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BioPharma Commercial Development Activities & FDA Promotional Letters
- Jana Chisholm
- 5 days ago
- 9 min read
This week we've had Eyes On Commercial Development and the FDA. Several companies have announced partnerships / acquisitions to further boost their pipelines and strengthen their competitive advantage - Novo Nordisk partnered with Replicate Bioscience, AbbVie acquired Gilgamesh’s bretisilocin program, Novartis is buying Tourmaline to strengthen their CV franchise, Lilly announced the location for the first of 4 US based manufacturing plants, and the FDA started their crackdown on DTC advertising. Read the summaries below and check out the links for details.
Novo Nordisk is relying on innovative RNA technology to support its early-stage pipeline as the obesity pioneer loses ground in the competition for next-generation medications.
With a multi-year research partnership with Replicate Bioscience that might be worth up to $550 million, Novo will have access to Replicate’s platform to target cardiometabolic disease.
The agreement states that Novo will pay for Replicate’s research in exchange for the sole worldwide right to create and market the lead programs that are produced.
Replicate will receive a $550 million agreement value payment in an upfront tranche and possibly in milestones. Royalties from product sales resulting from the cooperation might also be given to the biotech.
Replicate creates self-replicating RNA (srRNA) molecules, which are made to replicate themselves and multiply once they reach the body, they can be administered at lower dosages than normal mRNA molecules. Once inside a cell, the RNA serves as a guide for the natural machinery of the cell to produce a medicine. A COVID-19 vaccine employing a similar technique, Arcturus Therapeutics and CSL’s Kostaive, has been authorised in Europe and Japan, and the biotech’s srRNA rabies vaccine just passed a phase 1 test.Replicate’s only clinical asset is the rabies vaccine; other preclinical candidates include molecules that target autoimmune diseases, lung cancer, and breast cancer, as well as a vaccine for the Epstein-Barr virus.
Novo was once the unchallenged heavyweight of the GLP-1 world, but has since had trouble keeping up with compounders and Eli Lilly, its main adversary. Long-time CEO Lars Fruergaard Jørgensen was fired this year, and Novo veteran Maziar Mike Doustdar took over shortly after the business cut its 2025 sales forecast because of the semaglutide market’s sluggish development.
Novo discontinued two obesity-related products earlier this month: a CB1 receptor blocker and a GLP-1/GIP co-agonist. Novo has lost its senior VP of marketing and patient solutions for U.S. operations since Doustdar took over, and the FDA has approved Wegovy for the treatment of adult metabolic dysfunction-associated steatohepatitis.
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AbbVie has agreed to pay up to $1.2 billion to acquire a psychedelic medicine candidate from Gilgamesh Pharmaceuticals in its long effort to treat psychiatric diseases. Last month, AbbVie was in negotiations to pay roughly $1 billion to Gilgamesh. The final agreement differs little from what the initial reports indicated. AbbVie has decided to purchase Gilgamesh’s bretisilocin program and allow the biotech to spin off other assets to form a new company, instead of purchasing the entire company.
Bretisilocin development milestones and upfront payments totalling up to $1.2 billion will be covered by AbbVie. The distinction between upfront and milestone payments has not yet been made public by the corporations. The news release describing the arrangement makes no mention of royalties or regulatory or commercial milestones.
Under the terms of the deal, AbbVie will get control of a product that recently saw a 94% remission rate in a phase 2 major depressive disorder (MDD) investigation. Forty patients were examined about a month following the initial treatment, which was administered in two doses spaced roughly two weeks apart.
The 5-HT2A receptor, which is essential to the hallucinogenic reaction to substances like LSD and psilocybin, is what Gilgamesh intended bretisilocin, commonly referred to as GM-2505, to interact with. The fact that bretisilocin has a shorter half-life than conventional psychedelics is one of its main advantages. The two-hour in-clinic framework that Johnson & Johnson established for their ketamine-derived medication Spravato may be supported by the half-life of bretisilocin.
At AbbVie, bretisilocin will slot into a well-established neurology section. In spite of a phase 2 failure, AbbVie is attempting to make money out of its $8.7 billion investment in Cerevel Therapeutics and has agreements with Gedeon Richter, the company’s source for the antipsychotic blockbuster Vraylar.
The agreement gives Gilgamesh financing for additional initiatives and Big Pharma support for bretisilocin. The biotech’s staff, other initiatives, and current agreement with AbbVie will all be housed within the new company, Gilgamesh Pharma. Other research and development initiatives include an M1/M4 agonist program, an ibogaine analogue, and an oral NMDA receptor antagonist.
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Novartis is paying $48 per share of the biotech, or $1.4 billion, to put Pacibekitug into its pipeline. This is a substantial rise from the $30.18 price at which Tourmaline’s shares finished on Monday and is far higher than the $20 price at which the company’s stock started the year.
Pacibekitug, an antibody that targets interleukin-6, is at the heart of the agreement. In May, it significantly decreased levels of C-reactive protein (CRP), a biomarker for the risk of cardivoascular disease, in patients with chronic renal disease, hitting the study’s primary aim.
Tourmaline has proposed using the data as a springboard to create pacibekitug as a treatment for several cardiovascular conditions, including atherosclerotic cardiovascular disease (ASCVD). Atherosclerosis is known to be influenced by inflammation, and interleukin-6 is a proinflammatory cytokine. Inflammation causes the liver to create CRP, and people with atherosclerosis usually have higher blood levels of the protein. Since there are currently no widely used anti-inflammatory treatments for lowering cardiovascular risk, pacibekitug, which targets IL-6 through a unique mode of action, holds promise for reducing residual inflammatory risk in ASCVD.
Tourmaline’s luck was improved by the Tranquilly phase 2 trial, which included 143 patients at high risk of ASCVD who had chronic renal disease and increased CRP levels.At Day 90, CRP levels decreased by an average of 86% in those who took 50 mg of pacibekitug, 75% in those who took 25 mg, and 85% in those who took 15 mg, while the placebo cohort experienced a 15% decrease.
The biotech at the time said that the study was the first to evaluate an IL-6 inhibitor in a clinical trial with quarterly dosage and characterised the decline in CRP levels as quick, profound, and long-lasting.
Pfizer was the original owner of Pacibekitug, which Tourmaline licensed in 2022. Apart from the cardiovascular indications, the company has been evaluating the antibody in a phase 2 trial for thyroid eye disease, an autoimmune ailment, while Pfizer has previously investigated Pacibekitug for rheumatoid arthritis, lupus, and Crohn’s disease.
With a $75 million private placement on the Nasdaq, Tourmaline was able to advance its only asset in 2023 through a reverse merger with Talaris Therapeutics.
In the summer, Novartis expanded its cardiovascular pipeline through a four-year agreement with ProFound Therapeutics and a comprehensive partnership with Chinese siRNAa startup Argo Biopharmaceutical. The acquisition of Tourmaline comes after that.
Novartis’ cardiovascular portfolio already consists of the heart failure drug Entresto and the cholesterol-lowering drug Leqvio. Pelacarsen is an antisense medication in the pharmaceutical company’s late-stage pipeline that is intended to prevent cardiovascular problems in people with increased lipoprotein(a) levels.
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The floodgates have opened since the FDA declared it was taking action against direct-to-consumer pharmaceutical advertisements that it deemed to be deceptive or misleading.Only one of what the agency claimed were thousands of letters alerting pharmaceutical companies to their alleged violations of federal pharma marketing regulations was made public in the initial days following the announcement. This letter was from the Centre for Biologics Evaluation and Research (CBER) and it targeted a television ad for AstraZeneca’s self-administered FluMist vaccine.
However, a plethora of untitled letters and more serious warning letters were later posted for public review by the Centre for Drug Evaluation and Research (CDER). Forty untitled letters, all dated September 9, the day when CDER Director Tidmarsh, M.D., Ph.D., signed the crackdown plans published by the Trump administration, make up the first swath.
Many of the largest pharmaceutical companies are the targets of the letters, and some of them have received more than one. At the top of the unnamed heap were three apiece for Bristol Myers Squibb, Novartis, UCB, Boehringer Ingelheim, and Phathom Pharmaceuticals, and five for AstraZeneca and another for its company that focusses on rare diseases, Alexion. Sanofi and Pfizer were among the companies that received one letter each, while AbbVie, Takeda, and Teva Pharmaceuticals each received two.
Each of the untitled letters makes the case that a specific DTC advertisement misbrands the medication it promotes by being inaccurate or deceptive. The businesses have been given fifteen days to formally address the accusations.
For instance, Novartis’ Kesimpta advertisements have been criticised for their commercial’s attention-grabbing imagery, which may detract from the main warning of risks and side effects, as well as its assertion that the multiple sclerosis medication can be taken at home in just one minute per month, which Tidmarsh claimed oversimplifies the procedure.
In the meantime, Boehringer’s three letters all address a separate Jardiance advertisement with a musical theatre theme. The FDA blasted the commercials in each letter for possibly diverting viewers’ attention from the drug safety information with their fast-paced, captivating images, numerous scene changes, and background music.
The majority of the nearly 70 marketing-related warning letters that have been uploaded target online pharmacies and sellers of compounded drugs, to which FDA Commissioner Marty Makary, M.D., promised in a recent JAMA op-ed to intensify marketing crackdown for their blatant promotion of medications that only highlight their benefits.
Of the warning letters, eight were sent to pharmaceutical companies: three to Eli Lilly, two to Aytu BioPharma, and one each to Novo Nordisk, Alora Pharmaceuticals, and CSL Behring. The final letter was sent by CBER, not CDER, because it was about the biologic medication Hizentra.
Novo’s warning letter relates to the GLP-1 medication TV special hosted by Oprah Winfrey last year. A Novo executive and two physicians who had previously served as paid consultants for the Big Pharma were included in the broadcast. The FDA claims that although Novo Nordisk personnel made multiple claims regarding the advantages of Wegovy, Ozempic, and Victoza in the special, they left out crucial risk information and generally downplayed the dangers of these medications.
Lilly’s own GLP-1 medicines, Mounjaro and Zepbound, are the subject of its three warning letters. One criticises the same Oprah-hosted show, which also featured Lilly officials. The other two concern local TV news pieces about Zepbound in Dayton, Ohio, and Oklahoma City, both of which were identified as business-sponsored and had a reporter interviewing two company executives. The FDA claims that neither section conveys any information regarding the drug’s risks.
Similar to the untitled letters, the FDA warned that companies who failed to effectively remedy any violations might face immediate legal action, including seizure and injunction, if they did not react within the allotted 15 days.
The FDA announced last week that it was in the midst of issuing 100 more serious cease-and-desist notices to companies it determined were broadcasting deceptive advertisements, in addition to thousands of letters instructing drugmakers to remove their misleading advertisements. They are taking the initiative to address decades of regulatory failure, the agency said.
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Eli Lilly has decided to build a $5 billion facility in Goochland County, Virginia, to manufacture active pharmaceutical ingredients. It is the first of four sizable production sites that Lilly intends to construct in the United States has been identified. The manufacturer unveiled the facility at a high-profile press event in Washington, D.C., over seven months ago, as part of a $27 billion investment plan. Each of the new plants, which Lilly refers to as “mega sites,” is expected to begin construction this year.
In reaction to the mounting threat of tariffs on pharmaceutical items imported from other nations, drugmakers have poured billions of dollars into the U.S., a trend that is reflected in Lilly’s decision to increase its domestic capacity and fortify its supply chain.
Goochland County is located northwest of Richmond, the capital of Virginia. Lilly intends to hire 650 people at the facility, and 1,800 more are anticipated to work on its construction. Within five years, the business expects all four of the new U.S. locations to be up and running.According to Lilly, the plant is the company’s first fully integrated API and pharma product facility specifically designed for its monoclonal antibody repertoire and bioconjugate platform. The business has stated that it intends to produce antibody-drug conjugates at the new location in addition to other goods.
The site selection is Virginia’s second significant victory of the summer. AstraZeneca pledged $50 billion in U.S. investment in July, including the construction of a large $4 billion drug substance production facility in the state.
Separate economic development packages of over $10 million each have been approved by Virginia legislators for the construction of AstraZeneca and Lilly’s factories. The property near Charlottesville is covered by AstraZeneca’s agreement.
According to the corporation, Lilly selected Goochland County from hundreds of applications due to its workforce potential, easy access to utilities and transportation, and advantageous zoning, in addition to the financial incentives.
Johnson & Johnson, which has announced a $55 billion strategy that involves strengthening its medtech business, and Roche, which has committed to spending $50 billion, are two other firms that have announced significant investment plans in the U.S. in recent months.By the end of the decade, Sanofi and Novartis have pledged to invest a minimum of $20 billion each in the United States.
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