Dalzanemdor

Biogen has made an offer to acquire its partner Sage Therapeutics, according to a Friday evening regulatory disclosure, following months of setbacks by the smaller company that have led to a long slide in its market value. In a letter to Sage CEO Barry Greene , Biogen CEO Chris Viehbacher submitted a non-binding offer to pay $7.22 per share, according to a filing Friday. Sage’s stock price closed the week at $5.55, and Viehbacher’s offer carries a 30% premium. The acquisition would value Sage at about $469 million, a fraction of what the biotech was worth even a year ago. That’s also less than the $569 million in cash and equivalents Sage said it had on hand last September. The Massachusetts biotech’s stock has dropped more than 90% over the past five years, beset by clinical failures and lackluster sales of Zurzuvae, the first pill for postpartum depression. In a statement, Sage said it would “carefully review and evaluate the proposal made by Biogen to determine the course of action that it believes is in the best interest of the Company and all Sage shareholders.” Biogen is interested in tapping its own commercial chops to boost sales of Zurzuvae, according to the offer letter. The two drugmakers partnered in November 2020 to jointly develop and sell Zurzuvae and another asset, SAGE-324. The latter drug failed a Phase 2 trial last year in essential tremor. “We believe that our deep expertise in neurology and global commercial capabilities will enable more streamlined operations and efficient commercial execution that will enable access to Zurzuvae for more patients in need of this important medicine,” Viehbacher wrote to Greene. Questions about Sage’s future have only grown since November, when its experimental Huntington’s disease treatment failed a Phase 2 study . The company said it would halt further development of that drug and has no other programs in the later stages of development. Unusually, the offer letter was publicly disclosed because of Biogen’s existing equity holdings in Sage. Biogen owns about 6.2 million shares of Sage, about 10% of the company. Biogen made that investment back in 2020, paying just over $104 per share. At the time, that 10% stake was worth about $650 million — more than what Biogen is now offering to pay for the whole company. “Because Biogen is a Sage shareholder, we were required to file a Schedule 13D when we made a non-binding proposal to Sage,” a Biogen spokesperson said in a statement to Endpoints News . “We are not going to comment on the proposed transaction at this time.” Biogen once had big hopes for Sage’s drugs, which are inspired by natural molecules called neurosteroids that are linked to a long list of brain diseases. Zurzuvae, for example, showed rapid and remarkable effects in alleviating postpartum depression in new mothers, but it had mixed results in major depressive disorder. In August 2023, the FDA shocked the company and its investors when it rejected Zurzuvae’s use in the more common condition, a market that was more than 40 times bigger than postpartum depression. Sage’s stock plummeted and was soon trading just above the amount of cash it had on hand. Last year, as the company struggled to commercialize the drug, it was beset by one clinical failure after another. Its experimental drug dalzanemdor failed three separate tests in Alzheimer’s disease, Huntington’s disease and Parkinson’s disease. And SAGE-324 failed a key study in essential tremor, spurring Biogen to drop it from the partnership. To survive, Sage ended earlier stage programs and resorted to multiple rounds of layoffs while it awaited the results of each of those programs. Its most recent reduction in October cut its R&D workforce to roughly one-third of the size a year-and-a-half prior, when it still had hopes for a broader commercial launch for Zurzuvae. Through it all, Biogen and Sage have insisted that they are committed to Zurzuvae’s use in postpartum depression, even as public investors deemed the drug effectively worthless. It was the first pill for a long-stigmatized form of depression that affects one-in-eight new mothers. As Sage’s fortunes soured, many wondered what would become of the treatment. The answer may now lie in Biogen’s hands. Editor’s note: This story has been updated with more context on Sage and Biogen’s history.

Roche’s alpha-synuclein-targeting antibody has failed to slow the progression of motor symptoms in a mid-stage Parkinson’s disease test, marking the latest setback in a largely challenging year for the disease pipeline. The pharma company’s prasinezumab missed statistical significance in the Phase 2b PADOVA study’s primary endpoint of time to confirmed motor progression versus placebo (p=0.0657), according to a Thursday release . The trial enrolled 586 people with early-stage Parkinson’s who were taking stable doses of levodopa or a monoamine oxidase-B inhibitor. Roche secured the rights to prasinezumab more than ten years ago, when it inked a global development and commercialization deal with the drug’s creator, Prothena, worth up to $600 million. Prothena’s share price $PRTA was down around 6% premarket Thursday. Prasinezumab seemed to have a stronger effect in the subset of Phase 2b patients taking levodopa, Roche said. There were also “positive trends” in multiple secondary endpoints. Roche plans to present the full Phase 2b data at a future medical meeting. In the meantime, the Swiss drugmaker will carry on with open-label extensions of PADOVA and a separate failed prasinezumab study called PASADENA. The latter trial missed its primary endpoint in 2020. Roche is not the only company to struggle with developing effective treatments for Parkinson’s. On Tuesday, UCB and Novartis reported that minzasolmin, which has the same mechanism as prasinezumab, failed to significantly slow signs of disease progression in a Phase 2a study. In April, Sage Therapeutics axed its Parkinson’s asset , dalzanemdor, on the heels of a Phase 2 disappointment. Two months later, the FDA rejected AbbVie’s 24-hour infusion therapy for Parkinson’s for the second time due to manufacturing concerns. AbbVie has had better luck with tavapadon, the Parkinson’s drug it acquired from Cerevel, which passed its third late-stage test earlier this month.