Helsinn and Eisai Announce Revised U.S. Collaboration for CINV Franchise

--Helsinn Therapeutics Inc. to obtain all rights to promote and distribute AKYNZEO® (netupitant/palonosetron) --

--Eisai and Helsinn to continue to co-promote and distribute ALOXI® (palonosetron HCl) injection--

Mar 18, 2016, 07:55 ET from Eisai Inc. from ,Helsinn Therapeutics Inc.

LUGANO, Switzerland and WOODCLIFF LAKE, N.J., March 18, 2016 /PRNewswire/ -- Helsinn, the Swiss pharmaceutical Group focused on building quality cancer care, and Eisai Inc., the U.S. pharmaceutical subsidiary of the research-based human healthcare company  Eisai Co., Ltd , announced today a revised agreement for their chemotherapy-induced nausea and vomiting (CINV) franchise. 

Under the new arrangement, Helsinn Therapeutics Inc., the U.S. affiliate of Helsinn, will obtain exclusive rights to promote and sell AKYNZEO (netupitant/palonosetron), its oral fixed dose combination product for the prevention of CINV.   AKYNZEO had previously been co-promoted in the U.S. by both Helsinn and Eisai.  As part of the revised agreement, Eisai and Helsinn will continue to co-promote ALOXI (palonosetron HCl) injection in the U.S. for CINV.  CINV is one of the most common side effects of chemotherapy.

"The acquisition of exclusive rights to AKYNZEO is an important milestone for Helsinn as it marks our commercial expansion in the U.S.," said Riccardo Braglia, Helsinn Group Vice Chairman and CEO.  "We are excited to have this unique opportunity with AKYNZEO while still maintaining our long-standing partnership with Eisai for ALOXI."

"This revised arrangement will enable Eisai to focus on ALOXI and our growing oncology franchise," said Shaji Procida, President and Chief Operating Officer, Eisai Inc.  "We are proud of our past collaboration with Helsinn and are pleased to continue to partner on making ALOXI available to the oncology community."

About AKYNZEO® (netupitant/palonosetron)

AKYNZEO is indicated 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 palonosetron and 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. 

AKYNZEO targets two critical signaling pathways associated with CINV by combining netupitant, an NK1 receptor antagonist, and palonosetron, a 5-HT3 receptor antagonist, in a single capsule for the prevention of CINV. AKYNZEO has now been approved and is marketed in both the US and Europe and more recently it has been included as a treatment option in the ASCO, NCCN and recently also in the MASCC/ESMO antiemetic guidelines. 

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) injection

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.

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

Contraindications

  • ALOXI is contraindicated in patients known to have hypersensitivity to the drug or any of its components

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 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. Patients should be informed of the increased risk of serotonin syndrome, especially if ALOXI is used concomitantly with other serotonergic drugs.

Adverse Reactions

  • In pediatric patients, while they require a higher dose of palonosetron, the safety profile is consistent with the established profile in adults; however, adverse reactions were reported in < 0.1% of pediatric patients
  • In adults, the most commonly reported adverse drug reactions include headache (9%) and constipation (5%)

ALOXI is available by prescription only.

For more information about ALOXI, please see full prescribing information. http://www.aloxi.com/docs/pdf/PI.pdf

About the Helsinn Group

Helsinn is a privately owned cancer supportive care pharmaceutical group with an extensive portfolio of marketed products and a broad development pipeline. Since 1976, Helsinn has been improving the everyday lives of patients, guided by core family values of respect, integrity and quality, through a unique integrated licensing business model working with long standing partners in pharmaceuticals, medical devices and nutritional supplement products. Helsinn is headquartered in Lugano, Switzerland, with operating subsidiaries in Ireland and the US, a representative office in China, as well as a product presence in about 90 countries globally.

For more information, please visit www.helsinn.com.

About Eisai Inc.

At Eisai Inc., human health care is our goal. We give our first thoughts to patients and their families, and helping to increase the benefits health care provides. As the U.S. pharmaceutical subsidiary of Tokyo-based Eisai Co., Ltd., we have a passionate commitment to patient care that is the driving force behind our efforts to help address unmet medical needs. We are a fully integrated pharmaceutical business with discovery, clinical, manufacturing and marketing capabilities. Our key areas of commercial focus include oncology and specialty care (Alzheimer's disease, epilepsy and metabolic disorders). To learn more about Eisai Inc., please visit us at www.eisai.com/US.  

Eisai Inc. has affiliates that are part of a global product creation organization that includes R&D facilities in Massachusetts, New Jersey and Pennsylvania, as well as a global demand chain organization that includes facilities in Maryland and North Carolina. Eisai's global areas of R&D focus include neuroscience; oncology; metabolic disorders; vascular, inflammatory and immunological reaction; and antibody-based programs.

Akynzeo® and Aloxi® are registered trademarks of Helsinn Healthcare SA.

Eisai Inc.       


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SOURCE Eisai Inc.; Helsinn Therapeutics Inc.



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