New Drug Approvals

Home » Posts tagged 'gbr 500'

Tag Archives: gbr 500

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

Blog Stats

  • 4,186,086 hits

Flag and hits

Flag Counter

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

Join 2,792 other subscribers
Follow New Drug Approvals on WordPress.com

Archives

Categories

Recent Posts

Flag Counter

ORGANIC SPECTROSCOPY

Read all about Organic Spectroscopy on ORGANIC SPECTROSCOPY INTERNATIONAL 

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

Join 2,792 other subscribers
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 AFRICURE PHARMA as ADVISOR, earlier assignment was with GLENMARK LIFE SCIENCES LTD, as CONSUlTANT, Retired from GLENMARK in Jan2022 Research Centre as Principal Scientist, Process Research (bulk actives) at Mahape, Navi Mumbai, India. Total Industry exp 32 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 Open superstar 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 32 PLUS year tenure till date Feb 2023, Around 35 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 100 million plus hits on Google, 2.5 lakh plus connections on all networking sites, 100 Lakh plus views on dozen plus blogs, 227 countries, 7 continents, 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 38 lakh plus views on New Drug Approvals Blog in 227 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 He has total of 32 International and Indian awards

Personal Links

Verified Services

View Full Profile →

Archives

Categories

Flag Counter

Glenmark’s Enrollment Begins of First Patient in Phase II Vatelizumab (GBR 500) Trial in Relapsing Remitting Multiple Sclerosis


Enrollment Begins of First Patient in Phase II Vatelizumab Trial in Relapsing Remitting Multiple Sclerosis 

Glenmark outlicensed Vatelizumab (GBR 500) to Sanofi for all indications in 2011

Mumbai – India, November 4, 2014: Glenmark announced today enrollment of the first patient in a multicenter Phase II clinical trial to evaluate Genzyme’s investigational infusion therapy vatelizumab in patients with relapsing remitting multiple sclerosis (RRMS). The trial, called EMPIRE, is designed to assess the efficacy of vatelizumab vs. placebo in RRMS patients. The safety, tolerability and pharmacokinetics of vatelizumab will also be assessed.

read at

http://bionews-tx.com/news/2014/11/06/first-rrms-patient-enrolled-glenmarkgenzymes-vatelizumab-trial/

The mechanism of action of vatelizumab, which is developed in a collaboration between Glenmark Pharmaceuticals and Genzyme, is not yet fully understood. However, the researchers believe that it will be able to block VLA-2 on activated immune cells, which may enable the interference with collagen-binding in areas of inflammation, as well as leading to the reduction of inflammatory cascade associated with MS.


“We are excited about the commencement of this trial and are pleased with the continued progress of our partnership with Sanofi/Genzyme,” said the President of Biologics and Chief Scientific Officer of Glenmark Pharmaceuticals Ltd., Michael Buschle. EMPIRE, which will be conducted for 12 weeks, is a global phase 2a/2b double-blind, randomized, placebo-controlled study that will study the efficacy, safety, and dose-response of vatelizumab in 168 patients with active RRMS at55 sites in ten different countries.

Vatelizumab is an immunomodulator. It binds to integrin alpha 2.[1]

Company Glenmark Pharmaceuticals Ltd.
Description mAb against integrin alpha(2) (VLA-2; CD49B)
Molecular Target Integrin alpha(2) (VLA-2) (CD49B)
Mechanism of Action Antibody
Therapeutic Modality Biologic: Antibody
Latest Stage of Development Phase I/II
Standard Indication Inflammatory bowel disease (IBD)
Indication Details Treat inflammatory bowel disease (IBD); Treat ulcerative colitis (UC)
Regulatory Designation
Partner

Sanofi

 

References

  1. World Health Organization (2011). “International Nonproprietary Names for Pharmaceutical Substances (INN). Proposed INN: List 105”(PDF). WHO Drug Information 25 (2).

Glenmark Pharmaceuticals Ltd. through its Swiss Subsidiary receives USD 5 Mn. as milestone fee payment from Sanofi


Glenmark Pharmaceuticals Ltd. through its Swiss Subsidiary receives USD 5 Mn. as milestone fee payment from Sanofi 

Total Payment received for GBR 500 monoclonal antibody programme from Sanofi is USD 55 Mn 

MUMBAI, April 15, 2014: Glenmark Pharmaceuticals Ltd. has informed the Stock Exchange today that the company through its Swiss subsidiary has received USD 5 million as

milestone payment from Sanofi on a collaboration of its VLA2 (alpha2-beta1) integrin monoclonal antibody. GBR 500 is a first-in-class therapeutic monoclonal antibody for chronicautoimmune disorders.

Glenmark has received from Sanofi already USD 50 Mn as an upfront payment in FY2011-12. Hence, the total amount received by Glenmark from Sanofi for its first in class VLA-2monoclonal antibody is USD 55 million

 

read at

Glenmark – Updates

http://www.moneycontrol.com/stocks/stock_market/corp_notices.php?autono=790416

(copy paste on browser)

MD and CEO Mr Glenn Saldanha

 

 

old updates

Glenmark GBR 500 enters into Phase II clinical development for ulcerative colitis

17 September 2012

Glenmark Pharmaceuticals, a wholly-owned subsidiary of Glenmark Pharmaceuticals, has commenced the Phase II study of GBR 500 for ulcerative colitis.

GBR 500, an antagonist of the VLA2 (alpha2-beta1) integrin, is a first-in-class therapeutic monoclonal antibody for chronic autoimmune disorders.

The randomised, double-blind, placebo-controlled study will investigate the efficacy and safety of GBR 500 in patients with moderate to severe ulcerative colitis (UC).

Glenmark Pharmaceuticals chief scientific officer Dr Michael Buschle said that UC represents an area of substantial unmet medical need, despite treatment advances in recent years.

“We’re pleased with the continued progress of our partnership with Sanofi and excited about the commencement of this trial,” Buschle said.

The trial, which will be conducted at multiple clinical sites in North America and Europe, is expected to involve approximately 84 patients.

Patients participating in the study will receive multiple doses of either GBR 500 or placebo, administered over a period of several weeks.

Glenmark has completed Phase I of GBR 500 in the US, won licensing rights to all therapeutic indications from Sanofi and is conducting the clinical development programme.

The trial is part of a strategic global collaboration between Glenmark and Sanofi to investigate GBR 500 for the treatment of chronic inflammatory disorders.

http://www.drugdevelopment-technology.com/news/newsglenmark-gbr-500-enters-into-phase-ii-clinical-development-for-ulcerative-colitis

 

MUMBAI, IndiaMay 16, 2011

Glenmark Pharmaceuticals Out-Licenses Novel Monoclonal Antibody, GBR 500, to Sanofi

Combined Upfront and Potential Development, Regulatory and Commercial Milestone Payments Could Total US$613 Mn

MUMBAI, India, May 16, 2011 /PRNewswire-FirstCall/ — Glenmark Pharmaceuticals S.A (GPSA), a wholly owned subsidiary of Glenmark Pharmaceuticals Limited India (GPL), announced today that it has entered into an agreement with Sanofi to grant Sanofi a license for the development and commercialization of GBR 500, a novel monoclonal antibody for the treatment of Crohn’s Disease and other inflammatory conditions. The transaction is expected to close in the coming month subject to customary closing conditions, including the expiration or early termination of the waiting period under the HSR Antitrust Improvements Act.

Under the terms of the agreement, Glenmark will receive an upfront payment of US$ 50 million, of which US$ 25 million will be paid upon closing of the transaction and US$ 25 million, which is contingent upon Sanofi’s positive assessment of certain data to be provided by Glenmark. In addition, Glenmark could receive potential success-based development, regulatory and commercial milestone payments. The total of these payments could reach US$613 Mn. In addition, Glenmark is eligible to receive tiered double-digit royalties on sales of products commercialized under the license.

GBR 500 is an antagonist of the VLA-2 (alpha2-beta1) integrin. It is a first-in-class therapeutic monoclonal antibody and has established proof of concept in animal models across a range of anti-inflammatory conditions. Glenmark has completed Phase I dosing of GBR 500 in the US and the drug has been well tolerated with a good pharmacokinetic profile. Plans are in place to initiate clinical proof of concept studies in Crohn’s Disease. Sanofi has licensed the rights to all therapeutic indications.

“There continues to be a strong medical need for safer and more efficacious products for the treatment of Inflammatory Diseases,” said Elias Zerhouni, M.D., President, Global Research & Development, Sanofi. “GBR500 brings an innovative approach to Sanofi’s Immuno-Inflammation portfolio, which we believe may address a significant gap in treating Inflammatory Diseases which would be of huge benefit to patients”.

Glenn Saldanha MD and CEO of GPL, “This collaboration on a novel first-in-class monoclonal antibody validates Glenmark’s world-class innovative R&D capabilities in the drug discovery arena. We are pleased to have this second licensing collaboration with Sanofi, one of the largest pharmaceutical companies in the world and the first one from Glenmark in the field of novel biologics”.

http://www.prnewswire.com/news-releases/glenmark-pharmaceuticals-out-licenses-novel-monoclonal-antibody-gbr-500-to-sanofi-121889273.html

%d bloggers like this: