April 10, 200'1
`
`MG~ Pf~A~MA S~G~S ~XCLUS~~~E
`t.mCEN$~ AGR~EME~T ~\fiTH HELSU~~
`HEAL THCAR,~ SA~
`FOR PALONOSETRO~, A PHAS~ 3 AN1"~"
`~~~~~"flC
`
`MINNEAPOLIS :and LUGANO, SWITZERLAND, April10, 2001 ~- MGJ PHARMA,
`INC., (Nasda:q: MOGN} and HELSINN HEAL THCARE SA, a privately owned
`pharmaceutical group with headquarters in Switzerland, today announced that
`they have signed the definitive agreement granting MGI PHARMA exclusive
`North /\rnerican license and distribution rights to palonosetron. The signing of
`the tetter of intent for this agreement was previously announced in February.
`Palonosetron is a potent and selective
`5-HT 3 antagonist with an
`extended half-life,
`in Phase 3 development
`for
`the prevention of
`chemotherapy-induced nausea and vomiting (CINV). Completion of trm
`Phase 3 trials could allow for NDA {New Drug Application) submission in the first
`half of 2002. When launched, pafonosetron will compete in the $1 billion North
`American ClNV 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
`palonosetmn, 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 PHf\RMA.
`"Paionosetron is another exciting addition to our growing oncology product
`portfolio,
`representing
`anotl1er well--advanced
`prodt.Jct
`that
`can
`be
`commercializecl in the near term."
`"Palonosetron is our first product entry into the United States, and we are
`pleasect to be working with MGt PHARMA for ttle North American distribution of
`this Innovative product in the supportive care segment of oncology," commented
`"We know that MG!
`Rlccardo Braglia, managing director of HFLS!NN.
`PHARMA's proven commercial organization, its experienced oncology sales
`force, and its present and ftJture cornmitrnent to palonasetron's role within the
`5-HT 2. antagonist marketplace will ensure the success of our new partnership.''
`
`When launched as a marketed product, palonosetron will be one of four products
`competing in the $1 billion North American market for 5-HT ;y antagonists. The
`extended half--life of pa!onosetron as compared to the other agents and the
`
`CONFIDENTIAL
`
`Dr. Reddy’s Laboratories, Ltd., et al.
`v.
`Helsinn Healthcare S.A., et al.
`U.S. Patent No. 9,(cid:20)(cid:26)(cid:22),(cid:28)(cid:23)(cid:21)
`HELSN0376719
`Reddy Exhibit 1047
`
`

`
`April 10, 200'1
`
`MG~ Pf~A~MA S~G~S ~XCLUS~~~E
`t.mCEN$~ AGR~EME~T ~\fiTH HELSU~~
`HEAL THCAR,~ SA~
`FOR PALONOSETRO~, A PHAS~ 3 AN1"~"
`~~~~~"flC
`
`MINNEAPOLIS :and LUGANO, SWITZERLAND, April10, 2001 ~- MGJ PHARMA,
`INC., (Nasda:q: MOGN} and HELSINN HEAL THCARE SA, a privately owned
`pharmaceutical group with headquarters in Switzerland, today announced that
`they have signed the definitive agreement granting MGI PHARMA exclusive
`North /\rnerican license and distribution rights to palonosetron. The signing of
`the tetter of intent for this agreement was previously announced in February.
`Palonosetron is a potent and selective
`5-HT 3 antagonist with an
`extended half-life,
`in Phase 3 development
`for
`the prevention of
`chemotherapy-induced nausea and vomiting (CINV). Completion of trm
`Phase 3 trials could allow for NDA {New Drug Application) submission in the first
`half of 2002. When launched, pafonosetron will compete in the $1 billion North
`American ClNV 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
`palonosetmn, 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 PHf\RMA.
`"Paionosetron is another exciting addition to our growing oncology product
`prodt.Jct
`that
`can
`be
`portfolio,
`representing
`anotl1er well--advanced
`commercializecl in the near term."
`"Palonosetron is our first product entry into the United States, and we are
`pleasect to be working with MGt PHARMA for ttle North American distribution of
`this Innovative product in the supportive care segment of oncology," commented
`"We know that MG!
`Rlccardo Braglia, managing director of HFLS!NN.
`PHARMA's proven commercial organization, its experienced oncology sales
`force, and its present and ftJture cornmitrnent to palonasetron's role within the
`5-HT 2. antagonist marketplace will ensure the success of our new partnership.''
`
`When launched as a marketed product, palonosetron will be one of four products
`competing in the $1 billion North American market for 5-HT ;y antagonists. The
`extended half--life of pa!onosetron as compared to the other agents and the
`
`CONFIDENTIAL
`
`HELSN0376719
`
`Exh. 1047
`
`

`
`results of Phase 2 trials assessing efficacy beyond 24 hours differenti<':ltes
`palonosetron from the three currently marketed 5-HT, antagonists indicated for
`CINV.
`CINV is estimated to occur in 85 percent of cancer patients undergoing
`chemotherapy and can result in delay or even discontim.Jation of treatment, and
`the advent .of 5-~·IT3 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 patlents have participated in Phase 1 and Phase 2 tria!s of
`palonosetron, Based on these results, HELSlNN inftiated a Phase 3 clinical trial
`progran1 that is intended to enroll more than 1,900 patients in several well~
`controlled, double-bllnd trials comparing palonosetron to Gurrently available 5-
`HT 3 antagonists - at approximately 80 centers in North America and Europe.
`Based on the extended harf~!ife of paionosetron and the results of the Phase 2
`trial, its efficacy wl!l 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 5hHT3
`antagonists and include headache and constipation,
`
`Under the terms of the exclusive license agreement, MGI PHARMA will make
`$·1·1 million in upfront payments, already including the initial $5 mHlion made
`upon signature of the letter of intent, and will make additional payments based
`on the <.'lchievement of certain milestones through the approval of palonosetron ln
`the U.S, HELS!NN Will continue to fund and conduct a!! development of
`palonosetron. MGl PHARMA wili also pay royalties and product supply fees
`based upon net sales. HELS!NN will supply finished product ready for
`
`PHRRmA
`distribution, the active ingredient of which is rnanufactured at HELS!NN'S new
`state-of-the-art facllity (HELSINN ADVANCED SYNTHESIS SA) dedicated to the
`production of high-potency active ingredients.
`
`About MGt PHAHMA
`
`is an onco!ogy~focused pharmaceutical comp.any that
`MGI PHARMA, I NG.
`acquires. develops and commercializes proprietary products that meet patient
`needs and build shareholder value. MG! focuses its sales efforts solely In the
`United States and collaborates with other pharmaceutical or biotechnology
`
`CONFIDENTIAL
`
`HELSN0376720
`
`Exh. 1047
`
`

`
`comp.:mies for its products in international markets. For more information about
`MGI, please vlslt the Company's web site at \r'\/V\Ivv.mglgt1arma.com,
`
`3
`
`CONFIDENTIAL
`
`HELSN0376721
`
`Exh. 1047