Prescribed Reading: What J&J says about the rest of pharma
A weekly guide to the goings-on in the biopharma industry.
Biopharma is a complex, rapidly evolving industry that is highly regulated and closely watched — and that means there is constant news. Here's a closer look at the clinical trials, M&A, cool science and regulations that are driving the industry this week.
In case you missed it
- Allergan and Novartis are teaming up in NASH.
- Former Dendreon CEO has a new public company.
- UniQure finally gives up on Glybera.
Mergers & analysis
Johnson & Johnson kicked off earnings season with its first quarter report on Tuesday. The big pharma is generally seen as a bellwether for the rest of its peers, and if that still holds true, this is going to be a rough first quarter for big pharma.
J&J failed to meet analysts’ expectations for sales and its pharma division in particular has experienced a slowdown. But there would be a few other read-throughs from the earnings report as well.
Despite biosimilar competition entering the market, J&J’s rheumatoid arthritis drug Remicade (infliximab) hasn’t been hurt by it just yet, suggesting biosimilar uptake is going to be a long, slow slog while patients and physicians learn more about the copycat biologics.
J&J management also had a lot to say about pricing; specifically, that it doesn’t expect to face as much push back for its upcoming medications because they are “specialty” products. Recent backlash to virtually all drug prices suggests that J&J might be in for a rude awakening on that one, but only time will tell.
The rest of big pharma and big biotech begin reporting their first quarter results next week. Keep an eye on BioPharma Dive for updates.
The week started off with a surprise regulatory decision when the Food and Drug Administration rejected Eli Lilly and Incyte’s rheumatoid arthritis drug, baricitinib. While the companies kept the Complete Response Letter details close to the vest, they did reveal that there might be a potential problem with the safety related to the most effective dose of 4mg – calling into question the risk/benefit profile.
Lilly and Incyte are determined to push ahead, but this opens up the market for several other major competitors in the space, particularly Pfizer, which already has an oral JAK inhibitor on the market. Pfizer’s Xeljanz has not been a major market force, but the big pharma has pegged it as one its major revenue drivers over the next few years, building out its inflammation and immunology unit around the drug. It brought in nearly $1 billion for Pfizer last year, but baricitinib was expected to upset this market – now, at least, Pfizer will have a reprieve.
Meanwhile, another drug company is hoping to avoid the same fate. CytRx is pushing ahead with a rolling New Drug Application to the FDA for aldoxorubicin, a soft tissue sarcoma (STS) treatment. The drug has some mixed data in its past, but CytRx is hopeful.
AbbVie announced data for two of its most closely watched drugs – the combination hepatitis C treatment glecaprevir/pibrentasvir (G/P) and the PARP inhibitor veliparib. Unfortunately for the North Chicago company, the bad news for the cancer drug completely overshadowed the expected positive data for G/P.
AbbVie announced positive 12-week sustained virologic response rates for G/P in cirrhotic patients at the International Liver Meeting this week. The pan-genotypic regimen was submitted for approval in December and has an estimated approval date in early August. The data from the Liver Meeting just further supports previous evidence of the drug’s effectiveness.
As for veliparib, the company revealed on Wednesday that it failed in two late-stage studies in patients with advanced or metastatic squamous non-small cell lung cancer (NSCLC) who had a history of smoking, and triple negative breast cancer (TNBC), respectively.
The company was hoping to augment chemotherapy in these patients, but came up short. It’s not the first time the drug has done so and the latest failures greatly diminish its chances of competing in an already crowded market.
Follow Lisa LaMotta on Twitter