New Drug Approvals

Home » NDA » Durata Therapeutics Announces FDA’s Acceptance for Priority Review of NDA for Dalvance (dalbavancin hydrochloride)

Durata Therapeutics Announces FDA’s Acceptance for Priority Review of NDA for Dalvance (dalbavancin hydrochloride)

DRUG APPROVALS BY DR ANTHONY MELVIN CRASTO .....FOR BLOG HOME CLICK HERE

ORGANIC SPECTROSCOPY

Read all about Organic Spectroscopy on ORGANIC SPECTROSCOPY INTERNATIONAL 

Categories

Blog Stats

  • 1,723,004 hits

Enter your email address to follow this blog and receive notifications of new posts by email.

Join 2,034 other followers

add to any

Share

CAS No. 171500-79-1
Chemical Name: Dalbavancin
Synonyms: MDL 63397;Dalbavancin
CBNumber: CB41028737
Molecular Formula: C88H100Cl2N10O28
Formula Weight: 1816.71

CHICAGO, Nov 26, 2013 (GLOBE NEWSWIRE via COMTEX) — Durata Therapeutics, Inc. DRTX +6.48% today announced that the New Drug Application (NDA) for its investigational drug, Dalvance (dalbavancin hydrochloride) for injection, has been accepted for priority review by the U.S. Food and Drug Administration (FDA) with an action date of May 26, 2014. Durata is seeking FDA approval of Dalvance(TM) for the treatment of patients with acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible Gram-positive microorganisms, including MRSA (methicillin resistant Staphylococcus aureushttp://www.drugs.com/nda/dalbavancin_131126.html

Dalbavancin, V-Glycopeptide, VER-001, BI-397 factor B0, BI-397
Vicuron Pharmaceuticals (Originator)
5,31-Dichloro-38-de(methoxycarbonyl)-7-demethyl-19-deoxy-56-O-[2-deoxy-2-(10-methylundecanamido)-beta-D-glucopyranuronosyl]-38-[N-[3-(dimethylamino)propyl]carbamoyl]-42-O-alpha-D-mannopyranosyl-N15-methylristomycin A aglycone; (3S,15R,18R,34R,35S,48S,50aR
Dalbavancin, which is also referred to in the scientific literature as BI397 or VER001, is a semi=synthetic glycopeptide mixture, the properties of which have been reported in U.S. Pat. Nos. 5,606,036, 5,750,509, 5,843,679, and 5,935,238.
U.S. Publication No. 20040224908;
J Antibiot1995,48,(8):869
Drugs Fut1999,24,(8):839

Dalbavancin is prepared by chemical modification of the natural glycopeptide complex A-40,926 as described in Malabarba and Donadio (1999) Drugs of the Future 24(8):839-846. The predominant component of dalbavancin is Factor Bo, which accounts for >75% of the whole complex.

[0042] The amount of each of the components present in a dalbavancin composition is dictated by a variety of factors, including, for example, the fermentation conditions employed in the preparation of the natural glycopeptide complex A-40926, which is the precursor to dalbavancin (see, e.g., U.S. Pat. No.5,843,679), the conditions employed to recover A-40926 from the fermentation broth, the chemical reactions employed to selectively esterify the caxboxyl group of the sugar moiety of A-40926, the conditions employed to amidate the peptidyl carboxyl group, the conditions employed to saponify the ester of the carboxyl group of the N-acylaminoglucuronic acid function, the conditions employed to recover dalbavancin from the synthetic mixture, and the like.

the semisynthetic glycopeptide dalbavancin was synthesized from the natural antibiotic A 40926, originally isolated from an Actinomadura culture (Malabarba et al., 1998, U.S. Pat. No. 5,750,509). Dalbavancin has shown greater efficacy against various bacterial strains than vancomycin or the antibiotic linezolid and represents a promising new treatment for skin and soft tissue infections (see, e.g., Jabés et al., 2004, Antimicrob. Agents Chemother. 48:1118-1123). According to U.S. Pat. No. 5,750,509, dalbavancin is a glycopeptide antibiotic with a monomethyl moiety at its N15 amino (see FIG. 1 for numbering), and this N15-monomethyl amino could be free (i.e. —NHCH3) or protected with an amino protecting group such as t-butoxycarbonyl, carbobenzyloxy, arylalkyl or benzyl. The method for making certain of the dalbavancin components reported in the ‘509 patent also produced N15,N15-dialkyl analogs of dalbavancin in minor-quantities, but these molecules were not characterized.

