`.
`W 9
`\‘\\W.»-.<
`
`1:90-xx
`
`3.‘. .-
`. . . .. ..
`. ‘.'.‘.‘.‘l 5 .. . .
`-.
`3
`.
`:
`E
`'~¢NVi€N\~\u‘\l<%£\'«N5~h.\\\\(Vs§\.'NII&-NRve\s~x‘:\n\\‘c9.‘¢\\\s\u\N'€\
`.~m~n:-a:-
`
`
`
`"~,\\\~
`‘-‘V\\\‘\"‘x\‘7\'v'"W.
`. . ..
`“F\\'\‘K‘23\\\\\‘¢¥\‘A\\V!'?'!€\'?‘P\\‘?2‘t‘3\Y?’,\'&‘.f‘..
`.
`'w-.4.«.a2-
`v.«~««..._.~:.-4.-«.:~.;.u.;¢«¢....-—-(wen-...¢4«1\~s-V.v.-«
`aIonoseir
`
`
`
`amefi ‘“U39<-
`
`’' ’'
`
`
`
`
`
`<man'sa__heimar@ baxter.com>
`<rbh@heieirm.corn>
`17.07.00 23.17.48
`Paionosetron
`
`Dear Racnld.
`Thank you for you ‘mares! in Baxter as a potential licensing partnerfor
`Palonosetrun. As we riscussed on Friday, July 14. we recentty oompleied
`market research as part of -our evaluation of Palonoeetron for the CINV
`indication and potential aweptmoe for a POW indication. I attach a file
`which summarizes the findings.
`(See attached fie: heisinn071300.ppi)
`
`In summary. the findings were positive for CINV. Acceptance and success of
`a new 5HT-3 antagonist wil require substantial ewcetion and aggressive
`promotion as well as a competitive price versus the currently marketed
`products for CINV. Our research also indicated that the POW lndmtion may
`not be viable In light ofthe current market conditions.
`
`As I mentioned in our conversation last Friday Baxter does not yet have an
`established worldwide presence in Oncology. This may be a viable
`opportunity for Baxter in the future but not justified at this line.
`Therefore we are not able to continue worldwide discussions on the '
`licensing oi Palonosetron.
`
`I wish you success with your endeavors and encourage you to contact Baxter
`In the future.
`
`I will return the confidential infomietion binders to you this week.
`
`with Best Regards,
`H .
`.
`
`,1-1,.,).o.<I.L«L ,
`
`HIGHLY CONFIDENTIAL - OUTSIDE COUNSEL EYES ONLY
`
`HELSN0389483
`
`Page 1 of 16
`
`Dr. Reddy's Laboratories, Ltd., et al_ v. Helsinn Healthcare S.A.
`Trial PG R201 6—00OO7
`
`Helsinn Healthcare Exhibit 2061
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`I have consulted our company files and found that palonoseiron has been
`reviewed by Berle): and Schering AG in the past. and was turned down.
`In
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`View of this history, I regret to inform you that there} is no interest in
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`continuing a discussion,
`
`
`
`
`Helena R. Axelrod, PhD.
`
`
`
`
`
`
`From: RBH@heisinn.cQm (Rachid Benharnza) AT lntgrnei an 09123199 0820B AM
`
`
`
`
`
`
`
`
`
`
`i\\\\;a
`
`To: Helena Axelrod/MWUSR/SHG
`
`
`
`cc:
`
`
`
`
`
`
`
`Subject: Licensing oppcnunity - Berlex USA
`
`Dear Dr. Axeirodi,
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`l have been given your nameand Dr. Brown name by your colleague Jess
`Sealer.
`
`I tried to send this eu-«mail to Dr; Brown and call you or him but without
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`success
`
`
`._ Thus I arr: trying your ‘e-amil address hopefully.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`I understand that your are dealing with Oncology products and that you are
`worki
`‘
`
`ng in Dr. Brown team.
`
`
`
`
`
`
`My e-mail to Dr. Brown is also of interest for you I believe and I'd
`
`
`
`
`
`
`
`
`
`
`
`
`
`appreciate if you cauld forward it to him.
`
`
`
`
`
`
`Thank you.
`
`
`
`
`
`
`
`
`
`Dear Dr. Brown‘,
`
`
`
`I have been given your cioordinates by Mr. Jess sesler from year company. I
`
`
`
`
`
`
`
`
`
`
`
`
`under stand you are; respansibile for business development.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Our company, a Swiss Pharmaceutical company. has currently a licensing
`
`
`
`
`
`
`
`
`
`
`opportuni ty for usuand is looking for a partner.
`
`
`
`
`
`
`
`
`
`
`The product is an »anti—emetic and .a'nti—nausea for chemotherapyltreated
`
`patients. The product belongs to the selmn famiiyand has some
`
`
`
`
`
`
`
`
`
`
`outstanding advantages. ov
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`er pier class pmducts. It is in phase lll clinical trials.
`Since Barlex has quiet an important franchise in Oncology I thought you
`
`
`
`
`
`
`
`
`
`
`
`could be interested In this opportunity.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`if this is the case. I wiouldbe glad to send you same non confidential data
`and mejeti with you during my next. trip tr; US beginning of Cictober to..s-Show
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`you further
`
`
`‘
`data.
