The circuit breakers activated almost immediately when the markets opened this morning as the Dow plummeted, with investors moving into cash and away from equities. Clearly, investors were not impressed with the Federal Reserve’s decision to slash its benchmark interest rate to nearly 0% to help combat the economic fallout from the coronavirus outbreak. After the 15-minute trading pause, the markets continued to push lower, although by noon today there were indications that they were moving off their lows, with the Dow down 7.6%. As far as the health care sector is concerned, the Nasdaq Biotech index was down about 4% and the iShares U.S. Medical Devices ETF that consists of equity holdings in the leading U.S. manufacturers in the medical device sector was down 6.6%.
“The remedy is worse than the disease.” As governments react full stop to halt the spread of COVID-19, those words are as true today as when Francis Bacon, a British philosopher and statesman, penned them 400 years ago. Consequently, the reaction to the novel coronavirus likely will have a longer-term impact on the drug and device supply chain than the bug itself. With social distancing, no-contact meetings, postponed inspections, delayed advisory committee meetings and the cancellation of jury trials, the routine processes of getting a drug or device from concept to market are being disrupted on just about every front.
Mainz, Germany-based Biontech SE and Shanghai’s Fosun Pharmaceutical Co. Ltd. plan to develop and commercialize BNT-162 to prevent COVID-19 infection. Fosun will make an equity investment of $50 million in Biontech should the drug be approved by China’s regulatory authorities. Both will work to develop the mRNA vaccine in China by conducting clinical trials there, with Biontech supplying the vaccine for the trials from European manufacturing facilities. If approved, Fosun will commercialize BNT-162 in China. It’s all part of Biontech’s Project Lightspeed, with clinical testing to begin in late April. Included in the project are discussions with Pfizer Inc. to develop the vaccine outside China. In the midst of a bear market, Biontech’s stock (NASDAQ:BNTX) soared at midday, up 26%.
The U.S. effort to deploy diagnostics for the novel coronavirus has been plagued by missteps by the CDC and the FDA from the outset, leading to delays and missed opportunities. The Trump administration declared a national emergency March 13, but concerns remain about how quickly the array of available tests can be conducted and whether there are enough testing supplies to handle the anticipated demand.
The past week has seen a lot of movement in terms of tests to detect SARS-CoV-2, the virus that causes COVID-19, with Roche Holding AG and other companies making big announcements. “It is notable that the diagnostics community is coming together in a way we have not seen in our 20 years covering this industry,” wrote William Blair analyst Brian Weinstein. “Regulators, lab professionals, and manufacturers are all in a frenetic fury to try and get testing up and running, and we generally see a sense of ‘in it together’ playing out.”
A U.S. Court of Appeals affirmation of a lower court ruling requiring the FDA to grant Eagle Pharmaceuticals Inc.'s bendamustine infusion product Bendeka seven years of orphan drug exclusivity appears to resolve a key piece of uncertainty that had troubled Eagle and others in similar circumstances. Barring legislative changes, the decision sets a precedent locking the regulator into granting seven years of exclusivity for any drug it designates as an orphan product during development, even if the new drug doesn’t demonstrate an improvement over what’s already on the market.
Several companies are awaiting regulatory decisions from the FDA over the next several months. The current month includes four products that are waiting in the wings to treat diverse indications such as multiple sclerosis, migraine and renal disease.
The articles from BioWorld’s ongoing coverage of the COVID-19 coronavirus outbreak are available at www.bioworld.com/coronavirus. The collection includes breaking research, clinical, regulatory and business development news on coronaviruses reaching back to 1991. Featured topics: vaccines and diagnostics in development, the science underpinning the virus, comparison to previous outbreaks such as Severe acute respiratory syndrome (SARS) and Middle Eastern respiratory syndrome coronavirus (MERS-CoV), global regulatory factors and the business news underpinning the research including development collaborations and investment trends. A list of all vaccines and therapeutics in development can be found at www.bioworld.com/covid19products.
Advanz, AGTC, Aimmune, Akebia, Amarin, Aptevo, Arcutis, Armas, Aurinia, Biocryst, Biocurepharm, Brainstorm, Can-Fite, Clarus, Correvio, Cortexyme, Cytodyn, Genetx, Homology, Kadmon, Kirin, Lilly, Medivir, Nanoviricides, Oncoquest, Protalix, Regeneron, Sanofi, Spherix, Tango, Tetraphase, Therapeuticsmd, Tracon, Twist, Ultragenyx, VIB, Xortx, Zai