Tag Archives: Seattle Genetics

Seattle Genetics to Host Conference Call and Webcast Discussion of First Quarter 2013 Financial Resu

By Business Wirevia The Motley Fool

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Seattle Genetics to Host Conference Call and Webcast Discussion of First Quarter 2013 Financial Results on May 7, 2013

BOTHELL, Wash.–(BUSINESS WIRE)– Seattle Genetics, Inc. (NAS: SGEN) announced today that it will report its first quarter 2013 financial results on Tuesday, May 7, 2013, after the close of financial markets. Following the announcement, company management will host a conference call and webcast discussion of the results and provide a general corporate update. Access to the event can be obtained as follows:

LIVE access on Tuesday, May 7, 2013
1:30 p.m. Pacific Time / 4:30 p.m. Eastern Time

REPLAY access

  • Telephone replay will be available beginning at approximately 3:30 p.m. PT on Tuesday, May 7, 2013 through 5:00 p.m. PT on Thursday, May 9, 2013 by calling 800-406-7325 (domestic) or 303-590-3030 (international); conference ID 4614604
  • Webcast replay will be available on the Seattle Genetics website at http://www.seattlegenetics.com/ in the Investors and News section

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 company’s lead program, ADCETRIS® (brentuximab vedotin), received accelerated approval from the U.S. Food and Drug Administration in August 2011 and approval with conditions from Health Canada in February 2013 for two indications. In addition, under a collaboration with Millennium: The Takeda Oncology Company, ADCETRIS received conditional marketing authorization from the European Commission in October 2012. Seattle Genetics also has four other clinical-stage ADC programs: SGN-75, ASG-5ME, ASG-22ME and SGN-CD19A. Seattle Genetics has collaborations for its ADC technology with a number of leading biotechnology and pharmaceutical companies, including Abbott, Agensys (an affiliate of Astellas), Bayer, Celldex Therapeutics, Daiichi Sankyo, Genentech, GlaxoSmithKline, Millennium, Pfizer and Progenics, as well as ADC co-development agreements with Agensys and Genmab. More information can be found at www.seattlegenetics.com.

Seattle Genetics and Collaborators Highlight Multiple Antibody-Drug Conjugate (ADC) Programs and Tec

By Business Wirevia The Motley Fool

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Seattle Genetics and Collaborators Highlight Multiple Antibody-Drug Conjugate (ADC) Programs and Technology Advances at AACR

– Presentations Highlight Preclinical Data for Novel SGN-CD33A and SGN-LIV1A Programs and Breakthroughs in Research to Develop Highly Stable Linkers and More Potent Chemotypes –

– AACR Highlights Phase 1 Data for Genentech’s DMUC5754A, an ADC for Ovarian Cancer Utilizing Seattle Genetics’ Technology –

BOTHELL, Wash.–(BUSINESS WIRE)– Seattle Genetics, Inc. (NAS: SGEN) today announced that research related to its antibody-drug conjugate (ADC) technology was presented in multiple sessions at the 104th Annual Meeting of the American Association for Cancer Research (AACR) being held in Washington, D.C. Three data presentations highlight the rapid progress being made in ADC technology and testing. This includes preclinical data evaluating ADCs using a potent and newly developed cytotoxic agent, pyrrolobenzodiazepine (PBD) dimer, against two targets, CD33 and CD70. The former, SGN-CD33A, is expected to be advanced into a phase 1 clinical trial in 2013 for patients with acute myeloid leukemia (AML). In addition, preclinical data demonstrate activity of a new ADC for metastatic breast cancer, SGN-LIV1A, utilizing the same proprietary ADC technology as ADCETRIS® (brentuximab vedotin). The company also presented research on a novel method for making highly stable linkers, an advance that is being evaluated for potential future ADCs. In addition, many of the company’s collaborators, including Genentech, Pfizer, Progenics and Genmab, are reporting preclinical and clinical data from multiple ADC programs utilizing Seattle Genetics‘ proprietary ADC technology.

“As the leader in developing ADCs for the treatment of cancer, we are focused on both the current and future technology of this important class of therapeutics. More than half of the ADCs currently in clinical development utilize our technology, and we continue to advance additional candidates, such as SGN-CD33A and SGN-LIV1A, at a rapid pace. We are also looking at ways to enhance the next generation of ADCs, and believe that new potent cytotoxic agents such as PBD dimers, advances in antibody technology such as engineered cysteine antibodies (EC-mAbs), and highly stable linkers are part of that future,” said Jonathan Drachman, M.D., Senior Vice President, Research and Translational Medicine at Seattle Genetics. “We are driven to test these ADC advances quickly because cancer patients need new options to fight this relentless disease.”

ADCs are designed to harness the targeting ability of antibodies to deliver cell-killing agents directly to cancer cells. …read more

Source: FULL ARTICLE at DailyFinance

Why Merrimack Is Poised to Outperform

By Brian D. Pacampara, The Motley Fool

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Based on the aggregated intelligence of 180,000-plus investors participating in Motley Fool CAPS, the Fool’s free investing community, biopharmaceutical company Merrimack Pharmaceuticals has earned a coveted five-star ranking.

With that in mind, let’s take a closer look at Merrimack and see what CAPS investors are saying about the stock right now.

Merrimack facts

Headquarters (founded)

Cambridge, Mass. (1993)

Market Cap

$582.4 million

Industry

Biotechnology

Trailing-12-Month Revenue

$48.9 million

Management

CEO Robert Mulroy
CFO William Sullivan

Trailing-12-Month Return on Capital

(871.1%)

Cash/Debt

$110.0 million / $39.9 million

Competitors

Immunomedics
Threshold Pharmaceuticals

Sources: S&P Capital IQ and Motley Fool CAPS.

On CAPS, 97% of the 36 members who have rated Merrimack believe the stock will outperform the S&P 500 going forward.

Just yesterday, one of those Fools, All-Star zzlangerhans, offered a cautiously bullish take on the Merrimack opportunity:

A recent rally was squelched when the company announced a delay in projected topline data of the NAPOLI-1 trial to H2 2013 from mid 2013. I would imagine that means Q4 2013 at the earliest, otherwise the company would have waited longer before announcing the delay to make sure the data wouldn’t be ready in Q3 after all.

NAPOLI-1 is evaluating the efficacy of MM-398 liposomal irinotecan in pancreatic cancer. The main issues I have with the prospects of success are prior failure of a liposomal irinotecan being developed by Neopharm, and the poor success rate of phase III therapies against pancreatic cancer in general. Fortunately for Merrimack, the [$582M] market cap places them outside the hopeless sub-[$300M] Feuerstein-Ratain echelon but the track record of the 300M-1B echelon isn’t that much better.

After MM-398, Merrimack has a substantial array of monoclonals in clinical trials for cancer which makes them reminiscent of successful outfits such as [Seattle Genetics] and [ImmunoGen], and also less successful outfits such as Immunomedics.

If you want market-topping returns, you need to put together the best portfolio you can. Of course, despite its perfect five-star rating, Merrimack may not be your top choice.

We’ve found another growth play we are incredibly excited about — excited enough to dub it “The Only Stock You Need to Profit from the NEW Technology Revolution.” We have compiled a special free report for investors to uncover this stock today. The report is 100% free, but it won’t be here forever, so click here to access it now.

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The article Why Merrimack Is Poised to Outperform originally appeared on Fool.com.

Fool contributor Brian Pacampara has no position in any stocks mentioned. The Motley Fool recommends ImmunoGen. Try any of our Foolish newsletter services free for 30 …read more
Source: FULL ARTICLE at DailyFinance

Seattle Genetics Submits Supplemental BLA to FDA for Retreatment and Extended Duration of Therapy wi

By Business Wirevia The Motley Fool

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Seattle Genetics Submits Supplemental BLA to FDA for Retreatment and Extended Duration of Therapy with ADCETRIS ® (Brentuximab Vedotin) in Relapsed Hodgkin Lymphoma and Systemic ALCL

BOTHELL, Wash.–(BUSINESS WIRE)– Seattle Genetics, Inc. (NAS: SGEN) announced today that it has submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) supporting the use of ADCETRIS (brentuximab vedotin) for retreatment and extended duration beyond 16 cycles of therapy in relapsed Hodgkin lymphoma (HL) and systemic anaplastic large cell lymphoma (sALCL). ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30, a defining marker of HL and sALCL, that was granted accelerated approval by the FDA in August 2011 for relapsed HL and relapsed sALCL.

“The sBLA submission includes data demonstrating ADCETRIS activity in managing HL and sALCL when used in the retreatment setting, as well as beyond the 16 cycles described in our current label, while retaining a manageable safety profile,” said Clay B. Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. “Our goal is to broaden the ADCETRIS U.S. labeling claims to provide both patients and physicians the opportunity to incorporate ADCETRIS into additional HL and sALCL treatment settings. The sBLA submission includes data that support these uses and we look forward to the regulatory outcome.”

The sBLA is based on results from a phase II clinical trial with two treatment arms. One arm evaluated retreatment with ADCETRIS in patients who previously responded to treatment with ADCETRIS, then discontinued treatment and subsequently had disease progression or relapse. The other arm allowed treatment extension and evaluated prolonged treatment with ADCETRIS beyond 16 cycles of therapy. The sBLA submission includes updated data sets from this phase II trial. Preliminary data from this trial were previously reported at the 2011 American Society of Hematology (ASH) Annual Meeting and at the 2012 American Society of Clinical Oncology (ASCO) Annual meeting.

At the 2012 ASCO Annual Meeting, retreatment data from the phase II trial were reported from 23 patients, including one patient who was treated twice. Patients had received a median of four prior systemic therapies, including ADCETRIS. Of 23 evaluable patients, 70 percent (16 of 23) achieved an objective response after retreatment with ADCETRIS, including nine complete remissions and seven partial remissions. Median duration of retreatment objective response was 8.8 months. Among retreated HL patients, nine of 16 (56 percent) achieved an objective response. Among retreated sALCL patients, seven of eight (88 percent) achieved an objective response. The most common adverse events were peripheral neuropathy (46 percent), nausea (42 percent), fatigue (38 percent), diarrhea (33 percent) and fever (29 percent).

…read more
Source: FULL ARTICLE at DailyFinance