Extrovis AG and Dr. Reddy’s announce the launch of the authorized generic of CARAC (fluorouracil cream), 0.5% in the U.S.

                                      

Extrovis AG
Bahnhof Park 4
6340, Baar, Switzerland
Media Relations Contact
Madhu Marur
[email protected]

                                        

Press Release

Extrovis AG and Dr. Reddy’s announce the launch of the authorized generic of CARAC (fluorouracil cream), 0.5% in the U.S.

Baar, Switzerland; August 14, 2025

Extrovis AG, a global pharmaceutical company focused on research–driven innovation, and Dr. Reddy's Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY, along with its subsidiaries together referred to as “Dr. Reddy's”), today announced the launch of Fluorouracil Cream, 0.5%, an authorized generic and therapeutic equivalent of Carac® (fluorouracil cream) 0.5%, in the US market, approved by the U.S. Food and Drug Administration (USFDA).

Manufactured in Texas at one of Extrovis’ facilities, Dr. Reddy’s Fluorouracil Cream, 0.5%, is indicated for the topical treatment of multiple actinic or solar keratoses of the face and anterior scalp.

“This product generic launch marks a key milestone in our commitment to increasing patient access and long–term value creation for the U.S. healthcare system. Our partnership with Dr. Reddy’s helps ensure that patients and healthcare providers in the United States have continued access to a high–quality and cost–effective product,” said Hans R. Kamma Co–CEO and Chief Strategy Officer of Extrovis AG.

“Dr. Reddy’s brings deep expertise in commercialization and distribution within the U.S. market,” added Raghavendra Rao PV, Chief Financial Officer of Extrovis AG. “This collaboration is aligned with our mission to strengthen pharmaceutical supply chains and serve public health needs responsibly.”

The partnership reinforces Extrovis’ strategy to extend the reach of its therapeutics while advancing long–term affordability and sustainability in healthcare.

Dr. Reddy’s Fluorouracil Cream, 0.5%, is supplied in a 30–gram tube for topical use only. Please click here to see the full prescribing information.

                                                                                     

Carac® is a trademark of Extrovis AG

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About Dr. Reddy’s
About Dr. Reddy’s: Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY) is a global pharmaceutical company headquartered in Hyderabad, India. Established in 1984, we are committed to providing access to affordable and innovative medicines. Driven by our purpose of ‘Good Health Can’t Wait’, we offer a portfolio of products and services including APIs, generics, branded generics, biosimilars and OTC. Our major therapeutic areas of focus are gastrointestinal, cardiovascular, diabetology, oncology, pain management and dermatology. Our major markets include – USA, India, Russia & CIS countries, China, Brazil and Europe. As a company with a history of deep science that has led to several industry firsts, we continue to plan ahead and invest in businesses of the future. As an early adopter of sustainability and ESG actions, we released our first Sustainability Report in 2004. Our current ESG goals aim to set the bar high in environmental stewardship; access and affordability for patients; diversity; and governance. For more information, log on to: www.drreddys.com.

About Extrovis AG
Extrovis AG is a Switzerland–based global biopharmaceutical company committed to developing and commercializing high–quality therapies for unmet and under–addressed medical needs. With R&D and manufacturing operations in the USA, Italy, Hungary, and India, Extrovis delivers innovative, differentiated products across key therapeutic areas. Backed by strong R&D capabilities, regulatory expertise, and a robust global quality framework, the company advances its mission to improve patient outcomes and expand access to essential health care products worldwide. For more information, log on to: http://www.extrovis.com

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Disclaimer: This press release may include statements of future expectations and other forward–looking statements that are based on the management’s current views and assumptions and involve known or unknown risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. In addition to statements which are forward–looking by reason of context, the words “may”, “will”, “should”, “expects”, “plans”, “intends”, “anticipates”, “believes”, “estimates”, “predicts”, “potential”, or “continue” and similar expressions identify forward–looking statements. Actual results, performance or events may differ materially from those in such statements due to without limitation, (i) general economic conditions such as performance of financial markets, credit defaults , currency exchange rates, interest rates, persistency levels and frequency / severity of insured loss events, (ii) mortality and morbidity levels and trends, (iii) changing levels of competition and general competitive factors, (iv) changes in laws and regulations and in the policies of central banks and/or governments, (v) the impact of acquisitions or reorganization, including related integration issues, and (vi) the susceptibility of our industry and the markets addressed by our, and our customers’, products and services to economic downturns as a result of natural disasters, epidemics, pandemics or other widespread illness, including coronavirus (or COVID–19). The company assumes no obligation to update any information contained herein.

 

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GLOBENEWSWIRE (Distribution ID 1001123392)

Dr. Falk Pharma and Allianthera (Suzhou) Biopharmaceuticals Forge Strategic Partnership for Novel AhR Agonist Development

Freiburg (Germany), Suzhou (China) and Boston (USA), July 30, 2025: 

Dr. Falk Pharma GmbH and Allianthera (Suzhou) Biopharmaceuticals Co., Ltd. Announce Strategic Partnership to Develop a Novel AhR Agonist for the Treatment of Moderate to Severe Ulcerative Colitis 

Dr. Falk Pharma GmbH, a research–based pharmaceutical company specializing in digestive and metabolic medicine, Allianthera (Suzhou) Biopharmaceuticals Co., Ltd., and its affiliate Allianthera Boston, Inc., a clinical stage biotechnology company focusing on novel drug research and development in immunology and inflammatory diseases, (Allianthera), are pleased to announce the signing of an agreement on the co–development, license option, manufacturing, and commercialization of the novel small molecule ATB102, an aryl hydrocarbon receptor (AhR) agonist currently undergoing a phase 1 clinical trial in the United States.

