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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