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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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06 Apr 2023

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Pipeline Prospector Dec 2022: Biotech indices fall on close of a volatile year

The year 2022 was a difficult one for the biotech sector. Marked with geopolitical unrest, rising interest rates, the Russian-Ukraine war, inflation, and most of all, a stricter regulatory environment, biotech companies had a tough going. Biotech stocks were on a roller coaster ride through the year, with the first few months witnessing bearish trends. The sector bounced back in the second half of 2022 due to M&A deals, strong earnings performance, new drug approvals and pipeline successes. But the joy was short-lived – the indices dipped once again in December.The Nasdaq Biotechnology Index (NBI) fell 3.4 percent to US$ 4,213. In November, it was up 5 percent. There was no change in the S&P Biotechnology Select Industry Index (SPSIBI) last month. It was up 1.1 percent in November. And the SPDR S&P Biotech ETF (XBI) rose 0.1 percent in December, as opposed to 1 percent rise in November.For the full year, NBI fell 11 percent, while both SPSIBI and XBI plummeted 28 percent. Overall though, biotech companies can take heart from the fact that 2022 was the worst year for S&P 500 and Nasdaq Composite since 2008.Access the Pipeline Prospector Dashboard for December 2022 Newsmakers (Free Excel)Novo gains post Wegovy launch in Denmark; Sanofi’s stock rises post legal winDecember was a big month for Novo Nordisk as the Danish drugmaker launched its diabetes drug Wegovy (semaglutide) in its home market, fulfilling its promise to launch the med outside of the US by 2022-end. Wegovy also received an add-on approval from the US Food and Drug Administration (FDA) to treat obesity in teens 12 years and above just before Christmas. All the good news resulted in an 8 percent rise in Novo’s stock. Another mega cap company that made gains on the bourses last month was French drugmaker Sanofi — its stock rose 7 percent. A big reason behind this was the dismissal of about 50,000 lawsuits by a US district judge. The lawsuits had claimed that the heartburn drug – Zantac – causes cancer. Shares of GSK and Sanofi also made gains due to the dismissal, adding more than US$ 20 billion in combined value soon after the court’s decision. Sanofi’s blockbuster dermatitis and asthma drug Dupixent (dupilumab) also received marketing authorization in Europe as the first and only targeted medicine for prurigo nodularis, a chronic and debilitating skin disease.In early 2022, Novo had faced supply bottlenecks for Wegovy. Last month, its chief rival Eli Lilly met the same fate as it failed to meet the demand for its newly approved diabetes injection Mounjaro (tirzepatide). FDA added Mounjaro to its list of drugs facing shortages, along with a second diabetes med, Trulicity (dulaglutide). Lilly’s stock was down 2 percent in December.Access the Pipeline Prospector Dashboard for December 2022 Newsmakers (Free Excel) FDA’s Aduhelm nod gets flayed post probe; Roche suspends Alzheimer’s drug trialIt wasn’t a good month for Biogen, whose stock dropped by 9 percent in December. Three patient deaths got linked with Eisai and Biogen’s second Alzheimer’s drug — Leqembi (lecanemab). And, towards the end of the month, there was news that an 18-month-long investigation conducted by two House of Representatives’ committees found FDA’s approval process of Biogen’s controversial Alzheimer’s disease drug — Aduhelm (aducanumab) — to be “rife with irregularities”.There was more bad news on drugs for Alzheimer’s. Roche (down 2 percent) decided to suspend most trials of its Alzheimer’s drug – gantenerumab – after it failed to slow advancement of the disease in late-stage studies. In another setback to the Swiss drugmaker, a combination of Tecentriq (atezolizumab) and Exelixis-Ipsen’s Cabometyx (cabozantinib) failed to meet the primary endpoint in a phase 3 lung cancer trial. Ipsen’s stock fell 6 percent.Access the Pipeline Prospector Dashboard for December 2022 Newsmakers (Free Excel) Madrigal zips past rivals in NASH race; Prometheus’ colitis drug posts trial winAmong mid-cap companies, Pennsylvania-based Madrigal Pharmaceuticals’ shares soared by over 300 percent in December after its experimental drug to treat nonalcoholic steatohepatitis (NASH) – resmetirom – met the main goal in a late-stage study. The trial’s success has propelled Madrigal to the forefront of a race to develop the first treatment for NASH, a form of