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By PharmaCompass
2023-06-08
Impressions: 1639
In April, the biotech indices had crawled up post the drubbing in March due to the collapse of Silicon Valley Bank. That rally could have gained momentum had the policymakers in the US not struggled to arrive at a debt ceiling deal, which was sealed only this month.
As a result, the Nasdaq Biotechnology Index (NBI) was down 4 percent in May at US$ 4054.54, against US$ 4,187.32 in April. The SPDR S&P Biotech ETF index (XBI) was up 2 percent at US$ 83.33, against US$ 80.20 in April, and the S&P Biotechnology Select Industry Index (SPSIBI) was up 1 percent at US$ 6458.99, against US$ 6,094.82 in April.
May was not a good month for deals — only two deals over US$ 1 billion were announced. This includes Ironwood’s acquisition of VectivBio (up 55 percent) for US$ 1 billion and Sobi’s acquisition of CTI BioPharma (up 80 percent) for US$ 1.7 billion.
Access the Pipeline Prospector Dashboard for May 2023 Newsmakers (Free Excel)
FTC’s lawsuit to block deal hits Amgen, Horizon stocks; AbbVie’s Humira sales down 25 percent
One of the biggest losers last month was AbbVie, with its stocks dipping 10 percent. Not only did its first quarter (Q1) results drag its stock down, but the weaker-than-expected performance of its blockbuster drugs — Skyrizi and Rinvoq — also played spoiler. Sales of Humira dipped by another 25 percent in Q1 due to the loss of patents. In positive news, Rinvoq received its seventh FDA approval – this time to treat patients with moderate to severe Crohn’s disease. And its Epkinly (epcoritamab-bysp), co-developed with Genmab, became the first and only bispecific antibody for treating relapsed or refractory diffuse large B-cell lymphoma (DLBCL) in adults.
Both Amgen (-8 percent) and Horizon Therapeutics (-10 percent) saw their stocks dip as the US Federal Trade Commission (FTC) filed a lawsuit to block the former’s US$ 27.8 billion takeover of the rare disease drugmaker. The lawsuit raises concerns that Amgen can exploit its market position to guard the monopolies of two Horizon drugs. Additionally, the US Supreme Court ruled against Amgen’s bid to revive patents on its cholesterol-lowering drug Repatha in a legal clash with Sanofi and Regeneron.
Johnson & Johnson (-5 percent) also faced losses on the bourses as a federal bankruptcy judge ordered the company and talc claimants to conduct settlement talks, after hearing J&J’s bankruptcy strategy. In April, J&J had offered to pay US$ 8.9 billion over 25 years to over 60,000 claimants in settlement.
Access the Pipeline Prospector Dashboard for May 2023 Newsmakers (Free Excel)
Novartis slides after Adakveo revocation news; Gilead dips despite patent lawsuit win
The European Medicines Agency (EMA) has recommended revoking the marketing authorization of Novartis’ sickle cell disease drug Adakveo (crizanlizumab-tmca). The decision comes after Adakveo failed to demonstrate effectiveness in a phase 3 trial. Novartis’ stock slid 7 percent in May.
Novo Nordisk (-4 percent) had a different problem at hand — due to soaring demand, it had to halt the promotion of its popular weight-loss drug Wegovy. Moreover, FDA rejected Novo’s experimental drug candidate concizumab as a treatment for hemophilia A and B.
Gilead Sciences saw a 7 percent drop in its stock. On May 9, the drugmaker scored a win in an HIV patent infringement case filed by the US government. Meanwhile, an antitrust trial against Gilead and Teva began in California, accusing both companies of colluding to delay generic competition for Gilead's HIV medications.
Sales of Regeneron’s wet macular degeneration drug — Eylea — dropped by 5 percent to US$ 1.43 billion in Q1. Though the Q1 sales for Regeneron increased by 7 percent (year-on-year) to US$ 3.16 billion, the stock market reacted to the drop in Eylea sales, which coincided with the launch of Roche’s Vabysmo in January this year. Overall, Regeneron’s stock dropped 9 percent in May.
Access the Pipeline Prospector Dashboard for May 2023 Newsmakers (Free Excel)
Lilly, Roche post gains due to trial wins; Apellis’ new eye drug gets off to good start
Eli Lilly’s share surged to 6 percent as its experimental Alzheimer’s drug — donanemab — slowed cognitive decline by 35 percent compared to a placebo in a late-stage trial. Lilly plans to file for full approval of this drug by June-end. Similarly, Roche (up 3 percent) said its multiple sclerosis drug, fenebrutinib, reduced brain lesions in a mid-stage trial.
Apellis saw its stock increase 7 percent last month due to a good start for its new vision loss drug — Syfovre — which bagged FDA approval in mid-February and was launched on March 1. In just a month, it brought in US$ 18.4 million for Apellis. Amongst mid-cap players, ImmunoGen reported positive top-line data from a late-stage trial of its ovarian cancer therapy Elahere, which pushed its stock up by 133 percent.
Access the Pipeline Prospector Dashboard for May 2023 Newsmakers (Free Excel)
Falling Covid sales, Alnylam’s lawsuits hit Pfizer stock; Bayer’s pharma revenues dip
During Q1 2023, Pfizer's revenues dropped to US$ 18.3 billion owing to a 64 percent drop in Comirnaty revenues (which were at US$ 13.5 billion) and a 58 percent drop in Paxlovid revenues (of approximately US$ 8 billion) as against Q1 2022. Pfizer saw a 5 percent drop in its stock in May. Pfizer and Valneva are pushing back a regulatory filing for their Lyme disease vaccine by a year (now planned for 2026) after the companies were forced to pull half of the participants from a phase 3 study in February.
The month also saw Alnylam (-6 percent) file its third set of lawsuits against the two largest manufacturers of Covid vaccines — Pfizer and Moderna (-4 percent). Alnylam is accusing the two drugmakers of violating its lipid particle delivery technology with their lucrative Covid-19 vaccines. In mid-May, Moderna hit back at Alnylam’s ‘baseless’ infringement claims. Alnylam had first sued Moderna in March 2022.
Bayer’s Q1 earnings were down 2 percent at €14.4 billion (US$ 15.7 billion), with its pharma business witnessing a 5 percent drop in Q1 revenues, at €4.4 billion (US$ 4.7 billion). Sales of its blood thinner Xarelto were down 13 percent in Q1 2023. Bayer’s stock was down 9 percent in May.
Access the Pipeline Prospector Dashboard for May 2023 Newsmakers (Free Excel)
Our view
Through much of May, pharma indices reacted negatively to the standoff in debt ceiling deal talks. An in-principle agreement between President Joe Biden and House Speaker Kevin McCarthy was reached only towards the end of May and Biden signed the debt ceiling bill early this month.
Post the deal, the indices are climbing up once again. However, Morgan Stanley is of the view that the deal could drive up stock market uncertainty. Seems like it could be months before the stock market regains stability.
Access the Pipeline Prospector Dashboard for May 2023 Newsmakers (Free Excel)
Pharma & Biotech Newsmakers in May 2023
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Image Credit : Pharma & Biotech Newsmakers in May 2023 by PharmaCompass license under CC BY 2.0
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