Verity Pharmaceuticals and Helsinn Therapeutics sign exclusive agreement for the promotion of Akynzeo ® and Valchlor ® in Puerto Rico

class="custom-text-block--copy"> Toronto, Ontario and Lugano, Switzerland (February 16, 2022) – Verity Pharmaceuticals International Ltd. (“ Verity Pharma ”), and Helsinn Therapeutics (U.S.), Inc. (“ Helsinn ”), today announced the signing of an agreement between the two parties for the exclusive rights to promote AKYNZEO ® IV/Oral and VALCHLOR ® in Puerto Rico. Under the terms of the agreement, Verity Pharma will promote the following products across the island of Puerto Rico, leveraging its existing commercial footprint and health care network: AKYNZEO ® (netupitant 300mg/palonosetron 0.5mg) capsule AKYNZEO ® (fosenetupitant 235mg/palonosetron 0.25mg) injection VALCHLOR ® (mechlorethamine) gel 0.016% Helsinn will maintain control of distribution, market access, and regulatory activities in Puerto Rico. “This suite of cancer supportive and therapeutic products has significant value to patients, in cancer treatment and effectively managing its side effects,” said Howard Glase, CEO of Verity Pharma . “Verity Pharma is delighted to be working with Helsinn in Puerto Rico to facilitate the commercialization of Akynzeo and Valchlor.” “Verity Pharma’s established salesforce and customer network in Puerto Rico will help expand patient access to our oncology portfolio,” said Paul Rittman, Chief Executive Officer of Helsinn Therapeutics . “Helsinn is pleased to be working with Verity Pharma in order to bring much needed supportive and therapeutic care to cancer patients in need of these important products in Puerto Rico.” About AKYNZEO ® AKYNZEO ® is the first and only 5-HT3 and NK1 receptor antagonists fixed combination approved for the prevention of chemotherapy-induced acute and delayed nausea and vomiting. A single dose of AKYNZEO ® given with dexamethasone has been shown to prevent chemotherapy-induced nausea and vomiting for up to 5 days. INDICATION AKYNZEO ® (netupitant 300mg/palonosetron 0.5mg) capsules was approved in October 2014 in the United States and is indicated in combination with dexamethasone in adults 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 ® (fosnetupitant 235mg/palonosetron 0.25) for injection was approved in April 2018 and AKYNZEO ® injection was approved in May 2020 in the United States. Each is indicated in combination with dexamethasone in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy. Limitations of Use: AKYNZEO ® for injection and AKYNZEO ® injection have not been studied for the prevention of nausea and vomiting associated with anthracycline plus cyclophosphamide chemotherapy. AKYNZEO ® is a combination of palonosetron, a serotonin-3 (5-HT3) receptor antagonist, and netupitant or fosnetupitant, substance P/neurokinin-1 (NK-1) receptor antagonists: palonosetron prevents nausea and vomiting mainly during the acute phase and netupitant/fosnetupitant prevents nausea and vomiting during both the acute and delayed phase after cancer chemotherapy. IMPORTANT SAFETY INFORMATION Warnings and Precautions: Hypersensitivity reactions, including anaphylaxis, have been reported in patients receiving palonosetron, one of the components of AKYNZEO ® , 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 for AKYNZEO ® : headache, asthenia, dyspepsia, fatigue, constipation, and erythema. Drug-drug Interactions: Use with caution in patients receiving concomitant medications primarily metabolized by CYP3A4 isoenzyme. 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 more than two-fold increase in the systemic exposure of dexamethasone was observed 4 days after a single dose of netupitant or a single infusion of fosnetupitant. 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. Avoid use in pregnancy, limited data is available, may cause fetal harm. For more information about AKYNZEO ® please see the full U.S. Prescribing Information .

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