Bayer has agreed to acquire Perfuse Therapeutics for up to $2.45 billion, the companies said, in a deal designed to broaden the buyer’s ophthalmology pipeline with Perfuse’s sole pipeline drug and two clinical phase programs for eye disorders.

Perfuse’s PER-001 is a small molecule endothelin receptor antagonist being developed for the treatment of ophthalmic diseases. Two of PER-001’s four programs are in Phase II development: One designed to treat open-angle glaucoma by improving the visual field for patients, and the other designed to treat diabetic retinopathy (DR) by improving contrast sensitivity and reducing ischemia in patients with the disorder.

Last year, Perfuse announced positive results from two Phase II clinical trials evaluating PER-001.

One was a Phase IIa trial (NCT05822245) assessing PER-001 in glaucoma, which showed that six months after a single intravitreal administration of PER-00, added to existing standard-of-care intraocular pressure (IOP)-reducing therapies, 22.2% of low-dose and 37.5% of high-dose patients experienced ≥7 decibel (dB) improvement in a pre-defined retina region of minimal five test points compared to 0% in control in six months.

The improvement was 8–14x better than the natural history of disease (2.7%) with currently available treatments, Perfuse said at the time.

In the other Phase IIa trial (NCT06003751), which focused on DR, patients showed a mean of +0.9 dB improvement in low luminance contrast sensitivity in the high-dose group and +0.65 dB in the low-dose group across multiple frequencies measured at week 20. In contrast, a mean of -2.1 dB worsening occurred in the control group over the same period.

The low luminance, low contrast visual acuity was better by a mean difference of 5.5 and 5.1 letters from baseline in low- and high-dose groups compared to control measured at week 20, Perfuse said at the time.

PER-001 is also in preclinical development for dry age-related macular degeneration (AMD)/geographic atrophy, as well as for retinal vein occlusion.

“We are excited by the work of the team at Perfuse Therapeutics and encouraged by the potential of PER-001,” Juergen Eckhardt, MD, head of business development and licensing at Bayer Pharmaceuticals, said in a statement. “With this acquisition, we are complementing our expertise in ophthalmology and our pipeline, reinforcing our commitment to developing urgently needed therapies for patients.”

Looking beyond Eylea^®

Bayer’s ophthalmology pipeline has long been dominated by the blockbuster drug Eylea^® (aflibercept), co-marketed with Regeneron Pharmaceuticals and initially approved in 2011. However, Eylea is close to losing exclusivity for key U.S. patents: According to Regeneron’s Form 10-K annual report for 2024, patents for Eylea expire between 2027 and 2039, starting with four formulation patents expiring on June 14, 2027. Patents for the higher-dose version, Eylea HD^®, expire between 2027 and 2032, starting with two formulation patents expiring on June 14, 2027.

Last year, Eylea and Eylea HD saw their sales slip in the mid-teens, generating a total combined $8.04 billion in revenue, consisting of $4.385 billion in U.S. net sales for Regeneron and €3.11 billion in ex-U.S. sales for Bayer (about $3.655 billion today, up from the $3.506 billion reported in January).

During the first quarter of this year, Regeneron reported $941 million in U.S. sales, down 10% from a year ago; Bayer plans to report Q1 sales on May 12.

PER-001 is an intravitreal bio-erodible implant administered into the vitreous cavity of the eye using a single-use, 25-gauge applicator and designed to provide a sustained release of the drug, allowing for a convenient dosing regimen, according to Perfuse and Bayer.

Bayer has agreed to pay $300 million upfront for Perfuse, which is headquartered in San Francisco with R&D facilities in Durham, NC. The remaining up to $2.15 billion in deal value hinges on Bayer achieving development, regulatory, and commercial milestones.

The acquisition deal is subject to approval by Perfuse shareholders and antitrust clearances.

“I’m incredibly proud of what the Perfuse team has accomplished and deeply thankful to all our investors and collaborators,” stated Sevgi Gurkan, MD, Perfuse’s founder and CEO. “Bayer’s vision aligns closely with ours, and they have the scale and global resources to unlock the full potential of PER-001 to change the trajectory of human blindness. We are very excited to see our mission continue with even greater momentum.”

The post Bayer to Acquire Perfuse for up to $2.45B, Seeing Ophthalmology Opportunity appeared first on GEN – Genetic Engineering and Biotechnology News.

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Over the past decade, our industry has witnessed the promise of cell and gene therapies. Patients with rare diseases or hard-to-treat diagnoses now have treatment options harnessing human cells and genes to alter disease. The accessibility of these therapies remains constrained not by what’s biologically possible, but how they are designed and manufactured.

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As cell therapies expand into larger patient populations and new indications, the need for manufacturing designed for reliability and scale from day one becomes more urgent. The therapies being developed today have the potential to transform millions of lives—but only if the systems supporting them are built to deliver at scale.

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The post From Discovery to GMP: Building Scalable Cell Therapy Manufacturing appeared first on GEN – Genetic Engineering and Biotechnology News.

After a tidal wave of blowback that culminated in a lawsuit, a nonprofit health system has reversed course in its plan to replace its Oregon emergency physicians with a national chain. 

PeaceHealth’s announcement Wednesday didn’t disclose what prompted its change of heart, but those familiar with the situation say it’s because the health system’s plan was poised for defeat in a legal challenge. When PeaceHealth said in February it was cutting ties with Eugene Emergency Physicians, the local group that had staffed its Oregon hospitals for 35 years, the news drew tremendous pushback from doctors, nurses, lawmakers, mayors, and emergency medicine groups. 

Then, on March 20, the Eugene emergency physicians sued, arguing that PeaceHealth’s plan to use the Atlanta-based staffing chain ApolloMD violated a new Oregon law prohibiting managed service organizations from directly owning medical practices or interfering with clinical decisions. The case has had four hearings, in which the judge was “quite clear” that the scheme violated the law, Senate Bill 951, said Hayden Rooke-Ley, an attorney who represented the doctors and a senior fellow for health care with the American Economic Liberties Project.

Continue to STAT+ to read the full story…

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