Pharma’s Biggest Losses: Once-Dropped Drugs Make Lucrative Comebacks

2023-05-10

上市批准并购临床3期

Pictured: Illustration of stacks of coins and a graph charting growth / iStock, Intpro In March 2023, Sanofi acquired the diabetes drug Tzield, along with its owner Provention Bio, for $2.9 billion. While not among the largest deals in the biopharma industry, it’s still a sizeable sum of money—especially for a treatment once discarded by another pharma giant. Initially developed by MacroGenics, the intravenous antibody treatment was scooped up by Eli Lilly in 2007, but Lilly dropped it three years later after a clinical trial in recently diagnosed type 1 diabetes patients failed to show a significant reduction in daily insulin dose or blood sugar levels in the treatment group compared to placebo. But it wasn’t the end of the road for Tzield. In 2018, MacroGenics licensed the drug to Provention for $6.1 million, according to SEC filings. In 2022, Sanofi took an interest, partnering with Provention to commercialize the drug. Late last year, the investment paid off—the FDA approved Tzield, and Sanofi moved forward with a complete acquisition of Provention and its drug. Such a convoluted history for therapeutics is not uncommon. Pharmaceutical companies may decide to sell the rights to their drug development programs when they have no intention of manufacturing the drug, or the research process doesn’t turn out as planned. However, sometimes the offloaded products perform better elsewhere, leading to big buyouts as companies try to expand their portfolios. The decision to license or sell a drug depends on profitability and a company’s strategic mission, said Andrew Lo, director of the Laboratory of Financial Engineering at MIT Sloan School of Management. “Even if a particular drug program is likely to be successful, and even if it generates a couple hundred million dollars a year in revenue, that might not be enough to justify putting the resources of the company to that drug because the same resources can be developing a billion dollar a year drug,” Lo told BioSpace. Similarly, if a company halves its work in a specific area, it may drop all products even if they’re successful. These decisions also depend on whether a company “believes” in the science of a drug, Lo said. Even if a drug doesn’t do well in clinical trials, another company may predict it will do well in the future and decide to buy it. In those cases, the original owner often retains an ownership stake in the product if it does well—to avoid the “egg on your face” of giving up a good product, as Lo described. As for acquisitions, those decisions depend on whether the acquiring company values all of the target company’s assets or just some. Lo said the trend of drugs changing hands would continue as some companies fall into financial need and sell their assets. “Stay tuned because the next six to 12 months are going to be periods of very active licensing deals and acquisitions." Here are a few more examples of drugs that ended up under the purview of large pharmaceutical companies after being dropped. 1. Momelotinib: Gilead’s Loss, GSK’s Gain First sale: YM Biosciences to Gilead Sciences for $510M (2012) Second sale: Gilead Sciences to Sierra Oncology for $3M (2018) Third sale: Sierra to GSK for $1.9B (2022) Momelotinib is a medication for patients with myelofibrosis, a form of bone marrow cancer. Gilead acquired the drug for $510 million in its 2012 acquisition of YM Biosciences, which had merged with Cytopia Limited in 2009. Gilead sold it to Sierra Oncology in 2018 for $3 million after clinical trials showed mixed results. Under the new ownership, the drug succeeded in clinical trials, and in June 2022, it was submitted to the FDA for approval. By then, GSK had already agreed to acquire the company for nearly $2 billion. Sierra awaits the agency’s decision, expected in June 2023. 2. Lebrikizumab: Roche’s Loss, Lilly’s Gain First sale: Roche to Dermira Dermira for $80M (2017) Second sale: Dermira Dermira to Eli Lilly for $1.1B (2020) Lebrikizumab is a monoclonal antibody used to treat atopic dermatitis. Dermira paid $80 million upfront to acquire the drug from Roche Group in 2017, and two years later, the FDA granted lebrikizumab fast-track designation. In 2020, Eli Lilly acquired Dermira Dermira for $1.1 billion. Lilly submitted the drug for approval in November 2022. 3. Zejula: Merck’s Loss, GSK’s Gain First sale: Merck to Tesaro for $7M (2012) Second sale: Tesaro to GSK for $5.1B (2019) Zejula (niraparib) is a poly ADP-ribose polymerase inhibitor poly ADP-ribose polymerase inhibitor that targets a family of proteins involved in cell response. Merck accepted $7 million upfront from Tesaro in 2012 to unload the drug from its portfolio. Five years later, the drug was approved for ovarian, fallopian tube or primary peritoneal cancer patients. Zejula’s success led GSK to acquire Tesaro for $5.1 billion in 2019. However, later concerns about PARP inhibitors PARP inhibitors led GSK to restrict the drug’s indications, even as the company explores Zejula’s utility for other cancer types. 4. Veltassa: Amgen’s Loss, Galenica’s Gain First sale: Amgen to Relypsa for $8.2M upfront (2009) Second sale: Relypsa to Galenica for $1.5B (2016) Veltassa (patiromer) is a drug developed for treating hyperkalemia, or high potassium in the blood. Relypsa, an offshoot of Amgen, received the rights to Veltassa from the parent company in 2009 for an upfront cost of $8.2 million. The drug was approved in 2015, and around the same time, Relypsa partnered with Vifor Fresenius Medical Care Renal Pharma—owned by Galenica—to commercialize the drug outside of the U.S. In 2016, Galenica fully acquired Relypsa for $1.5 billion and renamed the company CSL Vifor. 5. Cubicin: Lilly’s Loss, Merck’s Gain First sale: Eli Lilly to Cubist Pharmaceuticals for an undisclosed cost (1997) Second sale: Cubist to Merck for $8.4B (2014) In the late 1980s and early 1990s, Eli Lilly developed daptomycin, an intravenous antibiotic. However, the company suspended clinical trials after volunteers experienced adverse effects and discontinued its work on antibiotics altogether. Lilly then granted Cubist Pharmaceuticals the rights to develop and distribute daptomycin, which was approved in 2003 under the brand name Cubicin and 11 years later acquired by Merck for $8.4 billion. 6. Anidulafungin: Lilly’s Loss, Pfizer’s Gain First sale: Eli Lilly to Vicuron for $14M (1999) Second sale: Vicuron to Pfizer for $1.9B (2005) Vicuron obtained the antifungal drug anidulafungin from Eli Lilly in 1999 for $14 million. Initial Phase III clinical trials were successful, but in 2004 the FDA said a New Drug Application for the drug didn’t have enough data to support its efficacy, leading to lawsuits by shareholders per SEC filings. A year later, Pfizer acquired Vicuron for $1.9 billion. After submitting additional clinical data and adding another indication, the drug was approved in 2006 under the brand name Eraxis. Nadia Bey is a freelance reporter in North Carolina. She can be reached at beynadiaa@gmail.com.