Sun Pharma Advanced Research Adopts 'Higher-Risk Approach': Morgan Stanley
For SPARC, 79% of the portfolio contribution is from new chemical entities which have a high risk of failure.
Sun Pharma Advanced Research Co. is adopting a "higher-risk" approach to build its product pipeline, according to Morgan Stanley.
The company is targeting neuro-degenerative diseases, cancer, auto-immune disorders and ophthalmology therapy areas, the research firm said in a note, citing updates on clinical studies and new drug filings provided by the company at its annual conference on Oct. 13.
SPARC, spun off from Sun Pharmaceutical Industries Ltd. in 2007, is working on five new drug delivery systems and four new chemical entity compounds.
For SPARC, 79% of the portfolio contribution is from new chemical entities. These are known to have a high risk of failure in the development process and results in huge expenditure.
Morgan Stanley expects the five NDDS molecules to be in the market by FY25, subject to regulatory approvals. The management also provided tentative timelines for clinical studies or new drug application filings for its NCEs.
Here are the key highlights from Morgan Stanley's update on SPARC's pipeline:
SPARC has changed its business strategy to a higher-risk approach to build its product pipeline.
Among its portfolio, 43% has 'best-in-class' and 57% has 'first-in-class' positioning.
It is focusing on new chemical entities which consist of 79% of its portfolio, biologics with 14%, and complex modalities with 7%.
Key therapeutic areas include neuro-degenerative diseases, cancer, auto-immune disorders and ophthalmology.
Company expects about $93 million (Rs 766 crore) in cash inflow from warrant conversion by December 2022.
Given its cash spend projection of $90 million (Rs 742 crore) in the ensuing six quarters, this gives it a cash runway until FY24.
NDDS Product Pipeline
Out of five products, two—Elepsia XR and Xelpros—have been approved.
Elepsia XR is out-licensed to Tripoint Therapeutics and commercialisation commenced in 2021 with 40 medical representatives.
According to SPARC's website, Xelpros is licensed and commercialised in the U.S. market by a subsidiary of Sun Pharma.
In two ophthalmology filings for FY23, SPARC is partnered with Visiox Pharma for commercialisation.
The filing for the fifth compound—phenobarbital (Sezaby) for the treatment of neonatal seizures in ICU settings—has been submitted and the review date is November 2022.
Assuming one to two years of approval time, all five of these compounds could be in the market by FY25, subject to regulatory approval, Morgan Stanley said citing the company's update.
NCE Pipeline
SPARC has four key compounds/indications in clinical studies:
Vodobatinib CML is the lead compound, with phase III pivotal study readout expected in FY24.
Vodobatinib PD and LBD—proof of concept readout in FY24. POC refers to the earliest point in the drug development process at which the weight of evidence suggests that it is 'reasonably likely' that the key attributes for success are present and the key causes of failure are absent.
Vibozilimod, licensed to Sun Pharma—phase II POC study ongoing.
SCO-120—phase II study initiation in FY24, targeted filing submission in FY27.
SPARC disclosed SBO-154 as its first biologic (mAb-oncology: monoclonal antibodies used to treat cancer) in-licensed from Biomodifying. Investigational new drug application filing is targeted for FY24.