ENHERTU® Granted Priority Review in the U.S. for Patients with HER2 Positive Metastatic Breast Cancer Treated with a Prior Anti-HER2-Based Regimen

ENHERTU® Granted Priority Review in the U.S. for Patients with HER2 Positive Metastatic Breast Cancer Treated with a Prior Anti-HER2-Based Regimen




ENHERTU® Granted Priority Review in the U.S. for Patients with HER2 Positive Metastatic Breast Cancer Treated with a Prior Anti-HER2-Based Regimen

  • Based on groundbreaking DESTINY-Breast03 results showing Daiichi Sankyo and AstraZeneca’s ENHERTU reduced the risk of disease progression or death by 72% versus ado-trastuzumab emtansine (T-DM1)
  • Application being evaluated under FDA Real-Time Oncology Review and Project Orbis

TOKYO & MUNICH & BASKING RIDGE, N.J.–(BUSINESS WIRE)–Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) and AstraZeneca (LSE/STO/Nasdaq: AZN) have received notification of acceptance by the U.S. Food and Drug Administration (FDA) of the supplemental Biologics License Application (sBLA) of ENHERTU® (fam-trastuzumab deruxtecan-nxki) for the treatment of adult patients in the U.S. with unresectable or metastatic HER2 positive breast cancer who have received a prior anti-HER2-based regimen. The application has also been granted Priority Review.

ENHERTU is a HER2 directed antibody drug conjugate (ADC) being jointly developed by Daiichi Sankyo and AstraZeneca.

The FDA grants Priority Review to applications for medicines that, if approved, would offer significant improvements over available options by demonstrating safety or efficacy improvements, preventing serious conditions, or enhancing patient compliance. The Prescription Drug User Fee Act date (PDUFA), the FDA action date for their regulatory decision, is during the second quarter of the 2022 calendar year.

The sBLA is being reviewed under the Real-Time Oncology Review (RTOR) program and Project Orbis, two initiatives of the FDA which are designed to bring effective cancer treatments to patients as early as possible. RTOR allows the FDA to review components of an application before submission of the complete application. Project Orbis provides a framework for concurrent submission and review of oncology medicines among participating international partners.

Breast cancer is the most common cancer worldwide, with more than two million cases diagnosed in 2020, resulting in nearly 685,000 deaths globally.1 Approximately one in five cases of breast cancer are considered HER2 positive.2 Despite initial treatment with trastuzumab and a taxane, patients with HER2 positive metastatic breast cancer will often experience disease progression.3 More treatment options are needed to further delay progression and extend survival.3,4,5

This regulatory review of ENHERTU in the U.S. marks the first time this medicine is participating in both the Real-Time Oncology Review and Project Orbis programs,” said Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo. “The FDA’s prioritization of our application underscores the potential of this medicine and the continued need to expedite the availability of new treatment options, while making it possible to potentially receive approvals in several countries concurrently.”

This review across geographies and the priority review in the U.S. as part of Project Orbis is so important because it speaks to the transformative potential of ENHERTU based on the unprecedented progression-free survival benefit in this setting,” said Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca. “The news reinforces the importance of bringing this potential new option to patients as quickly as possible.”

The sBLA is based on data from the pivotal DESTINY-Breast03 phase 3 trial that were presented at the 2021 European Society for Medical Oncology (ESMO) Congress. In the trial, ENHERTU demonstrated a 72% reduction in the risk of disease progression or death compared to T-DM1 (hazard ratio [HR] = 0.28; 95% confidence interval [CI]: 0.22-0.37; p=7.8×10-22) in patients with HER2 positive unresectable and/or metastatic breast cancer previously treated with trastuzumab and a taxane. The median progression-free survival (PFS) for patients treated with ENHERTU was not reached (95% CI: 18.5-NE) compared to 6.8 months for T-DM1 (95% CI: 5.6-8.2) as assessed by blinded independent central review (BICR). In the secondary endpoint analysis of PFS assessed by investigators, patients treated with ENHERTU experienced an improvement in PFS of 25.1 months (95% CI: 22.1-NE) compared to 7.2 months (95% CI: 6.8-8.3) for T-DM1 (HR=0.26; 95% CI: 0.20-0.35). There was a strong trend towards improved overall survival (OS) with ENHERTU (HR=0.56; 95% CI: 0.36-0.86; p=0.007172), however, this analysis is not yet mature and is not statistically significant. Nearly all patients treated with ENHERTU during the trial were alive at one year (94.1%; 95% CI: 90.3-96.4) compared to 85.9% of patients treated with T-DM1 (95% CI: 80.9-89.7). Confirmed objective response rate (ORR) was more than doubled in the ENHERTU arm versus the T-DM1 arm (79.7%; n=208; 95% CI: 74.3-84.4) versus 34.2% (n=90; 95% CI: 28.5-40.3; p<0.0001).

The safety profile of the most common adverse events with ENHERTU in DESTINY-Breast03 was consistent with previous clinical trials with no new safety concerns identified. The most common grade 3 or higher drug-related treatment emergent adverse events in the ENHERTU arm were neutropenia (19.1%), thrombocytopenia (7.0%), leukopenia (6.6%), nausea (6.6%), anemia (5.8%), fatigue (5.1%), vomiting (1.6%), increase in ALT (1.6%), decreased appetite (1.2%), increase in AST (0.8%), diarrhea (0.4%) and alopecia (0.4%). Overall, 10.5% of patients had interstitial lung disease (ILD) or pneumonitis related to treatment as determined by an independent adjudication committee. The majority of ILD events (9.7%) were low grade (grade 1 (2.7%) or grade 2 (7.0%)) with two grade 3 (0.8%) events reported. No grade 4 or grade 5 ILD or pneumonitis events occurred.

In September 2021, ENHERTU received its fourth Breakthrough Therapy Designation (BTD) in the U.S. for the treatment of adult patients with unresectable or metastatic HER2 positive breast cancer who have received one or more prior anti-HER2-based regimens.

About HER2 Positive Breast Cancer

Breast cancer is the most common cancer and is one of the leading causes of cancer-related deaths worldwide.1 More than two million cases of breast cancer were diagnosed in 2020, resulting in nearly 685,000 deaths globally.1 Approximately one in five cases of breast cancer are considered HER2 positive.2

HER2 is a tyrosine kinase receptor growth-promoting protein expressed on the surface of many types of tumors including breast, gastric, lung and colorectal cancers.6 HER2 protein overexpression may occur as a result of HER2 gene amplification and is often associated with aggressive disease and poor prognosis in breast cancer.7

Despite initial treatment with trastuzumab and a taxane, patients with HER2 positive metastatic breast cancer will often experience disease progression.3 More treatment options are needed to further delay progression and extend survival.3,4,5

About DESTINY-Breast03

DESTINY-Breast03 is a global, head-to-head, randomized, open-label, pivotal phase 3 trial evaluating the efficacy and safety of ENHERTU (5.4 mg/kg) versus T-DM1 in patients with HER2 positive unresectable and/or metastatic breast cancer previously treated with trastuzumab and a taxane. The primary efficacy endpoint of DESTINY-Breast03 is PFS based on blinded independent central review. Secondary efficacy endpoints include overall survival, ORR, duration of response, PFS based on investigator assessment and safety. DESTINY-Breast03 enrolled 524 patients at multiple sites in Asia, Europe, North America, Oceania and South America. For more information about the trial, visit ClinicalTrials.gov.

About ENHERTU

ENHERTU® (trastuzumab deruxtecan; fam-trastuzumab deruxtecan-nxki in the U.S. only) is a HER2 directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC technology, ENHERTU is the lead ADC in the oncology portfolio of Daiichi Sankyo and the most advanced program in AstraZeneca’s ADC scientific platform. ENHERTU consists of a HER2 monoclonal antibody attached to a topoisomerase I inhibitor payload, an exatecan derivative, via a stable tetrapeptide-based cleavable linker.

A supplemental New Drug Application in Japan is under review for the treatment of adult patients in Japan with HER2 positive unresectable or recurrent breast cancer previously treated with trastuzumab and a taxane. Additionally, a Type II Variation is currently under review by the European Medicines Agency (EMA) for the treatment of adult patients with unresectable or metastatic HER2 positive breast cancer who have received one or more prior anti-HER2-based regimens. Both submissions are based on the results from the DESTINY-Breast03 trial.

ENHERTU (5.4 mg/kg) is approved in more than 30 countries for the treatment of adult patients with unresectable or metastatic HER2 positive breast cancer who have received two or more prior anti-HER2 based regimens based on the results from the DESTINY-Breast01 trial.

ENHERTU (6.4 mg/kg) is approved in several countries for the treatment of adult patients with locally advanced or metastatic HER2 positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen based on the results from the DESTINY-Gastric01 trial.

A Type II Variation is currently under review by the EMA for the treatment of adult patients with locally advanced or metastatic HER2 positive gastric or GEJ adenocarcinoma who have received a prior anti-HER2-based regimen.

ENHERTU is approved in the U.S. with Boxed WARNINGS for Interstitial Lung Disease and Embryo-Fetal Toxicity. For more information, please see the accompanying full Prescribing Information, including Boxed WARNINGS, and Medication Guide.

About the ENHERTU Clinical Development Program

A comprehensive global development program is underway evaluating the efficacy and safety of ENHERTU monotherapy across multiple HER2 targetable cancers including breast, gastric, lung and colorectal cancers. Trials in combination with other anticancer treatments, such as immunotherapy, are also underway.

ENHERTU was highlighted in the Clinical Cancer Advances 2021 report as one of two significant advancements in the “ASCO Clinical Advance of the Year: Molecular Profiling Driving Progress in GI Cancers,” based on data from both the DESTINY-Gastric01 and DESTINY-CRC01 trials, as well as one of the targeted therapy advances of the year in NSCLC based on the interim results of the HER2 mutated cohort of the DESTINY-Lung01 trial.

About the Daiichi Sankyo and AstraZeneca Collaboration

Daiichi Sankyo and AstraZeneca entered into a global collaboration to jointly develop and commercialize ENHERTU in March 2019 and datopotamab deruxtecan (Dato-DXd) in July 2020, except in Japan where Daiichi Sankyo maintains exclusive rights for each ADC. Daiichi Sankyo is responsible for the manufacturing and supply of ENHERTU and datopotamab deruxtecan.

U.S. Important Safety Information for ENHERTU

Indications

ENHERTU is a HER2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of adult patients with:

  • Unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting.

    This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

  • Locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who have received a prior trastuzumab-based regimen.

 

WARNING: INTERSTITIAL LUNG DISEASE and EMBRYO-FETAL TOXICITY

  • Interstitial lung disease (ILD) and pneumonitis, including fatal cases, have been reported with ENHERTU. Monitor for and promptly investigate signs and symptoms including cough, dyspnea, fever, and other new or worsening respiratory symptoms. Permanently discontinue ENHERTU in all patients with Grade 2 or higher ILD/pneumonitis. Advise patients of the risk and to immediately report symptoms.
  • Exposure to ENHERTU during pregnancy can cause embryo-fetal harm. Advise patients of these risks and the need for effective contraception.

Contraindications

None.

Warnings and Precautions

Interstitial Lung Disease / Pneumonitis

Severe, life-threatening, or fatal interstitial lung disease (ILD), including pneumonitis, can occur in patients treated with ENHERTU. Advise patients to immediately report cough, dyspnea, fever, and/or any new or worsening respiratory symptoms. Monitor patients for signs and symptoms of ILD. Promptly investigate evidence of ILD. Evaluate patients with suspected ILD by radiographic imaging. Consider consultation with a pulmonologist. For asymptomatic ILD/pneumonitis (Grade 1), interrupt ENHERTU until resolved to Grade 0, then if resolved in ≤28 days from date of onset, maintain dose. If resolved in >28 days from date of onset, reduce dose one level. Consider corticosteroid treatment as soon as ILD/pneumonitis is suspected (e.g., ≥0.5 mg/kg/day prednisolone or equivalent). For symptomatic ILD/pneumonitis (Grade 2 or greater), permanently discontinue ENHERTU. Promptly initiate systemic corticosteroid treatment as soon as ILD/pneumonitis is suspected (e.g., ≥1 mg/kg/day prednisolone or equivalent) and continue for at least 14 days followed by gradual taper for at least 4 weeks.

Metastatic Breast Cancer

In clinical studies, of the 234 patients with unresectable or metastatic HER2-positive breast cancer treated with ENHERTU 5.4 mg/kg, ILD occurred in 9% of patients. Fatal outcomes due to ILD and/or pneumonitis occurred in 2.6% of patients treated with ENHERTU. Median time to first onset was 4.1 months (range: 1.2 to 8.3).

Locally Advanced or Metastatic Gastric Cancer

In DESTINY-Gastric01, of the 125 patients with locally advanced or metastatic HER2-positive gastric or GEJ adenocarcinoma treated with ENHERTU 6.4 mg/kg, ILD occurred in 10% of patients. Median time to first onset was 2.8 months (range: 1.2 to 21.0).

Neutropenia

Severe neutropenia, including febrile neutropenia, can occur in patients treated with ENHERTU.

Monitor complete blood counts prior to initiation of ENHERTU and prior to each dose, and as clinically indicated. For Grade 3 neutropenia (Absolute Neutrophil Count [ANC] <1.0 to 0.5 x 109/L) interrupt ENHERTU until resolved to Grade 2 or less, then maintain dose. For Grade 4 neutropenia (ANC <0.5 x 109/L) interrupt ENHERTU until resolved to Grade 2 or less. Reduce dose by one level. For febrile neutropenia (ANC <1.0 x 109/L and temperature >38.3ºC or a sustained temperature of ≥38ºC for more than 1 hour), interrupt ENHERTU until resolved. Reduce dose by one level.

Metastatic Breast Cancer

In clinical studies, of the 234 patients with unresectable or metastatic HER2-positive breast cancer who received ENHERTU 5.4mg/kg, a decrease in neutrophil count was reported in 62% of patients. Sixteen percent had Grade 3 or 4 decrease in neutrophil count. Median time to first onset of decreased neutrophil count was 23 days (range: 6 to 547). Febrile neutropenia was reported in 1.7% of patients.

Locally Advanced or Metastatic Gastric Cancer

In DESTINY-Gastric01, of the 125 patients with locally advanced or metastatic HER2-positive gastric or GEJ adenocarcinoma treated with ENHERTU 6.4 mg/kg, a decrease in neutrophil count was reported in 72% of patients. Fifty-one percent had Grade 3 or 4 decreased neutrophil count. Median time to first onset of decreased neutrophil count was 16 days (range: 4 to 187). Febrile neutropenia was reported in 4.8% of patients.

Left Ventricular Dysfunction

Patients treated with ENHERTU may be at increased risk of developing left ventricular dysfunction. Left ventricular ejection fraction (LVEF) decrease has been observed with anti-HER2 therapies, including ENHERTU. In the 234 patients with unresectable or metastatic HER2-positive breast cancer who received ENHERTU, two cases (0.9%) of asymptomatic LVEF decrease were reported. In DESTINY-Gastric01, of the 125 patients with locally advanced or metastatic HER2-positive gastric or GEJ adenocarcinoma treated with ENHERTU 6.4 mg/kg, no clinical adverse events of heart failure were reported; however, on echocardiography, 8% were found to have asymptomatic Grade 2 decrease in LVEF. Treatment with ENHERTU has not been studied in patients with a history of clinically significant cardiac disease or LVEF <50% prior to initiation of treatment.

Assess LVEF prior to initiation of ENHERTU and at regular intervals during treatment as clinically indicated. When LVEF is >45% and absolute decrease from baseline is 10-20%, continue treatment with ENHERTU. When LVEF is 40-45% and absolute decrease from baseline is <10%, continue treatment with ENHERTU and repeat LVEF assessment within 3 weeks. When LVEF is 40-45% and absolute decrease from baseline is 10-20%, interrupt ENHERTU and repeat LVEF assessment within 3 weeks. If LVEF has not recovered to within 10% from baseline, permanently discontinue ENHERTU. If LVEF recovers to within 10% from baseline, resume treatment with ENHERTU at the same dose. When LVEF is <40% or absolute decrease from baseline is >20%, interrupt ENHERTU and repeat LVEF assessment within 3 weeks. If LVEF of <40% or absolute decrease from baseline of >20% is confirmed, permanently discontinue ENHERTU. Permanently discontinue ENHERTU in patients with symptomatic congestive heart failure.

Embryo-Fetal Toxicity

ENHERTU can cause fetal harm when administered to a pregnant woman. Advise patients of the potential risks to a fetus. Verify the pregnancy status of females of reproductive potential prior to the initiation of ENHERTU. Advise females of reproductive potential to use effective contraception during treatment and for at least 7 months following the last dose of ENHERTU. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with ENHERTU and for at least 4 months after the last dose of ENHERTU.

Additional Dose Modifications

Thrombocytopenia

For Grade 3 thrombocytopenia (platelets <50 to 25 x 109/L) interrupt ENHERTU until resolved to Grade 1 or less, then maintain dose. For Grade 4 thrombocytopenia (platelets <25 x 109/L) interrupt ENHERTU until resolved to Grade 1 or less. Reduce dose by one level.

Adverse Reactions

Metastatic Breast Cancer

The safety of ENHERTU was evaluated in a pooled analysis of 234 patients with unresectable or metastatic HER2-positive breast cancer who received at least one dose of ENHERTU 5.4 mg/kg in DESTINY-Breast01 and Study DS8201-A-J101. ENHERTU was administered by intravenous infusion once every three weeks. The median duration of treatment was 7 months (range: 0.7 to 31).

Serious adverse reactions occurred in 20% of patients receiving ENHERTU. Serious adverse reactions in >1% of patients who received ENHERTU were interstitial lung disease, pneumonia, vomiting, nausea, cellulitis, hypokalemia, and intestinal obstruction. Fatalities due to adverse reactions occurred in 4.3% of patients including interstitial lung disease (2.6%), and the following events occurred in one patient each (0.4%): acute hepatic failure/acute kidney injury, general physical health deterioration, pneumonia, and hemorrhagic shock.

ENHERTU was permanently discontinued in 9% of patients, of which ILD accounted for 6%. Dose interruptions due to adverse reactions occurred in 33% of patients treated with ENHERTU. The most frequent adverse reactions (>2%) associated with dose interruption were neutropenia, anemia, thrombocytopenia, leukopenia, upper respiratory tract infection, fatigue, nausea, and ILD. Dose reductions occurred in 18% of patients treated with ENHERTU. The most frequent adverse reactions (>2%) associated with dose reduction were fatigue, nausea, and neutropenia.

The most common (≥20%) adverse reactions, including laboratory abnormalities, were nausea (79%), white blood cell count decreased (70%), hemoglobin decreased (70%), neutrophil count decreased (62%), fatigue (59%), vomiting (47%), alopecia (46%), aspartate aminotransferase increased (41%), alanine aminotransferase increased (38%), platelet count decreased (37%), constipation (35%), decreased appetite (32%), anemia (31%), diarrhea (29%), hypokalemia (26%), and cough (20%).

Locally Advanced or Metastatic Gastric Cancer

The safety of ENHERTU was evaluated in 187 patients with locally advanced or metastatic HER2-positive gastric or GEJ adenocarcinoma in DESTINY-Gastric01. Patients intravenously received at least one dose of either ENHERTU (N=125) 6.4 mg/kg once every three weeks or either irinotecan (N=55) 150 mg/m2 biweekly or paclitaxel (N=7) 80 mg/m2 weekly for 3 weeks. The median duration of treatment was 4.6 months (range: 0.7 to 22.3) in the ENHERTU group and 2.8 months (range: 0.5 to 13.1) in the irinotecan/paclitaxel group.

Serious adverse reactions occurred in 44% of patients receiving ENHERTU 6.4 mg/kg. Serious adverse reactions in >2% of patients who received ENHERTU were decreased appetite, ILD, anemia, dehydration, pneumonia, cholestatic jaundice, pyrexia, and tumor hemorrhage. Fatalities due to adverse reactions occurred in 2.4% of patients: disseminated intravascular coagulation, large intestine perforation, and pneumonia occurred in one patient each (0.8%).

ENHERTU was permanently discontinued in 15% of patients, of which ILD accounted for 6%. Dose interruptions due to adverse reactions occurred in 62% of patients treated with ENHERTU. The most frequent adverse reactions (>2%) associated with dose interruption were neutropenia, anemia, decreased appetite, leukopenia, fatigue, thrombocytopenia, ILD, pneumonia, lymphopenia, upper respiratory tract infection, diarrhea, and hypokalemia. Dose reductions occurred in 32% of patients treated with ENHERTU. The most frequent adverse reactions (>2%) associated with dose reduction were neutropenia, decreased appetite, fatigue, nausea, and febrile neutropenia.

The most common (≥20%) adverse reactions, including laboratory abnormalities, were hemoglobin decreased (75%), white blood cell count decreased (74%), neutrophil count decreased (72%), lymphocyte count decreased (70%), platelet count decreased (68%), nausea (63%), decreased appetite (60%), anemia (58%), aspartate aminotransferase increased (58%), fatigue (55%), blood alkaline phosphatase increased (54%), alanine aminotransferase increased (47%), diarrhea (32%), hypokalemia (30%), vomiting (26%), constipation (24%), blood bilirubin increased (24%), pyrexia (24%), and alopecia (22%).

Use in Specific Populations

  • Pregnancy: ENHERTU can cause fetal harm when administered to a pregnant woman. Advise patients of the potential risks to a fetus. There are clinical considerations if ENHERTU is used in pregnant women, or if a patient becomes pregnant within 7 months following the last dose of ENHERTU.
  • Lactation: There are no data regarding the presence of ENHERTU in human milk, the effects on the breastfed child, or the effects on milk production. Because of the potential for serious adverse reactions in a breastfed child, advise women not to breastfeed during treatment with ENHERTU and for 7 months after the last dose.
  • Females and Males of Reproductive Potential: Pregnancy testing: Verify pregnancy status of females of reproductive potential prior to initiation of ENHERTU. Contraception: Females: ENHERTU can cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential to use effective contraception during treatment with ENHERTU and for at least 7 months following the last dose.

Contacts

Media Contacts:


Global:
Victoria Amari

Daiichi Sankyo, Inc.

vamari@dsi.com
+1 908 900 3010 (mobile)

US:

Don Murphy

Daiichi Sankyo, Inc.

domurphy@dsi.com
+1 917 817 2649 (mobile)

EU:
Lydia Worms

Daiichi Sankyo Europe GmbH

lydia.worms@daiichi-sankyo.eu
+49 (89) 7808751 (office)

+49 176 11780861 (mobile)

Japan:
Masashi Kawase

Daiichi Sankyo Co., Ltd.

kawase.masashi.a2@daiichisankyo.co.jp
+81 3 6225 1126 (office)

Investor Relations Contact:
DaiichiSankyoIR@daiichisankyo.co.jp

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Sensorion Updates on SENS-401 Phase 2 trial in Sudden Sensorineural Hearing Loss

Sensorion Updates on SENS-401 Phase 2 trial in Sudden Sensorineural Hearing Loss




Sensorion Updates on SENS-401 Phase 2 trial in Sudden Sensorineural Hearing Loss

  • Safe and well tolerated in 115-patient SSNHL study; primary endpoint not met
  • Sensorion will continue to analyze the data from the AUDIBLE-S study and update the market mid-March following the analysis of the secondary endpoints
  • Sensorion continues to develop SENS-401 in other indications
  • Three preclinical gene therapy programs, aimed at correcting hereditary monogenic forms of deafness, are in progress

MONTPELLIER, France–(BUSINESS WIRE)–Regulatory News:

Sensorion (Paris:ALSEN) (FR0012596468 – ALSEN) a pioneering clinical-stage biotechnology company which specializes in the development of novel therapies to restore, treat and prevent within the field of hearing loss disorders, today reports results from the 115-patient Phase 2 AUDIBLE-S study of SENS-401 (Arazasetron), for the treatment of sudden sensorineural hearing loss (‘SSNHL’).

SENS-401 was safe and well tolerated, however, it did not meet the primary endpoint of 15 dB, a significant improvement in pure tone audiometry (PTA, dB) in the affected ear from baseline in comparison to placebo at the end of the four-week treatment period.

A sub-analysis in participants with hearing threshold > 80dB, representing those with severe hearing loss, showed a better response compared to placebo at the two doses. This subgroup accounted for 30% of the overall study population. These results confirm the data we obtained in our preclinical model of severe noise induced hearing loss.

Sensorion will continue to evaluate the data from the AUDIBLE-S study and the secondary endpoints results will be released mid-March. We will outline plans for the development of SENS-401 SSNHL at that point.

”We are encouraged by the SENS-401 activity data that showed a continuous improvement from day 7 until day 28. We will review the full data as soon as possible and explore in particular the PTA comparisons at day 84 and the other secondary endpoints in the trial to determine the best development path for SENS-401,” commented Géraldine Honnet, CMO of Sensorion.

We’re naturally disappointed that the Phase 2 AUDIBLE-S trial of SENS-401 did not meet the primary endpoint of the study. However, we are looking forward to reviewing the secondary endpoints once these become available by mid-March. Sensorion is committed to continuing to develop novel therapies in indications to restore, treat and prevent hearing loss disorders. Through our pioneering R&D technology platform and with a number of promising new therapeutic approaches, including gene therapy programs, we are confident in our mission,” Nawal Ouzren, CEO of Sensorion, commented. “We would like to express our gratitude to the investigators, collaborators and partners who have worked with us and particularly the patients who participated in the trial.”

Mauricio Cohen-Vaizer, ENT, Department of Otolaryngology, Head and Neck Surgery, Rambam Health Care Center, Haifa, Israel, commented: “Sudden sensorineural hearing loss is a debilitating condition for which there are no therapeutic treatments currently available. Although the trial did not meet the primary endpoint, Sensorion and its investigators have acquired a wealth of knowledge around this poorly understood condition and are in a good position to explore further development options. Sensorion is doing valuable work in raising awareness and understanding of this condition.”

Sensorion is continuing to develop novel therapies in other indications to restore, treat and prevent within the field of hearing loss disorders. Sensorion submitted a clinical trial application for a proof of concept (POC) study of SENS-401 clinical study in cisplatin-induced ototoxicity (CIO) in December 2021. Separately, Sensorion and its partner Cochlear Limited plan to submit a clinical trial application for SENS-401 in patients scheduled for cochlear implantation by the end of January 2022. Sensorion has also launched three gene therapy programs, currently at preclinical stage, aimed at correcting hereditary monogenic forms of deafness including deafness caused by a mutation of the gene encoding for Otoferlin, hearing loss caused by GJB2 gene mutations as well as Usher Syndrome Type 1 to potentially address important hearing loss segments in adults and children.

About Sensorion

Sensorion is a pioneering clinical-stage biotech company, which specializes in the development of novel therapies to restore, treat and prevent hearing loss disorders, a significant global unmet medical need.

Sensorion has built a unique R&D technology platform to expand its understanding of the pathophysiology and etiology of inner ear related diseases, enabling it to select the best targets and modalities for drug candidates. Its portfolio combines both small molecule programs and a preclinical portfolio of inner ear gene therapies.

Its clinical-stage portfolio includes one Phase 2 product: SENS-401 (Arazasetron) progressing in a planned Phase 2 study of SENS-401 clinical study in cisplatin-induced ototoxicity (CIO) and, with partner Cochlear Limited, a study of SENS-401 in patients scheduled for cochlear implantation.

Sensorion has entered into a broad strategic collaboration with Institut Pasteur focused on the genetics of hearing. It has three gene therapy programs aimed at correcting hereditary monogenic forms of deafness including deafness caused by a mutation of the gene encoding for Otoferlin, Usher Syndrome Type 1 related deafness and hearing loss related to mutation in GJB2 gene to potentially address important hearing loss segments in adults and children. The Company is also working on the identification of biomarkers to improve diagnosis of these underserved illnesses.

www.sensorion.com

About AUDIBLE-S

The Phase 2 AUDIBLE-S study is a randomized, double-blind, placebo-controlled multi-center Phase 2 study. Primary objective of the study is to assess the efficacy of SENS-401 on hearing loss in comparison to placebo at the end of the 4-week treatment period. Patients with severe or profound sudden sensorineural hearing loss were recruited within 96 hours after onset of a sudden and severe hearing loss and randomized to either two treatment arms (29mg and 43.5mg twice a day oral dosing) or placebo. Change in pure tone audiometry PTA (dB) in the affected ear from baseline to the end of treatment visit is the primary outcome measure of the study.

About SENS-401

SENS-401 (Arazasetron), is a drug candidate that aims to protect and preserve inner ear tissue from damage that can cause progressive or sequelar hearing impairment. A small molecule that can be taken orally or via an injection, SENS-401 has received Orphan Drug Designation in Europe for the treatment of sudden sensorineural hearing loss, and Orphan Drug Designation from the US FDA for the prevention of platinum-induced ototoxicity in pediatric population. It has received Investigational New Drug (IND) clearance from the US Food and Drug Administration (FDA).

Label: SENSORION

ISIN: FR0012596468

Mnemonic: ALSEN

Disclaimer

This press release contains certain forward-looking statements concerning Sensorion and its business. Such forward looking statements are based on assumptions that Sensorion considers to be reasonable. However, there can be no assurance that such forward-looking statements will be verified, which statements are subject to numerous risks, including the risks set forth in the 2020 annual financial report published on April 9, 2021 and available on our website and to the development of economic conditions, financial markets and the markets in which Sensorion operates. The forward-looking statements contained in this press release are also subject to risks not yet known to Sensorion or not currently considered material by Sensorion. The occurrence of all or part of such risks could cause actual results, financial conditions, performance or achievements of Sensorion to be materially different from such forward-looking statements. This press release and the information that it contains do not constitute an offer to sell or subscribe for, or a solicitation of an offer to purchase or subscribe for, Sensorion shares in any country. The communication of this press release in certain countries may constitute a violation of local laws and regulations. Any recipient of this press release must inform oneself of any such local restrictions and comply therewith.

Contacts

Investor Relations
Catherine Leveau

Head of Investor Relations & Communication

ir.contact@sensorion-pharma.com
+ 33 6 72 18 00 22

International Media Relations
Consilium Strategic Communications

Mary-Jane Elliott/Jessica Hodgson

+ 44 7739 788014

+44 7561 424788

sensorion@consilium-comms.com

Pharmaron Appoints Dr. Antony Davies as Senior Vice President, UK CMC

Pharmaron Appoints Dr. Antony Davies as Senior Vice President, UK CMC




Pharmaron Appoints Dr. Antony Davies as Senior Vice President, UK CMC

BEIJING–(BUSINESS WIRE)–Pharmaron Beijing Co., Limited (Stock Code: 300759.SZ/3759.HK) (“Pharmaron”) today announced the appointment of Dr. Antony (Tony) Davies as Senior Vice President, UK CMC, effective January 10, 2022. The UK Chemistry, Manufacturing and Control (CMC) business includes operations in Hoddesdon and Cramlington, UK.

Tony has been Senior Vice President, Process R&D, since 2019, having been promoted from Vice President, Process Chemistry, a post he held since Pharmaron acquired the MSD Hoddesdon site in 2016. Prior to this, he was Director of Process Chemistry at MSD where he had worked for 25 years. Tony received his Ph.D. degree in organic chemistry from the University of East Anglia and his MBA from Cass Business School.

The UK CMC business currently includes operations in Hoddesdon and Cramlington, UK. The Hoddesdon site offers services in discovery, process development, early-stage cGMP API manufacturing, formulation development and drug product GMP manufacturing. The Cramlington site, acquired by Pharmaron on January 10, 2022, from Recipharm, offers cGMP manufacturing services ranging from pilot scale to commercial metric ton scale.

The expansion of Pharmaron’s world-class chemistry and manufacturing portfolio is an important component of its fully integrated platform. Given Tony’s leadership success at the Hoddesdon site, he has been appointed to oversee the UK CMC business, which includes the integration of the Cramlington site.

Tony reports directly to Pharmaron Chairman and CEO, Dr. Boliang Lou.

About Pharmaron

Pharmaron (Stock Code: 300759.SZ/3759.HK) is a premier R&D service provider for the life sciences industry. Founded in 2004, Pharmaron has invested in its people and facilities, and established a broad spectrum of research, development and manufacturing service capabilities throughout the entire drug discovery, preclinical and clinical development process across multiple therapeutic modalities, including small molecules, biologics and CGT products. With over 15,000 employees, and operations in China, the U.S., and the U.K., Pharmaron has an excellent track record in the delivery of R&D solutions to its partners in North America, Europe, Japan and China. www.pharmaron.com

Contacts

For more information, please contact:
Ellen Cabral (Media) Tel: +1 617 901 2216, ellen.cabral@pharmaron.com

Zymeworks Reports Inducement Grant Under New York Stock Exchange Listed Company Manual Rule

Zymeworks Reports Inducement Grant Under New York Stock Exchange Listed Company Manual Rule




Zymeworks Reports Inducement Grant Under New York Stock Exchange Listed Company Manual Rule

VANCOUVER, British Columbia & SEATTLE–(BUSINESS WIRE)–Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, today reported, as required by the New York Stock Exchange Listed Company Manual Rule 303A.08 (the “NYSE Rule”), an equity inducement award to Mr. Kenneth Galbraith, Zymeworks’ new Chair, President and Chief Executive Officer.

In accordance with the NYSE Rule, Zymeworks approved the grant of the following equity award to Mr. Galbraith as a material inducement to Mr. Galbraith entering into employment with Zymeworks: effective as of the date his employment with Zymeworks began, a stock option to purchase 500,000 of the company’s common shares (the “Options”). The Options have an exercise price per share of $14.97, which equals the closing price of the company’s common shares on January 14, 2022, and have a maximum term of 10 years. Mr. Galbraith’s employment with the company began on January 15, 2022 (the “Start Date”).

The Options will vest over a four-year period as follows: (i) 1/4 of the Options will vest on the one-year anniversary of the Start Date and (ii) 1/36 of the remaining Options will vest on the last day of each month following the one-year anniversary of the Start Date until all of the Options have vested, subject to Mr. Galbraith’s continued service. In addition, (i) if there is a change of control and within 12 months following, or within three months prior to, such change of control, his employment is terminated by the company without cause or (ii) upon his death or disability, 100% of the unvested Options will become fully vested as of the termination of his employment or the date of his death or disability, as applicable.

The Options were granted outside of the company’s Amended and Restated Stock Option and Equity Compensation Plan (the “Current Plan”) under the recently adopted Zymeworks Inc. Inducement Stock Option and Equity Compensation Plan and related option agreement, but will be subject to terms and conditions generally consistent with those in the Current Plan other than with respect to such other terms and conditions intended to comply with the NYSE inducement award exception.

About Zymeworks Inc.

Zymeworks is a clinical-stage biopharmaceutical company dedicated to the development of next-generation multifunctional biotherapeutics. Zymeworks’ suite of therapeutic platforms and its fully integrated drug development engine enable precise engineering of highly differentiated product candidates. Zymeworks’ lead clinical candidate, zanidatamab, is a novel Azymetric™ HER2-targeted bispecific antibody currently being evaluated in multiple Phase 1, Phase 2, and pivotal clinical trials globally as a targeted treatment option for patients with solid tumors that express HER2. Zymeworks’ second clinical candidate, ZW49, is a novel bispecific HER2‑targeted antibody-drug conjugate currently in Phase 1 clinical development and combines the unique design and antibody framework of zanidatamab with Zymeworks’ proprietary ZymeLink™ linker and cytotoxin. Zymeworks is also advancing a deep preclinical pipeline in oncology (including immuno-oncology agents) and other therapeutic areas. In addition, its therapeutic platforms are being leveraged through strategic partnerships with global biopharmaceutical companies. For more information on our ongoing clinical trials visit www.zymeworksclinicaltrials.com. For additional information about Zymeworks, visit www.zymeworks.com and follow @ZymeworksInc on Twitter.

Contacts

Investor Inquiries:
Ryan Dercho, Ph.D.

(604) 678-1388

ir@zymeworks.com

Jack Spinks

(604) 678-1388

ir@zymeworks.com

Media Inquiries:
Mary Klem

(604) 678-1388

media@zymeworks.com

Dermavant Presents New Patient Satisfaction Data from PSOARING 3 Long Term Extension Trial of Tapinarof in Adults with Plaque Psoriasis at the 2022 Winter Clinical Dermatology Conference

Dermavant Presents New Patient Satisfaction Data from PSOARING 3 Long Term Extension Trial of Tapinarof in Adults with Plaque Psoriasis at the 2022 Winter Clinical Dermatology Conference




Dermavant Presents New Patient Satisfaction Data from PSOARING 3 Long Term Extension Trial of Tapinarof in Adults with Plaque Psoriasis at the 2022 Winter Clinical Dermatology Conference

– Patients from PSOARING 3 who completed the survey preferred tapinarof to prior topical treatments with 81.7% considering it more effective –

LONG BEACH, Calif. & BASEL, Switzerland–(BUSINESS WIRE)–Dermavant Sciences, a clinical-stage biopharmaceutical company dedicated to developing and commercializing innovative therapeutics in immuno-dermatology, today announced results from a patient satisfaction questionnaire in the long-term, open-label Phase 3 PSOARING 3 extension study of tapinarof cream 1% once daily for the treatment of plaque psoriasis in adults. Patient responses demonstrated consistent high rates of satisfaction and positive perception of treatment with tapinarof across all patient-relevant parameters, including patient satisfaction with treatment efficacy, formulation elegance, ease of application, impact on daily life and preference for tapinarof versus prior psoriasis therapies. These results were presented during the 2022 Winter Clinical Dermatology Conference, held January 14-19 in Koloa, Hawaii.

“As a clinician, it’s paramount that my patients are satisfied with their treatment, as research shows that patients who are satisfied with their treatment are more likely to continue treatment, which may improve treatment efficacy. I am encouraged by these results with tapinarof showing consistent patient satisfaction, which has often been difficult to achieve with current psoriasis treatments, including steroidal topicals,” said Jerry Bagel, M.D., M.S., director of the Psoriasis Treatment Center of New Jersey and Eczema Treatment Center of New Jersey in East Windsor, a member of the National Psoriasis Foundation board of directors, and lead author of this publication. “Building on previous PSOARING 3 results, these findings demonstrate that tapinarof, subject to FDA approval, has the potential to be a long-awaited new treatment option to improve the care of patients suffering from this debilitating, chronic condition.”

Responses to the questionnaire, which were assessed at study completion (week 40 or early termination), demonstrated consistent high rates of satisfaction across all evaluated parameters. Of the 78.5% (599/763) of patients from PSOARING 3 who completed the survey:

  • Patients preferred tapinarof to prior topical treatments with 81.7% considering it more effective.
  • 85.8% either strongly agreed or agreed they could easily manage their psoriasis with tapinarof.
  • 82.5% expressed that they would use tapinarof again or continue using it if available.

“As a team that is driven by a passion for helping patients, we are delighted to present findings for patient satisfaction with tapinarof from PSOARING 3 during the 2022 Winter Clinical Dermatology Conference, highlighting our continued commitment to addressing unmet needs for patients with inflammatory skin conditions,” said Philip M. Brown, M.D., J.D., Chief Medical Officer of Dermavant. “We know that patients with plaque psoriasis and their physicians are looking for non-steroidal topical treatment options, and we hope to bring long-overdue innovation to this community.”

In August 2021, the FDA accepted a New Drug Application for tapinarof for the treatment of plaque psoriasis in adult patients and assigned a Prescription Drug User Fee Act target action date in Q2 2022.

About Dermavant’s Phase 3 Program for Tapinarof in Psoriasis

Dermavant’s pivotal Phase 3 clinical program for tapinarof in adult plaque psoriasis consists of PSOARING 1 (NCT03956355) and PSOARING 2 (NCT03983980), as well as PSOARING 3 (NCT04053387), a long-term extension study.

PSOARING 1 and PSOARING 2, which collectively enrolled 1,025 patients, were two identically designed, multi-center, randomized, vehicle-controlled, double-blind, parallel group studies conducted in North America that evaluated the safety and efficacy of tapinarof cream, 1% dosed once daily (QD) for 12 weeks versus vehicle QD in adult patients aged 18-75 years diagnosed with plaque psoriasis. The primary endpoint of both studies was the proportion of patients who achieved a PGA score of clear (0) or almost clear (1) with a minimum 2-grade improvement from baseline at Week 12.

PSOARING 3 was a long-term, open-label, extension study to evaluate the safety and efficacy of tapinarof cream, 1% for the treatment of plaque psoriasis in adults. Patients in the study had previously completed treatment with tapinarof or vehicle in either the PSOARING 1 or PSOARING 2 Phase 3 pivotal efficacy and safety studies. PSOARING 3 consisted of up to 40 weeks of tapinarof cream, 1%, and a 4-week safety follow-up period. As such, patients who received drug during PSOARING 1 and PSOARING 2 and who completed PSOARING 3, received treatment with tapinarof cream for up to 52 weeks. Greater than 90% of eligible patients who completed PSOARING 1 and PSOARING 2 enrolled in PSOARING 3. Dermavant released interim analysis results from PSOARING 3 in February 2021 and the study completed on April 5, 2021.

About Psoriasis

Psoriasis is a chronic, systemic, inflammatory skin disease characterized by red patches and plaques with silvery scales on the skin. Psoriasis affects approximately 8 million people in the United States and 125 million worldwide.

Psoriasis can begin at any age, but typically has two peaks of onset, the first at age 20 to 30 years and the second at age 50 to 60 years. People with psoriasis are at an increased risk of developing other chronic and serious health conditions. Comorbidities include psoriatic arthritis, inflammatory bowel disease, hypertension, diabetes, obesity, and depression. Psoriasis has a significant impact on quality of life and on psychological health.

About Dermavant

Dermavant Sciences, a subsidiary of Roivant Sciences, is a clinical-stage biopharmaceutical company dedicated to developing and commercializing innovative therapeutics in immuno-dermatology. Dermavant’s focus is to develop therapies that have the potential to address high unmet medical needs while driving greater efficiency in research and clinical development. The company’s robust medical dermatology pipeline includes both late-stage and earlier-stage-development product candidates the company believes could address important immuno-dermatological conditions, including psoriasis, atopic dermatitis, vitiligo, primary focal hyperhidrosis, and acne. Tapinarof is a novel, therapeutic aryl hydrocarbon receptor modulating agent, in development as a once-daily, steroid-free and cosmetically elegant topical cream for the treatment of plaque psoriasis and atopic dermatitis, which affect approximately 8 million and 26 million people in the United States, respectively. The company has reported positive Phase 3 results for tapinarof cream in adult patients with plaque psoriasis. For more information, please visit www.dermavant.com, and follow us on Twitter (@dermavant) and LinkedIn (Dermavant Sciences).

Contacts

Gilmartin:

Laurence Watts

Managing Director

laurence@gilmartinir.com
619-916-7620

dna Communications:

Angela Salerno-Robin

Senior Vice President, Media Relations, Healthcare

ASalerno-Robin@dna-comms.com
212-445-8219

U.S. FDA Approves Pfizer’s CIBINQO® (abrocitinib) for Adults with Moderate-to-Severe Atopic Dermatitis

U.S. FDA Approves Pfizer’s CIBINQO® (abrocitinib) for Adults with Moderate-to-Severe Atopic Dermatitis




U.S. FDA Approves Pfizer’s CIBINQO® (abrocitinib) for Adults with Moderate-to-Severe Atopic Dermatitis

CIBINQO is a once-daily oral treatment with proven efficacy to manage symptoms for adults who have not yet found relief with current options

NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE: PFE) announced today that the United States (U.S.) Food and Drug Administration (FDA) approved CIBINQO® (abrocitinib), an oral, once-daily, Janus kinase 1 (JAK1) inhibitor, for the treatment of adults living with refractory, moderate-to-severe atopic dermatitis (AD) whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies is inadvisable.

CIBINQO is approved at the recommended doses of 100 mg and 200 mg, with the 200 mg dose being recommended for patients who are not responding to the 100 mg dose. Additionally, a 50 mg dose was approved to treat moderate-to-severe AD specifically in patients with moderate renal impairment (kidney failure), certain patients receiving treatment with inhibitors of cytochrome P450 (CYP) 2C19, or patients who are known or suspected to be poor metabolizers of CYP2C19. For patients with moderate renal impairment who are not responding to 50 mg once daily, 100 mg once daily may also be prescribed.

“The reality for patients living with chronic inflammatory skin disease such as moderate-to-severe atopic dermatitis is that many experience debilitating symptoms that are not managed by current treatment options. Today’s approval of CIBINQO will provide an important new oral option that could help those who have yet to find relief,” said Jonathan Silverberg, MD, PhD, MPH, Department of Dermatology, The George Washington University School of Medicine and Health Sciences. “In multiple large-scale clinical trials, CIBINQO demonstrated strong efficacy at clearing skin, improving itch, and managing the extent and severity of eczema, offering a benefit-risk profile that supports the use of this treatment in the FDA-approved patient population.”

The FDA approval was based on results of five clinical trials from a large-scale clinical trial program of more than 1,600 patients. The safety and efficacy of CIBINQO was evaluated in three randomized, placebo-controlled, Phase 3 trials. Additionally, safety was evaluated through a randomized, placebo-controlled, dose-ranging trial and an ongoing long-term open-label extension trial. Across the trials, CIBINQO demonstrated a consistent safety profile and profound improvements in skin clearance, extent of disease, and severity, as well as rapid improvement in itch after two weeks, for some people living with AD versus placebo. In addition, a higher proportion of subjects treated with CIBINQO in two monotherapy trials achieved improvement in itching at week 12 compared to placebo.

“The FDA’s approval offers hope to the millions of patients across the U.S. who are suffering daily with an immuno-inflammatory condition that can cause intense and persistent itching, pain, discomfort, and distress if left uncontrolled,” said Mike Gladstone, Global President of Pfizer Inflammation & Immunology. “CIBINQO, an efficacious once-daily pill, is a medical breakthrough made possible by Pfizer researchers and the people living with moderate-to-severe atopic dermatitis who participated in our clinical trials.”

“Atopic dermatitis is so much more than just a rash, and it goes beyond the surface of the skin. It’s a chronic condition that can both significantly disrupt patients’ daily lives and negatively impact their emotional well-being,” said Julie Block, President and CEO, National Eczema Association. “We appreciate Pfizer’s commitment to this resilient patient community and eagerly await the positive impact CIBINQO could have on the treatment landscape for moderate-to-severe atopic dermatitis.”

The most common adverse events reported in ≥5% of patients with CIBINQO included nasopharyngitis (12.4% with CIBINQO 100 mg, 8.7% with CIBINQO 200 mg, and 7.9%, with placebo), nausea (6%, 14.5%, and 2.1%, respectively), and headache (6%, 7.8%, and 3.5%, respectively).

The full prescribing information for CIBINQO can be found here. CIBINQO will be made available in the coming weeks.

Additional Details on the CIBINQO Clinical Trial Program

Five clinical trials in the CIBINQO JAK1 Atopic Dermatitis Efficacy and Safety (JADE) global development program were included in the New Drug Application (NDA) to support the FDA approval.

The safety and efficacy of CIBINQO was evaluated in three Phase 3, randomized, placebo-controlled clinical trials. The trials evaluated measures of improvements in skin clearance, itch, disease extent, and severity, including the Investigator Global Assessment (IGA), Eczema Area and Severity Index (EASI), and Peak Pruritus Numerical Ratings Scale (PP-NRS). In each of the trials, over 40% of patients had prior exposure to a systemic therapy:

  • JADE MONO-1 and JADE MONO-2: A pair of randomized, double-blind, placebo-controlled trials designed to evaluate the efficacy and safety of two doses (100 mg and 200 mg once daily) of CIBINQO monotherapy in 778 patients 12 years of age and older with moderate-to-severe AD. The trials assessed the co-primary endpoints of IGA and EASI-75 responses at Week 12.
  • JADE COMPARE: A randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of two doses (100 mg and 200 mg once daily) of CIBINQO in 837 adult patients with moderate-to-severe AD on background topical medicated therapy. The trial also included an active control arm with dupilumab, a biologic treatment administered by subcutaneous injection, compared with placebo. The trial assessed the co-primary endpoints of IGA and EASI-75 responses at Week 12.

Select findings for CIBINQO 100 mg, 200 mg, and placebo follow (*p<0.01 or **p<0.001):

  • JADE MONO-1:

    • IGA Response Rate (Week 12): 24%*, 44%**, and 8%, respectively
    • EASI-75 Response Rate (Week 12): 40%**, 62%**, and 12%, respectively
  • JADE MONO-2

    • IGA Response Rate (Week 12): 28%**, 38%**, and 9%, respectively
    • EASI-75 Response Rate (Week 12): 44%**, 61%**, and 10%, respectively
  • JADE COMPARE

    • IGA Response Rate (Week 12): 36%**, 47%**, and 14%, respectively
    • EASI-75 Response Rate (Week 12): 58%**, 68%**, and 27%, respectively

Safety was additionally evaluated through a randomized dose-ranging trial and a long-term, open-label, extension trial (JADE EXTEND).

U.S. IMPORTANT SAFETY INFORMATION

WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS, AND THROMBOSIS

Serious Infections

Patients treated with CIBINQO may be at increased risk for developing serious infections that may lead to hospitalization or death. The most frequent serious infections reported with CIBINQO were herpes simplex, herpes zoster, and pneumonia.

If a serious or opportunistic infection develops, discontinue CIBINQO and control the infection.

Reported infections from Janus kinase (JAK) inhibitors used to treat inflammatory conditions:

  • Active tuberculosis, which may present with pulmonary or extrapulmonary disease. Test for latent TB before and during therapy; treat latent TB prior to use. Monitor all patients for active TB during treatment, even patients with initial negative, latent TB test.
  • Invasive fungal infections, including cryptococcosis and pneumocystosis. Patients with invasive fungal infections may present with disseminated, rather than localized, disease.
  • Bacterial, viral (including herpes zoster), and other infections due to opportunistic pathogens.

Avoid use of CIBINQO in patients with an active, serious infection, including localized infections. The risks and benefits of treatment with CIBINQO should be carefully considered prior to initiating therapy in patients with chronic or recurrent infections or those who have resided or traveled in areas of endemic tuberculosis or endemic mycoses.

Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with CIBINQO, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy.

Consider yearly screening for patients in highly endemic areas for TB. CIBINQO is not recommended for use in patients with active TB. For patients with a new diagnosis of latent TB or prior untreated latent TB, or for patients with a negative test for latent TB but who are at high risk for TB infection, start preventive therapy for latent TB prior to initiation of CIBINQO.

Viral reactivation, including herpes virus reactivation (eg, herpes zoster, herpes simplex), was reported in clinical studies with CIBINQO. If a patient develops herpes zoster, consider interrupting CIBINQO until the episode resolves. Hepatitis B virus reactivation has been reported in patients receiving JAK inhibitors. Perform viral hepatitis screening and monitoring for reactivation in accordance with clinical guidelines before starting therapy and during therapy with CIBINQO. CIBINQO is not recommended for use in patients with active hepatitis B or hepatitis C.

Mortality

In a large, randomized postmarketing safety study in rheumatoid arthritis (RA) patients 50 years of age and older with at least one cardiovascular risk factor comparing another JAK inhibitor to TNF blocker treatment, a higher rate of all-cause mortality (including sudden cardiovascular death) was observed with the JAK inhibitor. CIBINQO is not approved for use in RA patients.

Malignancies

Malignancies, including non-melanoma skin cancer (NMSC), were reported in patients treated with CIBINQO. Lymphoma and other malignancies have been observed in patients receiving JAK inhibitors used to treat inflammatory conditions. Perform periodic skin examination for patients who are at increased risk for skin cancer. Exposure to sunlight and UV light should be limited by wearing protective clothing and using broad-spectrum sunscreen.

In a large, randomized postmarketing safety study of another JAK inhibitor in RA patients, a higher rate of malignancies (excluding non-melanoma skin cancer [NMSC]) was observed in patients treated with the JAK inhibitor compared to those treated with TNF blockers. CIBINQO is not approved for use in RA patients. A higher rate of lymphomas was observed in patients treated with the JAK inhibitor compared to those treated with TNF blockers. A higher rate of lung cancers was observed in current or past smokers treated with the JAK inhibitor compared to those treated with TNF blockers. Patients who are current or past smokers are at additional increased risk.

Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with CIBINQO, particularly in patients with a known malignancy (other than a successfully treated NMSC), patients who develop a malignancy when on treatment, and patients who are current or past smokers.

Major Adverse Cardiovascular Events

Major adverse cardiovascular events were reported in patients treated with CIBINQO. In RA patients 50 years of age and older with at least one cardiovascular risk factor treated with another JAK inhibitor, a higher rate of major adverse cardiovascular events (MACE) (defined as cardiovascular death, myocardial infarction, and stroke), was observed when compared with TNF blockers. CIBINQO is not approved for use in RA patients. Patients who are current or past smokers are at additional increased risk. Discontinue CIBINQO in patients that have experienced a myocardial infarction or stroke.

Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with CIBINQO, particularly in patients who are current or past smokers and patients with other cardiovascular risk factors. Patients should be informed about the symptoms of serious cardiovascular events and the steps to take if they occur.

Thrombosis

Deep vein thrombosis (DVT) and pulmonary embolism (PE) have been reported in patients treated with CIBINQO. Thrombosis, including PE, DVT, and arterial thrombosis have been reported in patients receiving JAK inhibitors used to treat inflammatory conditions. Many of these adverse reactions were serious and some resulted in death. In RA patients 50 years of age and older with at least one cardiovascular risk factor treated with another JAK inhibitor, a higher rate of overall thrombosis, DVT, and PE were observed when compared with TNF blockers. CIBINQO is not approved for use in RA patients.

Avoid CIBINQO in patients that may be at increased risk of thrombosis. If symptoms of thrombosis occur, discontinue CIBINQO and treat patients appropriately.

Contraindication

CIBINQO is contraindicated in patients taking antiplatelet therapies, except for low-dose aspirin (≤81 mg daily), during the first 3 months of treatment.

Laboratory Abnormalities

Hematologic Abnormalities: Treatment with CIBINQO was associated with an increased incidence of thrombocytopenia and lymphopenia. Prior to CIBINQO initiation, perform a complete blood count (CBC). CBC evaluations are recommended at 4 weeks after initiation and 4 weeks after dose increase of CIBINQO. Discontinuation of CIBINQO therapy is required for certain laboratory abnormalities.

Lipid Elevations: Dose-dependent increase in blood lipid parameters were reported in patients treated with CIBINQO. Lipid parameters should be assessed approximately 4 weeks following initiation of CIBINQO therapy, and thereafter patients should be managed according to clinical guidelines for hyperlipidemia. The effect of these lipid parameter elevations on cardiovascular morbidity and mortality has not been determined.

Immunizations

Prior to initiating CIBINQO, complete all age-appropriate vaccinations as recommended by current immunization guidelines, including prophylactic herpes zoster vaccinations. Avoid vaccination with live vaccines immediately prior to, during, and immediately after CIBINQO therapy.

Renal Impairment

Avoid use in patients with severe renal impairment or end stage renal disease, including those on renal replacement therapy.

Hepatic Impairment

Avoid use in patients with severe hepatic impairment.

Adverse Reactions

Most common adverse reactions (≥1%) in subjects receiving 100 mg and 200 mg include: nasopharyngitis, nausea, headache, herpes simplex, increased blood creatinine phosphokinase, dizziness, urinary tract infection, fatigue, acne, vomiting, oropharyngeal pain, influenza, gastroenteritis.

Most common adverse reactions (≥1%) in subjects receiving either 100 mg or 200 mg also include: impetigo, hypertension, contact dermatitis, upper abdominal pain, abdominal discomfort, herpes zoster, and thrombocytopenia.

Use in Pregnancy

Available data from pregnancies reported in clinical trials with CIBINQO are not sufficient to establish a drug-associated risk for major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Advise females of reproductive potential that CIBINQO may impair fertility.

There will be a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to CIBINQO during pregnancy. Pregnant women exposed to CIBINQO and health care providers are encouraged to call 1-877-311-3770.

Lactation

Advise women not to breastfeed during treatment with CIBINQO and for one day after the last dose.

Indication

CIBINQO is indicated for the treatment of adults with refractory, moderate to severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies is inadvisable.

Limitations of Use: CIBINQO is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, or with other immunosuppressants.

About CIBINQO® (abrocitinib)

CIBINQO is an oral small molecule that selectively inhibits Janus kinase (JAK) 1. Inhibition of JAK1 is thought to modulate multiple cytokines involved in pathophysiology of AD, including interleukin IL-4, IL-13, IL-31, IL-22, and thymic stromal lymphopoietin (TSLP).

In addition to receiving regulatory approval in the U.S., CIBINQO has received marketing authorization in the European Union, Great Britain, Japan, Korea, the United Arab Emirates, Norway, Iceland, and Singapore.

About Atopic Dermatitis

AD is a chronic skin disease characterized by inflammation of the skin and skin barrier defects.i,ii Most people know AD is a skin condition. But many don’t realize it can be caused in part by an abnormal immune response beneath the skin. This dysregulated immune response is thought to contribute to inflammation within the skin and the signs of AD on the surface. Lesions of AD are characterized by erythema (red/pink or discolored skin patches, depending on normal skin color), itching, lichenification (thick/leathery skin), induration (hardening)/papulation (formulation of papules), and oozing/crusting.i,ii

AD is one of the most common inflammatory skin diseases, affecting approximately 5-10% of adults in the U.S.iii,iv Approximately 1 in 3 adults with AD have moderate-to-severe disease.v,vi

About Pfizer Inflammation & Immunology

At Pfizer Inflammation & Immunology, we strive to deliver breakthroughs that enable freedom from day-to-day suffering for people living with autoimmune and chronic inflammatory diseases, which can be debilitating, disfiguring and distressing, dramatically affecting what they can do. With a focus on immuno-inflammatory conditions in Rheumatology, Gastroenterology and Medical Dermatology, our current portfolio of approved medicines and investigational molecules spans multiple action and delivery mechanisms, from topicals to small molecules, biologics and biosimilars. The root cause of many immunological diseases is immuno-inflammation, which requires specifically designed agents. Our differentiated R&D approach resulted in one of the broadest pipelines in the industry, where we purposefully match molecules to diseases where we believe they can make the biggest difference. Building on our decades-long commitment and pioneering science, we continue to advance the standard of care for patients living with immuno-inflammatory diseases and are working hand-in-hand with patients, caregivers and the broader healthcare community on healthcare solutions for the many challenges of managing chronic inflammatory diseases, allowing patients to live their best lives.

Pfizer Inc.: Breakthroughs that Change Patients’ Lives

At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety, and value in the discovery, development, and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments, and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world’s premier innovative biopharmaceutical companies, we collaborate with health care providers, governments, and local communities to support and expand access to reliable, affordable health care around the world. For more than 170 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.pfizer.com. In addition, to learn more, please visit us on www.pfizer.com and follow us on Twitter at @Pfizer and @Pfizer_News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.

DISCLOSURE NOTICE: The information contained in this release is as of January 14, 2022. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.

This release contains forward-looking information about CIBINQO (abrocitinib), including its potential benefits, an approval in the U.S. and anticipated product availability, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for our clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; whether and when drug applications may be filed in any other jurisdictions for any potential indication for CIBINQO; whether and when any such other applications that may be pending or filed for CIBINQO may be approved by regulatory authorities, which will depend on myriad factors, including making a determination as to whether the product’s benefits outweigh its known risks and determination of the product’s efficacy and, if approved, whether CIBINQO will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of CIBINQO; uncertainties regarding the commercial or other impact of the results of Janus kinase (JAK) inhibitor studies and data and actions by regulatory authorities based on analysis of such studies and data, which will depend, in part, on benefit-risk assessments and labeling determinations; uncertainties regarding the impact of COVID-19 on our business, operations, and financial results; and competitive developments.

A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2020 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results”, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com.


i Hanifin JM, Reed ML. A population-based survey of eczema in the United States. Dermatitis. 2007;18(2):82-91.

ii Bieber T. Atopic dermatitis. Dermatology. 2012;1(3):203-217.

iii Oszukowska M, Michalak I, Gutfreund K, et al. Role of primary and secondary prevention in atopic dermatitis. Postep Derm Alergol. 2015:32(6):409-420.

iv Kim BE, Leung DYM. Significance of Skin Barrier Dysfunction in Atopic Dermatitis. Allergy Asthma Immunol Res. 2018;10(3):207-215. doi:10.4168/aair.2018.10.3.207.

v Silverberg JI. Public health burden and epidemiology of atopic dermatitis. Dermatol Clin. 2017;35:283-289.

vi Chiesa Fuxench ZC, Block JK, Boguniewicz M, et al. Atopic dermatitis in America study: a cross-sectional study examining the prevalence and disease burden of atopic dermatitis in the US adult population. J Invest Dermatol. 2019;139(3):583-590.

Contacts

Media Relations:
+1 (212) 733-1226
PfizerMediaRelations@Pfizer.com

Investor Relations:
+1 (212) 733-4848
IR@Pfizer.com

VastBiome Announces Large Exploratory Prospective Data Collection to Understand Basic Science of the Microbiome and Immune Checkpoint Inhibitor Therapy

VastBiome Announces Large Exploratory Prospective Data Collection to Understand Basic Science of the Microbiome and Immune Checkpoint Inhibitor Therapy




VastBiome Announces Large Exploratory Prospective Data Collection to Understand Basic Science of the Microbiome and Immune Checkpoint Inhibitor Therapy

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–VastBiome is announcing sponsorship of an observational clinical study designed to collect data to understand molecular associations between immune checkpoint inhibitor (ICI) therapy and the gut microbiome (the collection of bacteria and other bugs living in the gastrointestinal tract). This study, named PARADIGM (Pursuit to Analyze and Reveal Associated Drivers of Immunotherapy outcomes through the Gut Microbiome) is listed on ClinicalTrials.gov (NCT05037825) and actively enrolling patients.

PARADIGM will monitor patients’ immune system and microbiome across multiple cycles of ICI therapy and its findings may offer new insights into the microbiome’s role in cancer and its effects on the host immune system. PARADIGM will recruit a large cohort of patients with non-small cell lung cancer, malignant melanoma, renal cell carcinoma, and triple-negative breast cancer and will examine blood, stool, imaging and medical record information describing cancer diagnosis, treatment, comorbidities, and concurrent medications. This rich scientific information may inform development of improved ICI therapies for future patients.

VastBiome’s Co-Founder and CEO, Kareem Barghouti, said, “Links between the gut microbiome and ICI therapy have been made evident in a number of high-profile publications, and there remains great opportunity to build on these studies with larger and more cohesive patient datasets. Such data is necessary to understand useful mechanisms and identify potential therapies. PARADIGM will provide these data by profiling the microbiome and host at unprecedented depth. We are grateful to our clinical partners and most importantly, our patients who make PARADIGM—and a future for better treatments—possible.”

The microbiome space has evolved rapidly over the past several years with multiple live biotherapies, engineered strains, pre- and probiotics making their way into clinical testing. Through PARADIGM, VastBiome aims to enhance therapeutic development by understanding the activity of particular natural products produced by gut microbes, bringing together the chemical depth of the gut ecosystem with modern drug development processes.

About VastBiome

VastBiome, is a drug discovery company mining the gut microbiome for small molecules to treat immunological disorders and advance immunotherapy. Using artificial intelligence and synthetic biology, VastBiome indexes the microbiome for molecules with therapeutic properties. These proprietary assets enable development of best-in-class medicines, leveraging the chemical richness of the gut microbial ecosystem.

http://www.vastbiome.com.

Contacts

Hanane Arib, Head of Clinical Operations

Hanane@vastbiome.com

Global Pharmaceutical Packaging Industry 2021 – Temperature-sensitive Packaging for New-generation Biologics Presents Opportunities – ResearchAndMarkets.com

Global Pharmaceutical Packaging Industry 2021 – Temperature-sensitive Packaging for New-generation Biologics Presents Opportunities – ResearchAndMarkets.com




Global Pharmaceutical Packaging Industry 2021 – Temperature-sensitive Packaging for New-generation Biologics Presents Opportunities – ResearchAndMarkets.com

DUBLIN–(BUSINESS WIRE)–The “Global Pharmaceutical Packaging Growth Opportunities” report has been added to ResearchAndMarkets.com’s offering.

The COVID-19 pandemic has not only revealed supply chain challenges in terms of meeting pandemic-induced demand but also showcased weaknesses with regard to facing disruptions on a global scale. Immediate impacts include supply volatility, steep price increases, and high levels of uncertainty.

Despite the manufacturing reboot, supply chain interruptions have created a ripple effect. In addition, the lack of time stamps across the supply chain and the poor tracing of the chain of custody of drugs have reduced the shelf life of existing inventory and increased wastage-related risks.

With the Pfizer-BioNTech vaccine receiving FDA approval, the Moderna and the Johnson & Johnson vaccines reaching patients under emergency use authorization (EUA), and the authorization of booster doses, an exemplary supply chain is required, and it must comprise capabilities for direct shipment to point of use, local cross-docking of cooling boxes, and local warehousing. Considering the stringent storage requirements for vaccines, a robust cold-chain network for transportation and storage must be established. Therefore, local manufacturing deals, supply chain investments, and packaging innovation will continue to play important roles in the global push for immunization.

For the biopharma industry, positive long-term developments and growth opportunities can outweigh the detrimental short-term impacts of the ongoing pandemic. The industry will witness increased digitalization to build more resilient supply chains to drive flexibility and transparency across manufacturing, packaging, and documentation across the chain of custody.

Companies Mentioned

  • BioNTech
  • FDA
  • Johnson & Johnson
  • Moderna
  • Pfizer

This study will:

  • Provide an overview of the evolving pharmaceutical packaging industry ecosystem, with a focus on the billion-dollar growth opportunities in drug delivery packaging.
  • Highlight the potential disruptions in pharmaceutical packaging caused by blockchain technology, sensors, RFID, NFC, wearable technology, microchips, green NFC, and single-use products.
  • Address how innovative packaging solutions are overcoming key challenges such as drug counterfeiting, the localization of fill and finish, operational costs, complex supply chains, cold-chain handling, and chemical degradation and leaching.

Key Topics Covered:

1. Strategic Imperatives

2. Growth Opportunity Analysis

  • Scope and Segmentation
  • The Impact of the COVID-19 Pandemic on the Pharmaceutical Packaging Market
  • Market Background
  • Trends in the Handling of Biologics Products
  • Key Themes and Market Dynamics
  • Primary Forces Catalyzing Change
  • Growth Drivers
  • Growth Restraints
  • Vendor Ecosystem

3. Growth Opportunity Universe

  • GO Universe – A Summary
  • Growth Opportunity 1: Scalable Smart Packaging for Improved Health Outcomes
  • Illustrative Smart Packaging Solutions
  • Companies to Action
  • Growth Opportunity 2: Temperature-sensitive Packaging for New-generation Biologics
  • Advancements in Packaging for Cold Chain
  • Case Examples in Biopharma Cold Chain

4. Appendix

5. List of Exhibits

For more information about this report visit https://www.researchandmarkets.com/r/8o1x01

Contacts

ResearchAndMarkets.com

Laura Wood, Senior Press Manager

press@researchandmarkets.com

For E.S.T Office Hours Call 1-917-300-0470

For U.S./CAN Toll Free Call 1-800-526-8630

For GMT Office Hours Call +353-1-416-8900

ProtoKinetix Announces Annual General Stockholder Meeting Will Be Held Virtually Only

ProtoKinetix Announces Annual General Stockholder Meeting Will Be Held Virtually Only




ProtoKinetix Announces Annual General Stockholder Meeting Will Be Held Virtually Only

MARIETTA, Ohio–(BUSINESS WIRE)–ProtoKinetix, Incorporated (www.protokinetix.com) (the “Company” or “ProtoKinetix”) (OTCQB: PKTX), a clinical-stage biomedical company, today announced that it will hold its Annual General Meeting of the Stockholders of the Company (“AGM”) virtually with no option to attend the AGM in person due to ongoing COVID-19 concerns.

As set forth in the Company’s definitive proxy materials as filed with the Securities and Exchange Commission on December 30, 2021, the AGM will be held on Friday, February 11, 2022 at 4:00 p.m. Eastern Standard Time, via webcast at: www.virtualshareholdermeeting.com/PKTX2022.

If you have not received your proxy package, please contact the Company directly:

Clarence E. Smith

President and Chief Executive Officer

Telephone: 740-434-5041

Email: csmith@protokinetix.com

About ProtoKinetix, Incorporated

Cautionary Note Regarding Forward-Looking Statements

The information discussed in this press release includes “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. All statements, other than statements of historical facts, included herein concerning, among other things, planned capital expenditures, future cash flows and borrowings, pursuit of potential acquisition opportunities, our financial position, business strategy and other plans and objectives for future operations, are forward looking statements. Although we believe that the expectations reflected in these forward-looking statements are reasonable, they do involve certain assumptions, risks and uncertainties and are not (and should not be considered to be) guarantees of future performance. Refer to our risk factors set forth in our reports filed on Edgar. ProtoKinetix disclaims any obligation to update any forward-looking statement made here.

This press release does not constitute or form a part of any offer or solicitation to purchase or subscribe for securities in the United States.

Contacts

Clarence E. Smith
President and Chief Executive Officer
Telephone: 740-434-5041

Email: csmith@protokinetix.com
Twitter: @ProtoKinetix

LetsGetChecked Expands COVID-19 Offering With Antigen Testing and Virtual Observation Services To Empower Employers to Protect The Health and Wellbeing of Employees

LetsGetChecked Expands COVID-19 Offering With Antigen Testing and Virtual Observation Services To Empower Employers to Protect The Health and Wellbeing of Employees




LetsGetChecked Expands COVID-19 Offering With Antigen Testing and Virtual Observation Services To Empower Employers to Protect The Health and Wellbeing of Employees

The company’s latest offering will provide employers with the tools and support they need to foster a safe work environment for employees

NEW YORK–(BUSINESS WIRE)–LetsGetChecked, a global healthcare solutions company, announced today the introduction of its COVID-19 antigen test and virtual observation service for enterprise clients. This will build upon the company’s existing COVID-19 and home healthcare offering, which includes molecular diagnostic testing, biometric screening, and testing as well as virtual care and pharmacy support for a range of health and wellness conditions.

Despite the Supreme Court ruling to block the Biden administration’s U.S. Occupational Safety and Health Administration (OSHA) vaccine and testing mandate, LetsGetChecked’s COVID-19 testing, reporting, and compliance tools will help employers keep their employees safe at work.

“There is an unprecedented need for rapid testing with observation and our end-to-end virtual care model makes us uniquely poised to meet this demand,” said Peter Foley, Founder and CEO of LetsGetChecked. “Though our antigen test and virtual observation offering will initially be introduced to our enterprise clients, the platform has been developed to be test agnostic, meaning it can be plugged into any manufacturer’s supply chain and provided to any organization or individual.”

LetsGetChecked will introduce rapid testing with virtual observation and reporting to complement its existing gold standard lab-based molecular diagnostic offering and provide employers with an end-to-end solution to promote safe work environments. LetsGetChecked is committed to supporting employers as they navigate the increasingly complex testing requirements particularly as they are rolled out at a state level.

“We have listened to the market and understand the great need for a robust COVID-19 solution, including molecular diagnostics, lab pooling, antigen tests, and virtual observation capabilities,” said Mike Smit, CCO of LetsGetChecked. “LetsGetChecked’s end-to-end infrastructure as a healthcare solutions provider has enabled us to meet employer needs and empower them with all the tools and support they need in this ever changing regulatory landscape.”

LetsGetChecked will begin by supplying antigen tests and virtual observations for its enterprise clients, and will be expanding the offering to consumers in the near future. To date, the company has delivered nearly three million tests and served more than 300 corporate customers with testing services and biometric screening solutions since it was founded in 2015.

To learn more about LetsGetChecked, please visit www.LetsGetChecked.com.

About LetsGetChecked

LetsGetChecked is a global healthcare solutions company that provides the tools to manage health from home through direct access to diagnostic testing, virtual care, and medication delivery for a wide range of health and wellness conditions. LetsGetChecked’s end-to-end model includes manufacturing, logistics, lab analysis, physician support, and prescription fulfillment. Founded in 2015, the company empowers people with accessible health information and care to live longer, happier lives.

LetsGetChecked is available nationwide in the United States, the United Kingdom, and most EU countries. It is co-headquartered in Dublin and New York.

Contacts

Jacqueline Reed, letsgetchecked@azionepr.com