Zepbound, from Eli Lilly & Co., is aiding in the fight against obesity, a significant challenge to public health. Now, the pharma giant is tackling another pressing issue: sleep disturbances.
Through a deal potentially reaching $7.8 billion — approaching Lilly’s most substantial acquisition to date — the U.S. based corporation is procuring Centessa Pharmaceuticals Plc, a biotech enterprise innovating medications for narcolepsy and various conditions characterized by difficulties in maintaining full alertness throughout the day.
Investigations into narcoleptic canines during the 1990s ultimately revealed that numerous individuals suffering from this ailment, defined by overwhelming daytime sleepiness, exhibit a deficiency in the neuropeptide orexin within the brain. It required over a quarter-century, yet scientists formulated medications known as orexin receptor agonists which replicate the neuropeptide’s functions, thereby establishing a therapeutic category capable of notably diminishing the majority of the disease’s manifestations.
In human clinical trials concerning narcolepsy, a condition resulting from orexin shortage, the investigational drugs have demonstrated potent outcomes across a spectrum of symptoms, accompanied by relatively minimal adverse reactions. “It’s akin to providing insulin to individuals diagnosed with type 1 diabetes: you are replenishing what is lacking,” commented Thomas Scammell, a neurologist specializing in sleep disorder treatment at Beth Israel Deaconess Medical Center in Boston. The medications’ efficacy is promising, as they could extend beyond narcolepsy to encompass a broader array of wakefulness impairments, he noted.
Assuming the transaction proceeds, Lilly will face competition from other entities, including Takeda Pharmaceutical Co. and Alkermes Plc, in introducing novel medications to the market.
Takeda has achieved the greatest success thus far. This past February, its experimental medication, oveporexton, received priority review status from the FDA for the therapy of type 1 narcolepsy, with an anticipated decision later in the year. Takeda anticipates the medication could generate $2 billion to $3 billion in worldwide sales. Scammell serves as a consultant for the company. Similar to obesity medications, Lilly might not secure initial approval; however, the U.S. based enterprise is prepared to risk nearly $8 billion on the prospect of joining the multibillion-dollar market for narcolepsy and idiopathic hypersomnia, another sleep disorder for which Centessa is under development. Researchers suggest that the medication could potentially aid in sleep apnea, a more prevalent condition affecting millions.
There is also an even larger possibility. Research indicates that medications grounded in orexin could prove valuable for diverse neurological and psychiatric conditions. As an illustration, the biotech firm Alkermes is evaluating orexin receptor agonists for ADHD and fatigue linked to Parkinson's disease and multiple sclerosis.
The firms are demonstrating that the medications not only “induce alertness in healthy individuals and narcolepsy patients, but are also beginning to exhibit cognitive improvements” that might be particularly beneficial in neurodegenerative conditions, observed Giovanni Marigi, co-founder of Medicxi. Medicxi established Centessa via a combination of several biotech firms. “The fact that Lilly is prepared to allocate such a substantial sum for a small, early-stage molecule enterprise underscores the considerable interest and potential within this domain,” remarked Andrew Plump, Takeda’s president of research and development. In a study featured in December within JAMA Neurology, Takeda revealed that beyond its primary impact on alertness, oveporexton also enhanced attention, memory, and executive function in narcolepsy patients over an eight-week period.
The primary medication, Centessa, is presently in mid-stage clinical assessments, with the most frequently encountered adverse effects encompassing frequent urination, insomnia, and dizziness. Its mechanism mirrors that of Takeda’s medications.
Lilly’s involvement in next-generation sleep-disorder medications addresses a crucial void in the company’s offerings, noted RBC Capital Markets analyst Trung Huynh. The drug manufacturer has been striving to broaden its reach into central nervous system ailments, yet “the company lacked a robust position in insomnia, a category characterized by substantial unmet demand,” Huynh stated.
Should clinical assessments affirm that these innovative medications can extend their benefits beyond sleep disorders, “it signifies an immense market opportunity,” commented Jim Tananbaum, founder and CEO of Foresite Capital, an investor in Centessa.
Emmanuel Migneau, one of the scientists responsible for investigating canines with narcolepsy and uncovering the condition’s underlying cause, voiced confidence in the drugs’ potential. Orexin agonists “are poised to discover applications across numerous other medical fields where the issue of drowsiness or sedation is pertinent,” articulated Migneau, a sleep medicine professor at Stanford University.
This isn’t Lilly’s introductory venture into the area. The corporation’s popular Zepbound represents the exclusive medication sanctioned for the therapy of obstructive sleep apnea, a nighttime breathing disorder impacting over 23 million U.S. adults. Back in 2004, the organization also procured an insomnia medication from Merck KGaA, and several years afterward, it acquired Hypnion, a modest biotech company engaged in the creation of medications targeting insomnia and other sleep disorders.
Source: Bloomberg