Navigation Links
Mpex Candidate, MP-376, Granted U.S. Orphan Drug Status for the Treatment of Cystic Fibrosis
Date:3/4/2008

Phase 2b Trial Expected to Begin in the Second Quarter of 2008

SAN DIEGO, March 4 /PRNewswire/ -- Mpex Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration's (FDA) Office of Orphan Products Development has granted Mpex orphan drug designation for levofloxacin solution for inhalation for the treatment of pulmonary infections due to Pseudomonas aeruginosa and other bacteria in patients with cystic fibrosis. Levofloxacin is the active pharmaceutical ingredient in MP-376, the company's proprietary levofloxacin solution for inhalation.

Patients with cystic fibrosis (CF) suffer from chronic infections of the lower respiratory tract that can be caused by one or multiple bacteria, including Pseudomonas aeruginosa. Chronic pulmonary infections are difficult to eradicate and are implicated as the major cause of deterioration of pulmonary function and associated morbidity and mortality in CF patients. Chronic infection is associated with pulmonary exacerbations due to bacterial overgrowth, and a decrease in lung function over time from inflammation triggered by bacteria and their toxins.

"Obtaining orphan drug designation for MP-376 in cystic fibrosis is an important milestone for the program," stated Daniel Burgess, President and Chief Executive Officer of Mpex Pharmaceuticals, Inc. "This helps reinforce our belief that MP-376 has the potential to provide a valuable new treatment option in the management of cystic fibrosis. We look forward to working with CF patients, treatment providers and the FDA to rapidly advance this product candidate through to commercialization."

Orphan status is granted by the FDA to promote the development of products that demonstrate promise for the treatment of rare diseases affecting fewer than 200,000 Americans annually. Orphan drug designation will entitle Mpex to a seven-year period of exclusive marketing rights for MP-376 for the orphan indication following the date of the drug
'/>"/>

SOURCE Mpex Pharmaceuticals, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3

Related biology technology :

