C.H. Boehringer Sohn AG & Co. KG

Boehringer Ingelheim will overhaul its sales team for Cyltezo (adalimumab-adbm) amid lower than expected uptake of biosimilar versions of AbbVie’s Humira (adalimumab) in the US. The company confirmed to FirstWord on Friday that it will “streamline…customer-facing teams in favour of a hybrid in-person and virtual model” by June 30.Cyltezo launched in July last year alongside a raft of Humira biosimilars, although it was the only product to have interchangeable status, and even gained a place on commercial formularies from pharmacy benefit managers (PBMs) Optum Rx and Express Scripts. However, Boehringer said that despite this, the “adoption of Humira biosimilars at scale has not reached its anticipated potential.”The drugmaker blamed the slow adoption on “the complexities of a complicated landscape and several challenges with PBMs keeping Humira on formulary.” Boehringer added that it remains committed to Cyltezo, which will remain accessible to patients.Boehringer’s decision comes hot on the heels of continued efforts by the US government to boost uptake of biosimilars, something that has lagged in comparison to Europe. President Joe Biden’s budget for 2025 includes a provision that would allow substitution without the need for an interchangeable designation from the FDA.Despite the setback, Boehringer said it continues to “believe that the utilisation of high-quality, lower cost biosimilars may improve the sustainability of the US healthcare system.” For related analysis, see Physician Views Results: Lack of financial incentive and prescriber confidence stalling adoption of biosimilar Humira products.

Pictured: Nasdaq signage and building in New York City/iStock, hapabapa Contineum Therapeutics went public on Friday, trading on the Nasdaq Global Select Market under the ticker symbol CTNM and dialing back its expectations to raise $110 million for clinical trials of a challenger to Boehringer Ingelheim and Roche. The San Diego-based biotech filed to go public in March 2024 to fund development of two clinical-phase candidates. Johnson & Johnson paid $50 million upfront for one of the assets, PIPE-307, in April 2023 but Contineum still needs to fund a Phase II trial in relapsing-remitting multiple sclerosis (MS). The biotech also wants cash to trial its wholly owned idiopathic pulmonary fibrosis (IPF) and MS prospect, PIPE-791. Earlier this week, Contineum set out plans to sell 8.8 million shares for $16 to $18 a piece. The biotech downgraded its target to secure its transition on to the Nasdaq, ultimately agreeing to sell almost 6.9 million shares for $16 each. Contineum expects gross proceeds of around $110 million, before deducting underwriting discounts and commissions and other offering expenses. The company is planning to spend around $66 million on the development of PIPE-791. The candidate is an oral small molecule inhibitor of LPA1, a receptor implicated in scarring in the lung disease IPF and the promotion of neuroinflammation in MS. Studies also suggest LPA1 may limit remyelination, the holy grail of MS outcomes. Drug developers have tried for decades to promote remyelination, without success. Contineum is planning Phase II trials of PIPE-791 in IPF and progressive MS. Boehringer Ingelheim’s Ofev and Roche’s Esbriet currently compete for the IPF market. Preclinical studies and a Phase I trial suggest PIPE-791 may have a convenience advantage. Contineum plans to study once-daily doses of PIPE-791, whereas Ofev and Esbriet are respectively taken two and three times a day. The biotech is part of a clutch of drug developers that want to treat IPF by targeting LPA1. Bristol Myers Squibb shared Phase II data on a LPA1 antagonist in 2023, more than a decade after entering the space through the $325 million acquisition of Amira Pharmaceuticals. Contineum founder and chief scientific officer Daniel Lorrain used to work at Amira. Other companies are racing BMS to market. Amgen’s acquisition of Horizon Therapeutics included a Phase II LPA1 drug candidate. AbbVie joined the fray by buying DJS Antibodies for $255 million in 2022. Contineum’s exploration of LPA1 in progressive MS sets it apart from the competition. The biotech said PIPE-791 is the only brain-penetrant LPA1 receptor antagonist in clinical development progressive MS, an indication that has thwarted other companies. The IPO will also support the Phase II trial of PIPE-307 that got underway last year. Contineum agreed to complete the study of the M1R inhibitor in relapsing-remitting MS when J&J struck a deal for the asset. The biotech has earmarked $16.2 million from the IPO haul for the study. Contineum contends inhibition of M1R may directly promote remyelination. Contineum’s listing on the Nasdaq makes it part of the resurgence of IPOs seen in the first few months of this year. Like many other members of the class of 2024, the biotech has advanced deeper into the clinic before going public than the early-stage biotechs that listed during the IPO peak of 2021. Nick Paul Taylor is a freelance pharmaceutical and biotech writer based in London. He can be reached on LinkedIn.

Pictured: Boehringer Ingelheim's headquarters in Silicon Valley/iStock, Sundry Photography Boehringer Ingelheim is laying off some of its sales staff due to the slow uptake of its Humira (adalimumab) biosimilar Cyltezo (adalimumab-adbm) in the U.S., according to reporting from Reuters. The company declined to reveal how many of its employees will be affected by the layoffs but has said that it plans to cut back on customer-facing sales teams and instead transition to a hybrid model, including face-to-face and virtual operations. Boehringer’s decision to change its sales approach was driven in large part by pharmacy benefit managers, which have kept Humira on their list of drugs available for reimbursement, according to Reuters. Patients have largely favored the branded product over biosimilars like Boehringer’s Cyltezo. Owned and commercialized by AbbVie, Humira is a monoclonal antibody that targets and blocks the TNF protein, which is a key player in the inflammatory cascade. The FDA first approved Humira in December 2022 for the treatment of rheumatoid arthritis, and the treatment has since secured several indications for other immune-mediated and inflammatory disease, such as Crohn’s disease, plaque psoriasis and ulcerative colitis. With several approvals under its belt and a strong risk-benefit profile, Humira quickly became one of AbbVie’s best-performing assets. The treatment is also among the world’s top-selling drugs, clinching the top spot for several years. At its peak in 2022, Humira brought in more than $21 billion in annual sales. However, losing most of its patent protections in recent years has potentially threatened Humira’s market dominance. In 2023, Humira only generated $14.4 billion in sales worldwide, a 32.2% decline from its high the prior year. AbbVie attributed the sales hit to the erosion of its market. Several biosimilar developers have sought to take advantage of the opportunity and come out with their copycat versions of the blockbuster drug. Amgen opened the floodgates in January 2023 with the debut of Amjevita, followed by a flurry of launches in July 2023. This batch included Celltrion’s Yuflyma, Sandoz’s Hyrimoz, Oraganon and Samsung Bioepis’ Hadlima and Boehringer’s Cyltezo. Boehringer’s Humira biosimilar stands out from its peers for also having the FDA’s interchangeability designation, which allows it to be substituted for the reference branded product without needing to change the prescription or consult the prescriber. The company has also offered steep discounts for Cyltezo, launching an unbranded version in October 2023 that sells for 81% lower than Humira’s price. Still, AbbVie has kept its tight grip on the market, surrendering only 2% of its massive share to its biosimilar competitors, according to Samsung Bioepis’ 4th Biosimilar Market Report published in January 2024. Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com.