3SOF

Form 8-K for SEATTLE GENETICS INC /WA


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12-Oct-2010

Other Events, Financial Statements and Exhibits



Item 8.01 Other Events.
On October 11, 2010, Seattle Genetics, Inc. issued a press release announcing positive top-line data from its phase II clinical trial of brentuximab vedotin (SGN-35) in patients with relapsed or refractory systemic anaplastic large cell lymphoma (ALCL). The press release, dated October 11, 2010, entitled "Seattle Genetics and Millennium Announce Positive Top-Line Brentuximab Vedotin (SGN-35) Data from Phase II Trial in Relapsed or Refractory ALCL" is attached hereto as Exhibit 99.1 and is incorporated by reference herein.





Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.

99.1 Press Release of Seattle Genetics, Inc. dated October 11, 2010

SANTA MONICA, Calif. & BOTHELL, Wash., Oct 20, 2010 (BUSINESS WIRE) -- Agensys, Inc., an affiliate of Tokyo-based Astellas Pharma Inc., and Seattle Genetics, Inc. (SGEN) today announced that they have initiated a phase I clinical trial of ASG-5ME for the treatment of castration-resistant prostate cancer. ASG-5ME is an antibody-drug conjugate (ADC) targeting the SLC44A4 antigen and is being co-developed by both companies for the treatment of solid tumors.

"There is significant need for new prostate cancer therapies, given that more than 32,000 men are expected to die of prostate cancer in 2010," said Leonard Reyno, M.D., Senior Vice President and Chief Medical Officer at Agensys. "We believe ASG-5ME, which is an ADC designed to deliver the potent cytotoxic agent MMAE directly to tumor cells, has the potential to provide a new therapeutic option for men with advanced prostate cancer."

"This clinical trial, together with our ongoing phase I trial of ASG-5ME for pancreatic cancer, reflects continued progress in expanding our pipeline of clinical-stage ADCs for cancer," said Jonathan Drachman, M.D., Senior Vice President, Research and Translational Medicine of Seattle Genetics.

The single-agent phase I trial will evaluate the safety, tolerability, pharmacokinetic profile and antitumor activity of escalating doses of ASG-5ME. The study is designed to enroll up to 60 patients at multiple centers in the United States.

ASG-5ME is an ADC composed of a fully human antibody directed to SLC44A4, a solute carrier antigen family member identified by Agensys to be overexpressed in epithelial cancers, including more than 80 percent of samples derived from patients with prostate, pancreatic and gastric cancers. The antibody is attached to a potent, synthetic cell-killing agent, monomethyl auristatin E (MMAE), via an enzyme-cleavable linker using Seattle Genetics' proprietary technology. The ADC is designed to be stable in the bloodstream, but to release MMAE upon internalization into SLC44A4-expressing tumor cells, resulting in targeted cell-killing. Preclinically, ASG-5ME has demonstrated potent antitumor activity, inducing regressions in models of established prostate, pancreatic and colon cancers.

About Prostate Cancer

Prostate cancer forms in tissues of the prostate, a gland in the male reproductive system. According to the American Cancer Society, more than 217,000 new cases of prostate cancer will be diagnosed in the United States during 2010, making it the second most commonly diagnosed form of cancer. More than 32,000 men are expected to die of prostate cancer in the United States during 2010.

About Agensys

Agensys, Inc., an affiliate of Astellas Pharma Inc., is developing a pipeline of therapeutic fully human monoclonal antibodies (MAbs) to treat solid tumor cancers. The MAb product pipeline is being generated to Agensys' diverse portfolio of proprietary, clinically relevant cancer targets that encompass 14 types of solid tumors. Agensys' target portfolio and related products are protected by a large patent estate. The company has full capabilities to generate, develop and manufacture antibody products. Agensys is progressing a pipeline of both naked and antibody-drug conjugated (ADC) therapeutic antibodies, directed at a variety of cancer indications, including those of the prostate, kidney, pancreas, ovary, bladder, lung, colon, breast and skin. ADC products are based on drug platform technologies developed by Seattle Genetics. Agensys is developing a growing pipeline of clinical stage functional MAbs and ADC products.

About Astellas

Astellas Pharma Inc., located in Tokyo, Japan, is a pharmaceutical company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceutical products. Astellas has approximately 15,000 employees worldwide. The organization is committed to becoming a global category leader by rapidly establishing a business model in urology, immunology & infectious diseases, neuroscience, DM complications & metabolic diseases and oncology. Astellas has discovered a treatment for functional symptoms of benign prostatic hyperplasia (BPH), Vesicare(R) and an immunosuppressant, Prograf(R) (tacrolimus), which have enabled Astellas to become an established leader in both Urology and Transplant. For more information on Astellas Pharma Inc., please visit Astellas' website at http://www.astellas.com/en .

About Seattle Genetics

Seattle Genetics is a clinical-stage biotechnology company focused on the development and commercialization of monoclonal antibody-based therapies for the treatment of cancer and autoimmune disease. The company recently reported positive top-line data from both a pivotal Hodgkin lymphoma trial and phase II anaplastic large cell lymphoma trial with its lead product candidate, brentuximab vedotin, and plans to submit a Biologics License Application to the U.S. Food and Drug Administration in the first half of 2011. Brentuximab vedotin is being developed in collaboration with Millennium: The Takeda Oncology Company. In addition, Seattle Genetics has four other clinical-stage programs: SGN-75, ASG-5ME, dacetuzumab (SGN-40) and SGN-70. Seattle Genetics has collaborations for its ADC technology with a number of leading biotechnology and pharmaceutical companies, including Bayer, Celldex Therapeutics, Daiichi Sankyo, Genentech, GlaxoSmithKline, Millennium: The Takeda Oncology Company and Progenics, as well as ADC co-development agreements with Agensys, an affiliate of Astellas, and Genmab. More information can be found at www.seattlegenetics.com .

For Seattle Genetics, Inc.:

Certain of the statements made in this press release are forward looking, such as those, among others, relating to the therapeutic potential of ASG-5ME. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Factors that may cause such a difference include the inability to show sufficient safety in the phase I clinical trial and the risk of adverse clinical results as ASG-5ME advances in clinical trials. More information about the risks and uncertainties faced by Seattle Genetics is contained in the company's 10-Q for the quarter ended June 30, 2010, filed with the Securities and Exchange Commission. Seattle Genetics disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Photos/Multimedia Gallery Available: http://www.businesswire.com/cgi-bin/mmg.cgi?eid=6474572&lang=en

SOURCE: Seattle Genetics, Inc.


Agensys/Astellas
Jenny Keeney, 847-317-5405
[email protected]
or
Seattle Genetics
Peggy Pinkston, 425-527-4160
[email protected]

SGEN  Seattle Genetics and Millennium to Highlight Brentuximab... 

COLOGNE, Germany, Oct 25, 2010 (BUSINESS WIRE) -- Seattle Genetics, Inc. (SGEN, Trade ) and Millennium: The Takeda Oncology Company, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited , today announced that brentuximab vedotin (SGN-35) will be featured in three poster presentations at the 8th International Symposium on Hodgkin Lymphoma (ISHL) being held October 23-26, 2010 in Cologne, Germany.

The following posters will be presented on Tuesday, October 26, 2010:

Objective responses with SGN-35 retreatment in CD30-positive hematologic malignancies: a case series (Abstract #113) Activity, safety and tolerability of antibody-drug conjugate (ADC) SGN-35 in relapsed/refractory Hodgkin lymphoma and CD30+ hematologic malignancies (Abstract #74) Activity of SGN-35 in preclinical models of combination therapy and relapse prevention (Abstract #49)

"These presentations complement the recent positive results from our pivotal Hodgkin lymphoma and phase II systemic anaplastic large cell lymphoma (ALCL) trials, both in the relapsed or refractory setting, and describe the additional opportunities we are pursuing to meet the needs of patients with CD30-positive malignancies," said Thomas C. Reynolds, M.D., Ph.D., Chief Medical Officer of Seattle Genetics. "In addition, we are preparing our brentuximab vedotin Biologics License Application (BLA) for submission to the U.S. Food and Drug Administration (FDA) in the first half of 2011."

"The acceptance of these presentations at ISHL underscores the scientific community's continued interest in brentuximab vedotin," said Nancy Simonian, M.D., Chief Medical Officer of Millennium. "We maintain our focus on meeting with regulators in Europe to discuss filing strategies in relapsed or refractory Hodgkin lymphoma and relapsed or refractory ALCL."

About Brentuximab Vedotin

Brentuximab vedotin is an ADC comprising an anti-CD30 monoclonal antibody attached by an enzyme cleavable linker to a potent, synthetic drug payload, monomethyl auristatin E (MMAE) utilizing Seattle Genetics' proprietary technology. The ADC employs a novel linker system that is designed to be stable in the bloodstream but to release MMAE upon internalization into CD30-expressing tumor cells. This approach is intended to spare non-targeted cells and thus may help minimize the potential toxic effects of traditional chemotherapy while allowing for the selective targeting of CD30-expressing cancer cells, thus potentially enhancing the antitumor activity.

Seattle Genetics and Millennium recently reported top-line data from a pivotal trial of brentuximab vedotin for relapsed or refractory Hodgkin lymphoma and a phase II trial for relapsed or refractory ALCL. In the pivotal Hodgkin lymphoma trial, 75 percent of patients achieved an objective response as assessed by an independent central review. The median duration of response was greater than six months. In the phase II ALCL trial, 86 percent of patients achieved an objective response as assessed by an independent central review. The median duration of response has not yet been reached at a median follow up on study of approximately six months. The safety profile of brentuximab vedotin in these trials was generally consistent with prior clinical trial experience. More complete data sets from both trials will be presented in oral sessions at the American Society of Hematology (ASH) annual meeting, December 4-7, 2010, in Orlando, FL.

The companies are also conducting a phase III clinical trial (the AETHERA trial) for patients at high risk of residual Hodgkin lymphoma following autologous stem cell transplant, a phase II retreatment trial for relapsed patients who previously responded to brentuximab vedotin, and a phase I combination trial for the front-line treatment of Hodgkin lymphoma.

About the Seattle Genetics/Millennium Collaboration

Seattle Genetics and Millennium are jointly developing brentuximab vedotin. Under the terms of the collaboration agreement, Seattle Genetics has U.S. and Canadian commercialization rights and the Takeda Group has rights to commercialize brentuximab vedotin in the rest of the world. Seattle Genetics and the Takeda Group are funding joint development costs for brentuximab vedotin on a 50:50 basis, except in Japan where the Takeda Group will be solely responsible for development costs.

About Hodgkin Lymphoma

Lymphoma is a general term for a group of cancers that originate in the lymphatic system. There are two major categories of lymphoma: Hodgkin lymphoma and non-Hodgkin lymphoma. Hodgkin lymphoma is distinguished from other types of lymphoma by the presence of one characteristic type of cell, known as the Reed-Sternberg cell. A defining attribute of the Reed-Sternberg cell is its expression of the CD30 antigen.

According to the American Cancer Society, approximately 8,500 cases of Hodgkin lymphoma will be diagnosed in the United States during 2010 and more than 1,300 will die from the disease. Globally, there are more than 30,000 cases of Hodgkin lymphoma diagnosed each year. Although front-line combination chemotherapy can result in durable response rates, up to 30 percent of these patients relapse or are refractory to front-line treatment and have few therapeutic options beyond autologous stem cell transplant.

About Seattle Genetics

Seattle Genetics is a clinical-stage biotechnology company focused on the development and commercialization of monoclonal antibody-based therapies for the treatment of cancer and autoimmune disease. The company recently reported positive top-line data from both a pivotal Hodgkin lymphoma trial and phase II anaplastic large cell lymphoma trial with its lead product candidate, brentuximab vedotin, and plans to submit a BLA to the FDA in the first half of 2011. Brentuximab vedotin is being developed in collaboration with Millennium: The Takeda Oncology Company. In addition, Seattle Genetics has four other clinical-stage programs: SGN-75, ASG-5ME, dacetuzumab (SGN-40) and SGN-70. Seattle Genetics has collaborations for its ADC technology with a number of leading biotechnology and pharmaceutical companies, including Bayer, Celldex Therapeutics, Daiichi Sankyo, Genentech, GlaxoSmithKline, Millennium: The Takeda Oncology Company and Progenics, as well as ADC co-development agreements with Agensys, an affiliate of Astellas, and Genmab. More information can be found at www.seattlegenetics.com .

About Millennium

Millennium: The Takeda Oncology Company, a leading biopharmaceutical company based in Cambridge, Mass., markets a first-in-class proteasome inhibitor, and has a robust clinical development pipeline of product candidates. Millennium Pharmaceuticals, Inc. was acquired by Takeda Pharmaceutical Company Ltd. in May, 2008. The Company's research, development and commercialization activities are focused in oncology. Additional information about Millennium is available through its website, www.millennium.com .

For Seattle Genetics: Certain of the statements made in this press release are forward looking, such as those, among others, relating to the potential therapeutic benefit of brentuximab vedotin and plans for submission for regulatory approval to and obtaining regulatory approval from the FDA and the European Medicines Agency (EMA). Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Factors that may cause such a difference include that the safety and/or efficacy results of the pivotal trial in relapsed or refractory Hodgkin lymphoma will not be sufficient to gain marketing approval in the United States or any other country, that we will be required to amend our submission for marketing approval or that such submission will be refused. In addition, our regulatory plans may change as a result of consultation with the FDA or EMA. More information about the risks and uncertainties faced by Seattle Genetics is contained in the company's 10-Q for the quarter ended June 30, 2010 filed with the Securities and Exchange Commission. Seattle Genetics disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

SOURCE: Seattle Genetics, Inc.


Seattle Genetics, Inc.
Peggy Pinkston, 425-527-4160
[email protected]
or
Millennium
Lauren Musto, 617-551-7848
[email protected]

You Heard It Here First:
Seattle Genetics (SGEN) Is A Top Pick In Biotech Due To Their Industry Leading Antibody Technology And Deep Pipeline Says Senior Biotechnology Equity Research Analyst At RBC Capital Markets

On Thursday April 7, 2011, 2:58 pm EDT
67 WALL STREET, New York - April 7, 2011 - The Wall Street Transcript has just published its Biotechnology and Pharmaceuticals Report offering a timely review of the sector to serious investors and industry executives. This Biotechnology and Pharmaceuticals Report contains expert industry commentary through in-depth interviews with public company CEOs, Equity Analysts and Money Managers. The full issue is available by calling (212) 952-7433 or via The Wall Street Transcript Online.

Topics covered: Renewed Focus on Biotech and Pharmaceutical Acquisitions - Biotech IPOs in 2011 and Impact On Valuation - Biotech in the Midst of a New-Product Cycle

Companies include: Alexion (ALXN); Amgen (AMGN); Astellas (YPH.F); BioMarin (BMRN) and many more.

In the following brief excerpt from the 30 page , interviewees discuss the outlook for the sector and for investors.

Dr. Jason Kantor, Ph.D., joined RBC Capital Markets in 2005 as a Managing Director and Senior Biotechnology Equity Research Analyst. Previously he was a Managing Director and Senior Biotechnology Analyst at WR Hambrecht + Co from 2002 to 2005, and Vice President in Equity Research at JPMorgan Chase & Co. from 1998 to 2002. Previous equity research assignments also include Salomon Smith Barney and Josephthal Lyon & Ross, Inc. Dr. Kantor's health care expertise covers several important categories, including oncology, cardiology, antibody technology and infectious disease. Dr. Kantor has had several independent recognitions, including Fortune "All-Star Analyst" in 2004. The Wall Street Journal ranked him number two in 2004 and number four in 2010 in its "Best on the Street" survey, and the Financial Times and Starmine ranked him number two for earnings estimations in 2010. Dr. Kantor earned his B.A. cum laude in biology from the University of California, San Diego, and his Ph.D. in cell and developmental biology from Harvard University.

TWST: One of the companies you recently commented on is PDL BioPharma. What caught your attention about that company?

Dr. Kantor: PDLI (PDLI) is an unusual stock in biotech. It's a unique asset. It is essentially a royalty and dividend story. This is a company that developed technology in the space of antibodies, and that technology was licensed to many companies, including Genentech (ROG.VX), MedImmune (AZN) and Biogen (BIIB). Now they are getting royalties on some of the blockbuster products out there like Lucentis, Herceptin, Avastin and Tysabri. All of these bear royalties to PDLI. Several years back PDLI split its business up, and the current company has no real commercial or research operations. They simply exist to defend the patents, collect the royalties and distribute the cash to shareholders. So why has it been in the news? It's been in the news because there have been contract and patent disputes, and several of these issues have played out over the last several weeks, creating greater certainty in terms of their royalty flow.

TWST: Who are your top picks right now and why?

Dr. Kantor: I've got several ideas that I like now for different reasons. First is Seattle Genetics (SGEN), that is an antibody company. This is a company with a drug that has shown remarkable efficacy for the treatment of relapsed/refractory Hodgkin lymphoma. They just submitted for regulatory approval at the end of February. We expect that they will be approved and on the markets in the second half of the year. This is not a one-product company. It's got a deep pipeline of antibodies that they've developed for themselves, and also programs that their partners are developing. It's a company that is a pure-play antibody company with what I think is industry-leading antibody technology. Investors would do well to own it this year for the FDA approval and launch of the product, but I think you can hold it long term based on the pipeline and the partnerships and the technology. That's one of my favorites.

More near term and catalyst driven, there is a company called Cubist Pharmaceuticals (CBST). They have a hospital product for infection. It's an antibiotic to treat drug-resistant staph infection. It's called Cubicin. It's an over $600 million product currently and growing. The thesis here in the near term is that right now the stock has been depressed because there is an ongoing patent dispute with Teva (TEVA). There is a trial date set for April 25. We fully expect the two companies to reach a settlement agreement on or around that court date, and believe the stock will rally into the high-$20s or low-$30s on a settlement. That's more of a catalyst story. I also have some small-cap stocks where I have high convictions that are worth mentioning. One is Pharmacyclics (PCYC), which has a drug that has shown remarkable efficacy for non-Hodgkin lymphoma. It's a new class of anticancer drug called a Btk inhibitor, and they own all the rights to the drug, and they are developing in a broad Phase II program. The stock has traded down recently partially because the news flow has been light. But for anybody with a one to three-year holding period, I think that the stock is very attractive at these levels. Lastly I'm going to mention one that I think is going to be somewhat newsworthy.

SIGA Technologies (SIGA) has an antiviral treatment that treats smallpox. You may ask why you need to treat smallpox because it doesn't exist, and the answer is that it is one of the most feared bioterrorism threats in the world. Our country has already stockpiled approximately 300 million doses of vaccine, but it has no drug to treat it if anybody were to contract the disease. So they are in what I think is the final stages of negotiating a contract, which could be worth upwards of $2 billion with a part of the government called BARDA, which is responsible for procuring drugs for our Strategic National Stockpile. That's a company that can become near-term profitable shortly after signing a contract, and that can become a very lucrative near-term business opportunity for them.

The Wall Street Transcript is a unique service for investors and industry researchers - providing fresh commentary and insight through verbatim interviews with CEOs and research analysts. This Biotechnology and Pharmaceuticals Report is available by calling (212) 952-7433 or via The Wall Street Transcript Online .

The Wall Street Transcript does not endorse the views of any interviewees nor does it make stock recommendations.

For Information on subscribing to The Wall Street Transcript, please call 800/246-7673

InPlay:

2:01PM Seattle Genetics and Millennium present updated brentuximab vedotin data; median duration of complete remissions greater than 20 months in patients with relapsed or refractory hodgkin lymphoma (SGEN) 19.28 +0.34 : The co and Millennium, a Takeda Pharmaceutical unit, reported updated data from a pivotal trial of brentuximab vedotin (ADCETRIS) in relapsed or refractory Hodgkin lymphoma and a phase II trial in relapsed or refractory systemic anaplastic large cell. Per IRF, it was previously reported that 75 percent of patients achieved an objective response, including 34 percent with a complete remission (CR). The median duration of response for all responding patients was 6.7 months, and the median duration of response for patients achieving a CR had not yet been reached. In these updated data presented at ASCO based on additional patient follow-up, the median duration of response in patients with a CR was 20.5 months per IRF. At the time of last data analysis, 21 patients with a CR were alive and free of progression. The estimated 12-month overall survival for all patients was 89 percent... Across both trials, brentuximab vedotin treatment was associated with generally manageable adverse events.

Day's Range: 19.00 - 19.43
52wk Range: 11.27 - 19.80
Volume: 2,025,939
Avg Vol (3m): 1,086,180
Market Cap: 2.20B

Technicals
Percentage Gainer

Last Price Quote is:
2.83%above 13-day EMA
11.86%above 50-day EMA
RS Rating: 94 

Resistance: $20.35
Support: $19.22...$18.96...18.52

Recent CandleStick Analysis
Very Bullish
Date              Candle
Jun-03-2011  DOJI 

The Next Big Thing In the Battle Against Cancer?

Could it be the next big thing in the battle against cancer?

Seattle Genetics [SGEN  19.37    0.43  (+2.27%)   ] is hoping its new drug will get approval from the U.S. Food and Drug Administration by the end-summer. The drug combines a cancer cell-seeking antibody with a chemotherapy drug to target and poison tumor cells. It currently targets Hodgkin Lymphoma, but developers think the approach could be used in other cancers, too.

The FDA will make its decision by August 30. If approved, CEO Clay Siegall said the company could bring the product to market roughly one-week later.

With headquarters in Bothell, Wash., Seattle Genetics is the leader in antibody conjugates. In other words, Siegall said the company empowers antibodies.

"What we do is we attach therapeutic agents, chemotherapy agents to antibodies with a stable linker and then these agents can then go find the cancer cells and kill them and we have a very big pipeline of [these drugs]," Siegall said. "We have 14 different drugs in clinical trials using our technology right now."

Siegall appeared on the "Fast Money Halftime Report" from the American Society of Clinical Oncology's annual meeting in Chicago. Considered the biggest conference to bring cancer to light, Wall Street is turning its attention to companies that may have new treatments, like Seattle Genetics.

Watch the video to see the full interview with Siegall.
http://video.cnbc.com/gallery/?video=3000025722

Seattle Genetics Presents SGN-75 Clinical Data at ASCO Annual Meeting...

Press Release Source: Seattle Genetics, Inc. On Monday June 6, 2011, 9:00 am EDT

CHICAGO--(BUSINESS WIRE)-- Seattle Genetics, Inc. (Nasdaq:SGEN ) today announced the presentation of interim data from an ongoing phase I clinical trial of SGN-75 in renal cell carcinoma (RCC) and non-Hodgkin lymphoma at the American Society of Clinical Oncology (ASCO) 2011 Annual Meeting being held in Chicago, IL. SGN-75 is an antibody-drug conjugate (ADC) targeted to CD70. The interim data suggest that SGN-75 is generally well tolerated and induces objective responses in heavily pretreated RCC and non-Hodgkin lymphoma patients.



Among 25 RCC patients treated at escalating doses of SGN-75, two patients achieved a partial response, eight patients had stable disease, 11 patients had progressive disease and four patients were not evaluable for response. At doses of 2.0 milligrams per kilogram (mg/kg) and higher, two of nine patients with RCC who were evaluated for response achieved partial remissions lasting 23 weeks and 19+ weeks. Among 16 non-Hodgkin lymphoma patients treated with escalating doses of SGN-75, one patient with mantle cell lymphoma achieved a complete remission with duration of 31 weeks.



Two schedules of dose administration were tested in this study, a weekly dosing regimen and an every three week dosing regimen. The most common adverse events associated with SGN-75 treatment in the every three week dosing regimen were fatigue (30 percent), nausea (30 percent), dry eye (23 percent) and thrombocytopenia (23 percent). The maximum tolerated dose was determined to be 3.0 mg/kg every three weeks. Based on the observed ADC half life of six to 10 days, increased patient convenience and better safety profile, the every three week dosing schedule has been selected for further study. Enrollment of additional patients in up to 15-patient disease-specific cohorts is continuing at the 3.0 mg/kg every three week dose to further elucidate the safety and antitumor activity of SGN-75. (Abstract #3071)



"Despite the use of immunotherapy, tyrosine kinase inhibitors and mTOR inhibitors, many patients with kidney cancer ultimately experience progression of their disease," said John A. Thompson, M.D., Professor, Medical Oncology, University of Washington School of Medicine and Seattle Cancer Care Alliance. "SGN-75 represents a novel approach to targeted therapy. These interim data with SGN-75 provide encouraging evidence of antitumor activity in some patients who had experienced treatment failure on other systemic therapies."



About the SGN-75 Trial



Data were reported from 41 patients treated in the open-label, phase I clinical trial, including 25 with RCC and 16 with non-Hodgkin lymphoma. Cohorts of patients received SGN-75 on either an every three week basis at doses ranging from 0.3 to 4.5 mg/kg or on a weekly basis at doses ranging from 0.3 to 0.6 mg/kg. Enrolled patients in each indication had received a median of three prior systemic therapies.



The trial is evaluating the safety, tolerability, pharmacokinetic profile and antitumor activity of SGN-75. In addition, the trial was designed to establish a maximum tolerated dose and to identify a recommended administration schedule. Patients enrolled in the trial must have received at least one prior therapy and have confirmed CD70 expression.



SGN-75 is an ADC composed of an anti-CD70 antibody attached to a potent, synthetic cell-killing agent, monomethyl auristatin F (MMAF), using Seattle Genetics' proprietary technology. The ADC is designed to be stable in the bloodstream, and to release its cell-killing agent upon internalization into CD70-expressing tumor cells. This approach is intended to spare non-targeted cells and thus reduce many of the toxic effects of traditional chemotherapy while enhancing the antitumor activity.



About Renal Cell Carcinoma



Renal cell carcinoma (RCC) forms in the kidney, which filters and cleans the blood. Metastatic RCC occurs when the cancer has spread to other parts of the body. RCC is the most common type of kidney cancer in adults, representing approximately 90 percent of cases. The American Cancer Society estimated that more than 58,000 new cases of kidney cancer were diagnosed in the United States during 2010, and approximately 13,000 people died from the disease.



About Non-Hodgkin Lymphoma



Non-Hodgkin lymphoma represents a diverse group of cancers that develop in the lymphatic system and are characterized by uncontrolled growth and accumulation of abnormal lymphocytes. Lymphocytes are white blood cells that are responsible for defending the body against infection. The most common forms of non-Hodgkin lymphoma are follicular and diffuse large B-cell lymphoma. According to the American Cancer Society, more than 65,000 cases of non-Hodgkin lymphoma were diagnosed in the United States during 2010 and more than 20,000 patients died from the disease.



About Seattle Genetics



Seattle Genetics is a clinical-stage biotechnology company focused on the development and commercialization of monoclonal antibody-based therapies for the treatment of cancer and autoimmune disease. The U.S. Food and Drug Administration has granted priority review to Biologics License Applications for its lead product candidate, brentuximab vedotin, for the treatment of relapsed or refractory Hodgkin lymphoma and relapsed or refractory systemic anaplastic large cell lymphoma, with a PDUFA date of August 30, 2011. Brentuximab vedotin is being developed in collaboration with Millennium: The Takeda Oncology Company. In addition, Seattle Genetics has four other clinical-stage programs: SGN-75, ASG-5ME, dacetuzumab (SGN-40) and SGN-70. Seattle Genetics has collaborations for its ADC technology with a number of leading biotechnology and pharmaceutical companies, including Abbott, Bayer, Celldex Therapeutics, Daiichi Sankyo, Genentech, GlaxoSmithKline, Millennium, Pfizer and Progenics, as well as ADC co-development agreements with Agensys, an affiliate of Astellas, and Genmab. More information can be found at www.seattlegenetics.com.



Certain of the statements made in this press release are forward looking, such as those, among others, relating to the therapeutic potential and continuation of the ongoing phase I clinical trial of SGN-75. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Factors that may cause such a difference include risks related to adverse medical events or inconclusive clinical trial results in the ongoing phase I clinical trial, including the inability to show that SGN-75 is effective or to show sufficient safety in such clinical trials, and risks related to Seattle Genetics' ability to recruit and enroll a sufficient number of patients to participate in such clinical trials. More information about these and other risks and uncertainties faced by Seattle Genetics is contained under the heading "Risk Factors" in the company's quarterly report on Form 10-Q for the quarter ended March 31, 2011 filed with the Securities and Exchange Commission. Seattle Genetics disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Contact:
Seattle Genetics, Inc.Peggy Pinkston, [email protected]

Seattle Genetics and Millennium Present Updated Brentuximab Vedotin (SGN-35) Data at ASCO Annual Meeting
-Median duration of complete remissions greater than 20 months in patients with relapsed or refractory Hodgkin lymphoma-

-Median durations of overall responses and complete remissions both greater than one year in patients with relapsed or refractory systemic ALCL-


Press Release Source: Seattle Genetics, Inc. On Monday June 6, 2011, 2:00 pm EDT

CHICAGO--(BUSINESS WIRE)-- Seattle Genetics, Inc. (Nasdaq:SGEN) and Millennium: The Takeda Oncology Company, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited (TSE:4502.to - News), today reported updated data from a pivotal trial of brentuximab vedotin (ADCETRIS™) in relapsed or refractory Hodgkin lymphoma and a phase II trial in relapsed or refractory systemic anaplastic large cell lymphoma (ALCL). Brentuximab vedotin is an antibody-drug conjugate (ADC) directed to CD30, a defining marker of Hodgkin lymphoma and systemic ALCL, and a target also expressed in other malignancies. The updated data were presented today during poster presentations at the American Society of Clinical Oncology (ASCO) 2011 Annual Meeting being held in Chicago, IL.

In a pivotal trial of 102 relapsed or refractory Hodgkin lymphoma patients who had failed prior autologous stem cell transplant (ASCT), an independent review facility (IRF) evaluated the overall objective response rate and duration of responses. Per IRF, it was previously reported that 75 percent of patients achieved an objective response, including 34 percent with a complete remission (CR). The median duration of response for all responding patients was 6.7 months, and the median duration of response for patients achieving a CR had not yet been reached. In these updated data presented at ASCO based on additional patient follow-up, the median duration of response in patients with a CR was 20.5 months per IRF. At the time of last data analysis, 21 patients with a CR were alive and free of progression. The estimated 12-month overall survival for all patients was 89 percent. Patient follow-up is ongoing. (Abstract #8031)

In a phase II trial of 58 relapsed or refractory systemic ALCL patients, it was previously reported that, per IRF, 86 percent of patients achieved an objective response, including 53 percent with a CR. When previously reported, the median duration of response for all responding patients and for patients with a CR had not yet been reached. In updated data presented at ASCO based on additional patient follow-up, the rate of CRs per IRF increased to 57 percent. The median duration of overall objective response was 12.6 months and the median duration of response in patients with a CR was 13.2 months, both per IRF. Median overall survival had not been reached. Patient follow-up is ongoing. (Abstract #8032)

Across both trials, brentuximab vedotin treatment was associated with generally manageable adverse events. The most common adverse events of any Grade in the pivotal Hodgkin lymphoma trial were peripheral sensory neuropathy (47 percent), fatigue (46 percent), nausea (42 percent), upper respiratory tract infection (37 percent) and diarrhea (36 percent). The most common adverse events of any Grade in the phase II systemic ALCL trial were peripheral sensory neuropathy (41 percent), nausea (40 percent), fatigue (38 percent), fever (34 percent) and diarrhea (29 percent).

"The durability of the complete remissions among these highly treatment-refractory Hodgkin lymphoma patients is clinically meaningful, as it is uncommon for single-agent treatment to achieve complete remissions with a duration of more than 18 months," said Dr. Robert Chen, Assistant Professor, Hematology & Hematopoietic Cell Transplantation at City of Hope and the 2010-2011 recipient of the Tim Nesvig Research Fellowship in Lymphoma. "There is a substantial unmet medical need in this setting, evidenced by historical data showing that almost half of Hodgkin lymphoma patients who relapse following ASCT will survive less than two years. The activity and tolerability data with brentuximab vedotin suggest that, if approved, brentuximab vedotin could be an important option for relapsed or refractory patients."

"Systemic ALCL is an aggressive type of T-cell non-Hodgkin lymphoma for which there is a pronounced unmet need, particularly for patients with highly refractory disease such as those in this clinical trial," said Dr. Andrei Shustov, Assistant Professor of Hematology at the University of Washington School of Medicine and Attending Physician in the Hematologic Malignancies Program at the Seattle Cancer Care Alliance. "The overall response rate of 86 percent previously reported, combined with the new duration of response data presented at ASCO, continue to support the clinical development of brentuximab vedotin for relapsed or refractory systemic ALCL patients. These data also provide rationale for future clinical studies in other CD30-positive tumors."

About the Brentuximab Vedotin Trials

The pivotal Hodgkin lymphoma and phase II systemic ALCL trials were designed to assess the efficacy and safety of single-agent brentuximab vedotin in relapsed or refractory patients. Patients received 1.8 milligrams per kilogram of brentuximab vedotin every three weeks until disease progression, or up to a maximum of 16 total doses. The primary endpoint of both trials was objective response rate as assessed by an independent central review. Secondary endpoints included complete response rate, duration of response, progression-free survival, overall survival and tolerability.

In the pivotal Hodgkin lymphoma trial, the median age of patients was 31 years. Patients had received a median of 3.5 prior chemotherapy regimens. Seventy-one percent of patients were primary refractory, defined as patients who failed to achieve a complete remission to front-line chemotherapy or had relapsed within three months of receiving front-line chemotherapy. Forty-two percent of patients were refractory to their most recent prior therapy, and all patients had progressed following prior ASCT.

In the phase II systemic ALCL trial, the median age of patients was 52 years. Enrolled patients had received a median of two prior chemotherapy regimens. Sixty-two percent of patients were primary refractory. Seventy-two percent of patients were anaplastic lymphoma kinase (ALK) negative, generally suggesting a poor prognosis. Twenty-two percent of patients had not responded to any prior treatment, and 26 percent had failed prior autologous stem cell transplant.

About Brentuximab Vedotin

Brentuximab vedotin (ADCETRIS™) is an antibody-drug conjugate (ADC) comprising an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to a potent, synthetic drug, monomethyl auristatin E (MMAE) utilizing Seattle Genetics' proprietary technology. The ADC employs a linker system that is designed to be stable in the bloodstream but to release MMAE upon internalization into CD30-expressing tumor cells. This approach is intended to spare non-targeted cells and thus may help minimize the potential toxic effects of traditional chemotherapy while allowing for the selective targeting of CD30-expressing cancer cells, thus potentially enhancing the antitumor activity.

About Hodgkin Lymphoma

Lymphoma is a general term for a group of cancers that originate in the lymphatic system. There are two major categories of lymphoma: Hodgkin lymphoma and non-Hodgkin lymphoma. Hodgkin lymphoma is distinguished from other types of lymphoma by the presence of one characteristic type of cell, known as the Reed-Sternberg cell. A defining attribute of the Reed-Sternberg cell is its expression of the CD30 antigen.

About Systemic ALCL

Lymphoma is a general term for a group of cancers that originate in the lymphatic system. There are two major categories of lymphoma: Hodgkin lymphoma and non-Hodgkin lymphoma. ALCL is an aggressive type of T-cell non-Hodgkin lymphoma that highly expresses CD30.

About the Seattle Genetics/Millennium Collaboration

Seattle Genetics is jointly developing brentuximab vedotin with Millennium: The Takeda Oncology Company. Under the terms of the collaboration agreement, Seattle Genetics has U.S. and Canadian commercialization rights and the Takeda Group has rights to commercialize brentuximab vedotin in the rest of the world. Seattle Genetics and the Takeda Group are funding joint development costs for brentuximab vedotin on a 50:50 basis, except in Japan where the Takeda Group will be solely responsible for development costs.

About Seattle Genetics

Seattle Genetics is a clinical-stage biotechnology company focused on the development and commercialization of monoclonal antibody-based therapies for the treatment of cancer and autoimmune disease. The FDA has granted priority review to Biologics License Applications for its lead product candidate, brentuximab vedotin, for the treatment of relapsed or refractory Hodgkin lymphoma and relapsed or refractory systemic anaplastic large cell lymphoma, with a PDUFA date of August 30, 2011. Brentuximab vedotin is being developed in collaboration with Millennium: The Takeda Oncology Company. In addition, Seattle Genetics has four other clinical-stage programs: SGN-75, ASG-5ME, dacetuzumab (SGN-40) and SGN-70. Seattle Genetics has collaborations for its ADC technology with a number of leading biotechnology and pharmaceutical companies, including Abbott, Bayer, Celldex Therapeutics, Daiichi Sankyo, Genentech, GlaxoSmithKline, Millennium, Pfizer and Progenics, as well as ADC co-development agreements with Agensys, an affiliate of Astellas, and Genmab. More information can be found at www.seattlegenetics.com.

About Millennium

Millennium: The Takeda Oncology Company, a leading biopharmaceutical company based in Cambridge, Mass., markets a first-in-class proteasome inhibitor in the US, and has a robust clinical development pipeline of global product candidates. Millennium Pharmaceuticals, Inc. was acquired by Takeda Pharmaceutical Company Ltd. in May, 2008. The Company's research, development and commercialization activities are focused in oncology. Additional information about Millennium and Takeda are available through their respective websites, www.millennium.com and www.takeda.com.

About Takeda

Located in Osaka, Japan, Takeda is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to strive towards better health for patients worldwide through leading innovation in medicine. Additional information about Takeda is available through its corporate website, www.takeda.com.

For Seattle Genetics: Certain of the statements made in this press release are forward looking, such as those, among others, relating to the company's expectations for regulatory approval and commercial launch of brentuximab vedotin and initiation of future clinical trials. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Factors that may cause such a difference include risks that the safety and/or efficacy results of our clinical trials of brentuximab vedotin, including our pivotal clinical trial for relapsed or refractory Hodgkin lymphoma and the phase II trial for relapsed or refractory systemic ALCL will not support marketing approval for the submitted indications; that we receive a complete response letter to our BLAs for other reasons, including but not limited to, not satisfactorily completing pre-approval inspections of our contract manufacturers' or our facilities; major amendments to our marketing application that delay the planned U.S. commercial launch; and that even if we receive approval, we are delayed or unsuccessful in the commercial launch of brentuximab vedotin. Further, brentuximab vedotin may be approved pursuant to the accelerated approval regulations and we may be subject to completing post-marketing requirements and obtaining preapproval of our marketing and promotional materials. More information about the risks and uncertainties faced by Seattle Genetics is contained in the company's 10-Q for the quarter ended March 31, 2011 filed with the Securities and Exchange Commission. Seattle Genetics disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

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SGEN  Seattle Genetics Announces FDA Accelerated Approval...  by Business Wire  Aug 19 2011 2:08PM 

BOTHELL, Wash., Aug 19, 2011 (BUSINESS WIRE) -- ---Seattle Genetics to implement comprehensive reimbursement support and patient assistance program-

---Conference call Monday, August 22, 2011, at 8:30 a.m. ET to provide further information on the launch and commercialization of ADCETRIS-

Seattle Genetics, Inc. (SGEN) today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval of ADCETRIS(TM) (brentuximab vedotin) for two indications: (1) the treatment of patients with Hodgkin lymphoma after failure of autologous stem cell transplant (ASCT) or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not ASCT candidates, and (2) the treatment of patients with systemic anaplastic large cell lymphoma (ALCL) after failure of at least one prior multi-agent chemotherapy regimen. The indications for ADCETRIS are based on response rate. There are no data available demonstrating improvement in patient-reported outcomes or survival with ADCETRIS. ADCETRIS is the first drug approved by the FDA for Hodgkin lymphoma in more than 30 years, and provides a new therapeutic alternative for Hodgkin lymphoma and systemic ALCL in these settings. Seattle Genetics expects to make ADCETRIS available to patients next week. ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30.

"Bringing a new product to the market is a significant milestone for Seattle Genetics in fulfilling its mission to improve the lives of people with cancer," said Clay B. Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. "The approval of ADCETRIS is a result of more than a decade of research and development by talented scientists and physicians. The company has deep appreciation for the hundreds of patients who participated in ADCETRIS trials, and the passion and determination of the clinicians at sites around the world in investigating this first in a new class of targeted anticancer agents. We are committed to continued clinical investigation of ADCETRIS through a broad development program for CD30-positive malignancies, including confirmatory trials in front-line Hodgkin and T-cell lymphomas that we have planned in consultation with the FDA."

"The marked single agent activity seen with ADCETRIS, including a high durable complete remission rate, offers an opportunity to improve the treatment paradigm of patients for whom the treatment is indicated," said Owen A. O'Connor, M.D., Ph.D., Professor, and Director, Division of Hematology and Medical Oncology at NYU Cancer Institute. "This approval represents a major advancement in the care of these patients."

Seattle Genetics also announced that it has established a patient assistance program named SeaGen Secure(TM) that offers patients and providers access to ADCETRIS reimbursement support, benefit investigations and patient assistance programs. More information about SeaGen Secure is available at (855)-4SEAGEN (855-473-2436) Monday through Friday from 9:00 a.m. to 8:00 p.m. Eastern Time.

About ADCETRIS

ADCETRIS (brentuximab vedotin) is an antibody-drug conjugate (ADC) comprising an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to a microtubule disrupting agent, monomethyl auristatin E (MMAE), utilizing Seattle Genetics' proprietary technology. The ADC employs a linker system that is designed to be stable in the bloodstream but to release MMAE upon internalization into CD30-expressing tumor cells.

The ADCETRIS approvals were based on data from two open-label, single-arm clinical trials: a pivotal trial in Hodgkin lymphoma patients who relapsed after ASCT and a pivotal trial in relapsed systemic ALCL patients. The primary endpoint of both trials was overall response rate as assessed by an independent review facility.

In the pivotal Hodgkin lymphoma clinical trial, 102 patients were enrolled who had relapsed after ASCT. Data demonstrated that 73 percent (95 percent CI 65, 83) of patients achieved an objective response following treatment with ADCETRIS, including 32 percent (95 percent CI 23, 42) with complete remissions and 40 percent with partial remissions (95 percent CI 32, 49). The median duration of objective response was 6.7 months (95 percent CI 4.0, 14.8; range 1.3 to 21.9+ months).

In the pivotal systemic ALCL clinical trial, 58 patients with relapsed disease were enrolled. These data demonstrated that 86 percent (95 percent CI 77, 95) of patients achieved an objective response following treatment with ADCETRIS, including 57 percent with complete remissions (95 percent CI 44, 70) and 29 percent with partial remissions (95 percent CI 18, 41). The median duration of objective response was 12.6 months (95 percent CI 5.7, not estimable; range 0.1 to 15.9+ months).

Please see important safety information below, and the full prescribing information for ADCETRIS at www.seattlegenetics.com or www.ADCETRIS.com .

Indications and Usage

ADCETRIS is a CD30-directed antibody-drug conjugate indicated for the treatment of patients with Hodgkin lymphoma after failure of ASCT or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not ASCT candidates, and for the treatment of patients with systemic ALCL after failure of at least one prior multi-agent chemotherapy regimen. The indications for ADCETRIS are based on response rate. There are no data available demonstrating improvement in patient-reported outcomes or survival with ADCETRIS.

The recommended dose of ADCETRIS is 1.8 milligrams per kilogram administered only as an intravenous infusion over 30 minutes every three weeks. Treatment should be continued until a maximum of 16 cycles, disease progression or unacceptable toxicity.

Important Safety Information

Warnings and Precautions:

-- Peripheral neuropathy: ADCETRIS treatment causes a peripheral neuropathy that is predominantly sensory. Cases of peripheral motor neuropathy have also been reported. ADCETRIS-induced peripheral neuropathy is cumulative. Treating physicians should monitor patients for neuropathy and institute dose modifications accordingly.

-- Infusion reactions: Infusion-related reactions, including anaphylaxis, have occurred with ADCETRIS. Monitor patients during infusion. If an infusion reaction occurs, the infusion should be interrupted and appropriate medical management instituted. If anaphylaxis occurs, the infusion should be discontinued immediately and appropriate medical management instituted.

-- Neutropenia: Monitor complete blood counts prior to each dose of ADCETRIS. If Grade 3 or 4 neutropenia develops, manage by dose delays, reductions or discontinuation. Prolonged (greater-than or equal to 1 week) severe neutropenia can occur with ADCETRIS.

-- Tumor Lysis Syndrome: Patients with rapidly proliferating tumor and high tumor burden are at risk of tumor lysis syndrome and these patients should be monitored closely and appropriate measures taken.

-- Stevens-Johnson syndrome: Stevens-Johnson syndrome has been reported with ADCETRIS. If Stevens-Johnson syndrome occurs, discontinue ADCETRIS and administer appropriate medical therapy.

-- Progressive Multifocal Leukoencephalopathy (PML): A fatal case of PML has been reported in a patient who received four chemotherapy regimens prior to receiving ADCETRIS.

-- Use in pregnancy: Fetal harm can occur. Pregnant women should be advised of the potential hazard to the fetus.

Adverse Reactions:

ADCETRIS was studied as monotherapy in 160 patients in two phase II trials. Across both trials, the most common adverse reactions (greater-than or equal to 20%), regardless of causality, were neutropenia, peripheral sensory neuropathy, fatigue, nausea, anemia, upper respiratory tract infection, diarrhea, pyrexia, rash, thrombocytopenia, cough and vomiting.

Drug Interactions:

Patients who are receiving strong CYP3A4 inhibitors concomitantly with ADCETRIS should be closely monitored for adverse reactions.

For additional important safety information, please see the full prescribing information for ADCETRIS at www.seattlegenetics.com or www.ADCETRIS.com .

Seattle Genetics is jointly developing ADCETRIS with Millennium: The Takeda Oncology Company. Under the terms of the collaboration agreement, Seattle Genetics has U.S. and Canadian commercialization rights and the Takeda Group has rights to commercialize ADCETRIS in the rest of the world. Seattle Genetics and the Takeda Group are funding joint development costs for ADCETRIS on a 50:50 basis, except in Japan where the Takeda Group will be solely responsible for development costs.

Conference Call Details

Seattle Genetics' management will host a conference call and webcast to discuss the approval, the price of ADCETRIS, and the company's reimbursement and patient assistance program. The call will be held Monday, August 22, 2011 at 5:30 a.m. Pacific Time (PT); 8:30 a.m. Eastern Time (ET). The live event will be available from Seattle Genetics' website at www.seattlegenetics.com , under the Investors and News section, or by calling (877) 941-8609 (domestic) or (480) 629-9818 (international). The access code is 4466950. A replay of the discussion will be available beginning at approximately 7:30 a.m. PT on August 22, 2011 from Seattle Genetics' website or by calling (800) 406-7325 (domestic) or (303) 590-3030 (international), using access code 4466950. The telephone replay will be available until 5:00 p.m. PT on August 24, 2011.

More information about ADCETRIS is available at (855)-4SEAGEN (855-473-2436) Monday through Friday from 9:00 a.m. to 8:00 p.m. Eastern Time.

About Hodgkin Lymphoma and Systemic ALCL

Lymphoma is a general term for a group of cancers that originate in the lymphatic system. There are two major categories of lymphoma: Hodgkin lymphoma and non-Hodgkin lymphoma. Hodgkin lymphoma is distinguished from other types of lymphoma by the presence of one characteristic type of cell, known as the Reed-Sternberg cell(1). The Reed-Sternberg cell generally expresses CD30(2). Systemic ALCL is an aggressive type of T-cell non-Hodgkin lymphoma that also expresses CD30(2).

About Seattle Genetics

Seattle Genetics is a biotechnology company focused on the development and commercialization of monoclonal antibody-based therapies for the treatment of cancer. Seattle Genetics' first product, ADCETRIS(TM), was approved by the FDA on August 19, 2011 for the treatment of patients with Hodgkin lymphoma after failure of autologous stem cell transplant (ASCT) or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not ASCT candidates, and for the treatment of patients with systemic anaplastic large cell lymphoma (ALCL) after failure of at least one prior multi-agent chemotherapy regimen. In addition to ADCETRIS, Seattle Genetics has three other clinical-stage programs: SGN-75, ASG-5ME and ASG-22ME. Seattle Genetics has collaborations for its ADC technology with a number of leading biotechnology and pharmaceutical companies, including Abbott, Bayer, Celldex Therapeutics, Daiichi Sankyo, Genentech, GlaxoSmithKline, Millennium, Pfizer and Progenics, as well as ADC co-development agreements with Agensys, an affiliate of Astellas, and Genmab. More information can be found at www.seattlegenetics.com .

Certain of the statements made in this press release are forward looking, such as those, among others, relating to the company's statements regarding the potential for ADCETRIS to offer an improved treatment paradigm of patients for whom the treatment is indicated, and other statements that are other than statements of historical facts. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Factors that may cause such a difference include risks and uncertainties associated with fulfilling sales, marketing and distribution requirements; the acceptance of ADCETRIS in the marketplace; the status of reimbursement from third-party payors; the company's dependence on third-party manufacturers; and the company's compliance with applicable regulatory requirements, including the healthcare fraud and abuse laws and the company's post-marketing requirements. More information about the risks and uncertainties faced by Seattle Genetics is contained in the company's 10-Q for the quarter ended June 30, 2011, filed with the Securities and Exchange Commission. Seattle Genetics disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

(1)National Cancer Institute. Hodgkin lymphoma. Available at http://www.cancer.gov/cancertopics/types/hodgkin . Accessed August 15, 2011.

(2)Haluska FG, et al. The Cellular Biology of the Reed-Sternberg Cell. Blood. 1994; 84:1005-1019.

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SOURCE: Seattle Genetics, Inc.


Seattle Genetics, Inc.
Peggy Pinkston, 425-527-4160
[email protected]