Taclantis (paclitaxel injection concentrate for nanodispersion) / Sun Pharma Advanced Research Company - LARVOL DELTA

Development of Paclitaxel Injection Concentrate for Nanodispersion. (PubMed, AAPS PharmSciTech) - "The stability of the reconstituted nanodispersion did not show any change in physicochemical quality attributes over 24 h. These results not only validate our hypothesis of paclitaxel self-assembly driven in the presence of selected lipid and polymers reported in previous paper but also demonstrates that a convenient, scalable and stable protein-free alternative to existing paclitaxel formulations is offered for clinical use."

Journal

Antitumor Efficacy of Paclitaxel Injection Concentrate for Nanodispersion in Patient-Derived Breast, Head and Neck, and Non-Small Cell Lung Cancer Mouse Xenografts. (PubMed, AAPS PharmSciTech) - "However, in one tumor model (HNXF 1838) PICN 50 mg/kg (1/2 MTD) showed a slight benefit over the same dose of nab-paclitaxel. The nanoparticulate nature of PICN and nab-paclitaxel therefore seems to enhance tumor cell penetration compared to conventional paclitaxel, resulting in better antitumor efficacy."

Journal • Preclinical • Breast Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Transplantation

A Novel Self-Assembled Paclitaxel Nanodispersion Facilitates Rapid In-Vitro/In-Vivo Dissociation and Protein Binding. (PubMed, AAPS PharmSciTech) - "The results present a novel formulation design that forms sponge-like coacervate nanoparticle due to complimentary interactions of the excipients that otherwise are unable to self-assemble under similar conditions of dilution. This alternative formulation solves the limitations of currently marketed PtX products and can provide its effective delivery in clinical settings."

Journal • Preclinical

Phase I/II study of LDE225 in combination with gemcitabine and nab-paclitaxel in patients with metastatic pancreatic cancer (ESMO 2019) - P1/2; "This study shows that LDE225 in combination with gemcitabine and nab-paclitaxel is well-tolerated in patients with metastatic pancreatic cancer and has promising efficacy. Clinical trial identification: NCT02358161. Legal entity responsible for the study: J.W. Wilmink."

Clinical • Combination therapy • P1/2 data • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor

SPARC declines after USFDA denies application for cancer drug (Business Standard) - “Sun Pharma Advanced Research Company (SPARC) skids 2.21% to Rs 170 after the company said that the US drug regulator has ruled against its appeal related to Taclantis, its under-development product for the treatment of breast cancer. The Office of New Drugs (OND) of the U.S. Food and Drug Administration (USFDA) has denied the company's appeal of the Complete Response Letter in relation to the New Drug Application (NDA) for Taclantis…In its Appeal Denied letter, the OND requested the conductofa new Phase 3 study in metastatic breast cancer patients to support any potential re-submission of the Taclantis NDA. The company will review FDA's response and decide on appropriate next steps soon.”

FDA event • NDA • Breast Cancer • Oncology

"SPARC receives complete response letter from @US_FDA for Taclantis; @US_FDA sets a review date for @SunPharma_Live's Taclantis application in Feb 2020, learns @ekta_batra" (@CNBCTV18News)

Clinical • FDA event

SPARC slides after Abraxis' complaint in the US (Business Standard) - "The stock slid 2.14% to Rs 150.90 after Abraxis Biosciences LLC filed a complaint against the Indian company in the US District Court (New Jersey)....Sun Pharma Advanced Research Company (SPARC) announced that a complaint has been filed by Abraxis Biosciences LLC in the U.S. District Court for the District of New Jersey, which alleges that SPARC's filing of new drug application (NDA) for Taclantis injection (paclitaxel injection concentrate for suspension) is an act of infringement of the orange book listed patents for Abraxane."

Commercial • Patent

SPARC gains on acceptance of NDA by USFDA (Dalal Street Investment Journal) - "Sun Pharma Advanced Research Company (SPARC) informed the bourses that USFDA has accepted the company’s New Drug Application (NDA) for Taclanti (Paclitaxel Injection Concentrate for Suspension)....Paclitaxel is one of the most widely used cytotoxic agents and is approved for the treatment of Breast cancer, Ovarian cancer, Non-Small Cell Lung cancer and Pancreatic cancer."

NDA

ORIN1001 in Patients With Advanced Solid Tumors and Relapsed Refractory Metastatic Breast Cancer (clinicaltrials.gov) - P1; N=150; Not yet recruiting; Sponsor: Shanghai Fosun Pharmaceutical Development Co, Ltd.

Clinical • New P1 trial