Innovation in bone healing and tissue repair
20 Oct 16
Kuros Biosciences’ KUR-112 Receives Rare Pediatric Disease Designation

Schlieren (Zurich), Switzerland, October 20, 2016

Kuros Biosciences’ KUR-112 Receives Rare Pediatric Disease Designation

Kuros Biosciences announced today that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation to KUR-112, an investigational product candidate for the treatment of Solitary Bone Cysts (SBC).

SBCs are non-malignant fluid-filled cavities found primarily in the long bones of children. In severe cases, bone cysts may lead to pathological fractures. Currently used methods for the management of SBCs (bone grafting, intra-lesion corticosteroid injections and bone marrow injections) require multiple applications and show only limited efficacy. Hence, there is a clear need for a simple effective treatment of SBCs. It is estimated that there is an incidence of less than 1 case per 10,000 of the general population per year in Europe and the US, and the vast majority of these are pediatric.

KUR-112 is a parathyroid hormone-fibrin-based product. It is intended to be applied as a single percutaneous injection into SBCs and could therefore become a simpler, minimally invasive treatment for this condition.

 

Under the FDA’s Rare Pediatric Disease Priority Review Voucher program, a sponsor who receives approval of a new drug application or biologics license application for a rare pediatric disease is eligible for a voucher. This voucher can be redeemed to obtain priority review for any subsequent marketing application and may be sold or transferred to other companies or organizations. This voucher program is due to expire on 31 December 2016 and it is not certain the program will be renewed.

 

KUR-112 has already obtained Orphan Drug Designation by the FDA and the European Medicines Agency (EMA), which entitles the sponsor of the drug to receive assistance in the development process, exemption from application fees and several years of marketing exclusivity following approval. The sponsor may also be eligible for grant funding and significant tax credits.

 

Didier Cowling, Chief Executive Officer of Kuros, commented: “We are very pleased to have received this Rare Pediatric Disease Designation, which builds on the Orphan Drug Designation granted to KUR-112 by the FDA and the EMA previously. We will now carefully consider development options for KUR-112.”



Kuros Biosciences AG
Wagistrasse 25, 8952 Schlieren, Switzerland
Tel: +41 44 733 47 47   Fax: +41 44 733 47 40   Email: info@kuros.ch

About Kuros

  1. Overview
  2. Management
  3. Board

Products

  1. Pipeline
  2. Orthobiologics
    Fracture repair
    KUR-111
    KUR-113
    MagnetOs
    Spinal fusion
    KUR-113
    MagnetOs
    Solitary Bone Cysts
    KUR-112
  3. Sealants
    Neuroseal (KUR-023)

Technologies

  1. Overview
  2. Surface Science Technology
  3. Synthetic Cross-Linking Technology
  4. Fibrin-Based
  5. Immune Modulation
  6. Publications

Partnerships

  1. Collaborations
  2. Business development

Investors

  1. Share price
  2. Regulatory filings
  3. Reports & presentations
  4. Calendar
  5. Corporate governance
  6. Stay informed

News

  1. Press releases
  2. Conferences & Events

Contact

  1. Location
Article
20 Oct 16
Kuros Biosciences’ KUR-112 Receives Rare Pediatric Disease Designation

Schlieren (Zurich), Switzerland, October 20, 2016

Kuros Biosciences’ KUR-112 Receives Rare Pediatric Disease Designation

Kuros Biosciences announced today that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation to KUR-112, an investigational product candidate for the treatment of Solitary Bone Cysts (SBC).

SBCs are non-malignant fluid-filled cavities found primarily in the long bones of children. In severe cases, bone cysts may lead to pathological fractures. Currently used methods for the management of SBCs (bone grafting, intra-lesion corticosteroid injections and bone marrow injections) require multiple applications and show only limited efficacy. Hence, there is a clear need for a simple effective treatment of SBCs. It is estimated that there is an incidence of less than 1 case per 10,000 of the general population per year in Europe and the US, and the vast majority of these are pediatric.

KUR-112 is a parathyroid hormone-fibrin-based product. It is intended to be applied as a single percutaneous injection into SBCs and could therefore become a simpler, minimally invasive treatment for this condition.

 

Under the FDA’s Rare Pediatric Disease Priority Review Voucher program, a sponsor who receives approval of a new drug application or biologics license application for a rare pediatric disease is eligible for a voucher. This voucher can be redeemed to obtain priority review for any subsequent marketing application and may be sold or transferred to other companies or organizations. This voucher program is due to expire on 31 December 2016 and it is not certain the program will be renewed.

 

KUR-112 has already obtained Orphan Drug Designation by the FDA and the European Medicines Agency (EMA), which entitles the sponsor of the drug to receive assistance in the development process, exemption from application fees and several years of marketing exclusivity following approval. The sponsor may also be eligible for grant funding and significant tax credits.

 

Didier Cowling, Chief Executive Officer of Kuros, commented: “We are very pleased to have received this Rare Pediatric Disease Designation, which builds on the Orphan Drug Designation granted to KUR-112 by the FDA and the EMA previously. We will now carefully consider development options for KUR-112.”