Market Place
This was a week when the US President Joe Biden ended his reelection bid, after giving America the Inflation Reduction Act that allows Medicare to negotiate drug prices. The week didn’t see major drug approvals in the US. But China approved Lilly’s tirzepatide, a month after okaying Novo Nordisk’s Wegovy. This approval in the world’s second largest pharmaceutical market has intensified rivalry in the weight loss market.The week also saw a slew of activity around drug
manufacturing. Agilent has agreed to buy the Canadian contract development and
manufacturing organization (CDMO) Biovectra for US$ 925 million. Novo Nordisk
has broken ground on a 200-acre site to construct a new production plant.
BeiGene has opened a flagship facility in New Jersey with biologics
manufacturing capabilities and Pfizer has cut the ribbon on a US$ 743 million
extension of an API plant in Singapore.In trials, Merck’s antibody-based injection hit its main goal of protecting infants from the respiratory syncytial virus (RSV) and GSK’s Dovato proved to be non-inferior to Gilead’s Biktarvy in a head-to-head matchup in treating HIV.In other news from trials, Pfizer’s gene therapy for hemophilia A significantly cut the number of annual bleeding episodes in patients with the rare disorder. And Sage and Biogen have decided to scrap trials on a drug that was being studied as a treatment for essential tremor, a nervous system condition.The European Commission (EC) has accepted CSL Vifor’s offer to address potential EU antitrust violations after it allegedly disparaged its Danish rival Pharmacosmos. And the US Food and Drug Administration (FDA) hit Indian drugmaker Brassica with a warning letter after it found employees routinely fabricating data results.Merck’s RSV injection protects infants in trial, to file data with global regulatorsMerck said its monoclonal antibody jab to protect infants against RSV-related
infections has met the main goals of a
mid-to-late-stage trial. Merck didn’t go into details but said clesrovimab reduced medically attended lower respiratory infections caused by RSV through day 150.The New Jersey drugmaker will file the data with global
regulators. Currently, FDA has approved Sanofi and Astra’s Beyfortus for preventing RSV in children up to 24 months.GSK’s Dovato proves to be non-inferior to Gilead’s Biktarvy: In the largest study of its kind, GSK’s HIV drug Dovato (dolutegravir/lamivudine) was found to be non-inferior to Gilead Sciences’ Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) which is seen as the benchmark for HIV treatment.
Significantly, Dovato did so with lesser weight gain in a 48-week head-to-head
study of virologically suppressed HIV-1 patients. Both Dovato and Biktarvy are
single pill treatments for HIV given once a day. Biktarvy raked in US$ 11.9 billion in 2023.After Novo’s Wegovy, China approves Lilly’s tirzepatide for weight lossThe Novo Nordisk-Eli Lilly rivalry in the field of weight loss drugs has got intensified with China, the world’s second largest market for pharmaceuticals, approving Lilly’s weight loss drug tirzepatide. The approval from the Chinese regulators for tirzepatide comes around a month after its rival Novo Nordisk’s Wegovy (semaglutide) was approved in China.Agilent to buy CDMO
Biovectra; Novo, BeiGene, Pfizer expand capacitiesAgilent Technologies has agreed to buy the CDMO Biovectra for US$ 925 million.
Canada-based Biovectra is capable of fill-and-finish services and can produce
complex APIs. It also specializes in fast-growing segments like antibody-drug-conjugates (ADCs) and GLP-1 drugs.Meanwhile, there was a lot of news on capacity expansions. For
instance, Novo Nordisk purchased a 200-acre site
in the Danish city of Odense to build a new production plant, a Reuters report said. A report submitted to
authorities revealed the Danish drugmaker plans to include fill-finish
facilities to fill injector pens.Similarly, BeiGene has opened a flagship facility in Hopewell, New Jersey, which houses state-of-the-art biologics manufacturing capabilities and a clinical research and development center. The 42-acre facility is projected to “create hundreds of skilled high-tech jobs at the site by the end of 2025.” And Pfizer is investing SGD$ 1 billion (US$ 743
million) to expand its API manufacturing facility in Singapore to meet the needs of oncology, pain, and antibiotic medicines.CSL Vifor to highlight rival’s product in campaign to resolve anti-trust probeIn a unique settlement, CSL Vifor will launch a marketing campaign spotlighting its Danish rival’s product rather than its own in order to resolve an antitrust probe in the EU. This follows a two-year investigation by the European
Commission alleging Vifor disparaged Pharmacosmos' iron deficiency treatment
Monofer (ferric derisomaltose) in a campaign targeting
healthcare professionals. Monofer is possibly the sole competitor in Europe to
Vifor's flagship intravenous iron medicine Ferinject (ferric carboxymaltose). Vifor has made a 10-year pledge to “launch a comprehensive and multi-channel communication campaign to rectify and undo the effects of the potentially misleading messages previously disseminated by Vifor regarding the safety of Monofer.”Pfizer scores late-stage
trial win for its gene therapy for hemophilia AIn a late-stage trial, Pfizer’s gene therapy for hemophilia A — giroctocogene fitelparvovec — significantly cut the number of annual bleeding episodes in
patients with the rare disorder.The data takes Pfizer one step closer to securing an FDA approval
for this hemophilia A drug. In April, FDA had approved Beqvez as a one-time gene therapy for hemophilia B. If approved, Pfizer’s hemophilia A gene therapy will compete with BioMarin’s Roctavian.Biogen, Sage to abandon trial
on essential tremor drug after trial failureAfter Sage and its partner Biogen’s pill Zurzuvae (zuranolone) could not secure FDA approval for treating
clinical depression in August last year, the partnership has faced yet another setback.Their drug — SAGE 324 — which was being studied as a treatment for essential tremor (ET), a disorder that causes uncontrollable shaking of hands, arms and other parts of the body, has failed a phase 2 trial. “Given these results, Sage and Biogen will close the ongoing open label safety study of SAGE-324 in ET and do not plan to conduct further clinical development of SAGE-324 in ET,” a statement said.FDA issues warning letter to
Indian drugmaker after employees fabricate recordsIndian CDMO Brassica Pharma was hit with a warning letter from the FDA after the US agency found it was a “routine practice” at its plant “to not test all batches for sterility and to fabricate records for those samples not tested.” FDA also pointed out that operators wore torn and stained clothing while performing aseptic processing activities, which could lead to contamination. FDA deemed Brassica’s response to the Form 483 it issued to be inadequate.
Impressions: 632
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#Phispers by PharmaCompass
25 Jul 2024
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This week, a bill heralded as “critical” to help “end anti-competitive practices” was passed by the US Senate with unanimous bipartisan support. The bill tackles patent abuses by pharmaceutical companies.In deals, French drugmaker Ipsen signed its second antibody-drug-conjugate (ADC) deal of the year by securing the rights to an ADC from Foreseen Biotechnology.Phispers also brings you plenty of news from clinical trials. Pfizer announced “encouraging” data on its once-daily weight-loss pill danuglipron. Roche’s once-daily weight-loss pill CT-996 also posted gains in an early-stage trial. And a study undertaken by the University of Oxford to probe whether Novo Nordisk’s Ozempic (semaglutide) caused neurological problems revealed that the med, in fact, reduced risks of dementia and nicotine use.In a late-stage trial on prostate cancer patients, Bayer’s Nubeqa (darolutamide) plus androgen deprivation therapy (ADT) significantly slowed metastatic hormone-sensitive prostate cancer (mHSPC) from progressing. Meanwhile, Australian biotech Immutep shared encouraging data from a mid-stage trial of its investigational therapy that treats metastatic head and neck squamous cell carcinoma patients in the front-line setting. The company said it will begin discussions with regulatory agencies to bring the therapy to market.In news regarding investments, Swiss CDMO CordenPharma
said it is investing US$ 981 million to boost its manufacturing capacity in the
US and Europe in order to keep pace with the burgeoning demand for
glucagon-like peptide 1 (GLP-1) therapies. Sanofi said it is investing an
additional US$ 437 million at its facility in Hyderabad (India), and is likely
to add another 1,600 jobs.And in news from the US Food and Drug Administration (FDA), the agency said it is setting up a Rare Disease Innovation Hub to work across rare diseases.US Senate passes bipartisan bill to reduce ‘patent thickets’ by Big PharmaThe US Senate has unanimously voted to pass a bill to tackle patent abuses
by pharmaceutical companies. The
bipartisan
bill limits the number of patents companies can contend on a drug. The bill seeks to prevent drugmakers from using “patent thickets”, where dozens of patents are deployed to protect a drug from generic competition. The bipartisan bill originally included “product hopping”, where companies switch patients over to a follow-on product whose patent expires later. The bill is said to reduce the federal deficit by US$ 1.8 billion over 10 years.FDA to set up rare diseases
hub: The
FDA has announced its plans to establish a Rare Disease
Innovation Hub to work across rare diseases. This hub will
especially focus on products intended for smaller populations or for diseases
where the natural history is variable and not fully understood. The development
of therapies for these conditions can be particularly challenging.Ipsen gains rights to Foreseen’s ADC in potential US$ 1 bn dealIpsen has secured the rights to an ADC with first-in-class potential from Foreseen Biotechnology in a deal totaling US$ 1.03 billion in upfront and milestone payments. The candidate has already proven its first-in-class potential in treating multidrug-resistant cancers at the preclinical level. Now, Ipsen will make it phase 1 ready. This is the French drugmaker’s second ADC deal of 2024.Immutep eyes regulatory path
after mid-stage win in head, neck cancer treatmentImmutep shared data
from a phase 2b trial of its investigational therapy treating metastatic head and
neck squamous cell carcinoma patients in the front-line setting. Eftilagimod alfa, in combination with Merck’s Keytruda, achieved an objective response rate in 11 out of 31 patients (35.5 percent) and a disease control rate of 58.1 percent. The Australian biotech claimed the “results are among the highest recorded for a chemo-free approach in negative PD-L1 patients”.Pfizer rebounds in obesity,
advances once-daily weight-loss pill after setbackPfizer said it is moving ahead to mid-stage trials with a once-daily version of its GLP-1 drug danuglipron for weight loss. Pfizer trialed various once-daily formulations of the drug and after seeing “encouraging” data picked the candidate with the “most favorable profile”. In December, Pfizer had discontinued a twice-daily version of danuglipron on account of side effects.Second Roche obesity candidate
aces phase 1: Roche revealed that a second drug candidate from
its up to US$ 3.1 billion buyout of Carmot Therapeutics has delivered promising results in an early-stage trial. Its once-daily weight-loss pill CT-996 reduced on average 6.1 percent of participants’ starting weight after four weeks. CT-996 works in a similar manner as other blockbuster weight loss drugs, such as Wegovy and Zepbound.Bayer to expand Nubeqa’s use after late-stage win in prostate cancer trialBayer said its drug
Nubeqa (darolutamide) plus androgen deprivation
therapy (ADT) significantly slowed metastatic hormone-sensitive
prostate cancer (mHSPC) from progressing in a late-stage trial. Nubeqa is already approved for adults with mHSPC in combination with the chemotherapy docetaxel. But for those who can’t tolerate chemo, ADT therapy is recommended with hormone therapy. Nubeqa is on track to achieve blockbuster status this year. Bayer targets € 3 billion (US$ 3.28 billion) in peak annual sales for the hormone therapy.Novo’s Ozempic cuts dementia risk, nicotine use: A study done by the University of Oxford to explore if Novo Nordisk’s Ozempic (semaglutide) may cause neurologic
problems found instead that it reduced the risk of dementia and “nicotine misuse”. The findings are the latest in a series of studies that have implied that GLP-1 drugs may have cognitive benefits. The Oxford study puts to bed concerns that semaglutide may increase the risk of suicidal thoughts.CordenPharma to invest US$
981 mn in US, Europe to boost GLP-1 capacityIn order to keep pace with the burgeoning
demand for GLP-1 therapies, Swiss CDMO CordenPharma said it is investing € 900 million (US$ 981 million) to expand its peptide platform, both at its Colorado site and in Europe. It is the company’s biggest investment and will be used to construct a new facility in Europe for small to large-scale peptide development and manufacturing. The company expects to add about 400 new jobs.Sanofi invests US$ 437 mn in India: Sanofi is looking to expand its workforce in India with an investment of € 400 million (US$ 437 million). The investment will further expand the French drugmaker’s site in Hyderabad, making it the largest amongst Sanofi’s four global capacity centers. The site presently employs about 1,000 people and its workforce is set to grow to 2,600 over the next couple of years.
Impressions: 978
https://www.pharmacompass.com/radio-compass-phisper/us-senate-passes-bipartisan-bill-to-cut-pharma-patent-abuses-ipsen-inks-another-adc-deal
#Phispers by PharmaCompass
18 Jul 2024
This week saw Eli Lilly strike yet another deal as it announced the acquisition of Morphic Holding for about US$ 3.2 billion, thereby bolstering its position in the market for inflammatory bowel disease (IBD) drugs.Pfizer announced that its Chief Scientific Officer
(CSO) Mikael Dolsten, a key figure behind the development of its Covid vaccine
Comirnaty, will be stepping down after over 15 years with the drugmaker.A study found that Lilly’s glucagon-like peptide 1 (GLP-1) drug tirzepatide, used in its diabetes and weight-loss drugs Mounjaro and Zepbound, was more effective than its rival semaglutide, used in Novo Nordisk’s Ozempic and Wegovy, at shedding extra pounds.Another study found that GLP-1 drugs may have a role in preventing cancer. Meanwhile, a study undertaken by an American pharmacy found that only one in four patients in the US who were prescribed Novo Nordisk’s Wegovy or Ozempic for weight loss were still taking the popular medications after two years.Spain’s Grifols said it has received a takeover offer from its founding family and Brookfield Corporation to go private. The deal could potentially be worth about US$ 6 billion.Roche scrapped a trial testing its new immunotherapy tiragolumab in non-small cell lung cancer (NSCLC) patients after it failed to significantly improve survival more than a Keytruda-chemo combination. The Swiss drugmaker is reintroducing its eye therapy Susvimo in the US after voluntarily recalling it in October 2022.UniQure released promising 24-month data for its investigational gene therapy that showed AMT-130 significantly decreased disease progression in patients with Huntington’s disease.Lilly to acquire bowel
disease drug developer Morphic for US$ 3.2 billionEli Lilly said it is acquiring Massachusetts-based Morphic Holding for approximately US$ 3.2 billion in cash, bolstering its
presence in the US$ 26.65 billion IBD market. The Indiana drugmaker gains an investigational oral IBD therapy — MORF-057 — which will offer a more convenient dosing option compared to current injectable drugs, including Lilly’s Omvoh (mirikizumab). MORF-057 is being tested in three mid-stage studies to treat ulcerative colitis and Crohn’s disease, the two conditions that fall under IBD. Lilly sees the IBD space as a way to diversify beyond obesity.Pfizer’s R&D chief Mikael Dolsten, architect behind Comirnaty, to step downPfizer’s CSO Mikael Dolsten is stepping down after a 15-year career at the New York drugmaker.
Under Dolsten, Pfizer won approvals for over 35 drugs and vaccines
including for blockbuster drugs like its blood thinner Eliquis (apixaban), breast cancer med Ibrance
(palbociclib), and heart disease
treatment Vyndaqel (tafamidis meglumine). However, what stands out most is its Covid vaccine Comirnaty under Dolsten’s tenure. Jointly developed with BioNTech, the mRNA vaccine became the first Covid shot approved in the US. Comirnaty catapulted Pfizer’s sales to over US$ 100 billion in 2022.Lilly’s Mounjaro outperforms Novo’s Ozempic in weight loss studyElectronic records of over 18,000 obese or overweight US
adults showed Lilly’s tirzepatide helped patients shed more weight than its rival Novo’s semaglutide, with the effect increasing over time. The
study found that 82 percent of patients taking tirzepatide lost 5 percent
of their starting body weight compared to 67 percent of those taking
semaglutide, after a year. Novo pointed out that the analysis did not include
its weight-loss drug Wegovy and said a head-to-head clinical trial is the best way to compare the two
weight-loss drugs. Such a trial on tirzepatide and semaglutide is yet to
conclude.GLP-1 drugs linked to lower
cancer risk: Type 2 diabetes patients taking GLP-1 treatments “had a significant risk reduction” in developing 10 common types of cancers closely
associated with obesity compared to those on insulin, according to a study
published in JAMA Network Open. The study concluded that the “findings provide preliminary evidence of the potential benefit” of GLP-1 drugs for cancer prevention in high-risk populations.Few continue weight loss drugs after two years: Only one in four patients in the US who were prescribed Novo Nordisk’s Wegovy or Ozempic for weight loss were still
taking the popular medications two years later, a Reuters report said. The analysis, undertaken by an American
pharmacy, does not include details about why patients quit. Another news report
said only about 15 percent of people who began taking GLP-1 drugs such as Wegovy
stuck with them after two years.Grifols gets US$ 6 billion
takeover offer from founding family, BrookfieldSpanish multinational pharmaceutical company Grifols said it is evaluating a takeover offer from its founding
family and the Canadian investment management company Brookfield that
would delist the company from the Spanish and Nasdaq stock markets. Based on the company’s current market value, the deal is potentially worth around US$ 6 billion. The Grifols family holds a stake of about 30 percent, which they don’t plan to sell. Brookfield is mulling investing over € 5 billion (US$ 5.41 billion), part of which will be to refinance and restructure the company’s debt. The beleaguered drugmaker was rocked by allegations of
fraud earlier this year over manipulation of its debt.FDA rejects Novo’s weekly insulin, seeks manufacturing informationFDA has issued Novo Nordisk a complete
response letter (CRL), declining to approve the Danish drugmaker’s weekly insulin Awiqli (insulin icodec). The agency has requested information related to the manufacturing process and the type 1 diabetes indication before the review of the application can be completed, a company statement said. In May, an FDA panel had voted seven to four
against the benefits of Awiqli outweighing its risks.Roche scraps trial after new
immunotherapy loses to Keytruda-chemo comboRoche is putting an end to a trial testing its new immunotherapy
tiragolumab in non-small cell lung cancer (NSCLC) patients.
Tiragolumab is part of a new class of drugs called anti-TIGIT antibodies. The
study involving 524 patients with NSCLC tested tiragolumab in combination with Roche’s Tecentriq (atezolizumab) in the first line setting.
It failed to best Merck’s Keytruda (pembrolizumab) plus chemotherapy as a
first line of treatment in the phase 2/3 study.Meanwhile, Roche
is reintroducing Susvimo (ranibizumab injection) in the US after voluntarily recalling it in October 2022. The implant used to treat patients with neovascular age-related macular degeneration
(wet AMD) requires a one-time surgery to be inserted into the eye.UniQure posts strong data on gene therapy for Huntington’s diseaseUniQure released promising
24-month data
for its investigational gene therapy that showed AMT-130 significantly decreased disease progression in patients with Huntington’s disease. The early-mid stage data showed that among 29 US and European patients, those given the higher dose showed an 80 percent reduction of the neurodegenerative disease progressing, while those given the lower dose saw a 30 percent reduction of the same.
Impressions: 709
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#Phispers by PharmaCompass
11 Jul 2024
Lilly’s Alzheimer’s drug gets FDA nod; GSK buys rights to mRNA vaccines from Curevac for US$ 1.56 bn
This week, the US Food and Drug Administration (FDA) finally approved Eli Lilly’s Alzheimer’s drug donanemab after a long wait. Lilly also inked a radiopharma deal this week, and paid US$ 140 million for the option to acquire Radionetics Oncology for US$ 1 billion.GSK has struck a deal to buy the rights to Curevac’s Covid-19 and flu vaccines for up to € 1.45 billion (US$ 1.56 billion). Sanofi is investing up to US$ 1.6 billion in Frankfurt to boost production of its long-acting insulin shots.As part of its portfolio reprioritization, Bristol Myers
Squibb has walked away from the rights to the antibody-drug-conjugate (ADC)
farletuzumab ecteribulin after having paid Eisai US$ 650 million.A study published in JAMA Ophthalmology suggests that Novo Nordisk’s Ozempic and Wegovy may have increased the risk of developing a rare, sight-threatening eye condition.The US Supreme Court has rejected a US$ 6 billion bankruptcy settlement of OxyContin maker Purdue Pharma. European regulators have become the first in the world to approve Sanofi’s Dupixent to treat chronic obstructive pulmonary disease (COPD).And in regulatory news, FDA has reprimanded India’s Sun Pharma in a warning letter for “significant violations of Current Good Manufacturing Practice (CGMP) regulations” at its Dadra (western India) facility.Lilly’s Alzheimer’s drug gets FDA nod after months of delay, to get Medicare coverageFDA has approved Alzheimer’s drug donanemab, to be sold under the brand name Kisunla. It was a long-awaited win for Lilly after the US agency surprised the Alzheimer’s community in March when it delayed approving donanemab on its action date. Last month, an FDA advisory committee voted unanimously in favor of the drug’s benefits outweighing its risks. This approval, and that of Biogen and Eisai’s Leqembi (lecanemab)
last year, mark successes in treating the mind-wasting disease after three
decades of failed efforts.Kisunla is a monoclonal antibody infusion administered every four
weeks and will cost US$ 32,000 a year compared to US$ 26,500 for Leqembi. Both
work by clearing a protein called beta amyloid from the brain. The drug is
expected to be covered by Medicare.In deal with Radionetics, with option to buy it out: Eli Lilly has paid Radionetics Oncology US$ 140 million for the
exclusive right to acquire the San Diego-based
biotech for US$ 1 billion. Radionetics discovers and develops small molecule radiopharmaceuticals. As part of the option agreement, privately-held Radionetics will continue building its radiopharma drug pipeline through an “exercise period”. Lilly then can choose to acquire the company. This is the third radiopharma deal Lilly has struck in the recent past. In May, it had inked a potential US$ 1.16 billion deal with Aktis Oncology, and late last year, it had bought out Point Biopharma Global for up to US$
1.4 billion.GSK restructures deal with
CureVac, to buy rights to mRNA jabs for US$ 1.56 bnSince 2020, GSK and CureVac have worked together to
develop mRNA vaccines. But now, the two companies have restructured their existing collaboration into
a new licensing agreement. Under the terms of the new agreement, GSK will now acquire full rights to develop, manufacture and commercialize mRNA candidate vaccines for influenza and Covid-19, including combinations, for € 400 million (US$ 430 million) upfront and € 1.05 billion (US$ 1.13 billion) in contingent payments.Sanofi to invest US$ 1.6 bn in Germany: Sanofi is reportedly
planning to invest € 1.3 billion to € 1.5 billion (US$ 1.4 billion to US$ 1.6 billion) in Germany to upgrade its production of long-acting insulin shots. The news was reported by German newspaper Handelsblatt.Samsung Bio inks its biggest
contract ever: A public disclosure shows Korean CDMO giant Samsung Biologics has inked a US$ 1.06 billion agreement with an unnamed US pharmaceutical company. Details were sparse but the deal is Samsung Bio’s biggest contract ever, representing
over 39 percent of its total sales in 2023 (about US$ 2.7 billion).BMS walks away from ADC pact
with Eisai after paying US$ 650 mnBMS is walking away from its rights to
the ADC farletuzumab ecteribulin (FZEC) after having paid Japanese drugmaker Eisai US$ 650 million.
