If you look at the pharmaceutical industry’s most promising investigational drugs (which you can do right here), cancer therapies comprise the vast majority of the industry’s recent innovations; a fact which is increasingly important given that most industry experts acknowledge that the industry’s research and development train is slowing down. Blockbuster drugs are becoming harder and harder to come by, and analysts are constantly pointing to the looming threat of patent expirations.
Further, for many companies, there are no new drugs to replace aging top sellers. As a result, it seems as though companies are fractioning into those that actually and actively invest in research, and those which essentially “collect” smaller companies’ treatments, such as Valeant Pharmaceuticals Intl. Inc. (NYSE:VRX). “Industry R&D productivity has been very, very low, so how all companies grow in this industry is through making really good acquisitions,” Valeant’s CEO J. Michael Pearson told The New York Times earlier last week.
Oncology, though, is one arena in which there is plenty of work to be done where research is booming — and profitable. Cancer therapies have changed a lot in the past decade, and the past few years have seen yet another shift as immunotherapies and targeted drugs become more and more common, replacing older, broader-spectrum chemotherapies. That being said, there are quite a few aging blockbusters that are still steadily delivering sales growth after more than a decade. We’ll outline the top 10 best selling cancer drugs of 2013, and predict which we think will hold over, and which are due to be ousted by more recent innovations.
It’s worth noting that the top three best selling cancer drugs in 2013 were developed by Roche Holding Ltd. and its biotech subsidiary, Genentech; the company remains the biggest player in the oncology arena, drawing in sales of $31.3 billion from its cancer-fighting medicines alone. Right behind Roche is Novartis AG (NYSE:NVS), a company which CEO Joseph Jimenez says is “doubling down” on the cancer business, according to Forbes. The company recently bought GlaxoSmithKline Plc’s (NYSE:GSK) cancer business in the midst of a flurry of pharmaceutical mergers, which happened earlier this spring.
While Novartis may give Roche a run for its money, FirstWord Pharma notes that the company’s domination of the cancer market is still likely to continue into 2018, with newer therapies such as Perjeta, Kadcyla, and Gazvya replacing older medicines, all of which are likely to do well by the drugmaker, particularly Kadcyla, which costs an astounding $94,000 for a standard course of treatment.
Zytiga was a big deal for Johnson & Johnson (NYSE:JNJ) when it was first approved in 2011. The drug, which the company developed for the treatment of prostate cancer, was approved by the FDA two months ahead of schedule, suggesting that the FDA saw a profound need for the drug in the market.
The drug, which works by interfering with testosterone, has been a huge success ever since. The FDA even approved the drug as a first-line treatment after one study showed that the drug could add as much as 5 months to a patients’ survival period.
Last year, Zytiga brought in $1.7 billion in sales for J&J, and FiercePharma notes that the drug currently dominates about 34 percent of the market. Its sales have totaled $512 million for 2014 thus far, though analysts say competitors are in the process of producing similar medicines, such as Xtandi from Astellas and Medivation, which will no doubt dilute the market.
Though not necessarily a cancer drug so much as a preventative vaccine, Merck & Co. Inc.’s (NYSE:MRK) Gardasil deserves a mention on our list. The drug brought in $383 million during the first-quarter of 2014, and last year’s worldwide sales of the drug totaled $1.8 billion.
Gardasil, which was first approved by the FDA in 2006, has posted more sales growth in the past year than previously, though experts caution that Japan has stopped actively promoting the vaccine, which Merck says will lead to slower sales growth, and the company has posted revised earnings forecasts with this change in mind. The treatment has also come under fire from certain parents, who argue that the vaccine encourages pre-teens and teens to have sex by fostering a false sense of safety from infection with HPV, which is responsible for up to 70 percent of cervical cancer cases in the United States.
Gardasil is likely to continue to maintain steady sales, though analysts caution that its days of real sales growth may be over, according to a recent FiercePharma report.
Erbitux, developed as part of a partnership between Merck and Bristol-Myers Squibb Co. (NYSE:BMY), generated $1.87 billion in global sales in 2013, making it number 8 on our list. The drug, used in the treatment of colon, head, and neck cancers is specialized, however, and Merck has done little to expand the drug to new indications, resulting in a steady drop-off in sales.
The drug has also suffered poor results in a recent, 2012 phase III clinical trial in patients with stomach cancer, as well as trial which studied the drug’s efficacy in patients who had undergone surgery for the treatment of colon cancer. Analysts predict that sales of Erbitux will slide to $1.1 billion by 2018, according to FiercePharma, so while the drug may be doing well now, it seems as though its decline is imminent — if not already underway.
Acquired by Johnson & Johnson and Takeda Pharmaceuticals as part of a $8.8 billion takeover of rival Millenium Pharmaceuticals, Velcade — a multiple myeloma treatment — has been pulling its weight. The drug brought in about $2.6 billion in last year worldwide, contributing to Johnson & Johnson’s 10 percent rise in sales last year. The drug was also approved as a first line treatment for the blood cancer by the UK’s National Institute for Health and Care, a nice bonus for the two companies.
But Velcade, which has finally begun to pick up steam after being on the market for more than a decade — even snapping up FDA approval for subcutaneous injection in 2012 — isn’t likely to be driving sales for Johnson & Johnson for much longer. The drug’s patent is set to expire in 2017, and FiercePharma notes that rival Actavis Plc has already filed an application with the FDA to manufacture a generic version of the drug.
First developed to treat mesothelioma and later also approved for the treatment of lung cancer, Alimta remains one of Eli Lilly‘s (NYSE:LLY) best selling drugs behind the popular antidepressant medication Cymbalta.
Both Cymbalta and Alimta are rapidly nearing their patent expiration dates, sparking desperation at the struggling drugmaker; luckily, however, Eli Lilly won a ruling in which the drugmaker fought for patent protection for Alimta after it was challenged by competitor Teva Pharmaceutical, no stranger to court battles over drugs patents itself. The judge sided with Eli Lilly, claiming that the drugmaker’s patent should be upheld until 2022, though the company continues to fight similar battles in both the UK and Germany. Earlier last month, a UK court ruled against Eli Lilly, giving Actavis the go-ahead to produce a generic version of the drug for the UK.
Further, Lilly’s attempts at expanded the drug’s indications have largely failed, with phase III trials of the drug in patients with head and neck cancer resulting in disappointment. It seems Lilly’s blockbuster won’t save it any time soon.
Like several other drugs on this list, Revlimid is an older medicine, first approved by the FDA in 2006, but continues to boast impressive sales, bringing in a cool $1.09 billion in 2013. Perhaps even more impressive, it was largely due to Revlimid’s sales growth last year that drugmaker Celgene (NASDAQ:CELG) raised its earnings forecast three different times throughout 2013; the drug saw a 13 percent sales growth in the second-quarter, and followed up with a 12 percent sales growth during the third-quarter, according to FiercePharma.
But Revlimid has had more difficulty than certain other cancer medicines in expanding its indications beyond treatment for multiple myeloma and mantle cell lymphoma. Last year, Celgene was forced to cancer trials of the drug in patients with chronic lymphocytic leukemia. The drug, which is costly, at $6,195 a month, has also run into trouble with government health organizations such as the UK’s NICE, which refused to carry the drug, saying it couldn’t justify the costs.
Gleevec is another aging, yet blockbuster drug that was a bit of breakthrough on the market when it was first approved in 2001. Often called a “wonder drug” or “miracle drug,” Gleevec is perhaps best known for its astounding success rate; the drug effectively turned some blood cancers into chronic illnesses rather than terminal, life-threatening diseases, and has also nabbed a number of new indications since it was first released onto the market. It is now used as a part of the treatment for myeloid leukemia as well as its original indication for the treatment of blood cancer, and last year gained yet another indication as a treatment for acute lymphocytic leukemia in children. The drug brought in an impressive $4.69 billion in 2013, indicating its run is still far from over even as decades old drug.
But the drug, developed by Novartis AG, has had its share of setbacks as well; Novartis failed to gain patent protection in India for the drug, and the company has had to stave off copycat versions in the U.S. as well. Gleevec’s patent stands until February 2016, but the company is hustling patients to switch over to Tasigna, a follow-up drug. Thus far, Novartis seems to be succeeding: Tasigna brought in $1.3 billion in 2013, a massive, 31 percent increase over 2012.
Herceptin, generically known as trastuzumab and developed by Genentech (Roche), is one of the most widely used breast cancer treatments currently on the market. Prescribed primarily to patients with metastatic breast cancer, the drug is effective against tumors that “overexpress” the HER2 protein, and it’s thought that the drug may also be effective against other cancers that have the HER2 protein, such as ovarian, colon, endometrial, lung, bladder and prostate, and salivary gland tumors.
Global sales of Herceptin in 2013 topped $6.5 billion, and the drug, despite its age, remains a top three best seller after more than 15 years on the market. The drug is perhaps best known for being the first of a new wave of cancer therapies known as “targeted” therapies, which are aimed at cancers that have specific genetic characteristics. Such therapies have exploded in the last decade, with some of the most promising therapies of tomorrow falling under the same category.
While Herceptin may have blazed a trail for the new targeted therapies of the 2010s, the drug is aging rapidly, and its dominance on the market is likely to fade in the next few years, with Mylan, Inc. (NASDAQ:MYL) — a prominent generic drug manufacturer — launching its own versions in India and South Korean generics doing the same. Further, FiercePharma notes that generics of Herceptin could be introduced to the market as early as next year, meaning time is running short for this chemotherapy, which was once ahead of its time.
Another of Roche’s long standing cancer blockbusters, Avastin, like most of the medicines on our list, has now been on the market for a decade. The drug, which is known generically as bevacizumab, is used primarily to treat colon cancer, has gained several new expansions in the years since its initial approval in 2003, and is now used to treat lung, ovarian, brain, breast, and kidney cancers. The drug is also approved as a second line treatment for metastatic colorectal cancer in the U.S., and as a first line treatment for brain cancer in Japan.
Since the drug gained a new indication for the treatment of ovarian cancers, the drug has experienced a rise in sales growth, with a 13 percent jump in 2013 over the previous year; 2013 sales of the drug, which operates by essentially starving tumors of their blood supply, are impressive, totaling $6.75 billion worldwide.
Our top contender is also made by Roche, and is another former trail blazer in the oncology field. Rituxan, which was approved by the FDA way back in 1998, was the first monoclonal antibody drug, meaning that the drug was the first oncology drug developed to target a specific proteins or cells, which may then stimulate the body’s immune system to attack those cells.
Aside from being the first drug of its kind, Rituxan is also impressive in that it continues to generate sales growth even after 15 years on the market. Last year the drug’s sales rose 6 percent, and Rituxan global sales in 2013 totaled $7.78 billion. It’s not for nothing that this drug is considered the crowning jewel in a trio of cancer treatments developed by Roche, all of which are consistently big earners. The drug is approved to treat numerous cancers, though it is primarily used in the treatment of non-Hodgkin’s lymphoma and chronic lymphocytic leukemia. It has also approved for the treatment of rheumatoid arthritis, an indication which generates sizable sales of more than $1 billion each year, generally.
The trail blazing Rituxan is up for patent expiration in 2018, but luckily for Roche, most generic competitors have abandoned their projects for a copycat version of the drug. Additionally, the company has already gotten the ball rolling on a follow-up drug, which the company says is delivering impressive results in the treatment of CLL.