Aloxi (palonosetron oral) / Fosun Pharma, Helsinn, Otsuka, Roche, Eisai, Knight Therap, Immedica - LARVOL DELTA

Helsinn Group and ESTEVE sign a partnership agreement renewal to commercialize AKYNZEO and ALOXI in Germany (GlobeNewswire) - "Helsinn Group...and ESTEVE...announced the signing of the Distribution and Licence Agreement renewal in Germany for AKYNZEO (combination of netupitant-palonosetron) and ALOXI (palonosetron) for the treatment of chemotherapy-induced nausea and vomiting (CINV) in adult patients."

Licensing / partnership • Chemotherapy-Induced Nausea and Vomiting

PhaRmacogEnomiC medIcines optimiSatIon for peOple with caNcer – a multicentre teletrial enabled Interrupted Time Series trial (PRECISION-ITS): Pharmacogenomics primary study and discovery program (ANZCTR) - P=N/A | N=1470 | Recruiting | Sponsor: Peter MacCallum Cancer Centre | Not yet recruiting ➔ Recruiting | Initiation date: Jul 2024

Biomarker • Enrollment open • Trial initiation date • Breast Cancer • Colorectal Cancer • Head and Neck Cancer • Oncology

PhaRmacogEnomiC medIcines optimiSatIon for peOple with caNcer – a multicentre teletrial enabled Interrupted Time Series trial (PRECISION-ITS): Pharmacogenomics primary study and discovery program (ANZCTR) - P=N/A | N=1470 | Not yet recruiting | Sponsor: Peter MacCallum Cancer Centre

New trial • Breast Cancer • Colorectal Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Oncology

Efficacy and Safety of Intravenous Versus Oral 5-HT3 Antagonists Combined With NK-1 Receptor Antagonists for the Prevention of CINV in Breast Cancer (clinicaltrials.gov) - P4 | N=1028 | Not yet recruiting | Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

New P4 trial • Breast Cancer • Chemotherapy-Induced Nausea and Vomiting • Oncology • Solid Tumor

PHASE 3 EFFICACY AND SAFETY STUDY OF PALONOSETRON IV INFUSION VERSUS IV BOLUS FOR CHEMOTHERAPY-INDUCED NAUSEA AND VOMITING (CINV) PROPHYLAXIS FOLLOWING HIGHLY EMETOGENIC CHEMOTHERAPY (HEC) (MASCC-ISOO 2017) - P3; "...Currently administered as a 30-sec IV bolus, palonosetron is the preferred 5-HT3RA for MEC in ASCO and NCCN antiemetic guidelines, and in MASCC/ESMO guidelines for anthracycline-cyclophosphamide (AC) regimens when a neurokinin-1 (NK1)–RA is not available. This study was conducted in the context of developing the IV formulation for the netupitant (NK1RA) and palonosetron fixed combination (NEPA), currently available as an oral formulation...Phase 3, multinational, randomized (1:1) double-blind study in 440 chemotherapy-naive patients with solid tumors (NCT02557035) comparing efficacy/safety of 0.25-mg palonosetron 30-min IV infusion vs 30-sec IV bolus, 30 min before HEC (excluding AC), along with oral dexamethasone (20 mg [day 1]; 8 mg twice-daily [days 2–4])...Palonosetron IV infusion was non-inferior to IV bolus in acute CINV prevention after HEC. Safety profiles were similar."

Clinical • Head-to-Head • P3 data • Biosimilar • Oncology

A randomized, double-blind, placebo-controlled study of the safety and efficacy of olanzapine for the prevention of chemotherapy-induced nausea and vomiting in patients receiving moderately emetogenic chemotherapy. (ASCO 2017) - P2; "Olanzapine in addition to palonosetron and dexamethasone significantly improved the management of emesis and QOL among previously untreated patients receiving MEC, although the efficacy was limited to reduce the frequency of CINV."

Clinical • HEOR • Biosimilar • Oncology

Phase 3 safety evaluation of an intravenous formulation of NEPA, a novel fixed antiemetic combination of fosnetupitant and palonosetron (ESMO 2017) - P3; "...A single oral NEPA capsule plus dexamethasone (DEX) given prior to AC and non-AC highly emetogenic chemotherapy (HEC) showed superior prevention of chemotherapy-induced nausea and vomiting (CINV) over PALO plus DEX for 5 days post-chemotherapy; the safety of NEPA was also well-established in the Phase 2/3 clinical program in 1442 NEPA-treated patients...Cisplatin was the most frequent HEC (96% of patients) and lung cancer was most common (55% of patients)...Intravenous NEPA was shown to be safe and well-tolerated with a similar safety profile to oral NEPA in patients with various solid tumors receiving HEC."

Clinical • P3 data • Lung Cancer

Helsinn and Immedica enter exclusive partnership for commercialisation of cancer supportive care products in core European markets (GlobeNewswire) - "Helsinn Group...and Immedica Pharma AB...announce that the companies have entered an exclusive long-term license and distribution agreement for the commercialisation of two cancer supportive care products indicated for the prevention of chemotherapy-induced nausea and vomiting (CINV) in core European markets: AKYNZEO® (Netupitant-Palonosetron fixed combination) and ALOXI® (Palonosetron). Under the licence and distribution agreement Immedica will commercialise AKYNZEO® in Portugal, Spain, France, Switzerland, the Netherlands, Belgium, Luxembourg and Liechtenstein, ALOXI® in Switzerland, Belgium, Liechtenstein."

Licensing / partnership • Chemotherapy-Induced Nausea and Vomiting • Oncology

Knight Therapeutics and Helsinn Healthcare SA Enter into Exclusive License, Distribution, and Supply Agreement for Akynzeo and Aloxi (GlobeNewswire) - "Knight Therapeutics Inc....and Helsinn Healthcare SA...announced that Knight, through one of its wholly-owned subsidiaries, and Helsinn have entered into an exclusive license, distribution and supply agreement for AKYNZEO® oral/IV (netupitant/palonosetron / fosnetupitant/palonosetron) in Canada, Brazil, Argentina, Uruguay and Paraguay, and ALOXI® oral/IV (palonosetron) in Canada....Under the terms of the agreement, Knight shall have the exclusive right to distribute, promote, market and sell the Products in the licensed territories. Knight will begin commercial activities following a transition period from Helsinn’s current licensees."

Licensing / partnership • Oncology

Helsinn and Fosun Pharma sign exclusive license and distribution agreements for Aloxi Akynzeo oral, NEPA IV and anamorelin in Mainland China, Hong Kong SAR and Macau SAR (GlobeNewswire) - “Helsinn Group (‘Helsinn’)…announced today the signing of exclusive license and distribution agreements effective from October 1st 2021 in the territory of Mainland China for Aloxi®, Akynzeo® and anamorelin. Under the terms of the agreements, Helsinn will grant Fosun Pharmaceutical A.G. an exclusive license to distribute, promote, market, and sell the following products in the aforesaid territory…Helsinn will also grant Fosun Pharmaceutical A.G. an exclusive license for the said products in Hong Kong SAR and Macau SAR....Helsinn Pharmaceuticals Beijing Co. Ltd. (HPC) will provide Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd., a subsidiary company of Fosun Pharma with certain medical, marketing and commercial services, including co-promotion services in Shanghai, China, in support to the commercialization of the products in Mainland China, Hong Kong SAR and Macau SAR.”

Licensing / partnership • Oncology

Pharmacokinetics and safety evaluation of oral Palonosetron in Chinese healthy volunteers: A phase 1, open-label, randomized, cross-over study. (PubMed, Eur J Pharm Sci) - "The PK of palonosetron was found to be linear in the dose range of 0.25 to 0.75 mg. Oral palonosetron in doses up to 0.75 mg was well tolerated in healthy Chinese subjects. The PK and safety data obtained from this study were similar to previous phase I studies with IV palonosetron."

Clinical • Journal • P1 data • PK/PD data • Chemotherapy-Induced Nausea and Vomiting

Buccal Film Versus IV Injection Palonosetron for Moderately Emetogenic Chemotherapy Induced Nausea and Vomiting (clinicaltrials.gov) - P2; N=22; Recruiting; Sponsor: Xiamen LP Pharmaceutical Co., Ltd; Trial completion date: Dec 2020 ➔ Apr 2021

Clinical • Trial completion date • Chemotherapy-Induced Nausea and Vomiting

Buccal Film Versus IV Injection Palonosetron for Moderately Emetogenic Chemotherapy Induced Nausea and Vomiting (clinicaltrials.gov) - P2; N=22; Recruiting; Sponsor: Xiamen LP Pharmaceutical Co., Ltd

Clinical • New P2 trial • Chemotherapy-Induced Nausea and Vomiting

Management of acute and delayed chemotherapy-induced nausea and vomiting: role of netupitant-palonosetron combination. (PubMed) - Ther Clin Risk Manag - "It is currently recommended that patients who are administered highly emetogenic chemotherapy regimens should obtain a three-drug combination consisting of NK1RA, 5HT3RA, and dexamethasone. The recently available oral combination of NEPA plus dexamethasone provides an additional pharmacological management option that could be considered in this scenario."

Journal • Review • Biosimilar

Oral versus intravenous palonosetron in Chinese cancer patients receiving moderately emetogenic chemotherapy: A non-inferiority phase III trial. (PubMed, Eur J Cancer Care (Engl)) - "Non-inferiority of oral versus IV PALO in the acute phase was demonstrated in Chinese patients."

Clinical • Head-to-Head • Journal • P3 data • Chemotherapy-Induced Nausea and Vomiting • Oncology • Solid Tumor

U.S. top court rejects Helsinn over anti-nausea drug patent in win for Teva (Reuters) - "The U.S. Supreme Court on Tuesday refused to revive Swiss drug company Helsinn Healthcare S.A.’s patent on the lucrative anti-nausea drug Aloxi in a victory for Teva Pharmaceutical Industries, which launched a generic version of it last year. The nine justices unanimously upheld a lower court ruling that had canceled Helsinn’s patent on Aloxi for violating a provision in U.S. patent law that forbids sales of an invention before applying for a patent...Aloxi is used to prevent nausea and vomiting in patients receiving chemotherapy."

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