Navigation Links
Pharmalink AB Receives US Orphan Drug Designation for Nefecon(R) (PL-56)
Date:10/13/2010

Pharmalink AB Receives US Orphan Drug Designation for Nefecon(R) (PL-56) -- STOCKHOLM, October 13, 2010 /PRNewswire/ --


Advanced Search Search

  
Close
  1. Send a release
  2. Member sign in
  3. Become a member
  4. For journalists
  5. Global sites
PR Newswire: news distribution, targeting and monitoring
  1. Products & Services
  2. Knowledge Center
  3. Browse News Releases
  4. Contact PR Newswire
Health Care & Hospitals, Medical Pharmaceuticals, Pharmaceuticals, New Products & Services, FDA Approval Click to view news release full screen  

Pharmalink AB Receives US Orphan Drug Designation for Nefecon(R) (PL-56)

 

STOCKHOLM, October 13, 2010 /PRNewswire/ -- Pharmalink AB, a privately held Swedish pharmaceutical company, has received orphan drug designation by the US Food and Drug Administration (FDA) for its product candidate Nefecon (PL-56) for patients with IgA nephropathy, also referred to as Berger's Disease. This program is presently in clinical development phase II.

Johan Haggblad, Managing director of Pharmalink AB said: "Today's news marks a significant milestone for Pharmalink, and increases the commercial value of Nefecon(R) as it moves towards the market place. We believe this product candidate has great potential in treating IgA nephropathy. The orphan drug designation granted by the US FDA is very encouraging for our team as we now look to start executing on activities leading up to registration trials."

Pharmalink AB previously announced global patent coverage and highly promising results from a planned interim analysis of an ongoing open Phase II trial which was designed to evaluate the efficacy and safety of Nefecon(R) in IgA nephropathy, a glomerulonephritis leading to end-stage renal disease (ESRD). The interim results were confirmed in the final results obtained in early 2009. Nefecon(R) is an oral small molecule product which downregulates the inflammatory process in the kidneys. It is being co-developed by Pharmalink and Archimedes Pharma under a partnership agreed in January 2004 to bring the product candidate to proof-of-concept. Orphan drug designation is intended to encourage companies to develop therapies for the treatment of diseases that affect fewer than 200,000 people in the US. It provides companies with market exclusivity and can also lead to certain financial incentives that can help support the development of a specific compound.

The concept underlying the renal disease product candidate Nefecon is a patented invention by Professors Bengt Fellstrom and Roger Hallgren at Uppsala University, Sweden. It is delivered using Archimedes' proprietary TARGIT(R) drug delivery technology which enables the localized delivery of drugs to the lower small intestine or colonic regions of the gut. Archimedes is providing access to the TARGIT platform and providing all trial supplies of Nefecon. Pharmalink is responsible for the management of the clinical trials.

About Pharmalink

Pharmalink is a Swedish specialty pharma company developing high value products for niche indications. Pharmalink draws on its extensive experience of pharmaceutical product development and the excellence of medical science in Sweden to identify and progress products that address significant unmet medical needs. Pharmalink has introduced more than 15 pharmaceutical products to the market. Using a repurposing and reformulation strategy, Pharmalink minimizes the risk of product development. The Company's strategy is to develop drugs to clinical proof-of-concept and then to out-license or divest to a commercial partner. Pharmalink currently has two clinical phase development projects, Nefecon(R) and BusulipoTM, mature for out-licensing to a commercial partner and is actively in-licensing promising new projects to add to its pipeline. In June 2010, Pharmalink sold all intellectual property and assets related to its Xepol programme, the first medical treatment for post-polio syndrome, to Grifols, a group of companies which researches, develops, manufactures and markets products serving healthcare professionals and patients in over 90 countries around the world. Visit http://www.pharmalink.se for further information.

About Archimedes Pharma

Archimedes Pharma is an international specialty pharmaceutical company focused on the oncology, pain, neurology and critical care sectors. Archimedes Pharma is marketing an expanding portfolio of specialist products to hospital-based prescribers in Europe and has established commercial organizations in the UK, US, France, Germany, Ireland, and Spain.TARGIT is Archimedes Pharma's proprietary technology for the delivery of drugs to specific regions of the large intestine or the local treatment of disease, an area of great interest to the pharmaceutical industry. The TARGIT system offers the option of delivering high local concentrations of drug, which are ideal for the topical treatment of diseases such as ulcerative colitis, Crohn's disease, irritable bowel syndrome and bacterial infections. The ability of TARGIT to reliably deliver drugs into the lower GIT has been demonstrated in numerous clinical studies.

For further information, please contact: Pharmalink: Johan Haggblad, Managing Director, +46(0)70-668-0644 Email: johan.haggblad@pharmalink.se http://www.pharmalink.se Archimedes Pharma: Michael Clark, +44-118-931-5077 http://www.archimedespharma.com Citigate Dewe Rogerson: Chris Gardner/Nina Enegren, +44-207-638-9571
'/>"/>

SOURCE Pharmalink AB
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Pharmalink AB Receives Patent for Nefecon(R) Principle
2. Grifols Agrees to Acquire Intellectual Property for Treatment of Post-Polio Syndrome From Pharmalink AB
3. Reclast(R) Receives US FDA Approval as First and Only Once-Yearly Treatment for Women With Postmenopausal Osteoporosis
4. Indevus Receives Approvable Letter From FDA for VALSTAR(R) for Bladder Cancer Therapy
5. Auxilium Pharmaceuticals, Inc. Receives Clearance to Resume Clinical Trials for XIAFLEX(TM)
6. Abbott Receives Supplemental FDA Approval for its Best-in-Class in Sensitivity RealTime HIV-1 Viral Load Test
7. GlaxoSmithKline Receives New HHS Order for H5N1 Bulk Antigen. First North American Clinical Trials with GSKs Candidate Pre-pandemic Flu Vaccine to Start.
8. CryoCor Receives FDA Approval for Right Atrial Flutter
9. Ranbaxy Receives Approval to Manufacture and Market Hydrocodone Bitartrate and Acetaminophen Tablets USP
10. Dimericine(R) Receives FDA Fast Track Designation for Treatment Of Photosensitivity in XP Patients
11. Poniard Pharmaceuticals Receives FDA Fast Track Designation for Picoplatin for Treatment of Small Cell Lung Cancer
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/23/2016)... , June 23, 2016 Research ... "Pharmaceutical Excipients Market by Type (Organic Chemical (Sugar, Petrochemical, ... (Oral, Topical, Coating, Parenteral) - Global Forecast to 2021" ... The global pharmaceutical excipients market is ... a CAGR of 6.1% in the forecast period 2016 ...
(Date:6/23/2016)... June 23, 2016 Research and Markets ... Issue 52" report to their offering. ... treatment creates a favourable commercial environment for MedImmune to enter. ... base that will serve to drive considerable growth for effective ... serve to cap sales considerably, but development is still in ...
(Date:6/23/2016)... LONDON , June 23, 2016 ... environments  Oticon , industry leaders in ... the launch of Oticon Opn ™, the world,s ... world of possibilities for IoT devices.      ... Opn, Oticon introduces a number of ,world firsts,: ...
Breaking Medicine Technology:
(Date:6/24/2016)... ... June 24, 2016 , ... Those who have experienced traumatic events may suffer ... unhealthy avenues, such as drug or alcohol abuse, as a coping mechanism. To avoid ... healthy coping following a traumatic event. , Trauma sufferers tend to feel a range ...
(Date:6/24/2016)... ... ... Marcy was in a crisis. Her son James, eight, was out of control. Prone to ... , “When something upset him, he couldn’t control his emotions,” remembers Marcy. “If there ... my other children and say he was going to kill them. If we were ...
(Date:6/24/2016)... ... 24, 2016 , ... Global law firm Greenberg Traurig, P.A. announced that 20 ... by their peers for this recognition are considered among the top 2 percent of ... honors as members of this year’s Legal Elite Hall of Fame: Miami Shareholders ...
(Date:6/24/2016)... ... June 24, 2016 , ... Comfort Keepers® of San Diego, CA is excited ... To Recovery® program to drive cancer patients to and from their cancer treatments. ... highest quality of life and ongoing independence. Getting to and from medical treatments ...
(Date:6/24/2016)... ... June 24, 2016 , ... People across the U.S. ... magazine’s Code Talker Award, an essay contest in which patients and their families pay ... be presented at the 2016 National Society of Genetic Counselors (NSGC) Annual Education Conference ...
Breaking Medicine News(10 mins):