1. Odyssey Thera Granted U.S. Patent for Animal Imaging
2. ISTO Technologies Granted Key Patent for Cartilage Cell Expansion by the United States Patent Office
3. Pharmion and MethylGene Announce Orphan Drug Designation Granted by the European Medicines Agency (EMEA) for MGCD0103 for the Treatment of Hodgkins Lymphoma
4. PREOS(R) Granted U.S. Orphan Drug Status for Treatment of Hypoparathyroidism
5. Pharmions Oral Azacitidine Granted Fast Track Status for Myelodysplastic Syndromes
6. ADVENTRX Announces Fast Track Designation Granted By the FDA For CoFactor For the Treatment of Metastatic Colorectal Cancer
7. Raptor Pharmaceuticals Acquires Orphan Clinical Program
8. 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
9. Poniard Pharmaceuticals Announces European Commission Grants Orphan Medicinal Product Designation to Picoplatin for Treatment of Small Cell Lung Cancer
10. FDA Grants Orphan Drug Designation to TREANDA, an Investigational Treatment for Chronic Lymphocytic Leukemia
11. AGA Medical Corporation Responds to Occlutech Statement on the Status of the Ongoing Patent Litigation in Europe
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/15/2014)... January 15, 2014 This webinar will ... and clinical safety assessment in biosimilars. , Regulatory frameworks ... biosimilar drug development, however the complex nature of biopharmaceuticals ... safety and efficacy extremely challenging. Based on the specific ...
(Date:1/15/2014)... 2014 DTS Language Services, Inc . ... Portal for Life Science organizations who need document translations. ... matter of their documents in advance with a selection of ... of translations, often a critical factor in clinical and scientific ...
(Date:1/14/2014)... (PRWEB) January 14, 2014 Date: Friday, April ... Location: Warrington Country Club, 1360 Almshouse Road, Warrington, Pa. ... nonprofit organization solely dedicated to finding a cure for hepatitis ... worldwide, will host its annual Crystal Ball on Friday, April ...
(Date:1/14/2014)... 2014 EquitiesIQ, a leading informational research ... Alliqua is an emerging biomedical company acquiring, developing, manufacturing, ... market. , Free report download: http://equitiesiq.com/reports/alliqua/ , ... management team and Board, which launched the company’s new ...
Breaking Biology Technology:Xtalks Life Sciences Webinar Examines Safety Assessment of Biosimilars 2DTS Improves Efficiency for Life Science Document Translations 2Hepatitis B Foundation to Host Annual Crystal Ball Gala 2EquitiesIQ Initiates Coverage of Alliqua, Inc. 2EquitiesIQ Initiates Coverage of Alliqua, Inc. 3
... it Easy to Connect with Technology ... Specific Chemical Reactions, PRINCETON, N.J., July 14 ... for manufacturers that require service,and support in chemical ... products, industrial products and,higher-value chemicals. The all-new website ...
... Wyeth (NYSE: WYE ),announced today that Judge Jamie D. ... granted Wyeth,s motion for summary judgment in two,hormone therapy cases ... the cases of Bailey v. Wyeth, which was to have ... October 27 trial date. The,plaintiffs in both cases alleged they ...
... Vermillion, Inc.,(Nasdaq: VRML ), a molecular ... LLC., a global, growth-company investment bank, to,assist the ... enhance the potential of the Company,s proteomic tests,(OVA1(TM) ... stockholder value. No assurances can be given that ...
Cached Biology Technology:Informex365.com is Launched for Manufacturers in Search of Chemical Reactions Expertise 2Informex365.com is Launched for Manufacturers in Search of Chemical Reactions Expertise 3Vermillion Retains ThinkPanmure to Assist in the Evaluation of Potential Strategic Alternatives 2
(Date:4/17/2014)... Our eyes not ... with a continuous stream of information about our own movements. ... a car the world glides by us and leaves ... our brain calculates self-motion from this "optic flow". This way, ... during our own movements. Together with biologists from the University ...
(Date:4/17/2014)... If a restaurant ... he can expect his premises to be trashed. Warnings like ... is enough to make restaurant owners pay up. Similarly, mafia-like ... in other birds, nests. If the host birds throw the ... destroying the entire nest. Consequently, it is beneficial for hosts ...
(Date:4/17/2014)... meeting painted a stark warning on the possible effects ... greenhouse effect 32 times that of carbon dioxide. Now ... substances act as fully regenerable electron acceptors which helps ... wetlands instead of being released to the atmosphere. However, ... it may enter into a vicious cycle to release ...
Breaking Biology News(10 mins):How vision makes sure that little fish do not get carried away 2How vision makes sure that little fish do not get carried away 3How vision makes sure that little fish do not get carried away 4Fear of the cuckoo mafia 2Fear of the cuckoo mafia 3Methane climate change risk suggested by proof of redox cycling of humic substances 2
... is available in Spanish . ... chemical composition of the rock, etc give rise to ... coats detachment, dust accumulation, etc. , The treatments used ... been directed, almost exclusively, to preserve the beauty of ...
... German . , For quite some time, ... been considered the building material of choice for nanoscale objects. ... University in Bochum has now made a dodecahedron (a geometric ... in the journal Angewandte Chemie, these objects are formed in ...
... 1, 2008 -- New research suggests that the geological ... battle with the Earth,s oceans over magnesium. The research ... initial mass via chemical reactions involving the Earth,s crust, ... is dominated by magnesium and calcium, continents ultimately gain ...
Cached Biology News:New mineralogical techniques contribute to prevent national heritage damage 2New mineralogical techniques contribute to prevent national heritage damage 3Nano-softball made of DNA 2Continents loss to oceans boosts staying power 2
MW5...
... to qualitatively detect EGFR ... paraffin-embedded (FFPE) tissue sections, ... cell preparations, using Chromogenic ... Fluorescent In Situ Hybridization ...
From micro to giga sizes, from single prep to high-throughput, Invitrogen's range of plasmid purification kits offers superior performance to match the demands of your downstream application....
...
Biology Products: