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International Overdose Awareness Day addresses critical life-saving issues

Observed on Aug. 31 each year, International Overdose Awareness Day seeks to create better understanding of overdose, reduce the stigma of drug-related deaths, create change that reduces the harms associated with drug use, and acknowledge the grief of family and friends left behind.

 

People of all backgrounds and socio-economic levels are affected by addiction. Although substance use disorder is a disease, there still is social stigma associated with drug use and overdose deaths.

 

This day of overdose awareness reminds us that people lost to overdose are not just statistics – they are loved.

 

In 2021, 138 people died in Mercer County of a suspected overdose. The tragedy of overdose is far too frequent; but can be prevented. Overdose prevention, education, and recognition play a crucial role in saving lives.

The Mercer County Department of Human Services’ Office on Addiction Services encourages all residents to have access to naloxone, a medication that can help rapidly reverse an opioid overdose.

Every month, the Office on Addiction Services collaborates with Rutgers Robert Wood Johnson Medical School to host a free, virtual training on the use of naloxone (brand name Narcan).

Naloxone rapidly reverses an opioid overdose by attaching to opioid receptors and reversing and blocking the effects of other opioids. Examples of opioids include heroin, fentanyl, hydrocodone/Vicodin, codeine, and morphine.

In the United States, most overdoses are caused by opioids. When administering naloxone during an overdose, it is still is critical to call 911 so that the individual can receive immediate medical attention.

The next training hosted in conjunction with Rutgers Robert Wood Johnson Medical School is Sept. 22.

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Healthcare Lifestyle Science

ENHERTU® approved in the U.S. as the first HER2 directed therapy for patients with previously treated HER2 mutant metastatic non-small cell lung cancer

  • Based on DESTINY-Lung02 results which showed Daiichi Sankyo and AstraZeneca’s ENHERTU reported a confirmed objective response rate of 57.7% in patients with HER2 mutant disease

 

TOKYO & BASKING RIDGE, N.J. — (BUSINESS WIRE) — Daiichi Sankyo (TSE: 4568) and AstraZeneca’s (LSE/STO/Nasdaq: AZN) ENHERTU® (fam-trastuzumab deruxtecan-nxki) has been approved in the U.S. for the treatment of adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, as detected by an FDA-approved test, and who have received a prior systemic therapy. This indication is approved under accelerated approval based on objective response rate (ORR) and duration of response (DoR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

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

 

The accelerated approval by the FDA was based on the results from the DESTINY-Lung02 phase 2 trial. An interim efficacy analysis in a pre-specified patient cohort showed that ENHERTU (5.4 mg/kg) demonstrated a confirmed ORR of 57.7% (n=52; 95% confidence interval [CI]: 43.2-71.3) in patients with HER2 mutant unresectable or metastatic non-squamous NSCLC who had received one prior systemic therapy as assessed by blinded independent central review (BICR). Complete responses (CR) were seen in 1.9% of patients (n=1) and partial responses (PR) in 55.8% of patients (n=29) with a median duration of response of 8.7 months (95% CI: 7.1-NE).

 

ENHERTU is the first HER2 directed medicine to be approved for the treatment of patients with HER2 mutant metastatic NSCLC. This is the third tumor type approved by the FDA for ENHERTU in three years. The approval follows the recently received Priority Review, as well as the Breakthrough Therapy Designation granted in 2020 by the FDA for this specific type of lung cancer based on the results of the DESTINY-Lung01 phase 2 trial. Results from the DESTINY-Lung02 trial will be presented at an upcoming medical meeting. Concurrently with this approval, the FDA also approved companion diagnostic tests to detect HER2 mutations in lung tumor tissue and plasma.

 

“The approval of trastuzumab deruxtecan in non-small cell lung cancer is an important milestone for patients and the oncology community,” said Bob T. Li, MD, PhD, MPH, Medical Oncologist and Physician-Scientist, Memorial Sloan Kettering Cancer Center, New York. “After two decades of research into the role of targeting HER2 in lung cancer, the approval of the first HER2 directed treatment option validates HER2 as an actionable target in lung cancer and marks an important step forward for treating this patient population with unmet medical needs.”

 

“The availability of ENHERTU as the first HER2 targeted treatment option for HER2 mutant non-small cell lung cancer is great news for patients,” said Upal Basu Roy, PhD, MPH, Executive Director of Research, LUNGevity. “We are thrilled to see a novel treatment option available that targets this group of rare mutations in lung cancer. This approval is a great reminder that access to high-quality biomarker testing will be critical to ensuring that patients whose tumors have HER2 mutations have access to these new therapies.”

 

ENHERTU is approved with Boxed WARNINGS for interstitial lung disease (ILD)/pneumonitis and Embryo-Fetal toxicity. In the DESTINY-Lung02 phase 2 trial, the safety of ENHERTU was further evaluated in an analysis of 101 patients with unresectable or metastatic HER2 mutant NSCLC who received at least one recommended dose of ENHERTU (5.4 mg/kg). The most common adverse reactions (frequency ≥20%), including laboratory abnormalities, were nausea, decreased white blood cell count, decreased hemoglobin, decreased neutrophil count, decreased lymphocyte count, decreased platelet count, decreased albumin, increased aspartate aminotransferase, increased alanine aminotransferase, fatigue, constipation, decreased appetite, vomiting, increased alkaline phosphatase, and alopecia. Serious adverse reactions in >1% of patients who received ENHERTU were ILD/pneumonitis, thrombocytopenia, dyspnea, nausea, pleural effusion, and increased troponin I. Fatality occurred in one patient with suspected ILD/pneumonitis (1%). Increased rates of ILD/pneumonitis were observed at a higher dose.

 

“We are excited that the FDA has granted accelerated approval for ENHERTU for patients with HER2 mutant metastatic non-small cell lung cancer. ENHERTU has now been approved in three different tumor types, underscoring its significant potential across several HER2 targetable tumors,” said Ken Keller, Global Head of Oncology Business, and President and CEO, Daiichi Sankyo, Inc. “We are continuing to evaluate the efficacy and safety of ENHERTU versus standard chemotherapy in our DESTINY clinical trials in lung cancer.”

 

“HER2 mutant non-small cell lung cancer is an aggressive form of disease which commonly affects young patients who have faced limited treatment options and a poor prognosis to date,” said Dave Fredrickson, Executive Vice President, Oncology Business Unit, AstraZeneca. “Today’s news provides these patients with the opportunity to benefit from a targeted therapy and highlights the importance of testing for predictive markers, including HER2 in lung cancer, at the time of diagnosis to ensure patients receive the most appropriate treatment for their specific disease.”

 

Daiichi Sankyo and AstraZeneca are committed to ensuring that patients in the U.S. who are prescribed ENHERTU can access the medication and receive necessary financial support. Provider and patient support, reimbursement and distribution for ENHERTU in the U.S. will be accessible by visiting www.ENHERTU4U.com or calling 1-833-ENHERTU (1-833-364-3788).

 

Please visit www.ENHERTU.com for full Prescribing Information, including Boxed WARNINGS, and Medication Guide.

 

Financial Considerations

Following approval in the U.S., an amount of $125 million is due from AstraZeneca to Daiichi Sankyo as a milestone payment for a second-line indication for ENHERTU in HER2 mutant NSCLC.

 

Sales of ENHERTU in the U.S. are recognized by Daiichi Sankyo. For further details on the financial arrangements, please consult the collaboration agreement from March 2019.

 

About DESTINY-Lung02

DESTINY-Lung02 is a global phase 2 trial evaluating the safety and efficacy of two doses (5.4 mg/kg or 6.4 mg/kg) of ENHERTU in patients with HER2 mutant metastatic NSCLC with disease recurrence or progression during or after at least one regimen of prior anticancer therapy that must have contained a platinum-based chemotherapy. The primary endpoint of the study is ORR as assessed by BICR. Secondary endpoints include disease control rate (DCR), DoR, progression-free survival (PFS), investigator-assessed ORR, overall survival (OS) and safety. DESTINY-Lung02 enrolled 152 patients at multiple sites, including Asia, Europe and North America. For more information about the trial, visit ClinicalTrials.gov.

 

About DESTINY-Lung01

DESTINY-Lung01 is a global phase 2, open-label, two-cohort trial evaluating the efficacy and safety of ENHERTU (6.4 mg/kg and 5.4 mg/kg) in patients with HER2 mutant (cohort 2, n=91) or HER2 overexpressing (cohort 1 and 1a, n=90) (defined as IHC 3+ or IHC 2+) unresectable or metastatic non-squamous NSCLC who had progressed after one or more systemic therapies. The primary endpoint is confirmed ORR by independent central review (ICR). Key secondary endpoints include DoR, DCR, PFS, OS and safety. DESTINY-Lung01 enrolled 181 patients at multiple sites, including Asia, Europe and North America.

 

Data from the DESTINY-Lung01 phase 2 trial were published in The New England Journal of Medicine. Primary results from previously-treated patients with HER2 mutations (cohort 2) of DESTINY-Lung01 demonstrated an ORR of 54.9% (n=50; 95% CI: 44.2-65.4) in patients treated with ENHERTU (6.4 mg/kg) as assessed by ICR. Out of a total of 91 patients, one (1.1%) CR and 49 (53.8%) PRs were observed.

 

A confirmed DCR of 92.3% (95% CI: 84.8-96.9) was seen with a reduction in tumor size observed in most patients. After a median follow-up of 13.1 months, the median DoR for ENHERTU was 9.3 months (95% CI: 5.7-14.7). The median PFS was 8.2 months (95% CI: 6.0-11.9) and the median OS was 17.8 months (95% CI: 13.8-22.1).

 

The safety profile of the most common adverse events with ENHERTU in DESTINY-Lung01 was consistent with previous clinical trials with no new safety concerns identified. For more information about the trial, visit ClinicalTrials.gov.

 

About HER2 Mutant NSCLC

Lung cancer is the second most common form of cancer globally, with more than two million patients diagnosed in 2020.1 In the U.S., lung cancer is the second most commonly diagnosed cancer, with more than 236,000 patients expected to be diagnosed in 2022.2 For patients with metastatic NSCLC, prognosis is particularly poor, as only approximately 8% will live beyond five years after diagnosis.3

 

HER2 is a tyrosine kinase receptor growth-promoting protein expressed on the surface of many types of tumors, including lung, breast, gastric and colorectal cancers. Certain HER2 gene alterations (called HER2 mutations) have been identified in patients with non-squamous NSCLC as a distinct molecular target, and occur in approximately 2 to 4% of patients with this type of lung cancer.4,5 While HER2 gene mutations can occur in a range of patients, they are more commonly found in patients with NSCLC who are younger, female and have never smoked.6 HER2 gene mutations have been independently associated with cancer cell growth and poor prognosis, with an increased incidence of brain metastases.7

 

Although the role of anti-HER2 treatment is well established in breast and gastric cancers, there were no approved HER2 directed therapies in NSCLC prior to the accelerated approval of ENHERTU in unresectable or metastatic NSCLC.7,8 Next-generation sequencing has been utilized in the identification of HER2 (ERBB2) mutations.9

 

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.

 

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 a (or one or more) prior anti-HER2-based regimen, either in the metastatic setting or in the neoadjuvant or adjuvant setting, and have developed disease recurrence during or within six months of completing therapy, based on the results from the DESTINY-Breast03 trial. ENHERTU also is approved in several 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 (5.4 mg/kg) is approved in the U.S. for the treatment of adult patients with unresectable or metastatic HER2 low (immunohistochemistry (IHC) 1+ or IHC 2+/in-situ hybridization (ISH)-) breast cancer who have received a prior chemotherapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy, based on the results from the DESTINY-Breast04 trial.

 

ENHERTU (5.4 mg/kg) is approved in the U.S. for the treatment of adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, as detected by an FDA-approved test, and who have received a prior systemic therapy, based on the results of the DESTINY-Lung02 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.

 

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.

 

Regulatory applications for ENHERTU in breast and gastric cancer are currently under review in several countries based on the DESTINY-Breast01, DESTINY-Breast03, DESTINY-Breast04, DESTINY-Gastric01 and DESTINY-Gastric02 trials, respectively.

 

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.

 

Important Safety Information

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 a prior anti-HER2-based regimen either:

    – In the metastatic setting, or

    – In the neoadjuvant or adjuvant setting and have developed disease recurrence during or within six months of completing therapy

  • Unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received a prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy
  • Unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, as detected by an FDA-approved test, and who have received a prior systemic therapy

    This indication is approved under accelerated approval based on objective 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. A higher incidence of Grade 1 and 2 ILD/pneumonitis has been observed in patients with moderate renal impairment. 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 and HER2-Mutant NSCLC (5.4 mg/kg)

In patients with metastatic breast cancer and HER2-mutant NSCLC treated with ENHERTU 5.4 mg/kg, ILD occurred in 12% of patients. Fatal outcomes due to ILD and/or pneumonitis occurred in 1.0% of patients treated with ENHERTU. Median time to first onset was 5 months (range: 0.9 to 23).

 

Locally Advanced or Metastatic Gastric Cancer (6.4 mg/kg)

In 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).

 

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, then reduce dose by one level. For febrile neutropenia (ANC <1.0 x 109/L and temperature >38.3º C or a sustained temperature of ≥38º C for more than 1 hour), interrupt ENHERTU until resolved, then reduce dose by one level.

 

Metastatic Breast Cancer and HER2-Mutant NSCLC (5.4 mg/kg)

 

In patients with metastatic breast cancer and HER2-mutant NSCLC treated with ENHERTU 5.4 mg/kg, a decrease in neutrophil count was reported in 65% of patients. Sixteen percent had Grade 3 or 4 decreased neutrophil count. Median time to first onset of decreased neutrophil count was 22 days (range: 2 to 664). Febrile neutropenia was reported in 1.1% of patients.

 

Locally Advanced or Metastatic Gastric Cancer (6.4 mg/kg)

In 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. Assess LVEF prior to initiation of ENHERTU and at regular intervals during treatment as clinically indicated. Manage LVEF decrease through treatment interruption. 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. 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.

 

Metastatic Breast Cancer and HER2-Mutant NSCLC (5.4 mg/kg)

In patients with metastatic breast cancer and HER2-mutant NSCLC treated with ENHERTU 5.4 mg/kg, LVEF decrease was reported in 3.6% of patients, of which 0.4% were Grade 3.

Locally Advanced or Metastatic Gastric Cancer (6.4 mg/kg)

 

In 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.

 

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 7 months after the last dose of ENHERTU. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with ENHERTU and for 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, then reduce dose by one level.

 

Adverse Reactions

Metastatic Breast Cancer and HER2-Mutant NSCLC (5.4 mg/kg)

The pooled safety population reflects exposure to ENHERTU 5.4 mg/kg intravenously every 3 weeks in 984 patients in Study DS8201-A-J101 (NCT02564900), DESTINY-Breast01, DESTINY-Breast03, DESTINY-Breast04, and DESTINY-Lung02. Among these patients 65% were exposed for >6 months and 39% were exposed for >1 year. In this pooled safety population, the most common (≥20%) adverse reactions, including laboratory abnormalities, were nausea (76%), decreased white blood cell count (71%), decreased hemoglobin (66%), decreased neutrophil count (65%), decreased lymphocyte count (55%), fatigue (54%), decreased platelet count (47%), increased aspartate aminotransferase (48%), vomiting (44%), increased alanine aminotransferase (42%), alopecia (39%), increased blood alkaline phosphatase (39%), constipation (34%), musculoskeletal pain (32%), decreased appetite (32%), hypokalemia (28%), diarrhea (28%), and respiratory infection (24%).

 

HER2-Positive Metastatic Breast Cancer

DESTINY-Breast03

The safety of ENHERTU was evaluated in 257 patients with unresectable or metastatic HER2-positive breast cancer who received at least one dose of ENHERTU 5.4 mg/kg intravenously every three weeks in DESTINY-Breast03. The median duration of treatment was 14 months (range: 0.7 to 30).

 

Serious adverse reactions occurred in 19% of patients receiving ENHERTU. Serious adverse reactions in >1% of patients who received ENHERTU were vomiting, interstitial lung disease, pneumonia, pyrexia, and urinary tract infection.

 

Contacts

Media:

US:
Don Murphy

Daiichi Sankyo, Inc.

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

Japan:
Masashi Kawase

Daiichi Sankyo Co., Ltd.

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

Read full story here

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Ferring announces U.S. FDA Advisory Committee meeting for RBX2660 its investigational microbiota-based live biotherapeutic

  • Vaccines and Related Biological Products Advisory Committee will hold meeting on September 22, 2022
  • RBX2660 is an investigational microbiota-based live biotherapeutic studied for its potential to reduce recurrent C. difficile infection after antibiotic treatment

 

SAINT-PREX, Switzerland & PARSIPPANY, N.J. — (BUSINESS WIRE) — #FDA–Ferring Pharmaceuticals today announced that the Vaccines and Related Biological Products Advisory Committee (VRBPAC) of the U.S. Food and Drug Administration (FDA) will hold a meeting on September 22, 2022, to review data supporting the biologics license application (BLA) for RBX2660, a microbiota-based live biotherapeutic studied for its potential to reduce recurrent C. difficile infection (CDI) after antibiotic treatment.

“The gut microbiome is a highly diverse community of microbes that plays an essential role in human health. Emerging research has shown the promise of leveraging the microbiome to address a range of conditions, including serious diseases such as recurrent C. difficile infection,” said Elizabeth Garner, Chief Scientific Officer, Ferring Pharmaceuticals, U.S. “The cycle of recurrent CDI represents a significant public health burden, and Ferring is working to address that unmet need.”

 

The FDA intends to live stream the advisory committee meeting on the agency’s YouTube page, and the meeting will also be webcast from the FDA website.

 

About C. difficile infection

C. difficile infection (CDI) is a serious and potentially deadly disease that impacts people across the globe. The C. difficile bacterium causes debilitating symptoms such as severe diarrhea, fever, stomach tenderness or pain, loss of appetite, nausea, and colitis (an inflammation of the colon).1 Declared a public health threat by the U.S. Centers for Disease Control and Prevention (CDC) requiring urgent and immediate action, CDI causes an estimated half a million illnesses and tens of thousands of deaths in the U.S. alone each year.1,2,3

 

C. difficile infection can be the start of a vicious cycle of recurrence, causing a significant burden for patients and the healthcare system.4,5 It has been estimated that up to 35% of CDI cases recur after initial diagnosis and people who have had a recurrence are at significantly higher risk of further infections.6,7,8,9 After the first recurrence, it has been estimated that up to 65% of patients may develop a subsequent recurrence.8,9

 

About RBX2660

RBX2660 is an investigational microbiota-based live biotherapeutic studied for its potential to reduce recurrent C. difficile infection after antibiotic treatment. RBX2660 has been granted Fast Track, Orphan, and Breakthrough Therapy designations from the U.S. Food and Drug Administration (FDA). RBX2660 was developed by Rebiotix, a Ferring company.

 

About Ferring Pharmaceuticals

Ferring Pharmaceuticals is a research driven, specialty biopharmaceutical group committed to helping people around the world build families and live better lives. Headquartered in Saint-Prex, Switzerland, Ferring is a leader in reproductive medicine and maternal health, and in specialty areas within gastroenterology and urology. Ferring has been developing treatments for mothers and babies for over 50 years and has a portfolio covering treatments from conception to birth. Founded in 1950, privately owned Ferring now employs around 6,000 people worldwide, has its own operating subsidiaries in more than 50 countries, and markets its products in 110 countries.

 

Learn more at www.ferring.com, or connect with us on Twitter, Facebook, Instagram, LinkedIn and YouTube.

 

Ferring is committed to exploring the crucial link between the microbiome and human health, beginning with the threat of recurrent C. difficile infection. Ferring is working to develop novel microbiome-based therapeutics to address significant unmet needs and help people live better lives. Connect with us on our dedicated microbiome therapeutics development channels on Twitter and LinkedIn.

 

References:

  1. Centers for Disease Control and Prevention. What Is C. Diff? 17 Dec. 2018. Available at: https://www.cdc.gov/cdiff/what-is.html.
  2. Centers for Disease Control and Prevention. Biggest Threats and Data, 14 Nov. 2019. Available at: https://www.cdc.gov/drugresistance/biggest-threats.html
  3. Fitzpatrick F, Barbut F. Breaking the cycle of recurrent Clostridium difficile. Clin Microbiol Infect. 2012;18(suppl 6):2-4.
  4. Centers for Disease Control and Prevention. 24 June 2020. Available at: https://www.cdc.gov/drugresistance/pdf/threats-report/clostridioides-difficile-508.pdf.
  5. Feuerstadt P, et al. J Med Econ. 2020;23(6):603-609.
  6. Riddle DJ, Dubberke ER. Clostridium difficile infection in the intensive care unit. Infect Dis Clin North Am. 2009;23(3):727-743.
  7. Nelson WW, et al. Health care resource utilization and costs of recurrent Clostridioides difficile infection in the elderly: a real-world claims analysis. J Manag Care Spec Pharm. Published online March 11, 2021.
  8. Kelly, CP. Can we identify patients at high risk of recurrent Clostridium difficile infection? Clin Microbiol Infect. 2012; 18 (Suppl. 6): 21–27.
  9. Smits WK, et al. Clostridium difficile infection. Nat Rev Dis Primers. 2016;2:16020. doi: 10.1038/nrdp.2016.20.
  10. Leong C, Zelenitsky S. Treatment strategies for recurrent Clostridium difficile infection. Can J Hosp Pharm. 2013;66(6):361-368.

Contacts

Lisa Ellen

Director, Brand Communications
+1-862-286-5696 (direct)

lisa.ellen@ferring.com

Carine Julen
Corporate Communications Manager
+41-58-301-0178

carine.julen@ferring.com

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Zicam®, the #1 cold-shortening brand†, adds daily immune support products to its lineup

The brand’s first-ever immune support daily gummy supplements, Zicam Daily Immune Support* and Zicam Sleep + Immune Support* with Melatonin, are set to be released in July 2022 in select retailers nationwide and online

 

EWING, N.J. — (BUSINESS WIRE) — Zicam®, the #1 cold-shortening brand†, announces the launch of two new immune support gummy supplements – Zicam Daily Immune Support* and Zicam Sleep + Immune Support* with Melatonin – developed to provide immune support year-round, day and night.*


Zicam Daily Immune Support* provides immune support while Zicam Sleep + Immune Support* with Melatonin provides the same immune support plus melatonin to support sleep.*

 

Featuring its signature zinc formulas, the new gummy supplements offer 100% daily value of three immune-supporting ingredients: Zinc, Vitamin C, and Vitamin D per serving, with the addition of 3mg of melatonin per serving in Zicam Sleep + Immune Support* with Melatonin.

 

“For over 20 years, Zicam has led the way in helping consumers shorten their colds, and we’re constantly looking at new and innovative ways to aid consumers who care about their immune health,” said Michael Vercelletto, marketing director of Zicam. “Our expansion into the immune support space, with Zicam Daily Immune Support* and Zicam Sleep + Immune Support* with Melatonin, is focused on giving consumers the boost of support that they can rely on in an easy to take delicious gummy supplement — day and night.”

 

Zicam Daily Immune Support* is available in a Citrus Strawberry flavor and Zicam Sleep + Immune Support* with Melatonin is available in a Blackberry Lavender flavor. The daily supplements can be found online and select retailers nationwide, in July 2022, with an MSRP of $16.49.

 

To learn more about Zicam’s products, visit www.zicam.com.

 

About Zicam®

Zicam® is America’s #1 cold-shortening brand† and offers a range of over-the-counter products to shorten colds when taken at the first sign. Zicam delivers a portfolio of homeopathic zinc-based and nasal non-zinc based cold shortening formulas as well as products ranging across multiple categories including nasal health, congestion/sinus relief, immune support, and allergy relief products. With a variety of forms, Zicam is easy to take on the go – allowing consumers to feel equipped to take on any common cold that might come their way.

 

About Church & Dwight Co., Inc.

With a rich heritage of commitment to people and the planet for over 150 years, Church & Dwight is committed to conducting our operations in a sustainable and environmentally responsible manner using recycled materials in our cartons. We are continually assessing the impacts of our operations on the environment while developing, manufacturing, and marketing a broad range of consumer household, personal care and specialty products with sustainability efforts incorporated into our new product innovation including Arm & Hammer™, Xtra™, Trojan™, Oxiclean™, Waterpik™, Orajel™, Kaboom™, Nair™, Viviscal™, Flawless™, Toppik™, Zicam™, Batiste™, Replens™, RepHresh™ and First Response™.

 

*These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.

† Based on unit sales data, IRI Total US Multi-Outlet, latest 52 weeks-ending 5/29/22.

Contacts

Cristina DiCocco

646.964.4446

cristina@gcomworks.com

Categories
Business Education Healthcare

TrueFort expands advisory board with healthcare, financial, and intelligence community executives

Emerging Leader in Real-Time Workload Protection Adds Security Leaders from Humana, Markel, and NSA

 

WEEHAWKEN, N.J. — (BUSINESS WIRE) — #Applicationprotection—TrueFort, the real-time workload protection company, today announced that Parthasarathi Chakraborty, Head of Enterprise Security Architecture, Engineering and Innovation at Humana, Debora Plunkett, former National Security Agency executive and Patricia Titus, Chief Privacy and Information Security Officer at Markel Corporation have joined the TrueFort Advisory Board and will provide guidance on corporate, customer, and product strategies.

“Parthasarathi, Deborah, and Patricia bring decades of cyber security expertise from the healthcare, financial services, and intelligence community sectors to our advisory board,” said Sameer Malhotra, CEO of TrueFort. “Their background as both practitioners and industry leaders in their respective fields will help us grow our business and continue to innovate the TrueFort platform.”

 

Parthasarathi Chakraborty is Head of Enterprise Security Architecture, Engineering, and Innovation at Fortune 500 healthcare insurance provider Humana. He has held senior executive security roles at BMO Financial Group, Guardian Life, JPMorgan Chase, Bank of America, and Merrill Lynch.

 

Debora Plunkett is a former National Security Agency executive, Principal of cyber security consulting firm Plunkett Associates LLC, Senior Fellow at Harvard’s Belfer Center, and Board Member for several publicly traded companies.

 

Patricia Titus is Chief Privacy and Information Security Officer at Markel Corporation. She has served as CISO for Freddie Mac, Symantec, Unisys, and TSA. Patricia is also a Board Member for Black Kite and Girl Scouts of Virginia, and an advisor for the Executive Women’s Forum and YL Ventures.

 

They join current TrueFort Advisors:

Dr. Edward G. Amoroso, CEO of TAG Cyber

Marios Damianides, CISA, CISM, CPA, retired partner in the advisory practice of EY

Motti Finkelstein, Advisor at Capri Ventures and CTO-Capital Markets at BMO Financial Group

Steve Katz, Founder and President of Security Risk Solutions, LLC, Executive Advisor, Deloitte, and widely known as the first CISO

Izak Mutlu, former VP Information Security (CISO) at Salesforce

Adam Schwartz, Founder and CEO of Articulate

Scott Seese, Managing Director and Chief Information Officer for LPL Financial

Robert Strickland, Founder and CEO of M37 Ventures

Bob Williams, Advisor and Venture Partner, Canaan

 

About TrueFort

TrueFort is the leader in delivering zero trust protection for critical applications. Leveraging unique real-time, adaptive trust, and cloud-to-ground capabilities, TrueFort’s Fortress platform detects and contains security threats before they become business risks. Founded by former IT executives from Bank of America and Goldman Sachs, leading global enterprises trust TrueFort to deliver unprecedented application visibility and security. For more information visit https://truefort.com and follow us on LinkedIn and Twitter.

Contacts

Media:
Marc Gendron

Marc Gendron PR for TrueFort

617.877.7480

marc@mgpr.net

Categories
Business Healthcare Science

Rite Aid and Quest Diagnostics expand access to COVID-19 PCR testing nationwide

Testing available at no out-of-pocket cost for qualified insured individuals at Rite Aid drive-thru locations with appointment; at all other Rite Aid locations customers can schedule to pick up at-home specimen collection kits for PCR testing

 

PHILADELPHIA & SECAUCUS, N.J. — (BUSINESS WIRE) — Rite Aid (NYSE: RAD) today announced it is collaborating with Quest Diagnostics (NYSE: DGX) to provide access to quality, COVID-19 molecular testing (polymerase chain reaction or similar nucleic acid amplification test) to help Rite Aid customers detect and prevent the spread of COVID-19.

Quest is the world’s leading provider of diagnostic information services and a national leader in COVID-19 testing. The company has performed more than 69 million COVID-19 molecular tests since March 2020.

 

Through the collaboration, Rite Aid and Bartell Drugs’ more than 2,350 stores, now offer access to Quest PCR testing, either through their drive-thru locations or the addition of at home specimen testing kits from stores without drive-thrus, doubling the access to PCR testing for adults and children over 2 years old. Both options require an appointment be made through the Quest website. Quest Diagnostics will provide results electronically to individuals through the MyQuest online portal and app.

 

Customers can schedule to pick up a COVID-19 PCR testing kit with at-home specimen collection or schedule observed drive-thru collection at https://www.riteaid.com/pharmacy/services/covid-19-testing where they will be directed to request a test through Quest’s consumer-initiated test platform QuestDirect™. Bartell Drugs customers may visit bartelldrugs.com/covid19-testing. Quest’s kits come with a prepaid FedEx envelope for overnight shipping to a Quest laboratory. Currently, the average time for Quest Diagnostics to provide a test result is one to two days. Result turnaround times can fluctuate with demand levels and vary by region and other factors.

 

“As new variants spread throughout our communities, testing remains a critical tool as we continue to support our communities in the fight against COVID-19,” said Karen Staniforth, Chief Pharmacy Officer at Rite Aid. “Identifying COVID-19 infection helps individuals obtain the treatment they need while helping to prevent further spread of the disease. We are proud to collaborate with Quest to make testing easily accessible for our customers by expanding to all of our stores.”

 

“As people continue to navigate the COVID-19 pandemic, individuals and families need access to convenient, affordable and quality diagnostic testing in order to engage in activities more safely and responsibly,” adds Cathy Doherty, Senior Vice President, Regional Businesses, Quest Diagnostics. “PCR and other molecular diagnostic tests are the gold-standard for reliable COVID-19 testing. Our relationship with Rite Aid will extend our delivery of COVID-19 testing to more communities in the United States.”

 

PCR and other nucleic acid amplification tests are molecular diagnostic testing technologies. Unlike at-home antigen tests, they are performed in a laboratory. According to the CDC, NAAT is the gold standard for detection of SARS-CoV-2, and they may be useful in some cases in confirming an antigen test result. Customers should discuss their test results with their doctor.

 

In addition to the molecular tests, Rite Aid locations continue to provide rapid, over-the-counter at-home antigen COVID-19 test kits for customers. For more information on Rite Aid’s COVID-19 test options, visit riteaid.com. Rite Aid also continues to provide COVID-19 vaccines and boosters to eligible customers. Customers can schedule a COVID-19 vaccine by visiting: https://www.riteaid.com/pharmacy/scheduler.

All Rite Aid locations are able to dispense the oral medications, Paxlovid, and Lagevrio (molnupiravir), for treatment of COVID-19.

 

For the latest information on Quest’s COVID-19 testing efforts, visit Quest Diagnostics Newsroom – News Releases.

 

About Rite Aid Corporation

Rite Aid is a full-service pharmacy that improves health outcomes. Rite Aid is defining the modern pharmacy by meeting customer needs with a wide range of vehicles that offer convenience, including retail and delivery pharmacy, as well as services offered through our wholly owned subsidiaries, Elixir, Bartell Drugs and Health Dialog. Elixir, Rite Aid’s pharmacy benefits and services company, consists of accredited mail and specialty pharmacies, prescription discount programs and an industry leading adjudication platform to offer superior member experience and cost savings. Health Dialog provides healthcare coaching and disease management services via live online and phone health services. Regional chain Bartell Drugs has supported the health and wellness needs in the Seattle area for more than 130 years. Rite Aid employs more than 6,300 pharmacists and operates more than 2,350 retail pharmacy locations across 17 states. For more information, visit www.riteaid.com.

 

About Quest Diagnostics

Quest Diagnostics empowers people to take action to improve health outcomes. Derived from the world’s largest database of clinical lab results, Quest’s diagnostic insights reveal new avenues to identify and treat disease, inspire healthy behaviors, and improve health care management. Quest Diagnostics annually serves one in three adult Americans and half the physicians and hospitals in the United States, and our nearly 50,000 employees understand that, in the right hands and with the right context, our diagnostic insights can inspire actions that transform lives. www.QuestDiagnostics.com

Contacts

MEDIA:
Terri Hickey

717-975-5718

press@riteaid.com

Kim Gorode

mediacontact@questdiagnostics.com

Categories
Business Healthcare Science

Q2 update by PQE Group: Two acquisitions’ announcements with United Pharma Technologies Inc. & Quintian Pharma, and new two offices

FLORENCE, Italy — (BUSINESS WIRE) — #GPTWcertified–The first half of 2022 has closed highly positively for PQE Group, the global women-owned quality consulting company for Lifesciences. The Italian parent Group, after having concluded 2021 with + 20% increase in revenues, confirms its development plan with the announcement of two acquisitions and a new legal entity in Melbourne (Australia) and a new office in Buenos Aires (Argentina).


As stated at the beginning of 2022, most of the global staff development plan has been implemented with almost 400 new hires around the world, 200 of which are located in Italy or the US, followed by the PQE Group Mexican Affiliate.

 

With a strong focus on the United States and Latin America, the company managed by Gilda D’Incerti has started the acquisition process of two firms, announcing the affiliation of United Pharma Technologies Inc., a service company based in New Jersey, and Quintian Pharma, based in Malta.

 

The M&A model of the company embraces the concept of a Federation rather than a classic acquisition, which aims to exchange shares with different entities in local markets all over the world to create close knit alliances, allowing to scale up projects’ staff and capabilities faster and more efficiently.

 

“In our unique and different approach to M&A activities, we aim to engage with entrepreneurs and not just companies, bringing business development ideas to the table and acting as a whole organization by sharing the same vision, mission and network.” – Danilo Neri, Vice President Executive and Board Equity Partner at PQE Group.

 

Quintian Pharma, administered by Claude Vella Bonanno, is committed to providing services and support to the pharmaceutical industry, following all EU directives on new products. PQE Group will join the Board as main shareholder (51%) and support the strategic growth of the consulting agency specialized in applying EU Pharmacovigilance standards to clients in the Middle East.

 

United Pharma Technologies Inc., a service agency based in New Jersey – USA, was founded in 2014 and is currently managed by Vasantha Madasu, who will join PQE Group as a local partner in the US and Mexican affiliates and has been named Chief Talent Officer for the Americas.

 

Contacts

PQE Group – Press Office

+39 3491512075 | pressoffice@pqegroup.com

Categories
Business Culture Healthcare

Inspira Health appoints Tony Reed as Senior Vice President, Chief Quality and Safety Officer

Health care industry veteran assumes new role to advance the network’s strategic and continued growth

 

MULLICA HILL, N.J. — (BUSINESS WIRE) — Inspira Health today announced the appointment of Tony S. Reed, M.D., to Senior Vice President, Chief Quality and Safety Officer, effective August 1. In this role, Reed will focus on executing and expanding Inspira’s role as a high reliability organization through patient safety, quality and excellence.


Reed has more than 22 years of experience in health care, most recently serving as the Chief Medical Officer at Temple University Health System. Reed was with Temple University Health System for more than six years, where he also served as an adjunct professor at the Temple University Lewis Katz School of Medicine.

 

In his role as SVP, Chief Quality and Safety Officer, he will support Inspira’s goals of being a foremost high reliability and high safety organization by guiding us in continuing to achieve the highest quality outcomes and move us on our journey to zero harm under the leadership of Amy Mansue, President & CEO of Inspira Health.

 

“Dr. Reed brings with him an extraordinary amount of diverse clinical experience and is a respected member of the health care community,” said Mansue. “He has a very strong background in all aspects of what it takes to lead other clinicians in providing safe environments for our community members to get care. He will play a critical role in assisting in maintaining consistent, quality care across all Inspira Health sites in South Jersey.”

 

“Patient safety is the foundation of care,” said Reed. “I feel very fortunate to be part of such an outstanding health system at Inspira, and I look forward to being able to collaborate with all of the great clinicians here to improve the patient experience – from the moment they walk into any of our access points to when they are discharged. Our goal is to always provide safe, high-quality care to those who come to us.”

 

Reed graduated the Medical College of Pennsylvania/Hahnemann School of Medicine. He then trained in family medicine at The Reading Hospital and Medical Center, and then trained in sports medicine at The Ohio State University. From there, he began a diverse career in medicine as an educator and clinician. He has worked at hospital systems such as The Ohio State University College of Medicine and Public Health, Christiana Care Health System, University of Delaware, AtlantiCare and Temple University Health System.

 

For more information about Inspira Health, please visit www.InspiraHealthNetwork.org or call 1-800-INSPIRA. To stay connected with Inspira announcements and work being done in the community, please join the conversation on Facebook and Twitter. Inspira is proud to be the Official Health Care Partner of the Philadelphia Wings professional lacrosse team.

 

About Inspira Health

Inspira Health is a charitable nonprofit health care organization and a regional leader in physician training, with approximately 234 medical residents and fellows in 14 nationally accredited programs at its hospitals in Vineland, Mullica Hill and Elmer.

 

The system traces its roots to 1899 and comprises three hospitals, two comprehensive cancer centers, eight multi-specialty health centers, and more than 200 access points. These include urgent care; outpatient imaging and rehabilitation; sleep medicine labs; cardiac testing facilities; behavioral health, digestive health, wound care centers; home care and hospice; and more than 35 primary and specialty physician practices in Gloucester, Cumberland, Salem, Camden and Atlantic counties. Additionally, Inspira EMS services six South Jersey counties.

 

Inspira’s 1,300-member medical staff and 6,800 employees provide an unwavering commitment to delivering a superior patient experience at every point of the journey. Technology and innovation investments provide a robust provider directory and a range of services including online scheduling and virtual visits for both primary and specialty care providers. With a commitment to multi-channel digital access, Inspira is able to meet consumer demand for self-service and personalized care options.

 

Accredited by DNV Healthcare and committed to the principles of high reliability, the system’s clinical and support staffs are focused on clinical excellence and patient safety. For more information about Inspira Health, visit www.InspiraHealthNetwork.org or call 1-800-INSPIRA.

Contacts

Brownstein on behalf of Inspira Health

Madison Fertell

inspirapr@brownsteingroup.com

Categories
Business Healthcare Science

Iveric Bio announces post-hoc analysis from GATHER1 clinical trial of Zimura® at American Society of Retina Specialists meeting

PARSIPPANY, N.J. — (BUSINESS WIRE) — IVERIC bio, Inc. (Nasdaq: ISEE) recently announced that in a post-hoc analysis from the GATHER1 clinical trial, Zimura showed a reduction of geographic atrophy lesion growth, compared to sham, across all distances from the foveal center point. The analysis was presented by David R. Lally, MD, Director of Retina Research Institute at New England Retina Consultants, at the American Society of Retina Specialists Annual Meeting in New York, New York.


“The vast majority of patients in GATHER1 had GA lesions within the area that clinicians are most concerned about protecting,” said Dr. Lally. “As a result, the potential benefit of Zimura across a broad cross-section of GA patients was observed.”

 

“The multiple post-hoc analyses from GATHER1 continue to provide consistent results, which give us a great deal of confidence in the robustness of the GATHER1 data and the potential of Zimura as a treatment to help a broad patient population with GA,” stated Dhaval Desai, PharmD, Chief Development Officer of Iveric Bio.

 

The analysis reported that approximately 84% of patients had lesions within 500 microns of the foveal center point at baseline and that approximately 28% of patients had lesions within 100 microns of the foveal center point at baseline. These findings were generally balanced across all treatment arms and their corresponding sham control groups in the trial. The accompanying graphs summarize the results of this post-hoc analysis.

 

The most frequently reported ocular adverse events were related to the injection procedure. There were no drug related adverse events such as inflammation or endophthalmitis reported in GATHER1. No additional safety analysis was performed as part of this post-hoc analysis.

 

The full set of slides of the presentation is available on the Company’s website at https://investors.ivericbio.com/events-and-presentation.

 

About GATHER1 and GATHER2

The Company previously announced that in GATHER1, Zimura (avacincaptad pegol) met its pre-specified primary efficacy endpoint with statistical significance. The most frequently reported ocular adverse events in this trial were related to the injection procedure. The Company expects topline data for GATHER2, a second Phase 3 clinical trial for Zimura for GA, to be available in the third quarter of 2022, approximately one year after the enrollment of the last patient in the trial plus the time needed for database lock and analysis. If 12-month results from GATHER2 are positive, the Company plans to submit applications with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for marketing approval of Zimura for GA. There are no FDA or EMA approved treatments available for patients with GA.

 

About Zimura

Zimura (avacincaptad pegol) is an investigational drug product and has not been approved for use anywhere globally. Zimura is designed to target and inhibit the cleavage of complement protein C5 and the formation of its downstream fragments, C5a and C5b. By inhibiting the formation of these fragments, Zimura is believed to decrease or slow the chronic inflammation and cell death associated with the retinal aging process by decreasing the formation of membrane attack complex (MAC) and inflammasome activity, thereby potentially avoiding or slowing the degeneration of retinal pigment epithelial cells. This potential mechanism is the rationale for Zimura as a potential therapy for geographic atrophy.

 

About Iveric Bio

Iveric Bio is a science-driven biopharmaceutical company focused on the discovery and development of novel treatments for retinal diseases with significant unmet medical needs. The Company is committed to having a positive impact on patients’ lives by delivering high-quality, safe and effective treatments designed to address debilitating retinal diseases including earlier stages of age-related macular degeneration. For more information on the Company, please visit www.ivericbio.com.

 

Forward-looking Statements

Any statements in this press release about Iveric Bio’s future expectations, plans and prospects constitute forward-looking statements for purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. Forward-looking statements include any statements about the Company’s strategy, future operations and future expectations and plans and prospects for the Company, and any other statements containing the words “anticipate,” “believe,” “estimate,” “expect,” “intend”, “goal,” “may”, “might,” “plan,” “predict,” “project,” “seek,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” and similar expressions. In this press release, the Company’s forward looking statements include statements about its expectations regarding its development and regulatory strategy for Zimura, including the timing of receipt of topline data from the GATHER2 clinical trial and its plans to file for marketing approval for geographic atrophy if the results of GATHER2 are positive, the potential utility of Zimura and the clinical meaningfulness of clinical trial results and data, including from post-hoc analyses of the GATHER1 clinical trial. Such forward-looking statements involve substantial risks and uncertainties that could cause the Company’s development programs, future results, performance, or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, those related to the progress and success of research and development programs and clinical trials, developments from the scientific and medical community and other factors discussed in the “Risk Factors” section contained in the quarterly and annual reports that the Company files with the Securities and Exchange Commission. Any forward-looking statements represent the Company’s views only as of the date of this press release. The Company anticipates that subsequent events and developments may cause its views to change. While the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so except as required by law.

ISEE-G

Contacts

Investors:
Kathy Galante

Senior Vice President, Investor Relations

kathy.galante@ivericbio.com

or

Media:
Jeannie Neufeld

Senior Director, Public Relations & Communications

jeannie.neufeld@ivericbio.com

Categories
Healthcare Local News Science

Orcosa appoints Andrew C. von Eschenbach, M.D. and former commissioner of the FDA, as Senior Advisor

EWING, N.J. — (BUSINESS WIRE) — Orcosa Inc. (“Orcosa” or the “Company”), a clinical-stage life sciences company improving patient outcomes through its next generation drug delivery technology – the Rapid Infusion Technology (RITe™) Platform – today announced the appointment of Dr. Andrew C. von Eschenbach, former Commissioner of the U.S. Food and Drug Administration (“FDA”) as Senior Advisor. In his role, Dr. von Eschenbach will provide strategic counsel on regulatory and public affairs, clinical trial development, and other corporate matters.

“We are honored and privileged to have Dr. von Eschenbach join our team as Senior Advisor,” said Bryan Ridall, President of Orcosa. “His commitment to improving public health, and his uniquely complete understanding of patients’ needs, and the dynamics of biopharmaceutical research and development are an invaluable complement to our leadership team. We are grateful for his support as we continue to execute on our long-term strategy.”

 

Dr. von Eschenbach said, “As a physician and former FDA Commissioner, I was immediately impressed with Orcosa’s innovative drug delivery platform and thoughtful approach to clinical development and collaboration. The company’s RITe platform is already demonstrating how it has incredible potential to improve patient outcomes across a range of therapeutic areas – including most critically, in pain management to help reduce opioid usage. I am excited to be part of the Orcosa team, particularly at such a pivotal time in the company’s growth story.”

 

Dr. von Eschenbach is widely recognized as a leading physician, surgeon, oncologist, and executive, and served as Commissioner of the FDA from 2006 to 2009, after being appointed Acting Commissioner in 2005. In that role, he developed and oversaw the FDA’s Critical Path Initiative which aimed at improving the regulatory pathway for drugs and medical devices. Dr. von Eschenbach joined FDA after serving for four years as Director of the National Cancer Institute at the National Institutes of Health, and currently serves on the Board of Directors of the Reagan-Udall Foundation for the Food and Drug Administration.

 

Dr. von Eschenbach earned a B.S. from St. Joseph’s University and his medical degree from Georgetown University School of Medicine. After completing a residency in urologic surgery at Pennsylvania Hospital in Philadelphia, he was an instructor in urology at the University of Pennsylvania School of Medicine. He completed a Fellowship in Urologic Oncology at the University of Texas M.D. Anderson Cancer Center.

 

About Orcosa Inc.

Orcosa Inc. is a life sciences company modernizing the way medicines are taken and improving patient outcomes through its proprietary therapeutic delivery technology, the Rapid Infusion Technology (RITe™) Platform. Orcosa is the inventor, developer and exclusive owner of the RITe™ Platform, a fast acting, easy-to-take tablet engineered to enhance drug absorption. Orcosa’s lead program, ORAVEXX™, is a non-addictive proprietary cannabidiol composition that utilizes the RITe™ Platform to treat pain and has the potential to provide a safe, alternative treatment option to opioids and NSAIDs. The company is currently supporting clinical trials at leading American research institutions to evaluate the safety and effectiveness of ORAVEXX™ for pain management. For more information on Orcosa, please visit https://www.orcosa.com.

 

Forward-Looking Statements

Certain statements made herein constitute “forward-looking statements”. These forward-looking statements include, but are not limited to, the development of ORAVEXX™ and the RITe™ Platform. These statements are based on the current expectations of Orcosa and are not predictions of actual performance. Such forward-looking statements involve risks, uncertainties and other factors, which may cause the actual results, performance or achievements of Orcosa to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements.

Contacts

Devin Broda

FGS Global

Devin.Broda@fgsglobal.com
212-687-8080

Investor

IR@orcosa.com