Market Place
March was clearly a month of drug approvals, as the US Food and
Drug Administration (FDA) went on an overdrive, green-lighting several
therapies before the close of the first quarter (Q1 2024). Amongst them was the
first drug to treat non-alcoholic steatohepatitis (NASH) and a breakthrough
therapy that treats pulmonary arterial hypertension (PAH).However, the buoyancy in drug approvals didn’t play out in the stock markets and most pharma indices witnessed a marginal dip. The Nasdaq Biotechnology index (NBI) fell marginally (-0.43 percent) to 4,429.97 from 4,449. The SPDR S&P Biotech ETF index (XBI) dropped 4.6 percent to 94.89 after ending February at 99.44. And the S&P Biotechnology Select Industry index (SPSIBI) was down by 3.4 percent from 7,662.14 to 7,402.47 in March.In deals, AstraZeneca bought two companies, shoring up its cancer and rare disease pipelines. The Anglo-Swedish drugmaker first bought France’s Amolyt, which focuses on rare
endocrine diseases, for a total of US$ 1.05 billion and then acquired
next-generation cancer drugmaker Fusion Pharmaceuticals for around US$ 2 billion. AstraZeneca’s stock was up 4.6 percent in
March. Novo Nordisk (stock up 4.8 percent)
agreed to acquire Cardior Pharmaceuticals for up to US$ 1.1 billion in order to boost its
pipeline for cardiovascular diseases.Access the Pipeline Prospector Dashboard for March 2024 Newsmakers (Free Excel)FDA okays first drug for
NASH; Wegovy approved as med to reduce heart risksFor quite some time, the drug development field for the liver
condition non-alcoholic steatohepatitis (NASH) has been a graveyard for failed
programs. In March, the field celebrated a hurrah moment when Madrigal Pharmaceuticals (stock up 6 percent) won the race to have the first NASH treatment approved by the FDA. Madrigal’s oral drug Rezdiffra (resmetirom) treats adults with NASH, a
disease that causes histologic liver damage and occurs in patients who are not
alcoholics and are often obese or have type 2 diabetes. The approval has opened
a multi-billion dollar opportunity for Madrigal.The GLP-1 agonist drugs that are used to treat diabetes and
obesity have shown heart-related benefits too in clinical trials. Last month, FDA approved Novo Nordisk’s Wegovy (semaglutide) to reduce the risk of cardiovascular
death, heart attack, and stroke in obese or overweight adults with
cardiovascular disease (CVD). The move makes Wegovy the first weight-loss medication that is
also approved to help prevent
life-threatening cardiovascular events. The approval was hailed as a major advancement in public health.Another significant FDA approval was granted to Akebia’s anemia drug, vadadustat. After being turned down in March 2022, Akebia has
now been approved to treat anemia caused by chronic kidney disease (CKD)
in dialysis patients.Access the Pipeline Prospector Dashboard for March 2024 Newsmakers (Free Excel) FDA okays two meds for PAH; Italfarmaco’s Duvyzat approved for DMDFDA approved a breakthrough therapy
from Merck, known as Winrevair (sotatercept-csrk), to treat adults with hypertension that is
caused by constriction of the arteries in the
lungs, known as pulmonary arterial hypertension (PAH). The agency also approved Johnson & Johnson’s Opsynvi – a single-tablet combination of macitentan and tadalafil – for the chronic treatment of adults with PAH.
With this approval, Opsynvi became the only once-daily
combination therapy for PAH.Apart from PAH, there was another significant approval for
hypertension. FDA okayed Idorsia’s once-daily treatment
Tryvio (aprocitentan) in combination with other antihypertensive drugs, to lower blood pressure in adult patients who are not able to adequately control their BP on other drugs. Idorsia’s stock was up 50 percent in March.
Tryvio is the first oral anti-hypertensive therapy, which works via a new
therapeutic pathway, to be approved in almost 40 years.The US agency also approved Italfarmaco Group’s oral medication Duvyzat (givinostat) for the treatment of
Duchenne muscular dystrophy (DMD) in patients six years of age and older.