`
`I look forward to yuur news and remain.
`
`
`
`
`
`
`
`
`
`
`
`b with best regards.
`
`HIGHLY CONFIDENTIAL — OUTSIDE COUNSEL EYES ONLY
`
`
`
`
`Page2 of 16
`
`
`
`HELSN0389563
`
`
`
`r,»;;;,2,-,-;auxxx/////xxx/.;-)5}:
`
`
`
`
`From:
`
`To:
`Date:
`
`Subject:
`
`
`
`<HeIena__Axelrod@berlex.com>
`<RBH@helsin.n.cIom>
`
`9/30/99 3:48pm
`
`
`Re: Licensing opportunity -Berle’); USA
`
`
`
`
`
`
`
`
`
`Page 2 of 16
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`3
`
`=
`
`3
`
`;.
`3-
`I
`
`
`
`
`
`
`
`
`
`
`
`
`
`I II II I
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`I Bristol—Myers Squibb
`
`
`
`Pharmaceutical Research Institute
`PD. Box 4000 Priluxetcn. N] 085434000;
`
`
`
`
`
`
`(SE19 252-5530 Fax: 609 252-3 630
`
`
`
`
`
`kIeung@usccmail.bms.¢om
`
`
`
`
`'
`
`
`
`Vice Frwdenl
`
`Licensing
`
`
`
`April 10, 1999
`
`
`
`
`
`
`
`Ranhid Ben Hamza, Ph.D.Chem
`
`
`Manager, Licensing-Out
`
`Helsinn
`
`
`
`PO Box 357
`
`6915'Pam‘b1o-Notaneo
`
`
`Lugano
`Switzerland
`
`
`
`
`Fax: 41319932122
`
`
`
`
`
`
`
`
`
`Dear Dr. B~enHamza:
`
`
`
`
`
`
`to follow up on your letter ofAp:ri1 9 regarding a SHT3 antagonist, p on<Is§eh‘oi:1
`I am
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`which your company has recently laequired.
`‘I1
`I,.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`We presume that this is the compound, RS 25259, previously under development at Syfniex Iprior
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`to its being acquired by Roche. We have had the opportunity to review the data for thiii molfglcfilee
`
`
`
`
`
`
`
`
`
`
`
`
`‘I
`several
`ago and afler careful consideration, our Licensing Team concluded that} ,
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`I
`does not fit inte our current strategic objective since the anti-emeetic market is extreme!
`
`
`
`
`
`
`
`
`
`
`
`
`
`satisfied and market edynnxnics does not support any fuxther pure 5 HT3 antagonist develop ‘
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`We are, therefore, not be able to pursue this molecule further at this point. Ifuur simatien sliduld
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`change in the future, I will eontact you to revisit collaborative opportunities.
`} V
`I -
`=
`
`
`
`
`
`
`Welthank you for the opportunity to review the compound and wish you the best in theIr
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`development.
`I
`
`
`
`
`
`
`
`
`
`
`
`
`
`K. Alice Leung
`
`we
`
`
`
` A Bristal-Mlw.rs Squibb. Company _
`
`
`
`
`2159:: 292 See LJdZEI:ZI
`
`
`
`
`
`
`
`.
`4?;
`(:55.
`
`
`
`Edd
`
`
`
`
`HIGHLY CONFIDENTIAL — OUTSIDE COUNSEL EYES ONLY
`
`
`
`
`Page 3 of 16
`
`
`
`HELSN0389454
`
`
`
`Page 3 of 16
`
`
`
`
`
`CONFiDENTiAL
`
`
`
`
`Raiohiti Benhamza, F-”h..D.
`
`
`Manager, Licensing-Out
`Heisinn Healthoare SA
`
`
`
`PO. Box 357
`
`
`
`
`
`691$ Pamhio-Noranco (Lugano)
`Switzerland
`
`
`
`
`Dear Rachid:
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Decernher 22, 1999
`\
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`First of all Raohid, I hope you are doing well and have an enjoyabiei holiday and a happy
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`and healthy new year.
`I am sending you this document to mention to you that after a
`
`
`
`
`
`
`
`
`
`
`
`
`careful and thorough review, Cephaion has decided not to further pursue collaboration
`
`
`
`
`
`
`
`
`
`
`
`
`discussions incorporating palonosetron at this point in time. This decision is not meant
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`to be suggestiive of a lack of interest in this interesting product, but was predominantly
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`motivated by our currently restricted internai resources which would not allow us to do
`
`
`
`
`
`
`
`
`
`
`
`
`
`justice to the due diligence that the development of a product such as palotnosetron
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`deserves.
`I want to take this opportunity to thank you for being gracious enough to
`
`
`
`
`
`
`
`
`
`
`
`
`share this opportunity with Cephalon and for being forthcoming with your information on
`
`
`
`this intriguing product.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Let's. continue to keep in touch because I am confident that there will certainly be
`
`
`
`
`
`
`
`
`
`
`opportunities for a future Heisinn/Cephaion strategic alliance.
