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    Pipeline Prospector July 2024: Indices continue to climb; Lilly buys Morphic for US$ 3.2 bn, Kisunla bags FDA nod

    Pipeline Prospector July 2024: Indices continue to climb; Lilly buys Morphic for US$ 3.2 bn, Kisunla bags FDA nod

    The biotechnology sector ended in the green for the third month in a row in July, significantly outperforming the broader market. The Nasdaq Biotechnology Index (NBI) climbed by a robust 6.6 percent, closing at 4,843.6, up from a close of 4,545.28 in June. Similarly, the SPDR S&P Biotech ETF (XBI) index surged by 6.8 percent, reaching 99.06, up from June’s closing of 92.71. The S&P Biotechnology Select Industry Index (SPSIBI) followed suit, jumping 6.8 percent to 7,716.95 compared to a 4.25 percent rise in June, when it closed at 7,225.07.The month saw a few significant deals. Eli Lilly announced the acquisition of Massachusetts-based Morphic Holding for approximately US$ 3.2 billion in cash, bolstering its presence in the US$ 26.65 billion inflammatory bowel disease (IBD) market. Lilly also signed a strategic deal with radiopharmaceutical company Radionetics Oncology for US$ 140 million, with an option to purchase the entire company for US$ 1 billion. As the month drew to a close, Boehringer Ingelheim said it is acquiring Nerio Therapeutics for up to US$ 1.3 billion, in order to expand its immuno-oncology portfolio.Access the Pipeline Prospector Dashboard for July 2024 Newsmakers (Free Excel)Lilly’s donanemab finally gets approved; Dupixent okayed as add-on therapy for COPDWith the Alzheimer's Association International Conference (AAIC) taking place in Philadelphia (in the US), the spotlight was firmly on Alzheimer’s disease. In the last week of July, the US Food and Drug Administration (FDA) approved Alpha Cognition’s Zunveyl (benzgalantamine) to treat mild-to-moderate Alzheimer’s disease. In early July, and weeks prior to the conference, the FDA had granted a long-awaited approval to Eli Lilly’s donanemab, to be marketed as Kisunla, for the treatment of early symptomatic Alzheimer’s disease.In other approvals, European regulators became the first in the world to approve Sanofi and Regeneron’s Dupixent as an add-on therapy for chronic obstructive pulmonary disease (COPD) patients with high levels of certain white blood cells.In May, FDA had extended its target action date of its priority review of Dupixent as an add-on maintenance treatment for COPD by three months. The revised target action date is now September 27, 2024.Access the Pipeline Prospector Dashboard for July 2024 Newsmakers (Free Excel) Merck’s RSV jab shows efficacy in infants; GSK’s Dovato measures up to Gilead’s BiktarvyMerck said its monoclonal antibody jab to protect infants against RSV-related infections has met the main goals of a mid-to-late-stage trial. Clesrovimab reduced medically attended lower respiratory infections caused by RSV through day 150. Merck plans to submit the data to global regulators. Currently, Sanofi and Astra’s Beyfortus is approved by the FDA to prevent RSV in children up to 24 months.In the largest study of its kind, GSK’s HIV drug Dovato was found to be non-inferior to Gilead Sciences’ Biktarvy, 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.Pfizer’s gene therapy for hemophilia A, giroctocogene fitelparvovec, showed promising results in a late-stage trial by significantly reducing the number of annual bleeding episodes. This brings Pfizer closer to securing FDA approval, competing with BioMarin’s Roctavian. Pfizer also said it is moving ahead to mid-stage trials with a once-daily version of its glucagon-like peptide 1 (GLP-1) drug danuglipron for weight loss. In December, Pfizer had discontinued a twice-daily version of danuglipron on account of side effects. Pfizer’s stock also benefited from its healthy second quarter (Q2) results.Swiss drugmaker Roche is reintroducing Susvimo 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.Roche also revealed that a second drug candidate from its up to US$ 3.1 billion buyout of Carmot Therapeutics — an obesity drug —  has delivered promising results in an early-stage trial. This 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.Access the Pipeline Prospector Dashboard for July 2024 Newsmakers (Free Excel) Biogen-Sage’s essential tremor drug rejected; Novo’s weekly insulin hit with FDA’s CRLSeveral drugmakers faced setbacks last month. Novo Nordisk received a complete response letter (CRL) from the FDA, declining approval for its weekly insulin Awiqli. The agency requested additional information related to the manufacturing process, as well as on the type 1 diabetes indication. In May, an FDA panel had voted seven to four against the benefits of Awiqli outweighing its risks.Sage and Biogen’s partnership experienced another setback after the failure of their drug SAGE-324 in a phase 2 trial for essential tremor, a disorder that causes uncontrollable shaking of hands, arms and other parts of the body. This follows the previous failure of Zurzuvae to secure an FDA approval for clinical depression. Meanwhile, Eisai and Biogen’s Alzheimer’s drug Leqembi, faced a setback in Europe when the EU drugs regulator rejected its approval. The European Medicines Agency said the drug’s meager benefit on slowing cognitive decline in early Alzheimer’s did not outweigh the risk it brings of serious brain swelling. Leqembi is approved in the US market, where it has a new competitor — Lilly’s Kisunla.Also, BMS walked away from its rights to the ADC farletuzumab ecteribulin after having paid Japanese drugmaker Eisai US$ 650 million. As part of its portfolio reprioritization, BMS decided to end the co-development agreement.Access the Pipeline Prospector Dashboard for July 2024 Newsmakers (Free Excel) Our viewAs July drew to a close, several pharma majors announced their second quarter (Q2) earnings, including Pfizer, Merck, AbbVie and, AstraZeneca. Most of these drugmakers ended up beating Wall Street expectations. For instance, Pfizer saw revenue growth in Q2 after shrinking for five quarters. It posted revenues of US$ 13.3 billion in the second quarter of 2024, compared to US$ 13 billion in the corresponding quarter last year. It has subsequently raised its 2024 guidance by US$ 1 billion. This means it’s not just the indices and share prices, but even the brass tacks — the top line and the bottomline of drugmakers — are looking up. And that may bring more cheer to the markets in August.Access the Pipeline Prospector Dashboard for July 2024 Newsmakers (Free Excel)  

    Impressions: 1547

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    #PharmaFlow by PHARMACOMPASS
    01 Aug 2024
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    Pipeline Prospector June 2024: FDA approves Merck’s next-gen pneumococcal vaccine, Verona’s COPD therapy

    Pipeline Prospector June 2024: FDA approves Merck’s next-gen pneumococcal vaccine, Verona’s COPD therapy

    The pharma indices were back in the black in May, and the good streak continued through June with the Nasdaq Biotechnology Index (NBI) gaining 3 percent, the SPDR S&P Biotech ETF (XBI) index up over 3.1 percent and the S&P Biotechnology Select Industry Index (SPSIBI) rising 4.25 percent.The two summer months were similar in more ways than one. In May, Eli Lilly had announced an investment of US$ 5.3 billion to boost the supply of Zepbound and Mounjaro. In June, Novo Nordisk followed suit, investing US$ 4.1 billion to develop a new manufacturing facility to boost the supply of Ozempic and Wegovy.Similarly, the US Food and Drug Administration (FDA) continued to grant vaccine approvals in June after okaying Moderna’s mRNA respiratory syncytial virus (RSV) vaccine in May. Last month, Merck’s next-generation pneumococcal vaccine won an FDA nod, and the agency expanded the use of GSK’s respiratory syncytial virus (RSV) vaccine to include adults aged 50 to 59.However, June was a lackluster month for mergers and acquisitions. The month had to be content with some tie-ups. For instance, Roche signed an up to US$ 1.8 billion deal with Boston-based startup Ascidian Therapeutics to discover and develop novel gene therapies for difficult-to-treat neurological diseases. AbbVie inked a US$ 1.7 billion agreement with China’s FutureGen to bring the latter’s next-generation treatment (FG-M701) for inflammatory bowel disease to market. Takeda signed an option agreement with China’s Ascentage Pharma for an exclusive license to a promising drug for chronic myeloid leukemia and other blood cancers. And Day One Biopharmaceuticals struck a licensing deal with MabCare for a novel antibody drug conjugate (ADC) to treat multiple cancers. The deal’s potential value is US$ 1.2 billion.Access the Pipeline Prospector Dashboard for June 2024 Newsmakers (Free Excel)Merck’s pneumococcal jab wins FDA nod; Moderna’s combo vaccine scores trial winVaccines took centerstage in June. FDA approved Merck’s Capvaxive, a next-generation pneumococcal vaccine designed to protect adults from a broader range of pneumococcus bacteria strains that cause serious illnesses and pneumonia. Capvaxive targets 21 bacterial variations responsible for about 85 percent of invasive pneumococcal disease cases in older adults. Similarly, GSK secured FDA approval for its RSV vaccine for adults aged 50 to 59 years. This makes Arexvy the only RSV shot endorsed for that age group.In a late-stage trial, Moderna’s 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. The combo jab generated more antibodies than currently marketed flu vaccines and Moderna’s Spikevax. And the world’s first personalized mRNA cancer vaccine from Moderna has raised hopes for patients with skin cancer, as three-year data from a mid-stage trial showed some benefits on patients who took the vaccine in combination with Merck’s Keytruda.Despite these developments, Moderna’s stock dropped 19 percent in June after it said the efficacy of its RSV vaccine mRESVIA had vaned substantially to 50 percent after 18 months.Access the Pipeline Prospector Dashboard for June 2024 Newsmakers (Free Excel) Verona, Geron score maiden FDA approvals; BMS’ Augtyro bags tumor-agnostic nodTwo companies obtained their first FDA approvals last month. The first one was Verona Pharma (stock up 15 percent) — it received its maiden FDA approval for Ohtuvayre for treating chronic obstructive pulmonary disease (COPD). This is also the first inhaled COPD treatment with a novel mechanism of action.The second company to get its maiden FDA approval was Geron, a commercial-stage biopharmaceutical company. FDA signed off on Geron’s Rytelo for treating transfusion-dependent anemia in patients with low- to intermediate-risk myelodysplastic syndromes (MDS), a group of blood cancers.In June, FDA granted accelerated approvals to at least three drugs. BMS’ Augtyro was granted FDA’s accelerated approval for treating 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.Ipsen received FDA’s accelerated approval for Iqirvo, a first-in-class, once-daily oral medication for treating primary biliary cholangitis (PBC), a progressive liver disease affecting mostly women.Sarepta Therapeutics’ (stock up 24 percent) Elevidys received accelerated approval for Duchenne muscular dystrophy (DMD) despite failing its primary endpoint in a late-stage trial.Amongst other approvals, Argenx’s Vyvgart Hytrulo was approved to treat chronic inflammatory demyelinating polyneuropathy (CIDP). This is a novel treatment option for this rare and debilitating neuromuscular disorder. And BMS’ Krazati got its second approval for treating colorectal cancer with a specific KRAS mutation.Access the Pipeline Prospector Dashboard for June 2024 Newsmakers (Free Excel) GSK’s failed cancer drug posts trial win; Gilead’s HIV prophylaxis shows efficacyIn late-stage trials, GSK’s multiple myeloma therapy Blenrep cut the risk of disease progression or death by almost half compared to standard-of-care treatments. The once-failed ADC was pulled from the lucrative US market in 2022, but the results could signal a comeback for Blenrep.Intra-Cellular’s antipsychotic drug Caplyta scored another remarkable late-stage win for treating major depressive disorder (MDD). In another late-stage trial, Gilead’s (stock up 6 percent) long-acting injection proved to be more effective in preventing HIV infection in women compared to the daily pill Truvada. 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, Sunlenca could be a game-changer in HIV prevention. Analysts estimate that PrEP-related sales could be over US$ 1.7 billion.In a blow to millions affected by long Covid, Pfizer’s Paxlovid did not appear to improve the symptoms as was hoped. Pfizer’s stock fell 7 percent in June.Access the Pipeline Prospector Dashboard for June 2024 Newsmakers (Free Excel) Our view This was the second month when pharma indices showed an upward trend. It’s been a good first half for the US stock markets. But there are mixed reports on how markets will perform in the second half, given the uncertainties around interest rate cuts and the outcome of the presidential elections in the US slated to be held in November. Though for those tracking biopharma news, there are enough interesting developments to fret over the markets.Access the Pipeline Prospector Dashboard for June 2024 Newsmakers (Free Excel) 

    Impressions: 2329

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    https://www.pharmacompass.com/pipeline-prospector-blog/pipeline-prospector-june-2024-fda-approves-merck-s-next-gen-pneumococcal-vaccine-verona-s-copd-therapy

    #PharmaFlow by PHARMACOMPASS
    04 Jul 2024
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    Pipeline Prospector Feb 2022: Biotechs face cash crunch after stock market ‘bloodbath’

    Pipeline Prospector Feb 2022: Biotechs face cash crunch after stock market ‘bloodbath’

    Our January 2022 update of the Pipeline Prospector highlighted how the Omicron variant of the novel coronavirus drove the pharma and biotech stocks down. In February too, the bearish trend continued. The ongoing Russia-Ukraine war further spooked the global markets. The Nasdaq Biotechnology Index (NBI) sank by 5.5 percent to US$ 3,996 last month. In January, NBI had dropped 11 percent to US$ 4,187. Similarly, the S&P Biotechnology Select Industry Index (SPSIBI) sank by 5.4 percent to US$ 6,992. In comparison, the S&P 500 Index (SPX) fell 3.8 percent to US$ 4,373.94. On the earnings side, several drug companies have already reported their fourth quarter (Q4) results. Broadly, the medical sector posted mixed results, with Q4 earnings expected to rise 25.8 percent on a sales increase of 13.9 percent. Access the Pipeline Prospector Dashboard for February 2022 Newsmakers Biotechs’ hopes to raise fresh funds hampered by market rout Over the last two years, several loss-making biotechs raised a record US$ 32.7 billion in initial public offerings (IPOs). Today, 83 percent of the recently listed US biotech and pharma stocks are trading below their IPO price, says a report published in Financial Times. Biotech groups that listed in 2021 are trading on average 37 percent below their IPO price, as compared to a 22 percent fall for all newly US-listed companies. Many of these companies were hoping to raise fresh funds from their investors through a subsequent share sale with their drugs marching ahead on the R&D cycle. But their ability to do so has been hampered by a market rout for biotech stocks. Retail investors and generalist money managers have turned sour towards the industry. There is a “complete bloodbath across the board,” says Geraldine O’Keeffe, a partner at healthcare investment firm LSP. As a result, dozens of biotech companies are running low on cash and face an uphill task to raise fresh funds. However, experts feel biotech stocks still hold plenty of attraction, because the right ones can make investors wealthy. Access the Pipeline Prospector Dashboard for February 2022 Newsmakers Covid drug, vaccine makers continue to see drop in stock prices Covid-19 vaccine and drugmakers — such as Pfizer, BioNTech, Merck, Moderna Therapeutics, J&J and Roche — continued to see a drop in their stock prices last month. With Covid cases plummeting from all-time highs, experts have been questioning whether vaccines will be a sustainable revenue stream in the years to come. On February 14, shares of Moderna touched its lowest level in nearly a year. The reason — a slew of regulatory filings revealed four Moderna executives — including billionaire CEO Stéphane Bancel — had sold 23,281 shares for about US$ 3.6 million in early February. Out of this, Bancel had offloaded 19,000 shares. Bancel had reportedly been selling shares of Moderna since late 2019. However, suspicions of insider trading were raised when he cancelled his Twitter account without prior warning. Similarly, Pfizer and BioNTech saw a drop in their shares by 2 percent and over 9 percent respectively around mid-February as the duo delayed their FDA application for an emergency use authorization (EUA) of their Covid-19 vaccine in children aged between six months and four years.  Late last year, Johnson & Johnson had temporarily halted the production of its Covid-19 vaccine at its Leiden facility in the Netherlands. More negative news last month on J&J’s Covid vaccine led to a further 1.07 percent drop in its shares. According to a paper published in the New England Journal of Medicine, final analysis of a phase 3 study revealed that the vaccine provided only 52.9 percent protection against moderate to severe-critical Covid-19, and may be even less effective in the longer term. In the case of Merck, FDA’s revision of the EUA for Merck’s Covid-19 pill molnupiravir sent its shares down by 0.42 percent. The agency said it should only be used as a last line of defense if other treatments are available. Access the Pipeline Prospector Dashboard for February 2022 Newsmakers AbbVie, Astra, BMS, Lilly, Sanofi, Regeneron score wins When we look at mega cap gainers, AbbVie emerges as one of the top performers. AbbVie’s fortunes have hinged on Humira, and this autoimmune-disease drug is slated to face competition from biosimilars in the US market soon. However, experts are of the view that Humira won’t lose its mega-blockbuster tag anytime soon. Moreover, Humira’s successors — Rinvoq and Skyrizi — brought in sales of nearly US$ 4.6 billion in 2021. AbbVie projects combined global sales of US$ 15 billion from the two drugs in 2025, and the net increase could be enough to offset sales declines for Humira.  