Smith & Nephew Launches Regranex360™ - a New Support Network for Patients
Using REGRANEX® (becaplermin) Gel, 0.01%
FORT WORTH, Texas, Oct. 8, 2013
FORT WORTH, Texas, Oct.8, 2013 /PRNewswire/ --Smith & Nephew (LSE:SN,
NYSE:SNN), the global medical technology business,today announces the
introduction of Regranex360™, a comprehensive new program to support patients
in the U.S. using REGRANEX™ Gel. REGRANEX Gel is the first and only
FDA-approved platelet-derived growth factor (PDGF) therapy indicated as an
adjunct to good ulcer care for the treatment of lower extremity diabetic
"We are very pleased to introduce the Regranex360 program as part of our
ongoing commitment to offer evidence-based biologic therapeutics along with
best-in-class provider and patient support programs to the wound care market,"
said Rob Bancroft, President of Smith & Nephew Biotherapeutics. "In
particular, we are delighted to streamline and enhance the REGRANEX Gel
patient experience with a program designed to help each individual stay on
track with their treatment."
Regranex360 is a full service online portal designed to simplify the prior
authorization and product acquisition process. In addition, to promote
compliance and adherence to REGRANEX Gel, Regranex360 provides each patient
with a care coordinator they can contact via phone throughout their entire
course of therapy.
Regranex360 is simple to use and access. Clinicians submit enrollment forms
either through Regranex360.com or via fax. Regranex360 then obtains prior
authorization approval and forwards the prescription to an appropriate
pharmacy. A patient care coordinator will contact the patient to schedule
delivery, provide education and answer any questions about treatment. Patients
can also contact the Regranex360 hotline with any questions during their
course of therapy.
Regranex360.com is available to prescribers and patients 24 hours a day, 7
days a week; the hotline, 1-888-REGRANEX (734-7263) is accessible Monday
through Friday, 8:00am to 7:00pm EST.
In addition to the Regranex360 program, Smith & Nephew Biotherapeutics has
also launched a new REGRANEX Gel Web site (www.Regranex.com) that highlights
features of the product, including clinical research, provides a dosing
calculator and offers additional tips for patients.
Important Safety Information
WARNING: INCREASED RATE OF MORTALITY SECONDARY TO MALIGNANCY
An increased rate of mortality secondary to malignancy was observed in
patients treated with three or more tubes of REGRANEX Gel in a post-marketing
retrospective cohort study. REGRANEX Gel should only be used when the benefits
can be expected to outweigh the risks. REGRANEX Gel should be used with
caution in patients with known malignancy.
Indications and usage:
REGRANEX (becaplermin) Gel, 0.01% contains becaplermin, a human
platelet-derived growth factor that is indicated for the treatment of lower
extremity diabetic neuropathic ulcers that extend into the subcutaneous tissue
or beyond and have an adequate blood supply. REGRANEX Gel is indicated as an
adjunct to, and not a substitute for, good ulcer care practices.
Limitations of use:
oThe efficacy of REGRANEX Gel has not been established for the treatment of
pressure ulcers and venous stasis ulcers
oThe effects of REGRANEX Gel on exposed joints, tendons, ligaments, and
bone have not been established in humans
oREGRANEX Gel is a non-sterile, low bioburden preserved product that should
not be used in wounds that close by primary intention
REGRANEX Gel is contraindicated in patients with known neoplasm(s) at the
site(s) of application.
In clinical trials, erythematous rashes occurred in 2% of patients treated
with REGRANEX Gel or placebo; none occurred in patients receiving good ulcer
Please see Full Prescribing Information with Boxed Warning and Important
Safety Information at www.Regranex.com.
About Smith & Nephew
Smith & Nephew is a global medical technology business dedicated to helping
improve people's lives. With leadership positions in Orthopaedic
Reconstruction, Advanced Wound Management, Sports Medicine and Trauma, Smith &
Nephew has around 11,000 employees and a presence in more than 90 countries.
Annual sales in 2012 were more than $4.1 billion. Smith & Nephew is a member
of the FTSE100 (LSE: SN, NYSE: SNN).
References: 1.REGRANEX Gel Prescribing Information.
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Contact: Media Enquiries - Christie Teller, Smith & Nephew Biotherapeutics,
817.916.2242, or 817.905.7158 Mobile; Analyst/Investor - Phil Cowdy, +44 (0)
20 7401 7646
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