`In this regard, I would be
`
`
`
`
`
`
`
`
`
`
`
`extremely interested (anti appreciative) in hearing about other products in I-ieisinn’s
`
`
`
`
`
`
`
`
`
`
`
`
`portfolio aindfor pipeline that are open to collaboration ::li»scuss,io1ns' as they come about
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`If you have any questions with regard to the aforementioned, pietase do not hesitate to
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Contact me at (610) 738-6355. Thank you for your attention to this document and I
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`hope to see you again in the year 2006, possibly at an upcoming licensing conference.
`
`Kind Re
`
`it
`I
`erry Sega!
`
`
`
`Director, Licensing and Acquisitions
`
`
`Cephalon, Inc.
`
`
`(610) 738-6355
`Phone:
`
`
`
`(610 ?3j8~563’il5
`Fax:
`i<segaI@cephaion.com
`E-mail:‘
`
`
`
`
`
`
`
`
`
`
`
`
`
`HIGHLY CONFIDENTIAL — OUTSIDE COUNSEL EYES ONLY
`
`
`
`
`Page 4 of 16
`
`
`
`HELSN0389779
`
`
`
`Page 4 of 16
`
`
`
`@991
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
` =3 FAX ii§‘$I}$.5S3.%§§}
`
`
`
`
`GQULTER BUS DE?
`
`
`
`Swim“
`
`FHt~;mesA{:Eu.?ar;A L
`
`Via Fax: D3,}-I}l»9°S°3—2122 August 3%, 1999
`
`
`
`
`
`
`
`
`
`
`
`
`
`Raohid Benflamza, Phil, Chem
`
`
`
`
`
`
`Managar, L~icensIing—0ut
`Helsinn Heralthcare SA
`
`
`
`ES 15. Pambio-Noranco
`
`
`RG9. Box 357
`
`
`Lugaxm, Swizeriand
`
`
`
`
`Dear Rachid,
`
`
`
`Thank you fiar your recent e-ail and vcrice maii. Since my hat sorrespcmdence withVEric'h Hahn, we
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`have discussed paltmosatron in mom: detail internally. We have dscided, unfortunataiy, not so} wntinuc
`
`
`
`
`
`
`pursuing this crpporizunity at this time.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`our concerns center mainly around the competitive environment and th: pussgibly of generic Brusinn unce-
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Kytril and Zofran are offpatem. Additiomsliy, we were concealed about the lack of an oral alternative as
`
`
`
`
`
`
`
`
`
`
`
`
`well as the strength of the Iefficacy dam ctrtnpared ta altemativc compounds.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`I fhankyeu fur the oppanunily to ltmk :31 this ‘Iain: stage compound and wish yau the best in partnering
`
`
`
`
`
`
`
`
`
`
`
`
`palonomtron. I hcpevwe will .h.ave oppmtunifies to work. togethexr in the future.
`
`
`
`
`
`Best Regards,
`
`JeanneJew?
`
`
`
`
`
`
`
`Sr. Director, Business Development
`
`
`
`
`cs:
`
`
`
`
`Erich Hahn (H.-aim fiussaciatas}
`Arlene Mun-is
`
`
`
`
`
`$83 fizetwrasf Bauievard 9 Sgzuth San Fmnciscn. €CIai’rfnmia M883->?I‘2-i~§ I‘ e35€)553.2{¥QD 9 Fax: -£sSCI,.i%S3.2('2‘25
`
`HIGHLY CONFIDENTIAL — OUTSIDE COUNSEL EYES ONLY
`
`
`
`
`Page 5 of 16
`
`
`
`HELSN0389725
`
`
`
`Page 5 of 16
`
`
`
`
`
`¢.'<r.{;'_A
`
`
`
`From:
`
`To:
`Date:
`
`Subject:
`
`
`
`Alex,
`
`
`
`"Moody, Dewey" »<dmoody@ctiseatt1!e.cjom>
`
`
`
`
`
`“Alessandro Boss?“ <BA@helsinn.com>
`‘l2'..O6.0Ci 19,38,,54
`
`
`RE: B.usin.es_s opportunity
`
`
`
`
`
`
`
`C'3nQ€i<iiL€:
`
`
`First, an apology for my tardy reply due to my ‘intervening vacation.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`My early optimism on Palonsetron was not matched by my collfisguesiin our
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`clinical group. The consensus was that even with the improved safety and
`
`
`
`
`
`efficacy profile, this field wastoo crowded for CTI to consider making an
`
`
`
`
`
`
`
`
`entry. Thus we must ‘decline additional interest in this compound.
`
`
`
`
`
`
`
`
`
`
`
`
`
`I wish you good luck. with your partnering efforts.
`
`
`
`
`
`
`
`
`
`
`Sincerely,
`
`
`
`D. Moody
`
`
`
`
`I
`.
`> ..«-Original Mess—age~---—
`
`
`
`
`
`
`Alessandro Bossi‘ [S’MTP:_BA@helsinn.com]
`.> From:
`Wednesday. May 31, 20,00 6:25. AM
`> Sent:
`
`
`
`
`
`> To: Dmoody@ctiseattle.com
`
`
`
`
`
`>
`> Subject:
`Business opportunity
`
`
`
`
`
`
`
`Dear Dewey
`
`
`
`
`2 >
`
`
`
`
`
`
`
`
`
`
`
`
`
`Two weeks ago, you were provided with some literature on Palonosetron and
`
`
`> Helsinn. My understanding, from our initial conversation, is that Cell
`
`
`
`
`
`
`
`
`
`> Therapeutic (CT) is interested in entertaining into discussions on this
`
`
`
`
`
`
`
`
`
`
`
`> business opportunity.
