Pipeline Prospector November 2022: Positive news on RSV vaccines, cancer drugs bring gains for Big Pharma

By PharmaCompass

2022-12-08

Impressions: 2772

After bouncing back in October, biotech indices continued to rally in November. The Nasdaq Biotechnology Index (NBI) was up 5 percent to US$ 4,344 last month. In October, it was up 7.4 percent.

The S&P Biotechnology Select Industry Index (SPSIBI) was up 1.1 percent to US$ 6,514. In October, it was up 3 percent. And the SPDR S&P Biotech ETF (XBI) rose 1 percent in November, as against 3 percent in October.

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RSV therapy, vaccines bring gains for Sanofi-Astra, Pfizer, GSK

Several mega cap drugmakers posted impressive gains on the bourses last month. These include Novo Nordisk (15 percent), AstraZeneca (13 percent), Novartis (10 percent), Gilead (10 percent), AbbVie (9 percent), Merck (9 percent), Sanofi (5 percent) and Pfizer (4 percent).

Novo Nordisk’s stock rose in early November on raised FY22 outlook as its diabetes drug Ozempic (a once-weekly semaglutide injection) drove Q3 sales. On a year-over-year basis, Ozempic has reported an 86 percent increase in sales.

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The markets took well to news that Novartis is considering the sale of its ophthalmology and respiratory units — its stock went up 10 percent in November. According to Bloomberg, the ophthalmology unit could fetch about US$ 5 billion.

There was ample news on respiratory syncytial virus (RSV) therapies and vaccines. RSV is a major cause of respiratory illness in children. Sanofi and AstraZeneca’s drug Beyfortus (nirsevimab) bagged authorization in both Europe and the UK as the first preventive RSV treatment in newborns and infants.

In early November, Pfizer reported a positive update on its RSV vaccine — RSVpreF. The drugmaker said its vaccine is highly effective at protecting newborns when the shot is given to mothers late in their pregnancy. And this week, the US Food and Drug Administration accepted for priority review Pfizer’s application for the use of the shot in adults aged 60 years and older. The agency is slated to announce its decision by May 2023.

Another gainer was GSK (3 percent) — it scored a priority review from the FDA for its RSV vaccine candidate for older adults, a month before Pfizer. Other companies developing vaccines and drugs for RSV are Moderna (mRNA-1345), Merck (clesrovimab) and Bavarian Nordic. The FDA also granted priority review to Takeda’s (15 percent) biologics license application (BLA) for its dengue vaccine candidate, Qdenga (TAK-003).

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Lilly stock rises 4% despite fake tweet incident; Amgen gains on obesity drug news

The biggest event that rattled the bourses in mid-November was a fake tweet that erased over US$ 15 billion off Eli Lilly’s market capitalization. Impersonating the pharma giant, the tweet said Eli Lilly is providing insulin for free. The account — @EliLillyandCo — had a ‘verified’ blue check mark, a symbol that Twitter has been using for years to denote an account’s authenticity. As a result of this fake tweet, Lilly’s stock plummeted 5 percent.

Post this event, top drugmakers in the US halted ad spending on Twitter. However, Lilly’s stock recovered when later in the month the FDA approved its long-acting insulin — Rezvoglar — as an “interchangeable” product with Sanofi’s Lantus (insulin glargine). Lilly also said it plans to double the manufacturing capacity for its type 2 diabetes drug Mounjaro by 2023-end. Overall, Lilly’s stock was up 4 percent in November.

In other diabetes news, Provention Bio’s Tzield (teplizumab) won an FDA approval as a preventive treatment for type 1 diabetes in individuals aged eight years or older. This is the first drug to delay the onset of type 1 diabetes. Provention Bio’s stock was up 29 percent in November.

Similarly, Amgen’s stock gained 5 percent on positive news from a phase 1 trial of its new obesity drug — AMG 133. Buoyed by the trial’s success, the drugmaker is now planning to initiate a larger mid-stage study early next year. Amgen also published in-depth results from a phase 2 trial of its drug Olpasiran. It was found that the drug reduced levels of lipoprotein, which is a risk factor for cardiovascular disease. Amgen is now moving ahead swiftly with its phase 3 program, playing catch-up with a similar drug (pelacarsen) being developed by Novartis and its partner Akcea.

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Trial data on Alzheimer’s drugs causes volatility in Roche, Biogen, Eisai stocks

November was quite a newsy week for experimental Alzheimer’s drugs. While some drugs failed, others showed promise. Roche said its drug – gantenerumab – fell short of demonstrating that it may help patients with early-stage Alzheimer’s preserve abilities such as remembering, solving problems, orientation and personal care. Roche was developing the drug with partner MorphoSys. Roche’s stock was down 2 percent. And MorphoSys’ stock slid 20 percent following the news.

Roche’s loss was competitors’ gain. Stocks of its rivals in the Alzheimer’s drug race, such as Biogen, Eli Lilly and Prothena, jumped after the Roche announcement.

However, Biogen and Eisai’s stocks plunged around November-end, after reports of a second death in a late-stage trial of lecanemab. Eisai said the drug is not associated with an increased risk of death. After Eisai unveiled trial results, the stocks of both companies went up.

Lilly’s donanemab also showed promise in an early symptomatic Alzheimer’s study. In the study’s co-primary outcomes, brain amyloid plaque clearance was achieved in 37.9 percent of donanemab-treated participants, compared with 1.6 percent of Aduhelm-treated patients at six months. Similarly, Axsome announced positive data from a phase 3 Alzheimer’s agitation study evaluating its candidate, AXS-05. Currently, there is no approved therapy for this indication. Axsome’s stock went up by 51 percent last month.

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AbbVie, Merck report oncology gains; Astra’s drug combo bags second FDA nod

Oncology was another area where Big Pharma made big gains. The FDA accepted for priority review the BLA for AbbVie and Genmab’s treatment for relapsed/refractory large B-Cell lymphoma (LBCL) — epcoritamab. If approved, epcoritamab will become the first subcutaneous bispecific antibody available for the treatment of LBCL. AbbVie’s stock rose 9 percent, while Genmab’s was up 21 percent in November.

In other AbbVie news, its blockbuster immunology drug Skyrizi (risankizumab-rzaa) has been approved by the FDA as a treatment for adults with moderate-to-severe Crohn’s disease. Skyrizi is the first specific anti-interleukin 23 (IL-23) monoclonal antibody to treat Crohn’s disease. And its other blockbuster drug Rinvoq (upadacitinib) has been recommended by UK’s NICE as a once-daily pill to treat those with moderate-to-severely active ulcerative colitis (UC).

Merck’s blockbuster drug Keytruda and chemotherapy combo has met the primary goal in a phase 3 study for treating gastroesophageal junction adenocarcinoma, a type of gastric cancer. England’s NICE recommended Merck’s blockbuster drug Keytruda in combination with chemotherapy in adults with early-stage triple-negative breast cancer who are at high risk of recurrence or locally advanced breast cancer.

AstraZeneca’s drug combo – Imjudo (tremelimumab) and Imfinzi (durvalumab) – has received its second FDA approval within a month. In October, the combo received its first approval to treat adult patients with unresectable hepatocellular carcinoma (HCC). An FDA panel voted overwhelmingly (16 to 1) in favor of AstraZeneca and Avillion’s PT027 (albuterol /budesonide) for the treatment of asthma in people aged 18 years and older.

However, not every performer saw their stocks rise. Despite ample positive news, Regeneron saw its stock down 1 percent in November. First, the FDA approved Regeneron’s PD-1 inhibitor — Libtayo (cemiplimab-rwlc) — in combination with platinum-based chemotherapy as a first-line treatment for adult patients with advanced non-small cell lung cancer (NSCLC) with no EGFR, ALK or ROS1 aberrations. Second, Regeneron’s Evkeeza (evinacumab) bagged FDA's priority review status for use in children aged five to 11 years with the ultra-rare genetic disorder homozygous familial hypercholesterolemia (HoFH). And third, Regeneron inked a potential US$ 2 billion deal with CytomX Therapeutics to co-develop next-generation bispecific cancer treatments.

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4D Molecular’s stock rises 178% on positive wet AMD drug data; Verve down 40%

Among mid and small-cap drugmakers, 4D Molecular Therapeutics was the biggest gainer. Its stock went up 178 percent due to positive interim data of 4D-710 for cystic fibrosis and wet age-related macular degeneration (wet AMD) indications.

Incyte and Mirati Therapeutics (31 percent) have entered into a clinical trial collaboration and supply agreement to investigate the combination of INCB99280, Incyte’s small molecule PD-L1 inhibitor, and adagrasib, a KRASG12C selective inhibitor. This week, Mirati’s stock was down after the company posted results from a phase 2 trial of its experimental drug adagrasib in combination with Merck’s Keytruda.

Vir Biotechnology (22 percent) has presented new data evaluating the potential of VIR-2218 and VIR-3434 to achieve a cure for chronic hepatitis B virus (HBV) infection.

Amongst the mid and small cap losers were Verve Therapeutics (-41 percent) and Apellis Pharmaceuticals (-16 percent). FDA has halted Verve’s plan to test a new gene editing therapy for heart disease in the US. This week, the company divulged that it has received a letter from the FDA asking for more information to resolve the clinical hold. In the case of Apellis, the agency has delayed a decision on its eye disease drug after the biotech submitted updated data.

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Horizon’s stock rises 61% on buyout talks; Merck acquires Imago Biosciences

In M&A news, Horizon Therapeutics is said to be on the block and has drawn buyout interest from players like Amgen and Sanofi. Horizon, which makes drugs for rare, autoimmune and severe inflammatory diseases, saw its stock rise 61 percent in November. The company’s shares continued to rise since it released its third-quarter earnings. The encouraging sales of its thyroid eye disease treatment Tepezza and gout therapy Krystexxa boosted its annual guidance.

In acquisitions, Merck announced it will acquire cancer drug developer Imago BioSciences for US$ 1.35 billion in a bid to expand its portfolio of blood disorder treatments. Its lead drug — bomedemstat — is currently undergoing mid-stage studies for treating certain types of rare blood cancers. Imago BioSciences’ stock went up 100 percent in November.

AstraZeneca is acquiring Netherlands-based targeted cancer therapy developer, Neogene Therapeutics, for up to US$ 320 million in a bid to build its pipeline of cell-based cancer treatments. AstraZeneca has also inked a potential US$ 402 million licensing deal with British drug discovery firm C4X Discovery Holdings (C4XD) to develop an oral treatment for chronic obstructive pulmonary disease (COPD), along with other inflammatory and respiratory illnesses.

Viatris has announced it will acquire two eye disease drug developers — Oyster Point Pharma and Famy Life Sciences — for around US$ 700 million.

In collaborations, Australian vaccine maker CSL Seqirus inked a potential US$ 4.5 billion licensing deal with Arcturus Therapeutics to gain access to the US drug developer’s messenger RNA vaccine technology. And Sanofi entered into a potential US$ 1.2 billion partnership with artificial intelligence-based drug development firm Insilico Medicine to develop drugs for up to six new targets.

Access the Pipeline Prospector Dashboard for November 2022 Newsmakers (Free Excel)

Our view

The year 2022 has been a year most biotech companies may want to forget. The Ukraine-Russia war, stricter regulatory environment post the Covid lockdowns, rising interest rates, global inflation and other uncertainties sent key stock indices down during most months of the year. Even though the markets have been on a rebound, the year-to-date performance of the NBI is still down nearly 9 percent.

As we wrap up 2022, there is optimism that the trend of the last three months will continue. While it’s difficult to predict what 2023 will be like, there is hope that uncertainties will reduce and the many pathbreaking drugs in the pipeline will keep cheering the markets.

Access the Pipeline Prospector Dashboard for November 2022 Newsmakers (Free Excel)

Pharma & Biotech Newsmakers in November 2022

Company	Country	Currency	Market Cap (Bn)	Change In Market Cap (M)	Stock Price	Change In Price

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