Sun Pharma tie-ups with Chinese Pharma Co, to develop & commercialize Psoriasis treatment drug

VADODARA (BARODA) | MUMBAI | AHMEDABAD-GANDHINAGAR | RAJKOT – In a press-release submitted to the stock exchanges in India, pharma major Sun Pharma said of entering into licensing agreement with a Chinese company for development and commercialization of treatment for psoriasis and psoriatic arthritis.

The press release submitted to the Indian Bourses by the company said that, Sun Pharmaceutical Industries Ltd. (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715, “Sun Pharma” and includes its subsidiaries and/or associate companies) today announced that one of its wholly owned subsidiaries has entered into a licensing agreement with a subsidiary of China Medical System Holdings Ltd. (CMS) for the development and commercialization of Tildrakizumab, an innovative biologic product, for psoriasis and psoriatic arthritis in Greater China (including Mainland China, Hong Kong Special Administrative Region, Macao Special Administrative Region and Taiwan).

Under terms of the license agreement, CMS will pay Sun Pharma an initial upfront payment, regulatory and sales milestone payments, and royalties on net sales, the terms of which are confidential.

CMS will be responsible for development, regulatory filings and commercialization of the product in China.

The initial tenure of the agreement shall be 15 years from the first commercial sale of Tildrakizumab in Greater China, and may be extended for additional 3 years’ subject to certain conditions defined in the agreement.

“This licensing agreement marks our entry into the Greater China market which is the second largest pharmaceutical market globally. Sun Pharma is committed to growing its dermatology franchise, with Tildrakizumab as its lead product. We continue to build our pipeline and capabilities in this important therapeutic area of significant unmet need. We are excited to be partnering with a leading pharmaceutical company like CMS to offer Tildrakizumab as an alternative treatment for psoriasis and psoriatic arthritis in Greater China,” said Dilip Shanghvi, Managing Director, Sun Pharma.

Tildrakizumab-asmn is a humanized lgG1/k monoclonal antibody designed to selectively bind to the p19 subunit of interleukin-23 (IL-23) and inhibit its interaction with the IL-23 receptor, leading to inhibition of the release of pro-inflammatory cytokines and chemokines.

It was approved by USFDA in March 2018 and is being currently marketed in the US under the ILUMYATM brand name.

It is indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

The US FDA approval was based on data from the pivotal Phase-3 reSURFACE clinical development program, which consisted of two randomized, double-blind, placebo-controlled trials of more than 1,800 patients across over 200 clinical trial sites.

Results from the Phase-3 reSURFACE 1 and 2 studies were published in The Lancet in July 2017, with primary endpoints presented at the 25th European Academy of Dermatology and Venereology (EADV) Congress.

Both Phase-3 studies met the primary efficacy endpoints, with an average of 63 percent of patients receiving Tildrakizumab 100 mg achieving 75 percent of skin clearance (Psoriasis Area Sensitivity Index or PASI 75) by week 12, and 77 percent of patients achieving 75 percent skin clearance after 28 weeks (64 percent and 80 percent in reSURFACE 1, 61 percent and 74 percent
in reSURFACE 2).

Similarly, an average of 57 percent and 66 percent of patients receiving Tildrakizumab 100 mg had a Physician’s Global Assessment (PGA) score of “clear” or “minimal” at weeks 12 and 28, respectively.

Additionally, a higher number of Tildrakizumab-treated patients achieved PASI 90 and PASI 100 compared to placebo and etanercept.

Tildrakizumab has also been approved and commercialized in Australia under the ILUMYATM brand name and in Europe under the ILUMETRITM brand name.

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