Duvyzat is the first nonsteroidal drug approved to treat patients with all variants of DMD, a genetic disorder characterized by progressive muscle degeneration.Orchard Therapeutics’ Lenmeldy was also greenlit by the FDA as the first gene therapy in the US for a
debilitating and rare pediatric disorder, known as metachromatic
leukodystrophy (MLD).Access the Pipeline Prospector Dashboard for March 2024 Newsmakers (Free Excel) Breyanzi okayed for complex
leukemia; Tevimbra approved for esophageal cancerAmong cancer treatments, FDA granted an accelerated approval
to BMS’ Breyanzi, making it
the first and only CAR-T cell
therapy for adults with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). BMS’ stock was up 6 percent in
March.BeiGene’s PD-1 blocker Tevimbra (tislelizumab) finally got the go ahead from the FDA
as a treatment for adult patients with
unresectable or metastatic esophageal squamous cell carcinoma (ESCC) after
prior systemic chemotherapy that did not include a PD-(L)1 inhibitor.FDA also granted accelerated
approval to Takeda’s Iclusig (ponatinib) to be used with
chemotherapy for newly diagnosed patients with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL), a type of blood cancer of the bone marrow and blood.Access the Pipeline Prospector Dashboard for March 2024 Newsmakers (Free Excel) Pfizer-Takeda’s Adcetris posts trial win in DLBCL; FDA defers donanemab approvalIn clinical trials, there was some positive news from a phase 3
trial on Pfizer and Takeda’s drug Adcetris, which is known as a
standard of care in classical Hodgkin lymphoma. The med has now shown to be efficacious in diffuse large B-cell lymphoma (DLBCL), a common type of non-Hodgkin lymphoma, when used in combination with two other drugs — lenalidomide and rituximab.In a late-stage trial, Novo Nordisk’s broadly used blockbuster diabetes
drug Ozempic (semaglutide) slashed the risk of kidney disease
progression and death from cardiovascular or kidney complications by 24 percent in diabetic patients with CKD. In negative news from the trials, the much anticipated approval of Eli Lilly’s donanemab scheduled for March was deferred
as FDA opted to convene a panel of independent experts to assess the drug’s safety and efficacy. Similarly, Amylyx’s Relyvrio (sodium phenylbutyrate and taurursodiol), a promising investigational treatment for amyotrophic lateral sclerosis (ALS), or Lou Gehrig’s disease, failed to demonstrate it works better than a placebo in a 48-week long trial. ALS is a fatal motor neuron disease characterized by progressive degeneration of nerve cells.Access the Pipeline Prospector Dashboard for March 2024 Newsmakers (Free Excel) Our viewWith so many drug approvals, March was a good month for the biopharma industry. While it may look like the markets didn’t cheer the approvals, all the three indices — the NBI, XBI, and SPSIBI — ended the quarter in the green, growing 2.1 percent, 7.3 percent, and 6.4 percent, respectively, between January 2 and March 28. As we enter the second quarter of 2024,
we hope the buoyancy in drug approvals and the indices is maintained.Access the Pipeline Prospector Dashboard for March 2024 Newsmakers (Free Excel)
Impressions: 1812
https://www.pharmacompass.com/pipeline-prospector-blog/march-sees-approvals-of-pathbreaking-nash-drug-from-madrigal-two-meds-for-pah
#PipelineProspector by PharmaCompass
04 Apr 2024
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October was a gloomy month that saw Palestinian militant group Hamas attack Israel in the first week, resulting in the killing of hundreds of innocent people. Israel retaliated, formally declaring a war on Hamas. Another raging war, after the ongoing Russia-Ukraine conflict, doesn’t augur well for the planet, let alone humanity, economies and industries.The pharma indices reacted to the bloodshed, as also to the disappointing third quarter (Q3) results posted by some drugmakers. The Nasdaq Biotechnology Index (NBI) was down 8 percent, at US$ 3,637.05 while the SPDR S&P Biotech ETF (XBI) was down 12 percent, at US$ 64.12, and the S&P Biotechnology Select Industry Index (SPSIBI) was down by 9 percent, at US$ 4,991.31.On the upside,
the month saw several large deals. The biggest deal of the month was Roche’s acquisition of Telavant from Roivant for US$ 7.1 billion. BMS announced the acquisition of Mirati Therapeutics for US$ 4.8 billion. Through this acquisition, BMS will gain
access to the US Food and Drug Administration (FDA) approved lung cancer drug
Krazati (adagrasib). And Eli Lilly expanded its oncology capabilities by
acquiring Point Biopharma for US$ 1.4 billion.Access the Pipeline Prospector Dashboard for October 2023 Newsmakers (Free Excel)Sanofi, Takeda cut 2023 profit forecasts;
AbbVie, BMS post drop in Q3 salesSeveral
drugmakers announced their Q3 2023 results last month. Sanofi (stock down by 15 percent in October) reported a 4.1 percent drop in Q3 sales, at €11.9 billion (US$ 12.5 billion). What was worse, the French drugmaker lost €20 billion (US$ 21 billion) in market capitalization soon after announcing these results as it had abandoned its 2025 profit target of 32 percent. Instead of chasing
the lofty target, Sanofi has decided to focus on “long-term profitability”, and increase spending on immunology and inflammation drug development. Sales of Sanofi’s multiple sclerosis drug Aubagio dropped by a whopping 60.5 percent to €199 million (US$ 210.2 million) primarily due to competition from generics in the US market. Takeda (down by 7 percent) slashed its
