MGI Pharma Signs Exclusive License Agreement With Helsinn
`Healthcare SA, For Palonosetron, A Phase 3 Anti-Emetic I Evaluate
`
`Monday, June 29, 2015
`
`How We Use Cookies
`
`Products & Solutions
`News & Insight
`About Us
`Support
`Contact Us
`Welcome: Guest I Login or Register
`
`MGI Pharma Signs Exclusive License Agreement
`With Helsinn Healthcare SA, For Palonosetron, A
`Phase 3 Anti-Emetic
`
`Press Release
`Source
`Company Helsinn Group, MGI Pharma
`Licensing, Phase Ill, Gastro-Intestinal
`Tags
`Date
`April10, 2001
`Minneapolis, MN and Lugano, Switzerland-- April10, 2001 -- MGI Pharma, Inc., (Nasdaq: MOGN) and Helsinn Healthcare SA, a
`privately owned pharmaceutical group with headquarters in Switzerland, today announced that they have signed the definitive
`agreement granting MGI Pharma exclusive North American license and distribution rights to palonosetron. The signing of the letter of
`intent for this agreement was previously announced in February. Palonosetron is a potent and selective 5-HT3 antagonist with an
`extended half-life, in Phase 3 development for the prevention of chemotherapy-induced nausea and vomiting (CINV). Completion of
`the Phase 3 trials could allow for NDA (New Drug Application) submission in the first half of 2002. When launched, palonosetron will
`compete in the $1 billion North American CINV market.
`
`"We are looking forward to entering the supportive care segment of oncology, the successful completion of the Phase 3 program and
`approval process for palonosetron, and the opportunity to demonstrate the role that this novel agent can have in preventing
`chemotherapy-induced nausea and vomiting for cancer patients," commented Chuck Blitzer, president and CEO of MGI Pharma.
`"Palonosetron is another exciting addition to our growing oncology product portfolio, representing another well-advanced product that
`can be commercialized in the near term."
`
`"Palonosetron is our first product entry into the United States, and we are pleased to be working with MGI Pharma for the North
`American distribution of this innovative product in the supportive care segment of oncology," commented Riccardo Braglia, managing
`director of Helsinn. "We know that MGI Pharma's proven commercial organization, its experienced oncology sales force, and its
`present and future commitment to palonosetron's role within the 5-HT3 antagonist marketplace will ensure the success of our new
`partnership."
`
`About Palonosetron
`
`When launched as a marketed product, palonosetron will be one of four products competing in the $1 billion North American market
`for 5-HT3 antagonists. The extended half-life of palonosetron as compared to the other agents and the results of Phase 2 trials
`assessing efficacy beyond 24 hours differentiates palonosetron from the three currently marketed 5-HT3 antagonists i1ndicated for
`CINV.
`
`CINV is estimated to occur in 85 percent of cancer patients undergoing chemotherapy and can result in delay or even discontinuation
`of treatment, and the advent of 5-HT3 antagonists has revolutionized the manageme-nt of nausea and vomiting experienced by cancer
`patients undergoing chemotherapy.
`
`Palonosetron has been tested in a randomized, double-blind dose-ranging Phase 2 trial at multiple sites throughout the U.S. that
`evaluated its efficacy and safety when administered in a single intravenous dose for the prevention of nausea and vomiting in patients
`receiving highly emetogenic chemotherapy. Over 1,000 patients have participated in Phase 1 and Phase 2 trials of palonosetron.
`Dr Reddy's Laboratories Ltd et al
`ral
`Based on these results, Helsinn initiated a Phase 3 clinical trial program that is
`well-controlled, double-blind trials comparing palonosetron to currently availabl
`·
`'
`.,
`·
`in
`Helsinn Healthv~are S.A., et al.
`North America and Europe. Based on the extended half-life of palonosetron a
`assessed over Day 2 through Day 5 following treatment, in addition to the prim
`U.S. Patent No. 8,729,094
`Reddy Exhibit 1035
`
`he
`
`General Pa re I
`
`

`
`MGI Pharma Signs Exclusive License Agreement With Helsinn
`Healthcare SA, For Palonosetron, A Phase 3 Anti-Emetic I Evaluate
`
`Monday, June 29, 2015
`
`How We Use Cook~
`
`Products & Solutions
`News & Insight
`About Us
`Support
`Contact Us
`W elcome: Guest 1 Login or Register
`
`MGI Pharma Signs Exclusive License Agreement
`With Helsinn Healthcare SA, For Palonosetron, A
`Phase 3 Anti-Emetic
`
`Press Release
`Source
`Company Helsinn Group, MGI Pharma
`Licensing, Phase Ill, Gastro-Intestinal
`Tags
`Date
`April10, 2001
`Minneapolis, MN and Lugano, Switzerland-- Aprill 10, 2001 -- MGI Pharma, Inc., (Nasdaq: MOGN) and Helsinn Healthcare SA, a
`privately owned pharmaceutical group with headquarters in Switzerland, today announced that they have signed the definitive
`agreement granting MGI Pharma exclusive North American license and distribution rights to palonosetron. The signing of the letter of
`intent for this agreement was previously announced in February. Palonosetron is a potent and selective 5-HT3 antagonist with an
`extended half-life, in Phase 3 development for the prevention of chemotherapy-induced nausea and vomiting (CINV). Completion of
`the Phase 3 trials could allow for NDA (New Drug Application) submission in the first half of 2002. When launched, palonosetron will
`compete in the $1 billion North American CINV market.
