Genentech Plans Legal Battle to Protect Esbriet from Generic Competition

Biospace.com | February 05, 2019

Genentech, a Roche company, is flexing its litigation muscle this week. The South San Francisco-based company has filed 18 lawsuits over the past few weeks to block competitors from selling a generic version of a treatment for idiopathic pulmonary fibrosis, a fatal lung-scarring disease. Genentech’s treatment, Esbriet, was brought into the company’s pipeline in 2014 after Roche acquired Brisbane, Calif.-based InterMune, the company that developed the drug in an $8.3 billion deal. Esbriet was approved by the U.S. Food and Drug Administration (FDA) two months after the acquisition was announced.
At the time of the approval, Esbriet was estimated to have a potential patient population of about 100,000 people in the United States. Idiopathic pulmonary fibrosis (IPF) is a fatal disease caused by progressive scarring of the lungs, which makes breathing difficult and prevents the heart, muscles and vital organs from receiving enough oxygen to work properly. The disease can advance quickly or slowly, but eventually, the lungs will harden and stop working altogether. There is no known cure for IPF. The median survival time from diagnosis is two to five years, and the five-year survival rate is approximately 20 to 40 percent, Genentech said in a statement.

Spotlight

Leading scientists recently identified a dozen chemicals as being responsible for widespread behavioral and cognitive problems.

Spotlight

Leading scientists recently identified a dozen chemicals as being responsible for widespread behavioral and cognitive problems.

Related News

MEDICAL

GenScript Launches GMP Single-Strand and Double-Strand DNA Service for Supporting Gene and Cell Therapy Development

GenScript | May 18, 2022

GenScript USA Inc., the world's leading life-science research tools and services provider, announced the availability of new GMP-grade GenExact™ single-stranded DNA (ssDNA) and GenWand™ closed-end linear double-stranded DNA (dsDNA) services. These services will enable next-generation gene and cell therapy R&D programs to advance to IND filing and clinical trials faster and more efficiently. Today's announcement, made at the American Society of Gene & Cell Therapy (ASGCT) 25th annual meeting (booth #280), further establishes GenScript as the leading provider of non-viral homology-directed repair (HDR) template solutions for immune-cell engineering. GenScript now offers varying grades of non-viral HDR payload materials that support use cases across early discovery research, process development, and clinical studies. CRISPR-based non-viral gene insertion methods have gained popularity among research teams with concerns about the FDA's recent draft guidance concerning the use of viruses for gene and cell therapy. Non-viral HDR templates, in combination with CRISPR technology, can accelerate cell engineering compared to traditional GMP virus-based engineering, delivering results faster than alternate techniques. This new investment by GenScript demonstrates our commitment to non-viral delivery technology. We look forward to continuing to work with our partners and stakeholders in academia and industry to support their cell therapy R&D programs and further development of non-viral delivery platforms and workflows, We know this technology will be a more efficient and safer solution for cell engineering." Ray Chen, PhD, president of GenScript USA Life Science Group. GenScript's GMP ssDNA And dsDNA services enable faster CAR-T drug development: GenExact™ ssDNA up to 5000nt in length, 100mg/batch production scale GenWand™ closed-end, linear dsDNA up to 10,000nt in length, gram level/batch production scale GenScript has been collaborating with several academic and industry partners in the development of CRISPR non-viral gene insertion. Recently, Dr. Alex Marson's lab at UCSF published a paper demonstrating how CRISPR RNP technology can both knock out endogenous T-cell receptors and integrate replacement anti-cancer receptors. The UCSF team has been using GenScript's latest single-strand DNA to improve non-viral gene knock-in efficiency. Working in collaboration with GenScript, the team engineered modifications to the DNA payload to promote co-localization and delivery (or 'shuttle') to the nucleus. About GenScript Biotech Corporation GenScript Biotech Corporation (Stock Code: 1548.HK) is a global biotechnology group. Based on its leading gene synthesis technology, GenScript has developed four major platforms including the global cell therapy platform, the biologics contract development and manufacturing organization (CDMO) platform, the contract research organization (CRO) platform, and the industrial synthesis product platform. GenScript was founded in New Jersey, USA in 2002 and listed on the Hong Kong Stock Exchange in 2015. GenScript's business operation spans over 100 countries and regions worldwide, with legal entities located in the USA, mainland China, Hong Kong, Japan, Singapore, the Netherlands, and Ireland. GenScript has provided premium, convenient, and reliable products and services for over 100,000 customers.

