Navigation Links
European Commission Grants Orphan Medicinal Product Designation for Emmaus Medical's Sickle Cell Treatment
Date:7/17/2012

TORRANCE, Calif., July 17, 2012 /PRNewswire/ -- Emmaus Medical, Inc., a specialty pharmaceutical and regenerative medicine technology company, and subsidiary of Emmaus Life Sciences, Inc., today announced that the European Commission (EC) has granted Orphan Medicinal Product designation for the company's investigational drug Levoglutamide (L-glutamine) for the treatment of sickle cell disease. The EC designation follows the recommendation of the European Medicines Agency's (EMA) Committee for Orphan Medicinal Products announced in May.

Sickle cell disease affects approximately 2.5 in 10,000 people in the European Union, according to studies filed with EMA.  However, in some European countries, the concentration of those suffering from sickle cell disease is higher as a result of demographics, migration and geographic mobility, surpassing genetic disorders such as hemophilia and cystic fibrosis, according to a study in the Hematology Journal.

"The positive decision by the European Commission paves the way for us to provide accessible treatment to people throughout Europe who suffer from this debilitating disease," said Yutaka Niihara, M.D., MPH, founder and CEO of Emmaus.  "Throughout the world a new treatment option for sickle cell disease is urgently needed, and we are committed to bringing a treatment to market for this severely underserved patient population."

Emmaus said it currently is conducting a clinical trial that is in Phase III with the U.S. Food and Drug Administration (FDA) to study L-glutamine as a treatment for sickle cell disease. Research is being conducted at over 30 clinical trial sites around the country with over 175 people presently enrolled.  The company anticipates total enrollment of more than 200 and aims to complete the trial in 2013.  

"We are pleased to have received this important designation, which provides for marketing exc
'/>"/>

SOURCE Emmaus Medical, Inc.
Copyright©2012 PR Newswire.
All rights reserved

0

GOOD

Page: 1 2 3 4

Related medicine technology :