full-year profit forecast by 36 percent to 225 billion yen (US$
1.5 billion) as it contends with disappointments in its development pipeline
and the loss of patent protection in key products.BMS (down by 10
percent) reported Q3 revenue of US$ 11
billion,
a 2 percent decrease from the same quarter last year, mainly due to 41 percent
decline in sales of its cancer drug Revlimid.AbbVie (down by 5 percent) reported Q3 net revenues of US$ 13.92 billion, marking a 6
percent decrease over Q3 2022. This drop is attributed in part to the launch of
Humira biosimilars, which have caused a 36.2 percent reduction in the immunology drug’s net revenues. Additionally, AbbVie’s blood cancer drug Imbruvica’s net revenues have dropped by 20 percent.Access the Pipeline Prospector Dashboard for October 2023 Newsmakers (Free Excel) Low Covid sales hit Pfizer, BioNTech, Roche stocks; Pfizer’s Q3 sales dip by 42%Pfizer (down by 9 percent) saw a 42 percent decline in its
Q3 revenues — at US$ 13.23 billion — primarily due to lower sales of its Covid products. While sales of its mRNA vaccine Comirnaty fell by 70 percent (at US$ 1.3 billion), its Covid drug Paxlovid saw a 97 percent drop in sales over Q3 2022.Pfizer has significantly reduced its full-year revenue forecast and
also plans to save US$ 3.5 billion through job cuts and cost reductions. Its
partner for Comirnaty, BioNTech, is yet to announce its Q3 results, but
its stock fell by 13 percent during October.Roche’s Q3 sales also slipped by 3 percent to CHF
14.3 billion (US$ 15.9 billion) owing to a slump in Covid sales. The Swiss drugmaker has predicted a decline in 2023 sales of Covid products at about CHF 4.5 billion (US$ 4.99 billion). Its previous estimate was CHF 5 billion (US$ 5.5 billion). Roche’s stock was down by 6 percent last month.Access the Pipeline Prospector Dashboard for October 2023 Newsmakers (Free Excel) Merck, Novo raise 2023 guidance; Ozempic,
Wegovy boost Novo salesAmong the gainers
were mega-cap drugmakers Merck (stock up by 1 percent in October) and Novo Nordisk (up by 4 percent). Merck has reported
higher-than-expected third-quarter results on strong demand for its
Covid-19 treatment, Lagevrio (molnupiravir), cancer med Keytruda and HPV vaccine Gardasil. As a result,
Merck has revised its 2023 sales upwards, in the range of US$ 59.7 billion to
US$ 60.2 billion (from US$ 58.6 billion to US$ 59.6 billion).Novo Nordisk’s popular diabetes med Ozempic and weight loss med Wegovy are boosting the company’s sales.
Ergo, the company expects full-year sales to grow between 32 and 38 percent at
constant exchange rates. Moreover, Novo has acquired ocedurenone, a drug in late-stage trial, from KBP Biosciences for up to US$ 1.3 billion. Ocedurenone is an oral treatment for
uncontrolled hypertension with potential applications in cardiovascular and
kidney disease.Access the Pipeline Prospector Dashboard for October 2023 Newsmakers (Free Excel) Astra, Ventyx stocks hit by disappointing
trial data; Lilly, Vertex post gainsAstraZeneca’s stock was hit by disappointing
results from a late-stage trial of its experimental lung cancer drug — datopotamab deruxtecan. Astra’s stock was down by 6 percent in October and its partner in developing the drug, Daiichi Sankyo’s stock fell by 4 percent.Similarly, Ventyx Biosciences (down by 56 percent) announced positive results from a phase 2 trial in patients with moderate-to-severely active ulcerative colitis, but investors were unimpressed due to doubts about whether the candidate has an edge over rival Pfizer’s etrasimod and BMS’ Zeposia. Akero Therapeutics’ (down by 76 percent) nonalcoholic steatohepatitis (NASH) candidate, efruxifermin, failed mid-stage trial as it didn’t show any significant benefit for patients with cirrhosis caused by NASH, the most advanced and life-threatening stage of the fatty liver disease. Similarly, Sarepta Therapeutics’ treatment for Duchenne muscular dystrophy (a muscle-wasting disease) — Elevidys — failed a phase 3 study, taking its stock down by 44 percent in
October.In a positive
clinical trial news, Lilly’s Crohn’s disease experimental drug mirikizumab met the main goals of a phase 3
study.
Similarly, Vertex (up by 4 percent) posted encouraging positive clinical trial
results
of VX-880 to treat type 1 diabetes.Meanwhile, FDA issued a complete
response letter (CRL) to Alnylam Pharmaceuticals’ siRNA therapy Onpattro (patisiran) for the treatment of cardiomyopathy of transthyretin-mediated amyloidosis. It stated that Alnylam (down by 15 percent) has not provided enough evidence of the therapy’s benefit in the proposed indication.Access the Pipeline Prospector Dashboard for October 2023 Newsmakers (Free Excel) Our viewThe biopharma
industry is eagerly awaiting the approval of several experimental drugs
in Q4 2023, including Italfarmaco’s givinostat for Duchenne muscular dystrophy (DMD),
and Valneva’s single-shot chikungunya vaccine VLA1553.We are already seeing the market inch upwards. Let’s hope the exciting pipeline and new drug approvals are able to pull pharma indices out of the doldrums.Access the Pipeline Prospector Dashboard for October 2023 Newsmakers (Free Excel)
Impressions: 2173
https://www.pharmacompass.com/pipeline-prospector-blog/disappointing-q3-results-attacks-on-israel-gaza-drag-pharma-indices-down-further
#PipelineProspector by PharmaCompass
02 Nov 2023