Read More

MEDICAL

TeselaGen Biotechnology Announced the Launch of a New Protein Optimization Toolkit for Automated Biotherapeutic Drug Design and Development

TeselaGen Biotechnology | May 21, 2021

TeselaGen Biotechnology today announced the launch of a new protein optimization toolkit for biotherapeutic drug design and development, introducing significant enhancements to the company’s flagship TeselaGen® OS to form designing and developing pharmaceuticals and biotherapeutics faster and fewer expensive. The new capabilities, easily accessible via the cloud-based platform, simplify the planning of highly complex combinatorial protein libraries and support AI models for optimizing new peptides and proteins. New application programming interfaces (APIs) and integration tools have also been extended to further enhance users’ access to the new capabilities. TeselaGen integrates the facility of AI with one end-to-end platform for design, construction, data gathering, and analysis of bioproduct performance, from pharmaceuticals to food and fabrics, significantly accelerating time to plug and reducing costs. The platform’s DESIGN, BUILD, TEST, and find out modules enable researchers to effectively collaborate across an organization's development pipeline to style and build experiments, standardize and share data, and learn and preserve project results by embedding them during a machine learning model. TeselaGen’s DESIGN is an intuitive, user-interface-driven module that permits scientists to style highly complex combinatorial libraries. With this new release, the planning now supports aminoalkanoic acid parts which will be efficiently mapped to DNA. TeselaGen can then automatically generate biology protocols for efficiently synthesizing and assembling the corresponding DNA libraries. TeselaGen’s DISCOVER now supports AI models which will recommend new peptides and proteins supported by the training of supervised and unsupervised learning models. The platform also supports the modeling of unnatural amino acids and multicriteria optimization of proteins. R&D groups can utilize the TeselaGen OS to hurry the invention process. Datasets are uploaded and arranged within the platform and immediately useful for model building within TeselaGen’s DISCOVER module. TeselaGen has demonstrated that it can increase the planning and build speed of biological products and reduce the prices related to research & development by an order of magnitude. Current partnering companies are using the new capabilities for designing antibodies and optimizing their binding affinity, titer, specific productivity, immunogenicity, or other phenotypic variables of interest. Researchers also are looking to TeselaGen for rapidly engineering new vaccines - using methods like virus-like particles (VLPs), DNA, and RNA vaccines - opening the door to attacking rapidly mutating RNA and retroviruses like influenza, HCV, HIV, or coronaviruses. About TeselaGen Biotechnology TeselaGen Biotechnology has developed the primary artificial intelligence-enabled OS for biotechnology, enabling the event and commercialization of high-performance bioproducts – from pharmaceuticals to food to fabrics – faster and easier than ever. TeselaGen® connects biologists, lab technicians, and bioinformaticians so that they will collaboratively design and build experiments, organize and standardize data then test and continually learn from the info. TeselaGen has been deployed by Fortune 50 companies and emerging innovators in biopharmaceuticals, agriculture, and specialty chemicals. the corporate is privately held and based in San Francisco, California.

Read More

CELL AND GENE THERAPY

Matica Bio Announces Joint Research Agreement with Sartorius for the Development of Advanced Viral Vector Manufacturing Technology

Matica Biotechnology, Inc. | October 19, 2021

Matica Biotechnology, Inc, (Matica Bio) a contract development and manufacturing organization (CDMO) specializing in the clinical and commercial production of cell and gene therapies, today announced a joint research agreement (JRA) with Sartorius, a leading international partner of the biopharmaceutical industry. Under this agreement, Matica Bio and Sartorius will work on a number of studies together to streamline and optimize PAT technologies, automation software, and single-use platforms offered by Sartorius for large scale vector production. Michael Stewart, Chief Technology Officer at Matica Bio explained, "The generation of in-line real-time process data is one of the most significant obstacles to achieving consistent, high-producing viral vector titers during development that can be translatable to large scale production. In many respects, what is going on inside a bioreactor or within downstream operations is still a black box to us." Mr. Stewart continued, "Matica Bio's development, manufacturing and quality teams have decades of viral vector production experience. Applying our expertise together with Sartorius' industry-leading single-use and PAT technologies will allow us to provide more robust, consistent results for our clients, guiding informed decision-making throughout the manufacturing process and accelerating the overall development timeline to the clinic and market." "We are extremely excited to initiate this partnership with Sartorius. Our number one priority is to deliver for our clients. Our expert staff will be working to integrate more fully automated processes leading to an increase in the speed of information flow and a reduction in preventable errors. The end result will be increased product yields, higher quality as well as improved flexibility and responsiveness to our clients' ever-changing needs." Dr. Yun Jeong Song, Chief Executive Officer of Matica Bio The JRA with Sartorius underscores Matica Bio's commitment to applying integrated technology and bioprocess solutions to address production complexities like reduction of labor and risk while improving output efficiencies in the production of advanced therapies, including viral vector products. Together Sartorius and Matica Bio are dedicated to solving the challenges of large-scale cell culture and viral vector production, improving manufacturability and reducing the costs of novel cell and gene therapies, oncolytic vectors and vaccines. About Matica Biotechnology, Inc. Matica Bio is a contract development and manufacturing organization for gene therapies, cell therapies, vaccines, oncolytic vectors and other advanced biotherapeutic products. Our GMP facility in College Station, TX is designed for the rapid development, scale-up and production of clinical and commercial supply. Matica Bio offers process development, GMP production, product release and stability assessment, together with the quality oversight and regulatory guidance necessary to ensure our clients' success.

Read More