STADA Arzneimittel AG is a company that specializes in offering healthcare and pharmaceutical products. It operates in three main segments: Generics, Consumer Healthcare, and Specialty. The Generics division produces and distributes generic drugs, while the Consumer Healthcare division offers products such as over-the-counter medications, nutritional supplements, and certain consumer healthcare items like disinfectants and sunscreen. The Specialty division focuses on branded generics, specialty generics, and biosimilars. Some of the company's popular brands include Zoflora, Grippostad, Nizoral, and Shampoo & Ladival. STADA Arzneimittel AG was established in 1895 and is headquartered in Bad Vilbel, Germany.

Tags

Immune System Diseases

Skin and Musculoskeletal Diseases

Digestive System Disorders

Biosimilar

Monoclonal antibody

Fab fragment

Disease domain score

A glimpse into the focused therapeutic areas

Technology Platform

Most used technologies in drug development

Targets

Most frequently developed targets

Disease Domain	Count

Immune System Diseases	7
Endocrinology and Metabolic Disease	5
Nervous System Diseases	4
Infectious Diseases	4
Hemic and Lymphatic Diseases	2
Neoplasms	1

Top 5 Drug Type	Count

Small molecule drug	7
Biosimilar	7
Monoclonal antibody	4
Fab fragment	1
Recombinant polypeptide	1

Top 5 Target	Count

VEGF-A(Vascular endothelial growth factor A)	2
RARs(Retinoic acid receptors)	1
DNAJB3 x NF-κB	1
TNF-α(Tumor necrosis factor α)	1
CD20(B-lymphocyte antigen CD20)	1

Drugs associated with STADA Arzneimittel AG

Apomorphine Hydrochloride

Target

DRDs

Mechanism

DRDs agonists

Active Org.

Sumitomo Pharma America, Inc. [+10]

Originator Org.

STADA Arzneimittel AG

Active Indication

Parkinson Disease [+3]

Inactive Indication-

Drug Highest PhaseApproved

First Approval Ctry. / Loc.

European Union [+3]

First Approval Date28 May 2001

Fexofenadine Hydrochloride

Target

H1 receptor

Mechanism

H1 receptor antagonists

Active Org.

Opella Healthcare (Shanghai) Co Ltd.Startup [+13]

Originator Org.

Sanofi, Inc.

Active Indication

Chronic Urticaria [+7]

Inactive Indication

Persistent asthma [+2]

Drug Highest PhaseApproved

First Approval Ctry. / Loc.

United Kingdom

First Approval Date11 Mar 1996

Acitretin

Target

RARs

Mechanism

RARs agonists

Active Org.

Originator Org.

Active Indication

Inactive Indication

Drug Highest PhaseApproved

First Approval Ctry. / Loc.

Canada

First Approval Date31 Dec 1994

Clinical Trials associated with STADA Arzneimittel AG

NCT06716255

/ CompletedNot Applicable

Observational Single-center Comparative Study of the Efficacy of Buffered Acetylsalicylic Acid and Enteric-coated Acetylsalicylic Acid on Platelet Aggregation in Patients With Chronic Coronary Syndrome and Type 2 Diabetes Mellitus

Patients with diabetes mellitus are characterized by "hyperreactive" platelets and a reduced response to ASA compared to individuals without diabetes. ASA that is absorbed in the intestine is slower to enter the bloodstream and become therapeutic concentrations compared to ASA that is absorbed in the stomach. It seems rational to test the hypothesis that the use of buffered ASA may be more effective in patients with diabetes and chronic coronary syndrome (CCS).

