-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, SO2PDzOBh2v+lPJ+41hNPhk4XDde+UvfX3cb7GDcGlfDBkrj0j/2+68JqohrewCl 5KbJFfMxzTdSMNu04kVQsg== 0000950123-07-000965.txt : 20070129 0000950123-07-000965.hdr.sgml : 20070129 20070129152135 ACCESSION NUMBER: 0000950123-07-000965 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 4 CONFORMED PERIOD OF REPORT: 20070125 ITEM INFORMATION: Departure of Directors or Principal Officers; Election of Directors; Appointment of Principal Officers ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20070129 DATE AS OF CHANGE: 20070129 FILER: COMPANY DATA: COMPANY CONFORMED NAME: OSI PHARMACEUTICALS INC CENTRAL INDEX KEY: 0000729922 STANDARD INDUSTRIAL CLASSIFICATION: IN VITRO & IN VIVO DIAGNOSTIC SUBSTANCES [2835] IRS NUMBER: 133159796 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-15190 FILM NUMBER: 07560710 BUSINESS ADDRESS: STREET 1: 41 PINELAWN ROAD CITY: MELVILLE STATE: NY ZIP: 11747 BUSINESS PHONE: 631-962-2000 MAIL ADDRESS: STREET 1: 41 PINELAWN ROAD CITY: MELVILLE STATE: NY ZIP: 11747 FORMER COMPANY: FORMER CONFORMED NAME: ONCOGENE SCIENCE INC DATE OF NAME CHANGE: 19920703 8-K 1 y29622e8vk.htm FORM 8-K FORM 8-K
 

 
 
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
Current Report Pursuant to Section 13 or 15(d) of
The Securities Exchange Act of 1934
January 25, 2007
 
Date of Report (Date of earliest event reported)
OSI PHARMACEUTICALS, INC.
 
(Exact name of registrant as specified in its charter)
         
Delaware   0-15190   13-3159796
         
(State or other jurisdiction of
incorporation)
  (Commission
File Number)
  (I.R.S. Employer
Identification No.)
41 Pinelawn Road
Melville, NY 11747
 
(Address of principal executive offices)
(631) 962-2000
 
(Registrant’s telephone number, including area code)
N/A
 
(Former name or former address, if changed since last report.)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
 
 

 


 

ITEM 5.02. Departure of Directors or Principal Officers; Election of Directors; Appointment of Principal Officers; Compensatory Arrangements of Certain Officers.
     On January 25, 2007, Prosidion Limited, a wholly owned subsidiary of OSI Pharmaceuticals, Inc. (“OSI”), and Dr. Daryl Granner, a member of the Board of Directors of OSI (the “Board of Directors”), entered into a letter agreement (the “Letter Agreement”), which extends the term of the Scientific Advisory Board and Consulting Agreement, dated February 10, 2006 (the “Consulting Agreement”), through December 31, 2007. No other terms of the Consulting Agreement were modified. In consideration for his services under the Consulting Agreement, Dr. Granner receives a monthly fee of at the rate of $75,000 per year until the termination of the Consulting Agreement, and reimbursement of his travel and other out-of-pocket expenses.
     A copy of the Letter Agreement is filed hereto as Exhibit 10.1 and incorporated herein by reference.
     On January 26, 2007, OSI received notice from G. Morgan Browne of his resignation from the Board of Directors in accordance with the terms of OSI’s retirement policy for directors at age 72. Pursuant to the requirements of the retirement policy, the Nominating Committee of the Board of Directors will hold a meeting to consider whether or not Mr. Browne’s resignation should be accepted, and then make a recommendation to the Board of Directors.
ITEM 8.01. Other Events.
     On January 29, 2007, OSI issued a press release announcing that the European Commission has granted marketing authorization for Tarceva® (erlotinib) in combination with gemcitabine as first-line therapy for metastatic pancreatic cancer. A copy of OSI’s press release, dated January 29, 2007, is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
ITEM 9.01. Financial Statements and Exhibits.
     
Exhibit No.   Description
 
   
10.1
  Letter Agreement, dated January 25, 2007, by and between Dr. Daryl Granner and OSI Pharmaceuticals, Inc.
 
   
99.1
  Press release, dated January 29, 2007.

 


 

SIGNATURE
     Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
         
Date: January 29, 2007   OSI PHARMACEUTICALS, INC.
 
 
  By:   /s/ Barbara A. Wood    
    Barbara A. Wood   
    Vice President, General Counsel and Secretary   
 

 


 

     
Exhibit No.   Description
 
   
10.1
  Letter Agreement, dated January 25, 2007, by and between Dr. Daryl Granner and OSI Pharmaceuticals, Inc.
99.1
  Press release, dated January 29, 2007

 

EX-10.1 2 y29622exv10w1.htm EX-10.1: LETTER AGREEMENT EX-10.1
 

EXHIBIT 10.1
[PROSIDION LIMITED LETTERHEAD]
Dr Daryl Granner
Vanderbilt University Medical Centre
707 Light Hall
Nashville
Tennessee 37232
USA
10 January 2007
Dear Sirs
Scientific Advisory Board and Consulting Agreement, dated as of 10th February 2006 between Prosidion Limited and Dr Daryl Granner (the “Agreement”)
This letter will serve as notice of our desire to renew the term of the Agreement for an additional twelve-month period, through to 31st December 2007. All other terms and conditions of the Agreement will remain in full force and effect.
Please indicate your agreement to the foregoing by having both copies of this letter signed by an authorized representative of your company and returning one original, fully signed copy for the attention of Sian Bishop, General Counsel to the address listed above.
SIGNED for and on behalf of:
PROSIDION LIMITED
             
By:   /s/ Anker Lundemose    
         
 
      (Signature)    
Anker Lundemose    
     
 
      (Name Printed)    
January 25, 2007    
     
 
      (Date)    
 
           
ACCEPTED AND AGREED:    
DR DARYL GRANNER    
 
By:   /s/ Daryl K. Granner    
         
 
      (Signature)    
Daryl K. Granner    
     
 
      (Name Printed)    
January 25, 2007    
     
 
      (Date)    

EX-99.1 3 y29622exv99w1.htm EX-99.1: PRESS RELEASE EX-99.1
 

Exhibit 99.1
(OSI Pharmaceuticals, Inc. LOGO)
     
 
  NEWS RELEASE
Contacts:
     
OSI Pharmaceuticals, Inc.
  Burns McClellan, Inc. (representing OSI)
Kathy Galante (Investors/Media)
  Laura Siino (Investors)
Senior Director
  212-213-0006
631-962-2043
  Kathy Nugent (Media)
Kim Wittig (Media)
  205-401-0260
Director
   
212-824-3204
   
OSI PHARMACEUTICALS ANNOUNCES EUROPEAN REGULATORY
APPROVAL OF TARCEVA
â FOR TREATMENT OF PATIENTS WITH
PANCREATIC CANCER
MELVILLE, NY — January 29, 2007 — OSI Pharmaceuticals, Inc. (Nasdaq: OSIP) and Roche, its international partner for Tarcevaâ (erlotinib), announced today that the European Commission has granted marketing authorization for Tarceva in combination with gemcitabine as first-line therapy for metastatic pancreatic cancer. The Tarceva-gemcitabine combination is the only new treatment regimen in a decade to show, in a Phase III clinical trial, a statistically significant improvement in overall survival compared with gemcitabine alone, when administered as initial therapy to patients with advanced stages of pancreatic cancer.
“We are pleased that Tarceva will be available to pancreatic cancer patients throughout the European Union,” said Gabriel Leung, President, (OSI) Oncology. “Advanced pancreatic cancer is very difficult to treat and it is an important advance that Tarceva, when combined with gemcitabine, has been shown to produce a statistically significant increase in survival in a cancer where the average life expectancy for a newly diagnosed patient is only about four months. We hope that patients facing pancreatic cancer, and the healthcare providers who treat them, will benefit from this new treatment option.”
In November 2005, the U.S. Food and Drug Administration (FDA) approved the use of Tarceva in combination with gemcitabine for the first-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer in patients who have not received previous chemotherapy. The approval was based on a pivotal study, which demonstrated a 23% improvement in overall survival with gemcitabine plus Tarceva versus gemcitabine alone. This indication for Tarceva is also approved in 15 other countries worldwide.
-more-

 


 

About Pancreatic Cancer
Pancreatic cancer affects more than 216,000 people worldwide, according to the World Health Organization. In the US, pancreatic cancer accounts for just two percent of new cancer cases each year, but is the fifth leading cause of cancer death. The main risk factors for the disease include advanced age, cigarette smoking, a high-fat diet, diabetes mellitus, chronic inflammation of the pancreas (pancreatitis) — especially hereditary pancreatitis, and a family history of pancreatic cancer. The symptoms vary depending upon the location of the tumor in the pancreas, but include weight loss, abdominal pain and jaundice.
Additional Tarceva Information
Tarceva was approved by the FDA in November 2004 for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) after failure of at least one chemotherapy regimen. Tarceva is a small molecule designed to target the human epidermal growth factor receptor 1 (HER1) pathway, one of the factors critical to cell growth in NSCLC and other solid tumors. HER1, also known as EGFR, is a component of the HER signalling pathway, which plays a role in the formation and growth of numerous cancers. Tarceva is designed to inhibit the tyrosine kinase activity of the HER1 signaling pathway inside the cell, which may block tumor cell growth. Tarceva is the only HER1/EGFR-targeted therapy proven to significantly prolong survival in second-line NSCLC as a single agent.
Results from two earlier large, randomized, placebo-controlled Phase III clinical trials in first-line advanced NSCLC patients showed no clinical benefit with concurrent administration of Tarceva with doublet platinum-based chemotherapy (carboplatin and paclitaxel or gemcitabine and cisplatin) and its use is not recommended in that setting.
For Tarceva full prescribing information, please call 1-877-TARCEVA or visit http://www.tarceva.com.
Tarceva Safety Profile
The safety profile of Tarceva is well established. In the BR.21 NSCLC trial, the most common adverse reactions in patients receiving Tarceva were rash and diarrhea. Grade 3/4 rash and diarrhea occurred in 9 and 6 percent of Tarceva-treated patients, respectively. Rash and diarrhea each resulted in discontinuation of 1 percent of Tarceva-treated patients. Dose reduction for rash and diarrhea was needed for 6 and 1 percent of patients, respectively. Historically, there have been infrequent reports of serious interstitial lung disease (ILD), including fatalities, in patients receiving Tarceva for treatment of NSCLC or other advanced solid tumors. In the pivotal trial in NSCLC, severe pulmonary reactions, including potential cases of interstitial lung disease, were infrequent (0.8 percent) and were equally distributed between treatment arms. The overall incidence of ILD in Tarceva-treated patients from all studies was approximately 0.7 percent.
In the Phase III study in pancreatic cancer, Trial PA3, the most common adverse events reported were fatigue, rash, nausea, anorexia and diarrhea. Rash was reported in 69 percent of patients who received Tarceva plus gemcitabine and in 30 percent of patients who received gemcitabine plus placebo. Diarrhea was reported in 48 percent of patients who received Tarceva plus gemcitabine and in 36 percent of patients who received gemcitabine plus placebo. Two percent of the patients discontinued Tarceva because of rash and 2 percent because of diarrhea. In addition, severe and potential fatal adverse events included interstitial

 


