Navigation Links
Morphotek, Inc. Announces That Two Investigational Drugs Have Received Orphan Drug Designations
Date:6/8/2011

EXTON, Pa., June 8, 2011 /PRNewswire/ -- Morphotek®, Inc., a subsidiary of Eisai Inc., announced today that the United States Food and Drug Administration (FDA) has granted orphan drug designations to two of its investigational cancer drugs, MORAb-004 for the treatment of soft tissue sarcoma and MORAb-066 for the treatment of pancreatic cancer.  

The FDA grants this designation to drugs with the potential to treat a rare disease or condition that affects fewer than 200,000 people in the United States.  According to data from the National Cancer Institute, in the United States in 2010 the prevalence figure for soft tissue sarcoma was 101,982 and for pancreatic cancer was 32,993 (www.seer.cancer.gov).

"We are very pleased to receive orphan drug designations for not only one, but two investigational compounds for the potential treatment of cancer:  MORAb-004 for the treatment of soft tissue sarcoma and MORAb-066 for the treatment of pancreatic cancer," said Nicholas C. Nicolaides, Ph.D., President and CEO of Morphotek. "We believe that working toward treating disease, no matter the size of the patient population, is essential to the achievement of our human health care mission, which is to give first thought to patients and their families and to increasing the benefits that health care provides.  Ultimately, these compounds could significantly improve our ability to provide enhanced treatment options for patients suffering from two very serious diseases."  

MORAb-004 is a humanized monoclonal antibody to endosialin/tumor endothelial marker-1 (TEM-1), which is a protein that is expressed in many human malignancies, and which plays a role in tumor development. MORAb-004 binds to TEM-1, and has demonstrated antitumor activity in a variety of nonclinical models.  A phase I ascending dose study with MORAb-004 is currently being performed in subjects with a variety of cancers, including soft tissue sarcoma.  According to the American Cancer Society, in 2010 about 3,920 people died of soft tissue sarcoma and about 10,520 people were diagnosed with the disease (www.cancer.org).

MORAb-066 is a humanized monoclonal antibody to tissue factor, which is a protein that plays an important role in blood coagulation.  Tissue factor has also been shown to be present in a wide variety of tumor types, including pancreatic cancer.  A study published in 2007 (Clin. Cancer Res 13(10): 2870-2875) indicated that tissue factor expression could be observed in a majority of pancreatic cancer tissue samples, but not in normal pancreatic tissue.  A separate study (J. Immunother 2004: 27, S11) demonstrated that an antibody to tissue factor inhibits the growth of human pancreatic cancer cells in a xenograft model. According to the American Cancer Society, in 2010 about 36,800 people died of pancreatic cancer and about 43,140 people were diagnosed with the disease (www.cancer.org).

As a result of obtaining orphan drug designations, Morphotek receives certain tax credits to support the development of these compounds, a waiver of the FDA user fee if a marketing application is submitted, and a period of marketing exclusivity if the compounds are ultimately approved.  These incentives are intended to encourage pharmaceutical companies to develop orphan drugs; however, an orphan drug designation does not alter the standard regulatory requirements and process for obtaining marketing approval for the drug.  

About MorphotekMorphotek®, Inc., a subsidiary of Eisai Inc., is a biopharmaceutical company specializing in the development of protein and antibody products through the use of a novel and proprietary gene evolution technology.  The technology has been successfully applied to a broad variety of cell lines and organisms to yield genetically diverse offspring that are suitable for pharmaceutical product development in the areas of antibody therapeutics, protein therapeutics, product manufacturing, drug target discovery, and improved output traits for commercial applications.  The company is currently focusing its platform on the development and manufacturing of therapeutic antibodies for the treatment of cancer, inflammation and infectious disease.  For more information, please visit www.morphotek.com.

About Eisai Inc.Eisai Inc. was established in 1995 and is ranked among the top-20 U.S. pharmaceutical companies (based on retail sales).  The company began marketing its first product in the United States in 1997 and has rapidly grown to become a fully integrated pharmaceutical business.  Eisai's areas of commercial focus include neurology, gastrointestinal disorders and oncology/critical care.  The company serves as the U.S. pharmaceutical operation of Eisai Co., Ltd., a research-based human health care (hhc) company that discovers, develops and markets products throughout the world.  

