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Pipeline Prospector Nov 2023: Lilly, Novo post sharp rise in Q3 sales; AbbVie buys ImmunoGen for US$ 10.1 billion

Through much of 2023, markets remained volatile, with pharma indices managing to inch up only in some months. November bucked the trend — the Nasdaq Biotechnology Index (NBI) rose by 4 percent at 3,902.97 after an 8 percent drop in October. The SPDR S&P Biotech ETF index (XBI) spiked 12 percent to 75.52, compared to a drop of 12 percent in October. And the S&P Biotechnology Select Industry Index (SPSIBI) gained 12 percent to 5,882.09 after plunging 9 percent in October.The indices mirrored the bullish activity witnessed in the US stock markets, with the S&P 500 rebounding 8.92 percent in November. Importantly, healthcare stocks outperformed all 11 major sectors of the S&P 500.The month witnessed another significant deal in the antibody-drug conjugates (ADCs) space after Pfizer acquired Seagen in March for US$ 43 billion. As November drew to a close, AbbVie picked up ImmunoGen for US$ 10.1 billion, including its first-in-class ADC, Elahere, approved for platinum-resistant ovarian cancer (wherein patients relapse within six months of receiving platinum-based chemotherapy). ADCs are fast-growing, innovative biopharmaceutical products that target cancer cells, while protecting the healthy cells.In other big news, the United Kingdom became the first country to grant regulatory approval to a medical treatment involving the revolutionary CRISPR gene editing tool. And the month also saw several drugmakers announce their third quarter (Q3) results.Access the Pipeline Prospector Dashboard for November 2023 Newsmakers (Free Excel) Astra joins obesity med jamboree with Eccogene deal; Lilly, Novo ride GLP-1 waveNovember was a good month for Eli Lilly (stock up by 7 percent) as both the US Food and Drug Administration (FDA) and the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) approved its weight-loss injection Zepbound (tirzepatide). Moreover, the drugmaker’s Q3 revenue increased by an impressive 37 percent, driven by the growth of its GLP-1 diabetes treatment Mounjaro (tirzepatide) and breast cancer drug Verzenio (abemaciclib).The other drugmaker that rode on the popularity of GLP-1 meds is Novo Nordisk (up by 4 percent). The Danish drugmaker posted a rise in sales of 29 percent in the first nine months of 2023. Its diabetes and obesity care meds saw a gain of 36 percent, bringing in DKK 153.8 billion (US$ 20.6 billion) for Novo in the first nine months of 2023. Out of this, the GLP-1 meds (Saxenda, Ozempic, Rybelsus, Wegovy) contributed DKK 30.4 billion (or US$ 4.1 billion). The company also plans to expand its manufacturing capacities with an investment of over DKK 42 billion (US$ 6 billion) in Kalundborg (Denmark), and an additional investment of DKK 16 billion (US$ 2.3 billion) at its Chartres (France) facility to capitalize on the burgeoning market for weight loss drugs. Its weight loss med Wegovy has also shown heart protection benefits in a phase 3 trial.Not wanting to miss out on the bourgeoning market for weight loss drugs (estimated to reach an annual market size of US$ 100 billion by 2030), AstraZeneca (up by 2 percent) has entered into an exclusive license agreement worth US$ 2 billion with Chinese biopharma Eccogene for its investigational treatment ECC5004 for obesity, type-2 diabetes, and other cardio-metabolic conditions. The company has reported a 5 percent rise in its Q3 revenues (at US$ 11 billion), fueled by good performances in oncology, cardiovascular renal management, and rare diseases.Access the Pipeline Prospector Dashboard for November 2023 Newsmakers (Free Excel) GSK’s RSV jab nears US$ 1 bn in sales; Novartis, Sanofi post positive trial updatesLaunched in early May 2023, GSK’s (stock up by 3 percent) RSV vaccine, Arexvy, has made an impressive debut. GSK’s Q3 results show that its total sales increased by 10 percent, fueled by a 33 percent surge in vaccine sales. This includes £0.8 billion (US$ 0.97 billion) from sales of its shingles vaccine (Shingrix) and £0.7 billion (US$ 0.85 billion) from sales of Arexvy. In its first year of launch, Arexvy sales are poised to cross £1 billion (US$ 1.26 billion).In crucial phase 3 trials, Novartis’ (up by 4 percent) highly selective, oral Bruton’s tyrosine kinase (BTK) inhibitor remibrutinib showed clinically significant results in treating chronic spontaneous urticaria (CSU). Currently, H1-antihistamines are the only recourse for people plagued by chronic hives.Sanofi (up by 2 percent) also made trial gains as its blockbuster drug Dupixent (dupilumab) showed “overwhelming positive efficacy” in a second, large phase 3 trial undertaken to test it as a cure for chronic obstructive pulmonary disease (COPD). Sanofi now plans to seek FDA approval to expand its use for COPD. If approved, Dupixent will be the first biologic to treat the disease.Access the Pipeline Prospector Dashboard for November 2023 Newsmakers (Free Excel) UK okays CRISPR therapy for thalassemia, Madrigal’s NASH drug posts trial gainsIn a world first, the UK’s MHRA has given the go-ahead for CRISPR Therapeutics (up by 61 percent) and Vertex Pharmaceuticals’ (down by 4 percent) gene therapy Casgevy for patients aged 12 and above to cure the genetic conditions — β-thalassemia and sickle-cell disease (SCD). This renders it the first treatment ever that uses the gene-editing tool CRISPR, whose inventors won the 2020 Nobel Prize.Large-cap Alnylam (up by 8 percent) achieved robust Q3 commercial results, reporting US$ 313 million in revenue, driven by the successful launch of Amvuttra, a rare heart disease drug.Mid-cap Madrigal (up by 53 percent) announced positive data from a late-stage trial demonstrating broad treatment effects of resmetirom on nonalcoholic steatohepatitis (NASH) with liver fibrosis. It is the only investigational therapy for NASH that has achieved both fibrosis improvement and NASH resolution primary endpoints in a phase 3 trial. Among small-cap companies, FDA approved SpringWorks Therapeutics’ (up by 42 percent) Ogsiveo (nirogacestat) for adults suffering from rare desmoid tumors, rendering it the first approved treatment for the non-cancerous condition.Among losers, Bayer (down by 22 percent) scrapped a significant late-stage trial assessing the efficacy of a new anti-clotting drug, asundexian, compared to Eliquis (apixaban) in patients with atrial fibrillation at risk of a stroke. The drugmaker had hoped asundexian would generate revenues in excess of €5 billion (US$ 5.5 billion) and compensate for the drop in revenues of its blood thinner Xarelto, set to lose protection from key European patents in 2026. Bayer also voluntarily recalled a single lot of its cancer drug Vitrakvi due to microbial contamination.Access the Pipeline Prospector Dashboard for November 2023 Newsmakers (Free Excel) Our viewIn the US, the Federal Reserve left interest rates unchanged in its meeting in November. This has raised investor expectations, and hopes of inflation cooling down this winter.However, given the rise in bankruptcy filings, layoffs, weaker availability of finance to small and medium-sized businesses and larger concerns of a slowdown in the global economy, we would exercise caution before putting inflationary and other economic concerns to rest.Access the Pipeline Prospector Dashboard for November 2023 Newsmakers (Free Excel)

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07 Dec 2023

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Biotech indices inch up post SVB bloodbath; Covid drugmakers report drop in Q1 sales

In March, the collapse of Silicon Valley Bank (SVB) had dragged the biotech indices down. SVB had made considerable investments in the biotech space, and its downfall had left many life sciences and healthcare companies vulnerable.Within a month of the SVB storm, biotech indices have bounced back. The Nasdaq Biotechnology Index (NBI) gained 1 percent to end April at US$ 4,187.32. It was down 1.3 percent in March. The S&P Biotechnology Select Industry Index (SPSIBI) was up 2 percent at US$ 6,094.82, and the SPDR S&P Biotech ETF (XBI) increased 4 percent to US$ 80.20. Both SPSIBI and XBI had dropped by 8.3 percent and 8.2 percent, respectively, in March.In April, several drugmakers announced their first quarter (Q1) results. The month also saw three major M&A deals — Merck’s US$ 10.8 billion buyout of Prometheus Biosciences, Astellas Pharma’s US$ 5.9 billion acquisition of Iveric Bio and GSK’s US$ 2 billion deal to buy Bellus Health.Access the Pipeline Prospector Dashboard for April 2023 Newsmakers (Free Excel)Pfizer reports 29% drop in Q1 revenues, falls behind GSK in RSV vaccine raceWe have seen this happening for many months now, with Pfizer’s stock consistently falling since January. The Q1 results only echoed that sentiment — Pfizer’s revenues fell 29 percent to US$ 18.3 billion due to a 77 percent drop in sales of its Covid-19 vaccine Comirnaty. This led to a further 5 percent drop in the drug behemoth’s stock in April. What was going right for Pfizer was its experimental respiratory syncytial virus (RSV) vaccine. But GSK raced ahead of Pfizer this month when the US Food and Drug Administration (FDA) approved its RSV vaccine — Arexvy — for adults aged 60 years and older. The Prescription Drug User Fee Act (PDUFA) date for the Pfizer jab for older adults is this month too. GSK also announced the acquisition of Canada-based drug developer Bellus Health (up 114 percent) for US$ 2 billion.Among other Covid drugmakers, Moderna’s stock also suffered a 17 percent loss last month. What was worse, its experimental messenger RNA-based influenza vaccine failed to demonstrate effectiveness against influenza B. Moderna is planning to go ahead with a phase 3 study of mRNA-4157 (its investigational individualized neo-antigen therapy) and Keytruda combo in patients with adjuvant melanoma this year.Access the Pipeline Prospector Dashboard for April 2023 Newsmakers (Free Excel) Wegovy helps boost Novo’s Q1 revenues; Vabysmo brings gains for RocheIn April, both Novo Nordisk and Eli Lilly posted gains in the bourses. Wegovy’s success in the US helped Novo’s obesity care segment notch up a 131 percent increase in Q1 sales. Novo’s diabetes and obesity drug sales rose 33 percent and were at DKK 48.8 billion (US$ 7.11 billion). Overall, the Danish drugmaker posted an impressive 27 percent growth in its Q1 sales — which were at DKK 53.4 billion (US$ 7.7 billion) — while its stock rose 5 percent in April.Lilly is seeking to compete with Wegovy’s dominance in the obesity market with its own drug, Mounjaro. It recently posted favorable data from a late-stage trial, where Mounjaro achieved 21 percent weight reduction in non-diabetic patients, compared to 15 percent for Wegovy. Lilly is now conducting another Phase 3b trial to test Mounjaro against Wegovy. And in a separate trial, Mounjaro led to a 16 percent weight loss in patients with type 2 diabetes. The drugmaker‘s stock rose by a handsome 15 percent.Roche Group’s pharmaceutical division posted 9 percent growth in Q1 sales — at CHF 11.7 billion (US$ 12.7 billion) — due to strong demand for newer medicines. Eye diseases drug Vabysmo, approved last year, turned out to be the strongest growth driver, generating CHF 432 million (US$ 486 million) in global sales. Roche expects the drug to generate US$ 2 billion in revenue this year. The Swiss drugmaker also shared post-hoc analyses from four additional phase 3 studies showing Vabysmo to be more effective at drying retinal fluid than Regeneron’s Eylea in Age-related macular degeneration (AMD) and Diabetic Macular Edema (DME). Roche’s stock gained 11 percent.In addition, FDA approved Roche’s Polivy as part of a five-drug combination for previously untreated diffuse large B-cell lymphoma (DLBCL), the first new treatment in nearly 20 years to significantly improve outcomes in first-line DLBCL. In Q1, Roche reported a decline of 3 percent in group sales due to lower demand for Covid tests.Access the Pipeline Prospector Dashboard for April 2023 Newsmakers (Free Excel)Higher sales of key drugs take Novartis’ Q1 sales up 8%; J&J lowers 2023 guidanceNovartis’ Q1 sales grew 8 percent to US$ 12.95 billion, driven by strong performance of its heart failure drug Entresto, cancer meds Pluvicto and Kisqali, and multiple sclerosis drug Kesimpta. Based on higher Q1 sales, the Swiss drugmaker has raised its outlook for 2023.Novartis and partner BeiGene’s experimental drug tislelizumab showed promising results in treating certain types of gastric cancer in a late-stage trial. The partners hope this data will help make tislelizumab the first-line therapy for patients with advanced forms of gastric cancer. While Novartis’ stock went up 11 percent, BeiGene’s stock gained 17 percent in April.Though J&J’s Q1 results exceeded analyst expectations, the drugmaker lowered the 2023 guidance for its pharmaceutical business. Leaked data from a phase 3 trial showed that J&J and Legend’s cancer drug Carvykti performed better-than-expected in patients with multiple myeloma. J&J’s stock went up 4 percent. Legend’s stock rose 46 percent.Among small cap companies, Madrigal’s stock rose 24 percent in April on news of a breakthrough therapy designation for its drug Resmetirom as a treatment for nonalcoholic steatohepatitis.Access the Pipeline Prospector Dashboard for April 2023 Newsmakers (Free Excel)Merck acquires Prometheus for US$ 10.8 bn; Astellas buys Iveric Bio for US$ 5.9 bnApril proved to be a good month for both Merck and AstraZeneca, even though the two drugmakers reported a drop in their Q1 revenues due to decreased sales of their Covid-19 products.While Merck reported a 9 percent drop in Q1 sales (at US$ 14.5 billion), with sales of its Covid-19 antiviral pill Lagevrio (molnupiravir) dropping 88 percent, Astra reported a 4 percent decrease in revenue (at US$ 10.88 billion) in Q1. Stocks of both drugmakers rose by 6 percent.In early April, FDA had granted accelerated approval to Merck’s Keytruda in combination with Seagen and Astellas Pharma’s Padcev as a first-line treatment for adults with locally advanced or metastatic urothelial carcinoma. Later in the month, Merck announced it is acquiring San Diego-based biotech Prometheus Biosciences for US$ 10.8 billion to strengthen its immunology pipeline. Prometheus’ stock skyrocketed 76 percent on the news.A combination of AstraZeneca's cancer drugs — Imfinzi and Lynparza — met its main goal in a late-stage trial for patients with advanced epithelial ovarian cancer. Additionally, Astra’s Ultomiris also received a positive recommendation from the European Medicines Agency (EMA) for adult patients with neuromyelitis optica spectrum disorder.Japanese drugmaker Astellas Pharma announced its biggest deal last month when it acquired New Jersey-based eye drug developer Iveric Bio for US$ 5.9 billion, taking its stock up 9 percent. The deal will give Astellas access to Iveric Bio’s ophthalmology treatments, including its lead drug candidate for geographic atrophy — Zimura. Iveric Bio’s stock gained 22 percent.Access the Pipeline Prospector Dashboard for April 2023 Newsmakers (Free Excel)Disappointing Q1 sales drag AbbVie, BMS stocks downBoth AbbVie and Bristol Myers Squibb reported a drop in Q1 sales. AbbVie was hit due to weaker-than-expected performance of its blockbuster drugs Skyrizi and Rinvoq and dwindling sales of Humira (which experienced a sales drop of 25.2 percent in the face of biosimilar competition in the US). Its Q1 sales fell by 9.7 percent to US$ 12.25 billion, and its stock was down 6 percent. In positive news, FDA expanded the approval of AbbVie’s Qulipta as a preventive treatment for chronic migraine in adults. Rinvoq also received an add-on authorization in the EU as a treatment for moderate-to-severe active Crohn’s disease.BMS’ Q1 sales dropped 3 percent to US$ 11.3 billion, primarily due to an erosion in Revlimid’s sales in the face of competition from generic drugs. Revlimid’s revenues fell by 37 percent in Q1 compared to the same period last year. BMS’ stock experienced a 4 percent drop.Access the Pipeline Prospector Dashboard for April 2023 Newsmakers (Free Excel)Our viewThe collapse of three US banks over the last three months has dealt a blow to the US economy. Globally, the business scenario hasn’t improved much, with inflation, high interest rates, ongoing Russia-Ukraine war, supply chain kinks and other uncertainties continuing to pose challenges.If the biotech indices are able to hold up in these difficult times, it is an indication of strength and resilience within the sector.Access the Pipeline Prospector Dashboard for April 2023 Newsmakers (Free Excel)

