Ipca has priced Diulcus 15 mg gel at Rs 1365 per pack and will soon make it available across its pan-India network of 4000 distributors.
Ipca is targeting a Rs 100 crore market within the next three years.
Ipca in-licensed the topical therapy from Pune-based NovaLead to commercialise in the Indian market. Diulcus is developed by NovaLead by repurposing an age-old beta blocker Esmolol into topical gel formulation. Esmolol was originally approved to treat rapid heart rate.
As part of the licensing agreement, Ipca has agreed to pay Rs 13 crore upfront as licensing fee to NovaLead, and has agreed to pay royalties on sales and other milestone linked payments.
Ipca says Diulcus has to be used 3-6 months to be effective against healing the wounds. Diulcus was approved by Indian drug regulatory following phase-3 clinical trials demonstrating 60.3% ulcer closure rate within three months of treatment, patients continued to show an ulcer closure rate of 77.20% over six months, even after stopping treatment at three months.Currently the standard of care for the DFU is removal of dead skin and tissue, exudate control, dressing and control blood sugar levels.DFU is an open sore or wound that occurs in around 15% of patients with diabetes, and is responsible for a large number lower limb amputations.
As per the ICMR-INDIAB (2023) study, 10 crore people in India suffer from diabetes, with an additional 13.6 crore people affected by pre-diabetes, making a large number of people vulnerable to difficult to treat disease. Patients with DFUs have high mortality with 5-year mortality (46%).
“The approval of this patented repurposed drug is significant because DFU is the leading cause for lower limb amputations globally,” said Premchand Godha, executive chairman of Ipca.
“The (launch) demonstrates Ipca’s commitment towards the patients suffering from unmet medical need and its focus on diabetes therapy,” Godha said.
