Pharma Stock Roundup: ABBV, LLY Coronavirus Product Development Efforts, FDA Updates

This week Lilly (NYSE:LLY) signed a deal to co-develop antibody therapies with private biotech, AbCellera to treat and prevent coronavirus disease, COVID-19. AbbVie (NYSE:ABBV) informed that it is collaborating with European & U.S. health authorities to back studies on its HIV medicine Kaletra for treating COVID-19. Bristol-Myers (NYSE:BMY) immunotherapy combo, Opdivo + Yervoy was approved by the FDA for previously treated hepatocellular carcinoma, the most common form of liver cancer.

Recap of the Week’s Most Important Stories:

AbbVie, Roche & Lilly’s Coronavirus Updates: Lilly announced a collaboration deal with private biotech, AbCellera to co-develop antibody therapies to treat and prevent COVID-19. To develop these therapies, the companies will select from more than 500 unique antibodies identified by AbCellera and isolated from the blood sample of a U.S. COVID-19 patient who recovered from the disease. The companies will equally share initial development costs for the antibody products after which Lilly will take care of further development, manufacturing and distribution.

AbbVie is working with global health authorities to determine the efficacy of its HIV medicine, Kaletra/Aluvia against coronavirus disease. The company said it is coordinating with European and U.S. health authorities to support clinical studies on Kaletra/Aluvia for COVID-19 treatment. Kaletra/Aluvia is a combination of lopinavir and ritonavir.

Roche (OTC:RHHBY) announced that the FDA has granted Emergency Use Authorization (EUA) to its cobas SARS-CoV-2 test to detect virus that causes COVID-19. The test, which has not yet been approved by the FDA, can be performed on Roche’s cobas 6800/8800 systems. The test is available in markets that accept the CE mark and in areas where the SARS-CoV-2 virus is confirmed to be present. Several other biotech/drug companies are working on making treatments/vaccines to treat COVID-19.

Bristol-Myers Opdivo + Yervoy Combo Gets FDA Nod for Liver Cancer: The FDA granted accelerated approval to Bristol-Myers’s dual immunotherapy - Opdivo + Yervoy - for patients with hepatocellular carcinoma (HCC) previously treated with Bayer’s Nexavar (sorafenib). The approval was based on data from the CheckMate -040 study in which Opdivo + Yervoy showed an overall response rate of 33%. With approval for this most common and aggressive form of liver cancer, the Opdivo + Yervoy combination is now approved to treat four types of cancer.

Meanwhile, Bristol-Myers’ phase III study evaluating Empliciti plus Revlimid and dexamethasone (ERd) as a first-line treatment option for patients with multiple myeloma not eligible for transplant failed to meet its primary endpoint. Data from the study showed that the ERd combo failed to demonstrate statistically significant improvement in progression-free-survival (PFS) compared to a combination of Revlimid and dexamethasone (Rd). The ERd combo is already approved for the treatment of relapsed and refractory multiple myeloma (r/rMM).

AstraZeneca/Merck’s Ovarian Cancer Study on Lynparza Doublet Fails: AstraZeneca (NYSE:AZN) and Merck’s (NYSE:MRK) phase III study evaluating efficacy of a potential new medicine cediranib added to PARP inhibitor Lynparza did not meet the primary endpoint of PFS in patients with platinum-sensitive relapsed ovarian cancer. The GY004 study was led by NRG Oncology and sponsored by the U.S. National Cancer Institute (NCI) and evaluated cediranib plus Lynparza versus platinum-based chemotherapy

AbbVie/Roche Get EU Nod for Venclexta+Gazyva in First-Line CLL: The European Commission approved a combination of AbbVie/Roche’s Venclyxto (called Venclexta in United States) and Roche’s Gazyva as a fixed duration treatment for first-line chronic lymphocytic leukemia (CLL). The approval was based on data from the phase III CLL14 study. The approval was expected as the CHMP had given a positive opinion recommending approval of the combination in January. The combination was approved for the same indication by the FDA in May last year.

FDA’s Breakthrough Tag for J&J’s Lung Cancer Candidate: The FDA granted Breakthrough Therapy status to J&J’s (NYSE:JNJ) JNJ-6372, a dual-targeting EGFR-MET bispecific antibody, for the treatement of non-small cell lung cancer (NSCLC) in patients with EGFR Exon 20 insertion mutations. The designation was based on data from a phase I study evaluating the candidate in adult patients with advanced NSCLC.

Meanwhile, the FDA granted Fast Track designation to Lilly’s diabetes medicine Jardiance to reduce the risk of kidney disease progression and cardiovascular death in adults with chronic kidney disease. Jardiance is being evaluated in the EMPA-KIDNEY clinical study in the above patient population with or without diabetes.

The NYSE ARCA Pharmaceutical Index declined 12.89% in the last five trading sessions.

Here is how the seven major stocks performed in the last five trading sessions.

Last week, all the stocks were in the red with AstraZeneca declining the most (15.8%).

In the past six months, Lilly has risen the most (14.4%) while Pfizer (NYSE:PFE) declined the most (18.5%).

(See the last pharma stock roundup here: Trump, Pharma Executives Meeting on Coronavirus, FDA Updates)

What's Next in the Pharma World?

Watch out for regular pipeline and regulatory updates next week.

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