Pharma major Sun Pharmaceutical Industries on Wednesday announced that it has entered into an exclusive worldwide licensing agreement with the US-based Merck & Co (known as MSD outside the US and Canada) for the latter's investigational therapeutic antibody candidate tildrakizumab, used for treating chronic plaque psoriasis, a skin ailment.
The drug is currently in the Phase 3 registration trials and the estimated primary completion date is June 2015.
Under the terms of the agreement, Sun Pharma will acquire worldwide rights to use tildrakizumab in all human indications from Merck in exchange for an upfront payment of $80 million. Merck will continue all clinical development and regulatory activities, which will be funded by Sun Pharma.
Following the product approval, Sun Pharma will be responsible for regulatory activities, including subsequent submissions, pharmacovigilance, post approval studies, manufacturing and commercialisation of the approved product.
Merck is eligible to receive undisclosed payments associated with regulatory (including product approval) and sales milestones, as well as tiered royalties ranging from mid-single digit through teen percentage (that is, from about 5% to 19%) rates on sales.
According to a website of US National Institutes of Health, ClinicalTrials.gov, a 64-week, parallel design study to evaluate the efficacy and safety of subcutaneous tildrakizumab, was started in December 2012 and the estimated primary completion date is given as June 2015, which is the final data collection date for primary outcome measure. The estimated study completion date is given as August 2019, as per ClinicalTrials.gov website.
Kirti Ganorkar, senior vice president, business development, Sun Pharma, said in a release, "This collaboration is a part of our strategy towards building our pipeline of innovative dermatology products in a market with strong growth potential." The transaction is subject to customary closing conditions, including the requirements under the Hart Scott-Rodino Antitrust Improvements Act.
Iain D Dukes, Ph.D., senior vice president, business development and licensing, Merck Research Laboratories, said in the release, "Consistent with our previously announced global initiative to sharpen our commercial and R&D focus, including prioritizing our late stage pipeline candidates, we are pleased to enter into this agreement with Sun Pharma to help realise the potential of tildrakizumab for patients with chronic plaque psoriasis."
Ranjit Kapadia, senior VP – pharma, Centrum Broking, said, "The advantage will not be anytime soon and will only come through once the drug is commercialised. This is a long-term development though Sun has to pay $80 million (about Rs 490 crore) upfront to Merck. But then the benefit is going to accrue after 2019. When the drug will be commercialised, we have to see what would be the market size of the drug."
"Also, which are the other products available then in the market and what is the additional advantage this drug would offer over and above the existing molecules. It is also to see whether Sun would be eligible for any premium or not. If there is no therapy available, then Sun Pharma can get any amount of premium, but if there is therapy available and there are some alternate to that, then the premium would be lower. This is a patented product which would be launched in 2019 and Sun would enjoy the patent benefit for at least 10-12 years. The dermatology market is a big market and this would be a good opportunity for the company," he said.
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