Helsinn Healthcare Announce The Completion Of Patient
`Enrollment For First Palonosetron Phase 3 Pivotal Trial I Evaluate
`
`Monday, June 29, 2015
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`Helsinn Healthcare Announce The
`Completion Of Patient Enrollment For First
`Palonosetron Phase 3 Pivotal Trial
`
`Press Release
`Source
`Company Helsinn Group, MGI Pharma
`Tags
`Phase Ill, Gastro-Intestinal
`Date
`October 03, 2001
`Lugano, Switzerland - October 3, 2001 -- Helsinn Healthcare SA announced the completion of patient enrollment
`for the first of the pivotal Phase 3 trials of palonosetron, a novel 5-HT3 antagonist. Palonosetron is a potent, highly
`selective 5-HT3 antagonist with an extended half-life, currently in Phase 3 development in the United States and
`Europe for the prevention of chemotherapy-induced nausea and vomiting (CINV). HELSINN expects to complete
`patient enrollment for the remaining trials in the Phase 3 program near the end of 2001 and plans to submit a New
`Drug Application (NDA) in the U.S and Europe in the first half of 2002.
`
`The double-blinded, randomized Phase 3 clinical trial program aims to compare intravenous (IV) palonosetron to
`currently marketed 5-HT3 antagonists and is being conducted at medical centers across North America and
`Europe. It is expected that over 1 ,800 cancer patients receiving either highly- or moclerately-emetogenic
`chemotherapy will be enrolled in the trials. Based on the extended half-life of palonosetron and the results of a
`Phase 2 trial, its efficacy 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.
`
`Results of Phase 1 trials in healthy volunteers to assess the pharmacokinetic properties and safety
`of palonosetron were presented at this year's American Society of Clinical Oncologists (ASCO) meeting in May
`2001 . Palonosetron was found to have a plasma elimination half-life of 37 hours, which is at least three times longer
`than marketed agents in its class. This extended half-life of palonosetron and the results of Phase 2 trials assessing
`the efficacy beyond 24 hours differentiate palonosetron from the currently marketed 5-HT3 antagonists indicated
`for CINV.
`
`Having been studied in more than 1 ,000 subjects in Phase 1 and Phase 2 trials, palonosetron was well tolerated and
`had no unexpected or serious adverse reactions. The most frequent adverse events associated
`with palonosetron are similar to those seen with other 5-HT3 antagonists and include headache and constipation,
`which are generally mild to moderate.
`
`CINV is estimated to occur in approximately 85 percent of cancer patients undergoing chemotherapy and can result
`in delay or even discontinuation of treatment. The advent of 5-HT3 antagonists has revolutionized the management
`of nausea and vomiting experienced by cancer patients undergoing chemotherapy.
`
`HELSINN is the worldwide licensor of palonosetron and is conducting the Phase 3 trials of palonosetron that will
`form the basis for its registration in the United States. In April of this year, MGI PHARMA, an oncology-focused
`pharmaceutical company based in Minneapolis, and HELSINN signed an agreement granting MGI the exclusive
`U.S and Canadian licensing and distribution rights to palonosetron. Once approved, palonosetron will compete in
`Dr. Reddy's Laboratories, Ltd., et al.
`the CINV treatment market, which is rapidly approaching $1 billion in North Ame
`v.
`Helsinn Healthcare S.A., et al.
`U.S. Patent No. 8,729,094
`Reddy Exhibit 1034
`
`HELSINN's negotiations with potential European licensing partners are ongoing
`remaining markets will commence next year.
`
`General Paoe I
`
`

`
`Helsinn Healthcare Announce The Completion Of Patient
`Enrollment For First Palonosetron Phase 3 Pivotal Trial I Evaluate
`
`Monday, June 29, 2015
`
`How We Use Cookies
`
`~Evaluate·!
`Products & Solutions
`News & Insight
`About Us
`Support
`Contact Us
`Welcome: Guest 1 Login or Register
`
`Helsinn Healthcare Announce The
`Completion Of Patient Enrollment For First
`Palonosetron Phase 3 Pivotal Trial
`
`Press Release
`Source
`Company Helsinn Group, MGI Pharma
`Tags
`Phase Ill, Gastro-Intestinal
`Date
`October 03, 2001
`Lugano, Switzerland -- October 3, 2001 -- Helsinn Healthcare SA announced the completion of patient enrollment
`for the first of the pivotal Phase 3 trials of palonosetron, a novel 5-HT3 antagonist. Palonosetron is a potent, highly
`selective 5-HT3 antagonist with an extended half-life, currently in Phase 3 development in the United States and
`Europe for the prevention of chemotherapy-induced nausea and vomiting (CINV). HELSINN expects to complete
`patient enrollment for the remaining trials in the Phase 3 program near the end of 2001 and plans to submit a New
`Drug Application (NDA) in the U.S. and Europe in the first half of 2002.
`
`The double-blinded, randomized Phase 3 clinical trial program aims to compare intravenous (IV) palornosetron to
`currently marketed 5-HT3 antagonists and is being conducted at medical centers across North America and
`Europe. It is expected that over 1,800 cancer patients receiving either highly- or moderately-emetogenic
`chemotherapy will be enrolled in the trials. Based on the extended half-life of palonosetron and the results of a
`Phase 2 trial, its efficacy 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.
`
`Results of Phase 1 trials in healthy volunteers to assess the pharmacokinetic properties and safety
`of palonosetron were presented at this year's American Society of Clinical Oncologists (ASCO) meeting in May
`2001 . Palonosetron was found to have a plasma elimination half-life of 37 hours, which is at least three times longer
`than marketed agents in its class. This extended half-life of palonosetron and the results of Phase 2 trials assessing
`the efficacy beyond 24 hours differentiate palonosetron from the currently marketed 5-HT3 antagonists indicated
`for CINV.
`
`Having been studied in more than 1,000 subjects in Phase 1 and Phase 2 trials, palonosetron was well tolerated and
`had no unexpected or serious adverse reactions. The most frequent adverse events associated
`with palonosetron are similar to those seen with other 5-HT3 antagonists and include headache and constipation,
`which are generally mild to moderate.
`
`CINV is estimated to occur in approximately 85 percent of cancer patients undergoing chemotherapy and can result
`in delay or even discontinuation of treatment. The advent of 5-HT3 antagonists has revolutionized the management
`of nausea and vomiting experienced by cancer patients undergoing chemotherapy.
`
`HELSINN is the worldwide licensor of palonosetron and is conducting the Phase 3 trials of palonosetron that will
`form the basis for its registration in the United States. In April of this year, MGI PHAIRMA, an oncology-focused
`pharmaceutical company based in Minne·apolis, and HELSINN signed an agreement granting MGI the exclusive
`U.S. and Canadian licensing and distribution rights to palonosetron. Once approved, palonosetron will compete in
`the CINV treatment market, which is rapidly approaching $1 billion in North America.
`
`HELSINN's negotiations with potential European licensing partners are ongoing, and out-licensing activities for
`remaining markets will commence next year.
`
`General Page I
`
`Exh. 1034
`
`

`
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