Navigation Links
FDA Grants Orphan Drug Status to Merrimack Pharmaceuticals' MM-398, a Nanotherapeutic Encapsulation of Irinotecan, for the Treatment of Pancreatic Cancer

CAMBRIDGE, Mass., Aug. 1, 2011 /PRNewswire/ -- Merrimack Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted MM-398 orphan drug status for the treatment of pancreatic cancer. MM-398 is a novel, stable nanotherapeutic encapsulation of the marketed chemotherapy drug irinotecan.  MM-398 is partnered with PharmaEngine, Inc. for development and commercialization in Taiwan under the designation PEP02.


One of the purposes of the Orphan Drug Designation program is to provide orphan status to drugs and biologics intended for the safe and effective treatment, diagnosis or prevention of rare diseases/disorders that affect fewer than 200,000 people in the United States.  In the United States, the company that first obtains FDA approval for a designated orphan drug for the specified rare disease or disorder receives orphan drug marketing exclusivity for that drug for a period of seven years. This orphan drug exclusivity prevents the FDA from approving another application, including a full new drug application (NDA), to market the same drug for the same orphan indication, except in very limited circumstances.  Orphan drug designation in the United States also provides for a reduction in regulatory fees and additional regulatory support for research and development initiatives.

About PharmaEngine, Inc.

PharmaEngine is a biopharmaceutical company established in Taipei, Taiwan in 2003.  The company focuses on the development of new drugs to treat cancer and Asian prevalent diseases.  For further information on PharmaEngine, please visit the Company's website at

About Merrimack

Merrimack is a biopharmaceutical company discovering, developing and preparing to commercialize innovative medicines paired with companion diagnostics for the treatment of serious diseases, with an initial focus on cancer.  Merrimack applies Network Biology, its proprietary systems biology-based approach to biomedical research, throughout the research and development process. Merrimack currently has four targeted therapeutic oncology candidates in clinical development and a fifth expected to enter clinical development by the end of 2011.

Contact:  Kathleen Petrozzelli Gallagher, Corporate Communications, Merrimack, 617-441-1043,
Betsy Stevenson, RaymondStevenson Healthcare Communications, 860-984-1424,

SOURCE Merrimack Pharmaceuticals, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. UCLA Receives Six UC Health Quality Grants to Improve Hospital Care
2. China Grants COPAN Patent for Flocked Swabs
3. Edison Pharmaceuticals Announces FDA Grants EPI-743 Orphan Drug Designation
4. Optimer Pharmaceuticals Reports Inducement Grants Under NASDAQ Listing Rule 5635(c)(4)
5. FDA Formally Accepts Dune Medicals MarginProbe™ System Pre-Market Approval (PMA) Application and Grants Expedited Review Status
6. FDA Grants Orphan Drug Designation for Mithridions MCD-386CR to Treat Progressive Supranuclear Palsy
7. FDA Grants Orphan Drug Designation for Nektars Investigational Drug, NKTR-102, for Treatment of Women with Ovarian Cancer
8. FDA Grants Priority Review for VEGF Trap-Eye for the Treatment of Wet Age-Related Macular Degeneration
9. FDA Grants 510(k) Clearance to Life Technologies Stem Cell Growth Medium
10. Court Grants Preliminary Approval to Class Action Settlement that Provides Benefits Of Approximately $20 Million to Healthcare Providers that Purchased a SS1 Before January 1, 2009
11. Sequenom Reports Inducement Grants Under NASDAQ Listing Rule 5635(c)(4)
Post Your Comments:
(Date:6/23/2016)... , June 23, 2016 Bracket , ... launch its next generation clinical outcomes platform, Bracket eCOA (SM) ... held on June 26 – 30, 2016 in ... first electronic Clinical Outcome Assessment product of its kind to ... #715. Bracket eCOA 6.0 is a flexible platform ...
(Date:6/23/2016)... , June 23, 2016 Revolutionary ... Oticon , industry leaders in advanced audiology ... of Oticon Opn ™, the world,s first internet ... possibilities for IoT devices.      (Photo: ... introduces a number of ,world firsts,: , ...
(Date:6/23/2016)... FRANKLIN, Tenn. , June 23, 2016 ... for automating, integrating and transforming the patient ... launch of several innovative new products and ... depth of its revenue cycle offerings. These ... establish more efficient workflows, remain compliant in ...
Breaking Medicine Technology:
(Date:6/26/2016)... , ... June 27, 2016 , ... Quality metrics are ... in many ways they remain in the eye of the beholder, according to experts ... publication of The American Journal of Managed Care. For the full issue, click ...
(Date:6/26/2016)... (PRWEB) , ... June 26, 2016 , ... Brent Kasmer, a legally blind and certified ... be personalized through a fitness app. The fitness app plans to fix the two major ... only offer a one size fits all type program , They don’t eliminate ...
(Date:6/25/2016)... ... ... The temporary closing of Bruton Memorial Library on June 21 due to a possible lice ... overlooked aspect of head lice: the parasite’s ability to live away from a human host, ... a necessary one in the event that lice have simply gotten out of control. , ...
(Date:6/25/2016)... Oklahoma (PRWEB) , ... June 25, 2016 , ... ... both athletes and non-athletes recover from injury. Recently, he has implemented orthobiologic procedures ... Oklahoma City area —Johnson is one of the first doctors to perform the ...
(Date:6/24/2016)... , ... June 24, 2016 , ... Those who have ... these feelings, many turn to unhealthy avenues, such as drug or alcohol abuse, as ... Michigan, has released tools for healthy coping following a traumatic event. , Trauma sufferers ...
Breaking Medicine News(10 mins):