New licence Agreement: An opportunity to breathe new air into COPD in Australia
13 October 2010
iNova Pharmaceuticals (“iNova”), a growing company in the Asia-Pacific and South Africa region that markets prescription and over the counter medicines, has acquired exclusive Australian rights to a new therapy option, which will complement existing treatments for chronic obstructive pulmonary disease (COPD).
Under the licence and supply Agreement with Edmond Pharma S.r.l. in Italy, iNova will be responsible for the registration, marketing and distribution of Erdosteine mucolytic capsules.
The Agreement follows approval and marketing of Erdosteine in Europe, Asia and South America where it is used in the treatment of chronic and acute respiratory diseases. An original molecule fully developed and patented by Edmond Pharma, Erdosteine is marketed in more than 40 countries.
Erdosteine has been studied in clinical trials for the symptomatic treatment of adult COPD. Preliminary published results also suggest the drug may have a role to play in the long term treatment of COPD for which there is a clinical need to minimise the number of exacerbations and help preserve lung function.
A thiol compound that modulates mucus production and viscosity, in vitro and in vivo evidence shows Erdosteine can improve the rheological (flow) properties of sputum and reduce sputum volume. Erdosteine is also thought to reduce bacterial adhesiveness and to have anti-inflammatory and anti-oxidant properties.
iNova expects to file for registration of Erdosteine in Australia before results from the RESTORE study are available. This is a Phase III study assessing the 12 month efficacy and safety of Erdosteine in adults with moderate to severe COPD, which is currently enrolling patients in 7 EU countries.
COPD is the third leading cause of disease burden in Australia. Up to 1 in 5 people over 40 years of age are affected, while annual direct costs of the condition are estimated to exceed $900 million.
Andrew Howden, iNova CEO, said “Our strategic focus is to create patient value with a strong pipeline of products, including a growing portfolio of respiratory medicines. We are delighted to have a new partnership with Edmond Pharma for a new therapy option in managing a serious respiratory condition.”
"Edmond Pharma, has a long-standing commitment to the health of patients suffering from respiratory diseases worldwide," said dr.Mario Arbasino, President Edmond Pharma S.r.l. "The agreement with iNova, confirms our significant commitment and represents an important progress in our geographical expansion strategy increasing the availability of Erdosteine to 45 Countries worldwide"
Chris van Niekerk, iNova COO, said, “Erdosteine is expected to make an important contribution to our broad range of respiratory products and so we look forward to the successful completion of the RESTORE study to assist the commercialisation process.”
“As we progress the registration and commercialisation of Erdosteine, iNova looks forward to further opportunities with companies looking for a partner with well established business development, registration and marketing capabilities to commercialise their healthcare products in the regions we cover.”
For further information contact: Chris van Niekerk +61 (0) 438 231 812