Bivigam (immune globulin intravenous [human]) / ADMA Biologics - LARVOL DELTA

Safety and Efficacy of Intravenous Immune Globulin 10% (BIVIGAM®) in Children with Primary Immune Deficiency. (PubMed, J Clin Immunol) - No abstract available

Journal • Immunology • Pediatrics • Primary Immunodeficiency

Population Pharmacokinetic Modeling and Simulation of Immune Globulin Intravenous (Human), 10% Liquid in Pediatric and Adult Patients with Primary Immune Deficiency Disorders (CIS 2025) - P3, P4 | "Simulation from models with estimated and fixed allometric predicted trough IgG levels for a virtual population of 1000 subjects across pediatric age-groups with the recommended BIVIGAM® dosage of 300 to 800 mg/kg and confirmed clinically acceptable trough IgG levels (∼7 g/L) would be achieved to support dosing recommendations for patients ≥ 2 years of age with PIDD."

Clinical • PK/PD data • Immunology • Pediatrics • Primary Immunodeficiency

Treatment With Intravenous Immune Globulin 10% In A Real-World Outpatient Setting (AAAAI 2023) - "Originally approved in 2012 and then voluntarily withdrawn in 2016, IVIG 10% (BIVIGAM®) underwent manufacturing process improvements by a new manufacturer and was reintroduced to the US market in 2019...IVIG 10% was well-tolerated within this real-world outpatient setting. Infusion-related adverse reactions were low."

Clinical • Real-world • Real-world evidence • Asthma • Cardiovascular • Chronic Lymphocytic Leukemia • Dermatomyositis • Gastroenterology • Gastroesophageal Reflux Disease • Hematological Malignancies • Hypertension • Immunology • Leukemia • Myositis • Oncology • Primary Immunodeficiency • Pulmonary Disease • Respiratory Diseases

Study to Evaluate Safety and Pharmacokinetics of BIVIGAM® in Primary Immune Deficiency Subjects Aged 2 to 16 (clinicaltrials.gov) - P4 | N=16 | Completed | Sponsor: ADMA Biologics, Inc. | Active, not recruiting ➔ Completed

Trial completion • Immunology • Primary Immunodeficiency

A Study About Low Blood Pressure in Patients With Primary Immunodeficiency Disease Treated With Immune Globulin Products (clinicaltrials.gov) - P=N/A | N=200 | Active, not recruiting | Sponsor: ADMA Biologics, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Hypotension • Immunology • Primary Immunodeficiency

Study to Evaluate Safety and Pharmacokinetics of BIVIGAM® in Primary Immune Deficiency Subjects Aged 2 to 16 (clinicaltrials.gov) - P4 | N=16 | Active, not recruiting | Sponsor: ADMA Biologics, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Immunology • Primary Immunodeficiency

"$ADMA ADMA Biologics Announces Commercial Availability of Expanded Vial Size Offerings for BIVIGAM® and NABI-HB® https://t.co/K7ucSOmxFV #offering" (@stock_titan)

Study to Evaluate Safety and Pharmacokinetics of BIVIGAM® in Primary Immune Deficiency Subjects Aged 2 to 16 (clinicaltrials.gov) - P4; N=18; Recruiting; Sponsor: ADMA Biologics, Inc.; Trial completion date: Jun 2021 ➔ Dec 2022; Trial primary completion date: Mar 2021 ➔ Sep 2022

Trial completion date • Trial primary completion date • Immunology • Primary Immunodeficiency

A Study About Low Blood Pressure in Patients With Primary Immunodeficiency Disease Treated With Immune Globulin Products (clinicaltrials.gov) - P=N/A; N=200; Recruiting; Sponsor: ADMA Biologics, Inc.; Active, not recruiting ➔ Recruiting; N=27 ➔ 200; Trial completion date: Mar 2021 ➔ Jun 2023; Trial primary completion date: Mar 2021 ➔ Dec 2022

Enrollment change • Enrollment open • Trial completion date • Trial primary completion date • Hypotension • Immunology • Primary Immunodeficiency

A Study About Low Blood Pressure in Patients With Primary Immunodeficiency Disease Treated With Immune Globulin Products (clinicaltrials.gov) - P=N/A; N=27; Active, not recruiting; Sponsor: ADMA Biologics, Inc.; Recruiting ➔ Active, not recruiting; N=200 ➔ 27

Clinical • Enrollment change • Enrollment closed • Hypotension • Immunology • Primary Immunodeficiency

Manufacturing process optimization of ADMA Biologics' intravenous immunoglobulin products, BIVIGAM and ASCENIV™. (PubMed, Immunotherapy) - "This data driven, small-scale approach has led to manufacturing enhancements that have yielded consistent product improvements. The systematic approach to optimizing manufacturing has guided process changes, in-process, procedural and engineering controls that have reduced protein shearing and aggregation, and improved purity resulting in products with lot-to-lot consistency."

Journal • Immunology • Primary Immunodeficiency

ADMA Biologics receives PDUFA date for Bivigam regulatory submission (GlobeNewswire) - “ADMA Biologics…announces that the U.S. Food and Drug Administration (‘FDA’) has acknowledged receipt of ADMA’s PAS filing for review which seeks approval to amend the FDA approved BLA for BIVIGAM…Once the PAS is approved, ADMA intends to relaunch BIVIGAM® in the U.S.  The target action date for the PAS is October 25, 2018 under the Prescription Drug User Fee Act (‘PDUFA’).“

PDUFA date • Relaunch • Immunology • Primary Immunodeficiency

ATTEND: Autologous Transplant To End NMO Spectrum Disorder (clinicaltrials.gov) - P2/3; N=0; Withdrawn; Sponsor: Northwestern University; N=50 ➔ 0; Recruiting ➔ Withdrawn

Enrollment change • Trial withdrawal

ADMA Biologics Announces Commercial Relaunch and its First Commercial Sales of BIVIGAM® (GlobeNewswire, ADMA Biologics, Inc.) - "RAMSEY, N.J. and BOCA RATON, Fla., Aug 22, 2019 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc (NASDAQ: ADMA) (“ADMA” or the “Company”), a vertically integrated commercial biopharmaceutical and specialty immunoglobulin company that manufactures and markets three approved plasma-derived biologics for the treatment of immune deficiencies and the prevention of certain infectious diseases, announces the commercial relaunch and its first commercial sales of BIVIGAM®. As previously reported, BIVIGAM® had a Biologics License Application (“BLA”) manufacturing change Prior Approval Supplement (“PAS”) approved by the United States Food and Drug Administration (“FDA”) on May 9, 2019, enabling ADMA to resume marketing BIVIGAM® to US- based prescribers and healthcare professionals."

Commercial • Launch

ADMA Biologics Reports Second Quarter and First Half 2019 Financial Results (GlobeNewswire, ADMA Biologics, Inc.) - “We are pleased with our significant accomplishments reported during the second quarter of 2019, which include two United States Food and Drug Administration (“FDA”) approvals, BIVIGAM® and ASCENIV™, as well as the FDA authorizations of product license transfers for BIVGAM® and Nabi-HB®,” stated Adam Grossman, ADMA’s President and Chief Executive Officer. “During the second quarter, we completed an equity financing of approximately $52 million in gross proceeds, which we expect to use to support the commercial inventory build and product launches for BIVIGAM® and ASCENIV™, expand the manufacturing capacity of our Boca Raton, FL facility, the procurement of raw materials, plasma center expansion, other capital expenditures and for general corporate purposes.” . Obtained FDA approval for ASCENIV™ (formerly RI-002). Received FDA approval for license transfers for BIVIGAM® and Nabi-HB®....Commercial launches and sales of BIVIGAM® and ASCENIV™ in second half of 2019."

Commercial • Launch • Regulatory

ATTEND: Autologous Transplant To End NMO Spectrum Disorder (clinicaltrials.gov) - P2/3; N=50; Recruiting; Sponsor: Northwestern University; Initiation date: Jun 2019 ➔ Nov 2019

Trial initiation date

ADMA Biologics Receives FDA Approval for License Transfers for BIVIGAM® and Nabi-HB® (GlobeNewswire, ADMA Biologics, Inc.) - "ADMA Biologics, Inc....announces the United States Food and Drug Administration (“FDA”) has notified ADMA the licenses for BIVIGAM® and Nabi-HB® have been revoked from Biotest Pharmaceuticals Corporation, (“BPC”) U.S. License No 1792 and transferred and issued to ADMA’s U.S. License No 2019. “We are very pleased to announce the U.S. License transfer of BIVIGAM® and Nabi-HB® from BPC to ADMA, as this was the final remaining regulatory item from the acquisition of the Biotest Therapy Business Unit transaction,” stated President and Chief Executive Officer, Adam Grossman....Going forward, ADMA will manufacture and introduce both BIVIGAM® and Nabi-HB® into interstate commerce under ADMA’s U.S. License No. 2019..."

Clinical • Commercial • FDA event • Regulatory

Bivigam: Relaunch in US for primary humoral immunodeficiency in 2019 (Jefferies 2019 Healthcare Conference, ADMA Biologics)

Launch US

Bivigam: Relaunch in US for primary humoral immunodeficiency in 2019 (Jefferies 2019 Healthcare Conference, ADMA Biologics)

Launch US

"#ADMABiologics returning #Bivigam to market after 3-year absence https://t.co/S1XNX0fHJt @FiercePharma #immunedeficiency" (@PlexusVentures)

ADMA Biologics Reports First Quarter 2019 Financial Results (GlobeNewswire, ADMA Biologics, Inc.) - "Ongoing communications with the FDA to obtain approval of the BIVIGAM® drug substance Prior Approval Supplement ('PAS') required to relaunch the product. Potential commercial sales of...BIVIGAM®....Subsequent to March 31, 2019, ADMA accessed $27.5 million of additional funding from Perceptive Advisors, with another $12.5 million of funding from Perceptive available upon FDA approval of BIVIGAM®."

Financing • Regulatory • Sales

"$ADMA FDA Approves Prior Approval Supplement for BIVIGAM https://t.co/2vXywz61GU" (@BioStocks)

FDA event

ADMA Biologics Elects to Draw-Down $27.5 Million in Capital from Existing Perceptive Advisors Credit Agreement (GlobeNewswire, ADMA Biologics, Inc.) - "ADMA Biologics, Inc....announces that it has elected to draw-down $27.5 million from its existing credit agreement with Perceptive Advisors and each of the Company and Perceptive Advisors entered into an amendment to the original credit agreement...Perceptive has agreed to upsize the original credit facility with the availability of an additional funding commitment of $12.5 million, predicated upon FDA approval of BIVIGAM®. The additional $12.5 million commitment will be available to ADMA at its sole option following FDA approval until March 31, 2020."

Financing • Regulatory

ATTEND: Autologous Transplant To End NMO Spectrum Disorder (clinicaltrials.gov) - P2/3; N=50; Recruiting; Sponsor: Northwestern University; Initiation date: Mar 2019 ➔ Jun 2019

Trial initiation date

ADMA Biologics Reports Full Year 2018 Financial Results (GlobeNewswire, ADMA Biologics, Inc.) - “As part of our compliance enhancement upgrades to our Boca Raton, FL facility, we optimized the intravenous immunoglobulin ('IVIG') manufacturing process for BIVIGAM®. We continue to work with the FDA to finalize our BIVIGAM Prior Approval Supplement ('PAS') for drug substance, with the goal of reintroducing BIVIGAM® to the market this year. We are also working closely with the FDA on the pending application for RI-002’s...The increase in net loss of $22.0 million...increase in cost of product revenue from the manufacture of conformance lots production of RI-002 and BIVIGAM®, which can be used for commercial sales upon FDA approval...

Commercial • Regulatory