Regeneron | November 24, 2020
Covid-19 Regeneron antibody cocktail, one of the drugs of President Donald Trump was given after he was infected with the SARS-COV-02 virus, had been cleaned for emergency use by the FDA. And, despite the towering vaccine slide, one analyst still sees therapy as a $ 1 billion-plus business.
Authorization of Emergency Use (EUA) for Regn-COV2, a combination of monoclonal antibodies Kasarivimab and IMdevimab, marked the second for antibody therapy. The first to go to Bamlanivimab Eli Lilly, who was given EUA a few days ago.
In addition to the difference between Regn-COV2 is a concoction of several drugs, while Lilly's maintenance contains only one drug, both EUU is almost identical; The two of them for Covid-19 patients were light to medium for a minimum of 12 years old who were not hospitalized but at high risk to advance to Covid-19.
“The emergency authorization of these monoclonal antibodies administered together offers health care providers another tool in combating the pandemic,” Patrizia Cavazzoni, M.D., acting director of the FDA’s Center for Drug Evaluation and Research, said in a statement.
FDA fact sheet detail the criteria for determining "high-risk" patients. These include obese people with more than 35 body mass index, older patients in or more than 65 years, or people with fundamental conditions such as chronic kidney disease, diabetes, cardiovascular disease or breathing conditions, among others.
Data from a phase 1/2 study in 799 patients showed the cocktail could reduce viral load significantly better than placebo did. More importantly, there were lower rates of hospital visits among REGN-COV2-treated patients within 28 days. “This benefit was greatest in patients most at risk for poor outcomes due to high viral load, ineffective immune response at baseline or pre-existing risk factors,” George Yancopoulos, M.D., Ph.D., Regeneron’s chief scientific officer, said in a statement Saturday.
Through a $450 million agreement signed in July with the Trump administration’s Operation Warp Speed, Regeneron could provide up to 300,000 treatment doses of REGN-COV2 to the federal government for distribution.
The company plans to have the single-dose therapy available to about 80,000 patients by this month and hit the 300,000 mark by the end of January. The U.S. government has a separate $375 million pact with Lilly for 300,000 doses of bamlanivimab.
Antibody drugs are hard to produce, and 300,000 doses are dwarfed in comparison by the 2 million treatment courses Gilead Sciences has pledged to produce of its small-molecule therapy Veklury (remdesivir) by the end of this year. With that limited initial supply, Regeneron CEO Len Schleifer, M.D., Ph.D. warned that demand of REGN-COV2 may exceed supply during the early days.
TFF Pharmaceuticals | July 30, 2020
TFF Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company focused on developing and commercializing innovative drug products based on its patented Thin Film Freezing technology platform, today commented on the initial results of research evaluating the development of remdesivir as a dry powder for inhalation by Thin Film Freezing. Findings of the study conducted by a team of researchers at the University of Texas at Austin’s Division of Molecular Pharmaceutics and Drug Delivery, led by Robert O. (Bill) Williams III, the inventor of the TFF technology, was published yesterday as a preprint in bioRxiv.
The research team developed inhaled forms of remdesivir for protecting and treating the respiratory mode of infection, including an amorphous brittle matrix powder made by Thin Film Freezing.
“We are very pleased to report on the efforts of Dr. Williams and his team, who in the span of less than a month and responding to the societal need caused by the global pandemic, worked tirelessly to reformulate what may be one of the most important new COVID-19 therapeutics into a form that has the potential to make treatment more potent, easier to administer and more broadly available” said Glenn Mattes, President and CEO of TFF Pharmaceuticals.
Dicerna Pharmaceuticals, Inc. | December 27, 2021
Dicerna Pharmaceuticals, Inc. announced that the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended in connection with Novo Nordisk’s cash tender offer for Dicerna expired at 11:59 p.m., Eastern Time, on December 24, 2021.
As previously announced on November 18, 2021, Novo Nordisk commenced a cash tender offer to purchase all outstanding shares of Dicerna common stock for $38.25 per share in cash, without interest and subject to any withholding of taxes. The expiration of the HSR waiting period satisfies one of the conditions necessary for the consummation of the tender offer. Other conditions remain to be satisfied, including, among others, a minimum tender of shares representing one more share than 50% of the sum of the total number of Dicerna shares outstanding at the time of the expiration of the offer. Unless the tender offer is extended, the offer and withdrawal rights will expire at 5:00 p.m., Eastern Time, on December 27, 2021.
Dicerna Pharmaceuticals, Inc. is a biopharmaceutical company focused on discovering, developing and commercializing medicines that are designed to leverage ribonucleic acid interference to silence selectively genes that cause or contribute to disease. Using our proprietary GalXC™ and GalXC-Plus™ RNAi technologies, Dicerna is committed to developing RNAi-based therapies with the potential to treat both rare and more prevalent diseases. By silencing disease-causing genes, Dicerna’s GalXC platform has the potential to address conditions that are difficult to treat with other modalities. Initially focused on disease-causing genes in the liver, Dicerna has continued to innovate and is exploring new applications of its RNAi technology with GalXC-Plus, which expands on the functionality and application of our flagship liver-targeted GalXC technology to tissues and cell types outside the liver, and has the potential to treat diseases across multiple therapeutic areas. In addition to our own pipeline of core discovery and clinical candidates, Dicerna has established collaborative relationships with some of the world’s leading pharmaceutical companies, including Novo Nordisk A/S, Roche, Eli Lilly and Company, Alexion Pharmaceuticals, Inc.