Navigation Links
BMP Sunstone Receives SFDA Acceptance for Enablex(R) Clinical Trial
Date:5/6/2008

A Milestone Reached to Commercialize Leading OAB Drug in China

PLYMOUTH MEETING, Pa., May 6 /Xinhua-PRNewswire-FirstCall/ -- BMP Sunstone Corporation (Nasdaq: BJGP) ("BMP Sunstone" or the "Company") today announced that its Clinical Trial Application ("CTA") for Enablex(R) (Darifenacin) was officially accepted by China's State Food & Drug Administration ("SFDA"). CTA acceptance is a key SFDA requirement prior to pursuing a clinical trial and, ultimately, completing commercialization of a pharmaceutical product in China. The Company hopes to begin the clinical trial in the first half of 2009, and estimates that receipt of a market license could occur sometime in 2011.

Enablex(R) is a prescription medicine used in adults to treat symptoms of urinary incontinence, urgency and frequency related to an Overactive Bladder ("OAB"). Global annual sales of OAB medication are estimated to be USD$2.25 billion. In China, OAB afflicts an estimated 24-29% of the population over the age of 24, or over 200 million people. However, the treatment rates are historically low, with less than 15% of OAB sufferers in China seeking treatment.

"Today's announcement speaks to our unique ability to commercialize leading pharmaceutical products in the Chinese market," stated David Gao, Chief Executive Officer of BMP Sunstone. "CTA acceptance is one key step toward reaching marketability and we remain excited about the growth prospects for Enablex(R) in China. The addressable market for OAB medicines in China is a huge potentially opportunity and we believe we have the necessary resources to meet this developing market demand with Enablex(R)."

In November 2007, BMP Sunstone signed an exclusive agreement to register, market and distribute
'/>"/>

SOURCE BMP Sunstone Corporation
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3

Related biology technology :

1. Reclast(R) Receives US FDA Approval as First and Only Once-Yearly Treatment for Women With Postmenopausal Osteoporosis
2. Ciphergen Biosystems Receives Noncompliance Letter From The Nasdaq Stock Market
3. Indevus Receives Approvable Letter From FDA for VALSTAR(R) for Bladder Cancer Therapy
4. Anesiva Receives FDA Approval for Zingo(TM), a New, Innovative Product to Reduce Pain Associated with Needle Insertion Procedures in Children
5. IsoTis Receives FDA Clearance for Accell Family of Products
6. Actavis Receives Approval of Fentanyl Transdermal System in the U.S.
7. AGA Medical Corporation Receives FDA and CE Mark Approvals for the AMPLATZER Vascular Plug II
8. IDM Pharma Receives Not Approvable Letter for Mifamurtide (L-MTP-PE) for the Treatment of Osteosarcoma
9. XTL Receives Staff Letter From NASDAQ
10. XTL Receives Staff Letter From NASDAQ; XTL may Transfer its ADR Listing to the NASDAQ Capital Market
11. Hemo-Stream(TM) Chronic Dialysis Catheter Receives FDA Clearance

Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/3/2009)..., , HOUSTON, Dec. 3 ...it has updated its facility to offer patients a se... , along with the LAP-BAND® System that it ...rocedure at the facility was performed by surgeon ...2009. The patient is reported as doing well. ,,...
(Date:12/3/2009)..., , MELVILLE, N.Y., Dec. 3 /PRNewswire/ -...cal instruments, announced today that it has signe...anting Nikon the rights to use the Stochastic Opti...Under the terms of the agreement, Nikon will manuf... them with the N-STORM name. ,, Nikon Corporat...
(Date:12/3/2009)..., , DALLAS, Dec. 3 /PRNewswire-First...ulletin Board: ACCP), today provided an update on ...pproved treatment for oral mucositis, a debilitati...rapy. MuGard is commercially launched by Access, p...ding the UK, Germany, Italy, Norway, Greece and Sw...
(Date:12/3/2009)..., , SAN FRANCISCO, Dec. 3 /PRNewswire-Fir...P ), a biotechnology company focused on the develo...ular and metabolic disease, today announced that i...e 2 FDG-PET clinical trial of VIA-2291. ,, The...d out at five sites in the US and Canada including...
Breaking Biology Technology:JourneyLite of Houston Now Offering Sleeve Gastrectomy 2Nikon Corporation Acquires License From Harvard University For 'STORM' Super Resolution Microscopy -- Will Create Innovative New 'N-STORM' Microscope 2Nikon Corporation Acquires License From Harvard University For 'STORM' Super Resolution Microscopy -- Will Create Innovative New 'N-STORM' Microscope 3Access Pharmaceuticals Provides Update on MuGard Commercial Launch in Europe 2Access Pharmaceuticals Provides Update on MuGard Commercial Launch in Europe 3Access Pharmaceuticals Provides Update on MuGard Commercial Launch in Europe 4VIA Pharmaceuticals Completes Patient Visits in Phase 2 Trial of VIA-2291 2VIA Pharmaceuticals Completes Patient Visits in Phase 2 Trial of VIA-2291 3VIA Pharmaceuticals Completes Patient Visits in Phase 2 Trial of VIA-2291 4
... from the National Institute of Standards and Tech...have learned how to tweak a new class of polymer-b... and alignment of the components of the blend. The...could enable the design of practical, large-scale ...able, flexible electronic displays and other devic...
... us, gold is only valuable if we possess it in lar...ule isn,t the case for those interested in exploit...variety of chemical reactions, including the oxida...ss carbon dioxide at room temperatures. That proce...he effectiveness of catalytic converters that clea...
..., Sept. 5 Pharmasset, Inc.,(Nasdaq: VRUS ) manag...Day,being held September 8, 2008, at the Citi Exec...will also present at the Morgan Stanley Global,Hea... at the Grand Hyatt,Hotel, New York, NY. Schaefer ...rovide a brief overview of the company followed by...
Other Biology Technology:Bottoms up: Better organic semiconductors for printable electronics 2NIST and partners identify tiny gold clusters as top-notch catalysts 2Pharmasset to Present at the Upcoming Citibank and Morgan Stanley Investor Conferences 2
(Date:12/3/2009)... BIO-key International, I...ss public safety and finger-based biometric identi...ts shareholders at a Special Shareholder Meeting h...nforcement Division to Interact911 Mobile Systems ... and 1.2% were opposed. ,, (Logo: http://www.n...
(Date:12/3/2009)... and his co-workers discovered that specific types...er. Scientists soon found out how these pathogens ...the main culprits are viral proteins E6 and E7. Bo...functions, thus promoting cell growth. , Profes...now discovered another mechanism by which the E6 o...
(Date:12/3/2009)...rmation and adapt to changes in our daily environm...rs to lie in the minute junctions where nerve cell...gone Medicine Center researchers. The study is pub..., The scientists, led by Wen-Biao Gan, PhD, asso...NYU School of Medicine, discovered that a delicate...
Breaking Biology News(10 mins):BIO-key(R) Shareholders Overwhelmingly Approve Sale of Law Enforcement Division 2BIO-key(R) Shareholders Overwhelmingly Approve Sale of Law Enforcement Division 3Papillomavirus silences innate immune response 2Lifelong memories linked to stable nerve connections 2Chindex International Inc Launches World Class Cancer Treatment Center 53897 1Chindex International Inc Launches World Class Cancer Treatment Center 53897 2Chindex International Inc Launches World Class Cancer Treatment Center 53897 3Chindex International Inc Launches World Class Cancer Treatment Center 53897 4AMN Healthcare Announces Second Quarter 2009 Results 53895 1AMN Healthcare Announces Second Quarter 2009 Results 53895 2AMN Healthcare Announces Second Quarter 2009 Results 53895 3AMN Healthcare Announces Second Quarter 2009 Results 53895 4AMN Healthcare Announces Second Quarter 2009 Results 53895 5AMN Healthcare Announces Second Quarter 2009 Results 53895 6AMN Healthcare Announces Second Quarter 2009 Results 53895 7AMN Healthcare Announces Second Quarter 2009 Results 53895 8AMN Healthcare Announces Second Quarter 2009 Results 53895 9AMN Healthcare Announces Second Quarter 2009 Results 53895 10AMN Healthcare Announces Second Quarter 2009 Results 53895 11AMN Healthcare Announces Second Quarter 2009 Results 53895 12AMN Healthcare Announces Second Quarter 2009 Results 53895 13AMN Healthcare Announces Second Quarter 2009 Results 53895 14AMN Healthcare Announces Second Quarter 2009 Results 53895 15AMN Healthcare Announces Second Quarter 2009 Results 53895 16Osteotech to Present at the Canaccord Adams 29th Annual Global Growth Conference 53893 1
...30 BIO-key International, Inc. (OTC Bulletin Boar...arter 2009 financial results on Wednesday, May 6, ... the release, BIO-key has scheduled a conference c...t on Wednesday, May 6, 2009 at 10:00 a.m. Eastern ...n/prnh/20050509/BIOKEYLOGO ) , , , What: BI...
...sts from Canada, Spain and the United States has i...themselves against environmental stresses like dro...ormones that they produce naturally and that signa...am member Peter McCourt, a professor of cell and s...we can control these hormones we should be able to...
...Ind. - Fish don,t make noises or contort their fac...m their mouths, but a Purdue University researcher...eph Garner, an assistant professor of animal scien...feel pain, and their reactions to it are much like... published in the early online version of the jour...
Other Biology News:BIO-key(R) Announces First Quarter Earnings Release and Conference Call Schedule 2International team finds key gene that allows plants to survive drought 2Fish may actually feel pain and react to it much like humans 2
... Detection Kit contains a green fluorescent-labele...scein (FAM) derivative of valylalanylaspartic acid...or of caspase activity. When added to a populatio...h cell and covalently binds to a reactive cysteine...
Complement, Guinea Pig Serum from Calbiochem
...em, 220-240 V, uses floating pin printing technolo...hydrates, lipids, and other biomolecules onto a va...his system can generate high-density arrays with g...r than 57,000 spots per membrane with a capacity o...
...are high-precision microarrayers capable of printi...sArray ChipWriter Pro systems set new standards fo... deliver unparalleled quality arrays on a variety ...flexible software easily adapt to either micro-run...
Biology Products: