| | | |   | Good morning, everyone. Damian here with an update on Novavax's missed moment, Amgen's next big thing, and the impending conclusion of the Theranos saga. | | | Novavax’s shot at profitability might have fizzled Novavax, a company beset by delays and disappointments for its Covid-19 vaccine, again cut its sales projections after conceding that its updated booster proved no better than the original product.
In its third-quarter earnings presentation last night, Novavax forecast just $2 billion in sales for 2022. In August, the firm projected up to $2.3 billion on the year, itself a substantial revision from the company’s prior expectation of up to $5 billion in sales. Novavax also reported data from a pivotal study comparing its authorized vaccine, sold as Nuvaxovid, against a bivalent version that also targets the Omicron variant. The results made “a compelling case” for sticking with the original vaccine rather than using the updated version, the company said.
But that could pose commercial issues for Novavax, which did not provide revenue projections for 2023. Novavax’s FDA authorization, awarded last month, allows Nuvaxovid to be used as a booster only for adults who, for medical or accessibility reasons, cannot take one of the bivalent boosters from Moderna and partners Pfizer and BioNTech, or who otherwise wouldn’t get one. And unlike the other Covid vaccines, Novavax’s shot can only be used as a first booster shot; anyone who has already had one or multiple boosters can only get the others.
Disappointing demand for Nuvaxovid is already cutting into the company's business. In the third quarter, Novavax reported a $249 million charge related to "excess, obsolete, or expired inventory" and losses on previous purchase agreements. | Amgen’s obesity drug could roil a market in the making A new generation of treatments for obesity are expected to become multibillion-dollar products, and Amgen, while years behind its competitors, has a medicine that might stand out in a crowded field.
In data presented at the American Heart Association, the highest dose of Amgen’s treatment, called AMG133, led to a 16% reduction in body weight relative to placebo. The data come from a small, three-month Phase 1 study. But the fact that AMG133 is dosed once a month could be a benefit over weekly treatments like Novo Nordisk’s semaglutide and Eli Lilly’s tirzepatide, and analysts are hopeful Amgen’s treatment might lead to more dramatic weight loss in the longer clinical trials yet to come.
Wall Street’s enthusiasm for AMG133 has helped drive Amgen’s stock price up nearly 40% over the last 12 months. With more than 100 million people in the U.S. who meet the criteria for obesity, drugs like AMG133 are “the ‘electric vehicles’ of biopharma for this decade,” as SVB Securities analyst David Risinger wrote in a note to clients last week, “because the market opportunity is so significant and current penetration is extremely low.” | One company’s “voyage” to unlock the full translational potential of CNS gene therapies The field of CNS gene therapy has recently made important strides forward. While these milestones offer hope for patients, the field is still limited by challenges like the need for local administration to remote areas of the body and an inability to effectively dose beyond infancy. Voyager’s scientists have been pioneering novel AAV capsid engineering approaches to solve these issues and deliver treatments in a systemic way to key regions of the brain. Read more on how Voyager capsids have the potential to address gene therapy’s greatest challenges. | Why is the Supreme Court split on drug patents? The Supreme Court, faced with two ostensibly similar cases of alleged pharmaceutical patent infringement, decided to hear one but not the other, leaving legal scholars puzzled.
As STAT’s Ed Silverman reports, the court this week decided not to hear Bristol Myers Squibb’s argument that it’s entitled to $1.2 billion from Gilead Sciences over the patents to CAR-T cancer therapy. But just days earlier, the court agreed to hear Amgen’s case regarding a patent dispute with Sanofi and Regeneron Pharmaceuticals.
The issue appears to relate to two closely related, albeit distinct, legal concepts. In the Bristol case, the dispute was over whether the patent in question was invalid because it lacked a sufficient written description. For Amgen, the debate is over whether the patent claims are overly broad so as to be unfair. As one expert put it, “in taking Amgen but not Bristol, the court may have wanted to wade into this complex area one toe at a time.”
Read more. | The (likely) end of the Theranos saga is nigh After nearly a year of courtroom testimony and a pair of thwarted demands for retrials, former Theranos leaders Elizabeth Holmes and Ramesh “Sunny” Balwani will soon face sentencing.
This week, a federal judge threw out Holmes’ request for a new trial, the Associated Press reports, after dismissing a similar request from Balwani. Holmes, convicted on four of 11 charges of fraud, is scheduled for sentencing on Nov. 18, while Balwani, who was found guilty on 12 counts of fraud, will learn his fate Dec. 12.
Each faces up to 20 years in prison and hundreds of thousands of dollars in fines, but their sentences could diverge. Holmes was convicted of conspiracy to defraud investors and three counts of wire fraud, but the jury found her not guilty of conspiring to defraud patients and cleared her on two individual patient-related charges and one count of lying in paid advertisements. Balwani, whose role as chief operating officer put him closer to Theranos’ day-to-day business, was not as successful in court. | More reads - Faze Medicines, a biotech focused on neurological diseases, is shutting down, STAT
Brain implants that translate paralyzed patients’ thoughts into speech creep closer to reality, STAT - FDA commissioner Robert Califf tests positive for Covid, Reuters
- Talkspace names a new CEO as its stock price continues to struggle, STAT
| Thanks for reading! Until tomorrow,  | | | |
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