Navigation Links
Former FDA Official Tim Cote Joins Emmaus Medical as Regulatory Advisor
Date:5/9/2013

TORRANCE, Calif., May 9, 2013 /PRNewswire/ -- Timothy Cote , M.D., MPH, former director of the Office of Orphan Product Development of the U.S. Food and Drug Administration, has joined Emmaus Medical, Inc., a specialty pharmaceutical and regenerative medicine company, in an advisory capacity, the company announced today.  Dr. Cote will advise Emmaus on the regulatory pathway for the company's sickle cell disease treatment.

"Dr. Cote's extensive regulatory knowledge and experience in rare diseases will be extremely beneficial as we move toward completion of our phase 3 clinical trial and into the analysis phase of the study," said Yutaka Niihara , M.D., MPH, founder and CEO of Emmaus Medical. "We remain on track to complete the study this year and look forward to working closely with Dr. Cote as we reach this important milestone, both for our company and the sickle cell disease community."

Dr. Cote is a leading national regulatory expert in orphan drug development. As a part of 22 years of federal service at the FDA, National Institutes of Health (NIH) and Centers for Disease Control (CDC), Dr. Cote served as the Director of the FDA Office of Orphan Products Development (OODP) from 2007 to 2011. The OODP is the FDA's primary interface with companies seeking orphan designation for drug and device products or seeking guidance in navigating FDA processes in reviewing orphan products.  Dr. Cote was instrumental in implementing the Orphan Drug Act and personally signed more than 800 orphan drug designations in his time at the Agency.

Dr. Cote also has served as Senior Federal Advisor to the Director, District of Columbia Department of Health; Branch Chief, Therapeutics and Blood Safety, FDA Center for Biologics Evaluation and Research (CBER); and Medical Director, Cancer Statistics Branch, National Cancer Institute. In 2011 Dr. Cote was the Chief Medical Officer for the National Organization for Rare Disorders (NORD). Currently, he is the Professor of Regulatory Practice at the Keck Graduate Institute in Claremont, California and principal of Cote Orphan Consulting.

"Finding a widely available treatment for sickle cell diseases is a clear priority and goes to the heart of the creation of Sickle Cell Disease Initiative, a program launched by the U.S. Department of Health and Human Services nearly two years ago," Dr. Cote said.  "I look forward to collaborating with Emmaus on potentially bringing forward this much needed treatment."

Emmaus' patent-protected treatment for Sickle Cell Anemia and β0-Thalassemia has Fast Track designation from the FDA, Orphan Drug designation in the United States and Orphan Medicinal Product designation in the European Union.

About Emmaus Medical, Inc.

Founded in 2000, Emmaus Medical, Inc. is a specialty pharmaceutical company, and subsidiary of Emmaus Life Sciences, Inc., dedicated to the discovery, development and commercialization of innovative and cost-effective treatments and therapies for rare diseases. The company is completing its Phase 3 clinical trial for a treatment for sickle cell disease and has entered into a collaborative agreement for the research, development and commercialization of regenerative medicine products. For more information, please visit www.emmausmedical.com.

Contacts:

Media:
Lori Teranishi for Emmaus Medical, Inc.
415-981-1964
lteranishi@iqprinc.com

Investors:
Matt Sheldon for Emmaus Medical, Inc.
310-279-5975
msheldon@pondel.com


'/>"/>
SOURCE Emmaus Medical, Inc.
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Former NxStage Patient Nikolas Gieske Celebrates Kidney Transplant
2. Judge Upholds $3.3 Million Judgment In Favor of Fox Insurance Company Against Former Pharmacy Benefit Manager
3. Phonak and Special Olympics join forces with US Olympian, former Congressman Jim Ryun
4. Par Formulations (Formerly Edict Pharmaceuticals) Receives First ANDA Approval
5. Mike Golic, ESPN Radio Personality and Former Philadelphia Eagle, Holds Pre-Season "Training Camp" for People With Type 2 Diabetes
6. Lance Armstrong Update: Arrogant Even After Conceding Doping Charges, Asserts Former White House & WADA Spokesman Robert Weiner; Victory for Clean Sport but "Dark Message" Is Science Must Catch Up to Masking Agents Allowing Cheating
7. Cell Therapeutics, Inc. (CTI) Appoints Former Managing Director, Head of West Coast Biotechnology for Oppenheimer/CIBC Matthew J. Plunkett Executive Vice President, Corporate Development
8. Robert G. Savage, Former Worldwide Chairman, Johnson & Johnsons Pharmaceuticals Group, Joins Board of Nuovo Biologics, LLC
9. Prime Healthcare Hospitals Ranked as "Top Performers" by The Joint Commission
10. Omeros Responds to Misleading Announcement by Davis Wright Tremaine Concerning Settlement with Former Chief Financial Officer
11. NxStage Educational Reception at Annual Dialysis Conference Features Celebrity and Former NxStage User Stephen Furst
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/18/2017)... Pa. and KALAMAZOO, Mich. , Sept. 18, ... , and OptiMed Specialty Pharmacy of ... to offer a strategic hub service that expedites and ... sought-after personal spirometer, Spiro PD 2.0, and wellness management ... spirometer is a medical device used to measure lung ...
(Date:9/13/2017)... Sept. 13, 2017   OrthoAtlanta has been named ... Football Host Committee (AFHC) for the 2018 College Football Playoff ... 2018, at Mercedes-Benz Stadium in Atlanta, Georgia ... AFHC "I,m In" campaign, participating in many activities leading up ... ...
(Date:9/12/2017)... 12, 2017  Consumer reviews on the independent review site ... number one company for hearing aids, ranking it higher than ... ... by Consumers For Hearing Aids ... is an online store that provides high performance, state-of-the-art, German-engineered hearing ...
Breaking Medicine Technology:
(Date:10/13/2017)... ... October 13, 2017 , ... ProVest Insurance Group, a family ... and Raleigh regions, is organizing an extended charity drive to benefit the family ... abnormality. , After struggling since birth with several health challenges, T.J. was later ...
(Date:10/13/2017)... , ... October 13, 2017 , ... ... the certification process to promote standards of excellence for the field of eating ... for March 22 – 25, 2018 in Orlando, Florida at the Omni Resort ...
(Date:10/13/2017)... ... , ... Many families have long-term insurance that covers care for a family ... for care if the client has a cognitive impairment diagnosis. , “What this ... often waived, so the benefits from their insurance start immediately,” said Mechell Vieira, owner ...
(Date:10/13/2017)... ... 2017 , ... Talented host, actor Rob Lowe, is introducing ... new episode of "Success Files," which is an award-winning educational program broadcasted on ... subject in-depth with passion and integrity. , Sciatica occurs when the sciatic nerve ...
(Date:10/12/2017)... ... October 12, 2017 , ... CitiDent and San ... using cutting-edge Oventus O2Vent technology. As many as 18 million Americans are ... cessation in breathing. Oral appliances can offer significant relief to about 75 percent ...
Breaking Medicine News(10 mins):