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Top 10 failed drug sales in the past 5 years
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Top 10 failed drug sales in the past 5 years.
Obtaining the full commercial potential from approved drugs ensures that companies can recover R&D costs, provide funding for future drug discovery, and can satisfy investors with substantial profits. Ensuring the successful launch is arguably the most critical step in the life cycle of a drug.
The products on the list span different disease fields, covering oncology, immunology, infectious diseases, etc.
However, a recent LEK Consulting report found that about 40% of the drugs approved between 2004 and 2016 performed more than 20% lower than Wall Street’s pre-market sales forecast in the three years prior to launch.
Here, we list 10 drugs released in the past 5 years, which have encountered some of the most notable failures. The sales data of some of these drugs were significantly lower than expected, while the current financial situation of other drugs was stable, but still suffered major setbacks, raising questions about their long-term value.
1. Beovu, Novartis
- First approval : October 2019, US FDA
- Indications : Age-related macular degeneration (AMD)
- Past sales estimates : USD 4.38 billion by 2021, sales in 2020: USD 190 million
So far, Beovu’s sales are only $87 million, a 16% decrease compared to the same period last year.
When Novartis’ age-related macular degeneration (AMD) drug Beovu crossed the FDA’s finish line, it appeared to pose a huge threat to Regeneron’s blockbuster Eylea and Roche’s Lucentis. But its enemy has one more card to play: Beovu poses a greater security risk. This hindered its highly anticipated launch.
When Beovu was approved by the agency in October 2019, market observers had high hopes for it. The price of the drug is comparable to that of its competitors, and it can be used to treat AMD patients for a longer period of time. It is used quarterly or every other month.
At that time, Wall Street analysts predicted that Novartis’ new eye medicine would top the market in 2026. According to popular estimates, revenue by the end of 2021 would be approximately US$4.38 billion. Novartis executives talked about less frequent dosing schedules, encouraging patients to spend more time focusing on “important things in their lives.”
2. Dengvaxia, Sanofi
- First approval: In December 2015, the Mexican Federal Health Risk Protection Committee
- Indications: Dengue fever
- Past sales estimates: USD 1 billion by 2020, sales in 2020: not reported
Dengvaxia, which took 20 years and cost 1.5 billion euros to develop, initially carried people’s high hopes.
When Sanofi began obtaining global approval for dengue fever injection Dengvaxia at the end of 2015, the pharmaceutical industry seemed ready for the next large-scale vaccine release. However, within two years, everything has changed.
Mexico is the first approved by the State Dengvaxia, the Philippines is the first spring of the following year to their deployment to the country’s large national vaccination program.
Sanofi spent 20 years and 1.5 billion euros developing a vaccine, and it is expected that the product will become a blockbuster. Last year, Sanofi did not disclose Dengvaxia’s sales, which means they are not important to the company.
Who is the culprit? More than a year after its launch, Sanofi disclosed new safety data, indicating that the use of the vaccine may cause more serious cases for those who have not previously been infected with dengue fever.
3. Eucrisa, Pfizer
- First approval: December 2016, US FDA
- indication: atopic dermatitis
- Past sales estimates: peak sales in 2020 are 2 billion U.S. dollars, and in 2019 it will be 138 million U.S. dollars
Sanofi and Regeneron’s blockbuster antibody injection Dupixent has taken market share from Pfizer’s Eucrisa, a topical treatment for atopic dermatitis.
When Pfizer spent US$5.2 billion to acquire Anacor Pharmaceuticals in 2016, the core of the deal was crisaborole, a non-steroidal in vitro PDE4 inhibitor. Pfizer said its peak sales may reach or exceed US$2 billion.
Pfizer’s argument for this prediction sounds solid. A few months later, the FDA approved the drug under the trade name Eucrisa for the treatment of atopic dermatitis, affecting approximately 18-25 million people in the United States. Many children and infants suffer from this disease, and Pfizer hopes that Eucrisa can fill this unmet demand market given its relatively benign safety status.
In two phase 3 trials, Eucrisa significantly increased the number of mild to moderate patients with no or almost no eczema compared to the control group.
But Pfizer is obviously not ready to deal with the competitive threat posed by Sanofi and Regeneron’s antibody injection Dupixent. The IL-4/13 inhibitor won his eczema nod with its excellent efficacy data, only three months later than Eucrisa. In 2019, Dupixent was approved for adolescents as young as 12 years old, and the drug has recently achieved positive results in patients as young as 6 months old.
Eucrisa is approved for use in children as young as 3 months old, but its audience is patients with mild to moderate illness, while Dupixent is approved for moderate to severe illness. Dupixent is now recognized as the top choice for eczema; according to SVB Leerink’s calculation of IQVIA data, the total number of scripts per week has steadily increased to an average of about 32,000 in September. In contrast, the US version of Eucrisa seems to have declined since the fall of 2018 and is now about 6,700 per week.
4. Lartruvo, Eli Lilly
- First approval: October 2016, US FDA
- indication: Soft tissue sarcoma (withdrawn)
- Past sales estimate: USD 374 million by 2021, sales in 2020: none
Eli Lilly’s anti-cancer drug Lartruvo was withdrawn from the market about three years after receiving FDA approval for soft tissue sarcoma.
When Eli Lilly’s anti-cancer drug Lartruvo was approved in 2016, it was a much-needed victory because the Indianapolis pharmaceutical company just announced an ambitious plan to Twenty new drugs will be launched in the ten years between 2023. John Lechleiter, then CEO when laying out a new R&D blueprint, boasted that the company “is in the midst of the company’s 140-year history of launching the most new products.” But he also pointed out, “Given the nature of science and our business, there is nothing here. guarantee.”
Unfortunately, Lartruvo later fell into the wrong side of history.
Lartruvo (olaratumab) targets PDGFR-α to block cancer and was developed to treat soft tissue sarcoma. The drug received VIP treatment from the FDA throughout the regulatory process-from fast track and breakthrough therapy designation to priority review, which eventually led to accelerated approval in October 2016. The FDA emphasized that it is the first first-line treatment for soft tissue sarcoma (STS) with a history of more than 40 years. According to media reports, Wall Street analysts predict that Lartruvo’s sales will reach $373.7 million in five years.
But all this came to an abrupt end in 2019, when Lilly reported that Lartruvo had failed in its third phase confirmatory test called “Announcement.” In the entire STS population or subgroup of leiomyosarcoma, the trial failed to show that Lartruvo and doxorubicin had a life-prolonging benefit compared to doxorubicin alone.
5、Nuplazid, Acadia Pharmaceuticals
- First approval : April 2016, US FDA
- Indication : Parkinson’s disease, psychosis
- Past sales estimate : USD 841 million by 2020, sales in 2020: USD 441.8 million
Since Nuplazid was the first and only FDA nod, it has been stuck in safety dilemmas, federal marketing investigations, and surprising label expansion setbacks.
Nuplazid of Acadia Pharmaceuticals does not necessarily cross the FDA’s finish line. Out of safety concerns about the increased risk of death, this antipsychotic was finally approved by the agency in 2016. Despite the concerns, it is still hailed as a potential blockbuster by analysts.
After Nuplazid was first approved to prevent hallucinations and delusions in Parkinson’s disease patients, Evaluate Pharma expects potential sales of $841 million in 2020. Several analysts expect it to earn more than $1 billion in revenue within five years.
But this drug has not lived up to the hype. Nuplazid’s revenue last year was only $441.8 million. It is the first and only since the FDA nodded, it has been dragged down by safety issues, federal marketing investigations, and surprising label expansion frustrations.
6、Ocaliva, Intercept Pharmaceuticals
- First approval : May 2016, US FDA
- Indication : Primary biliary cholangitis
- Past sales estimate : up to 8.6 billion U.S. dollars, sales in 2020: 313 million U.S. dollars
By reassessing clinical trial data, Intercept hopes to convince regulators of the benefits of Ocaliva in NASH.
Unlike many other drugs included in this report, Intercept’s Ocaliva (obeticholic acid) has not yet received FDA approval in the company’s most sought-after indication. As early as 2017, the FDA approved Ocaliva for the treatment of rare liver disease primary biliary cholangitis, but Intercept has not yet convinced regulators to approve the drug in the lucrative non-alcoholic steatohepatitis (NASH) market.
NASH, a progressive fatty liver disease mainly caused by obesity, is the primary target of pharmaceutical manufacturers. Analysts believe that the value of this field may be as high as tens of billions, and Intercept was once the leader.
But in the past 18 months, regulatory setbacks have weakened these hopes.
Last summer, after the COVID-19 pandemic forced the FDA to postpone the review of the NASH drug several times, the agency stated that the drug’s “expected benefits…still uncertain” and that the safety risks were not worthwhile. After being rejected, Intercept laid off some employees to cut costs.
7、Rubraca, Clovis Oncology
- First approval : December 2016, US FDA
- indications : ovarian cancer and prostate cancer
- past sales estimates : 663 million U.S. dollars by 2021, sales in 2020: 164.5 million U.S. dollars
Since the launch of Rubraca, the PARP market has developed rapidly, and the advantages Rubraca once had are quickly erased by competitors.
Clovis Oncology’s Rubraca is the second PARP inhibitor to enter the market, two years later than AstraZeneca and Merck’s Lynparza. Rubraca has never been considered the best of its kind, but the statistics of Cortellis Consensus Forecast in August 2017 show that analysts still predict that its sales in 2021 may reach 663 million US dollars.
In the first half of 2021, Rubraca’s sales were only 74.9 million U.S. dollars. In contrast, Lynparza’s sales during the same period were $1.13 billion.
Rubraca accelerated the approval of BRCA mutant ovarian cancer after at least two chemotherapy treatments late in 2016. At the time, Rubraca’s three-line usage seemed to surpass Lynparza’s four-line usage label.
- First approval: December 2017, US FDA
- indications: Type 2 diabetes
- sales forecast: $1.09 billion in 2022, sales in 2020: undisclosed
Although other SGLT2 therapies are booming, Merck and Pfizer’s Steglatro are far from meeting expectations.
When Steglatro was approved for type 2 diabetes, it entered a crowded field, forcing partners Pfizer and Merck to catch up with a group of strong market competitors. But with the rapid expansion of the diabetes market, there seems to be enough room to develop another sodium-glucose cotransporter 2 (SGLT2) drug. Analysts touted the blockbuster potential of Steglatro and its combination therapy: Steglujan, which pairs the drug with Januvia; and Segluromet, which includes the generic stable metformin.
But Steglatro did not succeed, and probably never will.
Soon after the drug was approved, Clarivate Analytics and the Investor Business Daily predicted that sales in 2022 would reach US$1.09 billion. But the actual sales of the drug are so low that neither Pfizer nor Merck disclosed this information in their quarterly and annual reports. Neither company responded to Fierce Pharma’s request for sales data.
Steglatro has been at a disadvantage because it entered the market after Johnson & Johnson’s Invokana, AstraZeneca’s Farxiga and Boehringer Ingelheim, and Eli Lilly’s Jardiance and other SGLT2 treatments. All of these drugs launched in 2013 and 2014 have reached blockbuster status and brought in total sales of US$6.15 billion in 2020.
Pfizer, which developed the drug, and Merck & Co., which bought shares in the drug in 2013, tried to make Staglatro stand out in price competition. The two companies set Steglatro and its Segluromet combination at $8.94 per day, compared with $13 for Jardiance and $11.57 for Farxiga. But the initiative did not have much impact.
9 、 Vascepa, Amarin
- First approval : July 2012, US FDA
- indications : high cholesterol; reduction of cardiovascular risk.
- Past sales estimates : USD 1.5 billion by 2020, sales in 2020: USD 614 million
The upward trajectory of Amarin’s Vascepa is now threatened by competition from generic drugs in the United States.
Seven years after being marketed as a bad cholesterol-lowering drug, Vascepa received the FDA’s second approval, sparking great expectations for the fish oil derivative. In 2019, Vascepa became the first drug approved to reduce cardiovascular risk in people who have elevated triglyceride levels and do not respond to statins. Amarin was so encouraged by the brand expansion that its sales staff doubled.
But shortly after the seemingly transformative approval, Amarin’s fate changed. The combination of data that cast doubt on the benefits of Vascepa and the invalidation of several of its patents have brought a blow to the company that may never be recovered.
The timing of Vascepa has never been the best choice. When it was first approved by the FDA, omega-3 was no longer touted as the key to heart health. Nevertheless, as the only premium fish oil product made from pure eicosapentaenoic acid (EPA), Vascepa does get some attention. Vascepa’s sales increase by at least 25% every year.
But in March 2020, a judge in Nevada declared invalid the key patent protecting Vascepa-a major blow because it is the only product of Amarin. The judge declared that the drug created by Amarin was nothing special, saying it was “obvious to a skilled craftsman”.
10、Zynteglo, bluebird bio
- First approval : June 2019, European Commission
- Indication : β-Thalassaemia
- Past sales estimate : USD 1.87 billion by 2024, sales in 2020: none
Bluebird bio encountered a series of problems during the launch of the gene therapy Zynteglo, reflecting the difficulty of selling expensive drugs in a new way.
bluebird bio encountered a series of problems during the launch of Zynteglo, a gene therapy designed to treat the blood disease β-thalassemia. The launch encountered manufacturing problems, epidemic restrictions and safety issues. There is now a severe price drop in Europe, effectively forcing Bluebird to return to clinical stage biotechnology from a commercial company.
Zynteglo, also known as LentiGlobin or beti-cel, inserts a functional version of the beta-globin gene into the recipient’s hematopoietic stem cells. The goal is to help patients produce normal levels of hemoglobin.
The gene therapy was recommended by the European Medicines Agency (EMA) in March 2019 for the treatment of blood transfusion-dependent β-thalassemia, and a few months later it obtained a conditional marketing authorization from the European Commission.
In view of the market potential of beta thalassemia and sickle cell disease, Evaluate Pharma at the beginning of 2019 listed Zynteglo as one of the most valuable drug releases of the year, with estimated sales of $1.87 billion in 2024.
Top 10 failed drug sales in the past 5 years
(source:internet, reference only)