MGI PHARMA Signs Exclusive License Agreement With Helsinn Healthcare SA, For Palonosetron, a Phase 3 Anti-Emetic

Apr 10, 2001, 01:00 ET from MGI Pharma, Inc.

    MINNEAPOLIS and LUGANO, Switzerland, April 10 /PRNewswire/ --
     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 cancer 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 during the 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 PHARMA 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 MGI 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 international markets.  For more information
 about MGI, please visit the Company's web site at http://www.mgipharma.com
 
     About HELSINN HEALTHCARE SA
     HELSINN ( http://www.helsinn.com ) is a privately owned pharmaceutical
 group with headquarters in Switzerland.  HELSINN'S core business is licensing.
 The company's business strategy is to in-license new chemical entities at a
 certain stage of development.  HELSINN completes the development by performing
 pre-clinical and clinical studies as well as chemical and pharmaceutical
 development through the attainment of market approval in strategic markets
 (USA and Europe).  The finished products and active pharmaceutical ingredients
 are manufactured at HELSINN and supplied to its marketing partners for
 distribution.
 
     This news release contains forward-looking statements that may include
 statements regarding intent, belief or current expectations of the Company and
 its management.  These forward-looking statements are not guarantees of future
 performance and involve a number of risks and uncertainties that may cause the
 Company's actual results to differ materially from the results discussed in
 these statements.  Factors that might affect MGI PHARMA's results include, but
 are not limited to the ability of palonosetron, or MGI PHARMA's other product
 candidates, to be proven safe and effective in humans and to ultimately
 compete successfully with other therapies, development or acquisition of
 additional products, continued sales of MGI PHARMA's marketed products,
 reliance on contract manufacturing, changes in strategic alliances, and other
 risks and uncertainties detailed from time to time in the Company's filings
 with the Securities and Exchange Commission.  MGI PHARMA does not intend to
 update any of the forward-looking statements after the date of this news
 release to conform them to actual results.
 
 

SOURCE MGI Pharma, Inc.
    MINNEAPOLIS and LUGANO, Switzerland, April 10 /PRNewswire/ --
     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 cancer 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 during the 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 PHARMA 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 MGI 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 international markets.  For more information
 about MGI, please visit the Company's web site at http://www.mgipharma.com
 
     About HELSINN HEALTHCARE SA
     HELSINN ( http://www.helsinn.com ) is a privately owned pharmaceutical
 group with headquarters in Switzerland.  HELSINN'S core business is licensing.
 The company's business strategy is to in-license new chemical entities at a
 certain stage of development.  HELSINN completes the development by performing
 pre-clinical and clinical studies as well as chemical and pharmaceutical
 development through the attainment of market approval in strategic markets
 (USA and Europe).  The finished products and active pharmaceutical ingredients
 are manufactured at HELSINN and supplied to its marketing partners for
 distribution.
 
     This news release contains forward-looking statements that may include
 statements regarding intent, belief or current expectations of the Company and
 its management.  These forward-looking statements are not guarantees of future
 performance and involve a number of risks and uncertainties that may cause the
 Company's actual results to differ materially from the results discussed in
 these statements.  Factors that might affect MGI PHARMA's results include, but
 are not limited to the ability of palonosetron, or MGI PHARMA's other product
 candidates, to be proven safe and effective in humans and to ultimately
 compete successfully with other therapies, development or acquisition of
 additional products, continued sales of MGI PHARMA's marketed products,
 reliance on contract manufacturing, changes in strategic alliances, and other
 risks and uncertainties detailed from time to time in the Company's filings
 with the Securities and Exchange Commission.  MGI PHARMA does not intend to
 update any of the forward-looking statements after the date of this news
 release to conform them to actual results.
 
 SOURCE  MGI Pharma, Inc.