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Pipeline Prospector March 2023: Silicon Valley Bank collapse hits biotech indices; Pfizer buys out Seagen

Biotech indices have witnessed a lot of volatility throughout 2022 and 2023. Just when they were beginning to look up, the collapse of Silicon Valley Bank (SVB) in mid-March dragged them down once again. The bank's fall left many biotech firms uncertain about their future, as life sciences and healthcare accounted for 12 percent of SVB’s deposits of US$ 173 billion.The indices regained some ground by the end of the month — the Nasdaq Biotechnology Index (NBI) increased by 0.6 percent to US$ 4,125, but the S&P Biotechnology Select Industry Index (SPSIBI) and the SPDR S&P Biotech ETF (XBI) both registered declines, falling by 8.3 percent to US$ 5,898 and 8.2 percent to US$ 76.21, respectively. In February, the NBI had fallen by 6 percent, while the SPSIBI and XBI had both experienced declines of 7 percent and 8 percent, respectively.Several mega and large cap companies, such as Sanofi, Eli Lilly, Novartis, AstraZeneca, Novo Nordisk, GSK and Moderna, posted gains in March.Access the Pipeline Prospector Dashboard for March 2023 Newsmakers (Free Excel)Sanofi’s Dupixent succeeds in COPD trial, buys Provention Bio for its diabetes drug The biggest mega cap gainer on the bourses was Sanofi (its stock rose 17 percent in March). Its blockbuster anti-inflammatory drug Dupixent, developed along with Regeneron, succeeded in a late-stage clinical trial for chronic obstructive pulmonary disease (COPD), a disease that causes a progressive decline in lung function. If approved, Dupixent would become the first biologic treatment for COPD. Analysts estimate the label expansion to add US$ 3.5 billion in peak sales for Dupixent. In a further boost, the European Commission approved Dupixent for children aged six months to five years with severe atopic dermatitis. Regeneron’s stock was up 6 percent.In mid-March, Sanofi said it will purchase US-based Provention Bio (up 167 percent) for US$ 2.9 billion. The deal builds on an existing co-promotion agreement between the two companies, with Sanofi gaining full ownership of Provention Bio’s type 1 diabetes therapy Tzield. Also, Sanofi and partner Sobi’s treatment for severe hemophilia A (a hereditary bleeding disorder) in previously treated patients under 12 years, efanesoctocog alfa, met its primary endpoint in a phase 3 pivotal study.Access the Pipeline Prospector Dashboard for March 2023 Newsmakers (Free Excel) Novartis’ Kisqali proves effective in breast cancer trial; Astra’s Enhertu posts gainsNovartis (10 percent) and AstraZeneca (8 percent) were the other mega cap gainers in March. Novartis’ breast cancer drug Kisqali plus endocrine therapy following surgery proved to be effective in a phase 3 trial in treating patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) early breast cancer who are at risk of recurrence. The Swiss pharma also shared positive long-term data for its gene therapy, Zolgensma, as a treatment for spinal muscular atrophy, a genetic disease that affects muscle movement. Its subsidiary Sandoz received FDA approval for Hyrimoz, a biosimilar of adalimumab.AstraZeneca and partner Daiichi Sankyo (up 15 percent) announced positive results from a mid-stage trial of their blockbuster cancer drug Enhertu in multiple HER2-expressing advanced solid tumors. Astra and Merck’s Lynparza received authorization in the UK as a treatment for patients with metastatic castration-resistant prostate cancer (mCRPC).Similarly, AbbVie’s blockbuster drug Skyrizi achieved a win in a late-stage trial for adults with moderate-to-severe active ulcerative colitis, a type of bowel disease that affects the large intestine. The drug also showed positive results in a late-stage trial in adults with moderate-to-severe plaque psoriasis who still experience symptoms after six months of treatment with Novartis’ Cosentyx (secukinumab) and Lilly’s Taltz (ixekizumab).But AbbVie also faced a setback — FDA denied approval to AbbVie’s Parkinson’s therapy ABBV-951 and requested for more information on the device used to administer the medication. Overall, AbbVie’s stock rose 3 percent last month.In good news for Roche, a panel of external advisers to the FDA voted 11-2 in favor of expanding the use of its med Polivy in combination with other drugs for adults with diffuse large B-cell lymphoma. Roche also joined forces with Lilly to develop a blood test that can detect early signs of Alzheimer’s disease.Meanwhile, a combination of Roche’s immunotherapy Tecentriq and Exelixis’ cancer drug Cabometyx failed a late-stage trial in advanced renal cell carcinoma. Roche’s stock remained unchanged in March. Similarly, Merck’s anti-TIGIT therapy vibostolimab, in combination with Keytruda, failed to improve progression-free survival in patients with metastatic non-small cell lung cancer in a phase 2 trial. In a separate phase 2/3 study, Keytruda and chemotherapy significantly improved overall survival in patients with unresectable malignant pleural mesothelioma, a rapidly progressing cancer that develops in the lining of the lungs. Merck’s stock fell 1 percent. FDA brought out a draft guidance for accelerated approvals to improve clinical trials of cancer drugs.Access the Pipeline Prospector Dashboard for March 2023 Newsmakers (Free Excel) GSK, Pfizer’s RSV jabs get FDA panel’s backing; Pfizer buys out Seagen for US$ 43 bnA panel of external experts to the FDA backed both GSK (6 percent) and Pfizer’s respiratory syncytial virus (RSV) experimental vaccines, setting the stage for a race between the two rivals to bring out the first shot in the US against the disease. The final results of a trial published in the New England Journal of Medicine showed that Pfizer’s experimental maternal RSV vaccine was 82 percent effective in preventing serious illnesses in children when given to pregnant mothers.Though Pfizer announced its biggest buyout in recent times, its stock saw no change in March. It is acquiring cancer treatment specialist Seagen (up 12 percent) for US$ 43 billion as part of its move to mitigate a hit in revenues from declining sales of its Covid-19 products and patent expirations of some top drugs in the coming years. FDA approved Pfizer’s Zavzpret nasal spray for the treatment of acute migraine. It, however, recalled 4.2 million units of its Nurtec ODT prescription migraine drug because it failed to meet child-resistant packaging requirements.In March, Moderna (11 percent) and partner Merck said they will present phase 2 data of their investigational personalized cancer vaccine, mRNA-4157, at an oncology conference in April. The experimental drug, in combination with Keytruda, received FDA’s breakthrough therapy designation in February. Meanwhile, the vaccine maker said it will open offices in South San Francisco and Seattle as part of its plan to rapidly advance its pipeline of messenger RNA medicines amid declining Covid-19 vaccine sales.BioNTech said it expected the sale of its Covid-19 vaccine to fall from €17.3 billion (US$ 18.7 billion) in 2022 to €5 billion (US$ 5.4 billion) this year. The German mRNA company will allocate up to €2.6 billion (US$ 2.8 billion) towards R&D this year. Its stock fell 5 percent.Access the Pipeline Prospector Dashboard for March 2023 Newsmakers (Free Excel) Insulin makers cut prices by up to 75 percent; Vertex posts gains in cell therapy for diabetes March saw a lot of activity in the field of diabetes. FDA accepted Lilly’s application for Jardiance as a treatment for children 10 years and older who are suffering from type 2 diabetes. Last month, Lilly (9 percent) decided to slash the list prices of its commonly prescribed insulin products, Humalog and Humulin, by 70 percent in the US. Rival Novo Nordisk (11 percent) also said it would cut the US prices of its insulin therapies by up to 75 percent.Large cap biopharma Vertex Pharmaceuticals’ cell therapy candidate VX-264 received investigational new drug application clearance from the FDA as a potential treatment for type 1 diabetes. Vertex’s stock went up 8 percent. And small cap firm Biomea Fusion posted positive topline data from a phase 1/2 study evaluating its lead pipeline candidate — BMF-219 — in patients with type 2 diabetes. Biomea’s stock skyrocketed 129 percent.Access the Pipeline Prospector Dashboard for March 2023 Newsmakers (Free Excel) Our viewDespite showing some signs of a revival in January, the first quarter of 2023 has been lackluster for biotech indices. In terms of M&As, the industry witnessed the Pfizer-Seagen deal and the Sanofi-Provention Bio deal. But we are expecting a lot more from 2023.In April, FDA is likely to take some important drug approval decisions — such as the one on the expanded use of Pfizer’s pneumococcal vaccine Prevnar 20 for use in infants and children, approval of Emergent BioSolutions’ anthrax vaccine and Daiichi Sankyo’s cancer drug quizartinib, which is under priority review, among many others. These decisions are bound to have an impact on the bourses. We are looking forward to an eventful month.Access the Pipeline Prospector Dashboard for March 2023 Newsmakers (Free Excel)

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Pipeline Prospector Jan 2023: Mega cap drugmakers face rout at bourses even as biotech indices inch upwards

After facing the worst year since 2008, biotech indices opened 2023 on a positive note. All the three indices posted gains in January — while the Nasdaq Biotechnology Index (NBI) was up 4.4 percent (at US$ 4,360), the S&P Biotechnology Select Industry Index (SPSIBI) rose 8.7 percent to US$ 6,896 and SPDR S&P Biotech ETF (XBI) increased 9 percent to US$ 88.90. In December 2022, the NBI was down 3.4 percent to US$ 4,213, while XBI had risen only 0.1 percent and SPSIBI had witnessed no change.Several major drugmakers have shared their financial results for 2022 since last month. Pfizer posted an operational growth of 30 percent with 2022 revenues touching an all-time high of US$ 100.3 billion. Merck posted a 22 percent increase, with sales of Keytruda growing 22 percent to US$ 20.9 billion. GSK generated £29.3 billion (US$ 36.3 billion) in revenue in 2022, an increase of 13 percent over 2021 figures, and Amgen posted a gain of 1 percent.Drugmakers like Eli Lilly and Johnson & Johnson saw a huge drop in sales of their Covid-19 products. Lilly suffered a 9 percent drop and J&J saw a 4 percent decline in Q4 2022 revenue. More companies are expected to release their 2022 results this month.Access the Pipeline Prospector Dashboard for January 2023 Newsmakers (Free Excel)Lower 2023 forecast, vaccine’s safety concern hammer Pfizer’s stockDespite the indices showing signs of recovery, stocks of several mega cap companies ended the month in the red. Pfizer’s stock suffered the biggest loss, dropping 14 percent in January, due to an interplay of various factors even as the drug behemoth reported best-ever sales in 2022, owing to its Covid-19 vaccine Comirnaty and antiviral pill Paxlovid. First, the US Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) launched an investigation into the possibility of a stroke in older adults who had received its updated Covid-19 booster shot. Second, despite the stellar results, Pfizer’s forecast for 2023 was lower by 33 percent, with an estimated revenue of US$ 67 to 71 billion. With the pandemic receding, there has been a considerable drop in demand for Covid products. Pfizer’s Covid vaccine partner BioNTech also saw its stock go down 6 percent. The other big loser was AbbVie (drop of 9 percent) – its blockbuster immunology drug Humira (adalimumab) saw its exclusive run come to an end in the US with Amgen launching a copycat — Amjevita. Seven other biosimilars are due to be launched later this year.A federal appeals court in Philadelphia blocked J&J’s plan to use the Texas two-step bankruptcy strategy to resolve around 40,000 lawsuits alleging that its talc products cause cancer. In another setback, its Janssen unit halted a late-stage global trial of its HIV vaccine after the drug was found to be ineffective at preventing infection. All these factors led to a 8 percent drop in J&J stocks.AstraZeneca’s stock tumbled 6 percent in January due to factors such as a second cancer lawsuit filed by Bristol Myers Squibb, wherein it claimed Astra’s cancer treatment Imjudo infringes on two patents related to its blockbuster drug Yervoy. FDA also revoked the emergency use authorization (EUA) for AstraZeneca’s Covid-19 treatment Evusheld, expecting it to fail against the currently dominant Omicron sub-variant.January wasn’t a great month for Merck either, whose stock plummeted 4 percent. The drugmaker halted a late-stage trial of its blockbuster immunotherapy drug Keytruda in prostate cancer after interim data showed that the drug failed to extend survival or help improve patients’ lives. Meanwhile, the drugmaker said it has identified the source of a potential cancer-causing agent – Nitroso-STG-19 – in its popular diabetes drugs Januvia and Janumet, and plans to resolve the issue by the end of the year.Access the Pipeline Prospector Dashboard for January 2023 Newsmakers (Free Excel) Bayer gains on sales forecast for Kerendia, Nubeqa; lawsuit settlements benefit TevaThree large cap companies — Bayer AG (14 percent), Teva (10 percent) and Vertex Pharmaceuticals (12 percent) – posted double digit gains on the bourses last month. Bayer hiked sales targets for two of its meds – heart drug Kerendia and prostate cancer treatment Nubeqa – to US$ 3.2 billion each.Israeli drugmaker Teva said it has either already settled with or confirmed participation of 48 US states to move forward with its US$ 4.25 billion proposed national settlement agreement to resolve thousands of lawsuits over its alleged role in the US opioid crisis.Vertex Pharmaceuticals said it plans to file for the US approval of its CRISPR gene-editing therapy exa-cel as a treatment for beta-thalassemia and sickle cell disease in the first quarter. If approved, the drug is expected to generate peak annual sales of over US$ 2 billion. Vertex has already applied for the drug’s authorization in the EU and UK. Vertex is also testing a non-opioid drug, VX-548, for acute pain in a late-stage trial.Among small cap companies, Massachusetts-based Theseus Pharmaceuticals posted a 180 percent surge in its stock price in January. The drugmaker said it plans to release clinical data from a phase 1/2 trial of its lead candidate – THE-630 – for advanced gastrointestinal stromal tumor patients, later this year. Analysts expect THE-630 to compete against Pfizer’s Sutent (sunitinib), with projected sales of over US$ 1 billion by 2035. Theseus is also developing two other early-stage candidates.Access the Pipeline Prospector Dashboard for January 2023 Newsmakers (Free Excel) Accelerated nods bring gains for Biogen, Seagen; Lilly loses on Alzheimer’s setback Biogen’s second Alzheimer’s drug – Leqembi (lecanemab) — received FDA’s accelerated approval to treat patients who are in the earliest stages of the neurodegenerative disease. However, Eli Lilly’s bid for an accelerated approval pathway for its experimental Alzheimer’s disease drug donanemab suffered a setback. FDA rejected the drug as Lilly did not provide enough data from patients who were treated for at least a year. However, days later Lilly’s cancer drug Jaypirca (pirtobrutinib) won accelerated approval as a treatment for mantle cell lymphoma, a rare form of blood cancer. FDA also accepted Lilly-Boehringer Ingelheim’s application for cancer drug Jardiance (empagliflozin) as a treatment for chronic kidney disease (CKD) in adult patients. Overall, while Biogen’s stock was up 5 percent in January, Lilly’s was down 7 percent.In another cancer drug update, FDA granted accelerated approval to Seagen’s Tukysa (tucatinib) to treat HER2-positive unresectable or metastatic colorectal cancer. Seagen’s stock rose 8 percent last month. And BeiGene’s cancer drug Brukinsa (zanubrutinib) received an approval in the US as a treatment for adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), pushing its stock up 11 percent. The drug has also received authorization in the UK.Access the Pipeline Prospector Dashboard for January 2023 Newsmakers (Free Excel) Our viewAs always, the new year began with the JP Morgan Healthcare Conference (San Francisco, January 9 to 12). For the last three years, the conference has been lackluster insofar as M&As were concerned. But this year, there were a number of buyouts – AstraZeneca said it will acquire US-based drug developer CinCor Pharma for up to US$ 1.8 billion. Italy’s privately-held Chiesi Farmaceutici announced it is buying Ireland-based rare diseases drugmaker Amryt Pharma for up to US$ 1.48 billion. And Ipsen picked up Albireo for US$ 952 million. Stocks of CinCor, Amryt and Albireo shot up by over 100 percent following the takeover news. While we do hope these buyouts signal an uptick in M&A activity, we also know that drugmakers who made billions from the pandemic are now facing a steep Covid cliff. Among these are Pfizer, BioNTech, Moderna, Gilead Sciences, AstraZeneca and Merck. The 2022 results announced so far confirm this trend. Insofar as biotech indices are concerned, we hope January has set the tone for the coming months.Access the Pipeline Prospector Dashboard for January 2023 Newsmakers (Free Excel)

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Pipeline Prospector March 2023: Silicon Valley Bank collapse hits biotech indices; Pfizer buys out Seagen