OSIP Osi Pharmaceuticals Inc. (MM)

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

SCHEDULE TO

(Rule 14d-100)

TENDER OFFER STATEMENT UNDER SECTION 14(d)(1)

OR 13(e)(1) OF THE SECURITIES EXCHANGE ACT OF 1934

(Amendment No. 16)

OSI Pharmaceuticals, Inc.

(Name of Subject Company (Issuer))

Ruby Acquisition, Inc.

Astellas US Holding, Inc.

Astellas Pharma Inc.

(Name of Filing Persons (Offerors))

Common Stock, Par Value $.01 Per Share

(Including the Associated Stock Purchase Rights)

(Title of Class of Securities)

671040103

(CUSIP Number of Class of Securities)

Masafumi Nogimori

President and Chief Executive Officer

Astellas Pharma Inc.

3-11, Nihonbashi-Honcho

2-chome, Chuo-ku

Tokyo 103-8411, Japan

(81) 3-3244-3000

(Name, Address and Telephone Number of Person Authorized

to Receive Notices and Communications on Behalf of Filing Persons)

Copies to:

Michael O. Braun, Esq.

Craigh Leonard, Esq.

Morrison & Foerster LLP

1290 Avenue of the Americas

New York, New York 10104

(212) 468-8000

CALCULATION OF FILING FEE

Check the appropriate boxes below to designate any transactions to which the statement relates:

Check the following box if the filing is a final amendment reporting the results of the tender offer:   ¨

This Amendment No. 16 to Schedule TO (this “Amendment No. 16”) amends and supplements the Tender Offer Statement on Schedule TO as originally filed with the Securities and Exchange Commission on March, 2, 2010 (together with any amendments and supplements thereto the “Schedule TO”) relating to the offer by Ruby Acquisition, Inc. (“Purchaser”), a wholly-owned subsidiary of Astellas US Holding, Inc. (“Parent”), a wholly-owned subsidiary of Astellas Pharma Inc. (“Astellas”), to purchase all issued and outstanding shares of the common stock, par value $0.01 per share (the “Common Stock”, and together with the associated stock purchase rights, the “Shares”), of OSI Pharmaceuticals, Inc., a Delaware corporation (the “Company”), at a price of $57.50 per Share, net to the seller in cash, without interest and subject to any required withholding of taxes, upon the terms and subject to the conditions set forth in the Offer to Purchase dated March 2, 2010 (together with any amendments and supplements thereto, including the Amendment and Supplement to the Offer to Purchase dated May 19, 2010, the “Offer to Purchase”) and in the related Letter of Transmittal, as amended or supplemented from time to time. This Amendment No. 16 is being filed on behalf of Astellas, Parent and Purchaser. You should read this Amendment No. 16 together with the Schedule TO. All capitalized terms used in this Amendment No. 16 and not otherwise defined have the respective meanings ascribed to them in the Offer to Purchase.

The information set forth in the Offer to Purchase, including Schedule I thereto, is hereby incorporated by reference in answer to Items 1 through 13 of this Schedule TO, and is supplemented by the information specifically provided herein.

Items 1 through 9 and Item 11.

Items 1 through 9 and Item 11 are hereby amended and supplemented to include the following:

The initial offering period expired at 12:00 midnight, New York City time, on Wednesday, June 2, 2010. Upon expiration of the Offer, Purchaser accepted for payment in accordance with the terms of the Offer all Shares that were validly tendered and not withdrawn prior to the expiration of the Offer (excluding all shares delivered through notices of guaranteed delivery), and payment for such Shares will be made promptly in accordance with the terms of the Offer. The Depositary for the Offer has advised Astellas and Purchaser that as of the expiration of the Offer, a total of 53,430,205 Shares were validly tendered to Purchaser and not withdrawn (including 5,014,478 Shares delivered through notices of guaranteed delivery) representing approximately 87% of the Shares outstanding.

On June 3, 2010, Astellas issued a press release announcing that Purchaser had commenced a Subsequent Offering Period for all remaining untendered Shares. The Subsequent Offering Period will expire at 12:00 midnight, New York City time, on Monday, June 7, 2010, unless extended. Any such extension will be followed by a public announcement no later than 9:00 a.m., New York City time, on June 8, 2010.

The same $57.50 per Share price (net to the seller in cash, without interest and subject to any required withholding taxes) offered in the initial offering period will be paid during the Subsequent Offering Period. Purchaser will immediately accept for payment all Shares validly tendered during this Subsequent Offering Period, and payment will be made promptly after

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acceptance, in accordance with the terms of the Offer. Procedures for tendering Shares during the Subsequent Offering Period are the same as during the initial offering period with two exceptions: (1) Shares cannot be delivered by the guaranteed delivery procedure, and (2) pursuant to Rule 14d-7(a)(2) promulgated under the Securities Exchange Act of 1934, as amended, Shares tendered during the Subsequent Offering Period may not be withdrawn.

Following the expiration of the Subsequent Offering Period, if Purchaser acquires at least 90% of the issued and outstanding Shares, Purchaser intends to complete the acquisition of the Company through the short-form merger procedure available under Delaware law. The short form merger procedure will permit the Purchaser to merge with and into the Company, with the Company surviving as an indirect wholly-owned subsidiary of Astellas, without a vote or meeting of the Company’s stockholders. In the merger, each outstanding Share not tendered and purchased in the Offer (other than Shares in respect of which appraisal rights are validly exercised under Delaware law and other than Shares held in the treasury of the Company and Shares owned by Purchaser, Parent or Astellas or any direct or indirect subsidiary of Purchaser or Astellas) will be converted into the right to receive the same $57.50 per Share net to the seller in cash, without interest and subject to any required withholding taxes, that was paid in the Offer. As a result of the merger, the Company’s common stock will cease to be traded on the Nasdaq Global Select Market. The full text of the press release issued by Astellas on June 3, 2010 announcing the commencement of a Subsequent Offering Period is filed as Exhibit (a)(5)(T) to the Schedule TO and is incorporated by reference into the Schedule TO.

Item 12 of the Schedule TO is hereby amended and supplemented to add the following exhibits:

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SIGNATURES

After due inquiry and to the best of their knowledge and belief, each of the undersigned certifies that the information set forth in this statement is true, complete and correct.

Dated June 3, 2010

POWER OF ATTORNEY

KNOW ALL MEN BY THESE PRESENTS, that the undersigned hereby constitutes and appoints each of Seigo Kashii, Linda F. Friedman and Stephen Knowles, individually and severally, and with full power of substitution, the undersigned’s true and lawful attorney-in-fact with full power to execute and file with the Securities and Exchange Commission and any stock exchange or similar authority, any report required to be filed pursuant to Section 14 of the Securities Exchange Act of 1934, (as amended, the “Act”), with respect to a third-party tender offer subject to Rule 14d-1, giving and granting unto said attorney-in-fact the power and authority to act in the premises as fully and to all intents and purposes as the Company might or could do if personally present by one of its authorized signatories, hereby ratifying and confirming all that said attorney-in-fact shall lawfully do or cause to be done by virtue hereof.

This Power of Attorney shall remain in full force and effect until the earliest of: (i) a revocation in writing by the undersigned; (ii) such time as the person to whom power of attorney has been hereby granted ceases to be an employee of the undersigned or any subsidiary company thereof; or (iii) March 2, 2011.

IN WITNESS WHEREOF, the undersigned has caused this Power of Attorney to be executed as of this 2nd day of March, 2010.

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EXHIBIT INDEX

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