Today, the OASIS study group will present initial results of the CURRENT-OASIS 7 clinical trial at the European Society of Cardiology congress in Barcelona. Sanofi-aventis (EURONEXT: SAN, and NYSE: SNY) and Bristol-Myers Squibb (NYSE: BMY), co-commercialization and co-development partners for PLAVIX(R) (clopidogrel bisulfate), were sponsors of the study.

CURRENT-OASIS 7 is the largest clinical trial (25,087 patients) to evaluate different dosing regimens of PLAVIX(R) plus aspirin in a broad range of acute coronary syndrome (ACS) patients (UA/NSTEMI/STEMI). The study was designed to assess the efficacy and safety of an intensified clopidogrel regimen (600 mg loading dose day 1 / 150 mg days 2-7 / 75 mg days 8-30) versus the approved PLAVIX dosage (300 mg loading dose day 1 / 75 mg days 2-30) for patients managed with an early invasive strategy with an intent for percutaneous coronary intervention (PCI).

The primary end-point (cardiovascular death, heart attack, or stroke at thirty days) for the entire study population (including subpopulations of patients that underwent PCI (70%) or not (30%) examining the difference between the high-dose and standard-dose PLAVIX(R) (clopidogrel bisulfate) regimens did not reach statistical significance (4.2% vs. 4.4%, HR 0.95, p=0.37).

For clinically relevant subgroups that were pre-specified for preliminary analyses, such as the PCI subgroup (70% of the trial population, 17,232 patients), potentially medically relevant differences in patient outcomes were observed. In this subgroup, analysis showed an improvement in outcome for patients taking the higher dose regimen (600 mg loading / 150 mg for days 2-7 / 75 mg days 8-30) over the standard dose regimen (300 mg loading / 75 mg for days 2-30), as shown by the reduction of the same composite end-point of cardiovascular death, myocardial infarction and stroke by 15% (4.5% vs 3.9%, p=0.037). In addition, analysis showed an important 42% relative risk reduction in definite stent thrombosis (1.2% vs 0.7%, p=0.001) with the higher dose regimen of clopidogrel over the standard loading dose.

"An artery opening procedure with stent placement exposes a patient to an increased risk of stent occlusion and subsequent heart attack," said Doctor Jean-Pierre Lehner, Chief Medical Officer, sanofi-aventis. "CURRENT-OASIS 7 provides important new information about a high-dose regimen of PLAVIX(R) in ACS patients planned for PCI. We are pleased to contribute to furthering the understanding of patient care during the acute phase of coronary intervention."

The primary safety end-point was assessed by the stringent bleeding definition of OASIS and while a significant increase in the primary safety end-point of major bleeding with the high-dose compared to the standard-dose PLAVIX(R) regimen was observed in the overall trial population (2.5% vs 2.0%, HR 1.25, p=0.01) and the PCI population (1.6% vs 1.1%, HR 1.44, p=0.006), there was no statistically significant difference in intracranial bleeding or fatal hemorrhage in the overall population and the PCI population.

Sanofi-aventis and Bristol-Myers Squibb believe that the CURRENT-OASIS 7 data add to the broad clinical experience with PLAVIX(R), which has been used in over 90 million patients during the 11 years it has been on the market.

About PLAVIX(R) (clopidogrel bisulfate)

Please see full prescribing information for the United States by visiting www.PLAVIX.com. For the most updated PLAVIX(R) labelling information in Europe please refer to: http://www.emea.europa.eu/humandocs/PDFs/EPAR/PLAVIX/H-174-PI-en.pdf.

About sanofi-aventis

Sanofi-aventis, a leading global pharmaceutical company, discovers, develops and distributes therapeutic solutions to improve the lives of everyone. Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY). For more information, please visit: www.sanofi-aventis.com.

About Bristol-Myers Squibb

Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to extend and enhance human life. For more information, visit www.bms.com.

Statement on Cautionary Factors

Sanofi-aventis

This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include product development, product potential projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future events, operations, products and services, and statements regarding future performance. Forward-looking statements are generally identified by the words "expects," "anticipates," "believes," "intends," "estimates," "plans" and similar expressions. Although sanofi-aventis' management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of sanofi-aventis, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMEA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such products candidates, the absence of guarantee that the products candidates if approved will be commercially successful, the future approval and commercial success of therapeutic alternatives as well as those discussed or identified in the public filings with the SEC and the AMF made by sanofi-aventis, including those listed under "Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements" in sanofi-aventis' annual report on Form 20-F for the year ended December 31, 2008. Other than as required by applicable law, sanofi-aventis does not undertake any obligation to update or revise any forward-looking information or statements.

Bristol-Myers Squibb

This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995, regarding the research, development and commercialization of products. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Among other risks, there can be no guarantee that the clinical trials described in this release will support a regulatory filing. Forward-looking statements in the press release should be evaluated together with the many uncertainties that affect Bristol-Myers Squibb's business, particularly those identified in the cautionary factors discussion in Bristol-Myers Squibb's Annual Report on Form 10-K for the year ended December 31, 2008, its Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K. Bristol-Myers Squibb undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise.

Ingrid Gorg-Armbrecht, Media, +33-153-774-625, Mobile: +33-686-056-688, or
ingrid.goerg-armbrecht@sanofi-aventis.com, Sebastien Martel, Investors,
+33-153-774-545, or ir@sanofi-aventis.com, both of sanofi-aventis; Laura Hortas,
Media, +1-609-240-7025, or laura.hortas@bms.com , John Elicker, Investors,
+1-609-252-4611, or john.elicker@bms.com, both of Bristol-Myers Squibb

Under the 2005 licensing agreement, Bristol-Myers Squibb received an exclusive license to develop and commercialize a series of biogenic amine reuptake inhibitors from AMRI's proprietary research program. To date, Bristol-Myers Squibb has selected two compounds from this program for approval to initiate Phase I studies. The two companies will continue to evaluate additional compounds under this collaboration to develop improved treatments for diseases of the central nervous system (CNS).

Per terms of the agreement, AMRI is potentially eligible to receive up to $66 million per compound in development and regulatory milestone payments for the first two compounds, and additional potential payments of up to $22 million per compound on subsequent compounds. In addition, AMRI will receive royalties on worldwide sales of commercialized compounds.

Albany Molecular Research, Inc. provides scientific services, products and technologies focused on improving the quality of life.

((Comments on this story may be sent to newsdesk@closeupmedia.com))

"The company is making important strides, both financially and operationally," said Douglas E. Williams, Ph.D., Chief Executive Officer of ZymoGenetics. "RECOTHROM sales trends continue to improve. We presented final Phase 1b clinical trial results for PEG-Interferon lambda with positive results for tolerability and antiviral activity, and the Phase 2 clinical trial is underway, triggering a $70.0 million milestone payment from our partner Bristol-Myers Squibb."

Financial Results

RECOTHROM net sales were $8.5 million for the third quarter of 2009 compared to $1.8 million for the third quarter of 2008. The product continues to gain market share and as of the end of the quarter, RECOTHROM had an estimated 15% share of the U.S. topical thrombin market as of September 2009. In the third quarter of 2009, RECOTHROM hospital unit demand increased approximately 25% from the second quarter of 2009.

Collaboration and license revenues were $18.5 million for the third quarter of 2009 compared to $8.5 million for the third quarter of 2008. The primary reason for the increase was incremental revenues from the PEG-Interferon lambda collaboration with Bristol-Myers Squibb. This increase was partially offset by reduced revenues from our RECOTHROM collaboration with Bayer HealthCare.

Research and development expenses for the third quarter of 2009 were $21.3 million, a decrease of $8.9 million from the third quarter of 2008. The decrease was primarily the result of the elimination of atacicept co-development collaboration costs and overall reduced headcount in research and development. These reductions were partially offset by increased costs related to the PEG-Interferon lambda collaboration with Bristol-Myers Squibb.

Selling, general and administrative expenses were $13.7 million for the third quarter of 2009 compared to $15.0 million in the third quarter of 2008. The decrease primarily resulted from reduced personnel-related costs, stock compensation and legal costs, partially offset by higher selling commissions payable to Bayer resulting from increased RECOTHROM net sales.

Net other expense totaled $2.5 million for the third quarter of 2009 compared to $5.3 million of net other income for the third quarter of 2008. In the third quarter of 2008, the company recorded a $7.1 million gain related to the sale of vacant land next to its corporate headquarters. The remainder of the difference is largely due to interest expense on the $25.0 million outstanding under the Deerfield Management debt facility, which was drawn in November 2008 and must be repaid by June 2013.

As of September 30, 2009, the company had $103.4 million of cash, cash equivalents and short-term investments. This amount does not include the $70.0 million milestone expected to be received this month from Bristol-Myers Squibb related to the initiation of the PEG-Interferon lambda Phase 2 clinical trial.

Business Highlights

ZymoGenetics recent business highlights included the following.

PEG-Interferon lambda

Final Phase 1b results were presented at the American Association for the Study of the Liver Diseases annual meeting on November 3, 2009. The dose-ranging clinical trial evaluated PEG-Interferon lambda as a single agent and with ribavirin in relapsed and treatment naive patients with hepatitis C. The results indicated that four week treatment with PEG-Interferon lambda and ribavirin was well tolerated with significant antiviral activity at all dose levels tested. The company is developing PEG-Interferon lambda in collaboration with Bristol-Myers Squibb. On October 26, 2009, a Phase 2 study in treatment naive patients was initiated, triggering a $70.0 million milestone payment from Bristol-Myers Squibb payable within 30 days.

RECOTHROM

RECOTHROM sales continued to increase in the third quarter. Hospital demand increased by approximately 25% in the third quarter of 2009 compared to the second quarter of 2009.

Interleukin-21 (IL-21)

In August 2009, the company completed enrollment in the Phase 2 study in metastatic melanoma. The single-agent study is evaluating IL-21 in patients with no prior systemic therapy for metastatic melanoma. The company continues to anticipate progression-free survival and overall survival results to be available in early 2010.

Conference Call and Webcast Information

ZymoGenetics Third Quarter 2009 Financial Results Conference Call will be held on Thursday, November 5, 2009 at 4:30 p.m. Eastern Time and may be accessed at www.zymogenetics.com or by dialing 877-407-0778 (International: 201-689-8565). Participants should dial in to the call approximately 10 minutes prior to the scheduled start time to register. A live audio webcast and slide presentation can be accessed by going to: www.zymogenetics.com. The webcast will be archived for 60 days.

For replay, please visit www.zymogenetics.com or use the following information:

-- U.S. callers: 877-660-6853

-- International callers: 201-612-7415

Replay passcode account #: 286

Conference ID #: 334609

About ZymoGenetics

ZymoGenetics is focused on the creation of novel protein drugs to improve patient care and address unmet medical needs. The company's strategy is to discover, develop and commercialize its products independently, in collaboration with partner companies or through out-licensing. ZymoGenetics developed and markets RECOTHROM(R) Thrombin, topical (Recombinant), a synthetic version of a human blood-clotting enzyme used to stop bleeding during surgery. The company is developing a proprietary portfolio of immune-based product candidates. PEG-Interferon lambda is a novel type-3 interferon in clinical development for the treatment of chronic hepatitis C infection. Interleukin-21 is a novel cytokine in clinical development for the treatment of metastatic melanoma and renal cell carcinoma. Several other proprietary product candidates are in preclinical development. In addition, ZymoGenetics has licensed rights to multiple clinical and preclinical drug candidates being developed by other companies. For further information, visit www.zymogenetics.com.

This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, those related to the Company's results of operations and expenses, RECOTHROM sales and commercialization efforts, milestone payments in connection with PEG-Interferon lambda development, the Company's clinical development programs and the timing and potential benefits thereof and the ability of ZymoGenetics to successfully partner with third parties to assist with development and commercialization efforts. These forward-looking statements are based on the current intent and expectations of the management of ZymoGenetics. These statements are not guarantees of future performance and involve risks and uncertainties that are difficult to predict and that could cause actual results and the timing and outcome of events to differ materially from those expressed in or implied by the forward-looking statements. These risks include, but are not limited to, risks associated with the Company's unproven product sales and marketing, manufacturing and commercialization capabilities, the risk that the Company is not able to establish, maintain or derive anticipated benefits from strategic partnerships and collaborations, the risk that the Company's revenues generated are smaller than anticipated and that its expenses and cash needs are greater than anticipated, the risk that the Company is unable to advance its clinical programs and regulatory applications and action at the rate it expects or at all, the risk that milestone payments under partnering or collaboration agreements are not earned when expected or at all and other risks detailed in the Company's Annual Report on Form 10-K for the year ended December 31, 2008 and from time to time in other reports filed by ZymoGenetics with the U.S. Securities and Exchange Commission. ZymoGenetics undertakes no obligation to update any forward-looking or other statements in this press release, whether as a result of new information, future events or otherwise.

RECOTHROM(R) Thrombin, topical (Recombinant) is a registered trademark of ZymoGenetics, Inc.

ZYMOGENETICS, INC.
STATEMENTS OF OPERATIONS
(in thousands, except per share amounts)
(unaudited)
                                          Three Months Ended            Nine Months Ended
                                          September 30,                 September 30,
                                             2009           2008           2009           2008
Revenues:
Product sales, net                        $  8,492       $  1,758       $  18,999      $  4,129
Royalties                                    420            1,598          1,036          4,832
Collaborations and licenses                  18,544         8,520          54,838         29,009
Total revenues                               27,456         11,876         74,873         37,970
Costs and expenses:
Costs of product sales                       1,722          695            4,101          994
Research and development                     21,349         30,216         75,223         102,524
Selling, general and administrative          13,658         15,038         45,398         45,620
Total costs and expenses                     36,729         45,949         124,722        149,138
Loss from operations                         (9,273  )      (34,073 )      (49,849 )      (111,168 )
Other (expense) income, net                  (2,534  )      5,283          (7,064  )      4,103
Net loss before income tax benefit           (11,807 )      (28,790 )      (56,913 )      (107,065 )
Income tax benefit                           363            --             363            --
Net loss                                  $  (11,444 )   $  (28,790 )   $  (56,550 )   $  (107,065 )
Basic and diluted net loss per share      $  (0.17   )   $  (0.42   )   $  (0.82   )   $  (1.56    )
Weighted-average number of shares used in
computing net loss per share                 69,073         68,724         68,993         68,632

BALANCE SHEETS
(in thousands)
(unaudited)
                                                   September 30,      December 31,
                                                        2009                 2008
Cash, cash equivalents and short-term investments  $    103,366       $      89,887
Inventory                                               57,081               28,241
Other current assets                                    12,089               14,828
Property and equipment, net                             59,651               63,676
Deferred financing costs, net                           5,541                6,726
Other assets                                            5,663                6,688
Total assets                                       $    243,391       $      210,046
Current liabilities                                $    113,138       $      56,968
Lease obligations                                       66,918               67,366
Debt obligation                                         25,000               25,000
Collaboration obligation                                26,900               ---
Other long-term liabilities                             33,196               37,353
Shareholders' (deficit) equity                          (21,761 )            23,359
Total liabilities and shareholders' equity         $    243,391       $      210,046

SOURCE: ZymoGenetics, Inc.

Investor and Media Contact 
ZymoGenetics, Inc. 
Susan Specht 
Director, Corporate Communications 
206-442-6592

Under the 2005 licensing agreement, Bristol-Myers Squibb received an exclusive license to develop and commercialize a series of biogenic amine reuptake inhibitors from AMRI's proprietary research program. To date, Bristol-Myers Squibb has selected two compounds from this program for approval to initiate Phase I studies. The two companies will continue to evaluate additional compounds under this collaboration to develop improved treatments for diseases of the central nervous system (CNS).

Per terms of the agreement, AMRI is potentially eligible to receive up to $66 million per compound in development and regulatory milestone payments for the first two compounds, and additional potential payments of up to $22 million per compound on subsequent compounds. In addition, AMRI will receive royalties on worldwide sales of commercialized compounds.

Albany Molecular Research, Inc. provides scientific services, products and technologies focused on improving the quality of life.

((Comments on this story may be sent to health@closeupmedia.com))