Zavegepant

Various kinds of medical pills with Rx sign on smartphone screen , online pharmacy concept Atstock Productions/iStock Big Pharma has finally gotten its arms around something advocates have wanted for a long time: direct-to-consumer sales. Eli Lilly and Pfizer are leading the way. Big Pharma is finally beginning to offer what patient advocates have been asking for: a direct-to-consumer option to buy medicines straight from the manufacturer. This past week, Eli Lilly announced the addition of starter Zepbound vials to its DTC platform, called LillyDirect, expanding options for patients to self-pay for the popular weight loss drug. A day later, Pfizer announced the digital portal PfizerForAll , which provides access to the New York pharma giant’s vaccines, plus migraine and respiratory drugs. The two programs connect patients to telehealth care and a third-party service for the delivery of medicine. “It does just make the full digital telehealth pharmacy experience online really seamless,” Dedham Group Principal Manny Jurado told BioSpace . “It’s like you’re able to integrate everything into almost more or less a one-stop shop.” Jurado says these DTC approaches are a long time coming. Advocates have been calling for a new way for patients to access medicines that could help bring down costs by cutting out the so-called middle-men that pharma industry groups say push up prices. But DTC adoption has been slow. These latest announcements are a welcome advancement, Jurado said. “I’m sure pharma already had a lot of plans about this multiple years ago, but it’s now finally that we’re able to see it come to fruition,” he said, acknowledging the complexity of developing these programs in terms of compliance and regulatory hurdles. While the process cuts out the trip to the pharmacy, patients are not exactly receiving the medicine from Lilly or Pfizer’s personal storage rooms. Jurado said the pharmas have contracted third-party providers for the actual distribution. He noted that the DTC idea is not new. Amgen and AbbVie have existing platforms and the pharma industry has played around with the idea previously with minimal success. Now that Lilly and Pfizer are diving in, he suspects more—including Lilly’s chief rival Novo Nordisk —will follow suit. Zepbound Pushes Lilly Toward DTC Option Lilly was a natural entrant given the craze around Zepbound and the supply hurdles the company has faced. LillyDirect launched in January , just two months after Zepbound’s approval. Then last week, Lilly announced the availability of single-dose vials of Zepbound at a 50% discount compared to the list price of other treatments in the incretin class. CEO David Ricks said during a fourth quarter earnings call in February that the idea came from the challenges patients have experienced accessing obesity treatment. “Finding medicines in their pharmacies, that’s a been a challenge,” Ricks said on the call. “And I think particularly as supplies are tight, many patients report driving to five, six, seven pharmacies to find the medicine they need. This simplifies that process.” The direct pharmacy also gives patients confidence that they are getting a genuine Lilly-manufactured drug, as compounded or illicit versions of Zepbound have trickled into the market, the CEO added. “We haven’t thought about it as a way to create some new retail distribution business. It’s a way to serve the patients that want our medicines better,” Ricks said. But Lilly will benefit from getting new patients started on treatment, Jurado said. While the online pharmacy serves as an option for patients whose insurance has denied coverage of the weight loss drug, the single-dose vial offered through LillyDirect is just a starter dose—patients will eventually have to step up to a higher dose which will need to be accessed another way, according to Jurado. In addition, as the coverage landscape for weight loss medication evolves, cash-pay patients will likely switch over to insurance and long-term care. Lilly did not frame the new vial offering as a way to cut costs for patients. The drug launched last year in its injectable form with a list price of $1,059.87 a month for the various doses. But removing the injectable from the equation does lead to a savings in terms of the overall price and some of the manufacturing complexity. A number of third-party providers have been pulled together to deliver LillyDirect. EVERSANA and others are conducting pre-authorizations; Form Health and 9amHealth are doing the telehealth services; and TruePill and Amazon Pharmacy are offering the pharmacy services, among other providers. Pfizer tackles an ‘overwhelming’ system While Lilly is doubling down in DTC, Pfizer is just getting started. With PfizerForAll, patients can purchase prescription drugs, over-the-counter medications and diagnostic tests, available for pick-up at a local pharmacy or through home delivery. The service will also connect patients with in-person or online appointments with healthcare professionals and offer a scheduling tool for adult COVID-19, flu, pneumococcal pneumonia and respiratory syncytial virus (RSV) vaccinations. In addition, PfizerForAll provides access to the company’s savings programs, which include solutions for co-pay and insurance. “People often experience information overload and encounter roadblocks when making decisions for themselves or their family in our complex and often overwhelming U.S. healthcare system. This can be extremely time-consuming and lead to indecision or inaction – and as a result, poor health outcomes,” Aamir Malik, Pfizer’s executive vice president and chief U.S. commercial officer, said in an August 27 statement. “We are pleased to offer PfizerForAll to help relieve this burden on people, especially as we enter the fall season in the U.S., and streamline the path for those seeking better health.” While Lilly is trying to address a nearly insatiable demand for its weight loss drug, Jurado said that migraine medicines have also been in demand. Pfizer markets Nurtec and Zavzpret. “We’re seeing more and more of these pseudo-retail type products and retail therapies starting to make more sense from a direct-to-consumer standpoint and ease of online access,” Jurado said, adding that migraine treatment requires a neurologist, which can be hard to access. Pfizer has stated plans to expand the program, potentially to a broader range of conditions. In announcing PfizerForAll, Pfizer also did not mention slashing prices as a reason behind the move. While the program connects patients to existing affordability programs, no new options were released to coincide with the DTC launch. Ready, Set, Launch When contacted by BioSpace , AbbVie pointed to the Synthroid Delivers program, which offers the brand name thyroid hormone medicine directly to patients for $25 per month for a 90-day prescription. AbbVie uses Eagle Pharmacy to fulfill the orders. Amgen did not return multiple requests for comment, but STAT identified the company as one that has used virtual care in the past for its migraine drugs. Jurado suspects there may soon be more companies joining the DTC marketplace. “I would assume that there’s going to be a lot of other players who are either potentially launching, or are even thinking about launching,” Jurado said.

The biopharmaceutical landscape is quietly undergoing a transformation, with neuroscience emerging as a hotspot amidst the industry's shifting dynamics. While the cancer therapy arena has seen setbacks with dual antibodies and ADCs, the metabolic disease space, led by weight loss treatments, has experienced a surge in popularity. Concurrently, the neuroscience (CNS) field is witnessing a renaissance, marked by clinical breakthroughs and a series of high-profile mergers and acquisitions.   The renewed focus on neuroscience is driven by the immense unmet medical needs and recent advancements in fundamental research. According to WHO projections, neurological disorders are poised to become the second leading cause of death within the next 20 years. Alarmingly, the number of individuals diagnosed with Alzheimer's disease (AD) and other forms of dementia continues to rise, with an estimated 50 million people worldwide affected. Additionally, the prevalence of depression and severe mental illnesses is on the rise, with a worrying trend towards younger populations.   Despite this growing burden, the efficacy of existing treatment options for neurological disorders remains below 50%, presenting a vast clinical demand and market potential. In this landscape, even minor therapeutic differences can lead to commercial success, as "you don't need a cure to have a blockbuster, just an incremental improvement." Moreover, the rapid advancements in sequencing technologies and the resulting drop in costs have enabled exponential growth in genetic research related to neurodegenerative diseases. By analyzing relevant genes, scientists have been able to identify critical signaling pathways and drug targets.   The approval of Biogen's Aduhelm, the first Alzheimer's drug targeting the Aβ cascade, has served as a catalyst for the resurgence of the CNS field. Although Aduhelm faced challenges due to its significant side effects, leading to commercial failure, the recent full approval of Eisai and Biogen's Leqembi (lecanemab) in the United States and China marks a significant milestone. Leqembi is the first drug capable of slowing the progression of early-stage Alzheimer's disease, a landmark achievement in this notoriously difficult-to-treat field.   Sensing the renewed promise of neuroscience, multinational corporations (MNCs) have accelerated their efforts to establish a presence in this space. However, the shadows of past failures have made them more cautious, leading them to favor low-risk, late-stage transactions that avoid the risks associated with early and mid-stage clinical trials. In 2022, Pfizer acquired Biohaven for $11.6 billion, gaining access to the migraine drug Nurtec ODT (rimegepant). In 2023, Pfizer's CGRP receptor antagonist nasal spray, Zavzpret, successfully obtained FDA approval.   The neuroscience field has witnessed three major acquisition deals in 2023: Bristol Myers Squibb's $14 billion acquisition of Karuna Therapeutics, which provided the company with the schizophrenia drug KarXT; AbbVie's $8.7 billion purchase of Cerevel, securing the Parkinson's disease candidate Tavapadon and the schizophrenia and Alzheimer's psychosis candidate Emraclidine; and Biogen's $7.3 billion acquisition of Reata, gaining access to the Nrf2 activator Omaveloxolone for neurological indications.   As the industry navigates the complexities of the neuroscience landscape, the promise of genetic research, advancements in AI-driven precision medicine, and the recent regulatory successes have ignited a renewed sense of optimism. The stage is set for MNCs to continue their aggressive pursuit of promising neuroscience assets, driven by the urgent need to address the growing burden of neurological disorders and the potential for significant commercial rewards.