Helsinn Group to Present Data at 2015 ASCO

May 20, 2015, 03:00 ET from Helsinn Group

LUGANO, Switzerland, May 19, 2015 /PRNewswire/ --

Helsinn, a Swiss Group focused on building quality cancer care, announced today that three abstracts highlighting new study results will be presented at the 51th Annual Meeting of the American Society of Clinical Oncology (ASCO), taking place in Chicago from 29 May to 2 June, 2015.

"We are anchored by our mission to improve health and quality of life in every person affected by cancer. Helsinn's commitment to patients and their families is evidenced by our focus on developing cancer supportive care treatment options that have the potential to impact these communities," said Riccardo Braglia, Helsinn's Group Chief Executive Officer. "Oncology continues to be a key area for our company and we have built a diverse portfolio of supportive care agents. The studies being presented at this year's ASCO Annual Meeting reflect our mission and commitment to providing options for cancer patients in need."

There will be an oral presentation from Jennifer Temel, MD, Director, Cancer Outcomes Research Clinical Director, Thoracic Oncology, Massachusetts General Hospital Cancer Center at 8am on June 1, 2015, on the results of the anamorelin Phase III studies in advanced Non-Small Cell Lung cancer patients with cachexia.

The full list of abstracts accepted for presentation at this year's ASCO Symposium is below:


   
    Product                  Abstract name

    Anamorelin               Phase III Trials of anamorelin in Patients with
    Abstract No: 9500        Advanced Non-Small Cell Lung Cancer (NSCLC) and
                             Cachexia (ROMANA 1 and 2).
                             Oral Presentation


    NEPA                     Should all antiemetic guidelines recommend
    (Akynzeo(R))             adding a NK1 receptor antagonist (NK1RA) in
    Abstract No: 9597        patients (pts) receiving carboplatin (carbo):
                             Evaluation of the efficacy of NEPA, a fixed
                             combination of the NK1RA, netupitant, and
                             palonosetron
                             Poster Presentation
   
    Palonosetron HCl         Palonosetron vs ondansetron: prevention of
    injection                chemotherapy-induced nausea a and vomiting in
    (Aloxi(R))               pediatric patients in a multi-cycle study
    Abstract No: 10077       Poster Presentation

Anamorelin is an investigational agent that has not yet been approved by any regulatory authority. The information discussed in this release is not intended to convey conclusions about its efficacy and safety.

About anamorelin and ghrelin 

Anamorelin HCl is an investigational selective, novel, orally active ghrelin receptor agonist that is under development for the treatment of Anorexia, Cachexia, and Unintended Weight Loss in NSCLC patients. Ghrelin is an endogenous peptide primarily secreted by the stomach. Upon binding to its receptor, ghrelin stimulates multiple pathways in the positive regulation of body weight, lean body mass, appetite and metabolism.

About AKYNZEO® (netupitant/palonosetron) 

AKYNZEO is indicated in the USA for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy. AKYNZEO is an oral fixed combination of a 5-HT3 receptor antagonist, palonosetron, and an NK1 receptor antagonist, netupitant: palonosetron prevents nausea and vomiting during the acute phase and netupitant prevents nausea and vomiting during both the acute and delayed phase after cancer chemotherapy.

On March 26, 2015, the Committee for Medicinal Products for Human Use (CHMP) at the EMA adopted a positive opinion recommending that AKYNZEO be granted in the European Union the marketing authorization for the prevention of acute and delayed nausea and vomiting associated with highly emetogenic cisplatin-based cancer chemotherapy and moderately emetogenic cancer chemotherapy.

Most recently the Australian Therapeutic Goods Administration (TGA) has approved AKYNZEO for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately and highly emetogenic cancer chemotherapy.

Additional applications for NEPA are planned worldwide.

AKYNZEO Important Safety Information 

Warnings and Precautions

  • Hypersensitivity reactions, including anaphylaxis, have been reported with or without known hypersensitivity to other 5-HT3 receptor antagonists
  • Serotonin syndrome has been reported with 5-HT3 receptor antagonists alone but particularly with concomitant use of serotonergic drugs.  Serotonin syndrome can be life threatening.  Symptoms associated with serotonin syndrome may include the following combination of signs and symptoms: mental status changes, autonomic instability, neuromuscular symptoms, seizures, and gastrointestinal symptoms. Patients should be monitored for the emergence of serotonin syndrome, and if symptoms occur, discontinue AKYNZEO® and initiate supportive treatment.  Patients should be informed of the increased risk of serotonin syndrome, especially if AKYNZEO is used concomitantly with other serotonergic drugs

Adverse Reactions

  • Most common adverse reactions: headache, asthenia, dyspepsia, fatigue, constipation and erythema

Drug Interactions

  • Use with caution in patients receiving concomitant medications primarily metabolized by CYP3A4. The plasma concentrations of CYP3A4 substrates can increase when co-administered with AKYNZEO. The inhibitory effect on CYP3A4 can last for multiple days
    • Dexamethasone doses should be reduced when given with AKYNZEO. A two-fold increase in the systemic exposure of dexamethasone was observed 4 days after single dose of netupitant
    • Consider the potential effects of increased plasma concentrations of midazolam or other benzodiazepines metabolized via CYP3A4 (alprazolam, triazolam) when administering with AKYNZEO. When administered with netupitant, the systemic exposure to midazolam was significantly increased
  • Avoid concomitant use of AKYNZEO in patients on chronic use of a strong CYP3A4 inducer such as rifampin as this may decrease the efficacy of AKYNZEO

Use in Specific Populations

  • Avoid use of AKYNZEO in patients with severe hepatic impairment, severe renal impairment, or end-stage renal disease

AKYNZEO is available by prescription only.

For more information about AKYNZEO, click here for the full Prescribing Information.

About ALOXI® (palonosetron HCl) 

Indication in Adults

ALOXI injection 0.25 mg is indicated in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy, and the prevention of acute nausea and vomiting associated with initial and repeat courses of highly emetogenic chemotherapy.

Indication in Pediatrics

ALOXI injection 20mcg/kg (max 1.5mg) is indicated in patients ≥ 1 month up to 17 years of age, for the prevention of acute nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including highly emetogenic chemotherapy

Important Safety Information

  • ALOXI is contraindicated in patients known to have hypersensitivity to the drug or any of its components
  • Hypersensitivity reactions, including anaphylaxis, have been reported with or without known hypersensitivity to other 5-HT3 receptor antagonists
  • Serotonin syndrome has been reported with 5-HT3 receptor antagonists alone, but particularly with the use of serotonergic drugs. Serotonin syndrome can be life threatening. Symptoms may include the following combination of signs and symptoms: mental status changes, autonomic instability, neuromuscular symptoms, seizures, and gastrointestinal symptoms. Patients should be monitored for the emergence of serotonin syndrome, and if symptoms occur, discontinue ALOXI and initiate supportive treatment

ALOXI is available by prescription only.

For more information about ALOXI, click here for the full Product Information or visit http://www.ALOXI.com.

About the Helsinn Group 

Helsinn is a family run, privately owned pharmaceutical group focused on building quality cancer care with a large portfolio of products. Founded in 1976 with headquarters in Lugano, Switzerland, Helsinn also has operating subsidiaries in Ireland, the U.S. and a representative office in China. Helsinn's business model is focused on the licensing of pharmaceuticals, medical devices and nutritional supplement products in the therapeutic area of cancer care.

Helsinn Group in-licenses early-to-late stage new chemical entities, completing their development by performing preclinical and clinical studies and associated manufacturing activities. Helsinn then prepares necessary regulatory filings in order to achieve marketing approvals worldwide. Helsinn's products are out-licensed to its global network of marketing and commercial partners that have been selected for their local market knowledge. Helsinn supports these partners by providing a full range of product and scientific management services, including commercial, regulatory, and medical marketing advice. In March 2013, Helsinn established a new commercial organization within its subsidiary, Helsinn Therapeutics (U.S.), Inc., in order to conduct direct sales and marketing activities within the U.S. market. Helsinn's products are manufactured according to the highest quality, safety, and environmental standards at Helsinn's GMP facilities in Switzerland and Ireland from where they are then supplied worldwide to customers. Further information on Helsinn Group is available at http://www.helsinn.com.

For more information, please contact:
Helsinn Group
Paola Bonvicini
Head of Communication & Press Office
Tel: +41-91-985-21-21
info-hhc@helsinn.com

For media / external inquiries
Consilium Strategic Communications  
Mary-Jane Elliott / Jessica Hodgson / Matthew Neal / Laura Thornton
Tel: +44(0)203-709-5700
Helsinn@consilium-comms.com

SOURCE Helsinn Group