Dalbavancin (INN, trade name Zeven) is a novel second-generation lipoglycopeptideantibiotic. It belongs to the same class as vancomycin, the most widely used and one of the few treatments available to patients infected with methicillin-resistant Staphylococcus aureus (MRSA).[1]

Dalbavancin (BI397) is a novel semisynthetic lipoglycopeptide that was designed to improve upon the natural glycopeptides currently available, vancomycin and teicoplanin.[2]

It possesses in vitro activity against a variety of Gram-positive pathogens[3][4] includingMRSA and MRSE.[5] It is a once-weekly, two-dose antibiotic that Pfizer acquired when it bought Vicuron Pharmaceuticals in 2005.[6]

Dalbavancin has undergone a phase III clinical trial for adults with complicated skin infections, but in Dec 2007 the FDA said more data was needed before approval.[6] On September 9, 2008, Pfizer announced that it will withdraw all marketing applications in order to conduct another Phase 3 clinical trial.[7] Durata Therapeutics acquired the rights to dalbavancin in December 2009 and has initiated two new Phase III clinical trials for treatment of acute bacterial skin and skin structure infections.[8] Preliminary results in Dec 2012 looked good.[9]

  1.  Vicuron Pharmaceuticals Submits New Drug Application for Dalbavancin to U.S. Food and Drug Administration
  2.  Scheinfeld NS. (May 2006). “Dalbavancin: A review for dermatologists.”. Dermatology Online Journal 12 (6). Unknown parameter |numero= ignored (helpPMID 17083861
  3.  Chen AY, Zervos MJ, Vazquez JA (2007). “Dalbavancin: a novel antimicrobial”. Int. J. Clin. Pract. 61 (5): 853–63. doi:10.1111/j.1742-1241.2007.01318.xPMC 1890846.PMID 17362476.
  4.  Das B, Sarkar C, Biswas R, Pandey S (2008). “Review: dalbavancin-a novel lipoglycopeptide antimicrobial for gram positive pathogens”. Pak J Pharm Sci 21 (1): 78–88. PMID 18166524.
  5.  Dalbavancin: A Novel Lipoglycopeptide Antibacterial
  6.  UPDATE 1-Pfizer says US FDA wants more data on antibiotic. Dec 2007
  7.  “Pfizer Will Withdraw Global Marketing Applications for Dalbavancin to Conduct a New Trial” (Press release). Pfizer Inc. 2008-09-09. Retrieved 2008-09-11.
  8.  Durata Begins Dalbavancin Study Enrollment. Drug Discovery & Development – October 05, 2011.
  9.  Durata Therapeutics Announces Phase 3 Clinical Trial Results for Dalbavancin in the Treatment of ABSSSI

DAPTOMYCIN

VANCOMYCIN

Advertisements

4 Comments

  1. when will available in Pakistan???

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s

DR ANTHONY CRASTO

Follow New Drug Approvals on WordPress.com

Enter your email address to follow this blog and receive notifications of new posts by email.

Join 2,034 other followers

DR ANTHONY MELVIN CRASTO Ph.D

DR ANTHONY MELVIN CRASTO Ph.D

DR ANTHONY MELVIN CRASTO, Born in Mumbai in 1964 and graduated from Mumbai University, Completed his Ph.D from ICT, 1991,Matunga, Mumbai, India, in Organic Chemistry, The thesis topic was Synthesis of Novel Pyrethroid Analogues, Currently he is working with GLENMARK PHARMACEUTICALS LTD, Research Centre as Principal Scientist, Process Research (bulk actives) at Mahape, Navi Mumbai, India. Total Industry exp 29 plus yrs, Prior to joining Glenmark, he has worked with major multinationals like Hoechst Marion Roussel, now Sanofi, Searle India Ltd, now RPG lifesciences, etc. He has worked with notable scientists like Dr K Nagarajan, Dr Ralph Stapel, Prof S Seshadri etc, He did custom synthesis for major multinationals in his career like BASF, Novartis, Sanofi, etc., He has worked in Discovery, Natural products, Bulk drugs, Generics, Intermediates, Fine chemicals, Neutraceuticals, GMP, Scaleups, etc, he is now helping millions, has 9 million plus hits on Google on all Organic chemistry websites. His friends call him worlddrugtracker. His New Drug Approvals, Green Chemistry International, All about drugs, Eurekamoments, Organic spectroscopy international, etc in organic chemistry are some most read blogs He has hands on experience in initiation and developing novel routes for drug molecules and implementation them on commercial scale over a 29 year tenure till date Aug 2016, Around 30 plus products in his career. He has good knowledge of IPM, GMP, Regulatory aspects, he has several International patents published worldwide . He has good proficiency in Technology transfer, Spectroscopy, Stereochemistry, Synthesis, Polymorphism etc., He suffered a paralytic stroke/ Acute Transverse mylitis in Dec 2007 and is 90 %Paralysed, He is bound to a wheelchair, this seems to have injected feul in him to help chemists all around the world, he is more active than before and is pushing boundaries, He has 9 million plus hits on Google, 2.5 lakh plus connections on all networking sites, 25 Lakh plus views on dozen plus blogs, He makes himself available to all, contact him on +91 9323115463, email amcrasto@gmail.com, Twitter, @amcrasto , He lives and will die for his family, 90% paralysis cannot kill his soul., Notably he has 13 lakh plus views on New Drug Approvals Blog in 212 countries......https://newdrugapprovals.wordpress.com/ , He appreciates the help he gets from one and all, Friends, Family, Glenmark, Readers, Wellwishers, Doctors, Drug authorities, His Contacts, Physiotherapist, etc

Personal Links

View Full Profile →

TWITTER

bloglovin

Follow my blog with Bloglovin The title of your home page You could put your verification ID in a comment Or, in its own meta tag Or, as one of your keywords Your content is here. The verification ID will NOT be detected if you put it here.
%d bloggers like this: