StemCell Therapy

Public release date: 6-Jul-2012 [ | E-mail | Share ]

Contact: Phyllis Edelman pedelman@genetics-gsa.org 301-634-7302 Genetics Society of America

BETHESDA, MD July 6, 2012 Yona Goldshmit, Ph.D., is a former physical therapist who worked in rehabilitation centers with spinal cord injury patients for many years before deciding to switch her focus to the underlying science.

"After a few years in the clinic, I realized that we don't really know what's going on," she said.

Now a scientist working with Peter Currie, Ph.D., at Monash University in Australia, Dr. Goldshmit is studying the mechanisms of spinal cord repair in zebrafish, which, unlike humans and other mammals, can regenerate their spinal cord following injury. On June 23 at the 2012 International Zebrafish Development and Genetics Conference in Madison, Wisconsin, she described a protein that may be a key difference between regeneration in fish and mammals.

One of the major barriers to spinal regeneration in mammals is a natural protective mechanism, which incongruously results in an unfortunate side effect. After a spinal injury, nervous system cells called glia are activated and flood the area to seal the wound to protect the brain and spinal cord. In doing so, however, the glia create scar tissue that acts as a physical and chemical barrier, which prevents new nerves from growing through the injury site.

One striking difference between the glial cells in mammals and fish is the resulting shape: mammalian glia take on highly branched, star-like arrangements that appear to intertwine into dense tissue. Fish glia cells, by contrast, adopt a simple elongated shape called bipolar morphology that bridges the injury site and appears to help new nerve cells grow through the damaged area to heal the spinal cord.

"Zebrafish don't have so much inflammation and the injury is not so severe as in mammals, so we can actually see the pro-regenerative effects that can happen," Dr. Goldshmit explained.

Studies in mice have found that mammalian glia can take up the same elongated shape, but in response to the environment around the injury they instead mature into scar tissue that does not allow nerve regrowth.

Dr. Goldshmit and her colleagues have focused on a family of molecules called fibroblast growth factors (Fgf), which have shown some evidence of improving recovery in mice and humans with spinal cord damage. The Monash University group found that Fgf activity around the damage site promotes the bipolar glial shape and encourages nerve regeneration in zebrafish.

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Zebrafish reveal promising mechanism for healing spinal cord injury

BOTHELL, Wash.--(BUSINESS WIRE)--

Seattle Genetics, Inc. (SGEN) today announced updated survival data from a pivotal clinical trial of single-agent ADCETRIS (brentuximab vedotin) in patients with relapsed or refractory Hodgkin lymphoma (HL) after autologous stem cell transplant (ASCT) showing that the median overall survival has not been reached after a 26.5 month median follow-up. The data will be reported during an oral presentation at the 17th European Hematology Association (EHA) Annual Meeting being held June 14-17, 2012 in Amsterdam, Netherlands. ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30.

Heavily pretreated Hodgkin lymphoma patients who relapse following autologous stem cell transplant often have a poor prognosis and there is a high unmet medical need for effective treatment options, said Scott Smith M.D., Ph.D., Loyola University Medical Center. These updated overall survival results from the pivotal trial are encouraging and demonstrate that ADCETRIS may play an important role in the treatment of patients with relapsed or refractory disease.

Long-term Follow-up Results of an Ongoing Pivotal Study of Brentuximab Vedotin in Patients with Relapsed or Refractory Hodgkin Lymphoma

A pivotal trial was conducted in 102 patients with relapsed or refractory HL after ASCT. The primary endpoint was objective response rate (ORR) per independent review. The secondary endpoints were complete remission (CR) rate, duration of response, progression-free survival (PFS), overall survival (OS), and safety and tolerability. At the time of the long-term follow-up analysis, the median observation time from first dose was 26.5months. Data, to be presented by Dr. Smith, include:

Patients received 1.8milligrams per kilogram of ADCETRIS every 3 weeks as a 30-minute outpatient intravenous infusion for up to 16cycles. Patients received a median of nine cycles of ADCETRIS while on trial. The median age of patients in the pivotal trial was 31 years. Enrolled patients had received a median of 3.5 (range 113) prior cancer-related systemic therapies, excluding ASCT. Seventy-one percent of patients had primary refractory disease, defined in the study protocol as patients who relapsed within three months of attaining CR or failed to achieve a CR, and 42 percent had not responded to their most recent prior therapy.

Details of the oral presentation are as follows:

About ADCETRIS

ADCETRIS (brentuximab vedotin) is an 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.

ADCETRIS received accelerated approval from the U.S. Food and Drug Administration (FDA) 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 (sALCL) 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.

Excerpt from:
Seattle Genetics Highlights Updated Survival Data from ADCETRIS® Pivotal Trial in Patients with Relapsed or Refractory ...

BOTHELL, Wash.--(BUSINESS WIRE)--

Seattle Genetics, Inc. (Nasdaq: SGEN - News) today announced that interim results from an investigator-sponsored phase II clinical trial of ADCETRIS (brentuximab vedotin) in patients with relapsed cutaneous T-cell lymphoma (CTCL) were presented at the Society for Investigative Dermatology annual meeting being held May 9-12, 2012 in Raleigh, NC. ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30. ADCETRIS has not been approved for use in CTCL.

The trial enrolled CTCL patients with mycosis fungoides (MF) or Sezary syndrome. At the time of data analysis, 17 patients had been enrolled, including 16 with MF and one with Sezary syndrome. Patients had received a median of six prior therapies, including a median of four prior systemic therapies. The primary endpoint of the trial is clinical response rate. Secondary endpoints include correlation of clinical response with CD30 expression levels, duration of response, progression-free survival and safety. The study is led by principal investigator Dr. Youn H. Kim, Professor, Department of Dermatology, and Director, Multidisciplinary Cutaneous Lymphoma Program at Stanford University School of Medicine in Stanford, CA. Key findings include:

This is the second data set reported with ADCETRIS in CTCL patients. At the T-Cell Lymphoma Forum in January 2012, interim data were presented from a phase II investigator-sponsored trial in CD30-positive CTCL patients, including lymphomatoid papulosis, primary cutaneous anaplastic large cell lymphoma (pcALCL) or MF. In the trial, which is being conducted by Dr. Madeleine Duvic at The University of Texas MD Anderson Cancer Center, 11 of 17 evaluable patients (65 percent) achieved an objective response, including seven complete remissions (CRs) and four partial remissions (PRs). The most common adverse events were Grade 1, including diarrhea, chest tightness, alopecia, nausea, elevated liver enzymes and peripheral neuropathy.

Seattle Genetics and Millennium: The Takeda Oncology Company recently initiated a randomized phase III clinical trial of ADCETRIS for relapsed CD30-positive CTCL patients. The trial will assess ADCETRIS versus investigators choice of methotrexate or bexarotene in patients with CD30-positive CTCL, including those with pcALCL or MF. The primary endpoint of the study is overall response rate lasting at least 4 months. Approximately 124 patients will be enrolled in the pivotal trial. The phase III trial is being conducted under a Special Protocol Assessment agreement from the U.S. Food and Drug Administration (FDA). The study also received European Medicines Agency scientific advice.

About CTCL

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. Cutaneous lymphomas are a category of non-Hodgkin lymphomas that primarily involve the skin. According to the Cutaneous Lymphoma Foundation, CTCL is the most common type of cutaneous lymphoma and typically presents with red, scaly patches or thickened plaques of skin that often mimic eczema or chronic dermatitis. Progression from limited skin involvement is variable and may be accompanied by tumor formation, ulceration and exfoliation, complicated by itching and infections. Advanced stages are defined by involvement of lymph nodes, peripheral blood and internal organs. According to published literature, up to 50 percent of CTCL patients lesions express CD30.

About ADCETRIS

ADCETRIS (brentuximab vedotin) is an 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.

ADCETRIS (brentuximab vedotin) received accelerated approval from the U.S. Food and Drug Administration 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 (sALCL) 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.