Under the terms of the newly signed agreement, Dr. Falk Pharma and Allianthera will collaborate to develop ATB102 for inflammatory bowel disease (IBD), with an initial focus on refractory moderate–to–severe ulcerative colitis (UC). Dr. Falk Pharma will enjoy the exclusive rights to license, manufacture, and commercialize ATB102 worldwide, excluding Mainland China, Hong Kong, Macau and Taiwan. As part of the agreement, Allianthera will receive a signing fee, significant development milestone payments as well as a licensing fee, followed by sales milestone payments and tiered royalties.

ATB102, developed by Allianthera, is a gut–enriched AhR agonist which represents a new therapeutic approach for IBD. It is designed to specifically target inflammation and mucosal damage within the gastrointestinal tract, with a particular emphasis on treating refractory moderate–to–severe UC. In pre–clinical research, ATB102 supports immune homeostasis, restores mucosal barrier integrity, and confers anti–fibrotic and anti–oxidative benefits, making it a potential new option for patients unresponsive to or relapsed from existing therapies.

Dr. Falk Pharma, in cooperation with its fully–owned subsidiary Losan Pharma GmbH, a leading contract development and manufacturing organisation (CDMO) partner and formulation expert, will develop an innovative colonic–release formulation of ATB102 to complement the current immediate release formulation.

“The aryl hydrocarbon receptor represents a truly novel mechanism of action to address the significant unmet needs in inflammatory bowel disease – especially in ulcerative colitis. The ATB team has discovered what we believe to be the best–in–class AhR agonist optimized for safety, gut enrichment, and therapeutic impact. We are delighted to join forces with Dr. Falk Pharma, who has deep expertise in formulation and clinical development. By combining our complementary strengths, we are confident that we will accelerate this program and deliver a much–needed, high–quality therapy to patients faster than ever before,” said Yuanhua Ding, CEO of Allianthera.

Kai Pinkernell, M.D., Managing Director, Science & Innovation at Dr. Falk Pharma, added, “We are excited about the addition of ATB102 to our R&D pipeline and to further exploring the potential of this novel molecule in future clinical trials together with Allianthera. The partnership with Allianthera reflects the strength of scientific excellence, mutual trust and a shared vision to better the lives of patients suffering from IBD. This collaboration not only reflects our growing global development and commitment to innovation in areas of high unmet medical need, it will also enhance Dr. Falk Pharma´s portfolio to treat digestive diseases and conditions.”


About Ulcerative Colitis
Ulcerative colitis is one of the disorders known as inflammatory bowel disease (IBD). Other disorders within this group of conditions include Crohn’s disease and two forms of microscopic colitis, called lymphocytic and collagenous colitis.

Ulcerative colitis is confined to the colon and typically begins in the rectum, spreading continuously throughout the rest of the large intestine. The exact cause of ulcerative colitis is still unclear; however immune system dysfunction, genetic factors, gut microbiome imbalance and dysregulation of the intestinal mucosal integrity as well as environmental factors are currently being investigated as potential contributors.

For more information, visit Dr. Falk Pharma’s website: https://drfalkpharma.com/en/indications/ulcerative–colitis/


About Allianthera 
Allianthera was established in November 2020 with a research and development (R&D) center in Suzhou, China, and a subsidiary in Boston, USA. Allianthera strives to become a global leader in therapeutic innovation by combining their deep disease biology knowledge and industry–leading R&D expertise with partners’ technologies while leveraging unique strengths in different geographies, East or West. The company is building a strong portfolio through internal R&D programs and external partnerships with an initial focus on diseases with unmet medical needs in immunology and inflammatory diseases.

Further information on Allianthera can be found on LinkedIn: https://www.linkedin.com/company/allianthera–suzhou–biopharmaceutical–co–ltd


About partnering with Dr. Falk Pharma
Dr. Falk Pharma engages in a variety of collaboration and partnership models to develop and deliver innovative treatment concepts with great potential. These treatments can be based on any type of pharmacological approach, from small molecules to biologics to novel drug delivery technologies. The company is involved in partnership projects across the range of phases and partners, from all stages of pre–clinical/clinical development and marketing as well as with academic researchers, start–ups, and established companies.

Dr. Falk Pharma is an industry leader in innovative pharmaceutical formulations that deliver active substances to specific functional segments of the gastrointestinal tract. Many of their products have attained standard–of–care status. The company enjoys strong, long–standing collaborations with renowned clinical centres and with academic and clinical key opinion leaders in the fields of gastroenterology, hepatology and metabolic diseases.

For more information go to https://drfalkpharma.com/en/partnering/


About Dr. Falk Pharma GmbH
Dr. Falk Pharma GmbH has been developing and marketing innovative medicines to treat a wide range of gastrointestinal disorders like inflammatory bowel disease or eosinophilic esophagitis as well as hepatobiliary disorders such as primary biliary cholangitis for over 60 years. As the international experts in digestive and metabolic medicine, the company brings together physicians, scientists, and patients to devise new and powerful approaches to patient care. Dr. Falk Pharma engages in pre–clinical and clinical stage research that aims to meaningfully improve therapeutic practice as well as patient health and well–being. A family–owned business with a global presence, Dr. Falk Pharma has ten affiliates in Europe and Australia and is continuously growing. The company has its headquarters and R&D facilities in Freiburg, Germany, its pharmaceutical products are manufactured in Europe, mainly at sites in Germany, France, Italy and Switzerland. Dr. Falk Pharma employs approximately 1400 individuals globally and 340 in Freiburg.

Further information on Dr. Falk Pharma can be found online: https://drfalkpharma.com


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