On May 21, 2019 Sesen Bio (Nasdaq: SESN), a late-stage clinical company developing targeted fusion protein therapeutics for the treatment of patients with cancer, reported that the Company has completed its Type C CMC meeting and has reached agreement with the U.S. Food and Drug Administration (FDA) on the Analytical Comparability Plan, and that, subject to final comparability data to be provided in the BLA submission, no additional clinical trials to establish comparability are deemed necessary at this time (Press release, Eleven Biotherapeutics, MAY 21, 2019, View Source [SID1234536501]).

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In its Phase 2 and 3 clinical trials, Sesen Bio manufactured Vicinium in its facility in Winnipeg, Manitoba. Based on the Company’s assessment of the global demand potential for Vicinium, Sesen Bio sought a commercial manufacturer with outstanding manufacturing quality, a proven track record with regulatory agencies, and the capacity to meet global demand forecasts.

In October 2018, Sesen Bio entered into an agreement for the manufacturing process and technology transfer of Vicinium production with FUJIFILM Diosynth Biotechnologies U.S.A., Inc. (FUJIFILM). In April 2019, the first in a series of full-scale, commercial GMP runs was successfully completed at FUJIFILM. The final bulk drug substance produced in this first run met all release specifications.

"Because we are changing manufacturing sites, it was important to agree on an approach to establish product comparability, which will be part of the BLA submission for Vicinium," said Dr. Thomas Cannell, president and chief executive officer of Sesen Bio. "Gaining FDA agreement with our proposed Analytical Comparability Plan was the primary objective for yesterday’s meeting with the FDA. This is a very positive outcome and brings us one step closer to regulatory approval of Vicinium, and our ability to help save and improve the lives of patients."

On June 6, 2019, Sesen Bio will meet with the FDA for its second scheduled meeting, a Type B Pre-BLA meeting, to discuss the registration strategy for Vicinium. Due to the wide-range of topics to be discussed at the Pre-BLA meeting, the Company plans to provide an update on the outcome of that meeting upon receipt of the final meeting minutes, which is typically within 30 days.

About Vicinium
Vicinium, a locally-administered fusion protein, is Sesen Bio’s lead product candidate being developed for the treatment of high-risk non-muscle invasive bladder cancer (NMIBC). Vicinium is comprised of a recombinant fusion protein that targets epithelial cell adhesion molecule (EpCAM) antigens on the surface of tumor cells to deliver a potent protein payload, Pseudomonas Exotoxin A. Vicinium is constructed with a stable, genetically engineered peptide tether to ensure the payload remains attached until it is internalized by the cancer cell, which is believed to decrease the risk of toxicity to healthy tissues, thereby improving its safety. In prior clinical trials conducted by Sesen Bio, EpCAM has been shown to be overexpressed in NMIBC cells with minimal to no EpCAM expression observed on normal bladder cells. Sesen Bio is currently conducting the Phase 3 VISTA trial, designed to support the registration of Vicinium for the treatment of high-risk NMIBC in patients who have previously received a minimum of two courses of bacillus Calmette-Guérin (BCG) and whose disease is now BCG-unresponsive. Additionally, Sesen Bio believes that Vicinium’s cancer cell-killing properties promote an anti-tumor immune response that may potentially combine well with immuno-oncology drugs, such as checkpoint inhibitors. The activity of Vicinium in BCG-unresponsive NMIBC is also being explored at the US National Cancer Institute in combination with AstraZeneca’s immune checkpoint inhibitor durvalumab.

On May 21, 2019 Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Peloton Therapeutics, Inc. reported that the companies have entered into a definitive agreement under which Merck, through a subsidiary, will acquire privately held Peloton, a clinical-stage biopharmaceutical company focused on the development of novel small molecule therapeutic candidates targeting hypoxia-inducible factor-2α (HIF-2α) for the treatment of patients with cancer and other non-oncology diseases (Press release, Merck & Co, MAY 21, 2019, View Source [SID1234536502]). Peloton’s lead candidate is PT2977, a novel oral HIF-2α inhibitor in late-stage development for renal cell carcinoma (RCC).