`
`
`
`
`In this event, I would like to proceed as follows:
`
`
`
`
`
`
`
`
`
`
`
`> >
`
`
`> >
`
`1) CT and Helsinn to sign a ICDA.
`
`
`
`
`
`
`
`
`
`
`
`> 2) Helsinn to give a presentation on Palonosetron at your offices andto
`
`
`
`
`
`
`
`
`
`
`> discuss the pmject strategy.
`
`
`
`
`
`3-) Helsinn to provide the confidential package on the product.
`
`
`
`
`
`
`
`
`
`
`
`> 4) CT to prepare a 5-year forecast.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`> 5) CT and Helsinn to negotiate the general business terms and the
`> agreement.
`
`
`I envision that this
`‘ Please advise if this schedule is acceptable to you.
`
`
`
`
`
`
`
`
`
`
`
`
`> schedule will be fulfilled in June.
`I will be back to the office on
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`> Monday 5.
`
`
`
`
`
`
`
`
`
`
`
`> >
`
`I look forward to hearing from you soon.
`
`
`
`
`
`
`
`
`
`
`
`
`
`> >
`
`
`> >
`
`= Best regards
`
`> Alex
`
`
`> >
`
`
`
`
`
`
`
`
`
`Alex Bossi
`
`
`> Director Business Development North America
`
`
`
`
`
`> Helsinn Healthcar.e:SA
`
`
`
`
`> PO Box 35?
`
`
`> 6915 Pamblo-Norah-:0
`
`
`
`’> (Lugano) Switzerland
`
`
`HIGHLY CONFIDENTIAL — OUTSIDE COUNSEL EYES ONLY
`
`
`
`
`Page6 of 16
`
`
`
`HELSN0389568
`
`
`
`Page 6 of 16
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`> Phone: i011E41-91-985-21421
`
`
`
`
`
`> Fax: 01141-91-993-21—22
`> e-maiiiz ba@heIsinn.1:Som
`
`
`
`
`
`HIGHLY CONFIDENTIAL — OUTSIDE COUNSEL EYES ONLY
`
`
`
`
`Page 7 of 16
`
`
`
`HELSN0389569
`
`
`
`Page 7 of 16
`
`
`
`
`§.§§£fy Rmsearni: L:aE3::sr2a&z:rE::s..L.L......
`
`
`A Dsxzéssors of £35 Lem: gm: CL2;3m;3e.flf'
`
`
`
`
`
`
`
`:_3Bv CL~.z‘_o<:r:a$s: C:ant';%.r
`'
`
`
`
`Ermismpcfis. §:‘EdI:':l'}3 48285
`
`
`
`
`'s_-'V:T)Ir_I_ FMS.
`:}i‘>I‘.(1 5:5,
`
`
`
`"s-‘am: .7’.-ez5‘ra'&‘.:: F3$’i5$‘.-‘Ch .t7~'cs4:::_w:-;%'43x‘a
`
`
`
`
`
`
`_
`E
`
`
`Apfil 15, 1999
`
`
`
`
`
`
`Rachid Benflamza, PILD.
`
`
`
`I-Ielsiml Healthcare SA
`
`
`
`P.O‘. Box 35?
`
`
`6915 Pambio-Noranco
`
`
`Lugano, Switzerland
`
`
`
`
`Dear Dr. Bcnflamzaz
`
`Re: Palonosetron
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Thank you for your letter af April 9, 1999 regarding
`
`Paionosetron.
`
`
`
`
`
`
`
`
`
`
`The informatinn you pmvided is impressive and as y-an
`
`
`
`
`
`
`
`
`described it, may have pmmising. future potential. However,
`
`
`
`
`
`
`
`
`
`
`given our am"-rent business priorit—ies and areas of focus, we axe
`
`
`
`
`
`
`
`
`
`
`
`unable ti} pursue} further discussions on this oppommity at this
`
`time.
`
`
`
`
`
`
`
`
`
`
`
`We very much appreciate your consideration ofEli Lilly and
`
`
`
`
`
`
`
`
`
`Company for this interesting opportunity and hope you will
`
`
`
`
`
`
`consider us -again in the future.
`
`Sincerely,
`
`
`
`
`
`
`
`
`
`HIGHLY CONFIDENTIAL — OUTSIDE COUNSEL EYES ONLY
`Page 8 of 16
`
`
`
`HELSN0389817
`
`
`
`Page 8 of 16
`
`
`
` s:::::se«a
`
`t‘.-9&3» ;““{‘L
`.
`s s
`
`I
`
`DIRECT L1NE:2l2-224—6873 ‘:4 gt ;_,
`{Lise
`some
`
`I
`
`
`
`M,
`L
`_
`
`
`
`
`«Rachid Benhamza, Ph.Di Chem.
`
`
`
`Manager, Licensing Out
`
`Helsinn I-Iealtheaxe SA
`
`
`PO. Box 357
`
`
`
`
`
`6915 Pambi_o—Noranco (Lugano)
`
`
`
`
`Dearkaichid,
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Thank you for giving Forest Laboratories the opportunity to review palonosetron. We have
`
`
`
`
`
`
`
`
`
`
`
`made a business decision not to pursue a partnership for the marketing of palonosetron.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Although Forest believes palonosetron will receive approval, we do not believe ‘that, for Forest,
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`the net income justifies the expenses involved with marketing of the product necessary to gain
`
`
`market share.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Based upon our marketing research, Oncologists would use palonosetron in about 15% of their
`
`
`
`
`
`
`
`
`
`
`
`
`patients.“
`physicians seem content withithe anti-emetic alternatives available today and
`
`
`
`
`
`
`
`
`
`
`
`prescribesrbased upon a favorable: pricing, contract negotiated directly with the company. We
`
`
`
`
`
`
`
`
`
`
`
`have enclosed some details of the marketing research we had conducted.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Regarding the Anzemet patent situ_ation,l we urge you to be careful while eons-idering its impact
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`on your strategic plan. You
`that you spoke with FDA and they told you there, was an
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`extension to 2011. The FDA now updates the Orange Book on a daily basis on-line and no such
`
`
`
`
`
`extension appears as oflyestmday.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Again, thank you for considering Forest Laboratories as a potential partner. We wish Helsinn
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`the best of luck for the successful development and marketing ofLpalonosetron. Please feel free
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`to contact meif‘ you have any questions. We look forward to continued interactions with
`I-Ielsinn.
`
`
`
`
`Best Regards,
`
`Scott Kozak
`
`
`
`Director of Licensing
`
`
`
`/sbk
`
`
`
`
`
`
`enclosure: Marketing Research (Kurkowsky 1/2000)
`
`
`
`HIGHLY CONFIDENTIAL — OUTSIDE COUNSEL EYES ONLY
`
`
`
`
`Page 9 of 16
`
`
`
`HELSN0389797
`
`
`
`Page 9 of 16
`
`
`
`
`
`ta
`
`*
`
`-
`
`.
`
`Fujisawa Healthcare. Inc.
`
`
`
`Parkway North Center, Three Parkway North
`
`
`
`
`
`
`Deerfield, Illinois 60015-2548
`
`
`
`TeI.: 847l317-8800
`Fax: 847/317-5977
`
`
`
`
`
`
`
`
`September 22, 1999
`
`
`
`
`
`
`
`
`Rachid BenHamza, Ph.D. Chem
`
`
`Manager, Licensing-Out
`Helsinn
`
`P.O. Box 357
`
`
`
`Pambio—Noranco
`Switzerland
`
`
`
`
`
`
`Dear Dr. BenHamza:
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Thank you very much for your recent faxes and phone call regarding Palonsetron, your
`
`
`
`
`Phase III 5HT3 antagonist product.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`While we have reviewed this opportunity and found it interesting, it does not fit with
`
`
`
`
`
`
`
`
`
`
`Fujisawa‘s current strategic focus and we must regretfully decline further consideration.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Thank you for considering Fujisawa as a potential business partner. Please keep us in
`
`
`
`
`
`
`
`
`
`mind if other opportunities should occur in the future.
`
`Sincerely,
`
`
`
`/3’/5/cfla/147K z/031‘
`
`
`
`
`B. Richard Vogt. Ph.D.
`Vice President
`
`
`
`
`
`
`New Product Planning and Licensing
`
`
`
`BRV/avr
`1577
`
`
`
`
`
`
`
`
`
`HIGHLY CONFIDENTIAL - OUTSIDE COUNSEL EYES ONLY
`
`Page 10 of 16
`
`HELSNO394974
`
`
`
`Page 10 of 16
`
`
`
`
` i'§i"E7"Fi"§”ii7t”§'§i‘is’i’3“E“iE”iii‘3”7F?E:
`
`i_i‘<:’€ii
`
`
`infi 6i5p§i5”iT:I"i‘i’iT"'"
`”
`”
`'“m”"‘W‘W"”
`‘
`“Mi
`
`....
`
`Pa‘gei
`
`‘Waits, Alan“ <A|an.Walts@genzyme.com>
`
`
`Rachid Benhamza <RBH@helsinn.com>
`
`
`
`
`12.05.00 14.4328
`
`
`
`RE: Licensing opportunity
`
`
`
`
`
`
`
`eeeyrie ~oee
`
`Q
`
`hf/‘ Q
`23
`fix
`
`
`
`
`From:
`To:
`
`
`Date:
`Subject:
`Dear Rachid,
`
`
`
`
`P
`gh
`I
`a
`
`Thank you very much for contacting me regarding the opportunity to
`
`
`
`
`
`
`
`
`
`
`
`
`commercialize Palonosetron. As promised. i have spoken with a number of my
`
`
`
`
`
`
`
`
`
`
`colleagues in both our Molecular Onooiogy and Therapeutics divisions
`
`
`
`
`
`
`
`
`
`regarding this opportunity.
