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:9/18/2014)... that when people are too stressed they are often ... Brain Mind Institute (BMI) at EPFL have just highlighted ... chronic stress and the loss of social skills and ... a synaptic regulatory molecule in the brain. This was ... . , Carmen Sandi,s team went to look ...
(Date:9/18/2014)... world, are the ideal animal in which to study ... the ocean into tens of thousands of freshwater streams ... skeleton to adapt to the new environment. , Breeding ... have turned up one of the genes that controls ... that gene,s regulation in a freshwater population is associated ...
(Date:9/18/2014)... invisible is probably the ultimate form of camouflage: you ... And this strategy is not as uncommon as you ... Baltimore County, USA, explains that the larval life stages ... one part of the anatomy that most creatures cannot ... eyes have to shield each individual eye unit with ...
Breaking Biology News(10 mins):How stress tears us apart 2Counting fish teeth reveals regulatory DNA changes behind rapid evolution, adaptation 2Counting fish teeth reveals regulatory DNA changes behind rapid evolution, adaptation 3Transparent larvae hide opaque eyes behind reflections 2
... , This release is available in Spanish . ... Agriculture (USDA) scientists working as part of an international team have ... in the journal Nature reported today. The achievement ... speed up development of wheat varieties with enhanced nutritional value. ...
... part of their ongoing research on the role of ... Diabetes Center scientists, in collaboration with scientists at the ... associated with type 1 diabetes and other autoimmune diseases ... upcoming issue of Diabetes . Recent studies ...
... aestivum ) is one of the "big three" globally important ... Fully 35% of the world,s 7 billion people depend on ... scientists, including a group from Cold Spring Harbor Laboratory (CSHL), ... The study reveals the evolution of bread wheat ...
Cached Biology News:USDA scientists and cooperators sequence the wheat genome in breakthrough for global food security 2USDA scientists and cooperators sequence the wheat genome in breakthrough for global food security 3Joslin researchers increase understanding of genetic risk factor for type 1 diabetes 2Bread wheat's large and complex genome is revealed 2Bread wheat's large and complex genome is revealed 3
(Date:9/18/2014)... , Pennsylvanie, 18 septembre 2014 ... en 1974, a été depuis 40 ... les évaluations cliniques traditionnelles par des évaluations ... et sur les impacts économiques des traitements. ... A cours d,une récente ...
(Date:9/18/2014)...   Sigma-Aldrich Corporation (Nasdaq: ... a new gene editing partnership with the University ... the partnership, Sigma-Aldrich will provide the Vector Core ... dedicated gene editing bioinformaticians. The partnership ... the U-M Medical School. One initiative already underway, ...
(Date:9/18/2014)... 2014 OMICS Group International invites ... participate in the ‘Open Access Week’ by actively ... OMICS Group Pharma Journals from 20-26th October, ... fastest emerging Sciences, accelerating with a tremendous speed ... the globe. The industry is gearing with innovation ...
(Date:9/18/2014)... SeqLL Inc., the owner of ... today the closing of a $1M Series-A funding ... Diagnostic Technologies, will increase the power of tSMS™ ... in March 2013 by Daniel Jones, a former ... BioSciences, SeqLL has continued to offer Helicos’ sequencing ...
Breaking Biology Technology:1974 - 2014 - Mapi fête ses 40 ans 2Sigma-Aldrich, University of Michigan Medical School Establish CRISPR Core Lab Partnership 2Sigma-Aldrich, University of Michigan Medical School Establish CRISPR Core Lab Partnership 3Sigma-Aldrich, University of Michigan Medical School Establish CRISPR Core Lab Partnership 4Pharma and Omics Journals to Address Global Challenges during Open Access Week 2Pharma and Omics Journals to Address Global Challenges during Open Access Week 3SeqLL Closes Series-A Funding Round for Expansion of Single Molecule Sequencing 2
... ... sectors suffer, savvy investors like Prudential target healthcare , ... Minneapolis (Vocus) – Even as other commercial real ... healthcare real estate. Recent deals have included $250 million in new debt and $30 ...
... , BETHESDA, Md., July 30 Micromet, Inc. ... proprietary antibodies for the treatment of cancer, inflammation and autoimmune ... 14,000,000 shares of its common stock at a public offering ... are being offered by Micromet. The gross proceeds to ...
... , , , ... CRTX ), a specialty pharmaceutical company focused ... the respiratory and related markets, today announced that it ... a leading European pharmaceutical company headquartered in Parma, Italy. ...
Cached Biology Technology:Millions Flowing into Medical Real Estate 2Millions Flowing into Medical Real Estate 3Micromet Announces Pricing of Public Offering of Common Stock 2Micromet Announces Pricing of Public Offering of Common Stock 3Micromet Announces Pricing of Public Offering of Common Stock 4Cornerstone Therapeutics Announces Closing of Chiesi Transaction 2Cornerstone Therapeutics Announces Closing of Chiesi Transaction 3Cornerstone Therapeutics Announces Closing of Chiesi Transaction 4Cornerstone Therapeutics Announces Closing of Chiesi Transaction 5Cornerstone Therapeutics Announces Closing of Chiesi Transaction 6
... Last innovation from Magnetofection technology, SilenceMag ... system available. Simple, rapid and easy ... and non toxic. Specifically designed for ... silencing at very low doses of ...
... Purity is >95%NEN Radiolabeled Ligands\n\nReceptor-related research has ... of new radiolabeled ligands selected to keep ... wide range of products and services for ... 400 state-of-the-art radioligands. If you do not ...
... The Fluorescence Test Plate consists of an ... with Inert Organic Fluorescent Compounds embedded in ... used on BioTeks FLx800 and Synergy Multi-Detection ... for GLP compliance while reducing the need ...
... Feature Extraction Software reads and ... to prepare microarray data for ... * one 2-year license ... NFP/Academic accounts , * ...
Biology Products: