TGA Registration for Cellmid Limited's Evolis™ Hair Products
Published: Feb 16, 2012
The registration has removed a major hurdle from the commercial launch which is now planned for May 2012 in pharmacies nationally.
TGA registration is not only a validation of the clinical performance and safety of the products; it is also a key step towards a market, which has few products that can match the strong scientific and regulatory credentials of the Évolis™ range. Australian GMP manufacture in a TGA licensed facility has already commenced in preparation for the commercial launch. The Évolis™ products will not require a prescription and will be sold as over the counter medicines in individual pharmacies as well as pharmacy chains. The company has appointed a distributor with a target of making the products available for sale in up to 400 pharmacies within 12 months.
It is estimated that 40% of women and 50% of men in western countries are affected by hair loss at some stage in their life. Current hair growth products either have serious side effects or lack evidence of efficacy. The key competitive advantage for the Évolis™ range is safety combined with efficacy and as such the products represent a significant market opportunity.
Cellmid, via its wholly owned subsidiary Advangen International Pty Ltd, holds exclusive manufacturing and distribution rights for the products in Australia, USA, Europe, India and South America with significant combined sales potential. Commercial launch outside Australia is expected to commence in late 2012.
About Cellmid Limited (ASX: CDY)
Cellmid is an Australian biotechnology company developing innovative novel therapies and diagnostic tests for inflammatory diseases, heart attack and cancer. Cellmid holds the largest and most comprehensive portfolio of intellectual property related to midkine and midkine antagonists globally. The Company’s most advanced clinical development program is for the treatment of acute myocardial infarction (AMI) utilising the midkine protein. Cellmid is also developing anti-midkine antibodies for the treatment of inflammatory and autoimmune disorders. In addition, Cellmid is commercialising midkine as a biomarker for cancer diagnosis. Elevated midkine concentration in the blood and other body fluids is strongly indicative of cancer. Cellmid’s first product, the MK-ELISA, is a blood test that sensitively and accurately measures serum midkine levels.
About Advangen International Pty Ltd
Advangen International Pty Ltd is the wholly owned subsidiary of Cellmid Limited. Advangen develops and sells scientifically validated products to prevent and treat various forms of hair loss. The company’s products have well understood mechanism of action and have been extensively tested for safety and efficacy with published validation data. Advangen has two market ready product ranges, one for pharmacies (Évolis™) and one for professional hair salons (Jo-Ju™ and Lexilis™). In addition, the company is developing midkine in a high performance formulation for the treatment of age related hair loss.
About Advangen’s Products
Advangen’s products are based on using FGF-5 (Fibroblast Growth Factor 5) inhibitors to prevent hair loss, extend the growth phase of the hair cycle and activate resting follicles prompting them to grow. FGF-5 is known to cause hair to fall out and suppress hair growth. Its absence results in strong hair growth. FGF-5 has no other functions rendering its inhibitors safe. Advangen’s FGF-5 inhibitor products are plant extracts that have been tested for their ability to inhibit FGF-5 with propriety high through put assay. Several products have been developed, of which the Advangen range (Jo-Ju™ and Léxilis™) will be sold through hair salons as cosmeceuticals. The Évolis™ range has been registered by the TGA as a listed medicine and will be sold as an over the counter product in pharmacies.
Maria Halasz, CEO
T +612 9299 0311