Helsinn & MGI Pharma Announce Completion Of Pivotal Phase 3
`Trials Of Palonosetron I Evaluate
`
`Monday, June 29, 2015
`
`How We Use Cookies ]
`
`~Evaluate· I
`
`Products & Solutions
`News & Insight
`About Us
`Support
`Contact Us
`Welcome: Guest 1 Login or Register
`
`Helsinn & MGI Pharma Announce
`Completion Of Pivotal Phase 3 Trials Of
`Palonosetron
`
`Press Release
`Source
`Company Helsinn Group, MGI Pharma
`Tags
`Phase Ill, Gastro-Intestinal
`Date
`January 16, 2002
`Lugano, Switzerland and Minneapolis, MN --January 16, 2002 -- Helsinn Healthcare SA, a privately owned Swiss
`pharmaceutical group, and MGI Pharma, Inc., (Nasdaq: MOGN) an oncology-focused pharmaceutical company
`based in Minneapolis, today announced that patient treatment is completed and the data analysis is underway for
`the pivotal Phase 3 trials of their investigational agent, Palonosetron. Palonosetron is a potent, highly selective 5-
`HT3-receptor antagonist in development in North America and Europe for the prevention of chemotherapy-i nduced
`nausea and vomiting (CINV). Submission of the New Drug Application (NDA) for Palonosetron is now planned to
`occur in the third quarter of 2002.
`
`The Phase 3 clinical trial program was initiated in April 2000 and was designed to compare intravenous
`(IV) Palonosetron to currently marketed 5-HT3 antagonists. The trials were conducted at more than 130 medical
`centers across North America and Europe, with more than 1,800 cancer patients receiving! either highly- or
`moderately-emetogenic chemotherapy. Based on the extended half-life of Palonosetron and the results of a Phase
`2 trial, the efficacy of Palonosetron in the Phase 3 trial is being assessed over Day 2 through Day 5 following
`treatment, in addition to the primary efficacy measure of complete response during the 24-hour period after the start
`of chemotherapy.
`
`"We are pleased to have completed all patient treatment and to have begun analysis of the data collected in
`the Palonosetron Phase 3 clinical program," said Luigi Baroni, senior director of Scientific Affairs Division at
`HELSINN. "The Phase 2 clinical trial results were promising, and we are hopeful that the Phase
`3 Palonosetron data will demonstrate that it can make a difference for cancer patients suffering from CINV.'"
`
`"The half-life of other available 5-HT3 receptor antagonists ranges from approximately five to nine hours,
`whereas Palonosetron has a plasma elimination half-life of nearly 40 hours," notes Dr. John MacDonald, senior vice
`president of Research and Development at MGI. "The activity seen with Palonosetron in the Phase 2 trial, coupled
`with its safety profile observed to date, led to the initiation of a Phase 3 program to assess the ability of the drug to
`provide prolonged protection against CINV with a single dose."
`[Source· EvaluateTM I ©2015 Evaluate Ltd, All rights reserved.]
`0
`Print
`~
`Bookmark
`HOME
`OUR PRODUCTS
`LATEST NEWS & INSIGHT
`SUPPORT
`CONTACT US
`SHARE THIS PAGE
`
`Privacy
`Terms & Conditions.
`Legal
`Careers
`Sitemap
`WorkSpace Terms & Conditions
`
`Join Us On
`
`rl Twitter
`
`HOW W E USE COOKIES
`
`Dr. Reddy's Laboratories, Ltd., et al.
`v.
`Helsinn Healthcare S.A., et al.
`U.S. Patent No. 8,729,094
`Reddy Exhibit 1 033
`
`General Page l
`
`Exh. 1033
`
`

`
`© 2015 Evaluate Ltd. ALL RIGHTS RESERVED.
`<img width=" 1" height="1" all="" src="http://logW309.xiti.com/hit.xiti?s=558237 &s2=&p=&an=&ac=" >
`
`Inserted from <http://www.evaluategroup.com/Universai/View.aspx?type=Story&id=35999>
`
`General Page 2
`
`Exh. 1033