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Glenmark Pharmaceuticals inaugurates new Antibody Manufacturing Facility in La Chaux-de-Fonds, Switzerland
Glenmark Pharmaceuticals inaugurates new Antibody Manufacturing Facility in La Chaux-de-Fonds, Switzerland
Glenmark opens a new cGMP-compliant monoclonal antibody manufacturing facility in La Chaux-de-Fonds, Switzerland
• State of the art manufacturing facility for supply of clinical trial material
• With the facility Glenmark has end-to-end capabilities for the development of novel, state-of-the-art monoclonal antibodies including bi-specific antibodies
La Chaux-de-Fonds, Switzerland, June 4, 2014 – Glenmark Pharmaceuticals S.A (GPSA), a wholly owned subsidiary of Glenmark Pharmaceuticals Limited, India (GPL), announced the opening of its new cGMP compliant monoclonal antibody manufacturing facility in La Chaux-de-Fonds, Switzerland. This manufacturing facility supplements Glenmark’s existing in-house discovery and development capabilities and will supply material for clinical development.
The manufacturing facility has been designed for use of single use bioreactor systems and also houses a suite for manufacturing cell banks. The facility is fully compliant with quality, environmental and safety standards for manufacturing clinical trial material.
http://www.moneycontrol.com/stocks/stock_market/corp_notices.php?autono=813829
4th-Jun-2014 10:33
Source: BSE
The company says the facility supplements existing in-house discovery and development capabilities and will supply material for clinical development. Glenmark Pharmaceuticals’ Swiss research centre is an integrated antibody discovery and development unit with in-house capabilities and infrastructure for conducting antibody discovery, cell line development, in vitro testing and characterisation of antibodies, process development and analytical research. The new manufacturing facility supplements the research and development capabilities and will enable production of clinical grade material.
Single-use bioreactor systems and a suite for manufacturing cell banks are included in the new facility, which is fully compliant with quality, environmental and safety standards for manufacturing clinical trial material. Michael Buschle, President – Biologics, at Glenmark Pharmaceuticals, said: ‘This state-of-the-art manufacturing facility is a testimony to Glenmark’s commitment to growing its R&D and manufacturing facility in the canton of Neuchâtel.
We have been doing cutting-edge work in the area of novel monoclonal antibodies and have several monoclonal antibody candidates and bispecific antibodies in the pipeline.
The manufacturing facility will help us bring these antibodies to the clinic faster.’ There are currently 69 staff at the research centre developing biologics for the treatment of pain, inflammatory, oncologic and respiratory conditions. In 10 years, the centre has filed several patents on novel biologic entities: GBR 500, its most advanced candidate, has been licensed to Sanofi and is currently in Phase II development; GBR 900, a molecule for the treatment of chronic pain, is currently in Phase I; and GBR 830, an anti OX-40 antagonist, is scheduled to enter the clinic later this year
La Chaux-de-Fonds, Switzerland ………city
India business robust in terms of growth: Glenmark….videos
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India business robust in terms of growth: Glenmark on Q1 …
NDTV Profit News Video Clip on India business robust in terms of growth: … chairman and managing director …
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FY14 looks solid, though local market has slowed: Glenmark …
May 8, 2013Glenn Saldanha, chairman and MD, Glenmark Pharmaceuticals, says that FY14 will bring in solid growth for …
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Outperformed peers in domestic market: Glenmark …
profit.ndtv.com/…/news/video-outperformed-peers-in-…Jan 30, 2013Visit NDTVProfit.com to Watch Outperformed peers in domestic market: Glenmark Pharmaceuticals Video …
Glenmark Kicks Off Monoclonal Antibody Pain Studies
Glenmark Pharmaceuticals S.A., a wholly owned Swiss subsidiary of Glenmark Pharmaceuticals Ltd., announced that GBR 900, a novel monoclonal antibody is entering human trials. GBR 900 targets TrkA, a receptor for nerve growth factor (NGF) involved in chronic pain signaling.
In 2010, Glenmark gained an exclusive worldwide license from Lay Line Genomics S.p.A. (Italy) for anti-TrkA antibodies and their entire intellectual property portfolio in the TrkA field. GBR 900 is the optimized anti-TrkA antibody emerging from this exclusive worldwide license.
read all at
http://www.dddmag.com/news/2014/04/glenmark-kicks-monoclonal-antibody-pain-studies
Glenmark Kicks Off Monoclonal Antibody Pain Studies
Glenmark Pharmaceuticals today said its novel monoclonal antibody for potential treatment of chronic pain is entering human trials.
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
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.
MUMBAI, India, May 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”.
Glenmark conferred with Best Biotech New Molecular Entity Patent award
IDMA best biotech NEW MOLECULAR ENTITY patent award to Glenmark
YEAR 2012-2013 YEAR in Mumbai India
PATENT US 8236315
GLENMARK PHARMACEUTICALS, S.A., SWITZERLAND
INVENTORS
Elias Lazarides, Catherine Woods, Xiaomin Fan, Samuel Hou, Harald Mottl, Stanislas Blein, Martin BertschingerALSO PUBLISHED ASCA2712221A1, CN101932606A,EP2245069A1, US20090232804,WO2009093138A1
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USPTO, USPTO Assignment, Espacenet, US 8236315
The present disclosure relates generally to humanized antibodies or binding fragments thereof specific for human von Willebrand factor (vWF), methods for their preparation and use, including methods for treating vWF mediated diseases or disorders. The humanized antibodies or binding fragments thereof specific for human vWF may comprise complementarity determining regions (CDRs) from a non-human antibody (e.g., mouse CDRs) and human framework regions.
The present disclosure provides a humanized antibody or binding fragment thereof specific for vWF that comprises a heavy chain variable region sequence as set forth in SEQ ID NO: 19 and a light chain variable region sequence as set forth in SEQ ID NO: 28 ……….. CONT
MR GLEN SALDANHA
MD , CEO GLENMARK
INDIAN DRUG MANUFACTURERS’ ASSOCIATION (IDMA)
102-B Poonam Chambers, Dr A B Road, Worli, Mumbai 400 018, INDIA
Tel : +91 – 22 – 24944625 / 24974308. Fax : ++91 – 22 – 24957023
email: ppr@idmaindia.com website : http://www.idma-assn.org
Glenmark receives final ANDA approval for Desoximetasone Ointment USP, 0.25%
Desoximetasone 382-67-2 cas
September 23, 2013: Glenmark Generics Inc., USA the subsidiary of Glenmark Generics Limited has been granted final abbreviated new drug approval (ANDA) from the United States Food
and Drug Administration (U.S. FDA) for Desoximetasone Ointment USP, 0.25% their generic version of Topicort® by Taro Pharmaceuticals USA Inc and shipping will commence immediately.
Desoximetasone Ointment is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. According to IMS Health sales data for the
12 month period ending June 2013, Desoximetasone Ointment garnered annual sales of approximately USD 40 million.
more info
Desoximetasone is a medication belonging to the family of medications known as topical corticosteroids. It is used for the relief of various skin conditions, including rashes. It helps to reduce redness, itching, and irritation. Desoximetasone is a synthetic corticosteroid, a class of primarily synthetic steroids used as anti-inflammatory and anti-pruritic agents.
There are two brand name products:
- Topicort Emollient Cream (0.25% desoximetasone)
- Topicort LP Emollient Cream (0.05% desoximetasone)
When using desoximetasone, some of the medication may be absorbed through the skin and into the bloodstream. Too much absorption can lead to unwanted side effects elsewhere in the body. To keep this problem to a minimum, avoid using large amounts of desoximetasone over large areas, do not use it for extended periods of time, and do not cover it with airtight dressings such as plastic wrap or adhesive bandages unless specifically told to by your doctor. Children may absorb more medication than adults do. Desoximetasone is for use only on the skin and should be kept out of the eyes.
Desoximetasone can also be used to treat some types of psoriasis.
Glenmark Gets USFDA Nod For Alcohol Abstinence Drug
GLENMARK- ELOVERA , for dry skin disorders
Compositions:
Elovera extract 10% cream, Vitamin E 0.5%
Category–Locally Acting Skin Preparations
Description
* Aqueeze adequate amount of elovera moisturizing body wash onto wet hands or wet loran and work into a creamy lather. apply it all ovr the body, keep for some time and then rinse with water.
| Products Name : | Elovera Moisturizing Body Wash 150ml – (Glenmark) |
Elovera Cream, manufacture by Glenmark pharmaceuticals limited , is cream enriched with vitamin E and Aloe Vera. It’s a very special cream specially for treating scars and other minor pimple spots on the face.
reviews from net
My skin is very much oily hence I get these ugly Pimples very profoundly. On top of it i have the habit of bursting out the puss from these pimples. I always play it with my hands and as a result forms some very ugly scars on my face which are visible from distant away.Though I am bit dark with my completion ,even then It’s clearly visible and my mother scolds me like hell for bursting the pimples out.Honestly I just can’t stop my hands reaching out for them no matter how busy I am so Finally has to resort to some ointments to reduce the visibility of the scars.
I did try few popular products but were of no use basically. The spots didn’t get reduced but instead effected the completion of my face.Finally my mother came to my rescue. She had hear about this Elovera Cream from some one and bought home one for me.Initially i was a bit skeptic but finally I thought of trying it. For the first few days it had no effect what-so-ever , but slowly it started clearing the skin blemishes. My skin started showing it’s effects and the scars became less visible. Not only does it clear the scars but it helped me to fight the ugly pimples as well.
My face became much more glowing and healthy and i use the cream regularly even now.It’s really a magical product and should try it for clearing the blemishes and other skin problem.
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