 

lung disease-like complications, myocardial infarction or ischemia, cerebrovascular accident, and microangiopathic hemolytic anemia with thrombocytopenia.
About OSI Pharmaceuticals
OSI Pharmaceuticals is committed to “shaping medicine and changing lives” by discovering, developing and commercializing high-quality and novel pharmaceutical products designed to extend life and/or improve the quality of life for patients with cancer and diabetes/obesity. The Company’s oncology programs are focused on developing molecular targeted therapies designed to change the paradigm of cancer care. OSI’s diabetes/obesity efforts are committed to the generation of novel, targeted therapies for the treatment of type 2 diabetes and obesity. OSI’s flagship product, Tarceva® (erlotinib), is the first drug discovered and developed by OSI to obtain FDA approval and the only EGFR inhibitor to have demonstrated the ability to improve survival in both non-small cell lung cancer and pancreatic cancer patients in certain settings. OSI markets Tarceva through partnerships with Genentech, Inc. in the United States and with Roche throughout the rest of the world. For additional information about OSI, please visit <http://www.osip.com>.
This news release contains forward-looking statements. These statements are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made. Factors that might cause such a difference include, among others, the completion of clinical trials, the FDA and other foreign review processes and other governmental regulation, OSI’s and its collaborators’ abilities to successfully develop and commercialize drug candidates, competition from other pharmaceutical companies, the ability to effectively market products, and other factors described in OSI Pharmaceuticals’ filings with the Securities and Exchange Commission.
# # #

 

