires, researches, develops, and commercializes proprietary products that address the unmet needs of patients. MGI PHARMA markets Aloxi® (palonosetron hydrochloride) Injection, Dacogen(TM) (decitabine) for Injection, and Gliadel® 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.
Source: MGI PHARMA
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