January 12, 2016 1:59pm

A Managed Access Program (MAP) in select countries across Europe, the Middle East, and Africa for patients with impaired hand functions due to scleroderma - BUY

 

A MAP will allow CYTX, upon completion of the statutory legal and regulatory requirements, to offer patients and their healthcare provider’s access to Cytori Cell Therapy ™, known as ECCS-50 … in advance … of the product’s full marketing authorization in their respective countries.

 

ECCS-50 is an autologous, adipose-derived cell therapy produced at the patient’s bedside and administered via a series of hand injections, in a single same-day procedure. ECCS-50 is an investigational product currently in P3 clinical trials in the U.S. and France.

  • Managed Access Programs provide companies with a way to allow ethical access to their pre-license/unlicensed medicines to help patients with unmet medical needs;
  • Access is provided in response to physician requests in a fully compliant manner, where no alternative treatment options are available;
  • The source of medicine funding varies and may include the hospital’s budget or country’s sickness fund or social security system.

 

The Bottom Line: European regulations allow patient’s access to innovative therapies under development in … certain situations, and given the safety profile and promising data thus far for ECCS-50 for patients with scleroderma of the hand.  Patients with this rare and debilitating condition have limited treatment options as there are currently NO … approved products available for impaired hand function due to scleroderma.

By partnering with IDIS in the design and implementation of Managed Access Programs, CYTX now offers a new choice of treatment for these patients

 

CYTX closed at $0.17 and is DOWN -$0.01. A BUY as the MAP also provides an initial penetration of these geographic areas for … reimbursement – thus, with a STRONG revenue component to off-set development costs to a potential break-even opportunity.

 

Idis has significant experience and expertise in the rare and orphan disease space, having managed early access to over 70 investigational rare disease drugs, across 130 countries, worldwide. Further, Idis involvement with the EURORDIS Round Table of Companies, CheckOrphan, and the Global Genes Project ensures Idis provides a strong platform to provide appropriate access.