Moreover, analysts see a lot of promise in its anti-psychotic drug Vraylar, which is awaiting add-on FDA approval for patients with major depressive disorder (MDD) who are already on antidepressants. Such an approval could take Vraylar beyond the expected US$ 4 billion in peak sales. In 2021, Vraylar generated just over US$ 1.7 billion in sales. Similarly, there was positive news from AstraZeneca, as the British-Swedish drugmaker and its Japanese partner Daiichi Sankyo scored a crucial win for their breast cancer drug Enhertu. Results from a phase 3 trial showed Enhertu boosted survival in patients with a type of tumor called HER2-low that had spread widely or couldn't be removed surgically. It’s the first time such a therapy has shown mortality benefit in patients with this kind of relatively common breast cancer. Riding on the success of its Covid vaccine, Astra reported 41 percent growth in its 2021 revenues. Its Covid-19 vaccine generated US$ 4 billion in 2021. Despite the FDA showing its unwillingness to approve Eli Lilly and its partner Innovent Biologics’ cancer treatment — Tyvyt — as the drug’s clinical data is solely from China, Lilly posted gains in February. The reasons were three-fold. One, the FDA issued an EUA for Eli Lilly’s antibody bebtelovimab to treat mild-to-moderate Covid-19 in patients above the age of 12. The company has claimed that bebtelovimab can neutralize the Omicron variant of coronavirus. Two, Lilly entered into an agreement with the US government to supply 600,000 doses of bebtelovimab for US$ 720 million. And three, the FDA approved Lilly and its partner Boehringer Ingelheim's drug, Jardiance, for expanded use in reducing the risk of death and hospitalization for all patients with heart failure. Other major gainers were Bristol Myers Squibb, Sanofi and Regeneron. While BMS announced a US$ 5 billion accelerated share buyback program, Sanofi bagged FDA approval for cold agglutinin disease (CAD) drug Enjaymo (sutimlimab). The disease affects around 5,000 people in the US. The French drugmaker also unveiled a new corporate identity. And Regeneron announced encouraging phase 2 results for high-dose aflibercept 8 mg in wet age-related macular degeneration (wet AMD). Among mid cap companies, Maravai LifeSciences’ stocks gained 30 percent after sources claimed that Germany-headquartered Sartorius has placed a US$ 11 billion bid for the Covid vaccine reagent vendor. Both the companies refused to comment about the bid. Access the Pipeline Prospector Dashboard for February 2022 Newsmakers Biocon acquires Viatris’ biosimilars business The biggest deal of the month was Biocon Biologics’ acquisition of Viatris’ biosimilars business for up to US$ 3.3 billion. The deal will be funded through a debt of US$ 1.2 billion, apart from stocks and cash. Biocon Biologics will acquire Viatris’ global commercial infrastructure in developed and emerging markets, its global biosimilars business and rights to Viatris’ biosimilar assets. Massachusetts-based Collegium Pharmaceutical acquired specialty pharmaceutical company BioDelivery Sciences International (BDSI) in a US$ 604 million all-cash transaction. BDSI has a portfolio of pain and neurology products that address serious and debilitating conditions. Other deals of February include Mersana Therapeutics’ research collaboration and license agreement worth US$ 1.04 billion with Janssen to advance antibody-drug conjugates (ADCs) targeting cancers, and Remix Therapeutics’ US$ 1.045 billion strategic collaboration with Janssen for the discovery and development of small molecule therapeutics. Similarly, ImmunoGen, a leader in ADCs for the treatment of cancer, announced a global, multi-year definitive licensing agreement with Eli Lilly. Under the deal, ImmunoGen is eligible to receive up to US$ 1.7 billion in potential target program exercise fees and milestone payments. And Takeda signed a US$ 2 billion biobucks deal with Code Biotherapeutics across four programs. In other major developments, Gilead reached a US$ 1.25 billion settlement with ViiV Healthcare to resolve a litigation pertaining to Biktarvy and ViiV’s Dolutegravir patents. In IPOs, Nuvectis Pharma, an oncology-focused biopharmaceutical company, announced the closing of its IPO of 3.2 million shares. Access the Pipeline Prospector Dashboard for February 2022 Newsmakers Our view The year 2022 began on a muted note, with bearish trends being witnessed due to the Omicron variant of the coronavirus. While there is hope that Covid-19 won’t play more havoc with our lives, the ongoing war between Russia and Ukraine has taken oil prices to record highs and sent stock markets into a tizzy. The war will have an impact on clinical trials — according to the FDA, 251 clinical trials for drugs and devices are underway in Ukraine. The war is also likely to impact the financial performance of drug companies across the world. The earlier the war ends, the better it is for everyone. For now, we can safely assume that next month’s Pipeline Prospector is unlikely to bring much cheer from the bourses. Though we certainly hope we are proved wrong. Access the Pipeline Prospector Dashboard for February 2022 Newsmakers 

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    https://www.pharmacompass.com/pipeline-prospector-blog/pipeline-prospector-feb-2022-biotechs-face-cash-crunch-after-stock-market-bloodbath

    #PharmaFlow by PHARMACOMPASS
    10 Mar 2022
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