1. Boston Scientific Announces CE Mark and European Launch of Emerge™ PTCA Dilatation Catheter
2. Biodels Intellectual Property Position Strengthened for Ultra-Rapid-Acting Insulin Programs by Notice of Intent to Grant from European Patent Office
3. Marken Acquires European Kit Building Operation From LabCorp Clinical Trials
4. Blood Disorders: European Hematologists Gather in Amsterdam, June 14-17, 2012
5. Mylan Launches Generic Lipitor® in Five European Countries
6. European Thrombosis Therapeutics Market is Experiencing an Urgent Need for Enhanced Products, Says Frost & Sullivan
7. Bristol-Myers Squibb to Present New Data on ORENCIA(R)? (abatacept) at the European League Against Rheumatism (EULAR) 2012 Congress
8. Cardium Announces Agreement With UK-Based Angel Biomedical For Excellagen Supply And Planned European Market Expansion
9. Study Results of Novocures NovoTTF™ Pivotal Phase 3 Trial Published in European Journal of Cancer
10. Cardiac Dimensions® Announces Publication of TITAN Clinical Trial Data in European Journal of Heart Failure
11. Pharmacyclics Announces Oral Presentations of Ibrutinib (PCI-32765) at the 17th Congress of the European Hematology Association
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/23/2013)... May 23, 2013   Direct to implant, ... is an appropriate option for many women with ... reduce their breast cancer risk, or with breast ... process and a second surgery to insert permanent ... same surgery as mastectomy can be a medically ...
(Date:5/23/2013)... May 23, 2013  Net Medical Xpress Solutions, Inc., ... announced today the company has signed a letter of ... based in Huntsville, AL . MedTel ... the staffing and recruitment of telemedicine physicians. Consideration for ... final agreement, which is expected by June 30, 2013. ...
(Date:5/23/2013)... , May 23, 2013 Israel ... Israel 2013 , Israel,s 1 st ... October 14 th -15 th in Tel ... most innovative city in the world by the Wall ... BrainTech Israel 2013 will showcase the latest breakthroughs ...
Breaking Medicine Technology:Direct to Implant ("One Step") Mastectomy Breast Reconstruction Reduces Number of Surgeries and Time to Final Cosmetic Results 2Direct to Implant ("One Step") Mastectomy Breast Reconstruction Reduces Number of Surgeries and Time to Final Cosmetic Results 3Net Medical Xpress Announces Acquisition of Telemedicine Staffing Company 2Net Medical Xpress Announces Acquisition of Telemedicine Staffing Company 3Israel Brain Technologies Announces Israel's 1st International Brain Technology Conference 2Israel Brain Technologies Announces Israel's 1st International Brain Technology Conference 3
... Calif. and HANGZHOU, China, Nov. 13 ... (OTC Bulletin Board: NIUS), a leading U.S.-based biotech company ... today announced that Mr. Ping (Vince) Huang was named ... Previously, Ms. Qinghua Hu, the Company,s chief executive officer, ...
... CHENGDU, China, Nov. 13 /PRNewswire-Asia-FirstCall/ -- ... supplier,of modernized traditional Chinese medicine ("TCM") based in Chengdu, ... September 30, 2009. , Revenue ... $13.4,million, an increase of 40.2% compared to $9.6 million ...
Cached Medicine Technology:Niusule Announces Key Additions to Management Team 2Niusule Announces Key Additions to Management Team 3Tianyin Pharmaceutical co., Inc. Announces Record First Quarter 2010 Financial Results 2Tianyin Pharmaceutical co., Inc. Announces Record First Quarter 2010 Financial Results 3Tianyin Pharmaceutical co., Inc. Announces Record First Quarter 2010 Financial Results 4Tianyin Pharmaceutical co., Inc. Announces Record First Quarter 2010 Financial Results 5Tianyin Pharmaceutical co., Inc. Announces Record First Quarter 2010 Financial Results 6Tianyin Pharmaceutical co., Inc. Announces Record First Quarter 2010 Financial Results 7Tianyin Pharmaceutical co., Inc. Announces Record First Quarter 2010 Financial Results 8Tianyin Pharmaceutical co., Inc. Announces Record First Quarter 2010 Financial Results 9Tianyin Pharmaceutical co., Inc. Announces Record First Quarter 2010 Financial Results 10
(Date:5/25/2013)... Chandler, AZ (PRWEB) May 25, 2013 ... whitening service page in partnership with JD Media Surge, ... whitening methods are now available and, depending on the ... home. During a routine visit, the best method will ... whitening is performed during a visit. A special peroxide-based ...
(Date:5/25/2013)... -- Many viruses and parasites that affect both dogs ... bacteria-borne illness than can result in liver or kidney ... to a veterinarian. These germs could be ... said Dr. Susan Nelson, a clinical associate professor at ... serious diseases can be fatal, even with treatment," she ...
(Date:5/25/2013)... 25, 2013 Providing patients with their best ... team of weight management professionals. But, aside from educating patients ... Diet Doc’s hCG diets also provide patients, who ... childhood like bullying, more control over their lives by achieving ... with the underlying factors of weight gain derived from earlier ...
(Date:5/25/2013)... By working diligently for months on this project, ... 2012 Lamborghini Aventador into their well-built fitments database. The ... list of vehicles lined by SizeItUp for the year ... thrill automobile lovers in the year 2013. , ... 2012 Lamborghini Aventador comes with extraordinarily spacious cabin space. ...
(Date:5/25/2013)... BC (PRWEB) May 25, 2013 According ... the most beautiful and powerful women that ever lived. ... felt by some of the most powerful men in ... many beauty remedies to keep her skin glowing and ... made with bees- wax, maringa oil and cyprus grass. ...
Breaking Medicine News(10 mins):Health News:Chandler Dentist Launches Teeth Whitening Service Page on Website in Partnership with JD Media Surge, LLC 2Health News:Hidden Dangers Dog Dog Parks 2Health News:hCGTreatments / Diet Doc hCG Diets & Weight Loss Plans Announces hCG Diet Plans for Those Suffering from Abuse-Related Weight Gain 2Health News:hCGTreatments / Diet Doc hCG Diets & Weight Loss Plans Announces hCG Diet Plans for Those Suffering from Abuse-Related Weight Gain 3Health News:Rim Fitments Provider SizeItUp Launches The Database Integration For The 2012 Lamborghini Aventador 2Health News:The Cleopatra Lift - A New Non Surgical Option to Aging Offered by Vancouver Physician 2Health News:The Cleopatra Lift - A New Non Surgical Option to Aging Offered by Vancouver Physician 3
... antidepressants, antipsychotics, benzodiazepines and ADHD Medication without withdrawal side. The new ... James Harper, researcher and founder of The Road Back Program, details ... chapters covering each of several classes of drugs. , ... ...
... Reform, But Majority Think It Can Be Done Without ... HighMENLO PARK, Calif., Feb. 25 As economic conditions ... the affordability and availability of care, with many postponing ... year and a notable minority forced into serious financial ...
... on President Obama,s address to CongressWASHINGTON, Feb. 24 ... issued the following statement after attending President ... reminded of why working men and women all around ... Obama. President Obama demonstrated vision, courage and the bold ...
... of 75 minute Restorative Yoga (RY) classes gained positive differences ... and spirituality (feeling calm/peaceful) compared to the control group. ... Psycho-Oncology focusing on physical activity, shows the women had ... feelings of peace and meaning after the yoga sessions. , ...
... Cross and Other Health Insurers Are Illegally Denying Treatment ... following is being released by Consumer Watchdog: Who: Guillermo ... John Nagle, father of Frank Nagle , ... of landmark insurance reform initiative, Proposition 103 , ...
... measures genes in urine, another combines PSA and other ... One study suggests that a simple urine test could ... Another study says that combining risk factors for prostate ... disease. , Both studies were presented Tuesday at the ...
Cached Medicine News:Health News:How to Get Off Psychiatric Drugs Safely 2Health News:More Than Half of Americans Say Family Skimped on Medical Care Because of Cost in Past Year; Worries About Affordability and Availability of Care Rise 2Health News:More Than Half of Americans Say Family Skimped on Medical Care Because of Cost in Past Year; Worries About Affordability and Availability of Care Rise 3Health News:More Than Half of Americans Say Family Skimped on Medical Care Because of Cost in Past Year; Worries About Affordability and Availability of Care Rise 4Health News:More Than Half of Americans Say Family Skimped on Medical Care Because of Cost in Past Year; Worries About Affordability and Availability of Care Rise 5Health News:'The Bold Leadership America Needs to Confront a Broken Healthcare System' 2Health News:Yoga provides emotional benefits to women with breast cancer 2Health News:Parents of Autistic Children Fight Back - Warn HMO Regulator Against Changing Rules to Favor Insurers That Deny Access to Medical Treatment 2Health News:Tests Might Diagnose, Predict Prostate Cancer 2Health News:Tests Might Diagnose, Predict Prostate Cancer 3
... on delicate urethral tissues. The ... coating provide nearly friction-free movement, ... easy to maintain sterility. You ... its own sterile water, avoiding ...
... Medical's line of Personal ... catheters you would choose ... product configurations - standard, ... hydro - are based ...
The latex-free, PVC-free Antibacterial Hydro Personal catheter combines two remarkable innovations into one exclusive catheter that delivers an antibacterial agent while providing the virtually frict...
The Antibacterial Personal Catheter® features a unique silicone composition that provides an antibacterial coated soft outer layer of silicone combined with a firm inner layer....
Medicine Products: