The year 2022 was a difficult one for the biotech sector. Marked with geopolitical unrest, rising interest rates, the Russian-Ukraine war, inflation, and most of all, a stricter regulatory environment, biotech companies had a tough going. Biotech stocks were on a roller coaster ride
through the year, with the first few months witnessing bearish trends. The
sector bounced
back in the second half of 2022 due to M&A deals, strong earnings performance, new drug approvals and pipeline successes. But the joy was short-lived – the indices dipped once again in December.The Nasdaq Biotechnology Index (NBI) fell 3.4
percent to US$ 4,213. In November, it was up 5 percent. There was no change in
the S&P Biotechnology Select Industry Index (SPSIBI) last month. It was up
1.1 percent in November. And the SPDR S&P Biotech ETF (XBI) rose 0.1
percent in December, as opposed to 1 percent rise in November.For the full year, NBI fell 11 percent, while
both SPSIBI and XBI plummeted 28 percent. Overall though, biotech companies can
take heart from the fact that
2022 was the worst year for S&P 500 and Nasdaq Composite since 2008.Access the Pipeline Prospector Dashboard for December 2022 Newsmakers (Free Excel)Novo gains post Wegovy launch in Denmark; Sanofi’s stock rises post legal winDecember was a big month for Novo
Nordisk as the Danish drugmaker launched
its diabetes drug Wegovy (semaglutide) in its
home market, fulfilling its promise to launch the med outside of the US by
2022-end. Wegovy also received an add-on approval from the US Food and Drug
Administration (FDA) to treat obesity
in teens 12 years and above just before
Christmas. All the good news resulted in an 8 percent rise in Novo’s stock. Another mega cap company that made gains on the
bourses last month was French drugmaker Sanofi — its stock rose 7 percent. A big reason behind this was the dismissal
of about 50,000 lawsuits by a US district judge. The lawsuits had claimed that the heartburn drug – Zantac – causes cancer. Shares of GSK and Sanofi also made gains due to the dismissal, adding more than US$ 20 billion in combined value soon after the court’s decision. Sanofi’s blockbuster dermatitis and asthma drug Dupixent (dupilumab) also
received marketing
authorization in Europe as the first and only targeted medicine for prurigo nodularis, a chronic and debilitating skin disease.In early 2022, Novo had faced supply bottlenecks for
Wegovy. Last month, its chief rival Eli
Lilly met the same fate as it failed to meet the
demand for its newly approved diabetes injection
Mounjaro (tirzepatide). FDA added Mounjaro to its list of
drugs facing shortages, along with a second diabetes med, Trulicity (dulaglutide). Lilly’s stock was down 2 percent in December.Access the Pipeline Prospector Dashboard for December 2022 Newsmakers (Free Excel) FDA’s Aduhelm nod gets flayed post probe; Roche suspends Alzheimer’s drug trialIt wasn’t a good month for Biogen, whose
stock dropped by 9 percent in December. Three patient deaths got linked with Eisai and Biogen’s second Alzheimer’s drug — Leqembi (lecanemab). And, towards the end
of the month, there was news that an 18-month-long
investigation
conducted by two House of Representatives’ committees found FDA’s approval process of Biogen’s controversial Alzheimer’s disease drug — Aduhelm (aducanumab) — to be “rife with irregularities”.There was more bad news on drugs for Alzheimer’s. Roche (down 2
percent) decided to suspend
most trials of its Alzheimer’s drug – gantenerumab – after it failed to slow advancement of the disease in late-stage studies. In another setback to the Swiss drugmaker, a combination of Tecentriq (atezolizumab) and Exelixis-Ipsen’s Cabometyx
(cabozantinib) failed to
meet the primary endpoint in a
phase 3 lung cancer trial. Ipsen’s stock fell 6 percent.Access the Pipeline Prospector Dashboard for December 2022 Newsmakers (Free Excel) Madrigal zips past rivals in NASH race; Prometheus’ colitis drug posts trial winAmong mid-cap companies, Pennsylvania-based Madrigal Pharmaceuticals’ shares soared by over 300
percent in December after its
experimental drug to treat nonalcoholic steatohepatitis (NASH) – resmetirom – met the main goal in a late-stage study. The trial’s success has propelled Madrigal to the forefront of a race to develop the first treatment for NASH, a form of non-alcoholic fatty liver disease. Madrigal plans to
move FDA for an accelerated approval of resmetirom
this year.Another mid-cap company Prometheus
Biosciences saw its stock
soar 171 percent after its lead drug candidate – PRA023 – met the endpoints in a phase 2 study in patients with moderate-to-severely active ulcerative colitis.A small cap company named Icosavax saw its stock soar 125 percent after it announced
a positive outcome for its respiratory syncytial virus (RSV) vaccine from a phase 1/1b study. Icosavax is a US-based, clinical stage vaccine company. A single dose of the shot, IVX-121, demonstrated a response against RSV that lasted six months.Access the Pipeline Prospector Dashboard for December 2022 Newsmakers (Free Excel) Horizon’s stock rises after Amgen acquires it for US$ 27.8 billionThe biggest
biopharma deal of 2022 was Amgen’s
acquisition of Horizon
Therapeutics for US$ 27.8 billion. News of Amgen and Sanofi’s buyout
interest in Horizon had led to a 61 percent rise in the rare disease drugmaker’s stock in November. Last month, Horizon’s shares increased by 10 percent after Amgen finally announced the acquisition.Another significant deal
inked in December was Japanese drugmaker Takeda’s (up 7
percent) acquisition of Nimbus Therapeutics’ experimental psoriasis drug for up to US$ 6
billion. This is Takeda’s biggest buyout since it purchased Shire for US$ 62 billion in 2019. The deal is also among the pharma industry’s largest single-asset purchases since Amgen bought Otezla from Celgene in 2019
for US$ 13.4
billion.Access the Pipeline Prospector Dashboard for December 2022 Newsmakers (Free Excel) Moderna’s mRNA vaccine-Keytruda combo succeeds in mid-stage skin-cancer trialA combination of Moderna’s
experimental messenger RNA cancer
vaccine and Merck’s
blockbuster immunotherapy Keytruda (pembrolizumab) was successful in a mid-stage skin cancer trial. Moderna’s stock grew 19 percent following the news, but it nosedived soon after. Merck is also carrying
out clinical trials of Keytruda that can be injected under the skin. The drugmaker is testing at least two versions of the drug in the hope that a new formulation will allow it to retain the drug’s patent edge and protect it from competition.Novartis’ stock
reported a 2 percent growth in December. Its drug Pluvicto showed survival
benefits in a late-stage prostate cancer trial. Its
rare blood disease drug iptacopan was also
successful in treating paroxysmal nocturnal hemoglobinuria in a late-stage
trial.Access the Pipeline Prospector Dashboard for December 2022 Newsmakers (Free Excel) Our viewSoothsayers do not have positive things to say
about 2023. The Ukraine-Russia war has played havoc with food and energy costs,
causing the highest rates of inflation. And a global recession seems inevitable
in 2023.Even as the world grapples with these challenges, innovation is likely to save the day for the biotech sector. In 2023, Eisai and Biogen’s Leqembi became the first drug to receive an accelerated approval from the FDA. Several other pathbreaking drugs will come up for approval this year, including vaccines and therapies for RSV, new treatments for Alzheimer’s disease, a gene therapy for Duchenne muscular dystrophy and several treatments for obesity. The heady mix of recession and innovation may also trigger more M&A activity. And we hope these innovations result in a better year for the sector.Access the Pipeline Prospector Dashboard for December 2022 Newsmakers (Free Excel)
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