non-alcoholic fatty liver disease. Madrigal plans to move FDA for an accelerated approval of resmetirom this year.Another mid-cap company Prometheus Biosciences saw its stock soar 171 percent after its lead drug candidate – PRA023 – met the endpoints in a phase 2 study in patients with moderate-to-severely active ulcerative colitis.A small cap company named Icosavax saw its stock soar 125 percent after it announced a positive outcome for its respiratory syncytial virus (RSV) vaccine from a phase 1/1b study. Icosavax is a US-based, clinical stage vaccine company. A single dose of the shot, IVX-121, demonstrated a response against RSV that lasted six months.Access the Pipeline Prospector Dashboard for December 2022 Newsmakers (Free Excel) Horizon’s stock rises after Amgen acquires it for US$ 27.8 billionThe biggest biopharma deal of 2022 was Amgen’s acquisition of Horizon Therapeutics for US$ 27.8 billion. News of Amgen and Sanofi’s buyout interest in Horizon had led to a 61 percent rise in the rare disease drugmaker’s stock in November. Last month, Horizon’s shares increased by 10 percent after Amgen finally announced the acquisition.Another significant deal inked in December was Japanese drugmaker Takeda’s (up 7 percent) acquisition of Nimbus Therapeutics’ experimental psoriasis drug for up to US$ 6 billion. This is Takeda’s biggest buyout since it purchased Shire for US$ 62 billion in 2019. The deal is also among the pharma industry’s largest single-asset purchases since Amgen bought Otezla from Celgene in 2019 for US$ 13.4 billion.Access the Pipeline Prospector Dashboard for December 2022 Newsmakers (Free Excel) Moderna’s mRNA vaccine-Keytruda combo succeeds in mid-stage skin-cancer trialA combination of Moderna’s experimental messenger RNA cancer vaccine and Merck’s blockbuster immunotherapy Keytruda (pembrolizumab) was successful in a mid-stage skin cancer trial. Moderna’s stock grew 19 percent following the news, but it nosedived soon after. Merck is also carrying out clinical trials of Keytruda that can be injected under the skin. The drugmaker is testing at least two versions of the drug in the hope that a new formulation will allow it to retain the drug’s patent edge and protect it from competition.Novartis’ stock reported a 2 percent growth in December. Its drug Pluvicto showed survival benefits in a late-stage prostate cancer trial. Its rare blood disease drug iptacopan was also successful in treating paroxysmal nocturnal hemoglobinuria in a late-stage trial.Access the Pipeline Prospector Dashboard for December 2022 Newsmakers (Free Excel) Our viewSoothsayers do not have positive things to say about 2023. The Ukraine-Russia war has played havoc with food and energy costs, causing the highest rates of inflation. And a global recession seems inevitable in 2023.Even as the world grapples with these challenges, innovation is likely to save the day for the biotech sector. In 2023, Eisai and Biogen’s Leqembi became the first drug to receive an accelerated approval from the FDA. Several other pathbreaking drugs will come up for approval this year, including vaccines and therapies for RSV, new treatments for Alzheimer’s disease, a gene therapy for Duchenne muscular dystrophy and several treatments for obesity. The heady mix of recession and innovation may also trigger more M&A activity. And we hope these innovations result in a better year for the sector.Access the Pipeline Prospector Dashboard for December 2022 Newsmakers (Free Excel)

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12 Jan 2023

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Pipeline Prospector Jan 2020: Deals and developments in pharma and biotech

We at PharmaCompass are pleased to announce the launch of Pipeline Prospector, in collaboration with SCORR Marketing, a leading health science marketing agency. The Pipeline Prospector is a free-access database of global drug development deals and updates designed for executives in the drug development industry. Our database will be updated every month. The first of this two-part rollout of the initial version of the Pipeline Prospector delivers access to a database of current deals and developments. In the second phase, we will add pipeline data to provide more in-depth therapeutic information. Access the Pipeline Prospector Dashboard for All Deals & Development Updates We begin 2020 with a compilation of all the major deals and developments which were announced in January. Dealmakers at JPMorgan Historically, January is the month of the annual JPMorgan Healthcare Conference in San Francisco — a platform where drug majors tend to announce significant deals and strategic shifts. Last year witnessed the US$ 74 billion acquisition of New Jersey-based cancer drug company Celgene by Bristol-Myers Squibb. After factoring in debt, the value of the deal ballooned to about US$ 95 billion, which according to data compiled by Refinitiv, was the largest healthcare deal on record. This year started on a muted note with Eli Lilly’s all-cash acquisition of California-based Dermira Inc being one of the only major deals. The acquisition will allow Eli Lilly to expand its immunology pipeline with a late-stage treatment for atopic dermatitis. The acquisition gives Lilly two key Dermira assets — lebrikizumab and Qbrexza (glycopyrronium) cloth. Lebrikizumab is a novel, investigational, monoclonal antibody designed to bind IL-13, which is believed to be a driver of signs and symptoms of atopic dermatitis. It is currently in two Phase III trials for the treatment of moderate-to-severe atopic dermatitis in adolescent and adult patients, aged 12 years and older. In late 2019, FDA granted fast-track designation to lebrikizumab, and analysts are of the view that the drug could be a challenger to Dupixent, a skin drug made by Regeneron and Sanofi that is expected to bring in over US$ 11 billion in annual sales. Access the Pipeline Prospector Dashboard for All Deals & Development Updates At the JPMorgan conference, Incyte and MorphoSys announced a collaboration and licensing agreement to further develop and commercialize MorphoSys’ proprietary anti-CD19 antibody tafasitamab (MOR208) globally. Tafasitamab is an Fc-engineered antibody against CD19 currently in clinical development for the treatment of B cell malignancies. MorphoSys and Incyte will co-commercialize tafasitamab in the US, while Incyte has exclusive commercialization rights outside of the US. As per the agreement, MorphoSys will receive an upfront payment of US$ 750 million. In addition, Incyte will make an equity investment into MorphoSys to the tune of US$ 150 million. Depending on the achievement of certain developmental, regulatory and commercial milestones, MorphoSys will be eligible to receive milestone payments amounting to nearly US$ 1.1 billion. MorphoSys will also receive tiered royalties on ex-US net sales of tafasitamab in a mid-teens to mid-twenties percentage range of net sales. An approval for tafasitimab could come as soon as mid-2020, according to MorphoSys, which submitted the drug to the US Food and Drug Administration in late 2019. Around the same time as these deals were announced, Biogen placed another bet on Alzheimer’s R&D by paying Pfizer US$ 75 million upfront for a candidate currently in Phase I trials. Access the Pipeline Prospector Dashboard for All Deals & Development Updates Amgen’s China bet January also saw the completion of two previously announced US$ 2.7 billion deals. As China, the world’s second largest pharmaceutical market, continues to remain a key growth area for Big Pharma, Amgen completed its acquisition of a 20.5 percent stake in the Chinese biotechnology firm Beigene worth approximately US$ 2.7 billion. The deal will give Amgen’s cancer drugs greater exposure to the Chinese market and also allow the firm to profit if BeiGene’s pipeline of molecularly targeted and immuno-oncology products prove to be effective and ready for commercialization. A month after Amgen had announced its investment in BeiGene, the FDA approved BeiGene’s cancer therapy zanubrutinib (branded as Brukinsa) months ahead of schedule. This was the first-ever FDA approval for a cancer therapy developed by a Chinese biotech. Access the Pipeline Prospector Dashboard for All Deals & Development Updates Merck’s oncology focus US-headquartered Merck, which is known as MSD (short for Merck Sharp & Dohme) outside the United States and Canada, completed its acquisition of ArQule through its subsidiary for US$ 2.7 billion. ArQule focusses on kinase inhibitor discovery and development for the treatment of patients with cancer and other diseases. The deal gives Merck access to ArQule’s experimental treatment ARQ 531 — a novel, oral Bruton’s tyrosine kinase (BTK) inhibitor currently in a Phase 2 dose expansion study for the treatment of B-cell malignancies. In January, Merck also announced an alliance with Japanese drugmakers Taiho Pharmaceutical and Astex Pharmaceuticals (a wholly owned subsidiary of Otsuka Pharmaceutical). The American drugmaker said it is willing to invest up to US$ 2.5 billion in order to gain access to small-molecule inhibitors against several drug targets, including the KRAS oncogene, from Taiho and Astex. Access the Pipeline Prospector Dashboard for All Deals & Development Updates According to a statement, Taiho, Astex and Merck will combine preclinical candidates and their data “with knowledge and expertise from their respective research programs.” In exchange for giving Merck an exclusive global license to their small-molecule inhibitor candidates, Taiho and Astex will get US$ 50 million upfront, with the US$ 2.5 billion “contingent upon the achievement of preclinical, clinical, regulatory and sales milestones for multiple products arising from the agreement, as well as tiered royalties on sales.” “Merck will fund research and development and will be responsible for commercialization of products globally,” the statement said. Taiho has retained co-commercialization rights in Japan and an option to promote the drugs (coming out of this alliance) in specific areas of South East Asia. KRAS is short for the gene Kirsten rat sarcoma viral oncogene homolog, which makes a protein (KRAS protein) that is critical in promoting cell growth and survival in non-cancerous cells. Cancers driven by KRAS mutations are both common and deadly. The year 2019 was a big one for KRAS, when several players — such as Amgen, Boehringer Ingelheim, Eli Lilly and Mirati — had reported progress in the field. For instance, Amgen had reported encouraging anti-tumor activity with its AMG 510 candidate, which targets a KRAS mutation known as G12C. In September last year, Boehringer Ingelheim (BI) had licensed an MEK inhibitor from Indian drugmaker Lupin that it intends to pair with its lineup of KRAS inhibitors. BI had also entered into a partnership with MD Anderson Cancer Centre in the US for another KRAS inhibitor. Access the Pipeline Prospector Dashboard for All Deals & Development Updates Acceleron’s shares skyrocket The share price of Boston-based Acceleron almost doubled in the month of January when new Phase 2 data on the success of an experimental heart drug, sotatercept, found a statistically significant decrease in pulmonary vascular resistance in patients with pulmonary arterial hypertension(PAH). Pulmonary arterial hypertension (PAH) is a rare, progressive disorder characterized by high blood pressure (hypertension) in the arteries of the lungs (pulmonary artery) for no apparent reason. The pulmonary arteries are the blood vessels that carry blood from the right side of the heart through the lungs. In November 2019, the FDA approved Acceleron’s luspatercept (brand name Reblozyl) for the treatment of anemia among patients with beta-thalassemia who require regular red blood cell transfusions. The approval provides patients with a therapy that, for the first time, will help decrease the number of blood transfusions. Access the Pipeline Prospector Dashboard for All Deals & Development Updates Setback for France’s Ipsen and Nektar Therapeutics French drugmaker Ipsen announced it was pausing a phase III trial of palovarotene, an experimental rare bone disease drug, after an interim analysis found it is unlikely to meet its primary efficacy endpoint. The decision to pause the trial is based on the results of a futility analysis reviewed by the Independent Data Monitoring Committee (IDMC). The announcement marked yet another blow for palovarotene, which had run into safety and efficacy problems since Ipsen acquired it in a US$ 1.3 billion (€1.1 billion) takeover of Clementia Pharmaceuticals. In December, a safety concern prompted the FDA to halt dosing in children. At the time of acquiring Clementia last year, David Meek, the then CEO of Ipsen, had called the drug “a largely derisked asset”. Since then, palovarotene has been the subject of a safety signal that led the FDA to stop the trial in children, a key population. The drug has now been rocked by an analysis that questions its efficacy. Access the Pipeline Prospector Dashboard for All Deals & Development Updates Last month, we also witnessed a major setback for Nektar Therapeutics as a joint FDA advisory committee voted 27-0 against the approval of oxycodegol for chronic low back pain. Oxycodegol’s key selling point was that its central nervous system absorption rate was much slower than that of the other often abused opioid drugs. The focus on drug development is constantly evolving and the Pipeline Prospector, our free access database of global drug development deals and development updates, is designed to provide the insights necessary for professionals to drive their business forward. Email us at support@pipelineprospector.com to learn more. Access the Pipeline Prospector Dashboard for All Deals & Development Updates

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