Sun Pharma Soared Higher with Psoriasis and Dengue Achievements
Mumbai headquartered Sun Pharma break out two significant news this week. Sun Pharma made public the endpoint achievement of its plaque psoriasis drug tildrakizumab and announced its collaboration with the International Centre for Genetic Engineering and Biotechnology (ICGEB), New Delhi, for the development of botanical drug Cipa for treating dengue.
Let us take a detailed account of these Sun Pharma achievements:
Insights on Collaboration with ICGEB
To start with the botanical drug Cipa, Sun Pharma made a collaborative agreement with the ICGEB. The collaboration is for the development of a novel botanical drug, Cipa, for the treatment of dengue. As a part of this deal, Sun Pharma commits to the development of Cissampelos pariera (Cipa) in which ICGEB shall duly collaborate. Sun Pharma is obliged to undergo a drug registration process that is similar to a new chemical entity, consisting of all required in vitro, in vivo, preclinical and clinical studies meeting all regulatory standards of India and other regulatory agencies worldwide. Both the collaborating parties back up this deal firmly and highlight a need of such a drug in dengue hit tropical countries like India.
Dengue, a mosquito-borne viral disease, poses a significant global public health risk. In tropical countries such as India where periodic dengue outbreaks can be correlated to the high prevalence of the mosquito vector, circulation of all four dengue viruses (DENVs) and the high population density, a drug for dengue is being increasingly recognized as an unmet public health need. Using the knowledge of traditional Indian medicine, we explored the indigenous herbal bio-resource to identify plants with pan-DENV inhibitory activity and identified CIPA as a safe, affordable and effective solution.
Commenting on the company’s partnership with ICGEB, Mr. Kirti Ganorkar, Senior Vice President – Business Development & Portfolio Management, Sun Pharma said, “Dengue poses a significant global public health risk. In tropical countries like India where dengue outbreaks are significantly intense, a drug for dengue is recognized as an unmet public health need. Our partnership with ICGEB aims to develop Cipa as a safe, effective & affordable botanical drug for treatment of dengue”.
Sun Pharma and ICGEB divide privileges as follows:
Sun Pharma shall:
- Have an access to all the intellectual properties of this drug across 17 countries
- Pay royalties on sales per commercialization
- Establish assay systems for development of cipa for treatment of dengue infection for a predefined time period
Through this collaboration ICGEB and Sun Pharma are developing and innovating botanical opportunities to identify herbal options and exploit them as inhibitors of replication of virus in living cells.
Dr. Navin Khanna of ICGEB is the Principal Investigator (PI) for this project. This innovative botanical drug collaboration has registered itself in the botanical world and its awaited outcomes can change the way we perceive drugs.
Insights on Successful Phase III trial
Now moving on to the other big news from Sun Pharma. Sun Pharma revealed the results of its two pivotal Phase III trials that had been evaluating the efficiency and safety of the investigational IL-23p19 inhibitor antibody, tildrakizumab, for the treatment of plaque psoriasis. The drug was administered to patients with severe to moderate plaque psoriasis and the results revealed that the drug achieved primary endpoints. The set endpoints of the placebo controlled studies were:
- Proportion of the patients with Psoriasis Area Sensitivity Index 75 (PASI 75) response at week 12 compared to placebo
- Proportion of the patients with Physician’s Global Assessment (PGA) score of clear to minimal with at least 2 grade reduction from baseline at week 12 as compared to placebo.
PSAI is a measure of the redness of the psoriasis plaque, its scaling, thickness and extent of involvement of body regions. On the other hand PGA measures lesion thickness, erythema and scaling across all of the lesions to determine the disease activity on a six point scale from clear to severe.
Tildrakizumab Phase III studies were randomized and placebo controlled. There were multicentre studies designed to demonstrate and compare the efficiency of tildrakizumab and placebo in moderate to severe plaque psoriasis.
According to Sun Pharma the preparations are being processed for submission of a Biologics Licence Application to the US Food and Drug Administration (FDA). Moreover the detailed account of the results of these trials will be revealed in an upcoming scientific meeting. It is noteworthy here that sun pharma wholly owned subsidiary, acquired worldwide rights to tildrakizumab from Merck in 2015. Funded by Sun Pharma, Merck is responsible for the completion of Phase III trials in patients with mild-to-moderate plaque Psoriasis, and submission of a Biologics License Application to the FDA .
Merck is also responsible for manufacturing finished goods to support Sun Pharma’s initial product launch.
Post-approval in the US, Sun Pharma will be responsible for all other regulatory activities, including subsequent submissions, pharmacovigilance, post-approval studies, manufacturing and commercialization of the approved product.
Merck is eligible to receive milestone payments, and royalties on sales of tildrakizumab.