Navigation Links
Sequella receives US and EU orphan drug status for SQ109 for the treatment of TB
Date:10/22/2007

ROCKVILLE, MD -- Sequella, Inc., a clinical-stage biopharmaceutical company focused on commercializing products to treat diseases of epidemic potential, announced today that the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) independently reviewed Sequella lead drug compound, SQ109, and both agencies granted SQ109 orphan drug status for the treatment of tuberculosis. SQ109 shows excellent in vitro and in vivo activity against drug-susceptible and drug-resistant TB bacteria, including XDR-TB. Further, SQ109 synergizes with other TB drugs in experimental animal models of TB, and could result in new TB drug combinations that have much greater activity than the current standard of care.

We are pleased that the FDA and the EMEA awarded Sequella orphan drug and orphan medicinal product status for the use of SQ109 (N-adamantany1-N-Geranyl-ehtylendiamine) for the treatment of tuberculosis (TB), a chronically debilitating and life-threatening infectious pulmonary and extrapulmonary disease, said Dr. Carol Nacy. With the resurgence of TB in a new drug-resistant form it is clear there is a need to readdress the treatment of this infectious and deadly disease. To accelerate our clinical programs, we will continue to work closely with the FDAs Office of Orphan Products Development and the EMEAs Committee for Orphan Medicinal Products as we move through the clinical and regulatory process.

The Orphan Drug Act (Public Law 97-414, enacted in 1983 and amended) provides for economic incentives to encourage pharmaceutical companies to develop drugs for rare diseases defined as those affecting fewer than 200,000 people in the United States. Orphan drug designation entitles Sequella, Inc. to seven years of market exclusivity for SQ109 for the treatment of patients with tuberculosis. Additional incentives for orphan drug development include tax credits related to certain development expenses, an exemption from the FDA user fee, and
'/>"/>

Contact: Alicia Moran
alicia@brightlinemedia.com
410-991-7027
Sequella
Source:Eurekalert

Page: 1 2 3

Related biology news :