`
`
`
`
`We have concluded that while the drug itself looks interesting. it does not
`
`
`
`
`
`
`
`
`
`
`
`
`fit with Genzymes commercial infrastructure and strategic focus. We
`
`
`
`
`
`
`
`
`
`
`believe that in order to realize the full potential of Palonosetron a
`
`
`
`
`
`
`
`
`
`
`
`sizable and focused sales and marketing effort will be required. Genzyme
`
`
`
`
`
`
`
`
`
`
`simply does not have the kind of sales and marketing resources that this
`
`
`
`
`
`
`
`
`
`
`
`
`
`product will require.
`
`
`
`
`
`
`
`
`Thank you again for contacting me, and I hope that you will consider Genzyme
`
`
`
`
`
`
`
`
`
`
`
`
`again in the future for other opportunities that may arise.
`
`
`
`
`
`
`
`
`
`
`
`
`
`All the best,
`
`
`
`
`
`Alan Waits
`
`
`
`
`Alan E. Waits
`
`
`
`Vice President, Corporate Development
`
`
`
`Genzyme Corporation
`
`
`One Kendall Square
`
`
`
`Cambridge, MA 02139
`
`
`
`aIan.walts@genzyme.com
`Offioe: 6172252-7656
`
`
`Fax: 617-374-7229
`
`
`
`
`
`
`
`
`----Original Message~—--
`
`From: Rachid Benhamza [mailto:RBH@heIsinn.com]
`
`
`
`Sent: Thursday, April 20, 2000 12:03 PM
`
`
`
`
`
`To: alan.walts@genzyme.oom
`
`
`Subject: Licensing opportunity
`
`
`
`
`
`
`Dear Alan,
`
`
`following our today phone conversation I am glad to attach the non
`
`
`
`
`
`
`
`
`
`
`confidential profile of Palonosetron, our new licensing opportunity.
`
`
`
`
`
`
`
`
`
`
`
`Palonosetron belongs to the new generation of antiemetics and antinauseants
`
`
`
`
`
`
`
`
`
`drugs : the serotonin antagonists (5-HT3). This class has 3 drugs
`
`
`
`
`
`
`
`
`
`commercialized in USA by resp. GW (Zofran), SB (Kytril) and HMR (Anzemet)
`
`
`
`
`
`
`
`
`
`
`
`with total sales of $ 797 millions in 1999, growing 19 '70 vs. 1998.
`
`
`
`
`
`
`
`
`
`
`
`
`The drugs are used in Supportive Care for the prevention of nausea and
`
`
`
`
`
`
`
`
`
`
`
`
`vomiting in chemotherapy treated patients.
`
`
`
`
`
`
`
`
`
`
`
`
`Palonosetron has been reviewed with the FDA at an end of phase 2 meeting in
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`March 99 while a month ago we have received the FDA first approval for the
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`firs! phase 3 clinical trials. Those studies will be run in USA and Europe.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`HIGHLY CONFIDENTIAL - OUTSIDE COUNSEL EYES ONLY
`
`
`
`
`Page 1 1 of 16
`
`
`
`HELSN0395041
`
`
`
`Page 11 of 16
`
`
`
`{Rachiaeenhamza-RE:Lettergrinigptiiex
`v...__....'......._...._.:....
`. Mm.
`.......
`«
`
`"’_"’"""M'"'""
`
`'
`
`“
`
`"
`
`‘
`
`i
`
`From:
`To:
`Date:
`Subject:
`Dear Alex;
`
`<ajecminek@ilexonc.corn>
`<BA@he|sinn.com>
`14.09.00 00:10:14
`RE: Letter of intent ILEX
`
`,s’
`
`,2
`
`I apologize for not getting back to you sooner; however, we just were able
`to make our presentation to the ILEX executive management team late last
`week and then I was out of the office until today. Unfortunately. I must
`inform you that the decision from the executive team was to turn down the
`offered opportunity for several reasons relating mainly to ILEX's focus and
`sales/marketing strategy. In particular, ILEX views Palonosetron primarily
`as a marketing play since the antiemtic marketplace is reasonably satisfied
`with existing treatments (with generic competition looming in the next 3-5
`years). and ILEX is not prepared at this time to make the investment
`required to effectively compete in this market without a product which will
`have a clear technical advantage. While we can see scenarios which wll give
`us the market penetration you are suggesting by your forecast, your forecast
`corresponds to our optimistic case and we can not exclude probable forecasts
`which will not justify the required up-thont investments. in addition.
`lLEX's primary focus has been and continues to be cancer treatment and/or
`prevention and antiemtics. while cancer related, do not fall within our
`primary focus or core expertise. Finally, our management team felt that the
`cost for completing due diligence was rather steep. particularly since the
`potential outcome of the phase III trial and potential label claim was an
`important factor in ascertaining the market potential of the product. I am
`personally sorry that we could not find a way to work together on this
`product and hope you will keep us in mind if other, perhaps more
`appropriate, opportunities become available. Best wishes. Al Jecmlnek
`
`-—-Original Message——-
`From: Alessandro Bcssi [mailto:BA@he|sinn.com]
`Sent: Tuesday. July 25. 2000 7:07 AM
`To: a]ecminek@llexonc.com
`Cc: twii|iamson@llexonc.com
`Subject Fwd: Letter oi Intent ILEX
`
`Dear Al
`
`Attached please fnd the draft Letter of intent (LOI) for your review.
`Please share it with Ze'ev, Tim and Amy.
`
`You will notice that the LOI outlines the business toms and conditions
`discussed during our meeting at your offices on July 14. The significant
`parts of the document are summarized as follows:
`
`1) Clause #1: The intent of the LOI is to set the business guidelines which
`will smoothly lead the two Parties into the final negotiation of the
`Distribution Agreement thus optimizing the efforts and the time required to
`pursue this goal. Once the L0! is discussed and executed. the two Parties
`will, in good faith, negotiate the final agreement.
`
`Annex A outlines these business terms and milestones payments.
`minimize llex's risks and financial obligations, the licensing fees
`(milestones payments) have been distributed over a 3-year period.
`
`in order to
`
`In the same spirit of above, the disclosure of the most
`2) Clause #4:
`critical and confidential documentation on Palonosetron is subject to a
`
`HIGHLY CONFIDENTIAL - OUTSIDE COUNSEL EYES ONLY
`
`HELSN0395073
`
`Page 12 of 16
`
`
`
`
`
`......_.._»._._~..M_._._..__...__...___.-d._...-....—...._...._"__...
`
`
` m_
`,.
`2
`f§E??fi? 's”$s§?n?37Sumrnary
`I‘
`
`399 E
`
`From:
`To:
`Date:
`Subject:
`
`Dear Rachld.
`
`"Allen. Russell" <RAlen@ligand.com>
`"'RBH@heIsinn.com" <RB'Fl@h‘e|sinn.oom>
`3.06.00 02.38.22
`Ligand Assessment Summary
`
`Li
`
`A [Q
`
`r-* USIY
`
`K-J
`
`Per your request, I‘m attaching a copy of our summary assessment for
`Palonosetron which resulted In the reduced interest by us in this
`opportunity. We never reforecast potential sales for this compound
`following this medicallteohnical assessment but would be pleased to share
`our observations with you should you wish. Hope this is helpful background
`for our upcoming oonferenoe call.
`
`Best regards,
`
`Russ Allen
`
`attachment PowerPoint overhead charts (4)
`
`00:
`
`‘EU. Ron“ <REld@|igand.com>, "Greener. Patrich" <PGreener@ligand.oom>
`
`HIGHLY CONFIDENTIAL - OUTSIDE COUNSEL EYES ONLY
`
`HELSN0395202
`
`Page 13 of 16
`
`
`
`COMPANY, INC. _
`i§iPosoME
`February 22, 2000
`
`‘59
`
`K
`
`Elena Magisfocchi
`Helsinn Healfhcare SA
`P.O. Box 367
`6915 Pdmbio-Noranco
`Lugano, Switzerland
`091-985-21-2!
`
`‘
`
`’
`
`Dear Ms. Mcrgistocchi:
`
`In foi|ow—up1’o your fax of February 10"‘ 2000. enclosed is the confidential
`material on Palonoseiron that you requested be returned.
`
`Thank you for considering The Uposome Company as a potential
`commercialization parrner for Palonoseiron.
`
`Sincerely,
`
`W
`
`1
`
`David carpi
`
`One Research Way
`
`Princeton Forrestai Center
`
`Pnnceion, New Jersey 08540-8619
`
`{(309} 452-7060
`
`Teiefax. (603: 452-1890
`
`HIGHLY CONFIDENTIAL - OUTSIDE COUNSEL EYES ONLY
`
`HELSN0395136
`
`Page 14 of 16
`
`
`
`
`
`ins,
`irrlersie is
`
`
`
`
`tiomsn Hesiitn
`=3
`
`
`
`
`
`
`FIG. fies £3
`
`
`
`West son: et 'ass:ss-ss:n
`Ry».
`/2.»;
`2.3"”
`.,«e‘'’‘‘
`5
`M 4:” M3!
`
`K”
`5}
`1‘
`E
`
`
`
`‘
`
`:1 73
`‘.«‘‘’v3‘‘‘‘\,
`H~::s§.s,«rie.»e'ss
`
`
`
`October 4, 1999
`
`
`
`
`
`
`
`
`Raehid Ben-Hamza, Ph.D. Chem
`
`
`Manager, Licensing-Out
`Helsinn Healthcare SA
`
`
`
`P.O. Box 357
`
`
`
`6915 Pambio—Noranco
`
`
`
`Lugano, Switzerland
`
`
`
`Dear Dr. Be:n~Ha1-nza:
`
`
`
`
`
`
`
`Thank you for your letter of September 20* regarding palonosetron, an antimausea &
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`anti-vomiting agent currently in Phase 2.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Merck & C0,, Inc. routinely receives unsolicited correspondence regarding product and
`
`
`
`
`
`
`
`
`
`
`
`
`promotional ideas, inventions, and suggestions. In some cases, this information is new;
`
`
`
`
`
`
`
`
`
`
`
`
`
`however, in other cases, the information may already be under review or development.
