Market Place
Pharma indices have rebounded after ending March and April in the red. May saw the Nasdaq Biotechnology Index (NBI) spike 5.6 percent from 4,168.63 to 4,401.1 and the SPDR S&P Biotech ETF (XBI) index rise 5.1 percent from 84.82 to 89.13. The S&P Biotechnology Select Industry Index (SPSIBI) saw a 5.3 percent gain to 6,930.67 from 6,584.4 at the end of April.The month didn’t see very many approvals from the US Food and Drug Administration (FDA). But what May lacked in approvals, it made up in acquisitions, deals, and trial news. Among the noteworthy approvals were Amgen’s (stock up 9 percent) Imdelltra, which won FDA’s accelerated approval to treat adults in
the advanced stages of small cell lung cancer
(SCLC). The agency okayed Tris Pharma’s Onyda XR, a once-a-day treatment for attention
deficit hyperactivity disorder (ADHD) for patients six years and older. This makes it the first
liquid non-stimulant ADHD drug approved in the US.Bristol Myers Squibb’s Breyanzi saw two FDA approvals in May. The agency first expanded its use to treat adults with a
type of blood cancer known as follicular lymphoma. FDA then okayed it to treat
relapsed or refractory mantle cell lymphoma. With
five approvals, Breyanzi is the only CAR T cell therapy approved in the US for
four distinct subtypes of non-Hodgkin lymphoma, bringing this personalized
therapy to the broadest array of patients with B-cell malignancies. And FDA
approved Moderna’s (stock up 39 percent) mRESVIA, an mRNA respiratory syncytial virus (RSV) vaccine,
to protect adults aged 60 years and older from lower respiratory tract disease
caused by RSV infection.Access the Pipeline Prospector Dashboard for May 2024 Newsmakers (Free Excel)J&J pays US$ 2.1 bn for eczema drug assets; Merck to buy EyeBio for up to US$ 3 bnSeeking to address the significant need in atopic dermatitis
(eczema), J&J spent US$ 2.1 billion on bispecific
antibody candidates. This included acquiring Proteologix for US$ 850 million and rights to Numab Therapeutics' NM26 for US$ 1.25 billion. NM26 is a promising phase 2-ready treatment. Bolstering its ophthalmology portfolio, Merck is acquiring EyeBio for up to US$ 3 billion. The deal includes an upfront
payment of US$ 1.3 billion and grants Merck access to EyeBio's lead candidate, Restoret, for diabetic macular edema and neovascular age-related macular degeneration.In a US$ 1.8 billion deal (including US$ 1.15 billion upfront), Biogen acquired Human Immunology Biosciences (HI-Bio) to gain access to felzartamab, a potential cure for various immune-mediated
diseases. Expanding its oncology portfolio, Novartis acquired Mariana Oncology for US$ 1 billion upfront and US $750 million in milestone payments. Mariana
focuses on developing novel radioligand therapies to treat cancers with high
unmet needs. Aiming to become a major player in the pharmaceutical industry,
Japanese conglomerate Asahi Kasei offered US$ 1.1 billion to acquire Swedish drugmaker Calliditas Therapeutics.Access the Pipeline Prospector Dashboard for May 2024 Newsmakers (Free Excel) Sanofi bails out Novavax with US$ 1.2 bn deal; Takeda nabs option to license Alzheimer’s therapiesNovavax has received a timely shot in the arm, as Sanofi will pay the former up to US$ 1.2 billion in exchange for a license to commercialize its
existing Covid vaccine and develop a combo jab to protect against Covid and influenza. The struggling Maryland biotech’s management, or lack thereof, had come under fire from
investors. Sanofi also gets a minority 4.9 percent stake in Novavax. Following
this, Novavax raised its 2024 revenue guidance from between US$ 800 million and US$ 1 billion to between US$ 970 million and US$ 1.17 billion. Novavax’s stock rocketed 200 percent in May.Japanese pharmaceutical giant Takeda made two significant moves. After an
upfront payment of US$ 100 million, Takeda now has the exclusive option to secure global rights to AC Immune's Alzheimer's vaccine and
immunotherapies targeting amyloid beta for another US$ 2.1 billion. Additionally, Takeda partnered with Shanghai-based Degron Therapeutics in a deal valued at up to US$1.2
billion. This collaboration focuses on discovering and
developing novel cancer, neurological, and inflammatory drugs using a promising new approach called "molecular
glue degraders."Access the Pipeline Prospector Dashboard for May 2024 Newsmakers (Free Excel) Novo scores late-stage wins in hemophilia, kidney disease; Lilly’s weekly insulin proves to be as effective as daily dosesNovo Nordisk’s Mim8 has hit its primary endpoint in a late-stage trial to treat people with hemophilia A.
This paves the way for filing for approval later this year and competing with Roche’s blockbuster Hemlibra. Meanwhile, Ozempic lowered the risk of death in type 2
diabetes patients with chronic kidney disease. A late-stage trial with 3,533
people showed weekly semaglutide injections reduced kidney failure and death
due to kidney complications by 24 percent.However, Novo did suffer a setback this month. FDA’s advisory panel voted seven to four that the benefits of Novo’s once-weekly insulin, Awiqli, do not outweigh its risks. The Danish drugmaker is in a race with Lilly to bring to market weekly injections
with long-acting insulins, which would lower the treatment burden for diabetes
patients. An increased risk of low blood sugar was flagged by the advisors in
patients with type 1 diabetes. Novo's sales increased 24 percent to DKK 65.3 billion (US$ 9.4 billion) in the first quarter of 2024.Eli Lilly’s once-weekly insulin jab, efsitora,
showed blood sugar reduction consistent with the daily insulins widely used today by patients with type 2
diabetes. Efsitora met its primary endpoints in two phase 3 trials. The Indiana
drugmaker said it is investing an additional US$ 5.3 billion at its Lebanon (Indiana, US)
manufacturing site to boost the supply of Zepbound and Mounjaro.Access the Pipeline Prospector Dashboard for May 2024 Newsmakers (Free Excel) Novartis tees up two rare kidney disease therapy approvals; Bayer’s menopause drug reduces hot flashes Novartis touted two promising late-stage readouts
for rare kidney disease treatments as it tees up two potential approvals in the renal therapy space. The Swiss drugmaker’s experimental drug, atrasentan, reduced proteinuria (elevated
protein in the urine) by 36.1 percent in IgA nephropathy patients. Fabhalta achieved a 35.1 percent proteinuria reduction in patients
with the ultra-rare kidney disease C3 glomerulopathy (C3G). C3G currently has
no approved therapies.Bayer said its non-hormonal drug, elinzanetant, significantly
reduced debilitating bursts of body heat (hot flashes) associated with
menopause. This tees it up to become only the second non-hormonal drug to do so
after Astellas’ Veozah.Access the Pipeline Prospector Dashboard for May 2024 Newsmakers (Free Excel) Our viewFor long, mental health
researchers have been captivated by psychoactive ingredients found in cannabis
and LSD. However, advocates suffered a setback in early June when an FDA
advisory panel voted against the first MDMA treatment for post-traumatic
stress disorder (PTSD). Still, June kicked off with the American Society of Clinical
Oncology (ASCO) annual meeting in Chicago, which saw tons of developments in
treating cancers. It is shaping up to be an interesting month with over a dozen
Prescription Drug User Fee Act (PDUFA) dates including for two drugs to treat chronic obstructive pulmonary disease (COPD) – Dupixent and ensifentrine.Access the Pipeline Prospector Dashboard for May 2024 Newsmakers (Free Excel)
Impressions: 1637
https://www.pharmacompass.com/pipeline-prospector-blog/j-j-inks-two-deals-totaling-us-2-1-bn-for-eczema-drugs-novo-scores-late-stage-wins-in-hemophilia-kidney-disease
#PipelineProspector by PharmaCompass
06 Jun 2024
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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: 1554
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
