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Pharma indices had begun to recede in March. Their red streak accelerated in April with the Nasdaq Biotechnology Index (NBI) falling 6 percent from 4429.97 in March to 4162.33 last month and the SPDR S&P Biotech ETF (XBI) index tripping 10 percent from 94.34 to 84.62. Similarly, the S&P Biotechnology Select Industry Index (SPSIBI) was down 11 percent from 7402.50 to 6584.40 in April.This
muted performance was also reflected in the first quarter (Q1) results. Biogen, Biomarin, Roche, Gilead, Merck, Sanofi, BMS and Johnson & Johnson announced their Q1 results in April.
While Roche and Biogen reported a drop in revenues, BMS posted a loss in Q1, even though its revenues increased. And
Sanofi reported a 14.7 percent drop in operating income due to competition from generics and currency fluctuations.
BioMarin, Gilead and Merck reported a 9 percent, 5 percent and 9 percent increase, respectively, in their Q1 revenues over Q1 2023.There were a handful of deals announced last month, the biggest
being Vertex Pharmaceuticals’ acquisition of Alpine Immune Sciences for US$ 4.9 billion. The deal gives Vertex access to Alpine’s protein-based immunotherapies for autoimmune diseases.Japanese drugmaker Ono Pharmaceutical agreed to acquire Massachusetts-based Deciphera Pharmaceuticals for US$ 2.4 billion. The acquisition gives Ono
access to Deciphera's oncology pipeline. Denmark’s Genmab agreed to acquire
privately-owned ProfoundBio for US$ 1.8 billion. ProfoundBio has three next-generation antibody drug conjugate
(ADC) candidates in its pipeline that will now go to Genmab.Access the Pipeline Prospector Dashboard for April 2024 Newsmakers (Free Excel)FDA okays ImmunityBio’s Anktiva, Day One’s Ojemda for bladder, brain cancerLike March, April too saw several significant drug approvals,
especially in oncology. ImmunityBio (its stock was up 50 percent
in April) won its first US Food and Drug Administration (FDA) approval as
the agency greenlit Anktiva as part of a combination therapy to treat a type of bladder cancer. With this
approval, Anktiva will compete with Merck’s Keytruda.AstraZeneca (stock up 12 percent)
and Daiichi Sankyo’s Enhertu has been granted accelerated
approval in the US to treat adult patients with
HER2-positive solid tumors that have spread or cannot be surgically removed. These patients
have undergone prior treatment and have no satisfactory alternatives available to them. J&J and Legend’s Carvykti has become
the first and only BCMA-targeted
therapy approved by the FDA for patients with relapsed or refractory
multiple myeloma, who have received just one prior line of treatment. The approval is an important milestone in J&J’s plans to make Carvykti a US$ 5 billion-plus asset at peak yearly
sales.Day One Biopharmaceuticals’ Ojemda has been granted FDA’s accelerated approval to treat certain types
of pediatric brain cancer. The pan-RAF kinase inhibitor has been
okayed for patients six months of age and
older with relapsed or refractory pediatric low-grade glioma (LGG)
harboring a BRAF fusion or rearrangement, or BRAF V600 mutation. This is the first FDA approval of a systemic therapy for treating what is the most common form of childhood brain tumor.Access the Pipeline Prospector Dashboard for April 2024 Newsmakers (Free Excel) Basilea’s antibiotic bags FDA nod; Vanda’s Fanapt approved for bipolar disorderThe agency also approved Vanda Pharmaceuticals’ (stock up 25 percent) Fanapt tablets for treating manic
or mixed episodes associated with bipolar-1 disorder in adults.
The atypical antipsychotic agent has been used for the treatment of
patients with schizophrenia since its FDA approval in 2009. This second
approval for bipolar-1 disorder patients (who experience manic episodes that
last at least seven days) could help revive Fanapt prescriptions.FDA has also approved Basilea Pharmaceutica’s Zevtera, an antibiotic for bacterial
infections including multidrug-resistant strains. The US agency has okayed it
for three conditions – treatment of adults with Staphylococcus aureus bacteremia, including those with right-sided infective endocarditis; adults with acute bacterial skin and skin structure infections; and adult and pediatric patients with community-acquired bacterial pneumonia.Access the Pipeline Prospector Dashboard for April 2024 Newsmakers (Free Excel) BMS’ schizo drug shows benefit sans weight gain; Imfinzi scores in lung cancer trialA common side effect associated with anti-psychotics is weight
gain. However, interim results from a late-stage trial
have shown that BMS’ schizophrenia drug KarXT continued to improve symptoms of the severe mental disease even at 52 weeks, and without weight gain.In another phase 3 trial, Imfinzi significantly improved overall survival and progression-free survival in
patients with limited-stage small cell lung cancer. This makes this blockbuster drug the first and only
immunotherapy to demonstrate survival benefit for this aggressive form of lung cancer. Imfinzi
had posted sales of US$ 4.24 billion in 2023.Intra-Cellular Therapies said a phase 3 study of its drug Caplyta in people with major
depressive disorder (MDD) met both its primary and key secondary endpoints.
Given once daily as an adjunctive therapy to antidepressants, Caplyta 42
mg significantly beat the
placebo at improving depression severity.Access the Pipeline Prospector Dashboard for April 2024 Newsmakers (Free Excel) Zepbound shows benefit in sleep disorder; Novartis’ Fabhalta reduces proteinuriaEli Lilly’s popular weight-loss
drug Zepbound cut irregular breathing episodes associated with a common sleep-related disorder – obstructive sleep apnea (OSA). Treatment with Zepbound reduced the frequency of irregular
breathing episodes by as much as 63 percent in adults with OSA and obesity across two late-stage trials. Lilly plans to submit the findings to FDA to expand Zepbound’s use for OSA. Roche’s Genentech said its drug Columvi,
in combination with
chemotherapy, demonstrated a statistically significant
improvement in overall survival for people with relapsed or
refractory diffuse large B-cell lymphoma (DLBCL). A late-stage study pitted the
Columvi-chemotherapy combination against a rituximab-chemotherapy combination in
patients who received at least one prior line of therapy and are not candidates
for autologous stem cell transplant. Patients in the Columvi group lived
longer.In another late-stage trial, Novartis' drug Fabhalta reduced proteinuria (protein in the urine) in patients with IgA nephropathy
by 38.3 percent. The Swiss drugmaker filed for FDA’s accelerated approval using the data, and the agency has granted it priority
review.Access the Pipeline Prospector Dashboard for April 2024 Newsmakers (Free Excel) Our viewAt
the start of 2024, the US market saw inflation falling and there were talks of
interest rate cuts by the Federal Reserve. But few months on, the outlook has darkened a bit with inflation refusing to let off steam and economic output slowing down in the US. This is getting reflected in the pharma indices and the Q1 results of several drugmakers. Though overall, we have faith in the pharma sector’s spirit of innovation and its zest for dealmaking. Despite the macroeconomic challenges, there is hope that the other three quarters of 2024 will look better.Access the Pipeline Prospector Dashboard for April 2024 Newsmakers (Free Excel)
Impressions: 1426
https://www.pharmacompass.com/pipeline-prospector-blog/pipeline-prospector-april-2024-indices-dip-amid-muted-q1-results-vertex-acquires-alpine-immune-for-us-4-9-bn
#PipelineProspector by PharmaCompass
09 May 2024
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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)
Impressions: 1883
https://www.pharmacompass.com/pipeline-prospector-blog/biotech-indices-inch-up-post-svb-bloodbath-covid-drugmakers-report-drop-in-q1-sales
#PipelineProspector by PharmaCompass
11 May 2023
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)
Impressions: 1571
https://www.pharmacompass.com/pipeline-prospector-blog/pipeline-prospector-dec-2022-biotech-indices-fall-on-close-of-a-volatile-year
#PipelineProspector by PharmaCompass
12 Jan 2023