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11 May 2023

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Pipeline Prospector Feb 2023: Low demand for Covid drugs hammers down Lilly, Moderna stocks

The year had opened on a buoyant note. But February quickly dashed any hopes of a market rebound and reinforced that volatility isn’t going anywhere in a hurry.After beginning the year on a positive note, biotech indices dipped in February. The Nasdaq Biotechnology Index (NBI) was down 6.3 percent (at US$ 4,075), the S&P Biotechnology Select Industry Index (SPSIBI) fell 7 percent to US$ 6,451 and the SPDR S&P Biotech ETF (XBI) dropped 7.7 percent to US$ 82.85. In January, NBI was up 4.4 percent, SPSIBI had increased by 8.7 percent, while XBI had risen by 9 percent.Many drugmakers announced their 2022 results last month. Several mega cap drugmakers, such as Eli Lilly, Johnson & Johnson and Pfizer saw their stocks get hammered for a straight second month. February didn’t witness any significant deal or buyout.Access the Pipeline Prospector Dashboard for February 2023 Newsmakers (Free Excel)Low demand for Covid drugs impacts Lilly, J&J; Moderna, Roche issue lower guidanceIn our last month’s report, we had carried news about Lilly and J&J posting lower revenues due to a drop in sales of their Covid-19 treatments. Not only did Lilly’s Q4 revenues decrease, its diabetes drug Mounjaro also failed to live up to investors’ expectations. All this news resulted in a 9 percent drop in Lilly’s stock.It was a tough month for J&J (-7 percent drop in stock) as well, whose Q4 revenues declined by 4 percent to US$ 23.7 billion and its Covid-19 vaccine experienced a 57 percent drop in sales. J&J’s autoimmune disease drug Remicade saw a 37 percent drop in sales due to competition from biosimilars. And, after a court rejected J&J’s two-step bankruptcy strategy for its talcum powder lawsuits, the US Supreme Court rejected the drugmaker’s appeal against a US$ 302 million verdict in a lawsuit filed by the state of California, accusing J&J of hiding the dangers associated with its pelvic mesh devices. Though Roche (-5 percent) posted a 2 percent increase in 2022 sales (at US$ 67.6 billion/CHF 63.3 billion), its guidance for 2023 cautions of a US$ 5.5 billion sales drop due to its Covid-19 therapy and diagnostic kits. Gilead (-5 percent) failed to register any growth in its 2022 revenues largely due to a 30 percent drop in sales of its Covid-19 treatment Veklury.Moderna (-20 percent) said it expects the annual sales of its Covid-19 vaccine to be around US$ 5 billion in 2023 – less than a third of the US$ 18.4 billion it had hauled in 2022 – due to falling demand for its vaccine. Its messenger RNA-based influenza vaccine demonstrated a strong immune response against A strains of the flu, but proved less effective against the less common influenza B strain.Access the Pipeline Prospector Dashboard for February 2023 Newsmakers (Free Excel)Astra posts 19% rise in 2022 revenues, Keytruda pushes up sales for MerckBolstered by a rise in the sales of its immunology, neuroscience and aesthetics treatments, AbbVie’s 2022 revenue grew by 3.3 percent to US$ 58 billion. Its stock rose 5 percent in February.AstraZeneca reported 2022 revenue of US$ 44.35 billion, a growth of 19 percent over 2021. Cancer treatments accounted for 35 percent of its business, with its blockbuster drugs Lynparza, Tagrisso, Imfinzi and Farxiga registering significant sales growth. Astra plans to deliver at least 15 new medicines this decade and initiate at least 30 new late-stage clinical trials this year. Astra's stock went up 3%.Buoyed by the sales of diabetes and obesity drugs, which brought in US$ 22.8 billion (DKK 156.4 billion), Novo Nordisk’s 2022 sales reached US$ 25.3 billion (DKK 177 billion), a growth of 26 percent year-over-year. Novo’s stock was up 2 percent.Merck (2 percent) reported an increase of 22 percent in 2022 sales, reaching US$ 59.3 billion. This growth was mainly driven by its blockbuster cancer drug Keytruda and human papillomavirus (HPV) vaccine Gardasil. The drugmaker continued to experiment with Keytruda across different types of cancer, achieving success in two trials while experiencing setbacks in two others. Meanwhile, Merck said it expects sales of its Covid-19 pill Lagevrio (molnupiravir) to decline from US$ 5.7 billion in 2022 to just around US$ 1 billion in 2023.Access the Pipeline Prospector Dashboard for February 2023 Newsmakers (Free Excel) Seagen gains on buyout report; GSK kept quiet about Zantac’s cancer risksSeagen’s stock surged by 30 percent last month. The cancer treatment specialist announced positive full-year results, with its revenue growing by 25 percent in 2022 due to an increase in sales of its antibody-drug conjugates. The Wall Street Journal reported that Pfizer was in early-stage talks to buy Seagen for over US$ 30 billion.Pfizer’s stock continued to slide. After registering a drop of 14 percent in January, Pfizer’s stock lost 7 percent in February. The drugmaker and its French partner Valneva decided to discontinue half of the total number of recruited participants in the US in a phase 3 trial of their experimental Lyme disease vaccine due to violations of clinical trial regulations by a third-party contractor.GSK’s stock dropped 3 percent in February. A damning report brought out by Bloomberg said GSK’s scientists knew for decades about the cancer risks associated with its popular heartburn drug Zantac (ranitidine), but the drugmaker chose to keep quiet about them.In positive news, an external panel of experts supported both Pfizer and GSK’s respiratory syncytial virus (RSV) vaccines. The US Food and Drug Administration granted full approval to GSK’s Jemperli (dostarlimab) in endometrial cancer. Moreover, the agency’s panel of external advisors backed GSK’s proposed single-arm trials to gain accelerated approval of Jemperli in rectal cancer.Access the Pipeline Prospector Dashboard for February 2023 Newsmakers (Free Excel) Apellis’ geographic atrophy drug bags FDA nod; FTC scrutinizes Amgen-Horizon dealSanofi (-4 percent) decided to halt a late-stage clinical trial of its oral drug for myasthenia gravis – tolebrutinib – that it had acquired through its US$ 3.7 billion takeover of Principia Biopharma. Despite its 2022 revenues growing by 7 percent to US$ 47.1 billion (€43 billion), Sanofi fell short of meeting market expectations. In a positive update, FDA approved Sanofi’s Altuviiio to prevent and treat bleeding episodes in people with hemophilia A. The Federal Trade Commission has issued a second request for information regarding Amgen’s US$ 28.3 billion acquisition of Horizon Therapeutics. Amgen’s stock dropped 6 percent. And in a setback to Jazz Pharmaceuticals, a US appeals court has upheld an injunction that states a patent related to the drugmaker’s narcolepsy drug should be removed from FDA’s Orange Book. Jazz’s stock lost 11 percent in February.Among mid- to small-cap companies, Apellis Pharmaceuticals’ drug Syfovre (pegcetacoplan) has been approved by FDA as the first-ever treatment for geographic atrophy, a major cause of blindness. Apellis’ stock went up 20 percent in February. And Ambrx Biopharma’s stock shot up 200 percent after it posted encouraging initial data from an ongoing phase 1 trial of its experimental prostate cancer drug.Access the Pipeline Prospector Dashboard for February 2023 Newsmakers (Free Excel) Our viewThe drop in sales of Covid drugs is contributing to a negative outlook around financial performance of some large drug companies. With the pandemic receding, this was bound to happen. Even though January raised hopes of market watchers, February has proven that we truly live in a VUCA (short for volatility, uncertainties, complexity and ambiguity) world.Access the Pipeline Prospector Dashboard for February 2023 Newsmakers (Free Excel)

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09 Mar 2023

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Pipeline Prospector Dec 2022: Biotech indices fall on close of a volatile year

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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12 Jan 2023

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