The Top Five Pharma Stories Of 2022
Executive Summary
Scrip has taken a look back at five of the biggest story themes in no particular order of 2022 where once again the biopharma industry had plenty on its plate.
1. A Ray Of Hope Returns To Alzheimer's Research
What a difference a year makes, especially in the graveyard that has been Alzheimer's disease research. This time 12 months ago, controversy still swirled around the US Food and Drug Administration's decision in June 2021 to approve the first disease-modifying drug for Alzheimer’s in the shape of Biogen, Inc. and Eisai Co., Ltd.’s Aduhelm (aducanumab), despite trial data failing to show clear benefit.
A jaw-droppingly high list price and failure to gain Medicare reimbursement saw Biogen lose CEO Michel Vounatsos and end its commercial efforts for Aduhelm earlier this year. The Alzheimer's space took another bashing last month as Roche Holding AG's anti-amyloid antibody gantenerumab failed to significantly beat placebo in the Phase III GRADUATE I and GRADUATE II trials.
However, the year is ending with renewed hope for a breakthrough in the search for a drug that might finally demonstrate a significant impact on cognition and function. Enter Eisai and Biogen's amyloid protofibril-clearing antibody lecanemab which showed a 27% reduction in the rate of cognitive and functional decline in the Phase III Clarity AD trial.
The FDA is set to make a decision on accelerated approval of lecanemab by 6 January. It may be closely followed by Eli Lilly and Company’s donanemab, which targets a modified form of beta-amyloid plaque called N3pG, and an FDA decision is expected early next year. The Alzheimer's pipeline is also looking well-stocked and while there is room for improving the magnitude of effect seen with anti-amyloid therapies, 2022 finishes with hopes rising for the next generation of drugs.
(Also see "How Biogen’s Aduhelm Bet Became A Commercial Bust" - Scrip, 6 Jun, 2022.)
(Also see "Roche’s Alzheimer’s Drug Fails In Phase III Giving Eisai/Biogen A Clear Run" - Scrip, 14 Nov, 2022.)
(Also see "Lilly CEO: Realistic Expectations Needed For Current Wave of Alzheimer’s Treatments" - Pink Sheet, 30 Nov, 2022.)
(Also see "Lecanemab Set A New Bar In Alzheimer’s, Now Many Drugs Are Seeking To Raise It" - Scrip, 16 Dec, 2022.)
2. Obesity Becomes A Major Market Opportunity
Obesity, unlike diabetes, has traditionally been viewed as a symptom of lifestyle choices rather than a chronic disease. That view has shifted dramatically during 2022 as interest in diabetes drugs reformulated specifically for obesity booms to the extent that analysts at Morgan Stanley have forecast that the latter sector will grow from a $2.4bn category this year to a whopping $54bn by 2030.
Much of the buzz around obesity drugs this year has centered around Novo Nordisk A/S's Wegovy, a 2.4mg injectable reformulation of the GLP-1 receptor agonist semaglutide. However, Wegovy has been in short supply due to production problems and huge demand fuelled in part by mainstream media interest and celebrity endorsements; Elon Musk tweeted this year that his weight loss to fasting and Wegovy.
The supply issues Novo Nordisk have endured with Wegovy and boosted sales of the Danish firm's older obesity drug Saxenda (liraglutide) while off-label use of the firm's diabetes drug Ozempic, a lower dose of semaglutide, has gone through the roof in the US, after being touted on social media as a substitute for Wegovy.
Supplies have also been affected of Lilly's diabetes drug Mounjaro (tirzepatide), which the FDA is expected to approve for obesity in 2023 next year. The GIP/GLP-1 analog is enjoying a strong launch, having been approved for diabetes in the US in May, and impressive data from the Phase III SURMOUNT-1 study of obese/overweight subjects who do not have diabetes suggest that tirzepatide will provide a very strong challenge to Novo Nordisk's dominance in the lucrative weight loss field.
The interest in the obesity space is growing as evidenced by the excitement that followed the first set of data on Amgen, Inc.’s GIPR/GLP-1 drug AMG 133, which suggested that its efficacy, durability and less frequent dosing could challenge Wegovy and Mounjaro in the future.
(Also see "Novo Targets Teens With Wegovy As It Heads Off Lilly Mounjaro Threat" - Scrip, 7 Nov, 2022.)
(Also see "Lilly Preparing For Increasing Mounjaro Demand On Top Of Solid Launch" - Scrip, 1 Nov, 2022.)
(Also see "Early Data On Amgen’s AMG 133 Show Potential Durability, Dosing Advantage In Obesity" - Scrip, 5 Dec, 2022.)
(Also see "Novo Nordisk’s New Diabetes Combo Shows Potential To Best Lilly’s Mounjaro" - Scrip, 23 Aug, 2022.)
3. Moratorium On Mega-M&A Continues
Observers hoping for an M&A bonanza in 2022 were left feeling nonplussed. While several big pharma firms were flush with cash, helped in some cases (especially Pfizer Inc.) by revenues from their COVID-19 products, prudence was the watchword for most and mega deals did not materialize.
Analysts had to wait until earlier this month for the biggest acquisition of 2022, when Amgen agreed to pay $27.8bn for Horizon Therapeutics plc after rivals Sanofi and Johnson & Johnson dropped out of the contest for the Dublin-domiciled rare diseases specialist. The US major was also involved in the year’s fifth-largest deal, the $3.7bn acquisition of ChemoCentryx, Inc.’s anti-neutrophil cytoplasmic antibody-associated vasculitis drug Tavneos (avacopan).
