Viswanath Pilla Moneycontrol News Sun Pharmaceutical Industries, India’s largest drug maker, Wednesday said it got US FDA approval for its much awaited psoriasis drug Ilumya.
Ilumya generically called as tildrakizumab-asmn falls in the category of specialty drugs - medications that treat complex or rare diseases such as cancer, autoimmune disorders, skin conditions among others.
Ilumya approval is a major breakthrough for Sun Pharma which is betting big on specialty drugs to stay ahead of generic rivals in the highly competitive US generics market, where the company sales are on a declining trend.
Specialty drugs are protected by patents and allow drug makers to set prices, but companies have to invest heavily on research & development and front end sales presence in the US.
Ilumya is used for the treatment of the most common plaque psoriasis – a chronic immune disease that appears on the skin.
“With the approval of Ilumya and our long-standing commitment in dermatology, we are focused on making a difference for people living with moderate-to-severe plaque psoriasis,” said Abhay Gandhi, President and Chief Executive Officer, North America of Sun Pharma in a press release.
“We are committed to working with all relevant stakeholders to make Ilumya available to appropriate people with plaque psoriasis,” Gandhi said.
The company didn’t disclose details such as timing of the launch or the peak sales potential of the drug.
In the third quarter earnings call – Dilip Shanghvi, Managing Director of Sun Pharma said the drug would take “anywhere between 2.5 years to 3” to achieve the peak sale potential.
Shanghvi said the initial supplies for market will also come from Merck till the company relocates manufacturing to Samsung Biologics.
“For the purpose of the marketing as well as promotion of the product, it is a Sun product post approval,” Shanghvi said.
Sun Pharma’s management said it has started hiring sales reps and putting in place the marketing infrastructure needed to sell the drug.
Analysts expect the company to launch the drug in next three months with a peak sale potential of USD 300 million.
“The peak sale potential of the drug is around USD 300 million, and may take around 3 to 3.5 year to reach that mark,” said Amey Chalke, Research Analyst at HDFC Securities.
Chalke said the approval will lead to Rs 15-20 increase of the per-share net present value (NPV).
“Sun continues to expand its specialty salesforce in the US, in anticipation of the launches. Hence, margin accretion would be limited till the specialty business achieves critical mass in 3-4 years,” said IIFL in its recent report on Sun Pharma.
Sun Pharma acquired rights for Tildrakizumab from US drug maker Merck in 2014 for USD 80 million.
While Merck was responsible for completion of phase-3 clinical trial and submission of biologics license application (BLA) to US FDA, Sun Pharma will be responsible for all other regulatory activities, including subsequent submissions, pharmacovigilance, post approval studies, manufacturing and commercialization of the approved product.
Applications for Tildrakizumab were accepted for review by the US FDA in May and by the European Medicines Agency in March this year.
USFDA accepted the BLA in May last year.
For the European market, Sun Pharma signed a licensing agreement with Almirall S.A. in July 2016 for development and commercialisation of Tildrakizumab. The drug in under review by Europe Medicines Agency (EMA).
The Europe approval is expected to come by end of this year.
The announcement came after market hours.
Shares of Sun Pharma declined 0.82 percent to close at Rs 504.70, while the benchmark Sensex gained 0.42 percent to end 33,136.18 points.
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