Vir and Alnylam Go Ahead with COVID-19 Gene Silencing Therapy
Vir Biotechnology (NASDAQ:VIR) announced a new COVID-19 drug candidate, VIR-2703. The company is collaborating with Alnylam Pharmaceuticals (ALNY) for developing this treatment which is an inhalable RNAi therapeutic which works by targeting the SARS-CoV-2 genome for potentially treating and/or preventing the respiratory illness. Both companies are now planning to meet with the FDA for a probable accelerate pathway for progressing to clinical trials stage.
The collaboration also seeks to identify up to three additional drug candidates for treating COVID-19 as well as other coronavirus ailments. Vir recently received infusion of $250 million from GlaxoSmithKline Plc (GSK). In March this year, Alnylam synthesized 350 siRNAs targeting the SARS-CoV-2 genome. Alnylam Pharmaceuticals CEO John Maraganore said, "To our knowledge, this is one of the most potent direct-acting antivirals targeting SARS-CoV-2 reported to date. As this pandemic continues to unfold, we are committed to acting with the utmost urgency to broaden and accelerate our efforts to develop investigational RNAi therapeutics against COVID-19, and potentially future coronavirus-mediated diseases." The companies are working closely to generate data for facilitating fast commercialization.
VIR-2703 takes a novel approach for treating coronavirus. It employs RNA interference or RNAi technology for silencing particular genetic material leading to the impact on production of proteins responsible for the disease. Alnylam currently has Givlaari and Onpattro, the FDA approved drugs in its portfolio and these drugs are intended to treat rare genetic diseases. The companies plan to file an Investigational New Drug (IND) or IND equivalent application for the drug candidate by the end of this year. The investigational RNAi therapeutic is being developed as an inhalation formula and would be delivered directly to the patient's lungs.
Alnylam is believed to have synthesized more than 350 small interfering RNAs or siRNAs as the company said that it is focusing on the highly conserved regions of the SARS-CoV-2 genome. VIR-2703 showed to have an effective concentration for 50% inhibition (EC50) of less than 100 picomolar in dose-response assays. It also demonstrated an EC95 of less than one nanomolar in the SARS-CoV-2 live virus model which was used for measuring the inhibition of infectious virion production.
VIR-2703 is also known as ALN-COV and showed 95 percent of its maximal effect at a concentration of one nanomolar in its dose response assays. The drug candidate has been called "one of the most potent direct-acting antivirals targeting SARS-CoV-2 reported to date" by Alnylam CEO John Maraganore. The companies are planning to develop up to three more host factor targeting development candidates for treating COVID-19.
Vir mainly focuses on developing treatments for infectious diseases while Alnylam specializes in developing RNAi treatments. Both the companies are also working on another product candidate VIR-2218, which seeks to treat hepatitis B virus. This drug candidate is an RNAi product and works by inhibiting the production of proteins such as hepatitis B virus surface antigen (HBsAg). VIR-2218 is currently in Phase 2 of development.
BioMarin Inks Gene Therapy Deal with DiNAQOR
BioMarin Pharmaceutical Inc. (BMRN) announced that it has collaborated with a Swiss biotech firm DiNAQOR AG. The deal is mainly concerned with the development of novel gene therapies for treating rare genetic cardiomyopathies. The license initially encompasses DiNAQOR's lead program, DiNA-001 for MYBPC3 hypertrophic cardiomyopathy. However, later the collaboration will expand to cover various pipeline programs of the Swiss company.
The companies did not disclose the financial terms of the deal but DiNAQOR will be entitled to an undisclosed sum as upfront payment and may also be eligible for biobucks. BioMarin will have the option to expand the license to cover additional programs of DiNAQOR on similar terms. Jean-Jacques Bienaimé, chairman and CEO at BioMarin said, " With this agreement, BioMarin is continuing to apply its gene therapy know-how and manufacturing expertise in new areas like cardiology. This collaboration extends our global leadership position in gene therapy and boosts our potential to transform the lives of patients worldwide with rare genetic cardiomyopathies." BioMarin has its own portfolio of gene therapy work.
It is estimated that nearly half a million people around the world have been diagnosed with HCM. Under the terms and conditions of the deal, DiNAQOR will also receive various other payments tied to the achievement of different development regulatory and commercial milestones in addition to tiered royalties. BioMarin expects the collaboration to help boost its position in the market and provide it global reach.
BioMarin also reiterated its 2020 GAAP net income estimates. The company expects its GAAP net income for the entire year to be in the range of $20 million and $80 million, taking the collaboration into account. DiNAQOR mainly focuses on developing gene therapies which can safely offer treatment to the heart muscle and carry out transduction of the cardiac cells while limiting the exposure of the therapy to other organs.
Teva Launches Rituxan Biosimilar, Offers Marginal Discount
Teva Pharmaceutical Industries (TEVA) announced the commercial availability of its Truxima in the United States. The company has collaborated with Celltrion Healthcare for this purpose. Truxima is the biosimilar to Roche (OTCQX:RHHBY) blockbuster Rituxan for treating rheumatoid arthritis.
The drug is approved to be used for treating rheumatoid arthritis in combination with methotrexate in adult patients suffering from moderately to severely active RA and who have not shown adequate response to one or more TNF antagonist therapies. Brendan O'Grady, Executive Vice President, North America Commercial of Teva said, "We are proud to make TRUXIMA available to patients and providers as a treatment option for these indications, especially as this is the only rituximab biosimilar indicated for rheumatoid arthritis. Following the launch of our other biosimilar earlier this year, we remain focused on our commitment to lower healthcare costs and increase price competition through the availability of biosimilars." Truxima was awarded a pass-through status in the hospital outpatient setting earlier this year. The status was granted by the Centers for Medicare and Medicaid Services.
Under its October 2016 agreement, Teva owns commercialization rights for the drug in the United States and Canada. Celltrion vice chairman Hyoung-Ki Kim said, "We believe that the continued use of biosimilars in the US market will contribute to addressing unmet needs for patients and providers."
It is expected that the drug will be available through primary wholesalers at a Wholesale Acquisition Cost of $845.55 per 100mg vial and $4,227.75 per 500mg vial. However, actual costs to individual patients and providers are likely to be lower as WAC does not take additional rebates and discounts into account. Teva will also provide dedicated patient support services through the CORE program.
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