Although the COVID-19 pandemic has decimated the economy and played havoc with the financial markets, there are promising signs that investors are slowly returning as infection curves begin to flatten thanks to social distancing measures. There is no doubt that they are showing confidence in those leading biopharmaceutical companies who they believe hold the keys to unlocking cures for the deadly infection. In addition, amid the intense activity related to COVID-19 research and development, the FDA did take some time to approve several new medicines, reinforcing the fact that innovation has not been completely throttled by the industry’s focus on the pandemic. As a result, the BioWorld Biopharmaceutical index has soared over 15% in value so far this month, well ahead of the general markets with the Dow Jones Industrial Average tracking at 8% during this period. (See BioWorld Biopharmaceutical index, below.)
Leading the way
Not surprisingly, those index group members at the forefront of COVID-19 have been among the leading gainers so far this month. Thousand Oaks, Calif.-based Amgen Inc. has seen its shares (NASDAQ:AMGN) burning rubber and are up almost 17% in the period. The company is collaborating with Seattle-based Adaptive Biotechnologies Inc. to discover and develop fully human neutralizing antibodies targeting SARS-CoV-2 to potentially prevent or treat COVID-19. The collaboration combines Adaptive’s immune medicine platform for the identification of virus-neutralizing antibodies with Amgen’s expertise in immunology and antibody therapy development. The companies will begin work immediately and finalize financial details and terms in the coming weeks.
Iceland-based Decode Genetics, a subsidiary of Amgen, is providing genetic insights from patients who were previously infected with COVID-19.
Regeneron Pharmaceuticals Inc. has recorded a similar 16.3% uptick in share value (NASDAQ: REGN). At the end of March, along with partner Sanofi SA, it announced the first patient outside of the U.S. had been treated as part of a global clinical program evaluating Kevzara (sarilumab) in patients hospitalized with severe COVID-19. The global clinical program has now been initiated in Italy, Spain, Germany, France, Canada, Russia and the U.S. Kevzara is a fully human monoclonal antibody that inhibits the interleukin-6 (IL-6) pathway by binding and blocking the IL-6 receptor. IL-6 may play a role in driving the overactive inflammatory response in the lungs of patients who are severely or critically ill with COVID-19 infection.
The study represents the second multicenter phase II/III trial as part of the Kevzara COVID-19 program, and the companies are continuing to work with health authorities around the world to secure initiation at additional sites.
This U.S.-based trial is taking place at medical centers in New York, one of the epicenters of the U.S. COVID-19 outbreak and will assess the safety and efficacy of adding Kevzara to usual supportive care, compared to supportive care plus placebo. The drug is approved in multiple countries to treat adults with moderately to severely active rheumatoid arthritis who have not responded to or tolerated previous therapy.
Regeneron’s share price could, however, come under pressure during the upcoming earnings season. It generates a considerable amount of its revenue from office administered injectables that will certainly be subject to delayed or cancelled physician office appointments during the latter part of the quarter and into Q2, according to a SVB Leerink report on large biopharma companies and the resilience of the demand for their medicines during the ongoing coronavirus pandemic.
Foster City, Calif.-based Gilead Sciences Inc., which is ramping up its antiviral remdesivir COVID-19 candidate production and research and is donating 1.5 million doses for compassionate use, has seen its shares push almost 9% higher this month. It recently published results in The New England Journal of Medicine from a cohort analysis of 53 severe patients hospitalized with severe complications from COVID-19, showing a cumulative incidence of clinical improvement of 84% after 28 days of follow-up, according to Kaplan-Meier analysis.
In the study, the patients were treated with the investigational antiviral remdesivir on an individual compassionate use basis. Improvements here were defined as discharge from the hospital and/or at least a two-point improvement from baseline on a predefined six-point scale.
Proving that there is activity taking place outside the realm of COVID-19, the FDA granted accelerated approval to Incyte Corp.'s Pemazyre (pemigatinib), the first treatment approved for adults with certain types of previously treated, advanced cholangiocarcinoma. The new drug, approved alongside a companion diagnostic, received a priority review following earlier designations as a breakthrough therapy and, in the U.S. and Europe, as an orphan drug. It remains under review by the EMA. As a condition of it continued U.S. approval, the Wilmington, Del.-based company will be required to complete and submit the results of a randomized trial demonstrating an improvement in progression-free survival. In parallel with the approval, Foundation Medicine Inc.'s genomic profiling assay, Foundationone CDx, gained the agency's nod for use in identifying patients with FGFR2 fusions and select rearrangements who may benefit from treatment with Pemazyre. The company’s shares (NASDAQ:INCY) have vaulted 38% in April driven by this catalyst and its involvement with the FDA to initiate a phase III trial to evaluate the efficacy and safety of ruxolitinib (Jakafi) plus standard-of-care (SoC), compared to SoC therapy alone, in patients with COVID-19-associated cytokine storm. The study is sponsored by Incyte in the U.S. and Basel, Switzerland-based Novartis AG everywhere else. Incyte also said it intends to initiate a separate open-label emergency expanded access program in the U.S., allowing eligible patients with severe COVID-19-associated cytokine storm to receive ruxolitinib while it is being studied. Ruxolitinib is a JAK1/JAK2 inhibitor. Because many patients with severe respiratory disease due to COVID-19 have features consistent with cytokine storm and increased activation of the JAK-STAT pathway, Incyte said ruxolitinib may be a possible treatment.
Ahead of the scheduled Aug. 20 PDUFA date, Seattle Genetics Inc. also won FDA clearance for the oral small-molecule breast cancer therapy tucatinib, a tyrosine kinase inhibitor branded Tukysa. Designed as highly selective for HER2 without significantly knocking down EGFR, Tukysa proved its worth in the HER2Climb study, which compared Tukysa in combination with Herceptin (trastuzumab, Roche Holding AG) plus capecitabine to Avastin/capecitabine in patients with locally advanced unresectable or metastatic HER2-positive disease. The company’s shares (NASDAQ:SGEN) are trading up 23% this month.
Deals still happening
Despite the uncertainty of the business climate generated by the coronavirus pandemic, the industry has managed to keep up its collective deal volume. Alnylam Pharmaceuticals Inc. shares (NASDAQ:ALNY) have jumped 33% so far this month driven by news of its $2 billion deal with the Blackstone Group Inc., which is acquiring 50% of royalties owed to Cambridge, Mass.-based Alnylam on the global sales of inclisiran, which is designed to treat hypercholesterolemia. The twice annually injectable proprotein convertase subtilisin/kexin type 9 (PCSK9) gene inhibitor is being reviewed by the FDA and has the potential to become the first siRNA based PCSK9 inhibitor to win U.S. approval.