`
`"We are looking forward to entering the supportive care segment of oncology, the successful completion of the Phase 3 program and
`approval process for palonosetron, and the opportunity to demonstrate the role that this novel agent can have in preventing
`chemotherapy-induced nausea and vomiting for cancer patients," commented Chuck Blitzer, president and CEO of MGI Pharma.
`"Palonosetron is another exciting addition to our growing oncology product portfolio, representing another well-advanced product that
`can be commercialized in the near term."
`
`"Palonosetron is our first product entry into the United States, and we are pleased to be working with MGI Pharma for the North
`American distribution of this innovative product in the supportive care segment of oncology," commented Riccardo Braglia, managing
`director of Helsinn. "We know that MGI Pharma's proven commercial organization, its experienced oncology sales force, and its
`present and future commitment to palonosetron's role within the 5-HT3 antagonist marketplace will ensure the success of our new
`partnership."
`
`About Palonosetron
`
`When launched as a marketed product, palonosetron will be one of four products competing in the $1 billion North American market
`for 5-HT3 antagonists. The extended half-life of palonosetron as compared to the other agents and the results of Phase 2 trials
`assessing efficacy beyond 24 hours differentiates palonosetron from the three currently marketed 5-HT3 antagonists indicated for
`CINV.
`
`CINV is estimated to occur in 85 percent of cance·r patients undergoing chemotherapy and can result in delay or even discontinuation
`of treatment, and the advent of 5-HT3 antagonists has revolutionized the management of nausea and vomiting experienced by cancer
`patients undergoing chemotherapy.
`
`Palonosetron has been tested in a randomized , double-blind dose-ranging Phase 2 trial at multiple sites throughout the U.S. that
`evaluated its efficacy and safety when administered in a single intravenous dose for the prevention of nausea and vomiting in patients
`receiving highly emetogenic chemotherapy. Over 1,000 patients have participated in Phase 1 and Phase 2 trials of palonosetron.
`Based on these results, Helsinn initiated a Phase 3 clinical trial program that is intended to enroll more than 1,900 patients in several
`well-controlled, double-blind trials comparing palonosetron to currently available 5-HT3 antagonists- at approximately 80 centers in
`North America and Europe. Based on the extended half-life of palonosetron and the results of the Phase 2 trial, its efficacy will be
`assessed over Day 2 through Day 5 following treatment, in addition to the primary efficacy measure of complete response durin g the
`
`General Page l
`
`Exh. 1035
`
`

`
`24-hour period after the start of chemotherapy. The most frequent adverse events associated with palonosetron are similar to those
`seen with other 5-HT3 antagonists and include headache and constipation.
`
`Under the terms of the exclusive license agreement, MGI Ph arm a will make $11 million in upfront payments, already including the
`initial $5 million made upon signature of the letter of intent, and will make additional payments based on the achievement of certain
`milestones through the approval of palonosetron in the U.S. Helsinn will continue to fund and conduct all development
`of palonosetron. MGI Pharma will also pay royalties and product supply fees based upon net sales. Helsinn will supply finished
`product ready for distribution, the active ingredient of which is manufactured at Helsinn's new state-of-the-art facility (Helsinn
`Advanced Synthesis SA) dedicated to the production of high-potency active ingredients.
`
`About MG I Pharma
`
`MGI Pharma, Inc. is an oncology-focused pharmaceutical company that acquires, develops and commercializes proprietary products
`that meet patient needs and build shareholder value. MGI focuses its sales efforts solely in the United States and collaborates with
`other pharmaceutical or biotechnology companies for its products in internati:onal markets. For more information about MGI, please
`visit the Company's web site at mgipharma.com .
`
`Source. Evaluate"' ©2015 Evaluate Ltd, All rights reserved
`0
`Print o--
`Bookmark
`Privacy
`HOME
`Terms & Conditions
`OUR PRODUCTS
`Legal
`LATEST NEWS & INSIGHT
`Careers
`SUPPORT
`Site map
`CONTACT US
`WorkSpace Terms & Conditions
`SHARE THIS PAGE
`© 2015 Evaluate Ltd. ALL RIGHTS RESERVED.
`<img width="1" height="1" alt="" src="http://logw309.xiti.com/hit.xiti?s=558237&s2=&p=&an=&ac=" >
`
`Join Us On HOW WE USE COOKIES
`~
`Twitter
`
`Inserted from <http:ljwww.evaluategroup.com/Universai/View.aspx?type=Story&ud=35967>
`
`General Page 2
`
`Exh. 1035