Bayer ends respiratory distress drug development in latest phase 2 cleanout

 Bayer has dropped an acute respiratory distress syndrome drug in phase 2 development for “scientific reasons,” the German pharma giant revealed in its latest earnings results.

The company “decided not to pursue further development activities” for the drug, called adrenomedullin pegol, in May, Bayer said in this morning’s second-quarter earnings release (PDF). Adrenomedullin is a human hormone that is involved in vasodilation, among other activities.

A phase 2 trial of the inhaled formulation wrapped up at the end of last year, according to ClinicalTrials.gov. While Bayer only alluded to “scientific reasons” as the cause of its decision, a note attached to the trials register said the study was terminated due to the results of part A of the trial and “not due to any safety data.”

It was not until May that the company decided “not to pursue further development activities” for adrenomedullin pegol, Bayer added.

Picking out some other notable pipeline developments over the first half of the year, Bayer used the same document to reaffirm two previously disclosed phase 2 pipeline culls. The company explained that a decision was made in April to halt work on runcaciguat, a soluble guanylate cyclase (sGC) activator that was being developed for chronic kidney disease (CKD).

Bayer didn’t give a reason for the decision, but did point out that it hasn’t given up on its sGC program entirely. The company is still pushing ahead with another sGC activator called BAY3283142. The oral therapy, which is currently in a phase 1 trial for CKD, is considered by Bayer to be a “follow-up” therapy to runcaciguat, with the added benefit of an “improved pharmacokinetic/pharmacodynamic profile.”

Finally, the company explained that a BDKRB1 receptor antagonist was benched because of the results of a phase 2a trial in neuropathic pain. 

https://www.fiercebiotech.com/biotech/bayer-ends-respiratory-distress-drug-development-latest-phase-2-cull-year

Bristol Myers, BeiGene end legacy Celgene deal with settlement years after China ban

 Back in 2020, a surprise manufacturing shortfall led to an import ban of Bristol Myers Squibb’s Abraxane, sold by BeiGene, in China. Legal finger-pointing ensued, and, now, the companies have decided to scrap their three-drug partnership altogether.

BMS and BeiGene on Tuesday agreed to end a China licensing deal that BeiGene signed with Celgene back in 2017 before its acquisition by Bristol, a securities filing shows. In the original deal, Celgene essentially sold its China business, including local rights to cancer drugs Revlimid, Abraxane and Vidaza.

Now, to end the deal, BMS will return nearly 23.3 million ordinary shares of BeiGene that Celgene had previously purchased. BeiGene won’t pay anything for those shares.

As of Tuesday, BeiGene’s American depositary shares on Nasdaq, each of which represents 13 ordinary shares, were worth more than $200 apiece. The price dropped to below $190 Wednesday amid a marketwide retreat in the U.S. Using that measurement, the total settlement was worth about $340 million.

Cracks started to form in the relationship in March 2020. At that time, Chinese authorities put Abraxane on an import and sale ban after spotting manufacturing problems at BMS' contractor Fresenius Kabi’s facility in Phoenix. Because of the quality misstep, BeiGene was disqualified from a national procurement program and banned from participating for two years. BeiGene has recorded no Abraxane sales since then.

Hurt by the sanction, BeiGene brought an arbitration case against BMS at the International Chamber of Commerce, accusing the U.S. company of a breach of contract. BMS responded by delivering BeiGene a notice in October 2021 to end the Abraxane collaboration.  

Now, the two sides have decided to settle the feud by ending the entire legacy Celgene deal, effective at the end of 2023. BeiGene is also allowed to sell all inventory of Revlimid and Vidaza in China until the end of 2024.

BeiGene has already shifted its attention from those drugs, which helped catapult the company to the commercial stage in 2017. BeiGene’s BTK inhibitor Brukinsa and PD-1 inhibitor tislelizumab have served as the company’s growth drivers lately.

Thanks to a U.S. approval in chronic lymphocytic leukemia, Brukinsa pulled in $308 million sales in the second quarter, up from $211 million in the first quarter. Sales of tislelizumab, which is so far only available in China, came in at $150 million in the second quarter, compared with $115 million in the first quarter.

By comparison, Revlimid brought BeiGene $21.8 million in sales and Vidaza $3.9 million during the three months that ended in June.

The termination comes as BeiGene and its partner Novartis are about to face off against BMS in the U.S. PD-1 inhibitor market. BeiGene and Novartis are awaiting a long-overdue FDA decision on tislelizumab, which might eventually compete with BMS’ Opdivo. The FDA recently completed a much-delayed manufacturing inspection in China, but the agency hasn’t communicated a new target decision date, according to BeiGene.

Meanwhile, BeiGene has been busy bolstering its own manufacturing capabilities. These include a $700 million-plus flagship manufacturing and R&D facility the company is building in Hopewell, New Jersey, which it says will be ready next year. BeiGene is also expanding its biologics facility in Guangzhou, China, and is constructing a new small-molecule campus in Suzhou, China.

https://www.fiercepharma.com/pharma/bristol-myers-beigene-end-legacy-celgene-deal-settlement-years-after-china-ban

Galapagos scraps applications for Jyseleca in Europe and slashes sales projection

 Galapagos has decided, based on the results of a phase 3 study, not to submit a Marketing Authorization Application (MAA) in Europe for Jyseleca (filgotinib) in Crohn’s disease.

The company also will not proceed with its MAA for filgotinib in ulcerative colitis (UC) in Switzerland. Galapagos revealed the moves in reporting its first-half earnings.

This is a major blow for Galapagos. For years, the company has been counting on the potential of its top drug to score in these lucrative indications.

Along with the moves, Galapagos has slashed its 2023 sales guidance for Jyseleca from 140-160 million euros ($154 million to $176 million) to 100-120 million euros ($110 million to $132 million). The drug is approved in Europe for rheumatoid arthritis and UC.

“The market and competitive landscape for the JAK class in Europe has changed significantly over the past six months,” Galapagos Chief Financial Officer and Chief Operating Officer Thad Huston said in a release. “We are in the process of evaluating strategic options for Jyseleca.”

The good news for Galapagos is on its balance sheet. The company has 3.9 billion euros ($4.3 billion) on hand to deploy for business development.

“There’s a tremendous opportunity for us to really drive an innovative approach to bringing life-saving therapies to patients,” Huston said in a conference call on Friday morning. “We’re doing some things that the other players are not doing that is really exciting.”

CEO Paul Stoffels, a Johnson & Johnson veteran known for his acumen in identifying promising drugs, took over at Galapagos in March of last year and quickly acquired two CAR-T companies for a combined $251 million.

On the call Friday, Stoffels said that the deals he is seeking will be for differentiated products and must be global. He said his timeline for making moves will be over the next 18 months.

Once a biotech powerhouse so attractive that it drew a $5 billion partnership with Gilead in 2019, Galapagos has seen its value plummet.

After its share price peaked in early 2020 at $268, shares have declined to $41.75. The downfall began three years ago when the FDA rejected filgotinib in rheumatoid arthritis for toxicity issues.

In November of last year, Galapagos executed a pipeline trim and the loss of 200 roles. The move was part of Stoffels’ strategy to concentrate on immunology and oncology “focusing on best-in-disease validated targets in our strategic therapeutic areas with shorter time-to-patient potential.”

https://www.fiercepharma.com/pharma/galapagos-scraps-applications-jyseleca-europe-and-slashes-sales-projection

Emergent to pivot away from contract manufacturing

 Big changes are brewing at Emergent BioSolutions, as the beleaguered contract manufacturer puts its CDMO business on the back burner in a bid to shore up its core medical countermeasures and Narcan businesses.

In turn, the company is also eliminating its chief operating officer role and axing hundreds of jobs.

Tuesday, Emergent said that it’s de-emphasizing its CDMO services business. As part of the move, Emergent will scale back operations at its Bayview facility in Baltimore, Maryland, as well as its plants in Canton, Massachusetts, and Rockville, Maryland.

Emergent’s contract manufacturing business has been on the back foot ever since a highly public cross-contamination mishap resulted in the destruction of hundreds of millions of COVID-19 vaccine doses.

Looking ahead, Emergent plans to focus on its core portfolio of medical countermeasures and the opioid overdose reversal spray Narcan.

Despite the reductions at its facilities, it will “maintain a level of operations at both Bayview and Canton to ramp up production in response to new demand," Emergent said.

The company plans to lay off around 400 employees across “all areas of the company.” In tandem with other cost reduction initiatives, Emergent’s business pivot is expected to result in yearly savings of more than $100 million, the company explained. The moves will cost Emergent around $20 million—costs it expects to incur in the third quarter of 2023.

The company employed around 2,500 employees at the start of the year, so the cuts will affect some 15% to 20% of the workforce. Already this year, Emergent disclosed 132 layoffs in January and a plan to sell its travel health business to Bavarian Nordic in February, resulting in the separation of another 280 staffers.

Given its shift away from services-based business, the company is also eliminating its chief operating officer role. In turn, Adam Havey, who currently holds the position, will depart the company Sept. 30. Bill Hartzel, senior vice president and head of bioservices, will take over responsibility for manufacturing operations, Emergent said.

While the last few years have certainly been turbulent for Emergent, the company has notched a number of wins in 2023.

In March, Emergent made history when its Narcan nasal spray successfully converted its prescription approval into an over-the-counter FDA nod. The move, which allows Narcan to be purchased in places like drugstores, convenience stores, supermarkets and gas stations, has been trumpeted as a major win for naloxone access in the fight against the U.S. opioid epidemic.

In July, meanwhile, Emergent won full approval for its anthrax vaccine Cyfendus in adults 18 to 65. Under a pre-emergency use authorization, Emergent had provided the Department of Health and Human Services with its anthrax vaccine for emergency preparedness since 2019.

https://www.fiercepharma.com/pharma/emergent-biosolutions-lay-400-staffers-and-eliminate-coo-position-pivot-away-contract

Ironwood Pharmaceuticals Swings to Q2 Adjusted Loss, Revenue Climbs

  LINZESS (Iinaclotide) EUTRx prescription demand growth increased 9% year-over-year; LINZESS U.S. net sales of $270 million, an increase of 9% year-over-year –

– Expands clinical utility of LINZESS with FDA approval for pediatric patients ages 6-17 years-old suffering from functional constipation (FC) –

– Strengthens GI development portfolio with acquisition of VectivBio Holding AG and its lead investigational asset, apraglutide, for the potential treatment of short bowel syndrome with intestinal failure –

– Completes STARS Phase III clinical trial enrollment; now expects topline data in March of 2024 –

FDA Approval of New Indication for LINZESS

• In June 2023, Ironwood announced that the U.S. Food and Drug Administration ("FDA") approved LINZESS as a once-daily treatment for pediatric patients ages 6-17 years-old suffering from functional constipation. LINZESS is the first and only FDA-approved prescription therapy for functional constipation in this patient population.

Acquisition of VectivBio Holding AG ("VectivBio")

• On June 29, 2023, Ironwood completed a tender offer to purchase outstanding ordinary shares of VectivBio (the "VectivBio Shares") at a price per share of $17.00, net to the shareholders of VectivBio in cash, without interest and subject to any applicable withholding taxes. The aggregate consideration paid by Ironwood to acquire the shares accepted for payment was approximately $1.2 billion. Ironwood financed the acquisition through proceeds from the borrowings under a revolving credit facility entered into in connection with the transaction, cash on hand, and cash of VectivBio.
• As of June 30, 2023, Ironwood holds 98% of the outstanding VectivBio Shares. Ironwood intends to effect a squeeze-out merger under Swiss law to acquire the remaining outstanding VectivBio Shares in the second half of 2023. The remaining outstanding VectivBio Shares are expected to be settled by Ironwood in cash.

Workforce Reductions and Restructuring

• In April 2023, Ironwood reduced its workforce by approximately 10% of its headquarters-based personnel in an effort to further strengthen the operational efficiency of the organization. The workforce reduction was substantially completed during the second quarter of 2023.
• In June 2023, Ironwood commenced the elimination of certain positions in connection with the VectivBio acquisition. The majority of the eliminations were initiated in June 2023 and the remaining eliminations are expected to be substantially completed during the third quarter of 2023.

https://www.benzinga.com/pressreleases/23/08/b33622314/ironwood-pharmaceuticals-reports-second-quarter-2023-results-raises-full-year-2023-linzess-u-s-net

Bioventus Full Year 2023 Financial Guidance

 For the twelve months ending December 31, 2023, the Company expects:

• Net sales of $490 million to $505 million
• Adjusted EBITDA* of $75 million to $80 million
• Non-GAAP EPS* of ($0.24) to ($0.20)

The Company does not provide U.S. GAAP financial measures, other than net sales, on a forward-looking basis, because the Company is unable to predict with reasonable certainty the impact and timing of acquisition related expenses, accounting fair-value adjustments, and certain other reconciling items without unreasonable efforts. These items are uncertain, depend on various factors, and could be material to the Company’s results computed in accordance with U.S. GAAP.

https://www.biospace.com/article/releases/bioventus-reports-second-quarter-financial-results-introduces-full-year-2023-financial-guidance/

Amphastar: Factors in sales increases in June Q

Changes in net revenues as compared to the second quarter of the prior year were primarily driven by:

• Glucagon sales increased primarily due to an increase in unit volumes, as a result of two suppliers discontinuing their glucagon injection products at the end of 2022

• Phytonadione sales increased due to increased unit volumes, as a result of supplier shortages

• Primatene MIST® sales decreased due to a decrease in unit volumes, as a result of inventory drawdowns by retailers

• The decrease in sales of epinephrine and lidocaine was primarily due to a decrease in unit volumes, as a result of suppliers returning to their historical distribution levels

• The decrease in sales of enoxaparin and naloxone was primarily due to a decrease in unit volumes

• Other finished pharmaceutical product sales increased primarily due to:

  • An increase in unit volumes for dextrose, atropine, calcium chloride, and sodium bicarbonate, due to increasing demand caused by supplier shortages

  • A full quarter of sales for ganirelix and vasopressin, which were launched in June 2022 and August 2022, respectively

  • Launch of regadenoson in April 2023

• Active Pharmaceutical ingredient ("API") sales increased primarily due to the timing of customer purchases

https://finance.yahoo.com/news/amphastar-pharmaceuticals-reports-financial-results-200500213.html