1. DuPonts first biologically derived polymer receives global recognition
2. OneWorld Health drug receives Orphan designation from U.S. and European regulatory agencies
3. Research on antibiotics receives historical recognition
4. Anthrax test, developed by army and CDC, receives FDA approval
5. Research team receives $7.5 million to study cassava
6. Virulizin granted orphan drug status in Europe
7. Genomatix Microarray Analysis Pipeline achieves Affymetrix GeneChip compatible?status
8. Sudden change in social status triggers genetic response in male fish, study finds
9. Gene expression test reveals ER and HER-2 status of breast tumors
10. MU researchers to study the status of black bears in Missouri
11. Protein discovery could unlock the secret to better TB treatment
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/25/2014)... false-color image from the Terra satellite show the different areas ... in Eastern Russia. The burn scars show up as ... wildfires have broken across the remote parts of Eastern Russia ... from the MODIS instrument, it is still possible to ... recent image features noted below show the devastating number of ...
(Date:7/25/2014)... study published online in the International Journal of ... to preventing cervical cancer based on findings showing successful ... of a discrete population of cells in the cervix. ... looked at squamocolumnar junction cells, or SCJ cells. These ... implicated as the origins of cervical cancer. A research ...
(Date:7/25/2014)... consume the healthcare community and remain priority ... To address the worldwide crisis of obesity ... global leaders in diabetes, epidemiology and public ... and development of diverse intervention programs in ... This book on "Global Health Perspectives in ...
Breaking Biology News(10 mins):Clearing cells to prevent cervical cancer 2What constitutes an effective response to the global 'diabesity' tsunami? 2
... , RENO, Nev. A team of scientists from ... and University of California, Davis has returned from a ... they are working to find solutions to the algae ... water source for local residents. The lake,s water ...
... linear collider in Menlo Park, California has already made a ... most prolific particle accelerator facilities dedicated to high energy particle ... source of x-rays a billion times brighter than any other ... molecules respond to intense radiation from the facility,s Linac Coherent ...
... of Alabama at Birmingham (UAB) departments of Pathology, Microbiology and ... Heart, Lung, and Blood Institute (NHLBI) to study so-called red ... changes in red blood cells that have been stored for ... focus on the mechanisms by which red blood cell storage ...
Cached Biology News:American team of scientists help protect Guatemala's Lake Atitlan 2American team of scientists help protect Guatemala's Lake Atitlan 3NHLBI grants $1.47 million to study red blood cell transfusion storage times and bioactivity 2
(Date:7/25/2014)... Pittsburgh, PA (PRWEB) July 25, 2014 ... annual Call for Topics for Conferee Networking. These two-hour ... similar interests to meet and resolve problems, discuss new ... , The deadline to submit a topic for consideration ... at pittcon.org . The Conferee Networking committee will ...
(Date:7/25/2014)... , July 25, 2014  Galmed Pharmaceuticals Ltd. ... company focused on the development and commercialization of a ... and cholesterol gallstones, today announced financial results for the ... 2014 Financial Summary: , Reported cash and cash ... with $137,000 at December 31, 2013.  , Reported ...
(Date:7/25/2014)... IN (PRWEB) July 25, 2014 At ... (FAA) has granted a 60-day extension for the public ... the Special Rule for Model Aircraft established by Congress ... of 2012. The 60-day extension establishes the new deadline ... United States Department of Transportation/FAA notice published in the ...
(Date:7/24/2014)... New York, NY - July 24, 2014 -- Keryx ... results from the long-term, randomized, active control Phase 3 ... ferric iron-based phosphate binder, for the treatment of hyperphosphatemia ... The PERFECTED study (PhosphatE binding and iRon delivery with ... the Journal of the American Society of Nephrology ...
Breaking Biology Technology:Pittcon 2015 Announces Call for Topics for Conferee Networking Sessions 2Galmed Pharmaceuticals Reports First Half 2014 Financial Results 2Galmed Pharmaceuticals Reports First Half 2014 Financial Results 3Galmed Pharmaceuticals Reports First Half 2014 Financial Results 4Galmed Pharmaceuticals Reports First Half 2014 Financial Results 5Galmed Pharmaceuticals Reports First Half 2014 Financial Results 6FAA Grants Comment Extension at the Request of AMA 2Zerenex (ferric citrate) long-term Phase 3 study results published in JASN 2Zerenex (ferric citrate) long-term Phase 3 study results published in JASN 3Zerenex (ferric citrate) long-term Phase 3 study results published in JASN 4
...  Rhythm announced today that Lex Van der Ploeg, PhD, ... Van der Ploeg brings to Rhythm more than 25 ... and other therapeutic areas. "Lex has considerable ... pathways we are targeting with our ghrelin and melanocortin ...
... for Nanotechnology (LCN) have discovered electronic stripes, called ,charge ... that make up a graphitic superconductor. This is the ... and the finding is likely to have profound implications ... scientists believe will play a key role in the ...
... /PRNewswire-iReach/ --  Quantum Leap Innovations announced today the ... Directors.  Michael Cusumano is the Sloan Management Review Distinguished ... Sloan School of Management, with a joint appointment in ... STAYING POWER , covers six enduring principles for ...
Cached Biology Technology:Rhythm Names Lex Van der Ploeg Chief Scientific Officer 2Graphene earns its stripes 2Michael Cusumano, MIT's Sloan Distinguished Professor of Management, Joins Quantum Leap Innovations Board of Directors 2Michael Cusumano, MIT's Sloan Distinguished Professor of Management, Joins Quantum Leap Innovations Board of Directors 3Michael Cusumano, MIT's Sloan Distinguished Professor of Management, Joins Quantum Leap Innovations Board of Directors 4
... but comes with a shutter (controlled via a ... The DH-2000 Deuterium Tungsten Halogen ... and tungsten halogen light sources in a single ... powerful, stable output from 215-200 nm. In addition, ...
... The MSD Security ... integrated GC/MS software application ... processing, quantification, library searching ... the aspects of data ...
... Microarrays designed for genome-wide microRNA expression ... and powerful Paraflo microfluidic on-chip synthesis ... part of our comprehensive microRNA Expression ... The Soil Nematode microRNA Microarray ...
... Proteolytic degradation is critical to the ... and regulatory proteins as important and ... metabolism, heat shock and stress response, ... receptors and ion channels, cell cycle ...
Biology Products: