Navigation Links
Tibotec Signs Multiple Agreements With Generic Manufacturers to Provide Access to New HIV Treatment
Date:1/27/2011

ame=news_56">Emcure Pharmaceuticals Ltd of India to broaden access to the medicines darunavir and etravirine in SSA and LDCs and to darunavir in India.

"We believe that voluntary licensing is an important mechanism by which to expand access to our HIV portfolio, including our newest medicines," said Will Stephens, Vice President of Global Access & Partnerships for Janssen Global Services, LLC. "Multiple licenses in place for TMC278 with generic manufacturers made before final regulatory approval in the U.S. and Europe underscore the seriousness and speed with which we're working to ensure that all patients in need, not just those in Western markets, will have timely access to the most current regimens."

Tibotec will provide the generic manufacturers with the technical information and knowledge to allow them to manufacture the single agent product. The generic manufacturers will pay royalties ranging from two to five percent. The generic manufacturers will be responsible for timely regulatory filing for generic TMC278 and for seeking pre-qualification from the World Health Organization (WHO) and ANDA approvals. To keep medicines affordable, the generic manufacturers are required to limit their gross profit margin on the sale of TMC278. Prior to the signing of these agreements, Tibotec submitted TMC278 for regulatory approval in the U.S., Europe, Canada, Switzerland, Australia, Russia and South Korea. Upon approval, it is expected that TMC278, in combination with other antiretroviral medicinal products, will be indicated for the treatment of HIV-1 infection in treatment-naïve adult patients.

The agreements cover the manufacture of TMC278 as a single agent medicine and a license to develop an FDC product using TMC278 with 300 mg tenofovir disoproxil fumarate and 300 mg lamivudine.

In July 2009, Tibotec announced that it had entered into a license and collaboration agreement with Gilead Sciences
'/>"/>

SOURCE Tibotec Therapeutics
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related medicine technology :

1. Medivir Notes That Partner Tibotec Announced Week 24 Interim Results From Phase 2b TMC435 PILLAR Study to be Presented as a Late-Breaker at AASLD
2. Tibotec Pharmaceuticals Seeks European Marketing Authorization for Investigational Once-Daily HIV Treatment TMC278
3. Tibotec Therapeutics Debuts Innovative Web Portal for HIV/AIDS Front-Line Service Providers
4. Tibotec Therapeutics Launches GRACE Campaign for Women and People of Color Living With HIV/AIDS
5. Tibotec Pharmaceuticals Announces Agreement to Develop and Commercialize a New Fixed-Dose Combination of TMC278 and Truvada(R) With Gilead Sciences
6. Tibotec Data Presented at ICAAC and HIV9 Follow Key Regulatory Approvals for Anti-HIV Compounds
7. Tibotec Presents Interim Findings for TMC435, an Investigational Genotype 1 Hepatitis C Treatment, at the AASLD Liver Meeting 2008
8. Ninety-Six Week Data on Tibotec Investigational NNRTI, TMC278, Presented at AIDS 2008
9. Tibotec Conducts Two Pivotal Phase III Clinical Trials Studying TMC278 in Treatment-Naive Adults with HIV
10. AHF Criticizes Tibotec Over Steep Price for Newest AIDS Drug, Etravirine
11. Codexis Signs First Japanese Biocatalysis Collaboration With Dainippon Sumitomo Pharma
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/28/2014)... VALLEY, Pa. , July 28, 2014  Air ... reliable, uninterrupted supply of medical oxygen is vital to ... to technical innovations that not only improve the efficiency ... use. Air Products will highlight these systems—including systems for ... that reduce oxygen loss—from August 4-5 at the ...
(Date:7/28/2014)... , July 28, 2014 Southern Research ... , Ph.D., President and CEO of Southern Research ... Release Society (CRS) for the 2014-2015 term.  The ... on July 12 in Chicago ... The Controlled Release Society is ...
(Date:7/28/2014)... , July 28, 2014  A prospective study ... Sweden has validated the performance of ... and has associated volumetrically assessed breast density measurements ... Epidemiology, Biomarkers & Prevention (DOI: 10.1158/1055-9965.EPI-13-1219), the ... tool for widespread breast cancer risk assessment," was ...
Breaking Medicine Technology:Air Products Highlights Its Medical Oxygen Supply Systems for Emergency Oxygen Supply and Reduced Oxygen Loss at ASHE 2Air Products Highlights Its Medical Oxygen Supply Systems for Emergency Oxygen Supply and Reduced Oxygen Loss at ASHE 3Arthur J. Tipton, Ph.D., Named President of Controlled Release Society 2Arthur J. Tipton, Ph.D., Named President of Controlled Release Society 3Karolinska Study Published in Cancer Epidemiology, Biomarkers & Prevention Validates Strong Agreement for VolparaDensity across Mammography Systems from Multiple Manufacturers 2Karolinska Study Published in Cancer Epidemiology, Biomarkers & Prevention Validates Strong Agreement for VolparaDensity across Mammography Systems from Multiple Manufacturers 3Karolinska Study Published in Cancer Epidemiology, Biomarkers & Prevention Validates Strong Agreement for VolparaDensity across Mammography Systems from Multiple Manufacturers 4
(Date:7/28/2014)... July 28, 2014 Shofner Vision ... Military June . Renowned LASIK and Cataract Surgeon, ... provide significant funds and public awareness for local ... military personnel and their families. “This was our ... give nearly $5,000 to a variety of local ...
(Date:7/28/2014)... more chronic medical conditions people have at retirement age, ... study claims. Since nearly four in five ... Hopkins Bloomberg School of Public Health in Baltimore said ... expectancy are slowing in the United States. "Living ... and heart failure is now the norm and not ...
(Date:7/28/2014)... DC (PRWEB) July 28, 2014 SIMpalm ... app for iOS, App is available on iTunes for ... of its kind, Audio Chef allows you to listen and ... cuisine the easy way: simply get out the ingredients and ... need to measure or prepare ingredients ahead of time, just ...
(Date:7/28/2014)... Lake City, Utah (PRWEB) July 28, 2014 ... protein powders and drinks, announced that it will be ... drink line of products this summer. The additional flavors ... with clean pure taste-free protein , Inspire Pomegranate Razz ... Vanilla - flavor of soft-serve vanilla cone , Bariatric ...
(Date:7/28/2014)... Camden, NJ (PRWEB) July 28, 2014 ... to provide enhanced access and reduced wait times for ... only six hospital systems in the state—and the only ... HealthNet Federal Services Patient-Centered Community Care program (PC3). PC3 ... Veterans Administration (VA) hospital cannot provide services due to ...
Breaking Medicine News(10 mins):Health News:Shofner Vision Center’s “Operation Military June” Provided Funds For Local Not-For-Profit Organizations Supporting Military And Their Families 2Health News:Shofner Vision Center’s “Operation Military June” Provided Funds For Local Not-For-Profit Organizations Supporting Military And Their Families 3Health News:Chronic Medical Conditions Can Shorten Seniors' Lives: Study 2Health News:Audio Chef Co. Releases Audio Cooking App for iPhone/iPad/iPod touch 2Health News:Audio Chef Co. Releases Audio Cooking App for iPhone/iPad/iPod touch 3Health News:Audio Chef Co. Releases Audio Cooking App for iPhone/iPad/iPod touch 4Health News:Bariatric Eating Announces Three New Protein Shake Flavors 2Health News:Lourdes Expands Military Partnership with Veterans 2Health News:Lourdes Expands Military Partnership with Veterans 3
... can be made from some of the same parts ... developed a way to measure the growth and drug ... a microscope. The new biosensor promises to speed ... the Richard Smalley Distinguished University Professor of Chemistry, Physics ...
... Thea Friedman, M.D., associate scientist and director of oncology ... Hackensack University Medical Center was recently awarded a National ... research grant to improve allogeneic blood and marrow transplantation ... million in funding over the next five years. ...
... Boston, Mass. Following a successful Phase 1 study ... Massachusetts Medical School (UMMS) today announced the beginning of ... a human monoclonal antibody they developed to prevent ... in transplant patients. The first patients were enrolled ...
... 18 January 2011 - A recent study by Merikangas ... the Journal of the American Academy of Child ... of adolescents that are affected with severely impairing mental ... The researchers found that approximately one third of adolescents ...
... have used a type of brain scanning, known as functional ... blood flow in the brain and to correlate this with ... which could improve is reported in the International Journal ... known since the 1890s that changes in blood flow and ...
... for breast cancer are well studied and documented. Thus, scientists ... onset of menopause and a family history of breast cancer ... neither an individual woman nor medicine can influence whether family ... - these are risk factors on which we have no ...
Cached Medicine News:Health News:See how they grow: Monitoring single bacteria without a microscope 2Health News:See how they grow: Monitoring single bacteria without a microscope 3Health News:Oncology basic research director at John Theurer Cancer Center continues transplantation research 2Health News:First liver transplant patients receive experimental drug to prevent hepatitis C infection 2Health News:First liver transplant patients receive experimental drug to prevent hepatitis C infection 3Health News:Adolescents with severe mental disorders have never received treatment 2Health News:Functional boost for magnetic resonance imaging 2Health News:Scientists identify avoidable breast cancer risk factors 2
... 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 ...
... ARUP Laboratories is a national reference laboratory ... research and development. ARUP offers an extensive ... medical tests in clinical and anatomic pathology. ... Laboratories' clients include more than half of ...
... ARUP Laboratories is a national reference ... laboratory research and development. ARUP offers an ... unique medical tests in clinical and anatomic ... ARUP Laboratories' clients include more than half ...
... reference laboratory and a worldwide leader in ... an extensive test menu of highly complex ... anatomic pathology. Owned by the University of ... half of the nation's university teaching hospitals ...
Medicine Products: