Pulmonary Valve Insufficiency

DALLAS--( BUSINESS WIRE )--AIC, a division of AIS Healthcare, now offers GLASSIA and ARALAST NP, manufactured by Takeda, for the treatment of adult patients with clinically evident emphysema due to severe hereditary deficiency of Alpha 1 -PI (alpha 1 -antitrypsin deficiency). The nationally accredited home infusion teams at AIC collaborate closely with physicians to provide specialized infusion services to patients in their home or at an infusion suite setting. The addition of these therapy options expands AIC’s ability to better serve patients with alpha 1 -antitrypsin deficiency. “We’re excited and proud to be able to add Takeda’s Alpha 1 therapies to our growing portfolio of infusion therapies,” said Jud Hall, President at AIC. “The addition of GLASSIA and ARALAST NP can help us provide patients with more options to meet individual treatment needs.” Approved by the U.S. Food and Drug Administration (FDA) in 2010 and 2002, respectively, GLASSIA and ARALAST NP are Alpha 1 -Proteinase Inhibitors (Human) (Alpha 1 -PI) indicated for chronic augmentation therapy in adults with clinically evident emphysema due to severe hereditary deficiency of Alpha 1 -PI. ARALAST NP increases antigenic and functional (anti-neutrophil elastase capacity, ANEC) serum levels and antigenic lung epithelial lining fluid levels of Alpha 1 -PI. The effect of augmentation therapy with GLASSIA, ARALAST NP, or any Alpha 1 -PI product on pulmonary exacerbations and on the progression of emphysema in Alpha 1 -PI deficiency has not been conclusively demonstrated in randomized, controlled clinical trials. Clinical data demonstrating the long-term effects of chronic augmentation and maintenance therapy of individuals with GLASSIA or ARALAST NP are not available. GLASSIA and ARALAST NP are not indicated as therapies for lung disease in patients in whom severe Alpha 1 -PI deficiency has not been established. Both GLASSIA and ARALAST NP are now available at all AIC locations (Valdosta, Georgia; Birmingham, Alabama; Panama City, Florida; Dallas, Texas). Like all AIC patients, those with alpha 1 -antitrypsin deficiency will receive a high level of care from AIC, including 24/7 access to clinical and support staff. Every patient is assigned a dedicated team of professionals, including clinical pharmacists, home infusion nurses, RN clinical review specialists and patient onboarding specialists to provide support throughout the treatment process. For providers, AIC is a full-service care delivery partner. We also work directly with patients, insurance companies, and provider offices to secure all needed insurance authorizations and approvals. AIC is dually accredited by URAC and the Accreditation Commission for Health Care (ACHC), further setting it apart from other infusion services providers. Physicians interested in AIC care services should contact their AIC representatives to get started or visit us at www.aiscaregroup.com/our-divisions/infusion-care/ About AIS Healthcare Advancing quality. Improving lives. As the leading provider of targeted drug delivery and infusion care solutions, AIS Healthcare is committed to doing more of what matters. From pharmacies that put patient safety first to comprehensive services that enhance the entire care experience, we go beyond the expected in everything we do. Learn more at aiscaregroup.com . About Takeda Takeda is focused on creating better health for people and a brighter future for the world. We aim to discover and deliver life-transforming treatments in our core therapeutic and business areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience and vaccines. Together with our partners, we aim to improve the patient experience and advance a new frontier of treatment options through our dynamic and diverse pipeline. As a leading values-based, R&D-driven biopharmaceutical company headquartered in Japan, we are guided by our commitment to patients, our people and the planet. Our employees in approximately 80 countries and regions are driven by our purpose and are grounded in the values that have defined us for more than two centuries. For more information, visit www.takeda.com .

FDA Approval Provides for Room Temperature (25°C) Storage Conditions for up to 4 Weeks at Any Point During the 36-Month Approved Shelf Life Extends the Prior Room Temperature Storage Allowance for the Full 36-months for ASCENIV and BIVIGAM Provides for Improved Inventory Management and Ease of Product Administration to Patients Approval of Extended Ambient Storage Conditions for ASCENIV & BIVIGAM is Immediately Effective and Now Commercially Available to U.S. Healthcare Providers RAMSEY, N.J. and BOCA RATON, Fla., March 11, 2024 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (NASDAQ: ADMA) (“ADMA” or the “Company”), an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty biologics, today announced the United States Food and Drug Administration’s (“FDA”) approval for its supplemental Biologics License Applications (BLAs) for both ASCENIV and BIVIGAM to extend the approved 4-week room temperature (25°C) storage conditions during the first 24 months of shelf life, to allow for a 4-week room temperature storage at any time during the entire 36-month approved shelf life. The room temperature approval applies to all existing ASCENIV and BIVIGAM lots currently in the commercial supply chain as well as to future production of ASCENIV and BIVIGAM. “With the FDA-approved extension of room temperature storage conditions, the Company expects to reach more customers who were previously inaccessible due to limited refrigeration space and cold chain capacity constraints,” said Adam Grossman, President and Chief Executive Officer of ADMA. “We believe that this added storage flexibility for both ASCENIV and BIVIGAM will meaningfully enhance our products’ market offerings, enabling more versatile utilization and better inventory management for providers.” The newly approved extension of room temperature storage conditions for both ASCENIV and BIVIGAM is immediately effective, and both products are commercially available to U.S. healthcare providers and patients. About ADMA Biologics, Inc. (ADMA) ADMA Biologics is an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty biologics for the treatment of immunodeficient patients at risk for infection and others at risk for certain infectious diseases. ADMA currently manufactures and markets three United States Food and Drug Administration (FDA)-approved plasma-derived biologics for the treatment of immune deficiencies and the prevention of certain infectious diseases: BIVIGAM® (immune globulin intravenous, human) for the treatment of primary humoral immunodeficiency (PI); ASCENIV™ (immune globulin intravenous, human – slra 10% liquid) for the treatment of PI; and NABI-HB® (hepatitis B immune globulin, human) to provide enhanced immunity against the hepatitis B virus. ADMA manufactures its immune globulin products at its FDA-licensed plasma fractionation and purification facility located in Boca Raton, Florida. Through its ADMA BioCenters subsidiary, ADMA also operates as an FDA-approved source plasma collector in the U.S., which provides its blood plasma for the manufacture of its products. ADMA’s mission is to manufacture, market and develop specialty biologics, human immune globulins targeted to niche patient populations for the treatment and prevention of certain infectious diseases and management of immune compromised patient populations who suffer from an underlying immune deficiency, or who may be immune compromised for other medical reasons. ADMA holds numerous U.S. and foreign patents related to and encompassing various aspects of its products and product candidates. For more information, please visit . About ASCENIV™ ASCENIV (immune globulin intravenous, human – slra 10% liquid) is a plasma-derived, polyclonal, intravenous immune globulin (IVIG). ASCENIV was approved by the United States Food and Drug Administration (FDA) in April 2019 and is indicated for the treatment of primary humoral immunodeficiency (PI), also known as primary immune deficiency disease (PIDD), in adults and adolescents (12 to 17 years of age). ASCENIV is manufactured using ADMA’s unique, patented plasma donor screening methodology and tailored plasma pooling design, which blends normal source plasma and respiratory syncytial virus (RSV) plasma obtained from donors tested using the Company’s proprietary microneutralization assay. ASCENIV contains naturally occurring polyclonal antibodies, which are proteins that are used by the body’s immune system to neutralize microbes, such as bacteria and viruses and prevent against infection and disease. ASCENIV is protected by U.S. Patents: 9,107,906, 9,714,283 and 9,815,886. Certain data and other information about ASCENIV can be found by visiting . Information about ADMA and its products can be found on the Company’s website at . About BIVIGAM® BIVIGAM (immune globulin intravenous, human – 10% liquid) is a plasma-derived, polyclonal, intravenous immune globulin (IVIG). BIVIGAM was approved by the FDA in May 2019 and is indicated for the treatment of primary humoral immunodeficiency (PI), including, but not limited to, the following group of genetic disorders: X-linked and congenital agammaglobulinemia, common variable immunodeficiency, Wiskott-Aldrich syndrome and severe combined immunodeficiency. BIVIGAM contains a broad range of antibodies similar to those found in normal human plasma. These antibodies are directed against bacteria and viruses and help to protect PI patients against serious infections. BIVIGAM is a purified, sterile, ready-to-use preparation of concentrated human Immunoglobulin antibodies. Certain data and other information about BIVIGAM or ADMA and its products can be found on the Company’s website at . Cautionary Note Regarding Forward-Looking Statements This press release contains “forward-looking statements” pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 about ADMA Biologics, Inc. and its subsidiaries (collectively, “our” or the “Company”). Forward-looking statements include, without limitation, any statement that may predict, forecast, indicate, or imply future results, performance or achievements, and may contain such words as “anticipate,” “intend,” “target,” “plan,” “expect,” “believe,” “will,” “is likely,” “will likely,” “should,” “could,” “would,” “may,” or, in each case, their negative, or words or expressions of similar meaning. These forward-looking statements also include, but are not limited to, the anticipated benefits and significance of the FDA’s room temperature storage approval. Actual events or results may differ materially from those described in this press release due to a number of important factors. Current and prospective security holders are cautioned that there also can be no assurance that the forward-looking statements included in this press release will prove to be accurate. Except to the extent required by applicable laws or rules, ADMA does not undertake any obligation to update any forward-looking statements or to announce revisions to any of the forward-looking statements. Forward-looking statements are subject to many risks, uncertainties and other factors that could cause our actual results, and the timing of certain events, to differ materially from any future results expressed or implied by the forward-looking statements, including, but not limited to, the risks and uncertainties described in our filings with the U.S. Securities and Exchange Commission, including our most recent reports on Form 10-K, 10-Q and 8-K, and any amendments thereto. COMPANYCONTACT: Skyler Bloom Senior Director, Business Development & Corporate Strategy | 201-478-5552 | sbloom@admabio.com INVESTOR RELATIONS CONTACT: Michelle Pappanastos Senior Managing Director, Argot Partners | 212-600-1902 | michelle@argotpartners.com

The company's in-house developed VenusP-Valve is designed with both flared ends to ensure the blood flow of the branchial artery with bare stents at the outflow end The VenusP-Valve TPVR system. (Credit: PR Newswire/Venus Medtech (Hangzhou) Inc.) China-based Venus Medtech (Hangzhou) has received approval from Health Canada for the VenusP-Valve transcatheter pulmonic valve replacement (TPVR) system. The company’s in-house developed VenusP-Valve is designed with both flared ends to ensure the blood flow of the branchial artery with bare stents at the outflow end. The TPVR system is intended to make delivery simple with a stable multi-point anchoring system without the need for pre-stenting before the procedure. Offered in a range of specifications with extensive applicability, VenusP-Valve can suit the needs of 85% of patients in the case of large right ventricular outflow tract (RVOT), according to Venus Medtech. The system is said to be the first self-expanding TPVR product approved in China and Europe. Venus Medtech CEO Lim Hou-Sen said: “Seeking effective treatments for major diseases that pose a serious threat to human health is what we do at Venus Medtech, which makes us proud to have received this Health Canada approval. “The approval of VenusP-Valve represents a meaningful expansion of clinical options for patients in the country.” The Chinese firm said that the TPVR system has performed better than similar products in areas like rates of arrhythmia and reintervention while maintaining safety and efficacy. A European clinical trial’s three-year follow-up data shows that TPVR with VenusP-Valve has a 100% success rate along with zero all-cause mortality and reintervention rates. Furthermore, there was no evidence of moderate or severe pulmonary regurgitation. In 96.87% of individuals, tricuspid regurgitation, and paravalvular leakage were mild or less. The results demonstrate superior efficacy, strong safety, and dependability, Venus Medtech added. They also showed steady improvements in patients’ cardiac function. In April 2022, VenusP-Valve obtained the CE mark under the Medical Devices Regulation (MDR), making it the first Class 3 implantable cardiovascular device authorised under the new MDR. The self-expanding TPVR product obtained its first ethical approval in the region in 2023 following the receipt of investigational device exemption (IDE) approval from the US Food and Drug Administration (FDA). This approval paved the way for the VenusP-Valve PROTEUS clinical study.