Start Date29 Feb 2024

Sponsor / Collaborator

Nizhpharm AO

CTR20232033

/ CompletedPhase 1

一项在中国健康受试者中评价单次给予盐酸阿扑吗啡注射液（皮下注射）的药代动力学特征、安全性、耐受性的I 期、开放性临床研究

[Translation] A Phase I, open-label clinical study to evaluate the pharmacokinetic characteristics, safety, and tolerability of a single dose of apomorphine hydrochloride injection (subcutaneous injection) in healthy Chinese subjects

主要目的：评估在中国健康受试者中单次给予盐酸阿扑吗啡注射液（皮下注射）1 mg、2 mg、3 mg 的药代动力学特征；次要目的：评估在中国健康受试者中单次给予盐酸阿扑吗啡注射液（皮下注射）1 mg、2 mg、3 mg 的安全性和耐受性。

[Translation]

Primary objective: To evaluate the pharmacokinetic characteristics of apomorphine hydrochloride injection (subcutaneous injection) of 1 mg, 2 mg, and 3 mg in healthy Chinese subjects; Secondary objective: To evaluate the safety and tolerability of apomorphine hydrochloride injection (subcutaneous injection) of 1 mg, 2 mg, and 3 mg in healthy Chinese subjects.

Start Date13 Jul 2023

Sponsor / Collaborator

Ignis Therapeutics (Suzhou) Limited

[+3]

NCT05579379

/ Unknown statusNot ApplicableIIT

DESENSITIZE-PD: Intestinal Levodopa + Entacapone Therapy (Lecigon®) to Support Dopaminergic Desensitization in Parkinson's Disease

20 patients with idiopathic Parkinson's disease, who are planned to undergo intestinal L-Dopa + entacapone (Lecigon®) treatment will be included into this observational single-armed study. These patient will be observed for hyperdopaminergic complications and neuropsychiatric fluctuations postprocedure at 3, 6 and 12 months.

Start Date01 Oct 2022

Sponsor / Collaborator

University Hospital Tübingen

[+1]

100 Clinical Results associated with STADA Arzneimittel AG

0 Patents (Medical) associated with STADA Arzneimittel AG

Literatures (Medical) associated with STADA Arzneimittel AG

01 Nov 2023·Journal of neural transmission (Vienna, Austria : 1996)

Practical use of apomorphine infusion in Parkinson’s disease: lessons from the TOLEDO study and clinical experience

Article

Author: Lees, Andrew ; Katzenschlager, Regina ; Henriksen, Tove ; Bhidayasiri, Roongroj ; Staines, Harry ; Lockhart, Donna

Abstract:

Subcutaneous apomorphine infusion is a device-aided therapy for Parkinson’s disease that can be considered when motor fluctuations become persistent and are no longer adequately controlled by oral/transdermal medication. Apomorphine infusion is less invasive than enteral levodopa, deep brain stimulation or focused ultrasound, and is often indicated even when neurosurgical approaches are contraindicated. This article aims to provide practical guidance for doctors and nurses initiating and treating patients with apomorphine infusion, and is based on both trial data and clinical experience from movement disorders specialists. A post hoc analysis of data from the TOLEDO randomized clinical trial of apomorphine infusion was conducted along with an analysis of ‘real world’ experience from 13 movement disorders specialists using a questionnaire that focused on starting patients on apomorphine infusion. Practical guidelines for starting treatment with apomorphine infusion are provided taking into consideration the regional disparities in healthcare. Apomorphine infusion is straightforward to administer but to be successful it requires concordance from the patient and family, and clinical support from an experienced team of doctors and nurses, particularly in the early months of treatment.

01 Feb 2021·Parkinsonism & related disorders

Long-term safety and efficacy of apomorphine infusion in Parkinson's disease patients with persistent motor fluctuations: Results of the open-label phase of the TOLEDO study

Article

Author: Henriksen, Tove ; Rascol, Olivier ; Deuschl, Günther ; Lees, Andrew ; van Laar, Teus ; Trenkwalder, Claudia ; Chaudhuri, K Ray ; Lockhart, Donna ; Katzenschlager, Regina ; Poewe, Werner ; Staines, Harry

INTRODUCTION:

The randomized, double-blind phase (DBP) of the TOLEDO study confirmed the efficacy of apomorphine infusion (APO) in reducing OFF time in PD patients with persistent motor fluctuations despite optimized oral/transdermal therapy. Here we report safety and efficacy results including the 52-week open-label phase (OLP).

METHODS:

All patients completing the 12-week DBP (including those switching early to open-label treatment) were offered OLP entry. The primary objective was the evaluation of long-term safety of APO.

RESULTS:

Eighty-four patients entered the OLP (40 previously on APO, 44 on placebo) and 59 patients (70.2%) completed the study. The safety profile of APO was consistent with experience from extensive clinical use. Common treatment-related adverse events (AEs) were mild or moderate infusion site nodules, somnolence and nausea. Fourteen (16.7%) patients discontinued the OLP due to AEs, those involving >1 patient were infusion site reactions (n = 4) and fatigue (n = 2); hemolytic anemia occurred in one case. Reduction in daily OFF time and improvement in ON time without troublesome dyskinesia were sustained for up to 64 weeks. Pooled data for week 64 (n = 55) showed a mean (SD) change from DBP baseline in daily OFF time of -3.66 (2.72) hours and in ON time without troublesome dyskinesia of 3.31 (3.12) hours. Mean (±SD) daily levodopa-equivalent dose decreased from DBP baseline to week 64 by 543 mg (±674) and levodopa dose by 273 mg (±515).

CONCLUSIONS:

The safety and efficacy of APO infusion were demonstrated with long-term use for persistent motor fluctuations, allowing substantial reductions in oral PD medication.

01 Dec 2020·Die PharmazieQ4 · MEDICINE

Retrospective post-authorisation safety study investigating the relationship of first-generation antihistamines with sedative effect and the risk of falls in older patients.

Q4 · MEDICINE

Article

Author: Gomez Perez, S. ; Schweimer, M. T. ; Giesel, B. ; Iwanowitsch, A. ; Hassel, I.

For patients at the age of 65 years or older an increased risk of falls in association with the intake of first-generation antihistamines with sedative effect is discussed. Currently, there are no valid data that can either confirm or disprove this risk. In this retrospective non-interventional safety study, the primary objective was to investigate a possible causal relationship between falls in patients ≥ 65 years of age and the intake of first-generation antihistamines. Secondary objectives were to investigate a possible causal relationship of falls after taking first-generation antihistamines for the subgroups < 65 years, 65-84 years and ≥ 85 years; to determine the fall rate of patients ≥ 65 years of age and of the subgroups < 65 years, 65-84 years and ≥ 85 years; and to identify causes of falls in patients ≥ 65 years. Out of the 13,866 physicians who were invited to participate in the study, 524 (3.8%) opened the link to the survey. The evaluation included verified data sets of 169 physicians who were either general practitioners or resident neurologists who had in total treated 313,046 patients within the previous six months. 9,922 patients had fallen at least once (total fall rate 3.2%). The rate of falls increased with age (< 65 years 1.1%; 65-84 years 3.9%; ≥ 85 years 9.9%). The fall rate of patients aged 65 years and older was 5.4%. Only a small proportion (2.9%, 8,942 patients) of the altogether 313,046 patients recorded had taken a first-generation antihistamine at any time within the previous six months. In the records of 9.5% (940 patients) of the 9,922 patients who had fallen the intake of first-generation antihistamines was documented. Detailed information was available for 379 of these patients with a total of 505 falls. The analysis of these cases indicates that in almost three quarters of falls (72.5%, 366 falls) there is no causal link between the intake of first-generation antihistamines and the fall. In almost 95% of the remaining 123 falls, the physicians suggested between one and seven possible alternative causes of falls (mainly underlying and concomitant diseases). This suggests that first-generation antihistamines do not play a relevant role in the fall incidents.

News (Medical) associated with STADA Arzneimittel AG

04 Feb 2025

·medcitynews.com

Supernus Wearable Device for Dosing Parkinson’s Drug Lands Long-Awaited FDA Approval - MedCity News

A new Supernus Pharmaceuticals medical device that continuously administers an old Parkinson’s disease drug is now FDA approved, giving patients another way to manage the motor control symptoms that return when the effects of standard treatment for the neurological disease wanes. The drug/device combination product, known in development as SPN-830, will be commercialized under the brand name Onapgo. Supernus said Tuesday it plans to launch Onapgo in the second quarter of this year. In an email, the Rockville, Maryland-based company, which specializes in treatments for central nervous system diseases, said it cannot comment on pricing of products before they become commercially available. The backbone of Parkinson’s treatment is levodopa, a compound that is converted to dopamine in the brain to boost levels of this brain chemical that patients lack. The periods when this medication works are called “on” times. But Parkinson’s patients also experience “off” times when levodopa therapy wears off and motor symptoms return. One treatment option for these off periods is a different drug, apomorphine. presented by sponsored content, Artificial Intelligence What Keeps Healthcare CIOs Up at Night: Balancing Technology Investments with Consumer Expectations When it comes to managing inbound phone calls, underperformance has devastating cost implications. By Stephanie Baum Apomorphine mimics dopamine, binding to receptors responsible for motor control. An FDA-approved injectable version of this drug has been available for more than 20 years for treating the off episodes of Parkinson’s. In 2020, Sunovion Pharmaceuticals’ sublingual film formulation of apomorphine received FDA approval for intermittent treatment of the off episodes of Parkinson’s. Supernus already has a presence in Parkinson’s. Its second-largest product by revenue is Gocovri, a capsule that treats dyskinesia and off time in Parkinson’s patients. The company also already markets apomorphine, dosed as needed via an injection pen product branded as Apokyn. But motor symptoms of Parkinson’s worsen as the disease progresses and off periods can happen at any time. Continuous infusion of apomorphine offers an additional way to manage these unpredictable off times. Supernus sources Apokyn from Britannia Pharmaceuticals, a subsidiary of German company Stada Arzneimittel. Britannia markets both injectable and continuous infusion apomorphine products in Europe. A license and supply agreement with Britannia grants Supernus the right to use and market injectable apomorphine in the U.S. The 2016 pact also covers the joint development of other apomorphine products, including drug administered as a continuous infusion. Supernus must pay Britannia royalties on net sales for products covered by the agreement. Britannia retains rights to its drug outside of the U.S. Onapgo, a device secured to the body by an elastic band worn around the waist, has had a rocky regulatory journey leading up to its FDA nod. Supernus applications seeking regulatory approval were turned back by the FDA in 2022 and again last April, as the agency asked for more information about various aspects of the drug/device combination product candidate. Last August, the FDA accepted Supernus’s resubmitted application and set a Feb. 1 target date for a regulatory decision. presented by Health IT Transforming Patient Care: The Role of AI-Powered Assistants The progress in artificial intelligence (AI) is reshaping patient care, across various dimensions, from facilitating faster discharge to curating treatment plans and suggesting lifestyle changes. By IT Medical The long-awaited FDA approval is based on the results of a placebo-controlled Phase 3 test that evaluated Onapgo for 12 weeks. Results showed that patients who received the Supernus treatment experienced a 2.6-hour reduction in daily off time compared to 0.9 hours for those who received a placebo. Patients who received the Supernus treatment also experienced an increase in on time for their Parkinson’s medications — 2.8 hours for the Onapgo arm compared to 1.1 hours for the placebo group. The most common adverse events reported in the study included infusion-site reactions, nausea, sleepiness, dyskinesia, headache, and insomnia. In Supernus’s announcement of the product approval, Dr. Rajesh Pahwa noted the 30-year history of continuous subcutaneous apomorphine infusions in Europe. Pahwa, a professor of neurology at the University of Kansas School of Medicine, director of the Movement Disorder Program at The University of Kansas Health System, and an investigator for Onapgo’s clinical trial, pointed to the significant reduction in off time and increase in on time for patients treated with the Supernus product. “Today’s approval of Onapgo means patients in the U.S. who are not responding well to their current treatment regimen, including levodopa, will now have the option of using a small and lightweight wearable device to deliver a continuous infusion without the need for an invasive surgical procedure,” Pahwa said. Photo by Supernus Pharmaceuticals

Clinical ResultDrug ApprovalPhase 3License out/in

07 Nov 2024

·www.globenewswire.com

Alvotech Attending Citi's Global Healthcare Conference on December 4, 2024, and Evercore’s HealthCONx Conference on December 5, 2024

REYKJAVIK, Iceland, Nov. 07, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today its participation in Citi’s 2024 Global Healthcare Conference in Miami, Florida on December 4, 2024, and in Evercore’s HealthCONx Conference in Coral Gables, Florida on December 5, 2024. Members of the management team will host one-on-one meetings at both conferences. Alvotech will also hold a fire-side chat at Evercore’s HealthCONx Conference on Thursday, December 5, 2024 starting at 12:55 ET (17:55 GMT). A live audio webcast of Alvotech’s fire-side chat at the Evercore HealthCONx Conference will be available to investors and the general public. Registration information for the audio webcast is available in the Investors Section of Alvotech’s website under News and Events – Events and Presentations. After the event, an audio recording of the event will be available for the next 90 days. About AlvotechAlvotech is a biotech company, founded by Robert Wessman, focused solely on the development and manufacture of biosimilar medicines for patients worldwide. Alvotech seeks to be a global leader in the biosimilar space by delivering high quality, cost-effective products, and services, enabled by a fully integrated approach and broad in-house capabilities. Alvotech has launched two biosimilars. The current development pipeline includes nine disclosed biosimilar candidates aimed at treating autoimmune disorders, eye disorders, osteoporosis, respiratory disease, and cancer. Alvotech has formed a network of strategic commercial partnerships to provide global reach and leverage local expertise in markets that include the United States, Europe, Japan, China, and other Asian countries and large parts of South America, Africa and the Middle East. Alvotech’s commercial partners include Teva Pharmaceuticals, a US affiliate of Teva Pharmaceutical Industries Ltd. (US), STADA Arzneimittel AG (EU), Fuji Pharma Co., Ltd (Japan), Advanz Pharma (EEA, UK, Switzerland, Canada, Australia and New Zealand), Dr. Reddy’s (EEA, UK and US), Biogaran (FR), Cipla/Cipla Gulf/Cipla Med Pro (Australia, New Zealand, South Africa/Africa), JAMP Pharma Corporation (Canada), Yangtze River Pharmaceutical (Group) Co., Ltd. (China), DKSH (Taiwan, Hong Kong, Cambodia, Malaysia, Singapore, Indonesia, India, Bangladesh and Pakistan), YAS Holding LLC (Middle East and North Africa), Abdi Ibrahim (Turkey), Kamada Ltd. (Israel), Mega Labs, Stein, Libbs, Tuteur and Saval (Latin America) and Lotus Pharmaceuticals Co., Ltd. (Thailand, Vietnam, Philippines, and South Korea). Each commercial partnership covers a unique set of product(s) and territories. Except as specifically set forth therein, Alvotech disclaims responsibility for the content of periodic filings, disclosures and other reports made available by its partners. For more information, please visit www.alvotech.com. Please visit our investor portal, and our website or follow us on social media on LinkedIn, Facebook, Instagram, X and YouTube. ALVOTECH INVESTOR RELATIONS AND GLOBAL COMMUNICATIONS Benedikt Stefansson, VPalvotech.ir@alvotech.com

Biosimilar

07 Nov 2024

·www.globenewswire.com

Alvotech Attending Citi's Global Healthcare Conference on December 4, 2024, and Evercore’s HealthCONx Conference on December 5, 2024

Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today its participation in Citi’s 2024 Global Healthcare Conference in Miami, Florida on December 4, 2024, and in Evercore’s HealthCONx Conference in Coral Gables, Florida on December 5, 2024. Members of the management team will host one-on-one meetings at both conferences. Alvotech will also hold a fire-side chat at Evercore’s HealthCONx Conference on Thursday, December 5, 2024 starting at 12:55 ET (17:55 GMT). A live audio webcast of Alvotech’s fire-side chat at the Evercore HealthCONx Conference will be available to investors and the general public. Registration information for the audio webcast is available in the Investors Section of Alvotech’s website under News and Events – Events and Presentations. After the event, an audio recording of the event will be available for the next 90 days. About AlvotechAlvotech is a biotech company, founded by Robert Wessman, focused solely on the development and manufacture of biosimilar medicines for patients worldwide. Alvotech seeks to be a global leader in the biosimilar space by delivering high quality, cost-effective products, and services, enabled by a fully integrated approach and broad in-house capabilities. Alvotech has launched two biosimilars. The current development pipeline includes nine disclosed biosimilar candidates aimed at treating autoimmune disorders, eye disorders, osteoporosis, respiratory disease, and cancer. Alvotech has formed a network of strategic commercial partnerships to provide global reach and leverage local expertise in markets that include the United States, Europe, Japan, China, and other Asian countries and large parts of South America, Africa and the Middle East. Alvotech’s commercial partners include Teva Pharmaceuticals, a US affiliate of Teva Pharmaceutical Industries Ltd. (US), STADA Arzneimittel AG (EU), Fuji Pharma Co., Ltd (Japan), Advanz Pharma (EEA, UK, Switzerland, Canada, Australia and New Zealand), Dr. Reddy’s (EEA, UK and US), Biogaran (FR), Cipla/Cipla Gulf/Cipla Med Pro (Australia, New Zealand, South Africa/Africa), JAMP Pharma Corporation (Canada), Yangtze River Pharmaceutical (Group) Co., Ltd. (China), DKSH (Taiwan, Hong Kong, Cambodia, Malaysia, Singapore, Indonesia, India, Bangladesh and Pakistan), YAS Holding LLC (Middle East and North Africa), Abdi Ibrahim (Turkey), Kamada Ltd. (Israel), Mega Labs, Stein, Libbs, Tuteur and Saval (Latin America) and Lotus Pharmaceuticals Co., Ltd. (Thailand, Vietnam, Philippines, and South Korea). Each commercial partnership covers a unique set of product(s) and territories. Except as specifically set forth therein, Alvotech disclaims responsibility for the content of periodic filings, disclosures and other reports made available by its partners. For more information, please visit www.alvotech.com. Please visit our investor portal, and our website or follow us on social media on LinkedIn, Facebook, Instagram, X and YouTube. ALVOTECH INVESTOR RELATIONS AND GLOBAL COMMUNICATIONS Benedikt Stefansson, VPalvotech.ir@alvotech.com

Biosimilar

100 Deals associated with STADA Arzneimittel AG

100 Translational Medicine associated with STADA Arzneimittel AG

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Pipeline

Pipeline Snapshot as of 26 Mar 2025

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

Discovery

Phase 1

Approved

Other

Current Projects

Drug(Targets)	Indications	Global Highest Phase

Adalimumab biosimilar(Alvotech) ( TNF-α )	Arthritis, Psoriatic More	Approved
Bevacizumab biosimilar(STADA Arzneimittel AG) ( VEGF-A )	metastatic non-small cell lung cancer More	Approved
Ranibizumab biosimilar (Xbrane Biopharma) ( VEGF-A )	Choroidal Neovascularization More	Approved
Ustekinumab biosimilar (Alvotech) ( IL-12 x IL-23 )	Arthritis, Psoriatic More	Approved
Apomorphine Hydrochloride ( DRDs )	Parkinson Disease More	Approved

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