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"This acquisition exemplifies Merck’s strategy to pursue novel therapeutic candidates based on exceptionally promising and innovative research," said Dr. Roger M. Perlmutter, president, Merck Research Laboratories. "Peloton scientists have applied their unique expertise in HIF-2α biology to develop PT2977, which has already shown intriguing activity in the treatment of renal cell carcinoma. We look forward to advancing this late-stage asset as part of our broad oncology R&D program."

Under terms of the agreement, Merck, through a subsidiary, will acquire all outstanding shares of Peloton in exchange for an upfront payment of $1.05 billion in cash. In addition, Peloton shareholders will be eligible to receive a further $1.15 billion contingent upon successful achievement of future regulatory and sales milestones for certain candidates.

"Merck is recognized as a leader in cancer research and shares our commitment to accelerating the development of candidates targeting HIF-2α to help patients with advanced cancers and other diseases," said John A. Josey, Ph.D., Peloton’s Chief Executive Officer. "We are proud to have advanced PT2977 to this stage of development and believe that Merck is well suited to build upon the progress our company has made."

The closing will be subject to certain conditions, including the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act and other customary conditions. The companies anticipate the acquisition will close in the third quarter of 2019.

Merck was represented by Covington & Burling LLP as legal advisor and Credit Suisse as financial advisor. Peloton was represented by Wilson Sonsini Goodrich & Rosati as legal advisor and Centerview Partners as financial advisor.

About PT2977

PT2977 is a potent, selective, investigational oral HIF-2α inhibitor currently being evaluated in multiple clinical studies. Specifically, PT2977 is being evaluated in a Phase 2 clinical trial in von Hippel-Lindau (VHL) disease-associated RCC, a Phase 2 clinical trial in combination with cabozantinib, a VEGFR-targeting agent, in metastatic RCC, a Phase 1/2 dose-escalation and dose-expansion clinical trial in patients with metastatic RCC, and an expansion arm of its Phase 1/2 clinical trial in glioblastoma multiforme (GBM). In cancer, HIF-2α is aberrantly activated in these diseases as a result of the inactivity of the VHL tumor suppressor. This inactivation of the VHL tumor suppressor is observed in over 90% of clear cell RCC, the most common form of kidney cancer. Results from a Phase 1/2 study of PT2977 demonstrated favorable safety and early signs of anti-tumor activity as a monotherapy for the treatment of patients with advanced or metastatic RCC.

On May 21, 2019 OncoSec Medical Incorporated (OncoSec) (NASDAQ: ONCS), a late-stage cancer biotechnology company developing intratumoral gene-delivery immunotherapies, reported that it intends to offer for sale a combination of shares of its common stock and warrants in an underwritten public offering (Press release, OncoSec Medical, MAY 21, 2019, View Source [SID1234536503]). The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

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A.G.P./Alliance Global Partners is acting as sole book-running manager for the offering.

This offering is being made pursuant to an effective shelf registration statement on Form S-3 (No. 333-213036) previously filed with the U.S. Securities and Exchange Commission (the "SEC"). A preliminary prospectus supplement and accompanying prospectus describing the terms of the proposed offering will be filed with the SEC and will be available on the SEC’s website located at View Source Electronic copies of the preliminary prospectus supplement and accompanying prospectus may be obtained, when available, from A.G.P./Alliance Global Partners, 590 Madison Avenue, 36th Floor, New York, NY 10022 or via telephone at 212-624-2006 or email: [email protected]. Before investing in this offering, interested parties should read in their entirety the prospectus supplement and the accompanying prospectus and the other documents that OncoSec has filed with the SEC that are incorporated by reference in such prospectus supplement and the accompanying prospectus, which provide more information about OncoSec and such offering.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On May 20, 2019 SpringWorks Therapeutics, a clinical-stage biopharmaceutical company focused on developing life-changing medicines for patients with severe rare diseases and cancer, reported that the first patient has been dosed in the Phase 3 "DeFi" (Desmoid/Fibromatosis) trial evaluating nirogacestat, an oral, selective, small molecule gamma-secretase inhibitor, in adult patients with progressing desmoid tumors (Press release, SpringWorks Therapeutics, MAY 20, 2019, View Source [SID1234536485]).

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Desmoid tumors are rare and often debilitating and disfiguring soft-tissue tumors that can aggressively invade surrounding healthy tissues, including joints, muscles, blood vessels, nerves and internal organs. Depending on their size and location, desmoid tumors can cause significant morbidities, including severe pain, disfigurement, internal bleeding, debilitating loss of range of motion, and, in rare cases, desmoid tumors can be fatal.1 It is estimated that 1,000 to 1,500 new cases of desmoid tumors are diagnosed each year in the United States.2,3 There are currently no therapies approved by the U.S. Food and Drug Administration (FDA) for the treatment of desmoid tumors.

"For patients living with these debilitating tumors, the DeFi trial marks a meaningful step forward in what we hope will result in the first approved treatment for this underserved patient community," said Saqib Islam, Chief Executive Officer of SpringWorks Therapeutics. "I am grateful for the persistence of our partners, colleagues and the patient advocacy community, whose collective efforts made it possible for SpringWorks to advance nirogacestat into our Phase 3 DeFi trial. We look forward to enrolling patients to confirm the clinical benefits of nirogacestat for people with desmoid tumors."

In June 2018, the FDA granted Orphan Drug designation for nirogacestat for the treatment of desmoid tumors, and in November 2018, the FDA granted Fast Track designation for nirogacestat for the treatment of adult patients with progressive, unresectable, recurrent or refractory desmoid tumors or deep fibromatosis.

About the DeFi Trial

The DeFi trial is a global, randomized, double-blind, placebo-controlled Phase 3 trial to evaluate the efficacy, safety and tolerability of nirogacestat in adult patients with progressing desmoid tumors. The study will enroll approximately 100 adult patients, who will receive 150 mg of nirogacestat or placebo twice daily. Key eligibility criteria include tumor progression by ≥20% as measured by Response Evaluation Criteria in Solid Tumors (RECIST 1.1) within 12 months prior to the first dose of study treatment.

The primary endpoint is progression-free survival (PFS), defined as the time from randomization until the date of assessment of progression or death by any cause using RECIST 1.1. Secondary endpoints include safety and tolerability measures, as well as overall response rate, tumor volume changes as assessed by MRI, and changes in baseline in patient-reported outcomes.

More information about the DeFi trial is available at www.clinicaltrials.gov under the identifier NCT03785964.

About Desmoid Tumors

Desmoid tumors (also referred to as aggressive fibromatosis or desmoid-type fibromatosis) are rare and often debilitating and disfiguring soft tissue tumors characterized by a growth pattern that can aggressively invade surrounding healthy tissues, including joints, muscles, blood vessels, nerves and internal organs. While they can arise in any part of the body, the most common sites are the upper and lower extremities, abdominal walls, thoracic areas, and the head and neck. The severity of desmoid tumors and associated symptoms varies based on their size, location and the aggressiveness of the growth pattern. Desmoid tumors can cause significant morbidities, including severe pain, disfigurement, internal bleeding, debilitating loss of range of motion, and, in rare cases, desmoid tumors can be fatal.1

Desmoid tumors can affect children and adults, and are more commonly diagnosed in young adults between 20-30 years of age, with a two-to-three-fold predominance in females.1,4 It is estimated that desmoid tumors affect 2 to 5 per million people worldwide, and that there are 1,000 to 1,500 new cases diagnosed per year in the United States.2,3

Historically, desmoid tumors were treated with surgical resection or in severe cases, amputation, but even with these interventions, high rates of tumor regrowth have been observed.5 There are currently no FDA-approved therapies for the treatment of desmoid tumors.

About Nirogacestat

Nirogacestat is an investigational, oral, selective, small molecule gamma-secretase inhibitor. Gamma secretase cleaves multiple transmembrane protein complexes, including Notch, which is believed to play a role in activating pathways that contribute to desmoid tumor growth.

Nirogacestat has been investigated in 24 patients with desmoid tumors across Phase 1 and Phase 2 clinical trials. In these studies, treatment with nirogacestat demonstrated 100% disease control rate as measured by RECIST criteria, and median PFS was not reached by the time of publication in either trial due to lack of tumor progression events. Nirogacestat also showed an encouraging tolerability profile in these earlier studies, with many patients remaining on treatment for years and only one patient in the combined trials discontinuing due to an adverse event. The most common adverse events in prior studies were diarrhea, skin disorders and hypophosphatemia.

On May 20, 2019 Clovis Oncology, Inc. (NASDAQ: CLVS) reported data demonstrating that patients with recurrent ovarian cancer who received Rubraca in the Phase 3 ARIEL3 study had longer periods of quality-adjusted time without clinically relevant symptoms as compared to patients who received placebo, and that Rubraca maintenance treatment continued to provide significant benefit in progression-free survival when weighted with patients’ perceptions of their wellbeing (Press release, Clovis Oncology, MAY 20, 2019, View Source [SID1234536486]). The presentation today at the International Society for Pharmacoeconomics and Outcomes (ISPOR) Annual Meeting in New Orleans highlights post-hoc evaluations of quality-adjusted time without symptoms or toxicity (Q-TWiST) and quality-adjusted PFS (QA-PFS) from the randomized, placebo-controlled study of Rubraca▼(rucaparib) for the maintenance treatment of patients with recurrent ovarian cancer. To the company’s knowledge, this is the first time that Q-TWiST data will be presented in the maintenance therapy setting in recurrent ovarian cancer.

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"The goal of maintenance therapy for recurrent ovarian cancer is to delay disease progression without compromising a patient’s quality of life," said Robert L. Coleman, MD, professor of Department of Gynecologic Oncology and Reproductive Medicine, The University of Texas MD Anderson Cancer Center. "The findings from QA-PFS and Q-TWiST analyses of ARIEL3 data demonstrate that the clinical benefits of rucaparib as maintenance therapy were retained across all trial populations. These results further support the positive benefit-risk profile of rucaparib in ARIEL3, including the absence of a detrimental effect on patient-centered outcomes across all treatment cohorts in the study."

During the study, patients were asked to complete EuroQol’s five-dimension, three-level (EQ-5D-3L) questionnaire at screening, on day 1 of each treatment cycle, at the treatment discontinuation visit, and at the 28-day follow-up visit. QA-PFS and Q-TWiST analyses were calculated using EQ-5D-3L data as described in the poster. Patient-centered outcomes were examined in the intent-to-treat (ITT) population (all randomized patients), in patients with a BRCA mutation, and in subgroups of patients with BRCA wild-type carcinomas based on loss of heterozygosity (LOH) status (BRCA wild type/LOH high; BRCA wild type/LOH low; and BRCA wild type/LOH indeterminate).

Results from the study include:

Mean QA-PFS was significantly longer in the Rubraca arm than placebo arm (12.02 vs 5.74 months) for the ITT population and for patients with a BRCA mutation (15.28 vs. 5.92 months)
In patients with a BRCA wild-type carcinoma, mean QA-PFS was longer in the Rubraca arm than the placebo arm regardless of LOH status
Mean Q-TWiST analysis using all grade ≥3 treatment-emergent adverse events (TEAEs) was significantly longer in the rucaparib arm than placebo for the ITT population (13.32 vs 6.44 months) and for patients with a BRCA mutation (16.42 vs 6.70 months)
In the analyses using TEAEs of interest (grade ≥2 TEAEs of nausea, vomiting, fatigue, and asthenia), Q-TWiST was also longer in the rucaparib arm than placebo for the ITT population (13.16 vs 6.40 months) and for patients with BRCA mutation (16.24 vs 6.68 months)
In patients with BRCA wild-type carcinoma, longer Q-TWiST was also observed in the Rubraca treated arm, regardless of LOH status
"It is very important to evaluate patients’ perceptions of their well-being during any type of treatment, particularly in the maintenance therapy setting in which patients may be on therapy for an extended period of time," said Professor Jonathan Ledermann, M.D., Professor of Medical Oncology, UCL Cancer Institute and UCL Hospitals, London. "These QA-PFS and Q-TWiST data from ARIEL3 integrate the patient perspective over the course of follow-up until progression to reflect their overall experience over time and suggests that the toxicity which may occur with rucaparib doesn’t outweigh its clinical benefit as maintenance treatment for women with recurrent ovarian cancer."

The Rubraca ISPOR poster will be available online at View Source as of the time it is presented at the meeting.

About Quality-Adjusted PFS (QA-PFS) and Quality-Adjusted Time Without Symptoms or Toxicity (Q-TWiST)

QA-PFS represents the duration of survival without disease progression, adjusted for the value the patient placed on their health status – i.e. it is a survival measure that adjusts for patient perceptions of treatment toxicity and any associated detrimental effects.
Q-TWiST results were derived by subtracting from the survival endpoint all time in which patients experienced treatment toxicity or disease symptoms, and then multiplying this area under the curve by a patient-derived utility value. Q-TWiST therefore adds additional value not available in a traditional TWiST analysis because it reflects patients’ perceptions of the impact of toxicity on the survival endpoint.
About the ARIEL3 Clinical Trial

The ARIEL3 pivotal study of rucaparib is a confirmatory randomized, double-blind study comparing the effects of rucaparib against placebo to evaluate whether rucaparib given as a maintenance treatment to platinum-sensitive ovarian cancer patients can extend the period of time for which the disease is controlled after a complete or partial response to platinum-based chemotherapy. The study enrolled 564 patients with high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer. To be eligible for the study, participants had to have received at least two prior platinum-based treatment regimens, been sensitive to the penultimate platinum regimen, and achieved a complete or partial response to their most recent platinum-based regimen. There were no genomic selection criteria for this study. Trial participants were randomized 2:1 to receive 600 milligrams of rucaparib twice daily (BID) or placebo. The study achieved its primary endpoint of improved PFS by investigator review in each of three populations. PFS was also improved in the rucaparib group compared with placebo by independent review, a key secondary endpoint, in all three populations. In addition, rucaparib improved objective response rate vs placebo among evaluable trial participants in all three study populations.

About Rubraca (rucaparib)

Rucaparib is an oral, small molecule inhibitor of PARP1, PARP2 and PARP3 being developed in multiple tumor types, including ovarian and metastatic castration-resistant prostate cancers, as monotherapy, and in combination with other anti-cancer agents. Exploratory studies in other tumor types are also underway.

Rubraca U.S. FDA Approved Indications

Rubraca is indicated as monotherapy for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.

Rubraca is indicated as monotherapy for the treatment of adult patients with deleterious BRCA mutations (germline and/or somatic) associated epithelial ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more chemotherapies and selected for therapy based on an FDA-approved companion diagnostic for Rubraca.

Select Important Safety Information

Myelodysplastic Syndrome (MDS)/Acute Myeloid Leukemia (AML) occur uncommonly in patients treated with Rubraca and are potentially fatal adverse reactions. In approximately 1100 treated patients, MDS/AML occurred in 12 patients (1.1%), including those in long-term follow-up. Of these, five occurred during treatment or during the 28-day safety follow-up (0.5%). The duration of Rubraca treatment prior to the diagnosis of MDS/AML ranged from 1 month to approximately 28 months. The cases were typical of secondary MDS/cancer therapy-related AML; in all cases, patients had received previous platinum-containing regimens and/or other DNA-damaging agents. Do not start Rubraca until patients have recovered from hematological toxicity caused by previous chemotherapy (≤ Grade 1).

Monitor complete blood counts for cytopenia at baseline and monthly thereafter for clinically significant changes during treatment. For prolonged hematological toxicities (> 4 weeks), interrupt Rubraca or reduce dose (see Dosage and Administration [2.2] in full Prescribing Information) and monitor blood counts weekly until recovery. If the levels have not recovered to Grade 1 or less after 4 weeks, or if MDS/AML is suspected, refer the patient to a hematologist for further investigations, including bone marrow analysis and blood sample cytogenetic analysis. If MDS/AML is confirmed, discontinue Rubraca.

Based on its mechanism of action and findings from animal studies, Rubraca can cause fetal harm when administered to a pregnant woman. Apprise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment and for 6 months following the last dose of Rubraca.

Most common adverse reactions in ARIEL3 (≥ 20%; Grade 1–4) were nausea (76%), fatigue/asthenia (73%), abdominal pain/distention (46%), rash (43%), dysgeusia (40%), anemia (39%), AST/ALT elevation (38%), constipation (37%), vomiting (37%), diarrhea (32%), thrombocytopenia (29%), nasopharyngitis/upper respiratory tract infection (29%), stomatitis (28%), decreased appetite (23%) and neutropenia (20%).

Most common laboratory abnormalities in ARIEL3 (≥ 25%; Grade 1–4) were increase in creatinine (98%), decrease in hemoglobin (88%), increase in cholesterol (84%), increase in alanine aminotransferase (ALT) (73%), increase in aspartate aminotransferase (AST) (61%), decrease in platelets (44%), decrease in leukocytes (44%), decrease in neutrophils (38%), increase in alkaline phosphatase (37%) and decrease in lymphocytes (29%).

Most common adverse reactions in Study 10 and ARIEL2 (≥ 20%; Grade 1–4) were nausea (77%), asthenia/fatigue (77%), vomiting (46%), anemia (44%), constipation (40%), dysgeusia (39%), decreased appetite (39%), diarrhea (34%), abdominal pain (32%), dyspnea (21%) and thrombocytopenia (21%).

Most common laboratory abnormalities in Study 10 and ARIEL2 (≥ 35%; Grade 1–4) were increase in creatinine (92%), increase in alanine aminotransferase (ALT) (74%), increase in aspartate aminotransferase (AST) (73%), decrease in hemoglobin (67%), decrease in lymphocytes (45%), increase in cholesterol (40%), decrease in platelets (39%) and decrease in absolute neutrophil count (35%).

Co-administration of Rubraca can increase the systemic exposure of CYP1A2, CYP3A, CYP2C9, or CYP2C19 substrates, which may increase the risk of toxicities of these drugs. Adjust dosage of CYP1A2, CYP3A, CYP2C9, or CYP2C19 substrates, if clinically indicated. If co-administration with warfarin (a CYP2C9 substrate) cannot be avoided, consider increasing frequency of international normalized ratio (INR) monitoring. Because of the potential for serious adverse reactions in breast-fed children from Rubraca, advise lactating women not to breastfeed during treatment with Rubraca and for 2 weeks after the last dose. You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Clovis Oncology, Inc. at 1-844-258-7662.

Click here for full Prescribing Information and additional Important Safety Information.

Rubraca▼ (rucaparib) EU Authorized Use and Important Safety Information

Rucaparib is indicated as monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy.

Rucaparib is indicated as monotherapy treatment of adult patients with platinum sensitive, relapsed or progressive, BRCA mutated (germline and/or somatic), high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have been treated with two or more prior lines of platinum-based chemotherapy, and who are unable to tolerate further platinum-based chemotherapy.

Summary warnings and precautions: Haematological toxicity: Patients should not start Rubraca until they have recovered from haematological toxicities caused by previous chemotherapy (≤ CTCAE Grade 1). Complete blood count testing prior to starting treatment with Rubraca and monthly thereafter is advised. Rubraca should be interrupted or dose reduced and blood counts monitored weekly until recovery for the management of low blood counts. Myelodysplastic syndrome/acute myeloid leukaemia (MDS/AML): If MDS/AML is suspected, the patient should be referred to a haematologist for further investigation. If MDS/AML is confirmed, Rubraca should be discontinued. Photosensitivity: Patients should avoid spending time in direct sunlight as they may burn more easily. When outdoors, patients should wear protective clothing and sunscreen with SPF of 50 or greater. Gastrointestinal toxicities: Low grade (CTCAE Grade 1 or 2) nausea and vomiting may be managed with dose reduction or interruption. Additionally, antiemetics may be considered for treatment or prophylaxis.

Click here to access the current Summary of Product Characteristics. Healthcare professionals should report any suspected adverse reactions via their national reporting systems.