Original post:
Seattle Genetics Announces Data from Investigator Trial of ADCETRIS™ in Relapsed Cutaneous T-Cell Lymphoma

BOTHELL, Wash.--(BUSINESS WIRE)--

Seattle Genetics, Inc. (Nasdaq:SGEN - News) today announced that the Journal of Clinical Oncology (JCO) published results of the companys pivotal clinical trial of ADCETRIS (brentuximab vedotin) in Hodgkin lymphoma (HL) patients with relapsed or refractory disease following an autologous stem cell transplant (ASCT). The findings, published today online, demonstrated that treatment with ADCETRIS as a single agent induced durable objective responses in 75 percent of patients and was associated with a manageable safety profile. ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30, which is expressed in HL and anaplastic large cell lymphoma (ALCL).

Additionally, a separate pivotal clinical trial of ADCETRIS for the treatment of relapsed or refractory systemic ALCL has been accepted for publication and is currently in press for an upcoming issue of JCO.

Although Hodgkin lymphoma is often viewed as a curable disease, up to 30 percent of patients relapse or are refractory following front-line chemotherapy regimens and subsequent treatments, leaving limited therapeutic options, said Dr. Anas Younes, Professor of Medicine and Director, Clinical Investigation and Translational Research Department of Lymphoma/Myeloma at The University of Texas MD Anderson Cancer Center. ADCETRIS represents a new approach that is changing the way we treat relapsed and refractory HL patients. The complete response rate and manageable safety profile we observed with ADCETRIS in the pivotal trial have also generated enthusiasm among the medical community for evaluating ADCETRIS in earlier lines of HL therapy.

Data from this pivotal trial served as the basis for the accelerated approval of ADCETRIS in August 2011 for relapsed Hodgkin patients, and is the foundation for our robust clinical development plan to broadly evaluate ADCETRIS in earlier lines of therapy, as well as in other CD30-positive malignancies, said Thomas C. Reynolds, M.D., Ph.D., Chief Medical Officer of Seattle Genetics. We are evaluating ADCETRIS across a broad array of CD30-positive malignancies, towards our goal of bringing it to additional patients in need.

The open-label, phase II study evaluated the efficacy and safety of ADCETRIS in 102 patients with relapsed or refractory, CD30-positive HL after ASCT.

Highlights from the study include:

About ADCETRIS

ADCETRIS (brentuximab vedotin) is an 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.

ADCETRIS is being evaluated in a phase III clinical trial (the AETHERA trial) for patients at high risk of residual Hodgkin lymphoma following autologous stem cell transplant (ASCT), a phase II trial for relapsed or refractory CD30-positive non-Hodgkin lymphomas, a phase II trial for CD30-positive non-lymphoma malignancies, a phase II retreatment trial for relapsed patients who previously responded to ADCETRIS, a phase I trial in combination with multi-agent chemotherapy for front-line treatment of Hodgkin lymphoma and a phase I trial in combination with multi-agent chemotherapy for front-line treatment of mature T-cell lymphomas. Three additional phase III trials are planned, including a trial in CD30-positive cutaneous T-cell lymphomas to begin in mid-2012, a front-line trial in Hodgkin lymphoma and a front-line trial in mature T-cell lymphomas. The front-line trials are expected to begin by late 2012 or early 2013.

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Seattle Genetics Announces Pivotal ADCETRIS™ (Brentuximab Vedotin) Hodgkin Lymphoma Study Published in Journal of ...

SEATTLE (TheStreet) --Let's examine the short thesis on Seattle Genetics(SGEN), which also perfectly illustrates an important point about short selling, generally. Last August, Seattle Genetics received FDA approval for Adcetris -- an anti-CD30 monoclonal antibody linked to the anti-cancer drug monomethyl auristatin E (MMAE) -- for the treatment of relapsed or refractory Hodgkin's lymphoma (HL) and systemic anaplastic large cell lymphoma (sALCL). Adcetris is a good treatment option for patients within the labeled indication and management deserves applause for getting the drug to market. Unfortunately, there's a problem: Adcetris sales estimates are too high. HL and sALCL are rare cancers with extremely effective initial therapeutic options, leaving few patients for the Seattle Genetics to treat. Usually, when a drug misses Wall Street estimates, the stock price of the company selling the drug falls. I believe Adcetris sales will fall short of Wall Street estimates, causing Seattle Genetics' stock price to tumble as well. Before I dig deeper into Seattle Genetics, I want to focus on that shadowy coalition with nefarious intentions which secretly controls global markets -- otherwise known as the shorts. [Insert sarcastic sneer here.] For the unfamiliar, short selling -- or "shorting" -- is a way to bet that a company (or nearly any other asset) is overvalued. An investor borrows and sells shares, promising to "return" those shares at a later date (the details are more complex, but that's the gist.) If the share price declines, the investor covers (buys and returns the borrowed shares) and pockets the difference for a profit. Missteps can be costly; a short has a maximum profit of 100% (an asset's value can only decline to zero), but unlimited downside. Unlike a long position, a short that moves in the wrong direction also becomes larger, thereby compounding the pain. As yet another perk, short sellers are often ostracized for daring to question management's vision. To be clear, those who illegally manipulate stock prices in either direction -- whether at a hedge fund, bank, mutual fund, or elsewhere -- should be caught and punished. Rather than focus on this tiny subgroup of criminals, doe-eyed optimists blame the shorts for nearly any unwanted outcome. Sadly, this practice isn't new. In the 17th century, the Netherlands banned short selling when an investor's bet against the Dutch East India Company went awry. Regulation would have been the better answer. Napoleon Bonaparte linked shorting with treason, banned the practice, and imprisoned offenders. A few years ago, prominent U.S. politicians lambasted short sellers for causing the financial crisis. (Global overleverage, mispriced assets, and governmental policies that encouraged bad decisions were legitimate targets apparently too nebulous.) This long-standing demonization of short selling ignores reality. Even quality assets like the cancer drug Adcetris can be undervalued, fairly valued, or overvalued at any given point in time. Admiring Seattle Genetics' regulatory accomplishment shouldn't require loving the stock too, however. Some executives obsessively assail short sellers publicly, which is often a red flag indicating shorts sellers are onto something. The best management teams don't worry about shorts. They focus on their business with the confidence and understanding that in today's extremely liquid markets, even massive short positions have little impact on a company's long-term prospects. Over time, fundamentals are what make or break a stock. In fact, CEOs should actively seek to meet with the shorts; convince a skeptic and you've created a new shareholder. I've had my say in defense of short selling. I also realize that most people's negative view of short selling isn't going to change. Shorts are, and likely always will be, vilified unfairly. I do feel a little better with that off my chest. Back to Seattle Genetics and Adcetris: Every year, 8,800 Americans develop and 1,300 die from Hodgkin's lymphoma (HL), according the National Cancer Institute's Surveillance, Epidemiology and End Results (SEER) database. HL is very sensitive to traditional chemotherapy, so front-line treatment produces objective responses (tumor shrinkage) in roughly 80-90% of patients; most patients do not require further therapy for years, if ever. Patients that relapse usually receive high-dose chemotherapy combined with autologous stem cell transplant (ASCT), a procedure that replaces unhealthy cells with healthy ones. This combination yields durable responses in many patients, with three-year progression free survival rates of 50-60%. Adcetris employs a neat drug-delivery technology to kill cancer. The antibody portion of Adcetris attaches to receptors found on the cancer cell. Once attached, Adcetris' toxic drug payload is cleaved off inside the tumor cell where it can maximize efficacy and limit toxicity. In relapsed HL, the Adcetris data are encouraging and clearly warranted FDA accelerated approval. Nearly a third of Adcetris-treated HL patients experienced a complete response (CR) and another 40% had partial tumor shrinkage (a partial response, or PR). Results in sALCL were even better: 59% of patients had a CR and 27% qualified as a PR. Seattle Genetics must still prove Adcetris' clinical benefit in a confirmatory Phase III trial, which the company will start later this year.

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Seattle Genetics: A Cancer Niche Too Small

(RTTNews.com) - Biotechnology company Seattle Genetics Inc. (SGEN) Monday reported a loss for the fourth quarter that narrowed from a year ago, due mainly to sales of Hodgkin Lymphoma drug Adcetris approved last August. Loss for the quarter was smaller when compared to analyst estimates, while revenues too came in ahead of expectations.

Looking ahead, Seattle Genetics detailed its revenue forecast for 2012. Nonetheless, investors were not too impressed with the results, sending Seattle Genetics shares down 7 percent in after hours trade on the Nasdaq.

The Bothell, Washington-based company reported fourth-quarter net loss of $27 million or $0.24 per share compared to net loss of $34.5 million or $0.34 per share last year.

On average, 14 analysts polled by Thomson Reuters expected a loss of $0.31 per share for the quarter. Analysts' estimates typically exclude special items.

Results for the 2011 quarter include an $8.7 million valuation adjustment related to holdings in auction rate securities.

The company reported revenues of $48.9 million, compared to $8.1 million in the prior year. Street analysts expected revenues of $39.12 million.

Adcetris product sales for the quarter was $33.2 million. Adcetris (brentuximab vedotin) was approved by the FDA last August 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.

The drug has been also approved for the treatment of patients with systemic anaplastic large cell lymphoma after failure of at least one prior multi-agent chemotherapy regimen. Adcetris is the first drug approved by the FDA for Hodgkin lymphoma in more than 30 years.

CEO Clay Siegall said, "...We are also executing on a broad clinical development program of Adcetris to evaluate its potential in earlier lines of therapy for Hodgkin lymphoma and mature T-cell lymphomas, as well as in other CD30-positive malignancies."

Total expenses for the quarter rose to $67.6 million from $43 million last year, reflecting higher selling expenses related to the launch of Adcetris, and increased research expenses.

Seattle Genetics expects full year 2012 revenues from collaboration and license agreements between $55 million and $65 million.

Analysts currently expect the company to report revenues of $196.21 million for 2012.

SGEN closed Monday on the Nasdaq at $18.96, up $0.36 or 1.96%, on a volume of 1.6 million shares. In after hours, the stock lost $1.34 or 7.07%.

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Seattle Genetics Loss Narrows; But Stock Down - Update

BOTHELL, Wash.--(BUSINESS WIRE)--

Seattle Genetics, Inc. (NASDAQ:SGEN - News) today reported financial results for the fourth quarter and year ended December 31, 2011. The company also highlighted the ADCETRIS (brentuximab vedotin) product launch, recent ADCETRIS clinical data, ongoing and planned clinical development activities and upcoming milestones.

“We are pleased with the successful launch of ADCETRIS and our execution in bringing this drug to patients in need,” said Clay B. Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. “Our commercialization initiatives continue to focus on expanding awareness of ADCETRIS among oncologists, particularly in the community setting, and ensuring an efficient reimbursement process. We are also executing on a broad clinical development program of ADCETRIS to evaluate its potential in earlier lines of therapy for Hodgkin lymphoma and mature T-cell lymphomas, as well as in other CD30-positive malignancies. Over the past few months, we have reported encouraging data in multiple settings that support our aggressive clinical development plans, including in front-line Hodgkin lymphoma, front-line systemic ALCL and relapsed CTCL. In addition, we and our collaborators are advancing a robust pipeline of clinical and preclinical ADC programs.”

Recent Highlights

Reported clinical data on ADCETRIS (brentuximab vedotin) in multiple settings, notably demonstrating strong progress towards the company’s goal of redefining front-line therapy for Hodgkin lymphoma and mature T-cell lymphomas. ADCETRIS has not been approved for use in any of the following settings. Data were presented from:

A phase I trial evaluating sequential and concurrent administration of ADCETRIS with multi-agent chemotherapy in front-line mature T-cell lymphomas, including systemic anaplastic large cell lymphoma (sALCL). A phase I trial evaluating concurrent administration of ADCETRIS with multi-agent chemotherapy in front-line Hodgkin lymphoma. An investigator-sponsored phase II clinical trial of ADCETRIS in patients with cutaneous T-cell lymphoma (CTCL). Case studies of two patients with peripheral T-cell lymphoma (PTCL). A case series of patients with Hodgkin lymphoma or sALCL who received greater than 16 cycles of ADCETRIS. An analysis of the outcome of patients with relapsed Hodgkin lymphoma or sALCL who received an allogeneic stem cell transplant after treatment with ADCETRIS.

Announced multiple recent clinical trial initiations to broadly evaluate ADCETRIS in CD30-positive malignancies. Highlights include:

Initiated a phase II clinical trial in relapsed or refractory CD30-positive non-Hodgkin lymphomas, including PTCL, diffuse large B-cell lymphoma and other less common lymphoma subtypes. Initiated a phase II clinical trial in patients with CD30-positive non-lymphoma malignancies, including solid tumors, leukemia and multiple myeloma. Supported five investigator-sponsored trials (ISTs), including trials to evaluate ADCETRIS in earlier lines of Hodgkin lymphoma therapy, in older people with Hodgkin lymphoma and in other CD30-positive malignancies; expect to support multiple additional ISTs utilizing ADCETRIS to begin during 2012.

Demonstrated continued progress across product pipeline of antibody-drug conjugates (ADCs), including:

Completed enrollment in a phase I trial of single-agent SGN-75 in non-Hodgkin lymphoma and renal cell carcinoma. Completed enrollment in a phase I clinical trial of ASG-5ME for patients with pancreatic cancer; patient enrollment in a phase I clinical trial of ASG-5ME for prostate cancer is ongoing. ASG-5ME is a co-development program with Agensys, an affiliate of Astellas. Continued patient enrollment in a phase I clinical trial of ASG-22ME for solid tumors. ASG-22ME is a co-development program with Agensys, an affiliate of Agensys.

Achieved multiple milestones driven by collaborator progress under ADC agreements, including:

Preclinical milestone payments from Pfizer and Abbott. Three payments from Agensys, an affiliate of Astellas, upon exercise of options for additional exclusive antigen licenses under the companies’ ongoing ADC collaboration.

Upcoming Milestones

Planning multiple milestones for ADCETRIS and other pipeline programs, including:

Initiating a phase III clinical trial of ADCETRIS in CTCL by mid-2012. Initiating a phase III clinical trial of ADCETRIS in front-line advanced stage Hodgkin lymphoma by late 2012 to early 2013. Initiating a phase III clinical trial of ADCETRIS in front-line mature T-cell lymphomas, including sALCL, by late 2012 to early 2013. Submitting an application during the first half of 2012 to Health Canada for approval of ADCETRIS in relapsed Hodgkin lymphoma and sALCL. Millennium/Takeda expects a decision during 2012 from the European Medicines Agency (EMA) on an ADCETRIS marketing authorization application (MAA) filed by Takeda Global Research & Development Centre (Europe); the MAA filing was accepted by the EMA in June 2011. Initiating during 2012 a phase Ib clinical trial to evaluate SGN-75 in combination with everolimus, an mTOR inhibitor, for renal cell carcinoma. Submitting an investigational new drug application during 2012 for SGN-CD19A, a CD19-targeted ADC.

Fourth Quarter and Year 2011 Financial Results

Revenues in the fourth quarter of 2011 were $48.9 million, compared to $8.1 million in the fourth quarter of 2010. Fourth quarter 2011 revenues include ADCETRIS net product sales of $33.2 million. For the year 2011, revenues were $94.8 million, compared to $107.5 million for the year 2010. Revenues for the year in 2011 include $43.2 million in ADCETRIS net product sales. In addition, 2011 revenues were driven by revenue under the company’s ADCETRIS and ADC collaborations. Revenues for the year ended December 31, 2010 included approximately $70 million earned in the first half of 2010 under the dacetuzumab collaboration with Genentech that ended in June 2010.

Total costs and expenses for the fourth quarter of 2011 were $67.6 million, compared to $43.0 million for the fourth quarter of 2010. For the year 2011, total costs and expenses were $239.2 million, compared to $175.7 million for the year 2010. The planned increases in 2011 costs and expenses were primarily driven by sales and marketing activities related to the launch of ADCETRIS and higher research and development expenses, including clinical development to evaluate potential additional applications of ADCETRIS and to advance the company’s ADC pipeline programs. Under the ADCETRIS collaboration with Millennium, development costs incurred by Seattle Genetics are included in research and development expense. Joint development costs are co-funded by Millennium on a 50:50 basis. Reimbursement payments received from Millennium are recognized as revenue over the development period of the collaboration along with other development payments received, including the upfront payment and milestone payments. Non-cash, share-based compensation expense for the year 2011 was $20.0 million, compared to $14.3 million for the year 2010.

Net loss for the fourth quarter of 2011 was $27.2 million, or $0.24 per share, compared to a net loss of $34.5 million, or $0.34 per share, for the fourth quarter of 2010. Net loss in the fourth quarter of 2011 includes an $8.7 million valuation adjustment for the company’s holdings in auction rate securities, resulting in a carrying value of $5.8 million. For the year ended December 31, 2011, net loss was $152.0 million, or $1.34 per share, compared to net loss of $66.3 million, or $0.66 per share, for year ended December 31, 2010.

As of December 31, 2011, Seattle Genetics had $330.7 million in cash and investments, compared to $294.8 million as of December 31, 2010. The increase in cash and investments reflects net proceeds of approximately $168 million from the company’s public offering of common stock in February 2011 and collaboration payments received during 2011 totaling approximately $70 million.

2012 Financial Outlook

Seattle Genetics anticipates that revenues from collaboration and license agreements in 2012 will be in the range of $55 million to $65 million. These revenues will be generated from fees, milestones and reimbursements earned through the company’s ADCETRIS and ADC collaborations. The company is not providing guidance on expected revenue from ADCETRIS product sales at this time.

Total research and development and selling, general and administrative expenses in 2012 are expected to be in the range of $245 million to $270 million, approximately 35 percent of which is expected to be attributable to selling, general and administrative expenses. Operating expenses will be directed primarily towards commercialization and clinical trials of ADCETRIS, development and clinical activities for SGN-75, ASG-5ME and ASG-22ME, IND-enabling activities for SGN-CD19A, and advancing other preclinical programs. Non-cash expenses are expected to be in the range of $30 million to $33 million in 2012, primarily attributable to share-based compensation expense.

Conference Call Details

Seattle Genetics’ management will host a conference call and webcast to discuss the financial results and provide an update on business activities. The event will be held today at 1:30 p.m. Pacific Time (PT); 4:30 p.m. Eastern Time (ET). The live event will be available from Seattle Genetics’ website at http://www.seattlegenetics.com, under the Investors and News section, or by calling (877) 941-8609 (domestic) or (480) 629-9692 (international). The access code is 4509854. A replay of the discussion will be available beginning at approximately 3:30 p.m. PT today from Seattle Genetics’ website or by calling (800) 406-7325 (domestic) or (303) 590-3030 (international), using access code 4509854. The telephone replay will be available until 4:00 p.m. PT on Wednesday, February 15, 2012.

About ADCETRIS

ADCETRIS (brentuximab vedotin) is an 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. ADCETRIS is approved for the treatment of patients with relapsed Hodgkin lymphoma and for the treatment of patients with relapsed sALCL.

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. The FDA granted accelerated approval of ADCETRIS in August 2011 for two indications. ADCETRIS is being developed in collaboration with Millennium: The Takeda Oncology Company. In addition, Seattle Genetics has three other clinical-stage ADC 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 http://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 expectations for initiation of future clinical trials, data availability from ongoing clinical trials, expectations for additional regulatory approvals and expectations for 2012 collaboration and license revenue. 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 ADCETRIS affect the commercial potential or ability to initiate future clinical trials of ADCETRIS. We may also be delayed in our planned trial initiations and regulatory submissions and approvals for reasons outside of our control. We may also fail to receive milestone payments under our collaborations and experience unforeseen increased expenses or unexpected reductions in revenues. More information about the risks and uncertainties faced by Seattle Genetics is contained in the company’s 10-Q for the quarter ended September 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.

  Seattle Genetics, Inc.
Condensed Consolidated Balance Sheets
(Unaudited)
(In thousands)     December 31,
2011   December 31,
2010 Assets Cash, cash equivalents, short and long term investments $ 330,696 $ 294,840 Other assets   94,520   35,096 Total assets $ 425,216 $ 329,936   Liabilities and Stockholders' Equity Accounts payable and accrued liabilities $ 53,048 $ 25,783 Deferred revenue and long-term liabilities 153,319 142,635 Stockholders' equity   218,849   161,518 Total liabilities and stockholders' equity $ 425,216 $ 329,936     Seattle Genetics, Inc.
Condensed Consolidated Statements of Operations
(Unaudited)
(In thousands, except per share amounts)    

Three months ended
December 31,

  Twelve months ended
December 31,   2011       2010     2011       2010   Revenues Net product sales $ 33,194 $ - $ 43,241 $ - Collaboration and license agreement revenues   15,693     8,146     51,537     107,470   Total revenues   48,887     8,146     94,778     107,470   Costs and expenses Cost of sales 2,391 - 3,115 - Research and development 40,239 32,520 163,396 146,410 Selling, general and administrative   24,954     10,522     72,659     29,258   Total costs and expenses   67,584     43,042     239,170     175,668   Loss from operations (18,697 ) (34,896 ) (144,392 ) (68,198 ) Investment income (loss), net   (8,468 )   350     (7,638 )   1,933   Net loss $ (27,165 ) $ (34,546 ) $ (152,030 ) $ (66,265 )   Basic and diluted net loss per share $ (0.24 ) $ (0.34 ) $ (1.34 ) $ (0.66 )  

Weighted-average shares used in computing basic and diluted net loss per share

  115,064     101,450     113,098     101,055    

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Seattle Genetics Reports Fourth Quarter and Year 2011 Financial Results

(06-18) 13:42 PDT SAN FRANCISCO -- Dr. Shinya Yamanaka, a stem cell researcher at UCSF's Gladstone Institutes who discovered a technique for transforming adult skin cells into "pluripotent" stem cells without resorting to human embryos, has won Japan's $550,000 Kyoto Prize, an international award that honors scientific, cultural and spiritual contributions to human knowledge.

His discovery resulted in a class of much-sought stem cells that scientists can induce to become virtually any other type of functioning human cell that one day might be used to treat varied diseases or injuries.

During their research, Yamanaka and his colleagues altered the genetics of adult skin cells by inserting four specific viral genes that produce proteins known as transcription factors into the cells. Those proteins in turn yielded other genes that reprogrammed the skin cells so they acquired all the characteristics that made them what are now known as induced pluripotent cells.

Before his discovery, those pluripotent human stem cells could only be harvested from human embryos, a source posing such powerful ethical issues that former President George W. Bush banned virtually all embryonic stem cell research eight years ago. The ban remained in force until President Obama reversed it last year.

Yamanaka, 47, who is attending the annual meeting of the International Society of Stem Cell Research in San Francisco this week, was not told of his award until just before midnight Pacific time on Thursday.

The Kyoto Prize is awarded annually by Japan's Inamori Foundation for major discoveries in many fields of advanced technology, and four other Bay Area scientists have won it in recent years.

They are Leonard Herzenberg, a Stanford geneticist and immunologist who developed a revolutionary cell-sorting machine now crucial to advanced biomedical research; Alan Kay, a Silicon Valley pioneer at Hewlett-Packard who led advanced computing technology for 40 years; Donald E. Knuth, a Stanford information technology expert and specialist in computer programming, language analysis and computerized printing and Richard Karp, a UC Berkeley computer scientist and pioneer in computational biology.

In addition to heading his laboratory at the Gladstone Institute for Cardiovascular Research on the Mission Bay campus of UCSF, Yamanaka is also a professor at Kyoto University, where he began his efforts seeking a way of transforming adult cells.

Besides resolving ethical issues by his achievement, Yamanaka's success also means that the pluripotent stem cells needed to treat a patient's disease can be obtained from the ordinary skin cells of a patient's own body - thus making stem cell therapy possible without the hazards involved in immunologic rejection of cells from other people.

Robert Lanza, chief scientific officer of Advanced Cell Technology and an adjunct professor at Wake Forest University's stem cell research center, said recently that Yamanaka's work "is likely to be the most important stem cell breakthrough of all time."

"The ability to generate an unlimited supply of patient-specific stem cells will revolutionize the future of medicine," Lanza said.

Read more: http://www.sfgate.com