Strike Novartis from the list of rivals to Incyte’s topical eczema drug Opzelura. After getting a look at early clinical data, Novartis has dumped (PDF) its topical pan-JAK inhibitor CEE321 over an unfavorable risk-benefit profile.
Virtual reality and artificial intelligence technology developer Jolly Good is likely feeling very jolly indeed after being tapped by Otsuka Pharmaceutical to develop a mental health treatment program combining pharmacological and psychotherapeutic techniques.
Biogen and Roche’s Genentech are looking to follow up on their multidecade history of getting medicines approved together, with the Aduhelm maker dishing out $30 million in the latest attempt.
Christophe Bourdon’s time at Danish meme stock Orphazyme, which has a rejected rare disease drug, will come to a head in March. He will assume the helm at Leo Pharma as it prepares to launch its eczema drug.
Sio Gene Therapies is dumping its midphase Parkinson’s disease program to eke out its cash into 2023. Years after the biotech, then known as Axovant, had a high-profile failure in Alzheimer’s, it has decided to cull its current riskiest bet and focus on two other programs under the leadership of a new CEO.
Takeda keeps pumping out biotech spinoffs. Months after spawning HilleVax, the Japanese drugmaker has packed off another pair of midphase programs to seed a new rare disease player: Oak Hill Bio.
Massachusetts-based Oak Hill starts life with a pair of assets that made it as far as phase 2 before losing momentum amid Takeda’s large pipeline. The lead candidate is OHB-607, a recombinant human version of IGF-1 that Takeda hailed as one of the jewels of its $62 billion takeover of Shire in 2019. Back then, Takeda pitched the drug as a potential breakthrough in the prevention of the complications of premature births.
Takeda kicked off a phase 2b trial to evaluate whether the therapy can cut the time preterm babies spend on respiratory support in 2019 and went on to initiate a long-term follow-up study the next year. The first trial has dragged on, with its targeted primary completion data slipping from 2022 to 2025, and Takeda is ducking out rather than see the project through to its conclusion.
Victoria Niklas, M.D., the global program leader on OHB-607 at Takeda, is transferring to Oak Hill with the drug. Niklas has taken up the chief medical officer role at Oak Hill, positioning her to continue working on the program as part of a C-suite that features Aslan Pharmaceuticals founder Mark McHale, Ph.D., and Josh Distler, formerly of hedge fund Athanor Capital. Norman Barton, M.D., another Takeda staffer who has worked on the program, is joining Oak Hill as a senior scientific adviser.
The team will advance OHB-607 alongside another asset licensed from Takeda, OHB-101. The candidate is a soluble recombinant version of the FcγR2B receptor that has now changed hands five times since 2015, when Baxter bought its originator SuppreMol.
Then known as SM101, the drug had completed a pair of phase 2a clinical trials at the time of the Baxter deal but has barely advanced since then. Oak Hill wants to get the program moving again, outlining plans to run a pair of phase 2b clinical trials in rare autoimmune diseases.
Takeda is supporting “the transition for continued research and development of the acquired programs” and receiving a financial package in return for the assets. The package features an upfront fee, a stake in Oak Hill and a chance to receive milestones and royalties.
Sarepta Therapeutics will pay GenEdit up to $57 million in the near-term for access to the Eli Lilly-backed biotech’s non-viral delivery platform for gene editing therapies.
Madrigal Pharmaceuticals has passed the first of two phase 3 nonalcoholic steatohepatitis (NASH) trials. With the study finding the ex-Roche drug reduces liver fat, Madrigal is heading to a more comprehensive efficacy readout with increased confidence in its chances of bucking the industry’s NASH losing streak.
Discovery scientists using traditional tech often need to make go-no-go decisions on sub-optimal data, says Charles River Laboratories, which has expanded its deal with SAMDI Tech to try and give sponsors more information about candidate compounds.
A big chunk of Pfizer’s plan to add $15 billion to sales just went up in smoke. Having gone over phase 2b data on cardiovascular drug vupanorsen, Pfizer has decided to return the rights to Ionis Pharmaceuticals, leaving it without a candidate it tipped to deliver peak sales of more than $3 billion.
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