Cell Therapy for Cartilage Regeneration Gets a Boost With Hyaluronic Acid Enriched Chondrocytes in a 3D Tissue Engineering Platform

Cell Therapy for Cartilage Regeneration Gets a Boost With Hyaluronic Acid Enriched Chondrocytes in a 3D Tissue Engineering Platform




Cell Therapy for Cartilage Regeneration Gets a Boost With Hyaluronic Acid Enriched Chondrocytes in a 3D Tissue Engineering Platform

ACI and MACI treatments could be improvised with the first of its kind feat by Edogawa Hospital, Tokyo

TOKYO–(BUSINESS WIRE)–Regenerative therapy to treat knee joint damages gets a boost with a breakthrough technology of growing ideal type of cartilage cells including chondroprogenitors and mesenchymal stem cells enriched with hyaluronic acid (HA), reported by Dr Shojiro Katoh, President, Edogawa Hospital in “The KNEE” journal (https://doi.org/10.1016/j.knee.2021.02.019). Edogawa Evolutionary Laboratory of Science (EELS) researchers accomplished this feat using a 3D tissue engineering scaffold, without externally added HA or growth factors. They hope this technology will improvise the clinical outcome of Autologous Chondrocyte Implantation (ACI) and Matrix Assisted Chondrocyte Implantation (MACI) treatments.


Regenerative medicine applications for articular cartilage repair require growing chondrocytes taken from patients’ own joint, in the lab, followed by transplantation to the disease affected portion, enable them restore, replace, rejuvenate or regenerate the cartilage in ACI or MACI procedures, practiced by orthopedicians and arthroscopy surgeons worldwide. The lab environment makes the chondrocytes, many a time, grow as fibrocartilage, whereas, hyaline cartilage is the ideal type of tissue required, which contributes to weight bearing function of the joint. Having proven hyaline cartilage growth in vitro (https://doi.org/10.1016/j.reth.2020.03.006) and their in vivo efficacy (https://doi.org/10.1016/j.jor.2017.01.003), EELS team has now proven that stem cell like progenitors and mesenchymal stem cells residing in the human cartilage could be grown without artificial reprogramming or animal proteins or feeder layers (https://doi.org/10.1016/j.jor.2021.01.005).

Hyaluranon (HA) in the matrix is essential for homeostasis of cartilage, which is injected to treat cartilage damages in clinics and in the lab, added from external sources to support chondrocyte culture. On the contrary, Dr Katoh`s team used a polymer scaffold that retains chondrocyte secreted HA to enhance their growth as a tissue, yielding higher HA content. This is another milestone in regenerative medicine, as it produces chondrocytes that are most suitable for clinical transplant with potentials for better healing and value addition to existing ACI and MACI procedures, after relevant clinical validation.

Further studies on miRNA-140, another essential cartilage component and the technology’s anti-aging capabilities are underway to address debilitating joint diseases affecting millions worldwide in this method termed “EELS-TALC”, (Enriched with Essentials and Lapped in Scaffold, Transplant-suitable Autologous Leveraged Chondrocytes) in collaboration among EELS, JBM Inc and GN Corporation.

Contacts

Samuel JK Abraham

info@gncorporation.com

Nathalie Doize Appointed Director of Operations – Rudolph Rosenberg Appointed Chief Financial Officer

Nathalie Doize Appointed Director of Operations – Rudolph Rosenberg Appointed Chief Financial Officer




Nathalie Doize Appointed Director of Operations – Rudolph Rosenberg Appointed Chief Financial Officer

PARIS–(BUSINESS WIRE)–Today, Excelya has announced that it has appointed Nathalie Doize as Director of Operations and Rudolph Rosenberg as Chief Financial Officer at Excelya. Following strong growth in 2020, Nathalie will aim to harmonize operations across Europe and oversee project delivery as Excelya aims to become the highest quality contract research organization across Europe. Rudolph Rosenberg will define group financial strategy and help Excelya scale up its business globally.

Nathalie has more than 30 years of experience in drug development working for both CROs and pharmaceutical companies. Nathalie joins Excelya from Syneos Health, where she served as Vice President of Operations and was responsible for the operation and oversight of operational teams in Europe and Asia Pacific. Before that, she served in a variety of roles in increasing seniority, including department management for Mapi Group, inVentiv Health Clinical and i3 Research.

Rudolph joins Excelya after more than 20 years leading finance organizations in the Technology sector. Rudolph’s range of experience includes scaling up mid-sized startups such as Groupe Allo-Media and Nibelis in a CFO capacity, as well as supporting the expansion and structuring in EMEA of large groups such as Dell Technologies.

Alan Morgan, CEO at Excelya: “I am delighted to welcome Nathalie and Rudolph. Nathalie’s deep expertise in operations for contract research organizations will enable us to deliver on our promise of excellence as we become a preferred one-stop provider across Europe. Rudolph’s breadth of experience in fast-paced environments will play a key role in defining and rolling out our strategy.”

About Excelya

Excelya is an independent European contract research organization with over 800 employees in 24 countries spread throughout Europe. Excelya offers all cooperation models, from consulting to functional service providing to full-service. It provides these research services across multiple industries, including pharmaceutical, biotech, medical devices, cosmetics and nutrition. As a fully integrated CRO, Excelya undertakes the design and execution of Phase I clinical trials to post-marketing studies, safety, biometrics and market access projects. Excelya is committed to providing preeminent experts who work hand-in-hand with its clients to accelerate end-to-end drug development, leverage data science and reimagine patient care.

For more information, please visit excelya.com.

Contacts

Amélie Janson, Communications Director

ajanson@excelya.com / +33 6 47 87 31 41

Avacta’s Rapid Antigen Test Is Confirmed to Detect SARS-CoV-2 New Variants

Avacta’s Rapid Antigen Test Is Confirmed to Detect SARS-CoV-2 New Variants




Avacta’s Rapid Antigen Test Is Confirmed to Detect SARS-CoV-2 New Variants

Avacta’s AffiDX SARS-CoV-2 lateral flow test detects both B117 ‘Kent’ and D614G variants of the virus

CAMBRIDGE, England & WETHERBY, England–(BUSINESS WIRE)–Avacta Group plc (AIM: AVCT), the developer of innovative cancer therapies and diagnostics based on its proprietary Affimer® and pre|CISION platforms, announces that the AffiDX® SARS-CoV-2 rapid antigen lateral flow test detects the dominant new variants of the coronavirus, known as the B117, or ‘Kent’, variant, and the D614G variant, as well as the original strain.

The SARS-CoV-2 virus, like most viruses, mutates over time into slightly different variants. Some of these variants are more infectious, and therefore more rapidly transmissible, and have the potential to become dominant strains.

Early on in the pandemic a variant referred to as D614G appeared, which rapidly became the dominant strain globally1. The B117 variant, which was first observed in Kent, is prevalent in the UK, has been found in more than 50 countries and, according to Professor Sharon Peacock (Professor of Public Health and Microbiology at Cambridge University) is likely to become the next dominant strain globally2.

Avacta has carried out analytical tests with the spike proteins isolated from both the B117 and D614G variants, and has confirmed that its AffiDX® SARS-CoV-2 rapid antigen lateral flow test detects both of these variants as well as the original strain.

Dr Alastair Smith, Chief Executive of Avacta Group commented:

“We are pleased to confirm that Avacta’s rapid antigen test detects the B117 strain, an important variant of the SARS-CoV-2 virus and one which is especially prevalent in the UK. We have also shown that our test detects the D614G variant, the current dominant global strain.

We will continue to monitor the performance of the Affimer reagents with future dominant variants as they become available to us. Since the Affimer reagents we use in Avacta’s range of SARS-CoV-2 tests do not bind in the region of the spike protein where the dominant mutations appear, we do not anticipate that the performance of the tests will be affected.

Now that we have developed a robust lateral flow test architecture, we can easily insert Affimer reagents that can be very rapidly developed for new variants if necessary, and indeed in response to any other future pandemic virus.

Our next key milestone is full clinical validation and CE marking of our lateral flow antigen test which we anticipate will be around the end of this quarter and I look forward to updating the market when that milestone is achieved.”

This announcement contains information which, prior to its disclosure, was considered inside information for the purposes of Article 7 of Regulation (EU) No 596/2014 (MAR).

Disclaimer: AffiDX® SARS-CoV-2 Lateral Flow Rapid Antigen Test not currently for sale in the United States.

Further information

1 https://www.nature.com/articles/s41586-020-2895-3

2 https://www.itv.com/news/2021-02-11/covid-kent-variant-will-become-dominant-strain-globally-scientist-says

 

Contacts

Zyme Communications (Trade and Regional Media)

Katie Odgaard

Tel: +44 (0) 7787 502 947

katie.odgaard@zymecommunications.com

Vifor Pharma and Cara Therapeutics announce U.S. FDA acceptance and Priority Review of NDA for KORSUVA™* injection in hemodialysis patients with moderate-to-severe pruritus

Vifor Pharma and Cara Therapeutics announce U.S. FDA acceptance and Priority Review of NDA for KORSUVA™* injection in hemodialysis patients with moderate-to-severe pruritus




Vifor Pharma and Cara Therapeutics announce U.S. FDA acceptance and Priority Review of NDA for KORSUVA™* injection in hemodialysis patients with moderate-to-severe pruritus

  • FDA has set Prescription Drug User Fee Act (PDUFA) target action date of 23 August 2021
  • If approved, KORSUVA™ injection would be first therapy for treatment of pruritus in hemodialysis patients

ST.GALLEN, Switzerland & STAMFORD, Conn.–(BUSINESS WIRE)–Regulatory News:

Vifor Pharma and Cara Therapeutics, Inc. (Nasdaq: CARA) today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review for the New Drug Application (NDA) for KORSUVA™ (difelikefalin) solution for injection for the treatment of moderate-to-severe pruritus in hemodialysis patients. The PDUFA target action date for KORSUVA™ is 23 August 2021. The FDA stated that currently it is not planning to hold an advisory committee meeting to discuss the application.

The FDA grants Priority Review to drug applications for potential therapies that, if approved, would be significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications. The NDA filing is supported by positive data from two pivotal phase-III trials KALM-1, conducted in the U.S. (New England Journal of Medicine 2020; 382:222-232) and the global KALM-2, as well as supportive data from an additional 32 clinical studies.

“We are delighted that the FDA accepted and granted Priority Review for this breakthrough therapy. Pruritus in hemodialysis patients is a debilitating condition with a significant impact on quality of life and increased risk for hospitalization and mortality. It impacts up to 40% of dialysis patients around the world. If KORSUVA™ is approved, we will be able to offer a medicine that is in line with our aim to deliver innovative therapies to patients with high unmet medical needs. We are highly committed to bringing this important new treatment to patients in the US as soon as possible following FDA approval, together with our partner Cara Therapeutics”, commented Stefan Schulze, CEO of Vifor Pharma Group.

“The FDA acceptance for filing and granting of Priority Review for the KORSUVA NDA marks a significant milestone for Cara and for the substantial number of hemodialysis patients with chronic intractable pruritus,” said Derek Chalmers, Ph.D., D.Sc., President and Chief Executive Officer of Cara Therapeutics. “FDA’s agreement to expedite the timeline through Priority Review designation aligns with our understanding of the therapeutic potential of KORSUVA to fundamentally change the treatment paradigm for this serious unmet need. We look forward to working with the FDA through the review process and, along with our commercial partner, Vifor Pharma, remain focused on preparing for the U.S. launch of KORSUVA injection, if approved.”

About Chronic Kidney Disease-associated Pruritus (CKD-aP)

CKD-aP is an intractable systemic itch condition that occurs with high frequency and intensity in patients with chronic kidney disease undergoing dialysis. Pruritus has also been reported in patients with stage III-V CKD who are not on dialysis. Aggregate, longitudinal, multi-country studies estimate the weighted prevalence of CKD-aP to be approximately 40% in patients with end-stage renal disease (ESRD), with approximately 25% of patients reporting severe pruritus. The majority of dialysis patients (approximately 60 to 70%) report pruritus, with 30 to 40% reporting moderate or severe pruritus.1,2,3 Recent data from the ITCH National Registry Study showed that among those with pruritus, approximately 59% experienced symptoms daily or nearly daily for more than a year. Given its association with CKD/ESRD, most afflicted patients will continue to have symptoms for months or years, with currently employed antipruritic treatments, such as antihistamines and corticosteroids, unable to provide consistent, adequate relief. Moderate-to-severe chronic pruritus has repeatedly been shown to directly decrease quality of life, contribute to symptoms that impair quality of life (such as poor sleep quality), and is associated with depression.4 CKD-aP is also an independent predictor of mortality among hemodialysis patients, mainly related to increased risk of inflammation and infections.

References:

1 Pisoni RL, et al. Pruritus in haemodialysis patients: international results from the Dialysis Outcomes and Practice Patterns Study. Nephrol Dial Transplant. 2006; 21:3495-3505.

2 Ramakrishnan K, et al. Clinical characteristics and outcomes of end-stage renal disease patients with self-reported pruritus symptoms. International Journal of Nephrology and Renovascular Disease. 2014; 7: 1-12.

3 Sukul et al. Self-reported Pruritus and Clinical, Dialysis-Related, and Patient-Reported Outcomes in Hemodialysis Patients. Kidney Med. 2020 Nov 21;3(1):42-53.

4 Mathur VS, et al. A longitudinal study of Uremic Pruritus in hemodialysis patients. Clin J Am Soc Nephrol. 2010; 5(8):1410-1419.

* The FDA has conditionally accepted KORSUVA™ as the trade name for difelikefalin injection in the US. CR845/difelikefalin is an investigational drug product and its safety and efficacy have not been fully evaluated by any regulatory authority.

About Vifor Pharma Group

Vifor Pharma Group is a global pharmaceuticals company. It aims to become the global leader in iron deficiency, nephrology and cardio-renal therapies. The company is a partner of choice for pharmaceuticals and innovative patient-focused solutions. Vifor Pharma Group strives to help patients around the world with severe and chronic diseases lead better, healthier lives. The company develops, manufactures and markets pharmaceutical products for precision patient care. Vifor Pharma Group holds a leading position in all its core business activities and consists of the following companies: Vifor Pharma and Vifor Fresenius Medical Care Renal Pharma (a joint company with Fresenius Medical Care). Vifor Pharma Group is headquartered in Switzerland, and listed on the Swiss Stock Exchange (SIX Swiss Exchange, VIFN, ISIN: CH0364749348).

For more information, please visit viforpharma.com

About Cara Therapeutics

Cara Therapeutics is a clinical-stage biopharmaceutical company focused on developing and commercializing new chemical entities designed to alleviate pruritus by selectively targeting peripheral kappa opioid receptors, or KORs. Cara is developing a novel and proprietary class of product candidates, led by KORSUVA™ (CR845/difelikefalin), a first-in-class KOR agonist that targets the body’s peripheral nervous system, as well as certain immune cells. In two phase-lII trials, KORSUVA injection has demonstrated statistically significant reductions in itch intensity and concomitant improvement in quality of life measures in hemodialysis patients with moderate-to-severe chronic kidney disease-associated pruritus (CKD-aP). Oral KORSUVA™ has successfully completed a phase-II trial for the treatment of pruritus in patients with CKD and is currently in phase-II trials in atopic dermatitis, primary biliary cholangitis and notalgia paresthetica patients with moderate-to-severe pruritus

Forward-looking Statements

Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Examples of these forward-looking statements include statements concerning the potential regulatory approval of KORSUVA solution for injection and the potential timeline for FDA review of the NDA and the potential of KORSUVA solution for injection to be a therapeutic option for CKD-aP in dialysis dependent patients. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Risks are described more fully in Cara’s filings with the Securities and Exchange Commission, including the “Risk Factors” section of Cara’s Annual Report on Form 10-K for the year ended 31 December 2020 and its other documents subsequently filed with or furnished to the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Except to the extent required by law, Cara undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

Contacts

Media Relations
Nathalie Ponnier

Global Head Corporate Communications

+41 79 957 96 73

media@viforpharma.com

Investor Relations
Julien Vignot

Head of Investor Relations

+41 58 851 66 90

investors@viforpharma.com

Cara Therapeutics contacts:

Media Contact
Claire LaCagnina

6 Degrees

315-765-1462

clacagnina@6degreespr.com

Investor Contact
Janhavi Mohite

Stern Investor Relations, Inc.

212-363-1200

janhavi.mohite@sternir.com

Genentech Provides Update on Tecentriq U.S. Indication in Prior-Platinum Treated Metastatic Bladder Cancer

Genentech Provides Update on Tecentriq U.S. Indication in Prior-Platinum Treated Metastatic Bladder Cancer




Genentech Provides Update on Tecentriq U.S. Indication in Prior-Platinum Treated Metastatic Bladder Cancer

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the company is voluntarily withdrawing the U.S. indication for Tecentriq® (atezolizumab) in prior-platinum treated metastatic urothelial carcinoma (mUC, bladder cancer). This decision was made in consultation with the U.S. Food and Drug Administration (FDA) as part of an industry-wide review of accelerated approvals with confirmatory trials that have not met their primary endpoint(s) and have yet to gain regular approvals. Genentech will work with the FDA over the coming weeks to complete the withdrawal process. This decision does not affect other approved indications for Tecentriq. Genentech is notifying healthcare professionals about this withdrawal. Patients being treated with Tecentriq for prior-platinum treated mUC should discuss their care with their healthcare provider.

“The Accelerated Approval Program allows people with difficult-to-treat cancers to receive certain new therapies earlier,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “While the withdrawal of Tecentriq for prior-platinum treated bladder cancer is disappointing, Tecentriq continues to demonstrate benefits across multiple cancer types and therefore remains a meaningful treatment option for many patients.”

The FDA’s Accelerated Approval Program allows conditional approval of a medicine that fills an unmet medical need for a serious condition, with specific post marketing requirements (PMRs) to confirm the clinical benefit and convert to regular approval.

Tecentriq was granted accelerated approval in 2016 for the treatment of prior-platinum treated mUC based on the results from the IMvigor210 study (Cohort 2). Continued approval for this indication was contingent upon the results of IMvigor211, the original PMR for the prior-platinum mUC indication. This study did not meet its primary endpoint of overall survival in the PD-L1 high patient population. Subsequently, the FDA designated the IMvigor130 study as the PMR which will still continue until the final analysis. However, as the treatment landscape in prior-platinum (second-line) mUC has rapidly evolved with the emergence of new treatment options, Genentech is voluntarily withdrawing this indication in recognition of the principles of the Accelerated Approval Program.

About Tecentriq (atezolizumab)

Tecentriq is a monoclonal antibody designed to bind with a protein called PD-L1. Tecentriq is designed to bind to PD-L1 expressed on tumor cells and tumor-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the re-activation of T cells. Tecentriq may also affect normal cells.

Tecentriq U.S. Indications

Tecentriq is a prescription medicine used to treat adults with:

A type of bladder and urinary tract cancer called urothelial carcinoma.

Tecentriq may be used in patients with urothelial carcinoma if their bladder cancer has spread or cannot be removed by surgery, and if they have any one of the following conditions:

  • They are not able to take chemotherapy that contains a medicine called cisplatin and their cancer tests positive for “PD-L1” or
  • They are not able to take chemotherapy that contains any platinum regardless of the levels of “PD-L1” status or
  • They have tried chemotherapy that contains platinum and it did not work or is no longer working

The approval of Tecentriq in these patients is based on a study that measured the amount of time until patients’ disease worsened. Continued approval for this use may depend on the results of an ongoing study to confirm benefit.

A type of lung cancer called non-small cell lung cancer (NSCLC).

Tecentriq may be used alone as the first treatment in patients with lung cancer if:

  • Their cancer has spread or grown, and
  • Their cancer tests positive for “high PD-L1” and
  • Their tumor does not have an abnormal “EGFR” or “ALK” gene.

Tecentriq may be used with the medicines bevacizumab, paclitaxel, and carboplatin as the first treatment in patients with lung cancer if:

  • Their cancer has spread or grown and
  • Is a type of lung cancer called “non-squamous NSCLC” and
  • Their tumor does not have an abnormal “EGFR” or “ALK” gene

Tecentriq may be used with the medicines paclitaxel protein-bound and carboplatin as the first treatment in patients with lung cancer if:

  • Their cancer has spread or grown and
  • Is a type of lung cancer called “non-squamous NSCLC” and
  • Their tumor does not have an abnormal “EGFR” or “ALK” gene

Tecentriq may be used alone in patients with lung cancer if:

  • Their cancer has spread or grown and
  • They have tried chemotherapy that contains platinum, and it did not work or is no longer working
  • If a patient’s tumor has an abnormal EGFR or ALK gene, they should have also tried an FDA-approved therapy for tumors with these abnormal genes, and it did not work or is no longer working.

A type of breast cancer called triple-negative breast cancer (TNBC).

Tecentriq may be used with the medicine paclitaxel protein-bound in patients with TNBC when their breast cancer:

  • Has spread or cannot be removed by surgery and
  • Their cancer tests positive for “PD-L1”

The approval of Tecentriq in these patients is based on a study that measured the amount of time until patients’ disease worsened. Continued approval for this use may depend on the results of an ongoing study to confirm benefit.

Tecentriq is not for use with the medicine paclitaxel (a different medicine than paclitaxel protein-bound) in patients with TNBC when their breast cancer has spread or cannot be removed by surgery.

A type of lung cancer called small cell lung cancer (SCLC).

Tecentriq may be used with the chemotherapy medicines carboplatin and etoposide as the first treatment in patients with SCLC when their lung cancer:

  • is a type called “extensive-stage small cell lung cancer,” which means that it has spread or grown.

A type of liver cancer called hepatocellular carcinoma (HCC).

Tecentriq may be used with the medicine bevacizumab in patients with HCC if:

  • Their cancer has spread or cannot be removed by surgery, and
  • They have not received other medicines by mouth or injection through their vein (IV) to treat their cancer.

A type of skin cancer called melanoma.

Tecentriq may be used with the medicines cobimetinib and vemurafenib when in patients with melanoma when their skin cancer:

  • has spread to other parts of the body or cannot be removed by surgery, and
  • has a certain type of abnormal “BRAF” gene.

Healthcare providers will perform a test to make sure this Tecentriq combination is right for the patient.

It is not known if Tecentriq is safe and effective in children.

Important Safety Information

The most important information about Tecentriq is:

Tecentriq can cause the immune system to attack normal organs and tissues and can affect the way they work. These problems can sometimes become serious or life-threatening and can lead to death. Patients can have more than one of these problems at the same time. These problems may happen anytime during treatment or even after treatment has ended.

Patients should call or see their healthcare provider right away if they get any symptoms of the following problems or these symptoms get worse.

Lung problems

  • Cough
  • Shortness of breath
  • Chest pain

Intestinal problems

  • Diarrhea (loose stools) or more bowel movements than usual
  • Blood or mucus in stools or dark, tarry, sticky stools
  • Severe stomach area (abdomen) pain or tenderness

Liver problems

  • Yellowing of the skin or the whites of the eyes
  • Severe nausea or vomiting
  • Pain on the right side of the stomach area (abdomen)
  • Drowsiness, dark urine (tea-colored)
  • Bleeding or bruising more easily than normal and feeling less hungry than usual

Hormone gland problems

  • Headaches that will not go away or unusual headaches
  • Eye sensitivity to light
  • Eye problems
  • Rapid heartbeat
  • Increased sweating
  • Extreme tiredness
  • Weight gain or weight loss
  • Feeling more hungry or thirsty than usual
  • Urinating more often than usual
  • Hair loss
  • Feeling cold
  • Constipation
  • The voice gets deeper
  • Dizziness or fainting

Kidney problems

  • Urinating less than usual
  • Blood in the urine
  • Swelling of your ankles
  • Loss of appetite

Skin problems

  • Rash
  • Itching
  • Skin blistering or peeling
  • Painful sores or ulcers in mouth or nose, throat, or genital area
  • Fever or flu-like symptoms
  • Swollen lymph nodes

Problems can also happen in other organs.

These are not all of the signs and symptoms of immune system problems that can happen with Tecentriq. Patients should call or see their healthcare provider right away for any new or worse signs or symptoms, including:

  • Chest pain, irregular heartbeat, shortness of breath, or swelling of ankles
  • Confusion, sleepiness, memory problems, changes in mood or behavior, stiff neck, balance problems, tingling or numbness of the arms or legs
  • Double vision, blurry vision, sensitivity to light, eye pain, changes in eyesight
  • Persistent or severe muscle pain or weakness, muscle cramps
  • Low red blood cells, bruising

Infusion reactions that can sometimes be severe or life-threatening. Signs and symptoms of infusion reactions may include:

  • Chills or shaking
  • Itching or rash
  • Flushing
  • Shortness of breath or wheezing
  • Dizziness
  • Feeling like passing out
  • Fever
  • Back or neck pain

Complications, including graft-versus-host disease (GVHD), in people who have received a bone marrow (stem cell) transplant that uses donor stem cells (allogeneic).

These complications can be serious and can lead to death. These complications may happen if a patient underwent transplantation either before or after being treated with Tecentriq. A patient’s healthcare provider will monitor them for these complications.

Getting medical treatment right away may help keep these problems from becoming more serious. A healthcare provider will check patients for these problems during their treatment with Tecentriq. A healthcare provider may treat patients with corticosteroid or hormone replacement medicines. A healthcare provider may delay or completely stop treatment with Tecentriq if patients have severe side effects.

Before receiving Tecentriq, patients should tell their healthcare provider about all of their medical conditions, including if they:

  • Have immune system problems (such as Crohn’s disease, ulcerative colitis, or lupus)
  • Have had an organ transplant
  • Have received or plan to receive a stem cell transplant that uses donor stem cells (allogeneic)
  • Have received radiation treatment to their chest area
  • Have a condition that affects the nervous system (such as myasthenia gravis or Guillain-Barre syndrome)
  • Are pregnant or plan to become pregnant. Tecentriq can harm an unborn baby.

    • Patients should tell their healthcare provider right away if they become pregnant or think they may be pregnant during treatment with Tecentriq.
    • Females who are able to become pregnant:

      • Should have a healthcare provider do a pregnancy test before they start treatment with Tecentriq and
      • Should use an effective method of birth control during their treatment and for at least 5 months after the last dose of Tecentriq
  • Are breastfeeding or plan to breastfeed. It is not known if Tecentriq passes into breast milk. Patients should not breastfeed during treatment and for at least 5 months after the last dose of Tecentriq

Patients should tell their healthcare provider about all the medicines they take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

The most common side effects of Tecentriq when used alone include:

  • Feeling tired or weak
  • Nausea
  • Cough
  • Shortness of breath
  • Decreased appetite

The most common side effects of Tecentriq when used in lung cancer with other anti-cancer medicines include:

  • Feeling tired or weak
  • Nausea
  • Hair loss
  • Constipation
  • Diarrhea
  • Decreased appetite

The most common side effects of Tecentriq when used in TNBC with paclitaxel protein-bound include:

  • A decrease in hemoglobin (anemia)
  • Decreased white blood cells
  • Hair loss
  • Tingling or numbness in hands and feet
  • Feeling tired
  • Nausea
  • Diarrhea
  • Constipation
  • Cough
  • Headache
  • Vomiting
  • Decreased appetite

The most common side effects of Tecentriq when used in hepatocellular carcinoma (HCC) with bevacizumab include:

  • High blood pressure
  • Feeling tired or weak
  • Too much protein in the urine

The most common side effects of Tecentriq when used in melanoma with cobimetinib and vemurafenib include:

  • Skin rash
  • Joint, muscle, or bone pain
  • Feeling tired or weak
  • Liver injury
  • Fever
  • Nausea
  • Itching
  • Swelling of legs or arms
  • Mouth swelling (sometimes with sores)
  • Low thyroid hormone levels
  • Sunburn or sun sensitivity

Tecentriq may cause fertility problems in females, which may affect their ability to have children. Patients should talk to their healthcare provider if they have concerns about fertility.

These are not all the possible side effects of Tecentriq. Patients should ask their healthcare provider or pharmacist for more information. Patients should call their doctor for medical advice about side effects of Tecentriq.

Report side effects to the FDA at (800) FDA-1088 or http://www.fda.gov/medwatch. Report side effects to Genentech at (888) 835-2555.

Please visit http://www.Tecentriq.com for the Full Tecentriq Prescribing Information for additional Important Safety Information.

About Genentech in cancer immunotherapy

Genentech has been developing medicines to redefine treatment in oncology for more than 35 years, and today, realizing the full potential of cancer immunotherapy is a major area of focus. With more than 20 immunotherapy molecules in development, Genentech is investigating the potential benefits of immunotherapy alone, and in combination with various chemotherapies, targeted therapies and other immunotherapies with the goal of providing each person with a treatment tailored to harness their own unique immune system.

In addition to Genentech’s approved PD-L1 checkpoint inhibitor, the company’s broad cancer immunotherapy pipeline includes other checkpoint inhibitors, individualized neoantigen therapies and T cell bispecific antibodies. For more information visit http://www.gene.com/cancer-immunotherapy.

About Genentech

Founded more than 40 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com.

Contacts

Media Contact:

Meghan Cox

(650) 467-6800

Advocacy Contact:

David Cooling

(202) 713-0083

Investor Contacts:

Lisa Tuomi

(650) 467-8737

Karl Mahler

011 41 61 687 8503

Lee’s Pharmaceutical Announces its Anti-PD-L1 Antibody Socazolimab, Licensed From Sorrento Therapeutics, Receives Clearance to Start Phase 3 Trial as a First-line Treatment of Extensive-stage Small-Cell Lung Cancer

Lee’s Pharmaceutical Announces its Anti-PD-L1 Antibody Socazolimab, Licensed From Sorrento Therapeutics, Receives Clearance to Start Phase 3 Trial as a First-line Treatment of Extensive-stage Small-Cell Lung Cancer




Lee’s Pharmaceutical Announces its Anti-PD-L1 Antibody Socazolimab, Licensed From Sorrento Therapeutics, Receives Clearance to Start Phase 3 Trial as a First-line Treatment of Extensive-stage Small-Cell Lung Cancer

  • Socazolimab is an anti-PD-L1 antibody licensed from Sorrento for the Greater China Territory by Lee’s Pharm.
  • China’s National Medical Products Administration (“NMPA”) clears Lee’s Pharm to conduct a Phase III, multicenter, randomized, double blinded, parallel-group clinical trial of Socazolimab (anti-PD-L1 monoclonal antibody, formerly known as ZKAB001) combined with chemotherapy in the first-line treatment of extensive-stage small-cell lung cancer.

SAN DIEGO, March 07, 2021 (GLOBE NEWSWIRE) — China Oncology Focus Limited (COF), an affiliate of Lee’s Pharmaceutical Holdings Limited (Lee’s Pharm, HKEX: 950) announced that its anti-PD-L1 antibody, Socazolimab, licensed from Sorrento to COF for the greater China territory, has been cleared to begin a multicenter, randomized, double blinded, parallel-group clinical trial of Socazolimab (anti-PD-L1 monoclonal antibody, formerly known as ZKAB001) combined with chemotherapy in the first-line treatment of extensive-stage small-cell lung cancer. The clearance is based on the results from an earlier Phase Ib trial in which Socazolimab combined with carboplatin and etoposide showed a promising efficacy and safety profile in patients with extensive-stage small-cell lung cancer. The Principal Investigator for the clinical trial will be Professor Shun Lu from the Shanghai Chest Hospital and the site is expected to initiate patient recruitment in the second quarter of 2021.

Socazolimab is an in-licensed product from Sorrento Therapeutics, Inc. (Nasdaq: SRNE, “Sorrento”) for the People’s Republic of China, Hong Kong, Macau and Taiwan. Three Phase I clinical trials of Socazolimab monotherapy have been completed: (1) recurrent or metastatic cervical cancer; (2) advanced urothelial carcinoma; and (3) high-grade osteosarcoma after adjuvant chemotherapy for maintenance purposes. For recurrent or metastatic cervical cancer, a pivotal study has been completed and breakthrough therapy designation was granted by the NMPA in February 2021. Lee’s Pharm expects to file the New Drug Application for Socazolimab in recurrent or metastatic cervical cancer in the second quarter of 2021. Apart from monotherapies, several studies of Socazolimab combining with chemotherapy are being conducted in advanced urothelial carcinoma (Phase Ib), extensive-stage small-cell lung cancer (Phase III), and neoadjuvant treatment in esophageal carcinoma (Phase Ib+II).

Dr. Henry Ji, Chairman and CEO of Sorrento Therapeutics, stated, “We at Sorrento are pleased with the collaboration with our colleagues at Lee’s Pharm and with the further advances of our first therapeutic antibody partnership in Socazolimab.”

About Socazolimab

Socazolimab is a fully human anti-PD-L1 monoclonal antibody identified by Sorrento using its proprietary G-MAB™ library platform. COF received exclusive rights to develop and commercialize the antibody for Greater China, which includes Mainland China, Hong Kong, Macau, and Taiwan. Socazolimab has the following potential advantages over its competitors:

  • Fully human antibody potentially allows it to have minimal immunogenicity; demonstrated by its negative antigen-derived antibody (ADA) generation in humans in studies to date.
  • Potentially lower dose required to achieve efficacy compared to other anti-PD-L1 antibodies.
  • Dual mechanism of action observed with both immune-checkpoint inhibition and antibody-dependent cellular cytotoxicity (ADCC) effect.

The antibody has been tested or is being tested in various cancer indications including recurrent or metastatic cervical cancer, maintenance therapy for high-grade osteosarcoma after adjuvant chemotherapy, locally advanced and metastatic urothelial carcinoma, extensive small cell lung cancer in combination with carboplatin and etoposide, and advanced urothelial carcinoma in combination with albumin-bound paclitaxel and esophageal carcinoma.

About Sorrento Therapeutics, Inc.

Sorrento is a clinical stage, antibody-centric, biopharmaceutical company developing new therapies to treat cancers and COVID-19. Sorrento’s multimodal, multipronged approach to fighting cancer is made possible by its extensive immuno-oncology platforms, including key assets such as fully human antibodies (“G-MAB™ library”), clinical stage immuno-cellular therapies (“CAR-T”, “DAR-T™”), antibody-drug conjugates (“ADCs”), and clinical stage oncolytic virus (“Seprehvir™”). Sorrento is also developing potential antiviral therapies and vaccines against coronaviruses, including COVIGUARD™, COVI-AMG™, COVISHIELD™, Gene-MAb™, COVI-MSC™ and COVIDROPS™; and diagnostic test solutions, including COVITRACK™, COVISTIX™ and COVITRACE™.

Sorrento’s commitment to life-enhancing therapies for patients is also demonstrated by our effort to advance a first-in-class (TRPV1 agonist) non-opioid pain management small molecule, resiniferatoxin (“RTX”), and SP-102 (10 mg, dexamethasone sodium phosphate viscous gel) (SEMDEXA™), a novel, viscous gel formulation of a widely used corticosteroid for epidural injections to treat lumbosacral radicular pain, or sciatica, and to commercialize ZTlido® (lidocaine topical system) 1.8% for the treatment of post-herpetic neuralgia. RTX has completed a Phase IB trial for intractable pain associated with cancer and a Phase 1B trial in osteoarthritis patients. SEMDEXA is in a pivotal Phase 3 trial for the treatment of lumbosacral radicular pain, or sciatica. ZTlido® was approved by the FDA on February 28, 2018.

For more information visit www.sorrentotherapeutics.com.

About China Oncology Focus Limited

COF is a subsidiary of Lee’s Pharm and a clinical development stage company focused on oncology. COF is currently developing several assets, including socazolimab (anti-PD-L1 antibody) in pivotal clinical trial stage; Zotiraciclib, an oral multi-kinase inhibitor in Phase I clinical trial for glioblastoma; Gimatecan, a topoisomerase I inhibitor in Phase I clinical trial for ovarian cancer and in Phase Ib/II clinical trial for small cell lung cancer in China; Pexa-vec (oncolytic virus) which is in global Phase Ib clinical trial for renal cell cancer. COF has built a pipeline of 10 assets through internal development and in-licensing. The diversity of its products creates a unique position for the company to use immune oncology as backbone therapy in combination with in-house products and develop potential paradigm-shifting treatment for cancer.

About Lee’s Pharmaceutical Holdings Limited

Lee’s Pharm is a research-driven and market-oriented biopharmaceutical company with more than 25 years of operation in the pharmaceutical industry in China. The Company is fully integrated with solid infrastructures in drug development, clinical development, regulatory, manufacturing, sales and marketing based in Mainland China with global perspectives. The Company has established extensive partnerships with over 20 international companies and currently markets 23 proprietary, generic and licensed-in pharmaceutical products in Mainland China, Hong Kong, Macau and Taiwan. The Company focuses on several key disease areas such as cardiovascular, woman health, paediatrics, rare diseases, oncology, dermatology, obstetrics and urology, and has more than 40 products under different development stages stemming from both internal research and development as well as from the licensing and development, commercialisation, and manufacturing rights from various United States, European and Japanese companies. Lee’s Pharm has also involved in the business in ophthalmology through its investment in Zhaoke Ophthalmology Limited, an associated company of the Group.

For more information visit www.leespharm.com.

Forward-Looking Statements

This press release and any statements made for and during any presentation or meeting contain forward-looking statements related to Sorrento Therapeutics, Inc., under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995 and subject to risks and uncertainties that could cause actual results to differ materially from those projected. Forward-looking statements include statements regarding the potential efficacy and safety profile of a Socazolimab product candidate; Lee’s Pharm’s plan to file a new drug application for Socazolimab in China; and the expected timing for filing a new drug application for Socazolimab in China. Risks and uncertainties that could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements, include, but are not limited to: risks related to Sorrento’s and its subsidiaries’, affiliates’ and partners’ technologies and prospects and collaborations with partners, including, but not limited to risks related to seeking regulatory approval for any Socazolimab product candidate; clinical development risks, including risks in the progress, timing, cost, and results of clinical trials and product development programs; risk of difficulties or delays in obtaining regulatory approvals; risks that clinical study results may not meet any or all endpoints of a clinical study and that any data generated from such studies may not support a regulatory submission or approval; risks that prior test, study and trial results may not be replicated in future studies and trials; risks of manufacturing and supplying drug product; risks related to leveraging the expertise of its employees, subsidiaries, affiliates and partners to assist Sorrento in the execution of its therapeutic antibody product candidate strategies; risks related to the global impact of COVID-19; and other risks that are described in Sorrento’s most recent periodic reports filed with the Securities and Exchange Commission, including Sorrento’s Annual Report on Form 10-K for the year ended December 31, 2020, and subsequent Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission, including the risk factors set forth in those filings. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release and we undertake no obligation to update any forward-looking statement in this press release except as required by law.

Media and Investor Relations Contact

Sorrento Therapeutics
Alexis Nahama, DVM (SVP Corporate Development)
Email: mediarelations@sorrentotherapeutics.com

Lee’s Pharmaceutical
Vivian Fung
Telephone: +852 2314 1282
Email: info@leespharm.com

Sorrento® and the Sorrento logo are registered trademarks of Sorrento Therapeutics, Inc.

G-MAB™, DAR-T™, SOFUSA™, COVIGUARD™, COVI-AMG™, COVISHIELD™, Gene-MAb™, COVIDROPS™, COVI-MSC™, COVITRACK™, COVITRACE™ and COVISTIX™ are trademarks of Sorrento Therapeutics, Inc.

SEMDEXA™ is a trademark of Semnur Pharmaceuticals, Inc.

ZTlido® is a registered trademark owned by Scilex Pharmaceuticals Inc.

All other trademarks are the property of their respective owners.

©2021 Sorrento Therapeutics, Inc. All Rights Reserved.

Masimo Monitoring Solutions Promote Newborn and Maternal Safety

Masimo Monitoring Solutions Promote Newborn and Maternal Safety




Masimo Monitoring Solutions Promote Newborn and Maternal Safety

New Neonatal Study Adds to Body of Clinical Evidence Demonstrating Masimo SET® Pulse Oximetry’s Unique Ability to Improve Care

NEUCHATEL, Switzerland–(BUSINESS WIRE)–Masimo (NASDAQ: MASI) provides a variety of innovative monitoring solutions designed to improve maternal and newborn safety during childbirth and the critical first minutes of life. Masimo SET® pulse oximetry’s ability to measure during motion and low perfusion has helped newborns, neonates, and pediatric patients like no other pulse oximetry. Not only has Masimo SET® helped clinicians reduce retinopathy of prematurity (ROP)1 and improve screening for critical congenital heart disease (CCHD),2-10 but it has helped push the standard of care for babies to new heights—the evidence from CCHD studies with SET®, for example, has been used in the establishment of screening guidelines used around the world.11


Today, on International Women’s Day, it is especially important to recognize that, as UNICEF reports, “newborns and mothers are still dying in appalling numbers.” Every day, approximately 7,000 babies in the first month of life die, and approximately 810 women die, from preventable complications related to childbirth or pregnancy.12 Similarly, according to the WHO, “Although important progress has been made in the last two decades, about 295,000 women died during and following pregnancy and childbirth in 2017. The most common direct causes of maternal injury and death are excessive blood loss, infection, high blood pressure, unsafe abortion, and obstructed labor, as well as indirect causes such as anemia, malaria, and heart disease.”13

Masimo’s first and ongoing focus has been helping neonatologists, pediatricians, OB-GYNs, and midwives around the world provide the best care possible for newborns and their mothers. The Masimo Newborn Sensor, the first and still the only sensor of its kind, was introduced in 2004 and is designed to provide accurate arterial oxygen saturation (SpO2) and pulse rate (PR) measurements in the fastest time possible during hectic neonatal resuscitation scenarios. Alongside Newborn Sensors, Pathway™, introduced in 2019 for the Root® platform, helps clinicians visualize their preferred SpO2 and PR protocol during neonatal resuscitation. Eve, a software application introduced in 2014, simplifies and automates the CCHD screening process, which Masimo SET® enabled. The Blue® Sensor, introduced in 2004, provides accurate monitoring in cyanotic children at low SpO2 levels to help clinicians care for them and was validated specifically on infants with cyanotic disease.14 rainbow® SpHb®, noninvasive hemoglobin monitoring, introduced in 2008, can measure hemoglobin levels during pregnancy and alert clinicians to the possibility of excessive blood loss during delivery.

Adding to the significant body of clinical evidence demonstrating the utility of SET® pulse oximetry and other Masimo newborn and maternal solutions, a new study published in the Journal of Clinical Neonatology investigated the use of comparing Masimo perfusion index (Pi) pre- and post-ductal values on pre-term infants to aid clinicians in diagnosing hemodynamically significant patent ductus arteriosus (hsPDA).15 Dr. Melek Büyükeren and colleagues at Hacettepe University in Ankara, Turkey found that the difference in right-hand and right-leg Pi values obtained using Masimo SET® pulse oximetry was significantly higher in pre-term infants with hsPDA, leading them to conclude that the difference in Pi “has diagnostic value in hsPDA and can assist diagnosis when echocardiography is not available.”

Marcelo Cardetti, MD, said, “As Head of the Neonatology Service of the Clinic and Maternity of the Center for Endocrinology and Human Reproduction (CERHU) in San Luis, Argentina, we have been using Masimo pulse oximetry monitors with SET® for approximately 8 years in all high-risk newborns and also for newborn resuscitation. In addition, we use Masimo SET® monitors for the detection of CHD and hypoxemia in all newborns in the mother-infant unit. Furthermore, our neonatal department is engaged in a research protocol on regional cerebral oxygenation (O3®) with neonatal sensors for Masimo Root – to know what happens with cerebral oxygenation during routine clinical procedures in the NICU. This monitoring, in addition to SpO2 and perfusion index (Pi), perfectly shows us what is happening with oxygenation of seriously ill newborns in real-time and in a noninvasive way. Masimo SET®’s innovative technology far overcomes the limitations of conventional oximetry and the Pi is an important clinical tool in the care of sick neonates. This monitor and the special neonatal RD sensors have been of great value for the prevention of ROP and for successful and quick, accurate, and reliable steps needed in resuscitation in the delivery room.”

Hernando Baquero, MD, commented, “I am a pediatrician, neonatologist, clinician, educator and researcher in a major university in Colombia, with several publications on noninvasive neonatal SpO2 monitoring and oxygenation. The introduction in the Latin American market of Masimo SET® technology dramatically improved neonatal care in our countries. In contexts with serious resource limitations, as is the case in most neonatal units in our countries, it was vital to be able to provide quality care to the most vulnerable population due to their health conditions (e.g. hypoperfusion) or their biological characteristics (e.g. prematurity). Having reliable, fast, and stable readings as provided by SET® and its neonatal sensors improved the chances of many of our newborns.”

Anne de-Wahl Granelli, PhD, Biomedical Scientist, RDCS(PE), Medical Centre Manager, Sweden, said, “The integration of pulse oximetry into the CCHD screening process has made a significant impact on the detection of congenital heart disease and neonatal health. In clinical studies, the use of pulse oximetry screening with SET® technology significantly improved the detection of duct dependent heart disease before hospital discharge. In 2011, the U.S. Department of Health and Human Services added pulse oximetry screening of newborns for CCHD to the Recommended Uniform Screening Panel. Today pulse oximetry has become a global standard of care when screening newborns for CHD.”

Sergio Golombek, MD, MPH, FAAP, Member of the Board and Past President of the Ibero-American Society of Neonatology (SIBEN), said, “I have authored and published several scientific studies in relation to newborn oxygenation and screening for CCHD. Masimo SET® and new innovations and sensor development like RD sensors for noninvasive monitoring represent excellent technology that we can trust, that work promptly and accurately when we need it the most, and are designed specifically with ill newborn babies in the NICU in mind. SET® technology allows us also to do the pulse oximetry test or CCHD screening on newborn babies in our units, knowing well that we can fully trust the results. The technology is very easy to use and understand, and makes us deliver better clinical care.”

Katsuyuki Miyasaka, MD, PhD, Executive Advisor, Wayo Women’s University Graduate School, Tokyo and Professor Emeritus, St. Luke’s International University, Tokyo, said, “As a critical care pediatric anesthesiologist, reliable and accurate pulse oximetry is paramount to optimal patient outcomes. Some suggest pulse oximetry is the fifth vital sign. Clinicians can rely on the sensitivity and specificity provided by Masimo’s measure-through-motion technology in the management of children in the PICU. The use of pulse oximetry can lead to fewer adverse events in the recovery room by capturing accurate readings even during movement such as shivering in critically ill or unstable patients.”

Mark Ansermino, MBBCh, MMed, Director of the Center for International Child Health and Professor, Department of Anesthesiology, Pharmacology & Therapeutics at the University of British Columbia, Canada, said, “Anemia is a significant public health problem that especially affects the quality of life, health status, and survival of mothers and children around the world. Having access to continuous hemoglobin monitoring technology can help provide visibility to hemoglobin levels. The noninvasive nature of the SpHb solution makes it comfortable for the mother and child and makes monitoring during childbirth feasible even in low-resource settings.”

Asrat Dibaba Tolossa, MD, MPH, is Chief of Party for the Global Affairs Canada ENRICH (Enhancing Nutrition Services to Improve Maternal and Child Health) Program, a multi-year, multi-country initiative designed to improve the health and nutrition of mothers, newborns, and children. As part of the program, ENRICH has been conducting a study in central Tanzania, where maternal and child care services are often overburdened, using the Masimo Rad-67® Pulse CO-Oximeter®, which provides spot-check SpHb measurements. Dr. Tolossa commented, “In our field experimentation with the Rad-67, we found out that the device can be used easily by lower-level health workers in the communities for screening and referral of patients to health facilities for further assessment and treatment. There was also a high acceptance rate by community members as the method is noninvasive.”

Joe Kiani, Founder and CEO of Masimo, said, “From our inception, we have been committed to improving outcomes for the youngest and most fragile patients. Our foundational SET® pulse oximetry was designed with newborns in mind. With rainbow® Pulse CO-Oximetry, we have made the noninvasive monitoring of child and mother clinically more meaningful. While we stand behind the fact that we have the best pulse oximetry for all patients, especially the most fragile patients, we continue to seek new ways to help clinicians provide newborns and their mothers with the best care possible. On this International Women’s Day, we thank the caregivers who have dedicated themselves to the health of newborns and their mothers, as well as women everywhere, for their achievements, their sacrifices, and for nurturing us all.”

SpHb is not intended to replace laboratory blood testing. Clinical decisions regarding red blood cell transfusions should be based on the clinician’s judgment considering, among other factors, patient condition, continuous SpHb monitoring, and laboratory diagnostic tests using blood samples.

Noninvasive, continuous SpHb has CE clearance for all patients and in the U.S. has received FDA clearance for patients >3 kg but is not currently indicated for patients <3 kg. As part of its U.S. FDA 510(k) clearance, spot-check SpHb on Rad-67 is contraindicated for use on pregnant patients and not indicated for use on pediatric patients or patients with renal disease. Eve has not obtained FDA clearance and is not available in the United States.

@Masimo | #Masimo

*ARMS accuracy is a statistical calculation of the difference between device measurements and reference measurements. Approximately two-thirds of the device measurements fell within +/- ARMS of the reference measurements in a controlled study.

About Masimo

Masimo (NASDAQ: MASI) is a global medical technology company that develops and produces a wide array of industry-leading monitoring technologies, including innovative measurements, sensors, patient monitors, and automation and connectivity solutions. Our mission is to improve patient outcomes and reduce the cost of care. Masimo SET® Measure-through Motion and Low Perfusion™ pulse oximetry, introduced in 1995, has been shown in over 100 independent and objective studies to outperform other pulse oximetry technologies.16 Masimo SET® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,1 improve CCHD screening in newborns,4 and, when used for continuous monitoring with Masimo Patient SafetyNet™ in post-surgical wards, reduce rapid response team activations, ICU transfers, and costs.17-20 Masimo SET® is estimated to be used on more than 200 million patients in leading hospitals and other healthcare settings around the world,21 and is the primary pulse oximetry at 9 of the top 10 hospitals according to the 2020-21 U.S. News and World Report Best Hospitals Honor Roll.22 Masimo continues to refine SET® and in 2018, announced that SpO2 accuracy on RD SET® sensors during conditions of motion has been significantly improved, providing clinicians with even greater confidence that the SpO2 values they rely on accurately reflect a patient’s physiological status. In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC™), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), Pleth Variability Index (PVi®), RPVi™ (rainbow® PVi), and Oxygen Reserve Index (ORi™). In 2013, Masimo introduced the Root® Patient Monitoring and Connectivity Platform, built from the ground up to be as flexible and expandable as possible to facilitate the addition of other Masimo and third-party monitoring technologies; key Masimo additions include Next Generation SedLine® Brain Function Monitoring, O3® Regional Oximetry, and ISA™ Capnography with NomoLine® sampling lines. Masimo’s family of continuous and spot-check monitoring Pulse CO-Oximeters® includes devices designed for use in a variety of clinical and non-clinical scenarios, including tetherless, wearable technology, such as Radius-7® and Radius PPG™, portable devices like Rad-67™, fingertip pulse oximeters like MightySat® Rx, and devices available for use both in the hospital and at home, such as Rad-97®. Masimo hospital automation and connectivity solutions are centered around the Masimo Hospital Automation™ platform, and include Iris® Gateway, iSirona™, Patient SafetyNet, Replica™, Halo ION™, UniView™, UniView :60™, and Masimo SafetyNet™. Additional information about Masimo and its products may be found at www.masimo.com. Published clinical studies on Masimo products can be found at www.masimo.com/evidence/featured-studies/feature/.

ORi and RPVi have not received FDA 510(k) clearance and are not available for sale in the United States. The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.

References

  1. Castillo A et al. Prevention of Retinopathy of Prematurity in Preterm Infants through Changes in Clinical Practice and SpO2 Technology. Acta Paediatr. 2011 Feb;100(2):188-92.
  2. Slitine N, et al. Pulse Oximetry and Congenital Heart Disease Screening: Results of the First Pilot Study in Morocco. Int J Neonatal Screen 6(53). 30 June 2020.
  3. Zhao et al. Pulse oximetry with clinical assessment to screen for congenital heart disease in neonates in China: a prospective study. Lancet. 2014 Aug 30;384(9945):747-54.
  4. de-Wahl Granelli A et al. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009;Jan 8;338.
  5. Ewer AK et al. Pulse Oximetry Screening for Congenital Heart Defects in Newborn Infants (Pulseox): A Test Accuracy Study. Lancet. 2011 Aug 27;378(9793):785-94.
  6. de-Wahl Granelli A et al. Noninvasive Peripheral Perfusion Index as a Possible Tool for Screening for Critical Left Heart Obstruction. Acta Paediatr 2007; 96(10): 1455-9.
  7. Meberg A et al. First Day of Life Pulse Oximetry Screening to Detect Congenital Heart Defects. J Pediatr 2008; 152:761-5.
  8. Schena F et al. Perfusion Index and Pulse Oximetry Screening for Congenital Heart Defects. J Pediatr. 2017 Apr;183:74-79.
  9. Hamilçıkan S, Can E. Critical Congenital Heart Disease Screening With a Pulse Oximetry in Neonates. J Perinat Med. 2018 Feb 23;46(2):203-207.
  10. Jawin V et al. Beyond Critical Congenital Heart Disease: Newborn Screening Using Pulse Oximetry for Neonatal Sepsis and Respiratory Diseases in a Middle-Income Country. PLoS One. 2015; 10(9): e0137580.
  11. Kemper et al. Strategies for implementing screening for critical congenital heart disease. Pediatrics. 2011 Nov;128(5):e1259-67. doi: 10.1542/peds.2011-1317.
  12. https://www.unicef.org/health/maternal-and-newborn-health
  13. https://www.who.int/health-topics/maternal-health#tab=tab_1
  14. Harris B et al. Ped Crit Care Med. 2016 Apr;17(4):315-20.
  15. Büyükeren M, Yiğit S, Aykan HH, Karagöz T, Çelik HT, Yurdakök M. Comparison of perfusion index and echocardiographic parameters in preterm infants with hemodynamically significant patent ductus arteriosus. J Clin Neonatol 2021;10:11-8.
  16. Published clinical studies on pulse oximetry and the benefits of Masimo SET® can be found on our website at http://www.masimo.com. Comparative studies include independent and objective studies which are comprised of abstracts presented at scientific meetings and peer-reviewed journal articles.
  17. Taenzer A et al. Impact of pulse oximetry surveillance on rescue events and intensive care unit transfers: a before-and-after concurrence study. Anesthesiology. 2010:112(2):282-287.
  18. Taenzer A et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
  19. McGrath S et al. Surveillance Monitoring Management for General Care Units: Strategy, Design, and Implementation. The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302.
  20. McGrath S et al. Inpatient Respiratory Arrest Associated With Sedative and Analgesic Medications: Impact of Continuous Monitoring on Patient Mortality and Severe Morbidity. J Patient Saf. 2020 14 Mar. DOI: 10.1097/PTS.0000000000000696.
  21. Estimate: Masimo data on file.
  22. http://health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview.

Forward-Looking Statements

This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of SET®, Newborn Sensors, Pathway™, Eve, Blue®, rainbow®, and SpHb®. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo’s unique noninvasive measurement technologies, including SET®, Newborn Sensors, Pathway, Eve, Blue, rainbow®, and SpHb, contribute to positive clinical outcomes and patient safety; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions and unique advantages; risks related to COVID-19; as well as other factors discussed in the “Risk Factors” section of our most recent reports filed with the Securities and Exchange Commission (“SEC”), which may be obtained for free at the SEC’s website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today’s date. We do not undertake any obligation to update, amend or clarify these statements or the “Risk Factors” contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Contacts

Masimo
Evan Lamb

949-396-3376

elamb@masimo.com

LSK Global PS Adopts Veeva Vault Clinical Applications to Streamline Global Trial Processes

LSK Global PS Adopts Veeva Vault Clinical Applications to Streamline Global Trial Processes




LSK Global PS Adopts Veeva Vault Clinical Applications to Streamline Global Trial Processes

Leading Korean CRO using Vault eTMF, Vault CTMS, and Veeva SiteVault Free for increased efficiency and collaboration with sponsors

SEOUL, South Korea–(BUSINESS WIRE)–Veeva Systems (NYSE: VEEV) announced that LSK Global Pharma Services Co. Ltd, a leading Korean contract research organization (CRO), has adopted Veeva Vault eTMF, Veeva Vault CTMS, and Veeva SiteVault Free. With Veeva Vault Clinical applications, LSK Global PS can streamline trial management and remotely collaborate with study monitors for document review and verification.

“As a leading CRO, our aim is to run faster, more efficient trials,” said Young-Jack Lee, Ph.D. and president of LSK Global Pharma Services Co. Ltd. “Veeva Vault Clinical applications enable us to operate remote trials, provides full visibility into end-to-end trial activities, and improves our collaboration with sponsors.”

Vault eTMF (electronic trial master file) and Vault CTMS (clinical trial management system) are part of the Veeva Vault Clinical Suite, the industry’s first cloud platform that unifies clinical data management and operations. SiteVault Free simplifies research by replacing paper-based processes. Together, these applications enable LSK Global PS to accelerate trial execution and deliver real-time visibility within a short timeframe.

“We are proud to support LSK Global PS,” said Chris Shim, Veeva vice president of Vault R&D and Quality Asia. “With Veeva Vault Clinical applications, LSK Global PS is innovating their clinical trial processes and running faster, high-quality studies.”

To learn how Vault Clinical Suite is helping CROs to streamline clinical trial processes and information exchange, visit veeva.com/Clinical.

Additional Information

Connect with Veeva APAC on LinkedIn: linkedin.com/company/veeva-systems-apac

Follow @veevasystems on Twitter: twitter.com/veevasystems

Like Veeva on Facebook: facebook.com/veevasystems

About Veeva Systems

Veeva is the global leader in cloud software for the life sciences industry. Committed to innovation, product excellence, and customer success, Veeva serves more than 975 customers, ranging from the world’s largest pharmaceutical companies to emerging biotechs. As a Public Benefit Corporation, Veeva is committed to balancing the interests of all stakeholders, including customers, employees, shareholders, and the industries it serves. For more information, visit veeva.com.

Forward-looking Statements

This release contains forward-looking statements, including the market demand for and acceptance of Veeva’s products and services, the results from use of Veeva’s products and services, and general business conditions (including the on-going impact of COVID-19), particularly within the life sciences industry. Any forward-looking statements contained in this press release are based upon Veeva’s historical performance and its current plans, estimates, and expectations, and are not a representation that such plans, estimates, or expectations will be achieved. These forward-looking statements represent Veeva’s expectations as of the date of this press announcement. Subsequent events may cause these expectations to change, and Veeva disclaims any obligation to update the forward-looking statements in the future. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially. Additional risks and uncertainties that could affect Veeva’s financial results are included under the captions, “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” in the company’s filing on Form 10-Q for the period ended October 31, 2020. This is available on the company’s website at veeva.com under the Investors section and on the SEC’s website at sec.gov. Further information on potential risks that could affect actual results will be included in other filings Veeva makes with the SEC from time to time.

About LSK Global Pharma Services Co., Ltd

LSK Global Pharma Services Co., Ltd.(http://www.lskglobal.com/), established in 2000 in Korea, is the nation’s largest integrated contract research organization (CRO) that has provided therapeutic area-specific services across oncology, cardiovascular disease and endocrinology.

LSK Global PS is a full-service CRO encompassing all of the major areas of clinical research, including clinical trials from phase I to IV, investigator-led clinical studies, PMS (post-marketing surveillance) studies, safety studies and observational studies. In addition, it provides consulting services for new drug development, regulatory affairs, study start-up, medical writing and research, clinical operation, project management, data management, statistical analysis, pharmacovigilance (PV), epidemiological research, and quality assurance.

LSK Global PS has conducted 1,277 clinical studies, including 144 global clinical studies and 110 IND studies, since its foundation (as of December 2020). It is the first Korean CRO to win a contract for an FIH (first-in-human) phase I study of an anticancer agent from a multinational pharmaceutical company, an achievement that was especially meaningful because LSK Global PS was competing against large global CROs to win this contract. Also, LSK Global PS has successfully completed a large-scale global phase III trial for an anticancer agent, which was conducted in 95 sites in 12 countries including the US, Europe, and Asia.

In March 2017, LSK Global PS became the first Korean CRO which acquired the ‘ISO (International Organization for Standardization) 9001:2015’ certification for Quality Management Systems in the entire areas of services relevant with clinical trials. In December 2019, it became the first Korean CRO to acquire the ‘ISO 37001’ certification for Anti-Bribery Management Systems.

LSK Global PS also became the first Korean CRO to establish a PV branch office in Europe in May 2019 and a DM (Data Management) branch office in Taiwan in February 2020.

Contacts

Jacqui Davis

Veeva Systems APAC

+61 411 284 900

jacqueline.davis@veeva.com

Bec Sands

Polkadot Communications

+61 416 119 858

bec@polkadotcomms.com.au

Transactions with shares and linked securities in Genmab A/S made by managerial employees and their closely associated persons

Transactions with shares and linked securities in Genmab A/S made by managerial employees and their closely associated persons




Transactions with shares and linked securities in Genmab A/S made by managerial employees and their closely associated persons

Company Announcement

COPENHAGEN, Denmark; March 7, 2021 – Genmab A/S (Nasdaq: GMAB) – In accordance with Article 19 of Regulation No. 596/2014 on Market Abuse and Implementing Regulation 2016/523, this document discloses the data of the transactions made in Genmab A/S (Nasdaq: GMAB) made by managerial employees and their closely associated persons.

The company’s managerial employees and their closely associated persons have given Genmab A/S power of attorney on their behalf to publish trading in Genmab shares by the company’s managerial employees and their closely associated persons.

Contact:          
Marisol Peron, Senior Vice President, Global Investor Relations & Communications
T: +1 609 524 0065; E: mmp@genmab.com

For Investor Relations:
Andrew Carlsen, Senior Director, Head of Investor Relations
T: +45 3377 9558; E: acn@genmab.com

This Company Announcement contains forward looking statements. The words “believe”, “expect”, “anticipate”, “intend” and “plan” and similar expressions identify forward looking statements. Actual results or performance may differ materially from any future results or performance expressed or implied by such statements. The important factors that could cause our actual results or performance to differ materially include, among others, risks associated with pre-clinical and clinical development of products, uncertainties related to the outcome and conduct of clinical trials including unforeseen safety issues, uncertainties related to product manufacturing, the lack of market acceptance of our products, our inability to manage growth, the competitive environment in relation to our business area and markets, our inability to attract and retain suitably qualified personnel, the unenforceability or lack of protection of our patents and proprietary rights, our relationships with affiliated entities, changes and developments in technology which may render our products or technologies obsolete, and other factors. For a further discussion of these risks, please refer to the risk management sections in Genmab’s most recent financial reports, which are available on www.genmab.com and the risk factors included in Genmab’s most recent Annual Report on Form 20-F and other filings with the U.S. Securities and Exchange Commission (SEC), which are available at www.sec.gov. Genmab does not undertake any obligation to update or revise forward looking statements in this Company Announcement nor to confirm such statements to reflect subsequent events or circumstances after the date made or in relation to actual results, unless required by law.

Genmab A/S and/or its subsidiaries own the following trademarks: Genmab®; the Y-shaped Genmab logo®; Genmab in combination with the Y-shaped Genmab logo®; HuMax®; DuoBody®; DuoBody in combination with the DuoBody logo®; HexaBody®; HexaBody in combination with the HexaBody logo®; DuoHexaBody®; HexElect®; and UniBody®. Arzerra® and Kesimpta® are trademarks of Novartis AG or its affiliates. DARZALEX® and DARZALEX FASPRO® are trademarks of Janssen Pharmaceutica NV. TEPEZZA® is a trademark of Horizon Therapeutics plc.

CVR no. 2102 3884
LEI Code 529900MTJPDPE4MHJ122

Genmab A/S
Kalvebod Brygge 43
1560 Copenhagen V
Denmark

Attachment

GLIDE-Carter Center Partnership Aims to Eliminate River Blindness in the Americas, Lymphatic Filariasis and Malaria on Hispaniola

GLIDE-Carter Center Partnership Aims to Eliminate River Blindness in the Americas, Lymphatic Filariasis and Malaria on Hispaniola




GLIDE-Carter Center Partnership Aims to Eliminate River Blindness in the Americas, Lymphatic Filariasis and Malaria on Hispaniola

 

ATLANTA & ABU DHABI, United Arab Emirates–(BUSINESS WIRE)–The Carter Center and The Global Institute for Disease Elimination (GLIDE) announced an exciting new partnership to support the Carter Center’s innovative disease elimination efforts in the Americas.

GLIDE, an initiative of the Crown Prince Court of Abu Dhabi and the Bill & Melinda Gates Foundation, has pledged substantial financial and technological support for the Center’s programs to eliminate two neglected diseases: river blindness (onchocerciasis) in the Amazon rainforest along the Brazil-Venezuela border and lymphatic filariasis (commonly called LF or elephantiasis) throughout Hispaniola, the island shared by Haiti and the Dominican Republic. The initiative also supports malaria elimination from Hispaniola.

This new partnership will help accelerate progress toward achieving the goals in the newly launched World Health Organization Neglected Tropical Diseases Roadmap 2021-2030, which includes targets for a 90% reduction in the number of people requiring treatment for NTDs and elimination of at least one NTD in 100 countries.

Eliminating onchocerciasis

Since 1993, the Carter Center’s Onchocerciasis Elimination Program for the Americas (OEPA) has been working to eliminate river blindness transmission in North, Central, and South America by partnering with six nations’ ministries of health, the Pan American Health Organization (PAHO), and many other partners. These joint efforts have succeeded in eliminating transmission of the disease from Colombia, Ecuador, Mexico, and Guatemala (each officially verified by the World Health Organization). In the Americas, transmission of the parasite continues only in an isolated, hard to reach area deep in the Amazon rainforest along the Brazil-Venezuela border, mainly affecting the Yanomami, a nomadic indigenous tribe living in that region.

River blindness is caused by bites of Simulium black flies infected by the parasitic worm Onchocerca volvulus; symptoms can include intense itching, rash, and visual impairment, potentially leading to permanent blindness. Transmission can be eliminated through long-term mass drug administration with the antifilarial medication ivermectin (donated by Merck & Co. Inc. under the brand name Mectizan®).

“The challenge is in finding and reaching the people who need the medication,” said Gregory Noland, Ph.D., M.P.H., director of both the Carter Center River Blindness Elimination Program and its Hispaniola Initiative. “To eliminate river blindness from the Americas, we must reach everyone, even those living in the deepest parts of the rainforest.”

The partnership with GLIDE will provide resources to test state-of-the-art technology to help locate and quickly treat people in the most remote unreached rainforest villages, the last vestige of the disease in the Western Hemisphere. Lessons learned from the Americas have helped to inform river blindness elimination efforts in Africa, where 99% of the remaining disease burden exists.

Eliminating lymphatic filariasis and malaria

The island of Hispaniola, shared by Haiti and the Dominican Republic, accounts for 95% of the lymphatic filariasis (LF) burden in the Americas and is the last remaining malaria-endemic island in the Caribbean. Through its Hispaniola Initiative, The Carter Center has been working since 2008 with the governments of Haiti and the Dominican Republic to eliminate transmission of LF and malaria from Hispaniola. Achieving elimination of both diseases would be a historic achievement.

LF, or elephantiasis, is a mosquito-transmitted disease that damages the lymphatic system and can cause limbs and genitals to swell to disabling proportions. It is prevented with a combination of the drugs diethylcarbamazine (DEC) and albendazole (donated by Eisai and GSK, respectively), which are administered annually to at-risk communities for several years. Together with the ministries of health, The Carter Center takes an active role in drug distribution, program monitoring and evaluation, and providing care (including mental health support) for those who suffer complications from chronic LF.

Malaria is a mosquito-borne parasitic disease that kills approximately 400,000 people each year, mostly children, with about 228 million cases of the disease reported worldwide. Symptoms include fever, intense headaches, vomiting, body-shaking chills, and other flu-like symptoms. Without treatment, malaria can lead to anemia, hypoglycemia, cerebral malaria, coma, and death.

GLIDE’s partnership will help Haiti and the Dominican Republic in their final push to eliminate both malaria and LF.

“We are privileged to help The Carter Center accelerate toward its goal of eliminating river blindness, LF, and malaria by partnering on this exciting, leading-edge initiative,” said Simon Bland, the chief executive officer of GLIDE. “The learnings may well provide clues for how we speed up elimination efforts in other remote global communities and takes us one step closer to consigning diseases of poverty to the history books.”

About GLIDE

GLIDE is a new global health institute, rooted in Abu Dhabi, focused on accelerating the elimination of four preventable diseases of poverty: currently malaria, polio, lymphatic filariasis, and river blindness by 2030 and beyond. Founded in 2019 as the result of a collaboration between His Highness Sheikh Mohamed bin Zayed, Crown Prince of Abu Dhabi, and the Bill & Melinda Gates Foundation, GLIDE identifies the latest scientific, cultural, and global health knowledge and puts it into action with its partners through programmes, funding, and skills development to support local health care systems and advance global thinking.

About The Carter Center

“Waging Peace. Fighting Disease. Building Hope.”

A not-for-profit, nongovernmental organization, The Carter Center has helped to improve life for people in over 80 countries by resolving conflicts; advancing democracy, human rights, and economic opportunity; preventing diseases; and improving mental health care. The Carter Center was founded in 1982 by former U.S. President Jimmy Carter and former First Lady Rosalynn Carter, in partnership with Emory University, to advance peace and health worldwide.

Contacts

The Carter Center, Atlanta:

Emily Staub

Emily.Staub@cartercenter.org

GLIDE, Abu Dhabi:

Priya Kanayson

priya@glideae.org