Pfizer did spend some of its COVID-19 gains, buying Biohaven Pharmaceutical Holding Company Ltd. and its oral CGRP inhibitor for migraine, Nurtec ODT (rimegepant), for $11.6bn. That was the second biggest purchase and Pfizer was involved in the third largest deal, paying $5.4bn to get hold of Global Blood Therapeutics, Inc. and its sickle cell therapy Oxbryta (voxelotor).
The year may not have seen any marquee transactions but there was still a high volume of deal-making as the pharma industry focused on feeding the R&D pipeline, underscored by looming patent cliffs for many players. 2022, like a year ago, saw a trend toward bolt-on acquisitions and licensing deals rather than major M&A deals and it would be a surprise if that trend changes much in 2023.
(Also see "Pfizer Leads Big Pharma M&A In 2022 – But Is There More To Come?" - Scrip, 12 Oct, 2022.)
(Also see "Finance Watch: Recent M&A Uptick Gives Biopharma A Needed Boost" - Scrip, 21 Jul, 2022.)
(Also see "Amgen To Enhance Rare Disease Franchise With $27.8bn Horizon Takeover" - Scrip, 12 Dec, 2022.)
(Also see "Pfizer's Plan To Establish A $6bn Migraine Franchise" - Scrip, 14 Dec, 2022.)
4. The Rise And Rise Of mRNA
Of the new modalities that have advanced over the past year, the most eye-catching has been messenger RNA (mRNA) technology. The science behind Pfizer and BioNTech SE's Comirnaty and Moderna, Inc.'s Spikevax COVID-19 vaccines has now entered the mainstream after decades of research, promising to transform the treatment of other diseases.
Earlier this month, there was huge excitement about the prospects of a personalized cancer vaccine based on mRNA technology upon release of data from a Phase IIb study in post-surgical stage III/IV melanoma patients. The results showed a 44% lower risk of recurrence or death for a combination of Moderna’s experimental mRNA personalized cancer vaccine and Merck & Co., Inc.'s anti-PD-1 blockbuster Keytruda (pembrolizumab) versus Keytruda monotherapy. Observers were queueing up to proclaim the combo as having the capacity to shift the paradigm in the treatment of cancer. A Phase III study is planned for 2023 and will be rapidly expanded to additional tumor types.
Like Moderna, BioNTech has also been deploying proceeds from its COVID-19 vaccine partnered with Pfizer to add cancer immunotherapy programs to its pipeline, the most recent being a licensing deal with Ryvu Therapeutics to access the Polish firm's portfolio of STING agonists. BioNTech, which has several mRNA-personalized vaccines in development including a combination with Roche's Tecentriq (atezolizumab) for pancreatic cancer, is also looking at applying its mRNA technologies in a host of other diseases and just last week initiated a Phase I study of BNT165b1, the first vaccine candidate from its malaria program.
There are still challenges in mRNA technology in terms of delivery, manufacturing and storage but the success of their COVID-19 vaccines has catapulted Moderna and BioNTech from promising but unproven players into global leaders exploring a new frontier for a variety of diseases.
(Also see "Moderna Chalks Up Industry Milestone With mRNA Cancer Vaccine Efficacy Success" - Scrip, 14 Dec, 2022.)
(Also see "BioNTech Bolsters Cancer Immunotherapy Ambitions In Pact With Cash-Poor Ryvu" - Scrip, 30 Nov, 2022.)
(Also see "Merck KGaA Exec On Gearing For mRNA Prime Time, De-Risking Manufacturing" - In Vivo, 14 Nov, 2022.)
(Also see "RNA Medicines: Advancements Leading To Investments" - In Vivo, 1 Dec, 2022.)
5. Mounting Lay-Offs Cause For Concern
Job cuts in the sector have been a far-too-regular occurrence in 2022, especially for smaller firms that faced more limited funding options. Some listed companies have seen their market value sink below cash while private start-ups chased venture capital as the IPO window remained shut and secondary offerings proved tricky.
The unfavorable market conditions are a result of a post-pandemic market correction in biotech and a challenging macro-economic environment affected by high inflation, rising interest rates and the war in Ukraine. One effect has been major restructuring across the sector which has seen research programs and jobs cut.
Some high-profile companies have conceded defeat, most recently Clovis Oncology, Inc. which filed for Chapter 11 bankruptcy protection this month. Over 20 biotechs announced lay-offs in November alone and big players are also making cuts; around 280 staff will be leaving Novartis AG earlier in the New Year when the Swiss giant will start to implement a program to shed around 8,000 jobs across its global operations.
Tough times indeed, but peaks and troughs are par for the course in the biopharma world. Take Zealand Pharma A/S's 2022, for example, which comprised a failed launch for hypoglycemia injection Zegalogue (dasiglucagon) and jobs slashed in the US and Denmark. The end seemed nigh but a deal with Novo Nordisk in September followed by a decent private placement means Zealand is back in the game, at least until the second quarter of 2024.
(Also see "Novartis To Cut 8,000 Jobs In Global Restructure" - Scrip, 29 Jun, 2022.)
(Also see "Clovis Close To Bankruptcy As Cancer Drug Outlook Worsens" - Scrip, 10 Nov, 2022.)
(Also see "Big Pharma Restructures Commercial Teams In India" - Scrip, 6 Dec, 2022.)
(Also see "Zest Is Back At Zealand With Cash Injection And A Clinical Win" - Scrip, 5 Oct, 2022.)