As part of its portfolio reprioritization, BMS decided to end the co-development agreement. In 2021, the New Jersey-based drugmaker had promised Eisai up to US$ 2.5 billion in milestone payments above a US$ 450 million upfront payment and US$ 200 million in R&D support.Eisai developing dementia
drug for US market: Eisai is reportedly
developing a dementia treatment with the goal to
commercialize it in the US market by 2030. The drug will work by targeting the tau protein, which causes symptoms of Alzheimer’s disease.Wegovy, Ozempic linked with
condition that causes blindness, suggests studyPeople taking Novo Nordisk’s Ozempic or Wegovy (both semaglutide) may have an increased risk of developing a rare sight-threatening eye condition, known as non-arteritic anterior ischemic
optic neuropathy (NAION), suggests a study published in JAMA Ophthalmology. NAION is a kind of eye stroke that results in a sudden, painless loss of vision in one eye. However, the authors stressed that the results aren’t conclusive, and more studies are needed to confirm a link between sight problems and the popular blockbuster drugs.EU first off the block to clear Sanofi’s Dupixent as add-on therapy for COPDEuropean regulators have become the first in the world to approve Dupixent (dupilumab) as an add-on therapy for COPD patients with high
levels of certain white
blood cells. Sanofi’s blockbuster significantly reduced exacerbations, improved lung function and also improved health-related quality of life. FDA’s deadline for reviewing Dupixent in COPD is September 27, after the agency delayed its decision by three months demanding more efficacy data.India’s Sun Pharma hit with FDA warning letter for significant CGMP violationsFDA has reprimanded India’s Sun Pharma in a warning letter for “significant violations of Current Good Manufacturing Practice (CGMP) regulations”. The company’s facility in Dadra (western India) failed to adequately clean, maintain and appropriately sanitize and/or sterilize equipment and utensils at proper intervals, FDA said. Sun Pharma was given 15 working days to respond.US Supreme Court rejects US$ 6 bn opioid deal that shielded Purdue’s Sackler familyThe US Supreme Court has struck down a bankruptcy settlement of OxyContin maker Purdue Pharma, which would have offered broad protections to its owners, the wealthy Sackler family. The prescription painkiller OxyContin is considered to have started America’s opioid epidemic, which has claimed the lives of hundreds of thousands since OxyContin was launched in 1996.
Impressions: 573
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#Phispers by PharmaCompass
04 Jul 2024
This week saw a couple of developments in the lucrative US market for glucagon-like peptide-1 (GLP-1) drugs that treat diabetes and obesity. Novo Nordisk is investing US$ 4.1 billion to develop a new facility in North Carolina to boost the supply of Ozempic and Wegovy. And Israel’s Teva Pharmaceuticals has launched a generic version of Novo Nordisk’s Victoza to treat type 2 diabetes.In approvals, the US Food and Drug Administration (FDA) has approved Verona Pharma’s drug for chronic obstructive pulmonary disease (COPD), a chronic lung disease. The agency has expanded the use of Sarepta Therapeutics’ gene therapy for Duchenne muscular dystrophy (DMD) in patients aged four and above who cannot walk, despite the drug failing in its late-stage trial. Additionally, FDA granted an accelerated approval to BMS’s Krazati, to be used in combination with cetuximab, as a targeted treatment option for adult patients with KRASG12C-mutated locally advanced or metastatic colorectal cancer.In late-stage trials, Gilead’s twice yearly HIV prevention drug proved to be superior to its daily pill Truvada, which could make it a game changer in the pre-exposure prophylaxis (PrEP) space. AstraZeneca’s blockbuster drug Imfinzi meaningfully improved survival in patients with muscle-invasive bladder cancer. And Merck KGaA has had to scrap a phase 3 trial after its once promising candidate xevinapant failed to show significant survival benefits in patients with locally advanced head and neck cancer.Novo invests US$ 4.1 billion
in new facility in US to boost Ozempic, Wegovy supplyNovo Nordisk is investing US$ 4.1 billion to develop a new manufacturing facility in Clayton, North Carolina (US). The funds will be
used to create a 1.4 million square foot
facility that
fills Ozempic and Wegovy (both semaglutide) injector pens. The Danish
drugmaker already operates three facilities at the site. This new 56-acre
facility is expected to add 1,000 new jobs to the 2,500 already employed at the
other three facilities.Teva launches first GLP-1
generic in US: Teva Pharmaceuticals has launched a generic version of Novo Nordisk’s Victoza (liraglutide) to treat type 2 diabetes
patients, rendering it the first generic for a GLP-1 drug in the
United States.FDA okays Verona’s COPD therapy; AbbVie-Genmab’s Epkinly bags second approvalFDA
has approved a therapy for COPD — Ohtuvayre — from Verona Pharma. Ohtuvayre is a new, inhaled non-steroidal,
maintenance treatment for COPD in adult patients. The chronic condition causes
restricted airflow and breathing problems. According to the company, Ohtuvayre is the first inhaled product with a novel
mechanism of action available for the maintenance treatment of COPD in more
than 20 years.Epkinly okayed for follicular
lymphoma: After bagging an FDA approval last year for diffuse large B-cell
lymphoma (DLBCL), AbbVie and Genmab’s Epkinly (epcoritamab-bysp) has now bagged an accelerated approval in patients with relapsed or refractory follicular lymphoma (FL) who have received two or more prior treatments.First drug for excessive
underarm sweating okayed: FDA has approved the first drug to treat primary
axillary hyperhidrosis (excessive underarm sweating). To be sold as a gel, Botanix Pharmaceuticals’ Sofdra (sofpironium) is a new chemical entity that presents a safe and effective solution to
patients who suffer from this socially challenging medical condition, the
company said.Gilead’s twice yearly HIV prevention drug found to be superior to daily pill TruvadaIn a late-stage study,
Gilead’s long-acting injection has proven to be more effective in preventing HIV infection in women compared to the daily pill Truvada (emtricitabine/tenofovir). This is the first time
that an HIV pre-exposure prophylaxis (PrEP) has shown zero infections in a
phase 3 trial, the drugmaker said. Dosed just twice a year, lenacapavir could be a game-changer in HIV
prevention.Astra’s Imfinzi chalks up win in treating bladder cancer: AstraZeneca’s Imfinzi (durvalumab) meaningfully improved event-free survival and
overall survival in patients with muscle-invasive bladder cancer (MIBC) in a late-stage trial. In the study, Imfinzi was
used in combination with chemotherapy before surgery, and as a monotherapy
after, and was compared with pre-surgical chemotherapy alone.Merck KGaA scraps trial after
failure in head, neck cancer: Merck KGaA said its candidate xevinapant has failed in a
late-stage trial to show significant survival
benefits in
patients with locally advanced head and neck cancer. An
independent data monitoring committee said xevinapant is unlikely to meet the primary endpoint of the study and the German drugmaker is discontinuing it. Xevinapant was seen as a promising drug and Merck had paid €188 million (about US$ 226 million) in upfront cash to acquire its global rights from Debiopharm International.FDA expands use of Sarepta’s Duchenne gene therapy despite late-stage failureFDA
has granted accelerated approval for the use of Sarepta Therapeutics’ gene therapy
for Duchenne muscular dystrophy (DMD) in patients aged four and above who cannot walk. The agency
okayed Elevidys (delandistrogene
moxeparvovec) for this group despite it missing its
primary goals of a late-stage trial. FDA also granted Elevidys a traditional
approval for DMD in patients four years of age and above who can walk.Argenx’s Vyvgart Hytrulo okayed for autoimmune disease: FDA has
approved Argenx’s Vyvgart Hytrulo for chronic inflammatory demyelinating polyneuropathy (CIDP), making it a new treatment option for patients with this rare
and debilitating neuromuscular disorder. This marks the first drug with a
novel, precision mechanism of action in over 30 years for CIDP, Argenx said.BMS’ Krazati okayed for colorectal cancer: FDA has granted Krazati (adagrasib) an accelerated approval, when used in combination
with cetuximab as a targeted treatment
option for adult patients with KRASG12C-mutated locally advanced or metastatic
colorectal cancer. This is the second approval for Krazati, which works by
targeting a mutated form of the gene known as KRAS. It was previously approved
to treat KRASG12C-mutated locally advanced or metastatic non-small cell lung
cancer.Lilly, OpenAI join hands to
fight antimicrobial resistance; Glenmark recalls drugEli Lilly has partnered OpenAI to leverage its generative
AI to invent novel antimicrobials that can be used to treat
drug-resistant bacteria. Antimicrobial resistance is one of the top public
health and development threats across the world.Glenmark recalls 114 batches
of potassium drug: Glenmark has recalled 114 batches in the US of 750 mg potassium chloride extended-release capsules
because of failed dissolution. As a result, the capsules
may cause high potassium levels, also known as hyperkalemia, which can result
in irregular heartbeat that can lead to cardiac arrest, the company said. The recall is voluntary and Glenmark hasn’t received any reports of serious side effects yet.
Impressions: 718
https://www.pharmacompass.com/radio-compass-phisper/novo-invests-us-4-1-bn-to-boost-wegovy-ozempic-supply-verona-s-copd-therapy-bags-fda-nod
#Phispers by PharmaCompass
27 Jun 2024
Merck wins FDA nod for pneumococcal vaccine; Roche partners Ascidian to develop novel gene therapies
This week saw the US Food and Drug Administration (FDA) approve Merck’s next-generation pneumococcal vaccine for adults. The agency also granted accelerated approval to Bristol-Myers Squibb’s Augtyro for adult and pediatric patients with solid tumors.In deals, Roche has promised up to US$ 1.8 billion to Boston-based startup Ascidian Therapeutics to discover and develop novel gene therapies for difficult-to-treat neurological diseases. The week also saw three deals involving Chinese companies, including AbbVie’s US$ 1.7 billion deal with China’s FutureGen Biopharmaceutical to develop and commercialize a promising treatment for inflammatory bowel disease (IBD).In trials, Intra-Cellular’s Caplyta scored another remarkable late-stage win for treating major depressive disorder (MDD). And a large study conducted by Stanford Medicine found the risk of CAR-T cell therapies causing secondary cancers to be low.There were some misses too. Takeda’s seizure drug failed to meet its endpoints in back-to-back late-stage trials. And AstraZeneca’s Truqap failed to prolong the life of patients with hard-to-treat breast cancer.FDA greenlights Merck’s next-generation pneumococcal vaccine for adultsFDA has approved
Merck’s next-generation vaccine designed to protect adults
from pneumococcus bacteria that causes serious illnesses and pneumonia. The
jab, known as Capvaxive, helped produce an immune response against all 21
variations (serotypes) of the bacteria that it targeted. These 21 strains
account for about 85 percent of invasive pneumococcal disease cases in adults
aged 65 and above. Pfizer’s Prevnar 20, the
current market leader, targets
strains that account for about 51 percent of cases in the said age group.
Analysts see Capvaxive as a key growth driver for Merck.BMS’ Augtyro bags tumor-agnostic nod: FDA has granted accelerated approval
to Augtyro (repotrectinib) for adult and
pediatric patients (over 12 years) with solid tumors that have a neurotrophic
tyrosine receptor kinase (NTRK) gene fusion, regardless
of where they occur in the body. This makes BMS’ therapy the
only FDA-approved treatment option for such tumors.Roche inks potential US$ 1.8 bn deal with Ascidian to develop novel gene
therapiesRoche has promised up to US$ 1.8 billion to Boston-based
startup Ascidian Therapeutics to discover and develop novel gene therapies for difficult-to-treat neurological diseases. Ascidian gets an initial payment of US$ 42 million. The startup’s RNA exon editing platform is designed to advance the therapeutic possibilities of RNA medicine and treat diseases not addressed by today's gene editing technologies.Sanofi, Belharra in immunology deal: Sanofi is collaborating with Belharra Therapeutics in a deal worth up to US$ 700 million including US$ 40 million in upfront and near-term payments. The collaboration will leverage Belharra’s non-covalent chemoproteomics platform to advance the discovery of novel small molecule therapeutics for immunological diseases.AbbVie to pay up to US$ 1.7 bn to China’s FutureGen for next-gen IBD therapyAbbVie has agreed to pay China’s FutureGen Biopharmaceutical up to US$ 1.56 billion, including an upfront payment of US$ 150 million, to develop and commercialize a next generation treatment for inflammatory bowel disease (IBD) — FG-M701. Currently in preclinical development, FG-M701 targets TL1A antibody (a clinically validated target in IBD).Takeda to license Ascentage’s leukemia drug: Japanese drugmaker Takeda has signed an option agreement with China’s Ascentage Pharma for an exclusive
license to its promising candidate olverembatinib. This experimental
drug is being developed to treat chronic
myeloid leukemia (CML) and other hematological cancers. If exercised, the
option would allow Takeda to license global rights to develop and commercialize
olverembatinib in all territories outside of mainland China, Hong Kong, Macau,
Taiwan and Russia. Takeda has paid Ascentage US$ 100 million upfront,
and the Chinese drugmaker stands to receive an additional US$ 1.2 billion in milestone payments.Day One in biobucks deal with MabCare: Day One Biopharmaceuticals has entered into a licensing agreement with China-based MabCare Therapeutics for an experimental novel antibody drug conjugate — MTX-13. The biobucks deal for MTX-13 is worth up
to US$ 1.2 billion, if the drug meets all milestones.
The drug is being developed for multiple kinds of adult and pediatric cancers.Intra-Cellular scores late-stage win for depression drug CaplytaIntra-Cellular’s antipsychotic drug
Caplyta (lumateperone) has scored another remarkable late-stage win for treating MDD. After six weeks on the 42 mg daily dose, US participants on Caplyta as an adjunctive therapy experienced a 4.5-point reduction on the Montgomery-Asberg Depression Rating Scale (MADRS) compared to the placebo. The results were notably similar to a previous study conducted worldwide.The New York City-based biopharma said it is confident lumateperone will become the “drug of choice for patients suffering from MDD who are having an inadequate response to antidepressant therapy.” If approved, Caplyta will compete with AbbVie’s blockbuster
antipsychotic drug Vraylar (cariprazine). Like Vraylar,
Caplyta is approved for schizophrenia and bipolar disorder, but MDD is reportedly the most lucrative
indication. Analysts predict an additional US$ 1 billion in annual peak sales from MDD by 2033.Takeda’s seizure drug fails to meet main goals in back-to-back phase 3 trialsTakeda’s soticlestat being
investigated in two epileptic disorders has failed in phase 3 trials,
albeit “narrowly”. The drug was being tested in combination with the standard of care for adults and kids with Dravet syndrome (DS) and Lennox-Gastaut syndrome (LGS) – rare and severe types of epilepsy that cause frequent, long-lasting seizures that usually start in infancy or early childhood. Takeda paid US$ 196 million to Ovid Therapeutics for the global
rights to soticlestat. It has promised an additional US$ 660 million in
milestone payments.Astra’s Truqap fails trial for hard-to-treat breast cancer: AstraZeneca’s Truqap (capivasertib), in combination with the common
chemotherapy paclitaxel, failed to help patients with hard-to-treat breast cancer live longer. A late-stage study was testing
Truqap in volunteers with inoperable triple-negative breast cancer (TNBC) that
had spread. TNBC remains among the most challenging forms of disease to treat.Study finds risk of secondary cancers after CAR-T cell therapy to be lowA large
study conducted by Stanford Medicine has found the risk
of CAR-T cell therapies causing secondary cancers to be low. According to
results published in The New England Journal of Medicine, a 724-patient study saw about 6.5 percent of patients get secondary
cancers over a median follow-up period of three years.Zentalis’ cancer drug put on partial clinical hold: FDA has placed three studies of Zentalis Pharma’s cancer drug — azenosertib — on partial clinical hold. This action was taken after deaths of two participants in a mid-stage study. Azenosertib was being tested against solid tumors in an early-stage study and in patients with a type of ovarian and uterine cancer in two mid-stage studies.
Impressions: 890
https://www.pharmacompass.com/radio-compass-phisper/merck-wins-fda-nod-for-pneumococcal-vaccine-roche-partners-ascidian-to-develop-novel-gene-therapies
#Phispers by PharmaCompass
20 Jun 2024
The US Food and Drug Administration’s (FDA) advisory committee has voted unanimously in favor of the benefits of Eli Lilly’s Alzheimer’s drug donanemab outweighing its risks. FDA has also granted accelerated approval to Ipsen’s Iqirvo to treat a rare liver disease (primary biliary cholangitis) that has not seen a new therapy approved in nearly a decade. Moreover, FDA handed Geron Corporation its first approval for blood disorder drug Rytelo.In vaccine news, Moderna’s combination vaccine against influenza and Covid elicited a higher immune response compared to separate shots in people aged 50 and above. Also, adults aged 50 to 59 years now have an RSV vaccine after FDA expanded the use of GSK’s Arexvy to include this age-group.In a blow to millions who are affected by long Covid, Pfizer’s Paxlovid did not appear to improve its symptoms as was hoped, according to a study undertaken by Stanford University. In yet another blow to Pfizer, its experimental gene therapy — fordadistrogene movaparvovec — failed to improve motion function in patients with Duchenne muscular dystrophy (DMD) in a late-stage trial.In regulatory news, FDA has chided China’s Jiangsu Hengrui in a Form 483 after employees destroyed documents during an inspection. And Johnson & Johnson has reached a US$ 700 million settlement with 42 US states and Washington, DC, over allegations that it misled consumers into believing its talc products were safe.Lilly’s Alzheimer’s drug donanemab wins unanimous backing of FDA’s expert panelAn FDA advisory committee has voted unanimously in favor of the benefits of
Eli Lilly’s Alzheimer’s drug donanemab outweighing its risks. Alzheimer’s disease afflicts over six million people in the US and has no cure. However, donanemab modestly slowed cognitive decline in early-stage patients but came with noteworthy risks including swelling and bleeding in the brain. The Alzheimer’s Association has welcomed the unanimous voting by the
panel in favor of the drug.Ipsen’s Iqirvo bags FDA nod to treat rare liver disease; Geron gets first FDA approvalFDA has granted accelerated approval to Ipsen’s Iqirvo (elafibranor) to treat the rare liver disease known as primary biliary cholangitis (PBC). The decision renders Ipsen’s first-in-class peroxisome proliferator-activated receptor (PPAR) agonist the first new medicine approved in nearly a decade for the treatment of PBC. Iqirvo is taken orally once a day and is estimated to cost US$ 11,500 a month. PBC affects about 100,000 people in the US and can cause liver failure. It mostly affects women aged 30 to 60 years.Iqirvo was discovered and developed by Genfit to treat the fatty liver
disease, now known as metabolic dysfunction-associated steatohepatitis (MASH).
But after flopping in phase 3 trial, it joined the
graveyard of MASH failures. Ipsen then licensed it from Genfit for up to € 480 million (US$ 515 million) to treat PBC.Geron’s maiden approval: FDA has signed off on Geron’s Rytelo (imetelstat) for treating transfusion-dependent anemia in patients with low- to intermediate-risk myelodysplastic syndromes (MDS), a group of blood cancers. This is
the first FDA approval for Geron since its inception in 1990. The use of BMS’ Reblozyl (luspatercept) was expanded last year by
the FDA to treat the same disease indication. However, this is reportedly an underserved population.Moderna’s two-in-one Covid-flu vaccine superior to individual shots, says studyModerna said mRNA-1083,
an investigational combination vaccine against influenza and Covid,
elicited a higher immune
response compared to separate shots in people aged 50 and
over. A late-stage study saw the messenger RNA technology-based combination
generate more antibodies than currently marketed flu vaccines and Moderna's
Spikevax.FDA okays GSK’s RSV vaccine for adults aged 50 to 59: FDA has expanded GSK’s respiratory syncytial virus
(RSV) vaccine to be administered in adults between the ages of 50 and 59 years. This makes Arexvy the only
RSV shot endorsed for that age group and is expected to add 13 million
individuals to its eligibility pool. Arexvy has been dominating the US market
since its launch in 2023, outperforming sales of its rival Pfizer’s Abrysvo.Pfizer’s Paxlovid fails long Covid test, its DMD gene therapy flunks phase 3 studyIn a blow to millions affected by long Covid, Pfizer’s Paxlovid did not appear to improve the symptoms as was hoped. Pfizer’s antiviral treatment was shown to be safe in a 15-day study conducted by Stanford University. However, it didn’t lower select symptoms of the syndrome. Long Covid symptoms include fatigue, brain fog and the inability to exercise and scientists don’t yet know exactly what causes it.In yet another blow to Pfizer, its experimental gene therapy fordadistrogene movaparvovec failed to improve motion function in patients with DMD in a late-stage trial. The therapy did not show a significant improvement compared to a placebo with regard to the trial’s primary and secondary endpoints.China’s Jiangsu Hengrui issued scathing Form 483 after staff destroys documentsFDA has admonished China’s Jiangsu Hengrui
Pharmaceuticals after an employee “diverted” inspectors while colleagues tore up and discarded documents. The employee called ahead as soon as FDA sought access to the waste area and then led inspectors down a long route. On arriving, FDA observed “personnel in a rapid-like manner placing documents in the waste bin, along with approximately 2 to 3 other individuals watching,” a Form 483 said. FDA also “observed black mold like growth on the floor below and around the condenser, which are approximately a foot from released finished drug products.” Following the January inspection at the manufacturing site in the Chinese city of Lianvungang (Jiangsu province), FDA issued a Form 483 with eight observations.J&J to pay US$ 700 mn to US states over allegations of misleading talc customersJohnson & Johnson has reached a US$ 700 million settlement with 42 US
states and Washington, DC, over allegations that it misled consumers into believing its talc products were safe. This puts to bed an investigation into its marketing of baby powder and other talc-based products, which J&J had sold for over 100 years. The products in question were alleged to have caused cancer. J&J still faces tens of thousands of lawsuits related to its talc.
Impressions: 651
https://www.pharmacompass.com/radio-compass-phisper/fda-panel-backs-lilly-s-alzheimer-s-drug-agency-approves-ipsen-s-med-to-treat-rare-liver-disease
#Phispers by PharmaCompass
13 Jun 2024
This week saw the American Society of Clinical Oncology (ASCO) annual meeting in Chicago where cancer researchers presented detailed findings from hundreds of clinical trials. Central to AstraZeneca’s ambitious plan to clock US$ 80 billion in annual revenue by 2030 is its cancer drugs. Trial results for Astra’s top-selling cancer drug Tagrisso as a maintenance therapy for certain lung cancer patients and for Enhertu in breast cancer suggested they could become the new standard of care. Meanwhile, in the
treatment of the currently incurable multiple myeloma (MM), GSK's Blenrep cut
the risk of disease progression or death by almost half compared to
standard-of-care treatments. Sanofi boasted a first-in-class win wherein
Sarclisa as a combination therapy bested standard of care in newly diagnosed MM
patients.Among the data presented at ASCO, the world’s first personalized mRNA cancer vaccine for skin cancer has excited doctors after Moderna’s mRNA-4157 (V940) plus Merck’s Keytruda halved the risk of patients dying or the disease returning. Also, Moderna’s mRESVIA has become the first mRNA RSV vaccine approved by the US Food and Drug Administration (FDA).In what came as a disappointment for advocates of psychedelic drugs for medical use, an FDA advisory panel has voted against the first MDMA treatment for post-traumatic stress disorder (PTSD) amid concerns about flawed trials.ASCO: Astra’s late-stage Tagrisso data in lung cancer trial gets standing ovationData presented at ASCO showed that AstraZeneca’s Tagrisso (osimertinib) reduced the risk of disease progression or
death by a whopping 84 percent in patients whose non-small cell
lung cancer (NSCLC) had an EGFR mutation and couldn’t be surgically removed. Patients on Tagrisso saw an average of 39.1 months without disease progression
compared to 5.6 months in the placebo group. The late-stage results were met
with a standing ovation as experts said the treatment could become the standard of care for one of the leading causes of cancer death.Imfinzi boosts
lung cancer survival: The
British-Swedish drugmaker said its human monoclonal antibody Imfinzi (durvalumab) is the first and only immunotherapy to show survival
benefit in limited-stage small cell lung cancer (LS-SCLC), in a global
late-stage trial. Imfinzi reduced the risk of death by 27 percent versus the
placebo. At the three-year mark, 57 percent of Imfinzi treated patients were
alive.Breast cancer
drug Enhertu shows strong results: AstraZeneca and Daiichi Sankyo’s Enhertu delayed the progression of breast cancer by about five months in women with low levels of HER2 protein whose cancer
progressed following endocrine therapy. The findings could significantly
increase the range of breast cancer patients that may benefit from the
antibody-drug-conjugate (ADC).GSK’s blood cancer drug eyes US comeback after cutting risk of death by almost half in phase 3 studyGSK's MM therapy Blenrep (belantamab
mafodotin) has cut the risk of disease progression or death
by almost half compared to standard-of-care
treatments, data touted at ASCO showed. After a year, 71 percent of patients on Blenrep, in
combination with pomalidomide plus dexamethasone (PomDex), were alive and saw no
worsening of their disease compared to 51 percent of patients on Takeda’s Velcade (bortezomib) plus PomDex. The once-failed ADC was pulled from the lucrative
US market in 2022, but the results could signal a comeback for Blenrep.Sanofi says
Sarclisa combo beat standard of care in phase 3: Sanofi's Sarclisa, combined with standard
care, achieved a 40 percent reduction in the risk of
progression or death compared to standard care alone in newly diagnosed multiple myeloma patients ineligible for a stem cell transplant. Takeda’s Velcade (bortezomib), BMS’ Revlimid (lenalidomide) and the steroid dexamethasone (VRd) is the current standard of care. Sarclisa is the first anti-CD38 monoclonal antibody to significantly improve PFS in combination with VRd, the French drugmaker said.Moderna’s mRESVIA becomes first mRNA RSV vaccine approved by FDAFDA approved Moderna’s 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. This is the first messenger RNA-based (mRNA) vaccine not for Covid to be approved in the US and is seen as a much-needed second product for the Boston-based biotech.Moderna’s mRNA cancer vaccine plus Keytruda cuts risk of death by nearly half:
Moderna and Merck presented three-year data on their investigational vaccine for patients with the
most deadly form of skin cancer, in combination with the blockbuster Keytruda (pembrolizumab). A mid-stage trial showed that
after 2.5 years, 75 percent of melanoma patients on the combination had
recurrence-free survival, compared with 55.6 percent on Keytruda alone.
Furthermore, at 34.9 months, mRNA-4157 (V940) in combination with Keytruda
reduced the risk of recurrence or death by 49 percent compared to Keytruda alone in these patientsSummit, Akeso's
antibody bests Keytruda in head-to-head phase 3 trial for NSCLC:
Ivonescimab met its primary endpoint of significantly improving
PFS over the world’s bestselling drug Keytruda. Ivonescimab
received marketing authorization in China in May and is licensed to Summit Therapeutics in the US, Canada, Europe,
and Japan. Keytruda is a PD-1 inhibitor, while ivonescimab is a bispecific
antibody targeting both PD-1 and vascular endothelial growth factor (VEGF)
proteins.FDA panel votes against first MDMA
treatment for PTSD amid concerns about flawed trialsAn FDA advisory panel has voted 10 against one, saying the benefits of using the party drug MDMA to treat PTSD do not
outweigh the risks. Data submitted by Lykos Therapeutics was reportedly marred by inconsistencies, poor study design and allegations of misconduct. While FDA is not required to follow the panel’s advice, a final decision is expected by August
11. There hasn't been a new treatment for PTSD in over two decades
and this marked the first time FDA advisers considered a Schedule I psychedelic for medical use.FDA's Operation Warp Speed for rare
disease treatments gets first candidatesSelected companies have joined the FDA's Operation Warp Speed for
rare disease treatments, known as the Support for Clinical Trials Advancing
Rare disease Therapeutics (START) Pilot Program. This initiative facilitates
closer collaboration between early-stage participants and FDA staff. Grace Science's GS-100 for NGLY1 deficiency, Denali's DNL126 for MPS IIIA (Sanfilippo syndrome type A), Larimar's nomlabofusp for Friedreich’s ataxia, and Neurogene's NGN-401 for Rett syndrome were among the chosen therapies.
Impressions: 704
https://www.pharmacompass.com/radio-compass-phisper/astra-s-cancer-drugs-impress-at-asco-moderna-s-mresvia-becomes-first-mrna-rsv-vaccine-approved-by-fda
#Phispers by PharmaCompass
06 Jun 2024
This week’s Phispers comes packed with news of investments, acquisitions, deals and trials. Eli Lilly has more than doubled its investment at its Lebanon (Indiana) site in the US by investing an additional US$ 5.3 billion. This investment will enhance Lilly’s capacity to manufacture the active pharmaceutical ingredient (API) used in its obesity and type 2 diabetes drugs — Zepbound and Mounjaro.In deals, Merck announced it is buying clinical-stage ophthalmology biotech EyeBio for US$ 1.3 billion. Johnson & Johnson has scooped up the rights to an eczema antibody for US$ 1.25 billion. Japanese conglomerate Asahi Kasei said it is buying Sweden’s Calliditas for US$ 1.1 billion. And, Takeda has inked a potential US$ 1.2 billion deal with Shanghai-based Degron Therapeutics to discover and develop a new class of drugs, known as molecular glue degraders (MGDs).The US Food and Drug Administration (FDA) has approved a
once-daily treatment to treat attention deficit hyperactivity disorder (ADHD) in patients who are six years of age or older. And, an FDA advisory panel has voted against the benefits of Novo Nordisk’s once-weekly Awiqli (insulin icodec) outweighing its risks.At the European Renal Association (ERA) congress, Novo Nordisk presented detailed results that showed Ozempic reduced the risk of death due to kidney disease in people with diabetes. The ERA congress also saw Novartis tout two promising late-stage readouts for rare kidney disease treatments. And, preliminary results from a confirmatory trial showed NS Pharma’s Viltepso failed to reach its primary endpoint after it was given FDA’s accelerated approval to treat Duchenne muscular dystrophy.Lilly to invest additional
US$ 5.3 bn in US site to boost Zepbound, Mounjaro supplyThe battle to gain a larger share of the
obesity-diabetes pie just got fiercer. Eli Lilly has more than doubled its investment at
its Lebanon (Indiana, US) manufacturing site with a new US$ 5.3 billion commitment. This raises Lilly’s investment at this site to US$ 9 billion, up from US$ 3.7 billion. This expansion will enhance Lilly’s capacity to manufacture the API — tirzepatide — for its Zepbound and Mounjaro injections so that more adults with chronic diseases like obesity and type 2 diabetes may benefit from these important treatments, the company said.Merck set to buy
clinical-stage ophthalmology biotech EyeBio for US$ 1.3 bnMerck has announced it is buying ophthalmology
biotechnology firm Eyebiotech Limited (EyeBio) for US$ 1.3 billion. The
deal also includes US$ 1.7 billion in additional milestone payments. London-headquartered EyeBio’s lead candidate Restoret has finished early to mid-stage
testing for diabetic macular edema (DME)
and neovascular age-related macular degeneration (NVAMD).J&J scoops up rights to eczema antibody for US$ 1.25 bn: Johnson & Johnson has agreed to buy the rights to an experimental skin disorder treatment from Numab Therapeutics for around US$ 1.25 billion. The therapy — NM26 — is phase 2-ready and targets two clinically proven pathways in atopic dermatitis (AD), commonly known as eczema. Last week, J&J had acquired Proteologix for US$ 850 million, which was also to
help it address key unmet needs for AD patients.Takeda inks potential US$
1.2bn deal with Degron; Asahi Kasei to buy CalliditasJapan’s Takeda has inked a deal with Shanghai-headquartered
Degron Therapeutics to discover and develop novel molecular glue degraders
(MGDs) for multiple targets in oncology, neuroscience, and inflammation.
The deal could be valued at around US$ 1.2 billion. MGDs are an emerging class
of potentially therapeutic compounds touted as exciting opportunities for novel drug discovery.Meanwhile, Japanese conglomerate — Asahi Kasei — said it has offered to buy out Swedish drugmaker
Calliditas Therapeutics for SEK 11.1 billion (US$ 1.1 billion) as the former seeks to become a global
player in the pharma industry. Calliditas focuses on novel treatments for
orphan indications and patients with unmet needs.FDA okays Tris Pharma’s once-daily, non-stimulant pediatric ADHD drugFDA has okayed Onyda XR (clonidine hydrochloride), 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. It is expected to be
available in pharmacies in the second half of 2024. FDA panel votes against Novo’s weekly insulin for type 1 diabetesFDA’s advisory committee on endocrinologic and metabolic drugs has voted seven to four against the benefits of Novo Nordisk’s once-weekly Awiqli (insulin
icodec). The panel said the benefits of Awiqli do not outweigh its risks. The Danish drugmaker was
aiming to bring to market the first weekly insulin product, 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.Ozempic impresses in
late-stage trial for kidney disease: Detailed results presented at the ERA congress and published in the New England Journal of Medicine showed Ozempic (semaglutide) 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
complication by 24 percent.Novartis tees up two rare
kidney disease therapy approvals after late-stage winsThe ERA congress also saw Novartis tout two promising late-stage readouts for rare kidney disease treatments as it tees up two potential approvals in
the renal therapy space. Interim results showed the Swiss drugmaker’s experimental drug atrasentan, along with supportive care, reduced proteinuria (elevated protein in the urine) by 36.1 percent in patients with IgAN. Novartis plans on applying for FDA’s approval in the first half of this year.The
other drug is Fabhalta (iptacopan), which was being trialed in patients with the ultra-rare kidney
disease C3 glomerulopathy (C3G). In combination with supportive care, Fabhalta
lowered proteinuria by 35.1 percent at six months. C3G currently has no
approved therapies.NS Pharma’s DMD drug fails confirmatory trial: Preliminary results from a confirmatory trial show NS Pharma’s Viltepso (viltolarsen) has failed to reach its primary endpoint after it was given FDA’s accelerated approval in August 2020 to treat Duchenne muscular dystrophy (DMD). However, NS Pharma remains confident in viltolarsen and said it is “conducting further detailed data analyses”.Four deaths mar J&J’s prostate cancer trial: Johnson & Johnson’s experimental prostate cancer drug that uses a rare
radioactive particle called actinium-225 has helped three patients by reducing their tumors
significantly. However, those results were marred by the death of four patients in the early-stage study. The first-in-human study concluded that “JNJ-6420 elicited profound and durable biochemical and radiographic responses.” However, 61 percent of the participants experienced grade 3 or higher treatment-emergent adverse events.
Impressions: 1131
https://www.pharmacompass.com/radio-compass-phisper/lilly-to-invest-additional-us-5-3-bn-to-boost-obesity-drug-supply-fda-panel-votes-against-novo-s-weekly-insulin
#Phispers by PharmaCompass
30 May 2024
In this week’s news, AstraZeneca has laid out an ambitious plan to achieve US$ 80 billion in revenue by 2030. The drugmaker also announced an investment of US$ 1.5 billion to set up an antibody drug conjugates (ADCs) plant in Singapore.In news from clinical trials, Eli Lilly’s once-a-week insulin shot — efsitora — scored two late-stage wins. GSK’s long-acting experimental asthma drug depemokimab reduced asthma attacks in two late-stage trials. And Bayer’s non-hormonal menopause drug significantly reduced hot flashes in two phase 3 studies.In approvals, the US Food and Drug Administration (FDA) has granted accelerated approval to Amgen’s targeted immunotherapy Imdelltra for adults in the advanced stages of small cell lung cancer that has proved hard to treat or has worsened despite chemotherapy. FDA also okayed the first two biosimilars for Regeneron’s blockbuster eye drug Eylea.A group of cancer victims have sued Johnson & Johnson accusing it of fraud in its plans to settle the talc lawsuits.In deals, Biogen is acquiring Human Immunology Biosciences (HI-Bio) for up to US$ 1.8 billion, Johnson & Johnson is buying California-based Proteologix for US$ 850 million and Eli Lilly has inked a potential US$ 1.1 billion collaboration with Aktis Oncology.Astra sets 2030 revenue
target at US$ 80 bn, invests US$ 1.5 bn to build ADC facilityAstraZeneca has laid out an ambitious plan to deliver US$ 80 billion in total revenue by 2030. That will be a 75 percent leap from the US$ 45.8 billion in revenue it posted in 2023. Astra expects to launch 20 new medicines by 2030. Astra’s targets are driven by its cancer portfolio, as also its biopharmaceuticals and rare disease portfolios. The drugmaker’s oncology portfolio had brought in US$ 17.1 billion last year.The update comes on the heels of Astra’s investment of US$ 1.5 billion in building a manufacturing facility in Singapore for ADCs to
enhance the global supply of its ADC portfolio.Meanwhile, Pfizer has launched a new multi-year program to cut costs by around US$ 1.5
billion by 2027-end. Last year, it had announced a US$ 4 billion cost cutting
plan.Lilly’s weekly insulin proves to be as effective as daily doses in two late-stage trialsEli 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. Lilly is
in a race with Novo Nordisk to bring to market weekly
injections with long-acting insulins, which would lower the treatment burden
for diabetes patients.There was disappointing news from its rival Novo on its long-acting weekly insulin — Awiqli (insulin icodec). FDA said the use of this med came with an increased risk
of low blood sugar in patients with type 1 diabetes, who are more
insulin-dependent. An FDA panel will meet on May 24 to review Novo’s application seeking approval for this once-weekly insulin.GSK sells remaining stake in
Haleon; scores trial wins for asthma drug: GSK has raised £ 1.25 billion (US$ 1.52 billion) by
dropping the remainder of its stake (4.2 percent) in Haleon. It also touted two late-stage wins for its experimental asthma drug
depemokimab. The med reduced asthma attacks over a year at a rate that
was clinically significant.Bayer’s menopause drug reduces hot flashes in trials: 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 (fezolinetant).Amgen’s med grabs FDA’s accelerated nod for small cell lung cancerFDA has granted accelerated approval to Amgen’s Imdelltra (tarlatamab-dlle)
for adults in the advanced stages of small cell lung cancer
(SCLC) that has proven to be hard to treat or has worsened despite platinum-based chemotherapy. The bi-specific antibody is
a targeted immunotherapy that shrank tumors in 40 percent of patients in a
mid-stage trial. SCLC is usually more aggressive and deadlier than non-small
cell lung cancer.First biosimilars for Regeneron’s Eylea okayed: FDA has approved the first interchangeable biosimilars to Eylea (aflibercept) to treat macular
degeneration and other eye conditions. The US agency greenlit Biocon Biologics’ Yesafili (aflibercept-jbvf) and Samsung Bioepis and Biogen’s Opuviz (aflibercept-yszy) to be used as a substitute for Regeneron’s blockbuster eye drug.Cancer victims sue J&J over fraudulent bankruptciesA group of cancer victims have sued Johnson & Johnson accusing it of fraud for the repeated efforts to use a shell company’s bankruptcy to resolve tens of thousands of lawsuits alleging its talc products contained asbestos and caused cancer.Biogen to buy HI-Bio for up to US$ 1.8 bn; Merck KGaA to buy Mirus BioBiogen has agreed to acquire Human Immunology
Biosciences (HI-Bio) for up to US$ 1.8 billion, including an upfront
payment of US$ 1.15 billion. The deal gives Biogen a promising candidate — felzartamab — that may be a cure
for a range of immune-mediated diseases.Meanwhile, Merck KGaA has agreed to buy Wisconsin-based Mirus Bio for US$ 600 million. Mirus Bio is a specialist
in the development and commercialization of transfection reagents that are used
to help introduce genetic material into cells. These reagents play a key role
in the production of viral vectors for cell and gene therapies.J&J to buy Proteologix for US$ 850 mn: Johnson & Johnson is acquiring
Proteologix for US$ 850 million in cash to advance its dermatology portfolio
with the opportunity to address significant unmet need in atopic dermatitis.Aktis in radiopharma deal with Lilly: Aktis Oncology is collaborating with Eli Lilly to discover and develop novel anti-cancer radiopharmaceuticals. Aktis will receive an upfront payment of US$ 60 million, and will be eligible for
milestone payments of US$ 1.1 billion.
Impressions: 487
https://www.pharmacompass.com/radio-compass-phisper/astra-targets-us-80-bn-revenue-by-2030-invests-us-1-5-bn-in-adc-plant-lilly-s-weekly-insulin-scores-late-stage-wins
#Phispers by PharmaCompass
23 May 2024
