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

October 22, 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:

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))

Item 2.02. Results of Operations and Financial Condition.

     On October 25, 2007, OSI Pharmaceuticals, Inc. (“OSI”) issued a press release regarding its financial results for the quarter ended September 30, 2007. A copy of this release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

     The information in this Item 2.02 (including Exhibit 99.1) is being “furnished” and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date of this report, except as shall be expressly set forth by specific reference in such filing.

Item 8.01. Other Events.

     On October 25, 2007, OSI held a webcast conference call regarding its financial results for the quarter end September 30, 2007. A textual representation of certain portions of the conference call is attached as Exhibit 99.2 to this Form 8-K and is incorporated herein by reference.

     On October 23, 2007, OSI provided a summary of data from pre-clinical studies involving OSI-906, an orally active, potent and selective inhibitor of the insulin-like growth factor-1 receptor, or IGF-1R, presented during the 2007 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics held from October 22, 2007 to October 26, 2007 in San Francisco, California. A copy of the OSI’s press release, dated October 23, 2007 is attached hereto as Exhibit 99.3 and is incorporated herein by reference.

     On October 22, 2007, OSI and Roche, the international partner of OSI for the distribution and sale of its oncology drug Tarceva^® (erlotinib), announced that Tarceva had been approved in Japan for the treatment of patients with nonresectable, recurrent and advanced non-small cell lung cancer which is aggravated following chemotherapy. A copy of OSI’s press release, dated October 22, 2007, is attached hereto as Exhibit 99.4 and is incorporated herein by reference.

     This Current Report on Form 8-K contains “forward-looking statements” that do not convey historical information, but relate to predicted or potential future events, such as statements of our plans, strategies and intentions. These statements can often be identified by the use of forward-looking terminology such as “believe,” “expect,” “intend,” “may,” “will,” “should,” or “anticipate” or similar terminology. All statements other than statements of historical facts included in this Current Report on Form 8-K are forward-looking statements. All forward-looking statements speak only as of the date of this Current Report on Form 8-K. Except for OSI’s ongoing obligations to disclose material information under the federal securities laws, OSI undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. In addition to the risks and uncertainties of ordinary business operations and conditions in the general economy and the markets in which OSI competes, the forward-looking statements of the Company contained in this Current Report on Form 8-K are also subject various risks and uncertainties, including those set forth in Item 1A, “Risk Factors”, in OSI’s Annual Report on Form 10-K for the fiscal year ended December 31, 2006, and in its subsequent filings made with the Securities and Exchange Commission.

Item 9.01. Financial Statements and Exhibits.

Exhibit No.	Description
99.1	Press Release dated October 25, 2007.
99.2	Textual representation of certain portions of the webcast conference call held on October 25, 2007.
99.3	Press Release dated October 23, 2007.
99.4	Press Release dated October 22, 2007.

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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: October 29, 2007	OSI PHARMACEUTICALS, INC.
	By:	/s/ Barbara A. Wood
		Barbara A. Wood
		Vice President, General Counsel and Secretary

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EXHIBIT INDEX

Exhibit No.	Description
99.1	Press Release dated October 25, 2007.
99.2	Textual representation of certain portions of the webcast conference call held on October 25, 2007.
99.3	Press Release dated October 23, 2007.
99.4	Press Release dated October 22, 2007.

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EX-99.1

Exhibit 99.1

NEWS RELEASE                    

Contacts:
OSI Pharmaceuticals, Inc.	Burns McClellan, Inc. (representing OSI)
Kathy Galante (investors/media)	Justin Jackson (media)
631-962-2043	Nicki Kahner (investors)
Kim Wittig (media)	(212) 213-0006
631-962-2135

OSI Pharmaceuticals Announces Third Quarter 2007 Financial Results

- Reports Earnings of $0.59 Per Share From Continuing Operations —

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- Tarceva Global Net Sales of $226 Million Up 32% Over The Third Quarter of 2006

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- Total Revenue Up 77% Over The Third Quarter of 2006 -

MELVILLE, NEW YORK — October 25, 2007 — OSI Pharmaceuticals, Inc. (NASDAQ: OSIP) announced today its financial results for the Company’s third quarter ended September 30, 2007. The Company reported net income from continuing operations of $35.9 million (or $0.59 per share) for the three months ended September 30, 2007, compared with net income from continuing operations of $159,000 (or $0.00 per share) for the third quarter of 2006.

Total worldwide net sales of Tarceva^® (erlotinib) for the third quarter of 2007, as reported by the Company’s collaborators for Tarceva, Genentech, Inc. and Roche, were approximately $226 million representing a 32% growth in global sales compared to the same period last year. For the nine months ended September 30, 2007 worldwide Tarceva net sales were approximately $635 million representing a 38% increase over the same period last year.

The Company reported total revenues from continuing operations of $100 million for the third quarter of 2007 compared to revenues of $57 million for the third quarter of 2006, an increase of 77%. Revenues were comprised of the following key items:

• Net revenues from the unconsolidated joint business for Tarceva of $42 million, compared to $40 million in the third quarter of 2006, arising from the Company’s co-promotion arrangement with Genentech. The net revenues are based on total U.S. Tarceva net sales of $101 million, compared to $100 million in the third quarter of 2006. U.S. net sales for the third quarter of 2007 were negatively impacted by approximately $13 million of reserve adjustments due to unusually high product returns related to expiring inventory returned to Genentech;

• Royalties of $25 million compared to $14 million in the third quarter of 2006 from Roche, the Company’s international partner for Tarceva. The royalty revenues are

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based on total rest of world Tarceva sales of approximately $125 million which increased 77%, compared to the $71 million reported in the third quarter of 2006;

•

License, milestone and other revenues of $33 million compared with $3 million in the third quarter of 2006. The increase is comprised primarily of licenses, milestone and royalty income related to worldwide non-exclusive licensing agreements under the Company’s DP-IV patent portfolio covering the use of DP-IV inhibitors for treatment of type 2 diabetes, the amortization of an upfront license fee related to a licensing agreement granted to Eli Lilly and Company, in January 2007, for our Glucokinase Activator program, and license revenue from Renovo in connection with their licensing agreement with Shire, plc for their TGF-beta 3 drug candidate Juvista®.

Operating expenses from continuing operations for the third quarter of 2007 were $64.4 million, compared to $56.8 million for last year’s third quarter. Research and development expenses for the third quarter of 2007 were $29.5 million compared to $29.8 million for the third quarter of 2006. The Company also recognized a $7.5 million in-process research and development charge related to its recently announced new drug discovery and translational research collaboration with AVEO Pharmaceuticals, Inc. Selling, general and administrative expenses for the third quarter of 2007 decreased to $24.8 million from $25.4 million for the third quarter of 2006. Operating expenses include $3.4 million (or $0.05 per share) of equity related compensation expense for the third quarter of 2007, compared to $2.9 million (or $0.05 per share) for the third quarter of 2006.

On November 6, 2006, we announced our intention to divest our eye disease business, a process which we expect to complete in 2007. Our eye disease business consists principally of Macugen^® (pegaptanib sodium injection), our marketed product for the treatment of wet age-related macular degeneration, as well as research assets in the eye disease area. As a result of our decision to divest the eye disease business, or Eyetech, the operating results for Eyetech, for all periods presented, is shown as discontinued operations in the accompanying consolidated statement of operations. Earlier in the third quarter, the Company announced the sale of its anti-platelet derived growth factor (PDGF) aptamer program, a key Eyetech research asset to Ophthotech Corporation.

The Company’s net income, including results from discontinued operations, was $29.6 million (or $0.49 per share) for the three months ended September 30, 2007, compared with a net loss of $21.3 million (or $0.37 per share) reported for the third quarter of 2006.

Conference Call
OSI will host a conference call reviewing the Company’s financial results, product portfolio and business developments on October 25, 2007 at 5:00PM (Eastern Time). To access the live webcast or the fourteen-day archive via the Internet, log on to www.osip.com. Please connect to the Company’s website at least 15 minutes prior to the conference call to ensure adequate time for any software download that may be needed to access the webcast. Alternatively, please call 1-866-550-6338 (U.S.) or 1-347-284-6930 (international) to listen to the call. The conference ID number for the live call is 4724151. Telephone replay is available approximately two hours after the call through November 9, 2007. To access the replay, please call 1-888-203-1112 (U.S.) or 1-719-457-0820 (international). The conference ID number is 4724151.

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 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.

OSI Pharmaceuticals, Inc. and Subsidiaries
Selected Financial Information

Consolidated Statements of Operations
(In thousands, except per share data)	Three Months Ended September 30,						Nine Months Ended September 30,
	2007			2006			2007			2006
	Unaudited			Unaudited			Unaudited			Unaudited
Revenues:
Net revenue from unconsolidated joint business	$	41,747		$	39,833		$	123,868		$	114,699
Royalties on product licenses		25,413			14,231			67,252			33,157
License, milestone, and other revenues		33,210			2,741			65,602			23,856
Total revenues		100,370			56,805			256,722			171,712
Expenses:
Cost of goods sold		2,142			1,246			6,093			5,467
Research and development		29,489			29,750			87,384			86,249
Acquired in-process research and development		7,500			—			7,500			—
Selling, general and administrative		24,816			25,350			73,983			78,860
Amortization of intangibles		461			454			1,378			1,353
Total expenses		64,408			56,800			176,338			171,929
Income (loss) from continuing operations		35,962			5			80,384			(217	)
Other income (expense):
Investment income — net		3,157			2,472			9,247			5,712
Interest expense		(1,811	)		(1,843	)		(5,423	)		(5,498	)
Other income (expense) — net		(1,404	)		(475	)		667			(1,902	)
Net income (loss) from continuing operations		35,904			159			84,875			(1,905	)
Loss from discontinued operations		(6,276	)		(21,416	)		(28,984	)		(379,182	)
Net income (loss) before extraordinary gain		29,628			(21,257	)		55,891			(381,087	)
Extraordinary gain		—			—			—			22,046
Net income (loss)	$	29,628		$	(21,257	)	$	55,891		$	(359,041	)
Basic and diluted income (loss) per common share:
Basic earnings (loss)
Continuing operations	$	0.62		$	0.00		$	1.48		$	($0.03	)
Discontinued operations	$	($0.11	)	$	($0.38	)	$	($0.50	)	$	($6.66	)
Net income (loss) before extraordinary gain	$	0.51		$	($0.37	)	$	0.97		$	($6.70	)
Extraordinary gain	$	0.00		$	0.00		$	0.00		$	0.39
Net income (loss)	$	0.51		$	($0.37	)	$	0.97		$	($6.31	)
Diluted earnings (loss)
Continuing operations	$	0.59		$	0.00		$	1.41		$	($0.03	)
Discontinued operations	$	($0.10	)	$	($0.37	)	$	($0.46	)	$	($6.66	)
Net income (loss) before extraordinary gain	$	0.49		$	($0.37	)	$	0.95		$	($6.70	)
Extraordinary gain	$	0.00		$	0.00		$	0.00		$	0.39
Net income (loss)	$	0.49		$	($0.37	)	$	0.95		$	($6.31	)
Weighted average shares of common stock outstanding:
Basic shares		57,756			56,974			57,536			56,918
Diluted shares		65,201			57,729			63,041			56,918

	September 30,		December 31,
	2007		2006
	Unaudited
Cash and investment securities (including restricted investments)	$	291,123	$	216,368

OSI Pharmaceuticals, Inc. and Subsidiaries
Reconciliation from Reported Income from Continuing Operations and Reported Diluted Income Per Share to Adjusted Income
from Continuing Operations and Income Per Share
(In thousands, except per share data)

	Three Months Ended September 30,				Nine Months Ended September 30,
	2007		2006		2007			2006
	Unaudited		Unaudited		Unaudited			Unaudited
Reported net income (loss) from continuing operations	$	35,904	$	159	$	84,875		$	(1,905	)
Non GAAP adjustments		317		—		(2,317	)		2,605
Adjusted net income from continuing operations	$	36,221	$	159	$	82,558		$	700
Reported diluted income (loss) per common share from continuing operations	$	0.59	$	0.00	$	1.41		$	(0.03	)
Non GAAP adjustments per share		0.00		—		(0.04	)		0.04
Adjusted diluted income per common share from continuing operations	$	0.59	$	0.00	$	1.37		$	0.01

	Three Months Ended September 30,				Nine Months Ended September 30,
	2007		2006		2007			2006
Adjusted amounts shown above include the following:
Facility related restructuring charges (a)	$	317	$	—	$	704		$	2,605
Severance related restructuring charges (b)		—		—		1,081			—
Curtailment gain (c)		—		—		(4,102	)		—
Total Non GAAP adjustments	$	317	$	—	$	(2,317	)	$	2,605

(a)	Represents facility restructuring charges included in SG&A.
(b)	Represents a charge for severance related to planned workforce reductions of $363 included in R&D and $718 included in SG&A for the nine months ended September 30, 2007.
(c)	Represents a gain recorded in other income (expenses) — net as result of the curtailment of the Company’s post retirement medical plan.

The table above details the charges excluded in the calculation of the Company’s adjusted income from continuing operations. Management believes that these charges are not reflective of the Company’s normal on-going operations. The adjusted financial results can assist in making meaningful period-over-period comparisons and in identifying operating trends that could otherwise be masked or distorted by the items subject to the adjustments. Management uses the adjusted results internally to evaluate the performance of the business, including the allocation of resources as well as the planning and forecasting of future periods and believes these results are useful to others in analyzing operating performance and trends of the Company. The adjusted amounts are not, and should not be viewed as, substitutes for U.S. GAAP amounts.

EX-99.2

Exhibit 99.2

On October 25, 2007, OSI Pharmaceuticals, Inc. (the “Company”) held a webcast conference call regarding its financial results for the quarter ended September 30, 2007 as well as an update on the Company’s business. The following represents a textual representation of remarks by Kathy Galante, Investor Relations, Colin Goddard, PhD., Chief Executive Officer of the Company, Gabriel Leung, Executive Vice President and President (OSI) Oncology and Michael G. Atieh, Executive Vice President and Chief Financial Officer of the Company.

Operator

[Operator’s Instruction]

Kathy Galante

[Kathy Galante’s Introduction]

Before we begin, I would like to remind you that we will be making forward-looking statements relating to financial results and clinical and regulatory developments on the call today. These statements cover many events that are outside of OSI’s control and are subject to various risks that could cause the results to differ materially from those expressed in any forward-looking statement. I refer you to our SEC filings for a detailed description of the risk factors affecting our business. Now over to Mike.

Michael Atieh

[Michael Atieh discusses quarterly information]

Dr. Colin Goddard

Thanks, Mike. As we’ve discussed previously over the last year and a half, we’ve been reengineering the business as a means of re-establishing the value creation and growth proposition that we believe is OSIP. We’ve been striving to strike the right balance between delivering financial performance and appropriate reinvestment in the business and, in addition to bringing our cost base into alignment, we’ve been primarily focused on the continued execution on our Tarceva program, prioritizing our R&D investments in oncology and diabetes and divesting the eye business, which we have consequently categorized as discontinued operations.

As Mike has already mentioned, with our 2007 EPS guidance now at US$1.65 per share, we have unequivocally put the business on a sound financial footing, we’ll be close to US$100 million in positive cash flow from continuing operations anticipated in 2007, we expect to close the year with a substantially improved cash position. While our 2007 income statement has been the beneficiary of strong deal and license related revenues, mainly from the Lily and Renovo deals, together with another exceptional year of licensing activity around the DP-IV patent estate, we believe we have our cost base aligned appropriately with our revenue growth and expect sustained profitability even as we advanced key R&D programs in 2008.

The last structural piece of our turnaround strategy is the completion of the divestiture of the eye business. As we noted on our second-quarter call, we are working towards divestiture of the remaining Macugen-related assets towards the end of the year. One of the more attractive aspects of this timing is it allows us to retain the opportunity to utilize the Eyetech-related net operating losses, which total over US$140 million and become available for us to utilize within the parent business on the second anniversary of the closing of the original transaction in November. A recent round of cutbacks in the eye business operation has reduced our eye business headcount to approximately 25 and the anticipated monthly cash burn going forward to about US$1.5 million per month.

Clearly the anchor for the growth of the reengineered overall business is still Tarceva, with the global growth of the brand with 32% growth in the third-quarter sales versus 2006, continues to be impressive. While the returns issue in the U.S. has impacted reported sales over the last two quarters, rest of world sales have been growing at a handsome fit, with rest of world sales at US$331 million year-to-date representing a 101% increase over the same period last year.

We also had recent developments in two key ex-U.S. markets, Japan and England. Last Monday, we announced the approval of Tarceva in Japan. Tarceva was approved for the treatment of patients with non-resectable, recurrent and advanced non-small cell lung cancer, which is aggravated following chemotherapy. Japan, where approximately 85,000 patients are newly diagnosed with non-small cell lung cancer every year, represents a key approval for the brand. The approval was supported by two Phase II trials that confirm the safety and efficacy of Tarceva in Japanese patients in support of the landmark BR.21 survival study.

Although there have been some past related serious adverse reactions, including Interstitial Lung Disease were reported in the Phase II studies; so Chugai, our partners in Japan, have agreed to a post-marketing surveillance for the first 3,000 patients who receive Tarceva.

In the UK, NICE have agreed to another review of their controversial decision not to recommend reimbursement of Tarceva by the National Health Service in England and Wales. This process will likely take up to a year and during this review period, our partners, Roche, have announced that they will offer a UK-specific Tarceva access program, under which they will subsidize the cost of Tarceva to the NHS such that patients can be offered Tarceva at the same average cost of docetaxel.

The Tarceva access program is not a price discount. The UK list price is unaffected. It was put in place immediately upon announcement of the last until NICE make their review decision. The net result of this, however, is that with the Japan launch anticipated around year end we will be selling Tarceva into important new territories in the first part of 2008.

Our progress in the third quarter is consistent with our view that the predominant global volume and sales gross profit for the brand in 2007 and early part of 2008 will be the strong growth in ex-U.S. sales. We then anticipate second half 2008 data from the SATURN front-line non-small cell lung cancer Phase III maintenance study and BETA lung Phase III Avastin Tarceva second-

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line combination study, driving a reacceleration of U.S. and global Tarceva sales thereafter, assuming, of course, positive data and successful registration.

Accrual to the key SATURN study continues on track with the anticipated data from this study due, as we said, in the second half of next year. Accrual to the other alliance sponsored important Phase III studies, that’s the BETA lung study and our RADIANT adjuvant non-small cell lung cancer study, also continues on track. Nonetheless, while we believe positive new trial data could materially impact the reacceleration of growth in the second half of 2008, we continue to anticipate some nearer-term benefit in the U.S. market from the reorganized selling effort for Tarceva and growing impact from the new dedicated OSI Genentech sales force. There are some indications that the commercial campaign reemphasizing the particular value of Tarceva in certain subsets of patients is starting to make inroads.

On the competitive front, we continue to await flex data in order to better assess the impact of this. However, we remind you that the flex study, which employed the less commonly used Navalbine Cisplatin combination, follows on the heels of the failed BMS-099 study and is the only one of eight major Phase III studies expected to read out over the last two years involving competitive agents such as Iressa, Erbitux, Telcyta and Velcade to turn positive. We believe this outcome represents a substantial lowering of the competitive risks surrounding Tarceva and a reminder of the value of our best in class therapeutics.

We were also pleased to receive official notification this quarter from the United States patent trademark office that the core Tarceva composition of matter patent has been extended through November the 8th, 2018. In addition, supplementary protections certificates have also been granted for Tarceva extending exclusivity with 14 countries, including key European markets such as France, Germany, Italy and the UK.

Moving beyond Tarceva, we have recognized that we need to do more than simply maximize Tarceva cash flows and deliver financial performance if we’re going to really build the strategic value of our business for our shareholders. We also recognize that our clinical assets is an expensive, overpriced, and highly competitive exercise that’s ripe with risk. We are therefore chosen to focus primarily on drawing out the value in our own high-quality oncology and diabetes development pipelines and to establish a differentiated research capability in oncology.

We are invested in our research and development pipeline in a highly disciplined manner. As such, for those core development assets where we clearly see ourselves as having differentiated best in class or first in class potential, we will tend to invest aggressively and maintain control of these assets in order to deliver a maximum step-up in value to our shareholders as we move them through development and into the marketplace. For those assets and programs that are less differentiated or face stiff competition, we are more likely to see partnering or out-licensing arrangements that will allow these programs to move forward competitively while freeing up resources to invest in the key core programs.

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In this regard, we were pleased to see our core IGF-1 receptor inhibitor program recognized on Tuesday as part of the media program at 2007 AACR-NCI-EORTC molecular targets and cancer therapeutics meeting in San Francisco. OSI-906, our potentially first in class small molecule IGF-1 receptor inhibitor is progressing through both continuous and intermittent dosing Phase I trials. OSI-906 has broad potential in all major tumor types, including lung, prostate, breast, and colorectal cancer and has demonstrated synergistic benefit with Tarceva in preclinical models.

We also continue to make progress with PSN9301, our potentially differentiated prandially dosed DP-IV inhibitor currently in Phase II trials. We announced the successful completion of a drug interaction study of PSN9301 with Metformin this quarter and continue to move forward in building an ultimate profile, whereby PSN9301 dosed prandially at breakfast and dinner, either as a monotherapy or in combination with Metformin, may deliver equivalent efficacy in terms of the maintenance of biologically relevant GLP-1 levels, so that achieved by established once a day DP-IV inhibitor competitors, while allowing near normal DP-IV activity inter-prandially and overnight on other important DP-IV substrate peptides, including Substance P, PYY and NPY. This could include the DP-IV activation of the appetite fact of PYY. Any weight loss or side effect profile benefits of PSN9301 may allow for differentiated positioning in this enormous emerging market. As we discussed on prior calls, we have chosen to focus our business development efforts on pursuing supplementary and complementary research efforts in technology that we can acquire, or in the case of the recent AVEO announcement, build collaborations around, such that we’re we are able to differentiate our research platforms and thereby to collectively increase the technology value of our business.

The AVEO collaboration is designed to support our efforts to build a unique differentiated and industry-leading oncology research effort in the area of Epithelial-to-Mesencymal Transition, or EMT, biology. Our EMT program is at the heart of our efforts to build on our core research expertise in small molecule — molecular, targeted therapy research by embarking upon a plan that builds on the core strength and expertise of the internal oncology research groups and orients them towards a goal of building a comprehensive platform of IT, proprietary know-how and integrated discovery and translational research capabilities in order to exploit our emerging understanding of EMT.

I’ll remind you that our interest in EMT first arrived from our translational research efforts into better understanding which patients gained optimal benefit from Tarceva therapy. We look forward to briefing our investors and the analyst community more fully on all of our R&D programs at our upcoming research analyst day, scheduled for Thursday, November the 29th in New York.

In summary, let me close by saying that we believe that this strong third quarter is another important milestone in our journey to re-establish the value creation and growth proposition of OSIP. Our turnaround plan has yielded nine-month year-to-date global Tarceva sales of US$635 million, growing at 38% versus the same period a year ago, the establishment of strong profitability for the business and a highly disciplined approach to balancing R&D investment in the business against financial performance. We believe that we have the Company well-

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positioned to enter 2008, which could provide robust clinical data for further accelerate Tarceva revenue growth and the emergence of high-quality core clinical pipeline assets to round out the business. We remain committed to growing shareholder value by building the strategic value of our Company in terms of both financial performance and step-ups in the value of our core assets by thoughtful and focused reinvestment in the business. Thank you for joining us on the call and with that, Blanche will be happy to open up the lines for Q&A.

[A question and answer session followed]

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EX-99.3

Exhibit 99.3

NEWS RELEASE                    

Contacts:
OSI Pharmaceuticals, Inc.	Burns McClellan, Inc. (representing OSI)
Kathy Galante (investors/media)	Justin Jackson (media)
631-962-2043	Carney Noensie (investors)
Kim Wittig (media)	(212) 213-0006
631-962-2135

OSI PHARMACEUTICALS SUMMARIZES DATA PRESENTED
ON OSI-906 AT THE AACR-NCI-EORTC INTERNATIONAL
CONFERENCE ON MOLECULAR TARGETS AND CANCER THERAPEUTICS

— Data on OSI-906, a small molecule in Phase I trials that selectively targets the IGF-1R
receptor, featured in Conference media program—

MELVILLE, NEW YORK — October 23, 2007 — OSI Pharmaceuticals, Inc. (Nasdaq: OSIP) announced today that pre-clinical data on OSI-906, an orally active, potent and selective inhibitor of the insulin-like growth factor-1 receptor (IGF-1R), were featured as part of a media program during the 2007 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics held October 22-26, 2007 in San Francisco, CA. OSI presented data that support the clinical development of OSI-906 for the treatment of human cancers as a single agent and in combination with other molecular targeted agents, including Tarceva^® (erlotinib).

OSI is currently enrolling patients with advanced solid tumors in two Phase I dose escalation studies of OSI-906. Data from both studies will be evaluated to establish a recommended dose and dosing schedule for Phase II clinical trials of OSI-906.

As highlighted in today’s media briefing, OSI-906 blocks IGF-1R activation of the key cancer cell signalling pathways called AKT and MAP kinase that are known to drive tumor cell growth. In preclinical studies, OSI-906 not only slowed tumor growth, but also decreased the size of pre-existing tumors known to be dependent on the human IGF-1R. Additionally, when OSI-906 was combined with Tarceva in mice with human colorectal tumors, the two drugs together decreased the size of pre-existing tumors more effectively than either drug alone.

“We are encouraged by our research demonstrating the ability of an orally dosed small molecule from our IGF-1R program to selectively diminish or halt tumor growth in preclinical cancer models,” said David M. Epstein, Ph.D., Vice President of Oncology Research, OSI Pharmaceuticals. “This research also supports our overall research strategy, which is built upon our core strength and expertise in the area of epithelial-to-mesenchymal transition, or EMT. In essence, we believe that pursuing EMT builds on our understanding of personalized medicine, not only finding the

‘right drug’ ‘right dose’ and ‘right target’ but also the ‘right combination’ of drugs to address the biological context of a patient’s tumor.”

Following are summaries of the key data presented on OSI-906:

Preclinical Characterization of OSI-906: A Novel IGF-1R Inhibitor in Clinical Trials- Qun-Sheng Ji, et al (Abstract # C192).

In this study, OSI-906 demonstrated robust anti-tumor activity in an IGF-1R dependent xenograft model when administered orally once a day at doses of 25 and 75 mg/kg. OSI-906 not only slowed the growth of IGF-1R-dependent tumors, but also reduced proliferation and/or survival of a broad panel of tumor cell lines. Specifically, among a panel of 28 human tumor cell lines, OSI-906 potently (EC₅₀ < 400 nM) reduced growth of 15 cell lines representative of colorectal, NSCLC, pancreatic, breast and pediatric cancers. In addition to the single agent activity, simultaneous treatment with a low dose of OSI-906 and Tarceva effectively blocked both AKT and MAP kinase pathways in human colorectal tumors, which resulted in a decrease in the size of pre-existing tumors which was better than the effect of either drug alone.

Inhibition of IGF-1R by OSI-906 Potentiates Efficacy of Various Molecular Targeted Agents by Blocking Feedback Loops Converging at the Level of IRS-1- Elizabeth Buck, et al. (Abstract # PR-1)

The IGF-1R receptor is a critical mediator of cell survival through its strong ability to couple to the AKT pathway. This study evaluated the ability of OSI-906, an orally active, potent and selective inhibitor of IGF-1R, to potentiate the sensitivity for other molecular targeted agents.

The researchers evaluated the effect of combining OSI-906 with inhibitors of three major oncogenic mediators: EGFR (Tarceva), MEK, and mTOR. These agents produced varying extents of tumor cell growth inhibition in vitro, but not cell survival, when dosed individually. However, in combination with OSI-906, the inhibitors of EGFR, MEK or mTOR promoted synergistic growth inhibition and apoptosis for select tumor cell lines. Inhibitors of EGFR, MEK and mTOR also promoted a shift in equilibrium toward IGF-driven AKT, and sustained inhibition of AKT was only achieved in combination.

The study also suggested that the combination of OSI-906 with Tarceva appears to be more active in epithelial tumor cells compared to those that have undergone an epithelial-mesenchymal transition (EMT). Mechanistically, inhibition of EGFR, MEK, or mTOR, relieves feedback inhibition imposed on IGF-1R signalling by altering the serine-phosphorylation state of IRS-1.

Background on OSI-906
IGF-1 and IGF-2 are growth factors, or hormones, known to stimulate growth and survival of cancerous cells. OSI-906 blocked the ability of IGF-1R to signal in xenograft mouse models of human colorectal cancer. Preclinical research also showed that colon cancer tumor cells respond to OSI-906 because they produce and are dependent on the growth-promoting effects of IGF-2. In addition to colorectal cancer, OSI-906 has also been shown to inhibit growth of human pancreatic and thyroid cancers in animal models. The IGF/IGF-1R signaling pathway has also been

implicated in protecting tumor cells from apoptosis induced by a number of cytotoxic agents as well as molecular targeted therapies including EGFR inhibitors.

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 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.

EX-99.4

Exhibit 99.4

NEWS RELEASE

Contacts:
Roche
Lester B. Davis
Phone: +41.61.688.2078
E-mail: lester.davis@roche.com
OSI Pharmaceuticals, Inc.
Kathy Galante(investors/media)
Phone: 631-962-2043
Kim Wittig (media)
Phone: 631-962-2135

TARCEVA^® (erlotinib) EARNS APPROVAL FOR LUNG CANCER PATIENTS IN JAPAN

BASEL, SWITZERLAND and MELVILLE, NEW YORK— October 22, 2007 — Roche and OSI Pharmaceuticals, Inc. (Nasdaq: OSIP) announced today that Tarceva^® (erlotinib) has been approved in Japan for the treatment of patients with nonresectable, recurrent and advanced non-small cell lung cancer (NSCLC) which is aggravated following chemotherapy. The Japanese Ministry of Health approval means that lung cancer patients in Japan will now have an important new treatment, which has been demonstrated to increase overall survival and offer an improvement in quality of life. NSCLC is suffered by over one million people worldwide. It is the most common form of lung cancer and is more deadly than colon, breast, and prostate cancers combined.¹ In 2005, the number of newly diagnosed patients with NSCLC in Japan reached 85,000.²

Tarceva’s approval in Japan is based on the submission of two Phase II studies that confirmed the safety and efficacy of Tarceva in Japanese patients, along with data from the landmark, randomized, Phase III BR.21 study which compared Tarceva to placebo in patients with advanced NSCLC after failure of at least one prior chemotherapy regimen. In this study, 31% of patients receiving Tarceva were alive at one year compared to 22% in the placebo arm and patients experienced a 42.5% improvement (6.7 months vs. 4.7 months) in the length of overall survival. In addition, significantly more patients on Tarceva had improvement in cough, pain, shortness of breath and overall physical function versus patients on placebo.³ The BR.21 study, also published in the New England Journal of Medicine, has led to the approval of Tarceva in

over 80 countries including the United States and the European Union for the treatment of patients with locally advanced or metastatic NSCLC after failure of at least one prior chemotherapy regimen.

Chugai Pharmaceutical, Co., Ltd., Roche’s alliance partner in Japan submitted the filing for this approval on April 14, 2006 to the Japanese Ministry of Health, Labour and Welfare. Following this formal approval, Tarceva is expected to launch in Japan by early 2008.

“Tarceva has the proven ability to prolong survival and improve quality of life in patients with the most common and deadly form of lung cancer,” says William M. Burns, CEO of the Pharmaceuticals Division at Roche. “This approval in Japan underscores our commitment to ensure that eligible patients around the world will have access to this effective treatment.”

“This is a huge milestone for lung cancer patients in Japan,” said Gabriel Leung, President, (OSI) Oncology. “The Japanese authorities have recognized the proven benefits of Tarceva and have acted admirably to make a significant difference to local patients, caregivers and oncologists battling this devastating disease.”

About Lung Cancer

According to the World Health Organization, lung cancer is the most common cancer worldwide, with 1.2 million new cases annually.⁴ NSCLC accounts for almost 80 percent of all lung cancer cases.⁵ In Japan specifically, the estimated incidence of lung cancer was 85,000 cases in 2005.²

Additional Tarceva Information

Tarceva was approved by the FDA in November 2004 and in the European Union in September 2005 as monotherapy for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) after failure of at least one chemotherapy regimen. 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.

There have been infrequent reports of serious Interstitial Lung Disease (ILD)-like events, including fatalities, in patients receiving Tarceva for treatment of NSCLC, pancreatic cancer or other

advanced solid tumors. In the pancreatic cancer trial, other serious adverse events associated with Tarceva plus gemcitabine and which may have included fatalities, were myocardial infarction/ischemia, cerebrovascular accident and microangiopathic hemolytic anemia with thrombocytopenia. When receiving Tarceva therapy, women should be advised against becoming pregnant or breastfeeding. Tarceva is pregnancy category D. The most common side effects in patients with NSCLC receiving Tarceva monotherapy 150 mg were rash and diarrhea. The most common side effects in patients with pancreatic cancer receiving the combination of Tarceva 100 mg plus gemcitabine were fatigue, rash, nausea, anorexia and diarrhea.

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 signalling 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.

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. In January 2007, the European Commission granted marketing authorization for Tarceva in combination with gemcitabine for the treatment of metastatic pancreatic cancer. Tarceva is the first drug in a Phase III trial to have shown a significant improvement in overall survival when added to gemcitabine chemotherapy as an initial treatment for pancreatic cancer.

For Tarceva full prescribing information, please call 1-877-TARCEVA or visit http://www.tarceva.com.

About Roche

Headquartered in Basel, Switzerland, Roche is one of the world’s leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As the world’s biggest biotech company and an innovator of products and services for the early detection, prevention, diagnosis and treatment of diseases, the Group contributes on a broad range of fronts to improving people’s health and quality of life. Roche is the world leader in in-vitro diagnostics and drugs for cancer and transplantation, a market leader in virology and active in other major

therapeutic areas such as autoimmune diseases, inflammation, metabolic disorders and diseases of the central nervous system. In 2006 sales by the Pharmaceuticals Division totalled 33.3 billion Swiss francs, and the Diagnostics Division posted sales of 8.7 billion Swiss francs. Roche has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai, and invests approximately 7 billion Swiss francs a year in R&D. Worldwide, the Group employs about 75,000 people. Additional information is available on the Internet at www.roche.com.

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.

Roche Disclaimer: Cautionary statement regarding forward-looking statements

This document contains certain forward-looking statements. These forward-looking statements may be identified by words such as ‘believes’, ‘expects’, ‘anticipates’, ‘projects’, ‘intends’, ‘should’, ‘seeks’, ‘estimates’, ‘future’ or similar expressions or by discussion of, among other things, strategy, goals, plans or intentions. Various factors may cause actual results to differ materially in the future from those reflected in forward-looking statements contained in this document, among others: (1) pricing and product initiatives of competitors; (2) legislative and regulatory developments and economic conditions; (3) delay or inability in obtaining regulatory approvals or bringing products to market; (4) fluctuations in currency exchange rates and general financial market conditions; (5) uncertainties in the discovery, development or marketing of new products or new uses of existing products, including without limitation negative results of clinical trials or research projects, unexpected side-effects of pipeline or marketed products; (6) increased government pricing pressures; (7) interruptions in production; (8) loss of or inability to obtain adequate protection for intellectual property rights; (9) litigation; (10) loss of key executives or other employees; and (11) adverse publicity and news coverage. The statement regarding earnings per share growth is not a profit forecast and should not be interpreted to mean that Roche’s earnings or earnings per share for any current or future period will necessarily match or exceed the historical published earnings or earnings per share of Roche.

OSI Forward-looking Statement

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.

References:

1. http://www.cancer.org/docroot/CRI/content/CRI221x_How_Many_People_Get_Non-small_Cell_Lung_Ca ncer.asp?sitearea

2. A. Oshima, T. Kuroishi, K. Tajima, “Cancer White Paper -Incidence/Death/Prognosis — 2004.”

3. Shepherd FA, Pereira JR, Ciuleanu T, Tan EH, et al. Erlotinib in previously treated non-small-cell lung cancer. New England Journal of Medicine 2005; 353:123.

4. http://www.who.int/mediacentre/news/releases/2003/pr27/en/print.html

5. Wilking N and Jonsson B. (2005) A Pan-European comparison regarding patient access to cancer drugs, Karolinska Institute in collaboration with Stockholm School of Economics, Stockholm, Sweden.