Seattle Genetics Announces ADCETRIS BLA Accepted for Filing by the FDA; Ligand Partner Rib-X Initiates Phase 3 Trial of Delafloxacin IV Print E-mail
By Staff and Wire Reports   
Tuesday, 14 May 2013 18:56
Below is a look at some of the headlines for companies that made news in the healthcare sector on May 14, 2013.

Seattle Genetics (NASDAQ: SGEN)
announced the U.S. FDA has accepted for filing a supplement to the Biologics License Application (sBLA) 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). The FDA is expected to take action on the application by September 14, 2013. 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.

“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,” said Clay B. Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. “The FDA's acceptance of our sBLA submission is an important step towards making ADCETRIS available in the retreatment and extended duration setting, and we look forward to the regulatory outcome.”

The sBLA is based on results from a phase 2 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 evaluated extended treatment with ADCETRIS beyond 16 cycles of therapy. The sBLA submission includes updated data sets from this phase 2 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. Highlights include:

Retreatment:  Of 23 evaluable patients who were retreated with ADCETRIS, 70 percent (16 of 23) achieved an objective response, including nine complete remissions and seven partial remissions. Median duration of retreatment objective response was 8.8 months. ADCETRIS was generally well tolerated in the retreatment setting. The most common adverse events were peripheral neuropathy (46 percent), nausea (42 percent), fatigue (38 percent), diarrhea (33 percent) and fever (29 percent), the majority of which were Grade 1 or 2. Extended duration of treatment:

Extended treatment data were reported from 17 patients with a median duration of treatment of 17.3 months (approximately 24 cycles of every three-week dosing). The overall objective response rate with extended treatment was 88 percent, including 76 percent complete remissions and 12 percent partial remissions. ADCETRIS was generally well tolerated in this setting, with the most common adverse events being peripheral neuropathy (71 percent), upper respiratory infection (53 percent) and fatigue (47 percent). Adverse events were effectively managed by dose delays and reductions, with less than ten percent of doses delayed or reduced. All events of peripheral neuropathy and upper respiratory infection were Grade 1 and 2 and one patient experienced a Grade 3 fatigue event. ADCETRIS is currently not approved for retreatment and extended duration beyond 16 cycles of therapy in relapsed HL and sALCL.


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Ligand Pharmaceuticals Incorporated (NASDAQ: LGND)
announced its partner Rib-X Pharmaceuticals, Inc. has initiated a Phase 3 clinical trial of a Captisol-enabled™ intravenous (IV) formulation of delafloxacin for the first-line treatment of acute bacterial skin and skin structure infections (ABSSSI), including infections caused by MRSA. Under the terms of a license and supply agreement, Ligand has earned a $500,000 milestone payment.

“Captisol is enabling yet another medically important late-stage candidate, and continues to deliver significant value to the business,” commented Matthew W. Foehr, Executive Vice President and Chief Operating Officer of Ligand. “Rib-X is an excellent partner, and we are confident in their ability to develop this late-stage asset. Additionally, today's announcement further reinforces the strength of Ligand's business model and the depth and quality of our portfolio of over 85 partnered programs.”


Also Tuesday:



AbbVie (NYSE: ABBV)
and Alvine Pharmaceuticals, a leader in celiac disease therapeutics development, announced today that they have entered into a global collaboration to develop a novel oral treatment for patients with celiac disease, currently in Phase 2 development.

AMERICAN SHARED HOSPITAL SERVICES (NYSE MKT:AMS)
, a leading provider of turnkey technology solutions for advanced radiosurgical and radiation therapy services, today announced financial results for the first quarter of 2013.

Atossa Genetics, Inc. (NASDAQ: ATOS)
, The Breast Health Company™, announced today that Dr. Steven Quay, Chairman, CEO & President, will speak and participate on the Diagnostics panel at the Sachs Associates Cancer Bio Partnering Forum on Wednesday, May 22, 2013, at the Westin Copley Place in Boston, Massachusetts.

BioLife Solutions, Inc. (OTCQB: BLFS)
, a leading developer, manufacturer and marketer of proprietary clinical grade hypothermic storage and cryopreservation freeze media for cells and tissues, and contract aseptic media manufacturer, today announced record revenue for the first quarter of 2013 of $2.2 million, including license revenue of $0.6 million, representing 5% sequential growth over the fourth quarter of 2012 and 158% growth over the first quarter of 2012.

Corgenix Medical Corporation (OTC BB: CONX)
, a worldwide developer and marketer of diagnostic test kits, today filed its third quarter Form 10-Q and reported its financial results.

Edwards Lifesciences Corporation (NYSE: EW)
, the global leader in the science of heart valves and hemodynamic monitoring, today announced that Thomas M. Abate, the company's chief financial officer, plans to retire later this year.

Gary Lauer, Chairman and Chief Executive Officer of eHealth, Inc. (NASDAQ: EHTH)
, the first and largest national private online health insurance exchange, during a national telephonic press conference today, challenged governors in the 16 states plus the District of Columbia that are planning to create their own online healthcare marketplaces to adopt a cost-free enrollment strategy.

GW Pharmaceuticals plc (Nasdaq: GWPH, AIM: GWP)
, a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform, will be announcing interim financial results for the six months ended 31 March 2013 on Monday, 3 June 2013, prior to the UK stock market open.

Inovio Pharmaceuticals, Inc. (NYSE MKT: INO)
announced today that in a preclinical study of Inovio's SynCon® DNA vaccine against Ebola and Marburg filoviruses, labeled "Category A" bioterrorism agents by the U.S. government, the vaccine induced strong and broad immune responses and demonstrated 100% protection against death following a challenge with multiple variants of the pathogen in two animal models.

Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD)
and Forest Laboratories, Inc. (NYSE: FRX) announced today they will present linaclotide-related data during Digestive Disease Week® 2013 in Orlando, Fla., May 18 through May 21, 2013.

KaloBios Pharmaceuticals, Inc. (Nasdaq: KBIO)
a biopharmaceutical company with a portfolio of patient-targeted, first-in-class, antibodies to treat serious medical conditions with a primary clinical focus on respiratory diseases and cancer, announced today its financial results for the first quarter ended March 31, 2013.

Ligand Pharmaceuticals Incorporated (NASDAQ: LGND)
announced today that its partner Rib-X Pharmaceuticals, Inc. has initiated a Phase 3 clinical trial of a Captisol-enabled™ intravenous (IV) formulation of delafloxacin for the first-line treatment of acute bacterial skin and skin structure infections (ABSSSI), including infections caused by MRSA.

MediSwipe Inc. (OTCQB: MWIP)
(www.MediSwipe.com) (MWIP), a data management solutions company for the medicinal marijuana and health care industry, today announced that the Company has launched the first HIPAA compliant toll free number and faxing application that will allow medical marijuana patients and their caregivers/dispensaries to send state certification forms and selected medical records to a cloud based data storage platform within the MediSwipe DMS application.

MYOS Corporation (OTCBB: MYOS)
, a company focused on the discovery, development and commercialization of muscle health nutritional supplements, functional foods, and therapeutic products, today announced its financial results for the first quarter ended March 31, 2013.

Omeros Corporation (NASDAQ: OMER)
today reported that it closed the registered direct offering of 3,903,004 shares of its common stock that was announced on May 9, 2013.

OPTIMIZERx Corp. (OTCQB: OPRX)
will be holding its Q-1 earnings call on Thursday, May 16th at 12:00 PM Eastern Daylight Time.

Palatin Technologies, Inc. (NYSE MKT: PTN)
, a biopharmaceutical company developing targeted, receptor-specific peptide therapeutics for the treatment of diseases with significant unmet medical need and commercial potential, today announced financial results for the third quarter ended March 31, 2013.

Patient Safety Technologies, Inc. (OTCBB: PSTX, OTCQB: PSTX)
today announced results for its first quarter ended March 31st, 2013.

PerkinElmer, Inc. (NYSE: PKI)
, a global leader in maternal and fetal health, and Verinata Health, an Illumina company and innovator of non-invasive prenatal tests (NIPT), today announced that several of the top health insurance plans have expanded coverage of the verifi® prenatal test for a variety of potential fetal health risks to over 80 million covered lives.

Quantum Materials Corporation (OTCQB:QTMM)
has chosen to relocate its tetrapod quantum dot laboratories to San Marcos, Texas to take advantage of facilities at STAR Park (Science, Technology and Academic Research Park).

Senesco Technologies, Inc. (OTC QB: SNTI)
, announced today that a poster presentation will be delivered at the 16th Annual Meeting of the American Society of Gene & Cell Therapy.

Simulations Plus, Inc. (NASDAQ: SLP)
, a leading provider of simulation and modeling software for pharmaceutical discovery and development, today announced that results of simulations using its GastroPlus™ software have been submitted to major regulatory agencies as part of applications by its customers.

Sinovac Biotech Ltd. (NASDAQ: SVA)
, a leading provider of biopharmaceutical products in China, announced today that management is scheduled to present at the UBS Global Healthcare Conference in New York City.

Teva Pharmaceutical Industries Ltd. (NYSE: TEVA)
will host a live audio webcast at the Bank of America Merrill Lynch 2013 Health Care Conference in Las Vegas, NV.



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