GRAPHIC 4 y29622y2962201.gif GRAPHIC begin 644 y29622y2962201.gif M1TE&.#EA80$F`-4@`,C+S*VQLOGY^9B>GM;8V<"1H.OL[*!9<)^DI>#(T+J^ MOZ:KJ_+R\L'%Q<_2TK2XN(@P3/#DZ-W?W^C6W-"MN)`^6+!UB+B#E/CR])A, M9,B?K*AG?-B[Q.3EYH`B0)&7F/___P`````````````````````````````` M```````````````````````````````````````````````````````````` M`````````````````````````````````"'Y!`$``"``+`````!A`28```;_ M0)`0E#@8#Y:A$PNF\_HM'K-;@LKGKB' MXJXO,1"YYPN*6"P4'@6";``?AX@`=HN,C8Z/BX:(AXIF@7(5D&Z#<@=#60D0 M>59K!`$!"(F:JZRM;`X!#JZFJ*IF<')TKFAX>GR@!Q4;I&V2'Y6[RIZ:TMG@X8V3']&V9`=Z%^)B$7H>$][G[/3U9*F'".:4 M9>YZ$?:BI).3!-*W@`CK/7A"`!&!?<>TZ]I%`UZ,CE)L/1=G`U\GB1`&0=.-R6G'`B`TN%N``4/F1B8.W>P@`8!&CAF+-?`$`.&%718 MXA?P`\%0)$".O!D*9KP-)(!X`&W)Z5,`2@^A+%<)[0Z#E4S]P-BR@-M/)!C. M:T!`@,1*7B.&8A6$@=$*))@"T35.TR7;U*JSJ-T#6R%IU7[O\RZ>$V.)G)'[ MH""W$FD&`JP?8)F)!'R3%K@7(I]@&`0,`"ZRD@A`$/K(=`?4L` M,$""3L2WW@<3%GA9?^0$`/_AA4I<*!L(NW4(PH#K-=$!?I-,.,V*Z^EW7DP" ME(@("&2IQ(0%>D!``0884)`'04U$,*0@&/BQ%A,_#21'%KHL<>0<#)W"X@<( M`.#`;C*^APB"AP0P(2(#["=`@QB>,HF&0XPVY@<2@.E0?`'(B8"@@([X3U27E*Z*2'CDID%X<2Z8QWJQY0 M..G!.E&@I^!L:[:*"*RY[8:<@:NJ1B@B(U)*YGI[G4C.`@0,)L&;H39@F0%X M0DC_X@HN&A&U MX`X1+[9\S5.P>PK32NP2_A"Y!(]O\32$L5$FX-T3X7D`17C".LLN$^A-:\P# M^X'`X;)""#"M$'L.RM\D[:'*K[>AW@SJ(3#/^^8TBS'!H;4['T(SLQH:<[/4 M(4ZZ!,!,#*RBUD+@=S,(AISZM3&MJ3R->C^#7'"83`DP2\%0ZLWP.`Y-TJP2@ M72.B.0B8XUNUP5=#O`372Q1,U=`#-!%YY8K'M-^VZ<6U5P8DSP?R_IB^8.N)-2#[[PLR=XP"9482N*5ZJNH>Z MX@&/'SOIZ\INQO/73X.>SMPPT;L3&1@_!`?:'>!Q$\1O9?\3S=E>])9'O2BP MKW2'")CC5E6]Z`VA.68;PE2:M\`+^:=?5E,"UDZ7P>EED$-E*\,!O80\`Y"C M<4.(7]S>D3*[P:UNVO$1R?[')!I&#'GGX\T#_S;")0A`-')JW@8/I[[1Z3"" M3F```12`'V1PB((YO`UCQ-=!\F6MBCDT(NR>\,,&!/&&V,,9@>JCPBNPT`EV MLQ4(,%`_[;P0+3956ST@8>4,86?!%8<05"R3CBA?TV0 MFQS`T)P[[K"./23`FQ#@``$*\H\*/%_SK(?$-JUI2^=`$Y88Z4`H/+*8`L.B M';GV13#(\EE:\B,)PS@$1*U'`J'$T2C?H94F3,!N<=C?L%99O#D"\&]`.T2W M\GC+=`[`6CVTXA/BF4Q"]E)M^*J/2=`3,\Y,0A9A.*8]C3A/K@E3'\3$$#RE M^4IJ#D$`$FI1CW:$JR7H2F-#H,`!X":D6O%OE$)0Y:^.YU`0V!*A0F`GJX0I M&WI"TGG_#!4"+Z9P)34"!Z0DC*;A62",)^F4@UFT*7(7.`ND8D3 M:>($/U`40E%SR<%#J$N>!`TD52*'B*=!#WWTQ`D`4-I0CV*G1R_4ZG:6P`E; M&6LHC/6JVU(VS87XTW,TA6D1.00A8Q!66P/=FAYERM9YO&L(8U6"!/X)N=0` M#C\(Z"?H9--$U^"G?)@5K231$[`S;6:()P6C^^#D&D1,*4I#8&./^!"*B4!V M6#(DPI&NTX<$)`!X<;#N&V'X)%;R;%YR"B%3=3;"@Q+`%.3X_]I+)[G6T*9T M'OA9@`0[%9*BRK4WR-Z)"B0BV9$L.`$@4LO#5KV#([*``\`2`W M=IF0+*8R@/-RZ!!CFXHCK$"1-;;OJ2C9/3*3*=`AJCR8^-Z53CXS"59XFL MV85#]27W/%/(M<"04LFQ+SDM8,A"6*V0)W3C(B,N,@_M([D",)@>X^O'":3Q MLW;,U.B0"A$."$\WF4`!W6$"N9&=4B?$^=7NC$>D'B#T]19`KE`-UX)RL>#" M=A/@P*W).)(>D9NI-V7);9H?#7ZQ:O]Z3-9&8^C!KNGTJ6,V-#(IHM,C*E&% MTTF@>>WIQ=,JD2(LC3B[2%H1ANCT`&1QT7!"`0L6,,(%C!(%+"1@`AI(]C"V M*X0(6/?:V'XV$_0!M M[MMTBP`/>("X[:ANO4".`."6@&R%X!=UYV7?AC1,`_:]&,K$K#`!^$QNZDV; MNX)N2Q$'`--LHVX'=.LQ[I[MN4^D",P`1@&@><.NHB*$-E*UV^ADN/+!G.I;4YTA/NBM9D(5N1M^BTJ=.=3M< MI.@<0;2BA5L\]:Y[?1''G0EVJ1OUKYO][&C@]DIPOG6NH_WM<(\"60"-D+&' :0<[YH'/<][[WJW=DJBG6^86DSO?"]SP(`#L_ ` end
-----END PRIVACY-ENHANCED MESSAGE-----