-----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, SCtBfBmW9spoSKe673hN3rnka6Aomq9j2fLFqkPusgLEH4X9FYRUNakah6u6vf6e elwjENQaGUtYeZpqE0NFDA== 0000950123-05-011500.txt : 20050926 0000950123-05-011500.hdr.sgml : 20050926 20050926170901 ACCESSION NUMBER: 0000950123-05-011500 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 9 CONFORMED PERIOD OF REPORT: 20050913 ITEM INFORMATION: Entry into a Material Definitive Agreement ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20050926 DATE AS OF CHANGE: 20050926 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: 1204 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-15190 FILM NUMBER: 051103412 BUSINESS ADDRESS: STREET 1: 58 SOUTH SERVICE RD. STREET 2: SUITE 110 CITY: MELVILLE STATE: NY ZIP: 11747 BUSINESS PHONE: 631-962-2000 MAIL ADDRESS: STREET 1: 58 SOUTH SERVICE RD. STREET 2: SUITE 110 CITY: MELVILLE STATE: NY ZIP: 11747 FORMER COMPANY: FORMER CONFORMED NAME: ONCOGENE SCIENCE INC DATE OF NAME CHANGE: 19920703 8-K 1 y13070e8vk.htm FORM 8-K 8-K
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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
September 13, 2005
 
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.)
58 South Service 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:
o   Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o   Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o   Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o   Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
 
 

 


TABLE OF CONTENTS

ITEM 1.01 Entry into a Material Definitive Agreement
ITEM 8.01 Other Events
ITEM 9.01 Exhibits
SIGNATURE
EXHIBIT INDEX
EX-10.1: SERVICE CONTRACT
EX-10.2: COMPENSATORY ARRANGEMENTS
EX-10.3: CHANGE IN CONTROL AGREEMENT
EX-10.4: AMENDED LETTER AGREEMENT
EX-10.5: AMENDED CHANGE IN CONTROL AGREEMENT
EX-99.1: PRESS RELEASE
EX-99.2: PRESS RELEASE
EX-99.3: PRESS RELEASE


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ITEM 1.01 Entry into a Material Definitive Agreement
     On September 20, 2005, the Compensation Committee of the Board of Directors of OSI Pharmaceuticals, Inc. (“OSI”) approved the terms of a Service Contract between Prosidion Limited, OSI’s wholly-owned subsidiary, and Dr. Anker Lundemose, pursuant to which Dr. Lundemose will serve as Chief Executive Officer of Prosidion Limited, President of (OSI) Prosidion (the diabetes and obesity business unit of OSI), and Executive Vice President of OSI where he also serves on OSI’s Executive Management Committee. The Service Contract provides for a base salary of £175,000 per annum, plus other such amounts, if any, as the Board of Directors may from time to time determine. In addition, Dr. Lundemose is entitled to receive other customary fringe benefits generally available to OSI’s executive employees. The Service Contract also provides that Dr. Lundemose will receive, on an annual basis, options to purchase a number of shares of common stock of OSI to be determined by the Compensation Committee of the Board of Directors of OSI. This Service Contract supersedes an earlier agreement between both Dr. Lundemose and Prosidion Limited. Further details of Dr. Lundemose’s employment are set forth in the Service Contract attached as Exhibit 10.1 to this Current Report on Form 8-K (“Form 8-K”) and incorporated herein by reference.
     On September 20, 2005, the Board of Directors approved the promotion of Dr. Neil Gibson to Chief Scientific Officer, and the Compensation Committee increased his salary to $280,000. The Committee also approved the terms of a Change in Control agreement with Dr. Gibson. Further details regarding Dr. Gibson’s salary and change in control agreement are set forth in the Compensatory Arrangements for Executive Officers, as amended, and the Change of Control Agreement attached as Exhibits 10.2 and 10.3 to this Form 8-K, respectively, and incorporated herein by reference.
     On September 20, 2005, the Compensation Committee also approved certain revisions to the letter agreement for Robert L. Simon and the Change of Control Agreement for Barbara A. Wood, Esq., to provide that upon a change of control (i) all outstanding unvested options will vest and become fully exercisable and (ii) the payment upon termination within six months following a change of control will include a prorated bonus in addition to twelve months salary. Further details regarding these revisions are set forth in the amended letter agreement for Mr. Simon and the amended Change in Control Agreement for Ms. Wood attached as Exhibits 10.4 and 10.5 to this Form 8-K respectively and incorporated herein by reference
ITEM 8.01 Other Events
     On September 13, 2005, OSI and its partner, Genentech, Inc., announced that the Oncologic Drug Advisory Committee appointed by the U.S. Food and Drug Administration voted 10 to 3 in favor of recommending approval of Tarceva® (erlotinib) in combination with gemcitabine for the treatment of advanced pancreatic cancer in patients who have not received previous chemotherapy. Details regarding the recommendation are set forth in OSI’s press release dated September 13, 2005 which is attached hereto as Exhibit 99.1 to this Form 8-K and is incorporated herein by reference.

 


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     On September 15, 2005, OSI announced that (OSI) Prosidion, its business unit focused on the discovery and development of diabetes and obesity therapeutics, presented preclinical research data on its Dipeptidyl Peptidase IV inhibitor, PSN9301, during the European Association for the Study of Diabetes 41st Annual Meeting held from September 10th – 15th in Athens, Greece. Details regarding the presentation are set forth in OSI’s press release dated September 15, 2005 which is attached hereto as Exhibit 99.2 to this Form 8-K and is incorporated herein by reference.
     On September 21, 2005, OSI announced that its international partner for Tarceva, Roche, received approval from the European Commission of Tarceva for the treatment of patients with locally advanced metastatic non-small cell lung cancer after failure of at least one prior chemotherapy regimen. Details regarding the approval are set forth in OSI’s press release dated September 21, 2005 which is attached hereto as Exhibit 99.3 to this Form 8-K and is incorporated herein by reference.
ITEM 9.01 Exhibits
         
Exhibit No.   Description
  10.1    
Service Contract, dated September 20, 2005, by and between Prosidion Limited and Dr. Anker Lundemose.
       
 
  10.2    
Compensatory Arrangements of Executive Officers, as amended.
       
 
  10.3    
Change in Control Agreement, dated September 20, 2005, by and between OSI Pharmaceuticals, Inc. and Dr. Neil Gibson.
       
 
  10.4    
Amended Letter Agreement, dated September 20, 2005, by an between OSI Pharmaceuticals, Inc. and Robert L. Simon.
       
 
  10.5    
Amended Change in Control Agreement, dated September 20, 2005, by and between OSI Pharmaceuticals, Inc. and Barbara A. Wood, Esq.
       
 
  99.1    
Press release, dated September 13, 2005.
       
 
  99.2    
Press release, dated September 15, 2005.
       
 
  99.3    
Press release, dated September 21, 2005.

3


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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: September 26, 2005                    
  OSI PHARMACEUTICALS, INC.
         
     
  By:   /s/ Michael G. Atieh    
    Name:   Michael G. Atieh   
    Title:   Executive Vice President and Chief Financial Officer   

 


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EXHIBIT INDEX
         
Exhibit No.   Description
  10.1    
Service Contract, dated September 20, 2005, by and between Prosidion Limited and Dr. Anker Lundemose.
       
 
  10.2    
Compensatory Arrangements of Executive Officers, as amended.
       
 
  10.3    
Change in Control Agreement, dated September 20, 2005, by and between OSI Pharmaceuticals, Inc. and Dr. Neil Gibson.
       
 
  10.4    
Amended Letter Agreement, dated September 20, 2005, by an between OSI Pharmaceuticals, Inc. and Robert L. Simon.
       
 
  10.5    
Amended Change in Control Agreement, dated September 20, 2005, by and between OSI Pharmaceuticals, Inc. and Barbara A. Wood, Esq.
       
 
  99.1    
Press release, dated September 13, 2005.
       
 
  99.2    
Press release, dated September 15, 2005.
       
 
  99.3    
Press release, dated September 21, 2005.

 

EX-10.1 2 y13070exv10w1.htm EX-10.1: SERVICE CONTRACT EX-10.1
 

EXHIBIT 10.1
PROSIDION LIMITED
SERVICE CONTRACT
This Agreement sets out the particulars of the terms and conditions of your employment with Prosidion Limited (hereafter referred to as “the Company”), of Watlington Road, Oxford, OX4 6LT as required by law.
1   NAME: DR ANKER LUNDEMOSE
 
2   ROLE: CEO AND DIRECTOR OF THE COMPANY, PRESIDENT OF (OSI) PROSIDION AND EXECUTIVE VICE PRESIDENT OF OSI PHARMACEUTICALS, INC., PARENT COMPANY OF THE COMPANY.
 
2.1   Your role is chief executive officer and director of the Company, President of (OSI) Prosidion, the diabetes and obesity business unit of OSI Pharmaceuticals, Inc. (“OSIP”) the parent company of the Company, and Executive Vice President of OSIP, pursuant to which OSIP office, you shall serve on the Executive Management Committee of OSIP.
 
3   LOCATION
 
    Your normal place of work is at the Company’s offices in Oxford, U.K., as set out above or such other location in the UK as the Company may from time to time require. During the course of your employment you may be required to work at other locations within the U.K. You may also be required to travel in the U.K. or overseas as the Company may from time to time require.
 
4   DATE OF COMMENCEMENT OF SERVICE CONTRACT: SEPTEMBER 20, 2005
 
5   REMUNERATION
 
5.1   Your employment is on a salaried basis. Your base salary is one hundred and seventy five thousand pounds (£175,000) per annum and will be paid monthly in arrears. All payments are by credit transfer into your nominated bank or building society account and will be equal to 1/12th of your annual salary for each full month worked. You shall also receive a car allowance of £1,200 per month.
 
5.2   Salary reviews will be carried out annually. Your salary may (but will not necessarily) be increased with effect from the review date. You will be notified in writing of any such change in salary.
 
5.3   In addition to your base salary, for each year that you are employed with the Company, you will be eligible to receive a bonus, determined and payable in accordance with OSIP’s practices applicable to bonuses paid to its executives. This bonus system is a discretionary annual performance-based incentive bonus system, approved by OSIP’s Board, and is based upon a combination of personal and corporate performance contributing to your maximum target.
 
5.4   The Company shall reimburse you for all of your costs in relation to home telephone expenses, cellular telephone expenses and home PC high-speed Internet connection (ADSL) upon the submission of receipts in a timely manner.
 
5.5   The Company will reimburse you, upon presentation of appropriate documentation, for all reasonable costs incurred by you in connection with the preparation of your annual UK tax return for the tax years 2004/ 2005 and 2005/2006.

 


 

5.6   The Company will reimburse you upon presentation of appropriate documentation, for all costs incurred by you in connection with the seeking of legal and financial advice relating to your tax affairs as a consequence of relocation to the UK, to a maximum sum of thirty thousand pounds (£30, 000).
 
5.7   On each date that annual stock options are granted by OSIP to its executive management group, so long as you then remain in the employ of the Company or OSIP, OSIP will grant to you an option (an “Annual Option”) to purchase a number of shares of Common Stock of OSIP to be determined by the Compensation Committee of the Board of Directors of OSIP based upon your grade level. The exercise price for each Annual Option will be the fair market value per share of Common Stock on the date the Annual Option is granted and the other terms and conditions of the Annual Option will be as set forth in the Plan and Option Agreement accompanying such Annual Option. Notwithstanding the foregoing, each Annual Option and any options to purchase shares of Common Stock of OSIP granted as at the date hereof shall automatically vest and be fully exercisable upon a Change of Control (as hereinafter defined).
 
6   RIGHT OF ABODE
 
    It is the Company’s policy to insist that all employees provide original documentation proving that they have a right to work in the UK.
 
7   HOLIDAYS
 
7.1   The holiday year will run from 1st April to 31st March of the following year. In addition to normal bank and public holidays in England, you will be entitled in every holiday year to thirty (30) working days paid holiday (and pro rata to the period employed in every such year in which your service is for less than the holiday year). This holiday entitlement is inclusive of your statutory holiday entitlement under the Working Time Regulations 1998, which shall, in each holiday year, be deemed to be taken first. The Company reserves the right to require you to take holiday on certain days determined by the Company and it is agreed that Regulation 15 of the Working Time Regulations 1998 is excluded.
 
7.2   On termination of your employment you are required to take any unused holiday entitlement during any period of notice unless notified to the contrary (and in writing) by the Company. Only if you are unable to take your unused entitlement because of the Company’s requirements of you during the notice period, or to the extent, if any, that such unused entitlement exceeds your period of notice, will a payment in lieu of such accrued but untaken holiday entitlement be made. Deductions from sums due to you on termination of employment will include a sum in respect of any day’s holiday you may have taken in excess of your actual holiday entitlement on termination. A day’s pay for the purposes of this clause means 1/260th of your annual salary.

 


 

8   PENSION SCHEME
 
    The Company is not contracted out of the State Earnings Related Pension Scheme and all employees contribute at ordinary rates to the National Insurance Scheme. The Company operates a group personal pension plan. Eligibility to join the scheme is determined by the Company and eligible employees may join the Scheme at the earliest opportunity following the month in which they commence employment. During the term of your employment, the Company will contribute twelve percent (12%) of your annual salary, on a pro rated monthly basis, to such plan. You may, at your discretion, make additional contributions to the plan, subject to statutory limits.
 
9   PRIVATE MEDICAL INSURANCE
 
    You are invited to join a free medical scheme and pay for dependents to be included. The Company reserves the right to change the provider and the scheme as necessary.
 
10   PERMANENT HEALTH INSURANCE
 
    Subject to you meeting the Insurers eligibility criteria, the Company will provide free permanent health insurance of seventy five percent (75%) of salary for absences over twenty-six (26) continuous weeks. The amount will be based on basic salary at the time of becoming ill and will not be increased during payment. In addition to your salary payments this benefit also covers your employer pension contribution in place at the time of becoming ill.
 
11   LIFE ASSURANCE
 
    You will be provided with Life Assurance by the Company to the amount of four (4) times your current salary at the time.
 
12   BENEFITS
 
12.1   If you are absent from work due to sickness or injury, the Company will pay you your normal remuneration, including benefits, for up to twenty-six (26) weeks in any calendar year. Thereafter, you may be entitled to continued permanent health insurance payment pursuant to Paragraph 10 or the Company may, in its discretion, continue payment as above for such longer period as the Company may, in its discretion, determine.
 
13   NOTICE
 
13.1   You are required to give the Company, in writing, the following prior notice to terminate your employment “without good reason” (as defined in paragraph 21.1(f)): three months
 
13.2   The Company’s normal retirement age, when your employment will automatically terminate, is 65 for both men and women.

 


 

14   ADOPTION
 
    Should you decide to adopt a child from a location outside of the UK, you will notify the Company of the time period of the adoption process, as soon as you are notified by the adoption authorities. Should this adoption necessitate that you stay at the location of the adoption for a prolonged period of time, you will be permitted to undertake the adoption process from such location for a period of up to six (6) weeks (or such greater period as is agreed with the Company) provided that you use reasonable endeavours to perform your duties in the Company during such period.
 
15   CONFIDENTIAL INFORMATION AND PUBLICATION
 
    You undertake that you will not without the prior consent in writing of the Company during the term of employment by the Company or OSIP (as the case may be), or at any time after termination of employment either make known or divulge in any manner whatsoever (and will use reasonable endeavors to prevent disclosure of) any information that you acquire by reason of your said employment not already generally available to the public (“Confidential Information”), concerning:
  (a)   any technical secrets, confidential research work, technical processes, formulae, inventions, patents,
 
  (b)   any transactions, finances or business affairs of the Company or OSIP, associated companies or of customers of the said Company of OSIP or companies.
    All notes, memoranda, records, papers, documents, correspondence, writings, drawings, plans, designs or other such documents which come into your possession relating to the business of the Company or OSIP, are the property of the Company or OSIP, as the case may be, and you will deliver them together with any equipment or other property belonging to the Company or OSIP immediately upon request and in any event on the termination of your employment and you will not make or keep any copies or extracts of such documents.
 
    If you make any discovery or invention or secret process or improvement in procedure (either alone or with any other person) during your employment which relates to the business of the Company or OSIP, you shall immediately disclose it in writing to the Company and it will (except to the extent provided otherwise by Section 39 of the Patents Act 1977) be the absolute property of the Company or OSIP. You will, on the request and at the expense of the Company, apply or join with the Company or OSIP, as the case may be, in applying for a patent, registered design or other appropriate protection in the United Kingdom, the United States or any other part of the world for any such discovery, invention, process or improvement and you will execute any documents and do any other things necessary for vesting absolutely that patent registered design or any other protection and all right title and interest to it, in the Company or OSIP, as the case may be. You irrevocably appoint the Company or its designee to be your attorney to execute and do any such document or thing and generally to use your name for the purpose of giving the Company and OSIP the full benefit of the provisions of this clause.
 
    It is mutually agreed that this undertaking shall in no way affect your right to make use of the general knowledge and skill that you acquire in the service of the Company or OSIP.
 
16   COLLECTIVE AGREEMENTS
 
    There are no collective agreements applicable to you or which affect your terms of employment.

 


 

 
17   DATA PROTECTION
 
    By signing this statement you acknowledge and agree that the Company is permitted to hold personal information about you as part of its personnel and other business records and may use such information in the course of the Company’s business. You agree that the Company may disclose such information to third parties (including where such third parties are based outside the European Economic Area) in the event that such disclosure is in the Company’s view required for the proper conduct of the Company’s business or that of any associated company. This Clause applies to information held, used or disclosed in any medium.
 
18   HEALTH AND SAFETY
 
    Every employee of the Company or OSIP, including you, has a legal duty to take reasonable care for the health and safety of themselves and of other persons who may be affected by their acts or omissions at work. You must also co-operate with the Company and OSIP so that the Company and OSIP can discharge their statutory obligations. You shall not intentionally or recklessly interfere with, or misuse, anything that is provided in the interests of health, safety or welfare.
 
    You may be required, in order to enable the Company and OSIP to fulfil their statutory obligations to undergo periodic medical checks and examinations. You shall be deemed to have agreed to the results of such checks and examinations being released to the Company and OSIP.
 
    Further Health and Safety information can be found on the Company intranet under the sections entitled Health and Safety and HR Policies.
 
    The Company and OSIP each has a non-smoking policy that all employees must observe. Failure to observe this policy will result in disciplinary action.
 
19   DUTIES
 
    Whilst employed by the Company or OSIP you must:-
  (a)   during your hours of work devote the whole of your time, attention and abilities to the business of the Company and OSIP and carry out your duties with due care and attention;
 
  (b)   not, without the Company’s or OSIP’s prior written consent, be in any way directly or indirectly engaged or concerned with any other business or employment whether during or outside your hours of work for the Company and OSIP;
 
  (c)   use your best efforts to promote and protect the interests of the Company and OSIP and observe the utmost good faith towards the Company and OSIP; and

 


 

  (d)   comply with all the Company’s and OSIP’s rules, regulations, policies and operating procedures from time to time in force. The Company and OSIP each maintains a section entitled HR Policies on their respective intranets which include key HR policies and which all employees should regularly review as it is updated from time to time.
20   TERMINATION OF EMPLOYMENT
 
20.1   Your employment with the Company shall end upon the earliest of the following to occur:
(a) Your death;
(b) Upon written notice to you of termination as a result of your Permanent Disability. “Permanent Disability” means your inability, by reason of any physical or mental impairment, to substantially perform your duties and responsibilities hereunder for a period of twenty six (26) weeks in any twelve (12) month period, as determined by a qualified physician with no history of prior dealings with you or the Company, as reasonably agreed upon by you (or, if you are unable to make such selection, by an adult member of your immediate family) and the Company. Such physician’s written determination of your Permanent Disability shall, upon delivery to the Company, be final and conclusive for purposes of this Agreement. The Company agrees not to terminate your employment where the effect of such termination would be to prevent you from receiving or continuing to receive Permanent Health Insurance (“PHI”) benefits in accordance with your entitlement at paragraph 10 hereof provided there are no other causal factors for such non-eligibility to receive or continue to receive PHI benefits. In the event of Permanent Disability, if you are prevented from receiving PHI due to your failure to meet PHI policy criteria and provided there are no causal factors for such non-eligibility arising from your act or omission (including without limitation non-disclosure of illnesses under the PHI policy) (“PHI Non-Eligibility”), the provisions of Paragraph 20.2(c) shall apply;
(c) Termination of your employment by the Company for “cause” as evidenced by, and effective upon, delivery by the Company to you of a Notice of Termination (as defined in paragraph 20.1(g) below). “Cause” shall mean, for purposes of this Agreement, (i) an act of fraud or embezzlement against the Company or OSIP or an unauthorized disclosure of Confidential Information (as defined in paragraph 15 hereof) of the Company or OSIP, in each case which is willful and results in material damage to the Company or OSIP, (ii) any criminal violation of the US Securities Act of 1933 or the US Securities Exchange Act of 1934, (iii) your conviction (or a plea of nolo contendere) of any felony, (iv) your gross neglect of your duties or your willful and continuing refusal to perform your duties, provided you have been given written notice of such neglect or refusal and within thirty (30) days have failed to cure such neglect and refusal, or (v) your material willful misconduct with respect to the business or affairs of the Company or OSIP;

 


 

(d) Termination of your employment by you for “good reason” by delivering to the Company a Notice of Termination (as defined in paragraph 20.1(g) below) not less than thirty (30) days prior to the effective date of such termination. For purposes of this Agreement, “good reason” shall mean the occurrence of any of the events hereinafter set forth which are not cured by the Company or OSIP within thirty (30) days after the Company or OSIP has received written notice from you specifying the particular events or conditions which constitute “good reason”:
     (i) a material reduction in your duties, title, responsibilities, authority, status, or reporting responsibilities unless you have previously consented in writing to such reduction (which consent may be given or withheld in your sole discretion);
     (ii) a material reduction in your base salary;
     (iii) Change of Control (as defined in paragraph 20.3 hereof); or
     (iv) Relocation of your normal place of work to any destination other than the U.K.
(e) Termination of your employment by the Company “without cause” by delivery by the Company to you of a Notice of Termination (as defined in paragraph 20.1(g) below) not less than thirty (30) days prior to the effective date of such termination. Your termination by the Company shall be considered to be “without cause” if you are terminated or dismissed by the Company for reasons other than death, Permanent Disability (as defined in paragraph 20.1(b) hereof) or for “cause” (as defined in paragraph 20.1(c) hereof).
(f) Termination of your employment by you “without good reason” by delivery by you to the Company of a Notice of Termination (as defined in paragraph 20.1(g) below). Your termination of your employment shall be considered to be “without good reason” unless you resign for “good reason” (as defined in paragraph 20.1(d) hereof).
(g) Any termination by the Company or by you shall be communicated by a written “Notice of Termination” to the other party hereto. A “Notice of Termination” shall mean a notice which indicates a termination date and the specific termination provision in this Agreement relied upon and which sets forth in reasonable detail the facts and circumstances claimed to provide a basis for termination under the provision so indicated.
20.2   Payments Upon Termination.
(a) Upon termination of your employment for any reason you will become entitled to (i) any accrued and unpaid base salary and contractual benefits up to the date of termination, and (ii) any accrued and unpaid vacation pay up to the date of termination ((i) and (ii) being collectively referred to as the “Accrued Compensation”).
The Company reserves the right in its absolute discretion to terminate your employment immediately or at any time after a Notice of Termination has been served by either party. Where applicable, the Company also reserves the right to make a payment in lieu of any notice which may be given by the Company and stated in such Notice of Termination. Such payment will consist of Accrued Compensation (as defined in paragraph 20.2(a) hereof) and pay and benefits for the period to the date on which your notice would otherwise have expired but excluding any payment for holiday accruing during any such unworked notice period. For the

 


 

avoidance of doubt, the Company’s right to make a payment in lieu of notice does not give you a right to receive such a payment in lieu of notice.
The Company may, at its absolute discretion, require you not to attend at work and/or not to undertake all or any of your duties hereunder during any period of notice (whether given by the Company or you), provided always that the Company shall continue to pay your salary and contractual benefits as detailed herein. For the avoidance of doubt, there is no obligation on the Company to provide you with any work during any period of notice and you will not be entitled to work on your own account or on account of any other person, firm or company during that period.
(b) Upon termination of your employment due to death, in addition to Accrued Compensation, your estate will become entitled to an amount equal to the bonus that you would have been entitled to receive for the fiscal year in which the termination of your employment occurs had you continued to be employed until the end of such fiscal year, multiplied by a fraction (i) the numerator of which is the number of days in such fiscal year through to the date on which your employment terminates and (ii) the denominator of which is 365 (a “Pro-rata Bonus”).
(c) Upon a termination of your employment (1) by the Company “without cause” (as defined in paragraph 20.1(e) hereof), (2) by you for “good reason” (as defined in paragraph 20.1(d) hereof) (including upon a “Change of Control” (as defined in paragraph 20.3) hereof)), or (3) by the Company where PHI Non-Eligibility occurs (as defined in paragraph 20.1(b)), in addition to Accrued Compensation, you will become entitled to (i) a sum equivalent to your base salary for twelve (12) months following the date of termination, and (ii) your Pro-rata Bonus.
(d) You shall not be required to mitigate the amount of any payment provided for under this paragraph by seeking other employment or otherwise and no payment shall be offset or reduced by the amount of any compensation or benefits provided to you in any subsequent employment. The Company’s obligation to make the payments provided for in this paragraph and otherwise perform its obligations hereunder shall not be affected by any circumstances, including, without limitation, set-off, counterclaim, recoupment, defense or other claim, right or action which the Company may have against you or others.
20.3   Change of Control. For purposes of this Agreement, a “Change of Control” shall mean the approval by stockholders of the parent company of the Company, OSIP (or, in the case of any transaction involving the share capital or the assets of the Company, the approval by OSIP) of (a) a merger or consolidation involving OSIP if the stockholders of OSIP, immediately before such merger or consolidation, do not, as a result of such merger or consolidation, directly or indirectly, continue to hold a majority of the voting power in the resulting entity, or (b) an agreement for the sale or other disposition of all or substantially all of the assets of the Company or (c) any transaction involving the Company if OSIP does not, as a result of such transaction, continue to hold a majority of the voting power in the Company or any resulting entity.

 


 

21   Entire Agreement.
 
    This Service Contract is the entire agreement between the parties as at the date hereof relating to the subject matter hereof and replaces, supercedes and terminates those earlier agreements between the parties dated 1st May 2004, 10th October 2003, 13th May 2003 and 1st February 2003 and those letters between the parties dated 1st February 2003 (regarding payment of UK national insurance) and between you and OSIP dated 1st February 2003 (regarding obtaining of financing), dated 1st February 2003 (regarding subscription for             shares in the Company) and dated 1st February 2003 (regarding indemnification for tax in relation to such subscription for shares). For the avoidance of doubt, the period of employment between the parties commenced on 1st February 2003 and shall continue until termination of this Service Contract. If any provision of this Agreement is judicially or administratively determined to be unenforceable, the provision will be reformed to most nearly approximate the Parties’ original intent, but otherwise this Agreement will continue in full force and effect.
I acknowledge receipt of this Service Contract, which sets out the principal terms of my employment.
I am aware that Employee Handbook and certain Company rules, policies and operating procedures that will apply to my employment can be obtained on the Company intranet under the section entitled HR Policies and I am aware that these may be changed and updated from time to time. I undertake to review these policies regularly during my employment.
I confirm that I understand and agree to abide by the terms and conditions contained in this Service Contract and in those rules and policies and operating procedures that are specifically stated to form part of my Service Contract.
SIGNED by the said DR ANKER LUNDEMOSE  /s/ Dr. Anker Lundemose
         
on
2005      
in the presence of:
Witness  /s/                                          
Full Name                                         
Address                                            
                                                            
Occupation                                        

SIGNED for and on behalf of
PROSIDION LIMITED
by  /s/                              
         
on
2005      

 

EX-10.2 3 y13070exv10w2.htm EX-10.2: COMPENSATORY ARRANGEMENTS EX-10.2
 

EXHIBIT 10.2
Compensatory Arrangements of Executive Officers
Amended as of September 20, 2005
     The Compensation Committee (the “Committee”) of the Board of Directors of OSI Pharmaceuticals, Inc. (“OSI” or the “Company”) approved the 2005 annual base salaries and 2004 cash bonuses for OSI’s executive officers including the Company’s named executive officers (as that term is defined in Item 402 of Regulation S-K) as set forth in OSI’s proxy statement dated February 2, 2005. The following table sets forth the annual base salary levels of such officers for 2005 as compared to 2004 as well as the 2004 cash bonuses for each such officer:
                         
    2004 Base   2005 Base    
Name and Position   Salary   Salary   2004 Bonus
Colin Goddard, Ph.D.
Chief Executive Officer
  $ 550,000     $ 600,000     $ 400,000  
Gabriel Leung
Executive Vice President and
President, (OSI) Oncology
  $ 361,000     $ 400,000     $ 145,000  
Anker Lundemose, M.D., Ph.D., D.Sc.(1)
Executive Vice President and
President, (OSI) Prosidion
  £ 150,000     £ 175,000     £ 60,000  
Robert Simon(2)
Executive Vice President,
Pharmaceutical Development and
Technical Operations
  $ 280,000     $ 335,000     $ 100,000  
Michael G. Atieh
Executive Vice President and Chief
Financial Officer
    n/a     $ 410,000       n/a  
Neil Gibson, Ph.D.
Chief Scientific Officer
  $ 252,000     $ 280,000     $ 90,000  
Barbara A. Wood
Vice President, General Counsel and
Secretary
  $ 277,000     $ 287,000     $ 90,000  
 
(1)   During fiscal 2004, Dr. Lundemose received an additional bonus of £94,000 related to the identification and successful acquisition by Prosidion Limited, OSI’s wholly-owned subsidiary, of certain assets from Probiodrug AG as per his Employment Agreement.
 
(2)   During 2004, Mr. Simon agreed to relocate from Boulder, Colorado to the Company’s headquarters in Melville, New York. In connection with his relocation, the Company agreed to a relocation package and the forgiveness of a $100,000 loan assumed by the Company as part of its 2001 acquisition of Gilead Sciences Inc.’s oncology business. The total amount of relocation costs reimbursed in 2004 were $251,423 including the forgiveness of the loan. The Company anticipates additional payments of relocation costs in fiscal 2005.

 


 

Bonuses
     The Committee’s policy of awarding annual bonuses is designed to specifically relate executive pay to Company and individual performance. All Company employees, including the executive officers, are assigned a grade level, and each grade level is assigned a bonus target, a percentage of which is tied to Company performance and a percentage of which is tied to individual performance. With respect to executive officers, the percentage tied to the Company performance is weighted more heavily than the individual performance. For example, in the case of a bonus for an executive officer with a grade level of 11, 25% of the bonus is based on individual performance and 75% of the bonus is based upon Company performance. With regard to each of the two components (Company performance and individual performance), an employee can earn a range around the target level (100%). The range for the Company performance component is 0% to 150% and the percentage is recommended by the CEO each year and approved by the Committee. The range for the individual performance component is also 0% to 150% and is based upon individual performance. Individual performance is measured in accordance with the Company’s employee performance management procedures, and the percentage is recommended by the CEO for the executive officers and approved by the Committee. For purposes of compensation decisions for 2004, the Committee measured the Company’s performance and that of each executive officer in fiscal year 2004 against goals established by the executive officers and ratified by the Committee under the Company’s Annual Business Plan prior to the start of the fiscal year. For 2004, the Committee awarded the respective executive officers’ discretionary bonuses in accordance with the foregoing process. For 2004, the Company performance component was set at 150%.
     The bonus targets for the executive officers are either set in accordance with their employment agreements or are based upon their respective grade levels, the latter of which are currently under review for 2005.
Stock Option Grants
     Executive officers are eligible for awards of stock options or shares of stock pursuant to the Company’s Amended and Restated Stock Incentive Plan. Such awards are made at the discretion of the Committee.
     Annual stock option grants for executive officers are a key element of the executive officer’s total compensation. As for all Company employees, the stock option grants made annually to the executive officers are made in accordance with the Company’s formula-based policy for granting options. According to the formula, each grade level is assigned a grant multiple. The number of options granted to an executive officer is determined by multiplying the executive officer’s salary by the grant multiple and then dividing the product by a stock price which is determined by the CEO and ratified by the Committee and is typically a 3-6 month trailing average. In 2004, the CEO recommended stock option grants for the executive officers based upon the foregoing criteria, and the Committee reviewed and approved the grants.

 


 

Perquisites
     The only perquisite granted to executive officers which is not available to other employees relates to the use of automobiles and is in the form of either the payment of a car lease or, in lieu thereof, a monthly cash payment. Currently, Mr. Atieh is the only executive officer who does not receive the perquisites.

 

EX-10.3 4 y13070exv10w3.htm EX-10.3: CHANGE IN CONTROL AGREEMENT EX-10.3
 

EXHIBIT 10.3
CHANGE OF CONTROL AGREEMENT
This Agreement dated September 20, 2005 between OSI Pharmaceuticals, Inc. and Neil Gibson:
In the event OSI is sold or merged with another company resulting in a change of control (“Change of Control”), the following shall apply:
  1.   All of your outstanding unvested options shall vest and be fully exercisable; and
 
  2.   If your employment with the controlling company is terminated (including if you voluntarily terminate your employment for “Good Reason”*) at any time within six (6) months following a CHANGE OF CONTROL transaction, unless such termination is for “cause”, death, disability or you voluntarily leave without “Good Reason”, you will be entitled to receive the benefits described below:
           (i) a lump sum severance payment equal to your annual salary for a period of twelve (12) months;
           (ii) your pro-rated bonus;
           (iii) all unpaid, accrued vacation through the date of termination; and
           (iv) continued coverage for you and your dependants for 12 months following termination under health and dental program in which you were eligible to participate as of the time of termination of your employment.
 
*   Good Reason for termination of employment includes (i) a decrease in your total compensation package, (ii) the assignment of duties or responsibilities which are not commensurate with your position immediately prior to the sale or Change of Control, or (iii) you are required to relocate to an office or facility more than forty (40) miles from your present location or forty (40) miles from your home.
OSI Pharmaceuticals, Inc.
                 
 
               
By:
  /s/ Coling Goddard       /s/ Neil Gibson    
 
               
 
  Colin Goddard
CEO
      Neil Gibson    

 

EX-10.4 5 y13070exv10w4.htm EX-10.4: AMENDED LETTER AGREEMENT EX-10.4
 

EXHIBIT 10.4
November 15, 2001
Amended September 20, 2005
Mr. Robert L. Simon
Dear Robert:
     This letter is to confirm our understanding with respect to your employment with OSI Pharmaceuticals, Inc., its subsidiaries or affiliates (the “Company”).
          1. Employment. The Company will initially employ you, and you agree to be employed by the Company as Vice President, Global Regulatory Affairs reporting to Nicole Onetto. The principal location at which you shall perform such services shall be the Company’s facility located in Boulder, Colorado. Your employment hereunder shall commence on or about January 1, 2002 (the “Commencement Date”) and shall continue on an “at-will" basis, meaning that either you or the Company may terminate your employment at any time and for any reason.
          2. Compensation.
               (a) Base Salary; Incentive Bonus. The Company shall pay you as your compensation for your services and agreements hereunder a base salary payable at the biweekly rate of $9,890, which annualized is $257,145 per year (the “Base Salary”), less any amounts required to be withheld under applicable law. Beginning with calendar year 2002, you will also be eligible to participate in the Company’s annual performance-based incentive bonus plan as approved by the Board solely in its discretion. You expressly acknowledge that you will not be eligible to receive any bonus from the Company in respect of calendar year 2001, which bonus, if any, shall be paid to you by Gilead Sciences, Inc.
               (b) Signing Bonus. You shall receive a $100,000 bonus (the “Signing Bonus”), payable in one lump sum payment, less any amounts required to be withheld under applicable law, upon the commencement of your employment with the Company. If you voluntarily terminate your employment or the Company terminates your employment for cause within one year of the Commencement Date, you shall be required to reimburse the Company for such Signing Bonus; provided that, the amount you shall be required to repay the Company shall be reduced 1/12th for each full month of service you have completed as of the termination date. This bonus is designated to pay off your Gilead loan.
               (c) Equity Compensation. Subject to approval by the Board, you shall receive stock options to purchase 25,000 shares of the Company’s common stock, at an exercise price to be determined based on the date of board approval, subject to, and in accordance with, the provisions of the Company’s 1999 Incentive and Non-Qualified Stock Option Plan.
               (d) Benefits. You shall be entitled to participate in such employee benefit plans as are generally made available for employees of the Company in positions at a level comparable to you.

 


 

          3. Severance Compensation.
               (a) In the event that your employment hereunder is terminated by the Company without “cause”, and in exchange for your execution of a general release of all claims against the Company:
                    (i) The Company will continue to pay you your Base Salary for a period of twelve (12) months commencing on the effective date of such termination.
               (b) In the event that the Company is sold or merged with another Company resulting in a change of control (a “Change of Control”), and if, at any time within six (6) months following a Change of Control transaction, your employment is terminated by the controlling company or if you voluntarily terminate your employment for a “Good Reason” (as defined below) unless such termination is for “cause”, death, disability or you voluntarily leave without “Good Reason”, you will be entitled to receive from the controlling company in lieu of any further salary and bonus payments to you for periods subsequent to the date of termination, (i) the salary described in subparagraph (a) above, (ii) your pro-rated bonus, (iii) all unpaid, accrued vacation time through the date of termination, and (iv) continued coverage for you and your dependents for 12 months following termination under any health and dental program in which you were eligible to participate as of the time of termination of your employment . In addition, upon a Change of Control, all outstanding unvested options held by you shall vest and be fully exercisable.
               (c) For purposes of this Section 3(b), “Good Reason” means (i) decrease in your total compensation package, (ii) the assignment of duties or responsibilities which are not commensurate with your position immediately prior to the sale or Change of Control, or (iii) you are required to relocate to an office or facility more than forty (40) miles from your present location or forty (40) miles from your home.
          4. Prohibited Competition. NOTE: Colorado statutes limit non-competes to situations involving (i) protection of trade secrets or (ii) “executive and management personnel,” or “professional staff to executive and management personnel.
               (a) Covenants Not to Compete. During the period in which you perform services for or at the request of the Company (the “Term”) and for a period of two (2) years following the expiration or termination of the Term, whether such termination is voluntary or involuntary, you shall not, without the prior written consent of the Company:
                    (i) For yourself or on behalf of any other person or entity, directly or indirectly, either as principal, agent, stockholder, employee, consultant, representative or in any other capacity, own, manage, operate or control, or be concerned, connected or employed by, or otherwise associate in any manner with, engage in or have a financial interest in any business which creates or develops products which are directly competitive with the products of the Company in any geographic location in which the Company is then operating (the “restricted Territory”), except that nothing contained herein shall preclude you from purchasing or owning securities of any such business if such securities are publicly traded, and provided that your holdings do not exceed three (3%) percent of the issued and outstanding

 


 

securities of any class of securities of such business; or
                    (ii) Either individually or on behalf of or through any third party, solicit, diver or appropriate or attempt to solicit, divert or appropriate, for the purpose of competing with the Company or any present or future parent, subsidiary or other affiliate of the Company which is engaged in a similar business as the Company, any customers or patrons of the Company, or any prospective customers or patrons with respect to which the Company has developed or made a sales presentation (or similar offering of services), located within the Restricted Territory; or
                    (iii) Either individually or on behalf of or through any third party, directly or indirectly, solicit, entice or persuade or attempt to solicit, entice or persuade any other employees of or consultants to the company or any present or future parent, subsidiary or affiliate of the Company to leave the services or the Company or any such parent, subsidiary or affiliate for any reason.
               (b) Reasonableness of Restrictions. You further recognize and acknowledge that (i) the types of employment which are prohibited by this Section 4 are narrow and reasonable in relation to the skills which represent your principal salable asset both to the Company and to your other prospective employers, and (ii) the specific but broad geographical scope of the provisions of this Section 4 is reasonable, legitimate and fair to you in light of the Company’s need to market its services and sell its products in a large geographic area in order to have a sufficient customer base to make the Company’s business profitable and in light of the limited restrictions on the type of employment prohibited herein compared to the types of employment for which you are qualified to earn your livelihood.
               (c) Survival of Acknowledgements and Agreements. Your acknowledgements and agreements set forth in this shall survive the expiration or termination of this Agreement and the termination of your employment with the Company for any reason.
          5. Protected Information. You shall at all times, both during and after any termination of this Agreement by either you or the Company, maintain in confidence and shall not, without the prior written consent of the Company, use, except in the course of performance of your duties for the Company, disclose or give to others any Confidential and Proprietary Information. For purposes of this Agreement, “Confidential and Proprietary Information” means confidential and proprietary information of the Company which was disclosed to or developed by you during the course of performing services for, or receiving training from, the Company, and is not available to the public, including but not limited to information and facts concerning business plans, customers, future customers, suppliers, licensors, licensees, partners, investors, affiliates or others, training methods and materials, financial information, sales prospects, client lists, inventions, or any other scientific, technical, trade or business secret of the Company or any third party provided to you or the Company under a condition of confidentiality, provided that Confidential and Proprietary Information shall not include information that is (1) in the public domain other than through any fault or act by you, (2) known to you prior to its disclosure to you in the course of your employment by the Company, or (3) lawfully disclosed to you by a source other than the Company which source has the legal right to disclose such information.

 


 

          6. Ownership of Ideas, Copyrights and Patents. You agree that all ideas, discoveries, creations, manuscripts and properties, innovations, improvements, know-how, inventions, designs, developments, apparatus, techniques, methods, biological processes, cell lines, laboratory notebooks and formulae which may be used in the business of the Company, whether patentable, copyrightable or not, which you may conceive, reduce to practice or develop during your employment with the Company (collectively, “the Inventions”), alone or in conjunction with another, or others and whether at the request or upon the suggestion of the Company, or otherwise, shall be the sole and exclusive property of the Company, and that you shall not publish any of the Inventions without the prior written consent of the Company. You hereby assign to the Company all of your right, title and interest in and to all of the foregoing. You further represent and agree that to the best of your knowledge and belief none of the Inventions will violate or infringe upon any right, patent, copyright, trademark or right of privacy, or any constitute libel or slander against or violate any other rights of any person, firm or corporation and that you will use your best efforts to prevent any such violation. You agree that you will fully cooperate with the Company, its attorneys and agents in the preparation and filing of all papers and other documents as may be required to perfect the Company’s rights in and to any of such Inventions.
          7. Disclosure to Future Employers. You agree that you will provide, and that the Company may similarly provide in its discretion, a copy of the covenants contained in Sections 4, 5 and 6 of this Agreement to any business or enterprise which you may directly, or indirectly, own, manage, operate, finance, join, control or in which you participate in the ownership, management, operation, financing or control, or with which you may be connected as an officer, director, employee, partner, principal, agent, representative, consultant or otherwise.
          8. Records. Upon termination of your relationship with the Company, you shall deliver to the Company any property of the Company which may be in your possession including products, materials, memoranda, notes, records, reports, or other documents or photocopies of the same.
          9. No Conflicting Agreements. You hereby represent and warrant that you have no commitments or obligations inconsistent with this Agreement and you hereby agree to indemnify and hold the Company harmless against loss, damage, liability or expense arising from any claim based upon circumstances alleged to be inconsistent with such representation and warranty.
          10. Other. Based upon financial evaluation of the value in your unvested Gilead options, OSI will be granting you 25,000 options of OSI common stock.

 


 

If the foregoing accurately sets forth our agreement, please so indicate by signing and returning to us the enclosed copy of this letter.
             
        Very truly yours,
 
           
        OSI PHARMACEUTICALS, INC.
 
           
 
      By:   /s/ Coling Goddard
 
           
 
      Name:   Colin Goddard
 
      Title:   CEO
 
           
          /s/ Robert L. Simon
           
 
           
Print Name       Robert L. Simon
          Date

 

EX-10.5 6 y13070exv10w5.htm EX-10.5: AMENDED CHANGE IN CONTROL AGREEMENT EX-10.5
 

EXHIBIT 10.5
ADDENDUM TO EMPLOYMENT OFFER
FOR BARBARA WOOD
CHANGE OF CONTROL AGREEMENT
This Agreement dated, October 4, 2001, and amended on September 20, 2005 between OSI Pharmaceuticals and Barbara Wood:
In the event OSI is sold or merged with another Company resulting in a change of control (“Change of Control”), the following shall apply:
  3.   All of your outstanding unvested options shall vest and be fully exercisable; and
 
  4.   If your employment with the Controlling Company is terminated (including if you voluntarily terminate your employment for “Good Reason”*) at any time within six (6) months following a CHANGE OF CONTROL transaction, unless such termination is for “cause”, death, disability or you voluntarily leave without “Good Reason”, you will be entitled to receive the benefits described below:
                   (i) A lump sum severance payment equal to your annual salary for a period of twelve (12) months;
                   (ii) your pro-rated bonus;
                   (iii) All unpaid, accrued vacation through the date of termination; and
                   (iv) continued coverage for you and your dependants for 12 months following termination under health and dental program in which you were eligible to participate as of the time of termination of your employment.
 
*Good Reason for termination of employment includes (i) a decrease in your total compensation package, (ii) the assignment of duties or responsibilities which are not commensurate with your position immediately prior to the sale or Change of Control, or (iii) you are required to relocate to an office or facility more than forty (40) miles from your present location or forty (40) miles from your home.
OSI Pharmaceuticals, Inc.
             
By:
       /s/ Colin Goddard            /s/ Barbara Wood
 
           
 
       Colin Goddard            Barbara Wood

 

EX-99.1 7 y13070exv99w1.htm EX-99.1: PRESS RELEASE EX-99.1
 

EXHIBIT 99.1
FDA Advisory Panel Recommends Tarceva(R) Approval for Pancreatic Cancer; Committee Supports New Indication for EGFR Inhibitor Tarceva
     MELVILLE, NY & SAN FRANCISCO—(BUSINESS WIRE)—Sept. 13, 2005—OSI Pharmaceuticals, Inc. (NASDAQ: OSIP) and Genentech, Inc. (NYSE: DNA) announced today that the Oncologic Drug Advisory Committee (ODAC) appointed by the U.S. Food and Drug Administration (FDA) voted 10 to 3 in favor of recommending approval of Tarceva(R) (erlotinib) in combination with gemcitabine for the treatment of advanced pancreatic cancer in patients who have not received previous chemotherapy. Tarceva is the first drug in a Phase III trial to have shown a significant improvement in overall survival when added to gemcitabine chemotherapy in first-line pancreatic cancer. Tarceva is an oral tablet currently approved for use in non-small cell lung cancer (NSCLC) for patients whose disease has progressed after one or more courses of chemotherapy. The FDA will now review the ODAC recommendation and a decision on Tarceva approval is anticipated by November 2, 2005.
     “We are pleased with the recommendation of the advisory committee and we look forward to the FDA’s decision on our pancreatic cancer application,” said Colin Goddard, Ph.D., Chief Executive Officer of OSI Pharmaceuticals. “Tarceva is the first new potential therapy in nine years to have shown, in a randomized clinical trial, a statistically significant improvement in survival of patients suffering from advanced pancreatic cancer, a disease with a very poor prognosis for most patients.”
     Pancreatic cancer has the highest one-year mortality rate of any cancer. The average life expectancy for a patient diagnosed with metastatic pancreatic cancer is three to six months, according to The Pancreatic Cancer Action Network (PanCAN), a national patient advocacy organization for the pancreatic cancer community.
     “We are encouraged by the ODAC’s recommendation as Tarceva represents a new advance in the struggle against pancreatic cancer. There is a tremendous need for new treatment options for this difficult-to-treat cancer,” stated Hal Barron, M.D., Genentech’s senior vice president, development and chief medical officer.
About the Study
     The randomized Phase III clinical study of Tarceva, in combination with gemcitabine chemotherapy, met its primary endpoint of improving survival. This international study was a multi-center, double-blind, placebo-controlled Phase III trial evaluating Tarceva in patients with unresectable locally advanced or metastatic pancreatic cancer. The study randomized 569 patients to receive gemcitabine plus concurrent Tarceva or gemcitabine plus placebo; 521 patients were randomized to receive 100 mg/day of Tarceva or placebo, and 48 patients were randomized to receive 150 mg/day of Tarceva or placebo. The ODAC review focused on the 100 mg/day cohort.
     Compared to gemcitabine plus placebo, those patients receiving gemcitabine plus Tarceva 100 mg/day demonstrated a statistically significant (23 percent) improvement in overall

 


 

survival (hazard ratio = 0.81, p = 0.028), which can also be referred to as a 19 percent reduction in the risk of death. After one year, 23 percent of patients receiving Tarceva plus gemcitabine were alive compared to 17 percent of patients receiving gemcitabine plus placebo. A statistically significant improvement in progression-free survival (hazard ratio = 0.77; p = 0.006) was also demonstrated. Although no difference in tumor response was observed (8.6 percent in patients receiving Tarceva plus gemcitabine versus 7.9 percent in the gemcitabine plus placebo arm), the disease control rate (complete response + partial response + stable disease) was significantly improved (59 percent in patients receiving Tarceva plus gemcitabine versus 49 percent in the gemcitabine plus placebo arm, p = 0.036). Rash and diarrhea were the principal Tarceva-related side effects seen in the study and were generally characterized as mild-to-moderate.
     Safety findings were generally consistent with previous studies of Tarceva in both monotherapy and combination settings. 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 two percent because of diarrhea. Possible interstitial lung disease (ILD) was experienced in 2.3 percent of patients in the Tarceva plus gemcitabine arm compared with 0.4 percent in the gemcitabine plus placebo arm. The incidence of serious ILD-like events in the Tarceva and gemcitabine arm was higher than the 0.8 percent incidence reported for both the Tarceva monotherapy and placebo arms in the Tarceva pivotal study in advanced NSCLC. The incidence of possible ILD from all clinical studies with Tarceva is 0.7 percent.
About Pancreatic Cancer
     According to the World Health Organization more than 216,000 people worldwide are diagnosed each year with pancreatic cancer. The American Cancer Society predicts that in 2005 about 32,180 people in the United States will be diagnosed with pancreatic cancer and about 31,800 will die of the disease. Although pancreatic cancer accounts for 2 percent of new cancer cases in the United States, it is the fourth leading cause of all cancer deaths. Most pancreatic tumors originate in the exocrine duct cells or in the cells that produce digestive enzymes (acinar cells). Called adenocarcinomas, these tumors account for nearly 95 percent of pancreatic cancers.
About Tarceva
     Tarceva is an oral tablet currently approved for use in non-small cell lung cancer (NSCLC) for those patients whose disease has progressed after one or more courses of chemotherapy. Tarceva is a small molecule designed to target the human epidermal growth factor receptor 1 (HER1) pathway, which is one of the factors critical to cell growth in a number of different cancer types. HER1, also known as EGFR, is a component of the HER signaling 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 EGFR therapy to show in a Phase III trial improved survival for advanced NSCLC patients. Additional early-stage trials of Tarceva are being conducted in other solid tumors.

 


 

About OSI Pharmaceuticals
     OSI Pharmaceuticals is committed to “shaping medicines and changing lives” by discovering, developing and commercializing high-quality and novel pharmaceutical products that extend life or improve the quality of life for cancer and diabetes patients worldwide. The company operates through two business teams, (OSI) Oncology and (OSI) Prosidion. (OSI) Oncology is focused on developing molecular targeted therapies designed to change the paradigm of cancer care. (OSI) Prosidion is committed to the generation of novel, targeted therapies for the treatment of type 2 diabetes and obesity. OSI’s flagship product, Tarceva(R) (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. OSI markets Tarceva through partnerships with Genentech, Inc. in the U.S. and with Roche throughout the rest of the world.
     In addition to Tarceva, (OSI) Oncology exclusively markets Novantrone(R) (mitoxantrone concentrate for injection) for its approved oncology indications and markets Gelclair(R) Bioadherent Oral Gel for the relief of pain associated with oral mucositis. The research and development pipeline consists of novel molecularly targeted anti-cancer agents focused on signal transduction pathways involved in cell proliferation, apoptosis and angiogenesis. The most advanced of these programs, targeting the co-inhibition of c-kit and VEGFR, has two candidates in development.
About Genentech BioOncology
     Genentech is committed to changing the way cancer is treated by establishing a broad oncology portfolio of innovative, targeted therapies with the goal of improving patients’ lives. The company is the leading provider of anti-tumor therapeutics in the United States. Genentech is leading clinical development programs for Rituxan(R) (Rituximab), Herceptin(R) (Trastuzumab), Avastin(R) (bevacizumab) and Tarceva(R) (erlotinib), and markets all four products in the United States alone (Avastin and Herceptin), with Biogen Idec Inc. (Rituxan) or with OSI Pharmaceuticals (Tarceva). Genentech has licensed Rituxan, Herceptin, and Avastin, and OSI Pharmaceuticals has licensed Tarceva to Roche for sale by the Roche Group outside of the United States.
     The company has a robust pipeline of potential oncology therapies with a focus on four key areas: angiogenesis, apoptosis (i.e. programmed cell death), the HER pathway and B-cell biology. Potential oncology therapies directed at the HER pathway include a therapeutic antibody currently in Phase II trials. Also in early development are a small molecule directed at the hedgehog pathway, a soluble human protein targeting apoptosis and a humanized anti-CD20 antibody for hematology/oncology indications.
     Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes biotherapeutics for significant unmet medical needs. A considerable number of the currently approved biotechnology products originated from or are based on Genentech science. Genentech manufactures and commercializes multiple biotechnology products directly in the United States and licenses several additional products to other companies. The company has headquarters in South San Francisco, California and is traded on the New York Stock

 


 

Exchange under the symbol DNA.
     For full prescribing information, including Boxed Warnings for Avastin, Rituxan and Herceptin, or for Tarceva full prescribing information, please call 800-821-8590.
Regarding OSI
     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 review process 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.
CONTACT: OSI Contact:
Kathy Galante, 631-962-2000
or
GNE Media Contact:
Kristina Becker, 650-467-6450
or
GNE Investor Contact:
Sue Morris, 650-225-6523
SOURCE: OSI Pharmaceuticals and Genentech

 

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EXHIBIT 99.2
OSI Pharmaceuticals Presents Research Data on its Dipeptidyl Peptidase IV Inhibitor, PSN9301, at the 41st Annual Meeting of the European Association for the Study of Diabetes
     MELVILLE, N.Y., Sep 15, 2005 (BUSINESS WIRE) — OSI Pharmaceuticals, Inc. (NASDAQ: OSIP) announced today that (OSI) Prosidion, its UK subsidiary focused on the discovery and development of diabetes and obesity therapeutics, presented preclinical research data on its Dipeptidyl Peptidase IV (DPIV) inhibitor, PSN9301, during the European Association for the Study of Diabetes 41st Annual Meeting held from September 10th — 15th in Athens, Greece. PSN9301 is a novel oral DPIV inhibitor currently undergoing Phase II clinical trials where its efficacy and safety are being evaluated in type 2 diabetic patients.
     Effects of Dipeptidyl Peptidase IV Inhibitor PSN9301 and Metformin Alone and in Combination on Glucose Tolerance and Body Weight in the fa/fa Zucker Rat, and in a Polygenetic Rat Model of Diabetes, J.G. McCormack, Ph.D., D.Sc et al (Abstract #789)
     PSN9301’s rapid onset, and relative short duration, of action facilitate an optimal meal-related dosing regimen, which may enhance the physiological gain from meal-related increases in incretin hormone levels (such as GLP-1) and reduce unwanted effects on other DPIV substrates between meals (“inter-prandial sparing”). Incretin hormones are secreted by specific cells located in the small intestine in response to food intake and act to stimulate insulin release.
     Researchers from OSI’s diabetes and obesity subsidiary (OSI) Prosidion presented data assessing the acute and subchronic anti-diabetic efficacy of PSN9301 in both mono- and poly-genetic animal models in comparison to, and in combination with, Metformin. In the male diabetic fa/fa Zucker rat model as well as in the poly-genetic Diet-Induced-Obese (DIO) rat model, sub-chronic administration of PSN9301 increased blood glucose clearance to a similar degree to Metformin, and its combination with Metformin further improved glucose homeostasis compared to Metformin and PSN9301 alone. In the DIO rat PSN9301 in combination with Metformin was further able to reduce body weight gain over the two-week study period compared to Metformin and PSN9301 alone. The results of these studies indicate that the combined administration of PSN9301 plus Metformin may be a highly promising therapeutic approach especially in obese type 2 diabetics.
     “We believe that PSN9301 provides us with a differentiated and competitive agent in the DP-IV arena and we look forward to data from the Phase II PSN9301 study by the end of 2005,” stated Anker Lundemose, M.D., Ph.D., President of (OSI) Prosidion.
About OSI Pharmaceuticals
     OSI Pharmaceuticals is committed to “shaping medicines and changing lives” by discovering, developing and commercializing high-quality and novel pharmaceutical products that extend life or improve the quality of life for cancer and diabetes patients worldwide. The company operates through two business teams, (OSI) Oncology and (OSI) Prosidion. (OSI) Oncology is focused on developing molecular targeted therapies designed to change the

 


 

paradigm of cancer care. (OSI) Prosidion is committed to the generation of novel, targeted therapies for the treatment of type 2 diabetes and obesity. OSI’s flagship product, Tarceva(R) (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. OSI markets Tarceva through partnerships with Genentech, Inc. in the U.S. and with Roche throughout the rest of the world.
     (OSI) Prosidion is the diabetes and obesity business team within OSI Pharmaceuticals dedicated to the discovery and development of novel drugs for the treatment of type 2 diabetes and obesity. (OSI) Prosidion’s lead compound, PSN9301, is a Dipeptidyl Peptidase IV (DPIV) inhibitor currently in Phase II clinical trials. Other product candidates include a glycogen phosphorylase inhibitor currently in a Phase I clinical trial and a glucokinase activator scheduled to enter a Phase I clinical trial in 2005. (OSI) Prosidion owns or has licensing rights to a portfolio of DPIV medical use patents with claims covering DPIV as a target for anti-diabetes therapy and the use of combinations of DPIV inhibitors with other anti-diabetes drugs such as metformin. A number of non-exclusive licenses to the patent estate have been granted to major pharmaceutical companies. (OSI) Prosidion operates through OSI’s wholly-owned subsidiary, Prosidion Limited, in Oxford, UK.
     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 review process 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.
SOURCE: OSI Pharmaceuticals, Inc.
OSI Pharmaceuticals, Inc.
Kathy Galante, 631-962-2000
or
Burns McClellan (representing OSI)
Justin Jackson, 212-213-0006

 

EX-99.3 9 y13070exv99w3.htm EX-99.3: PRESS RELEASE EX-99.3
 

EXHIBIT 99.3
OSI Pharmaceuticals Announces Tarceva(R) Granted Approval in the European Union for the Treatment of Advanced Non-Small Cell Lung Cancer
     MELVILLE, N.Y.—(BUSINESS WIRE)—Sept. 21, 2005—OSI Pharmaceuticals, Inc. (NASDAQ:OSIP) announced today that its international partner for Tarceva(R) (erlotinib), Roche, received approval from the European Commission of Tarceva for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) after failure of at least one prior chemotherapy regimen. Tarceva is an oral tablet indicated for daily administration, and is approved in the United States, Canada, and Switzerland. Tarceva is the only epidermal growth factor receptor (EGFR) therapy to demonstrate in a Phase III trial an increase in survival for advanced NSCLC patients.
     “We are pleased that lung cancer patients in the European Union now have a new treatment option with a proven survival benefit, coupled with a manageable side effect profile,” said Colin Goddard, Ph.D., Chief Executive Officer of OSI Pharmaceuticals. “We congratulate our partner, Roche, on their efforts, and continue to work closely with both Roche and Genentech to explore additional uses of Tarceva in solid tumors and in combination with other therapies.”
     The European Commission approved Tarceva for the treatment of patients with locally advanced or metastatic NSCLC after failure of at least one prior chemotherapy regimen. When prescribing Tarceva, factors associated with prolonged survival should be taken into account. No survival benefit or other clinically relevant effects of the treatment have been demonstrated in lung cancer patients with EGFR-negative tumors.
     The EU approval is based on data from a pivotal Phase III study, Trial BR.21, which was recently published in The New England Journal of Medicine. The study compared Tarceva to placebo for the treatment of patients with advanced NSCLC, following failure of first or second-line chemotherapy. As with the U.S., Swiss, and Canadian approvals, no mandatory testing for EGFR is required.
     “Despite being the biggest cancer killer, lung cancer is an often neglected disease,” said Dr. Giuseppe Giaccone, VU Medical Center, Amsterdam. “Over 50 percent of lung cancer patients in Europe are not receiving second-line treatment. With the approval of Tarceva, physicians now have a viable alternative to chemotherapy for their patients.”
About Non-Small Cell Lung Cancer
     According to the World Health Organization, lung cancer is the most common cancer worldwide with 1.2 million new cases annually with someone, somewhere dying of the disease every 30 seconds. NSCLC accounts for almost 80 percent of all lung cancer cases, and there are few treatment options available. There are an estimated 370,000 people suffering with lung cancer each year in Europe.

 


 

About Tarceva
     Tarceva is a small molecule designed to target the human epidermal growth factor receptor 1 (HER1) pathway, which is 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 signaling 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.
     In May 2004, OSI filed for a supplemental New Drug Application to the US Food and Drug Administration for the use of Tarceva plus gemcitabine chemotherapy in the treatment of patients with advanced pancreatic cancer who have not received any previous treatment. Tarceva is the first drug to significantly improve survival in a Phase III trial when added to gemcitabine chemotherapy in first-line pancreatic cancer compared to gemcitabine alone. Additional early-stage trials of Tarceva are being conducted in other solid tumors.
Tarceva Safety Profile
     In the pivotal NSCLC trial, the most common adverse reactions in patients receiving Tarceva were rash and diarrhea. Grade three/four rash and diarrhea occurred in nine and six percent of Tarceva-treated patients, respectively. Rash and diarrhea each resulted in discontinuation of one percent of Tarceva-treated patients. Dose reduction for rash and diarrhea was needed for six and one 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.
     Results from two earlier large, randomized, placebo-controlled 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.
About OSI Pharmaceuticals
     OSI Pharmaceuticals is committed to “shaping medicines and changing lives” by discovering, developing and commercializing high-quality and novel pharmaceutical products that extend life or improve the quality of life for cancer and diabetes patients worldwide. The company operates through two business teams, (OSI) Oncology and (OSI) Prosidion. (OSI) Oncology is focused on developing molecular targeted therapies designed to change the paradigm of cancer care. (OSI) Prosidion is committed to the generation of novel, targeted therapies for the treatment of type 2 diabetes and obesity. OSI’s flagship product, Tarceva(R) (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. OSI markets Tarceva through partnerships with Genentech, Inc. in the U.S. and with Roche throughout the rest of the world.

 


 

     In addition to Tarceva, (OSI) Oncology exclusively markets Novantrone(R) (mitoxantrone concentrate for injection) for its approved oncology indications and markets Gelclair(R) Bioadherent Oral Gel for the relief of pain associated with oral mucositis. The research and development pipeline consists of novel molecularly targeted anti-cancer agents focused on signal transduction pathways involved in cell proliferation, apoptosis and angiogenesis. The most advanced of these programs, targeting the co-inhibition of c-kit and VEGFR, has two candidates in development.
     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 review process 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.
CONTACT: OSI Pharmaceuticals, Inc.
Kathy Galante, 631-962-2000
or
Media:
Burns McClellan (representing OSI)
Justin Jackson, 212-213-0006
SOURCE: OSI Pharmaceuticals, Inc.

 

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