Sun Pharma Advanced Research Company Ltd. — Regulatory Filings 2021

Dec 10, 2021

SPARC/Sec/SE/2021-22/77

December 10, 2021

National Stock Exchange of India Ltd., Exchange Plaza, 5th Floor, Plot No. C/1, G Block, Bandra Kurla Complex, Bandra (East), Mumbai – 400 051.

BSE Limited, Market Operations Dept. P. J. Towers, Dalal Street, Mumbai - 400 001.

Ref: Scrip Code: NSE: SPARC; BSE: 532872

Dear Sir/Madam,

Sub: Corrigendum to the Press Release titled – “SPARC to present updated clinical data of vodobatinib (SCO-088) at the 63rd ASH annual meeting”

We had submitted the Press Release vide our letter dated December 10, 2021 bearing reference no. SPARC/Sec/SE/2021-22/76, however we have observed two minor corrections which are detailed hereunder:

On Page 1, Para 2, Line 5, the word “in” was missing which has now been inserted to read the sentence as under:

“Similar anti-leukemic activity (major cytogenetic response ≥60%) was observed in CML-CP patients with or without prior ponatinib treatment.”

On Page 2, under the heading “About Vodobatinib (SCO-088)”, Line 4, the term EMA was inadvertently mentioned as EMEA. The same has now been corrected to read the sentence as under:

“Vodobatinib has been granted Orphan Drug Designation for treatment of CML patients by USFDA and EMA .”

Pursuant to Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015, we enclose herewith the revised Press Release, which we shall be releasing after sending this letter to you.

This is for your information and dissemination.

Yours faithfully,

For Sun Pharma Advanced Research Company Ltd.

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Dinesh Lahoti Company Secretary and Compliance Officer ICSI Membership No. A22471 Encl: As above

FOR IMMEDIATE RELEASE

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SPARC to present updated clinical data of vodobatinib (SCO-088) at the 63rd ASH annual meeting

MUMBAI – December 10, 2021 , Sun Pharma Advanced Research Company Ltd. (SPARC) (Reuters: SPRC.BO, Bloomberg: SPADV IN, NSE: SPARC, BSE: 532872), announced today that an abstract on updated safety and efficacy outcomes of vodobatinib in refractory chronic myeloid leukemia (CML) subjects has been selected for oral presentation at the 63rd American Society of Hematology (ASH) Annual Meeting. The Phase 1 study outcomes will be presented by Prof. Jorge Cortes, the Principal Investigator for the study, on Saturday, 11 Dec 2021. Results from the ongoing vodobatinib clinical study are being presented for the second consecutive year at the ASH annual meeting, underlining the promising potential of vodobatinib for the treatment of heavily pre-treated CML.

Vodobatinib is a novel, third generation, selective BCR-Abl1 tyrosine kinase inhibitor (TKI) developed by SPARC for the treatment of patients with CML who are resistant or intolerant to ≥3 TKIs or ineligible for TKIs. Majority of the CML patients enrolled in the Phase 1 study had failed ≥3 TKIs. Similar anti-leukemic activity (major cytogenetic response ≥60%) was observed in CML-CP patients with or without prior ponatinib treatment. The current abstract provides longer term safety and efficacy updates to vodobatinib therapy. Vodobatinib has been granted Orphan Drug Designation for treatment of CML patients by USFDA and EMA. A Phase 2 study has been initiated and is recruiting globally.

“We look forward to presenting the data from the vodobatinib study at the 2021 ASH annual meeting. We are very encouraged by the anti-leukemic activity and safety profile of vodobatinib,” said Siu-Long Yao, Executive Vice President, Clinical Development and Operations of SPARC.

Details of the oral presentation are as follows:

An update of safety and efficacy results from Phase 1 dose-escalation and expansion study of Vodobatinib, a novel oral BCR-ABL1 Tyrosine Kinase Inhibitor (TKI), in patients with Chronic Myeloid Leukemia (CML) and Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ ALL) failing prior TKI therapies

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Abstract: 152548

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Date and Time: Saturday, 11 December, 2021, 4:30 PM EST

Session: 632. Chronic Myeloid Leukemia: Clinical and Epidemiological: Mechanisms of resistance and expanded therapies

Presenter: Prof Jorge Cortes, M.D.

Room: Georgia World Congress Center B304-B305

About CML:

Chronic Myeloid Leukemia (CML) is a myeloproliferative neoplasm that accounts for approximately 15% of newly diagnosed cases of leukemia in adults. Central to the pathogenesis of CML is the fusion of the Abelson murine leukemia (ABL1) gene on chromosome 9 with the Breakpoint Cluster Region (BCR) gene on chromosome 22. This rearrangement is known as the Philadelphia chromosome[1] . The American Cancer Society estimated that in the United States in 2018 there were about 8,430 new cases of CML (4,980 in men and 3,450 in women) and about 1,090 deaths due to CML (620 men and 470 women)[2] .

About Vodobatinib (SCO-088):

Vodobatinib is an investigational and selective BCR–Abl1 kinase inhibitor intended for the treatment of resistant Chronic Myeloid Leukemia (CML), including CML harboring BCR-Abl1 mutations[3] . Vodobatinib has been granted Orphan Drug Designation for treatment of CML patients by USFDA and EMA.

About SPARC (CIN: L73100GJ2006PLC047837):

Sun Pharma Advanced Research Company Ltd. (SPARC) is a pharmaceutical company focused on continuously improving standards of care for patients globally through innovation in therapeutics and delivery. SPARC consistently aims to lower costs and improve operational efficiencies to advance availability and affordability of cures for patients across the world. More information about the company can be found at www.sparc.life.

Disclaimer:

Statements in this document describing the Company’s objectives, projections, estimates, expectations, plans or predictions or industry conditions or events may be “forward looking statements” within the meaning of applicable securities laws and regulations. Actual results, performance or achievements could differ materially from those expressed or implied.

Media Contact:

Jaydeep Issrani Tel +91 22 66455645, Ext: 5787 Tel Direct +91 22 6645 5787 Mobile +91-9820216916 E-mail jaydeep.issrani@sparcmail.com

®, TM - All brand names and trademarks are the property of respective owners.

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Reference

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1. Elias Jabbour, Hagop Kantarjian; Am J Hematol. 2018;93:442–459.

2. American Cancer Society. Cancer Facts & Figures 2018 [https://www.cancer.org/content/dam/cancerorg/research/cancer-facts-and-statistics/annual-cancer-facts-and-figures/2018/cancer-facts-andfigures-2018.pdf.]

3. Antelope O, et al., Exp Hematol. 2019 Sep;77:36-40.e2

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