`
`
`
`
`
`
`
`
`
`
`
`
`
`Accordingly, it is our understanding that your submission has not been made in
`
`
`
`
`
`
`
`
`
`
`
`confidence, so we will not regard the disclosed information as confidential.
`
`
`
`
`
`
`
`
`
`
`
`
`
`Your submission has been reviewed internally. At this time, however, Merck is not
`
`
`
`
`
`sufficiently interested in the submission.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`While we understand our decision may be disappointing, we do thank you for your
`
`
`
`
`
`
`interest in Merck & Co, Inc.
`
`
`
`Sincerely,
`
`
`
`ffgd 5§l.r"l’\W
`
`Jill Tran
`
`
`
`
`Manager, Business Development
`
`
`
`CONFIDENTIAL
`
`
`Page 15 of 16
`
`HELSN0395207
`
`
`
`Page 15 of 16
`
`
`
`
`.:_.::.....-:
`= _,... .. ».
`
`
`
`
` Egehifi‘ ié»i‘r'='*ié..:I?€,‘-%’=. :;;;;“’ " "
`
`
`
`wnYa32zamemmmn22»m2=am«mnm»w.;swmmmmay;.w:amsm.mnm-« -'.:m.L-;;,~m«;.x:::zz,\~.mg'vc.-.~..-g-.mme.w;.\~¢».a~ v
`gauge 1 .
`
`w ewmew-us/I:
`
`
`
`
`
`Fmm:
`
`To:
`Date:
`
`
`Subjeat;
`
`
`
`wichaati.masierson@‘Iappharma.cam:o
`
`
`
`"Fxanhid Eerm‘am:a“ <:RBH@heI5inn.00m>~
`29.12.95 19:23:35
`
`
`
`Hie: Palaniisfiiifdn
`
`
`near Racfiics,
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`I regret to say that I have disappointing news; regarding our azcmiirmeti
`
`
`
`
`
`
`
`
`evaaiuation of Painnoaeimn, We have {eceniiy cnmpleted mgr finansiai pi-an
`
`
`
`
`
`
`
`
`
`
`
`
`
`for the year 2005 and a Long Range PIan (LRP) carmnuing mrcugh 2999. (me
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`6f the: prin‘::ig3Ie mpicsa of discuassiun in the LR?‘ was the focus =11’ future
`
`
`
`
`
`
`Iicensing mejects reiattive In fine saies and pmfii potentiai of wt
`
`
`
`
`
`
`
`
`
`currentproducts and pipsiines.
`
`
`
`
`
`
`
`
`
`
`
`Unforiunateiy, an anaiysis of our current pratiucts and pipeline reveals
`
`
`
`
`
`
`
`
`
`
`
`
`
`that we have mare than a sufficient number cf gzradueta in deveiapment ta
`
`
`
`
`
`
`
`
`
`
`
`
`meet mar Iaunch, sales and profit requirements thmugn the next five er six
`
`
`
`
`
`
`
`
`
`
`
`
`years. As a rzasuét, wa have determinad that our needs are far eariy siage
`
`
`
`
`
`
`
`ipraciinicai ar eariy Phase I) appcrtunifies.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Gfiviera this new fumes, ii does‘ 210% amfiear as ‘though we wiia be abfie to move
`
`
`farmer with GUI‘ evaluation of Palcsiosiemsn.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`It is my sincere Imps that despite mi5Eiurn at events, we will be 3333:; tea
`
`
`
`
`
`
`
`find other appmtunitieas to work tcigether in the future.
`!3iven*tI1e nature
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`9:‘ cur companies. it certainly appeass that it should be possibie In find
`
`
`
`
`opparkunities sf mutual benefit.
`
`
`
`
`Sinnereiy-I
`
`Rish
`
`
`
`
`
`
`
`
`
`
`"Rachid* Benhamza" <RBH@heI4s5nn.conr> cm 1211339 flB:54:I20 AM
`
`
`
`To: «richa:ti.masiersnn@~Iappharma.cnrn>
`"Arieiia Gottardi" <AG.HHCFO,HHC@heIsinn.mm>
`cc:
`
`
`
`
`
`
`
`
`Suhjeozttz ’Pa,I,onc3setroLn
`
`"‘* Secret M‘
`
`
`
`
`D38!‘ Réch,
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`during and of January H! be traveling in U8A with our American
`
`
`
`
`
`
`
`
`
`
`ccmsuitani. This person is able in present tha scieniific data on
`
`
`Paioraose’-Imn and discuss them with nun‘ pmantiai paiinara.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`I wander whether this couid be a guild oppariunity for you and arrange a
`
`
`
`
`
`
`
`
`
`
`
`meeting with yum" scientists: in dismiss more Ilmrcrughly abs at the prczduct ‘.7
`
`
`
`
`
`
`
`
`
`
`
`If yes, then piease give me few dates during 3rd andinr 41!-I week of January
`
`
`
`
`to meet.
`
`
`
`
`
`Looking forward to your news.
`
`
`
`
`Rachid.
`
`
`HIGHLY CONFIDENTIAL — OUTSIDE COUNSEL EYES ONLY
`
`
`
`
`Page 16 of 16
`
`
`
`HELSN0389855
`
`
`
`Page 16 of 16