Eisai has a global product creation organization that includes U.S.-based R&D facilities in Massachusetts, New Jersey, North Carolina and Pennsylvania as well as manufacturing facilities in Maryland and North Carolina.  The company's areas of R&D focus include neuroscience; oncology; vascular, inflammatory and immunological reaction; and antibody-based programs.  For more information about Eisai, please visit www.eisai.com/us. Contacts:Media Inquiries

Investor InquiriesTerry Cushmore

Rod Dausch Morphotek, Inc.

Morphotek, Inc. 610-423-6197

610-423-6111 tcushmore@morphotek.com

Dausch@morphotek.com   Media Inquiries

Investor InquiriesLynn Kenney

Alex Scott Eisai Inc.

Eisai Inc.201-746-2294

201-746-2177lynn_kenney@eisai.com

alex_scott@eisai.com
'/>"/>

SOURCE Morphotek, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Dendreon Announces Publication of Phase 1 Study Highlighting Immunologic and Clinical Activity of Lapuleucel-T (Neuvenge(R)) in Advanced Breast Cancer Patients
2. EDAP Announces Launch of Clinical Study Combining HIFU and Chemotherapy for Localized Aggressive High Risk Prostate Cancer
3. Cephalon Announces Positive Results from a Pivotal Study of FENTORA in Opioid-tolerant Patients with Non-cancer Breakthrough Pain
4. ADVENTRX Announces Fast Track Designation Granted By the FDA For CoFactor For the Treatment of Metastatic Colorectal Cancer
5. DOV Pharmaceutical, Inc. Announces Successful Phase Ib Results for DOV 21,947
6. Phosphagenics Announces Positive Phase 1b Transdermal Insulin Clinical Trial Results
7. Xenomics Announces Implementation of its First Diagnostic Test for Acute Myeloid Leukemia Into Clinical Practice
8. Emisphere Technologies, Inc. Announces 2007 Second Quarter Financial Results
9. Amicus Therapeutics Announces Second Quarter 2007 Financial Results
10. Genta Incorporated Announces Second Quarter 2007 Financial Results and Corporate Highlights
11. MicroDose Announces Positive Results From the QDose Inhaled Insulin Glucose Clamp Study
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/5/2016)... Progra m m e ... Oxitec , s mosquito in Cayman Islands ... by 96 %   Oxitec and the Cayman ... wild Aedes aegypti, the dangerous mosquito that spreads dengue, Zika and ... Grand Cayman .  MRCU, a global leader in mosquito control, is ...
(Date:5/5/2016)... , May 5, 2016 /PRNewswire/ ... announced the addition of the  "Europe ... - 2016"  report to their offering.  ... ) , ,The latest research ... Highlights - 2016, provides comprehensive insights ...
(Date:5/4/2016)... May 4, 2016  Compass Diversified Holdings (NYSE: ... an owner of leading middle market businesses, announced today ... March 31, 2016. First Quarter 2016 Highlights ... Reinvestment ("CAD" or "Cash Flow") of $13.6 million for ... loss of $15.0 million for the first quarter of ...
Breaking Medicine Technology:
(Date:5/5/2016)... ... , ... TLC Laser Eye Centers announced today that it has acquired Gordon ... be called “Gordon Schanzlin New Vision Institute, a TLC Laser Eye Center.” , ... ensure that patients continue to receive the highest quality of care. In addition, all ...
(Date:5/5/2016)... ... 05, 2016 , ... LELO has discovered many people are insecure ... out via email, social media and on the Volonté blog seeking advice about how ... masturbate ‘normal’ or ‘correct’?” , While some methods are more common than others, there ...
(Date:5/5/2016)... ... May 05, 2016 , ... ... master charity program created to assist the people of their local community. The ... nonprofit organizations and community leaders. Their hope is to bring awareness to important ...
(Date:5/5/2016)... ... May 05, 2016 , ... Vitenas Cosmetic Surgery has ... Awards, presented by the American Institute of Architects and the Academy of Architecture for ... renowned Perkins+Will and Harrell Architects, opened to patients in October of 2014. ...
(Date:5/5/2016)... ... 2016 , ... Sun Health registered nurse Brittany Eads and ... Care Transitions program at the 9th Annual Orthopedic and Spine Summit held ... Post-Acute Environment Through Effective Transitions of Care.” , Major changes are taking place ...
Breaking Medicine News(10 mins):