Grifols Receives FDA Approval for its Lung Disease Product

Grifols continues to expand its business outside Spain. The pharmaceutical company announced on Thursday, November 3rd, that its AlphaID At Home Genetic Health Risk Service, the first free, direct-to-consumer program in the United States to detect the genetic risk of alpha1-antitrypsin (alpha-1) deficiency, has been authorized by the U.S. Food and Drug Administration (FDA).

The service, also known as AlphaID At Home, is the company’s first FDA-cleared service for direct-to-consumer use. It will be available beginning in the second quarter of 2023 for U.S. adults to assess their level of genetic risk for developing alpha-1-associated lung or liver disease without a prescription.

Alpha-1 is the most common risk factor for chronic obstructive pulmonary disease (COPD), a group of respiratory diseases that includes emphysema and chronic bronchitis. It is estimated that 16 million Americans suffer from COPD, and it is believed that more than 90% of people with alpha-1 are undiagnosed.

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Grifols increased its turnover by 10.8% between January and June 2022, to  €2.81 billion

To use the safe saliva collection kit, individuals simply collect their samples and send them to a certified laboratory for processing. Within a few weeks, and through a secure online portal, they will know if they are at risk of developing alpha-1, a disease due to a lack of alpha1-antitrypsin (AAT). They are advised to share the results with their physician and assess possible treatment options.

A study conducted in a demographically diverse sample of the U.S. population (525 participants) analyzed users’ understanding of AlphaID At Home and showed that users easily understood the service’s reports, with an understanding rate of 90% or higher.

Grifols focuses on the treatment of conditions in a wide range of therapeutic areas: immunology, hepatology, intensive care, pulmonology, hematology, neurology, and infectious diseases.

The Catalan pharmaceutical company reduced its profit by 46% up to June 2022, a period in which it earned €144.1 million, according to the latest available results. The company justifies this slowdown with the higher financial expenses derived from the acquisition of Biotest, formalized in April 2022. The company’s turnover between January and June rose by 10.8% to  €2.81 billion.

Syna Therapeutics signs licensing agreement with Intas to commercialize its biosimilar

Syna Therapeutics shakes hands with Intas. The joint venture of Reig Jofre and Leanbio has announced the signing of a global license agreement with Intas Pharmaceuticals to commercialize its biosimilar drug LB-0702 for the treatment of pathologies in the field of hematology.

Under the terms of the agreement, Intas obtains exclusive licensing rights to commercialize LB-0702 worldwide and Syna Therapeutics will develop, manufacture, and supply the drug to Intas and its affiliates. The subsidiary Accord Healthcare, one of the key players in the global biosimilars market, has a sales and distribution network in 85 countries.

SynaTherapeutics will start clinical trials of LB-0702 in 2023 with the support of its partners Leanbio and Reig Jofre. The development and manufacturing of the biosimilar will utilize Leanbio’s technology platforms along with the expertise and capacity of Reig Jofre’s new plant in Barcelona specializing in sterile injectables and lyophilized biopharmaceuticals.

The company will develop, manufacture, and supply the drug to Intas and its subsidiaries

“The signing of this agreement is one of the most important milestones for Syna Therapeutics since the company was founded in 2018 and confirms the growing interest of the pharmaceutical industry and healthcare systems in biosimilar medicines,” said Andreu Soldevila, co-founder and CEO of Syna Therapeutics.

“This is a very satisfying agreement because we believe that the LB-0702 biosimilar will have a very positive impact on healthcare systems; moreover, the subsidiary Accord Healthcare is the ideal partner to commercialize our biosimilar in the global market,” Soldevila added.

Binish Chudgar, vice president and general manager of Intas, comments, “We are pleased to announce this agreement with Syna Therapeutics because it is in line with our long-term strategy and reinforces our commitment to improving access to high-quality biosimilar medicines for patients around the world.”

Syna Therapeutics is a joint venture of Reig Jofre and Leanbio that develops biosimilars and innovative molecules to meet the growing global demand for biologic treatments. The company has extensive experience and know-how in biosimilar drugs, covering the entire value chain to reach patients: cell bank creation, pharmaceutical development of the finished product, industrial production, and commercialization or licensing agreements.

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(Featured image by PublicDomainPictures via Pixabay)

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