Navigation Links
Neutropenia: Biosimilar Product from India Moves One Step Closer to European Market
Date:4/7/2008

VIENNA, Austria, April 7 /PRNewswire/ -- A biosimilar product for treating the negative effects that cancer chemotherapy can have on the white blood cells of patients is safe and exhibits an identical pharmacokinetic and pharmacodynamic profile compared to a reference product. This is the result of a clinical phase I trial conducted jointly by the Austrian company Kwizda Pharma GmbH and the Indian manufacturer INTAS Biopharmaceuticals Ltd. (IBPL). Upon completion of an upcoming clinical phase III trial, both companies will lodge an application to get the product approved for the European market. The market launch is planned for early 2010.

Neutropenia - a condition whereby the concentration of neutrophils (a type of white blood cell) in the blood is too low - is a serious side effect of cancer chemotherapy and can prevent the treatment from being successful. Granulocyte colony stimulating factor (G-CSF) is a human protein that can reverse neutropenia by initiating the production of neutrophils. Recombinant forms of the protein have already been approved for the European market. However, due to the high costs that are involved, the relevant authority (EMEA) is encouraging applications for biosimilar products.

Similar & Identical

Working in partnership with IBPL, the first and only biopharmaceutical company in India to comply with EU Good Manufacturing Practice (GMP), Kwizda Pharma has now completed a clinical phase I trial as part of the European application process for a biosimilar form of recombinant G-CSF known as Neukine. Neukine exhibits identical efficacy to the EU-approved reference product. Dr. Helmut Brunar, VP of Research & Business Development at Kwizda Pharma sums up the results of the trial: "Not only was Neukine cleared from the patients' blood plasma just as quickly as the reference, but the number of neutrophils also increased with identical kinetics after treatment. We are very pleased with these results." The study was a
'/>"/>

SOURCE Kwizda Pharma GmbH
Copyright©2008 PR Newswire.
All rights reserved

0

GOOD

Page: 1 2 3

Related medicine technology :

1. Trubion Initiates Phase 1/2 Study of TRU-016 in CLL, Announces Next-Generation Product Candidate for RA and Provides Product Pipeline Update
2. MAP Pharmaceuticals Reports Positive Results From Comparative Pharmacokinetic Trial for its Pediatric Asthma Product Candidate
3. Increasing Dairy Milk Production with Electrolyzed Drinking Water
4. Nuvelo Announces Phase 2 SONOMA-3 Trial Did Not Meet Target Product Profile and Discontinues Alfimeprase Development
5. Ception Therapeutics Initiates Phase II/III Clinical Trial for Its Lead Product Reslizumab in Eosinophilic Esophagitis (EE) in Children
6. ATS Medical Announces Initial Clinical Results of Stand-Alone Atrial Fibrillation Procedures Using ATS CryoMaze Product Line
7. On Second Anniversary, Compendia Bioscience Announces Significant Revenue Growth, Completion of Product Milestone and Expansion of Pharma Customer Commitments
8. Horizon Therapeutics Completes Enrollment in Phase 3 Trials for Lead Product Candidate HZT-501
9. Data Demonstrate that Obagi Medical Products Condition & Enhance Skin Care System is an Effective Complement to Facial Rejuvenation Procedures
10. Surgex(TM) Becomes the First and Only BSCG (Banned Substance Control Group) Certified Product Which is Clinically Proven Effective in Sports Recovery and Performance
11. IDM Pharma Announces Non-Binding Opinion of the European Committee for Medicinal Products for Human Use (CHMP) that Mifamurtide (L-MTP-PE) Provides a Possible Clinical Benefit in Survival
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/21/2013)... 2013  Decision Resources, one of the ... pharmaceutical and healthcare issues, finds that the ... efficacy endpoints, including overall survival and time ... over surveyed U.S. and European oncologists, prescribing ... breast cancer. The two novel emerging therapies ...
(Date:5/21/2013)... MOUNTAIN VIEW, Calif. , May 21, 2013 ... the design and manufacture of wireless personal healthcare ... to broaden its reach, announcing the release of ... of wireless blood pressure monitors and scales: the ... Tracker. (Photo: http://photos.prnewswire.com/prnh/20130521/SF17618 ) ...
(Date:5/21/2013)... , May 21, 2013 BioElectronics Corp. ... consumer electronic devices, announced that CEO, ... to the FDA,s Medical Advisory Committee, Orthopedic and ... products for over the counter sales. ... its medical device classification schema," Whelan said.  "While ...
Breaking Medicine Technology:Thought-Leader Opinion and Clinical Data Indicate that Emerging Agents from Two Drug Classes Have Efficacy Advantages Over Currently Used Therapies for HR-Positive, HER2-Negative Breast Cancer 2iHealth Lab adds new products and partners to mobile personal healthcare offering 2iHealth Lab adds new products and partners to mobile personal healthcare offering 3BioElectronics Presents FDA Reclassification Panel 2BioElectronics Presents FDA Reclassification Panel 3
... more ... study, DURANGO, Colo. and NEW HAVEN, Conn., ... innovation networks, today announced,that the company is providing ... Applied Spine,s Stabilimax NZ(R) Dynamic Spine,Stabilization System. Stabilimax ...
... 18 Worldwide markets of,approved EGFr/HEr2 inhibitors grew by ... more than $3.2 billion, exceeding total sales reported in,2005. ... for these drugs and fueling continued rapid market growth. ... 50 novel,agents targeting this pathway are in development. ...
Cached Medicine Technology:Syndicom SpineConnect Web Platform Chosen for Applied Spine's Leg and Back Pain Clinical Trial of Its Stabilimax NZ(R) Dynamic Spine Stabilization System 2Syndicom SpineConnect Web Platform Chosen for Applied Spine's Leg and Back Pain Clinical Trial of Its Stabilimax NZ(R) Dynamic Spine Stabilization System 3
(Date:5/21/2013)... Focus, a non-profit organization striving to improve the living ... Corridor region, is releasing results for its 2013 Creative ... May 23rd at 10:30 a.m. The survey follows ... The survey is a critical component to the organizations’ ... and retain people of diverse backgrounds, cultures and beliefs ...
(Date:5/21/2013)... (May 21, 2013) A paper recently published in ... co-written by physicians and scientists at the University of ... risk factor for pulmonary fibrosis can be used to ... , Researchers looked at a fairly common variant of ... component of the mucous produced by the bronchial tubes. ...
(Date:5/21/2013)... The Brazilian funding agency for scientific and technological research ... of So Paulo, announced an investment estimated in US$ ... Centers (RIDCs) for a period of up to eleven ... and 7. , Funding for the 17 RIDCs ... funding faculty, technicians, support personnel, and infrastructure). Host institutions ...
(Date:5/21/2013)... 21, 2013 Today, Zane Benefits, Inc. ... FSA accounts. Zane Benefits, which provides comprehensive and ... the leader in defined contribution and ... , According to Zane Benefits’ website, the Affordable Care ... into law in 2010 and impacts many areas of ...
(Date:5/21/2013)... While North Carolina is synonymous with ... guides. Brunswick Plantation & Golf Resort is synonymous with ... to 27 holes of "Top10" championship golf. , ... knowing the Top 10 from an industry ... overwhelming task of selecting the course to play. Guests ...
Breaking Medicine News(10 mins):Health News:Diversity Focus Announces Results from 2013 Creative Corridor Survey at News Conference on Thursday, May 23rd at 10:30 a.m. 2Health News:Researchers find genetic risk factor for pulmonary fibrosis 2Health News:Research at the cutting edge of knowledge 2Health News:Zane Benefits Publishes New Information on HRA, HSA and FSA Accounts 2Health News:Zane Benefits Publishes New Information on HRA, HSA and FSA Accounts 3Health News:Brunswick Plantation & Golf Resort Named in Top 10 Golf Resorts in North Carolina 2
... YORK, Sept. 26 The American Liver Foundation ... improving the,quality of life for the 30 million ... has been named to become the next President ... 5, 2007. Mr. Smith,a senior nonprofit executive with ...
... Today, at the annual,conference of the Colorado ... along with the Colorado Springs Police Department,announced the ... raise awareness and reduce demand for the highly ... was created by the Partnership, and is,currently operating ...
... researchers has found that adolescents may suffer from severe ... diagnosed with cancer and that parents tend to underestimate ... life experiences that can be so stressful that it ... develop post-traumatic stress symptoms (PTSS) go on to develop ...
... YORK, Sept. 26 Paramount Acquisition,Corp. (OTC Bulletin Board: ... its board of directors has established the close of,business ... determine Paramount,s,stockholders who will be entitled to receive notice ... stockholders to be held to consider and vote,on the ...
... TIGroup, Inc. (OTC,Bulletin Board: TISG), a California-based financial ... surgical centers (ASCs) and,other businesses designed to deliver ... named Dennis M. Smith as the company,s,chief financial ... the company,s board,since 2001. Smith was most ...
... Outside North America in Deal Valued at up ... to ... Sept. 26, NPS Pharmaceuticals, Inc. (Nasdaq: NPSP ) and,Nycomed ... licenses to Nycomed the rights to develop and commercialize,GATTEX(TM) (teduglutide) ...
Cached Medicine News:Health News:The American Liver Foundation Appoints Rick Smith, a Twenty-Year Veteran of The MS Society, as Chief Executive Officer 2Health News:Partnership for a Drug-Free America and Colorado Springs Police Department Introduce Methamphetamine Prevention Program to Colorado Law Enforcement 2Health News:Partnership for a Drug-Free America and Colorado Springs Police Department Introduce Methamphetamine Prevention Program to Colorado Law Enforcement 3Health News:Study finds post-traumatic stress symptoms in adolescent children of cancer patients 2Health News:Study finds post-traumatic stress symptoms in adolescent children of cancer patients 3Health News:Paramount Acquisition Corp. Announces Record Date of October 1, 2007 for Proposed Acquisition of Chem Rx 2Health News:Paramount Acquisition Corp. Announces Record Date of October 1, 2007 for Proposed Acquisition of Chem Rx 3Health News:Paramount Acquisition Corp. Announces Record Date of October 1, 2007 for Proposed Acquisition of Chem Rx 4Health News:TIGroup Names Dennis M. Smith as Chief Financial Officer 2Health News:TIGroup Names Dennis M. Smith as Chief Financial Officer 3Health News:TIGroup Names Dennis M. Smith as Chief Financial Officer 4Health News:NPS Pharmaceuticals and Nycomed Announce Licensing Agreement for GATTEX(TM) in Territories Outside North America 2Health News:NPS Pharmaceuticals and Nycomed Announce Licensing Agreement for GATTEX(TM) in Territories Outside North America 3Health News:NPS Pharmaceuticals and Nycomed Announce Licensing Agreement for GATTEX(TM) in Territories Outside North America 4
... Laboratories is a national reference laboratory and ... and development. ARUP offers an extensive test ... tests in clinical and anatomic pathology. Owned ... clients include more than half of the ...
... national reference laboratory and a worldwide leader ... offers an extensive test menu of highly ... and anatomic pathology. Owned by the University ... than half of the nation's university teaching ...
... Laboratories is a national reference laboratory and ... and development. ARUP offers an extensive test ... tests in clinical and anatomic pathology. Owned ... clients include more than half of the ...
... is a national reference laboratory and a ... development. ARUP offers an extensive test menu ... in clinical and anatomic pathology. Owned by ... include more than half of the nation's ...
Medicine Products: