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☆ Sanofi looks to widen Dupixent use to treat 'smoker's lung' after second trial win
▼ + stars: | 2023-11-27 | by ( Ludwig Burger | ) www.reuters.com time to read: +2 min

The logo of French drugmaker Sanofi is seen a the Sanofi Genzyme Polyclonals in Lyon, France, September 30, 2023. REUTERS/Gonzalo Fuentes/File photo Acquire Licensing RightsNov 27 (Reuters) - Sanofi (SASY.PA) plans to seek U.S. approval for it best-selling anti-inflammatory drug Dupixent to be used in the treatment of "smoker's lung", also known as COPD, after a second large trial showed significant benefits. The company had embarked on a second trial to bolster the statistical reliability of the read-outs. Details of the second trial would be presented at an as yet undisclosed medical conference, Sanofi added. The company has been discussing with major watchdogs across the world whether the BOREAS results were substantial enough to support a regulatory review and what role the second trial would play in reviews.

Persons: Sanofi, Gonzalo Fuentes, BOREAS, Ludwig Burger, Tassilo Hummel, Edwina Gibbs Organizations: Sanofi, Polyclonals, REUTERS, Food and Drug Administration, Thomson Locations: Lyon, France

☆ Sanofi loses $21 bln in market value after dropping 2025 profit target
▼ + stars: | 2023-10-27 | by ( Ludwig Burger | ) www.reuters.com time to read: +6 min

Under a push to spend more on immunology and inflammation drug development, the company abandoned a target for a 32% operating profit margin for 2025 to focus on "long-term profitability". EPS would see a strong rebound in 2025 but not enough to sustain the previous margin target. CONSUMER STAND-ALONECEO Hudson said the core innovative drugs business had improved enough to soon do without the more predictable cash flows from consumer products. The logo of French drugmaker Sanofi is seen a the Sanofi Genzyme Polyclonals in Lyon, France, September 30, 2023. The timing of the potential consumer listing, which Sanofi said would be in the fourth quarter of 2024 or later, would be set to maximize shareholder value.

Persons: Hudson, Sanofi, drugmaker, Paul Hudson, Terence McManus, Johnson, we've, Gonzalo Fuentes, Roche, Dupixent, Ludwig Burger, Sherry Jacob, Phillips, Mark Potter, Sharon Singleton Organizations: Sanofi, Bellevue Asset Management, Reuters, Barclays, Johnson, GSK, Pfizer, Bayer, Polyclonals, REUTERS, Provention, Merck & Co, Thomson Locations: France, Bellevue, Lyon, Paris

☆ Risky biotech M&A therapy will heal more fractures
▼ + stars: | 2023-10-19 | by ( Jonathan Guilford | ) www.reuters.com time to read: +8 min

NEW YORK, Oct 19 (Reuters Breakingviews) - How can a suitor offering $1 billion see eye-to-eye with a seller asking for $2 billion? Such contingent value rights, or CVRs, are a way to get around the inherent uncertainty of an unproven drug. Its $74 billion takeover of Celgene in 2019 included a $6.4 billion payout dependent on a trio of drug approvals. There have been only 27 biotech market debuts this year, raising $2.2 billion, according to LSEG data. Given the nagging fissures in valuation perspectives, however, more dealmakers are apt to try this risky M&A therapy.

Persons: Schulman, Sidley, Bristol Myers, Myers, CVRs, Andrew Weisenfeld, IPOs, ”, Dan Lepanto, biopharma, Eli Lilly’s, Bristol Myers Squibb, Jeffrey Goldfarb, Sharon Lam, Streisand Neto Organizations: Reuters, Dow, Marion Laboratories, LyondellBasell Industries, Mirati Therapeutics, JPMorgan, Sanofi, Health Partners, Nasdaq Biotechnology, Reuters Graphics Reuters, Reuters Graphics, Leerink Partners, Therapeutics, Public, Bristol Myers, U.S . Food, Drug Administration, Thomson Locations: Celgene, Genzyme, U.S

☆ Activist Elliott makes inroads at Catalent to build value. Here’s what could happen next
▼ + stars: | 2023-09-16 | by ( Kenneth Squire | ) www.cnbc.com time to read: +7 min

This segment also handles the formulation, development and manufacturing for parenteral dose forms, including vials and prefilled syringes. Activist Commentary: Elliott is a very successful and astute activist investor, particularly in the technology sector. While as an activist Elliott will do whatever it feels is necessary to enhance shareholder value, in the past the firm has made significant use of the strategy of offering to acquire its portfolio companies as the best catalyst to enhance shareholder value. Like Catalent, Syneos is an outsourced pharma solutions company: It outsources R&D for pharmaceutical companies, whereas Catalent outsources manufacturing. If this does turn from a strategic review to an operational review, there is no guarantee that he keeps his job.

Persons: Catalent, there's, Elliott, Steven Barg, Frank D'Amelio, Stephanie Okey, Michelle Ryan, Johnson, Barg, Ryan, John Greisch, There's, Danaher, Alessandro Maselli, Ken Squire Organizations: Oral Technologies, Clinical, Pfizer, Rom Holdings, Bloomberg, Merck, Citrix Systems, Nielsen Holdings, Square, Veritas Capital, Syneos Health, 13D Locations: COOs, North America

A general view of the drug product manufacturing laboratory in biologics and sterile injectables, Catalent, in Brussels, Belgium June 27, 2023. Catalent named three pharma industry executives and a senior Elliott executive to its board and said John Greisch, who has served on the board since 2018, will become executive chairman. Elliott, whose stake in Catalent became public last month, has been engaging with the company behind the scenes for months. Two of the directors were picked by Elliott, while two were mutually agreed by Elliott and Catalent. Catalent is also forming a new strategic and operational review committee which Greisch will chair.

Persons: Yves Herman, Elliott, Catalent, Alessandro Maselli, John Greisch, Max, William Blair, Maselli, Steven Barg, Goldman Sachs, Frank D'Amelio, Stephanie Okey, Michelle Ryan, Greisch, Merck KGaA, Svea Herbst, Bayliss, Maggie Fick, Sriparna Roy, Shinjini Ganguli, Catherine Evans, Mike Harrison Organizations: REUTERS, Catalent Inc, Elliott Investment Management, Reuters, Novo, pharma, U.S . Food, Drug Administration, Pfizer, Johnson, Catalent, Svea, Thomson Locations: Brussels, Belgium, ., Danish, Novo, United States, Catalent, GLP, Boston, London, Bengaluru

☆ Self-made millionaire: Smart risk-takers don't try to 'change the world'—here's what they do instead
▼ + stars: | 2023-06-07 | by ( Ashton Jackson | ) www.cnbc.com time to read: +3 min

Oftentimes, commencement speakers conclude their speeches with something to the effect of, "now go out and change the world." Taking smart risks can ultimately lead to revolutionary ideas, says John Crowley, executive chairman of Amicus Therapeutics, a biotechnology company. But if your ultimate career goal is to change the world, you may be setting yourself up for disappointment. "Very few people have changed the world," Crowley tells CNBC Make It. Crowley says that smart risk-takers avoid setting lofty, broad goals, opting instead for clear, tangible goals.

Persons: John Crowley, Crowley, they've, —, Bill Gates, Paul Allen, Steve Jobs, Steve Wozniak, Kelly Evans Organizations: Amicus Therapeutics, CNBC, Novazyme Pharmaceuticals, Genzyme Corporation, Microsoft, Apple

☆ Biogen CEO bets on Alzheimer's drug, pipeline to return to growth
▼ + stars: | 2023-02-15 | by ( Manas Mishra | ) www.reuters.com time to read: +2 min

Feb 15 (Reuters) - Biogen Inc (BIIB.O) Chief Executive Officer Christopher Viehbacher said on Wednesday he is banking on high-profile launches of Alzheimer's disease treatment Leqembi and depression drug zuranolone, as well as deals, to help the company return to revenue growth. A controversial approval and problematic launch of previous Alzheimer's disease drug Aduhelm, which like Leqembi was developed with Eisai Co Ltd (4523.T), have further dented investor sentiment. Biogen is also hoping to gain U.S. approval of depression treatment zuranolone this year. Biogen forecast full-year adjusted profit of $15 to $16 per share, compared with analysts' estimates of $15.72 per share. The company reported a fourth-quarter adjusted profit of $4.05 per share, beating estimates compiled by Refinitiv IBES by 57 cents.

☆ Biogen hires former Sanofi head Viehbacher as CEO
▼ + stars: | 2022-11-10 | by ( Manas Mishra | ) www.reuters.com time to read: +2 min

The appointment of Viehbacher, who founded private equity firm Gurnet Point Capital after being ousted from French drugmaker Sanofi (SASY.PA) in 2014, concludes a months-long search for a successor to Michel Vounatsos. "The selection of a new CEO has been front-of-mind for Biogen investors since Mr. Vounatsos' announced departure," said Wedbush analyst Laura Chico. Investors and analysts are now pinning their hopes on the second Alzheimer's drug Biogen is developing with Japan's Eisai Co Ltd (4523.T) after it slowed the progress of the memory-robbing disease by 27% in a trial. Viehbacher served as chief executive of Sanofi for six years and was instrumental in the company's $20 billion deal for Genzyme in 2011. Viehbacher will step into his role on Nov. 14, Biogen said.

"It is definitely a business school case study. Musk's attempt to take over Twitter is "a gift to professors and students", said Joshua White, a professor at Vanderbilt University, calling the situation "unprecedented". While the messages reflect his unusual approach to running a business, taking control of Twitter will mean managing it, at least initially. "What is to come is unclear," said Donna Hitscherich, a Columbia Business School professor. Success or failure, it will be an instant business school classroom staple, experts say.

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