Navigation Links
Sequella Lead Drug Compound SQ109 Receives Orphan Drug Status From the US FDA and Orphan Medicinal Product Designation From the European Medicines Agency for the Treatment of Tuberculosis

ROCKVILLE, Md., Oct. 22 /PRNewswire/ -- 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 FDA's Office of Orphan Products Development and the EMEA's 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 FDA assistance in clinical trial design. Importantly, the Orphan Drug Act facilitates a close working relationship between regulatory agencies and companies aimed at accelerating the drug development and approval processes for treatment of rare diseases. For further information, please visit:

The European Medicines Agency is the European Union body responsible for coordinating the existing scientific resources put at its disposal by Member States for the evaluation, supervision and pharmacovigilance of medicinal products. The Agency provides the Member States and the institutions of the EU the best-possible scientific advice on any question relating to the evaluation of the quality, safety and efficacy of medicinal products for human or veterinary use referred to it in accordance with the provisions of EU legislation relating to medicinal products.

In 2001, the EMEA established the Committee for Orphan Medicinal Products (COMP), and charged it with reviewing designation applications from persons or companies who intend to develop medicines for rare diseases (so-called 'orphan drugs'). Orphan Medicinal drug products are intended for the diagnosis, prevention or treatment of a life-threatening or chronically debilitating condition affecting no more than five in 10,000 persons in the European Union at the time of the submission of the designation application. Orphan Medical Product Designation of SQ109 for the treatment of tuberculosis entitles Sequella to incentives such as protocol assistance (scientific advice during the product-development phase), 10-year marketing exclusivity, certain fee reductions or exemptions, and national incentives detailed in an inventory made available by the European Union, including the ability to apply for EU grants. For more information, visit:

"These US and European Union incentives will allow Sequella to move SQ109 through the product development process more quickly and efficiently," said Dr. Nacy.

SQ 109 also received Fast Track Status from the FDA in January of 2007.

About Tuberculosis (TB)

TB is a contagious infectious disease caused by the bacterium Mycobacterium tuberculosis. TB bacteria can be inhaled into lungs and are able to avoid destruction by certain white blood cells. Without containment by immune cells, the bacteria can spread throughout the body, multiply, survive and remain dormant for years. TB is the leading cause of global deaths that result from a single-agent infectious disease.

About Sequella, Inc.

Sequella is a clinical-stage biopharmaceutical company focused on commercializing improved treatment paradigms for diseases of epidemic potential. The company leverages its global influence, infectious disease expertise and diverse product portfolio to proactively address emerging health threats with significant market opportunity. For more information, please visit

Forward-Looking Statement

This press release contains forwardlooking statements that are subject to risks and uncertainties, and includes statements that are not historical facts. Actual results could differ significantly from results discussed. Sequella disclaims any intent or obligation to update forward-looking statements, except as required by law.

SOURCE Sequella, Inc.
Copyright©2007 PR Newswire.
All rights reserved

Related biology technology :

1. Isolation and Characterization of Anti-Viral Nucleoside Compounds from the Chinese Herb Taraxacum Mongolicum
2. TSKgel ODS-100Z and TSKgel ODS-100V column series provides a universal solution for the analysis of samples containing acidic, basic, polar & non-polar compounds
3. UW compound counters Avian flu
4. Medical College receives $377K to study brain disease
5. Lucigen receives $750K grant to boost biofuel yields
6. Medical College receives $1.4M cancer grant
7. Wisconsin biotech firm receives $107K NIH grant
8. InvivoSciences receives NIH grant for heart technology
9. Medical College receives $11 million grant to study high blood pressure
10. Madison business receives $115,000 of new state biofuels funding
11. Superior receives funds for technical training
Post Your Comments:
(Date:11/24/2015)... , Nov. 24, 2015  Clintrax Global, Inc., a worldwide ... Carolina , today announced that the company has set a ... a 391% quarter on quarter growth posted for Q3 of 2014 ... and Mexico , with the establishment of ... December 2015. --> United Kingdom and ...
(Date:11/24/2015)... ... ... The Academy of Model Aeronautics (AMA), led by its Executive Council, has ... Prix, to represent the First–Person View (FPV) racing community. , FPV racing has exploded ... of racing and several new model aviation pilots have joined the community because of ...
(Date:11/24/2015)... Ltd. (OTCQB: TIKRF) today announced that its Annual General Meeting of Shareholders ... Israel time, at the law offices of Goldfarb Seligman ... Floor, Tel Aviv, Israel . ... to the Board of Directors; , election of Liat ... an amendment to certain terms of options granted to our Chief Executive ...
(Date:11/24/2015)... ... 2015 , ... In harsh industrial processes, the safety of ... can represent a weak spot where leaking process media is a possible hazard. ... , which are designed to tolerate extreme process conditions. They combine rugged design ...
Breaking Biology Technology:
(Date:11/19/2015)... 2015  Based on its in-depth analysis of the ... with the 2015 Global Frost & Sullivan Award for ... presents this award to the company that has developed ... of the market it serves. The award recognizes the ... on customer base demands, the overall impact it has ...
(Date:11/18/2015)... 18, 2015  As new scientific discoveries deepen our ... other healthcare providers face challenges in better using that ... In addition, as more children continue to survive pediatric ... and old age. John M. Maris, M.D ... of Philadelphia (CHOP) . --> John ...
(Date:11/17/2015)... 17, 2015 Paris from ... --> Paris from 17 th until ... biometrics innovation leader, has invented the first combined scanner in ... same scanning surface. Until now two different scanners were required: ... can capture both on the same surface. This innovation ...
Breaking Biology News(10 mins):