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Volume 37, Issue 5
With this year marking our 11th installment, we look back on Pharm Exec's first 10 Brands of the Year-why they were chosen and the challenges, changes, and successes since.
Every year since 2007, Pharm Exec has highlighted a drug, or drugs, as its “Brand of the Year.” With this year
marking our 11th installment, compiled ahead is a review of the first 10 years-reminding why each product was selected, and providing an update on where each one stands today.
2007, Gardasil, Merck & Co.
The inception of Pharm Exec’s annual Brand of the Year feature began, appropriately, with Merck & Co.’s vaccine, Gardasil. It was chosen because of its exemplification as a breakthrough medication, linking between science, commercialization, and humanity. The vaccine helps to empower girls and young women by providing hope in preventing human papillomavirus virus (HPV), which, at the time of the 2007 Pharm Exec write-up, killed an estimated 232,000 every year. Certain strains of HPV can lead to cervical, vaginal, vulvar, and anal cancers, and genital warts in girls and women; and anal cancer and genital warts in boys and men. While it does not treat cancer or genital warts, Gardasil covers a range of disease prevention caused by HPV for male and female patients between age nine and 26.
Today, Gardasil remains an effective preventative. Patients can choose from the original or the new Gardasil 9. Gardasil 9 is an updated version and can still be administered to both genders.
The update includes prevention against five additional types of HPV. Gardasil aids in prevention against types 6, 11, 16, and 18, while Gardasil 9 addresses types 6, 11, 16, 18, 31, 33, 45, 52, and 58, that can lead to certain kinds of cancer and genital warts.
2008, Chantix, Pfizer
Pfizer’s breakthrough treatment for nicotine addiction was nothing short of a miracle for smokers looking to kick the harmful habit. Despite an assortment of therapies available (patches, gums, nasal sprays) with success rates between 5% and 10%, Chantix’s success rate surpassed them all, at 22%. Pharm Exec was impressed with Pfizer’s approach to branding the drug, remaining consumer-oriented-including a patient education program and additional support-and limiting Chantix’s use to informed and motivated patients. The drug helped an estimated million or more smokers quit sustainably. Pfizer also made aware information about Chantix’s limitations upfront as ”not just a disclaimer, but an essential aspect of marketing,” Pharm Exec wrote in its profile.
An uphill battle since 2008, Pfizer continues the fight to convince the FDA, and the world, that Chantix is not the cause for some serious neuropsychiatric events. A win for Pfizer came in 2016 when the outcome of EAGLES (Evaluating Adverse Events in a Global Smoking Cessation Study) prompted the FDA to remove boxed warnings. EAGLES is the largest smoking cessation clinical trial, incorporating both patients with and without psychiatric disorders to determine the safety of Chantix. The study found that patients without a history of psychiatric disorders were not associated with an increase in neuropsychiatric adverse events.
2009, Crestor, AstraZeneca
AstraZeneca’s cholesterol-lowering statin may not have been a breakthrough therapy, or even new, when Pharm Exec chose it for its 2009 Brand of the Year, but sales of the drug were something of a marvel and mystery. Crestor made substantial gains and was successful likely due to AstraZeneca’s willingness to take big risks in demonstrating its belief in the treatment’s value. Crestor managed to survive the post-Vioxx storms and become the drug of choice for high-risk patients with cardiovascular disease.
Although AstraZeneca had tried to extend its patent for Crestor until 2026, last year it expired and the drug went generic. With its continued significant need, various companies such as Allergan and Mylan have launched Crestor generics (rosuvastatin calcium) in 5, 10, 20, and 40 milligram tablets. Additionally, Cigna entered into a contract with AstraZeneca that will further benefit patient treatment needs. The payer’s customers at risk for atherosclerotic cardiovascular disease, who need to diligently manage their low-density lipoprotein cholesterol, can prescribe and fill Crestor immediately without the need for previous authorization. This allows for high-risk patients to circumvent the “step therapy” process (when a generic substitute is attempted first)-and can save customers on out-of-pocket costs.
2010, Avastin, Roche
Avastin was chosen Brand of the Year for 2010 because of its success in creating a paradigm shift in clinical cancer treatments, with six indications in five types of tumors. The monoclonal antibody is approved in treating advanced-stage colorectal cancer, relapsed glioblastoma and renal/kidney tumors, early stage colon/rectal cancer, and cancers of the prostate, ovaries, and gastric system. Roche presently has 30 different ongoing discovery and development programs for Avastin to test its potential against various metastatic tumors, and the FDA has been steadily approving more indications for the drug. Because of its status as a conclusive treatment advancement, complementary strands from the government, academia, and industry have provided valuable research, and many drugs have surfaced in the US market modeled after Avastin.
Still a crucial player in cancer, the medicine has also gained more indications in combination treatment. Avastin was approved in use with fluoropyrimidine-based irinotecan or oxaliplatin chemotherapy for second-line treatment of people with colorectal cancer; and with paclitaxel and cisplatin or paclitaxel and topotecan to treat women with recurrent or metastatic carcinoma of the cervix. Currently, Avastin is in Phase II trials in combination with Tecentriq for advanced or metastatic renal cell carcinoma.
2011, Gilenya, Novartis
Novartis’s Gilenya (fingolimod), in 2010, became the first FDA-approved oral medication for relapsing multiple sclerosis (MS). While, of course, not a cure for MS, Gilenya does offer solutions to help manage symptoms and slow the progression of the debilitating disease, while providing patients with a sense of living a fairly normal lifestyle. Marketing a pill vs. a shot was paramount to the improvement of MS drugs. Gilenya set a precedent as an ease-of-use treatment for relapsing MS; several subsequent drugs with similar oral administration have entered the market.
Gilenya, involved in claims of adverse reactions and side effects, hasn’t had it easy since 2011. But the drug’s profile in the real-world setting has improved. Data from the ACROSS study-a 10-year observational study of 175 people with relapsing-remitting MS evaluating the efficacy of Gilenya-suggests a long-term effectiveness in significantly lowering disability progression with the continued use of Gilenya, as opposed to interrupting treatment. Additionally, a study in Japan found that long-term treatment with Gilenya limits relapses and detectable lesions in MS patients. Other postmarketing studies have also demonstrated improvement and long-term effectiveness, helping Gilenya capture some of its former glory.
2012, Humira, AbbVie
Ten years after its approval in late 2002, growth for Humira, the rheumatoid arthritis (RA) stalwart, was steady, making it the top contender for Brand of the Year. Along with RA, Humira treats such conditions as juvenile idiopathic arthritis, psoriatic arthritis, and psoriasis, as well as Crohn’s disease and ulcerative colitis. Humira’s effects can mean the difference between a crippling disability and a reasonably normal life for patients. The drug, now manufactured by Abbott Laboratories’ spinoff, AbbVie, was singled out by Pharm Exec in 2012 because of Abbott’s then-bold promotional approach with respect to payers, patients, and evidence-driven medicine. Another impetus in choosing Humira was its complete clinical efficacy and success in gaining new indications where others had not. The drug has an extensive coverage of indications and has delivered strong results in long-term safety and outcomes data.
Today, the drug also treats chronic inflammatory skin disease, moderate-to severe, hidradenitis suppurativa (also referred to as acne inversa), and moderate-to-severe fingernail psoriasis-becoming the first, and only, biologic to include data on fingernail psoriasis in US prescribing information. The increasing success of Humira has allowed for a greater understanding of the inflammatory process, knowledge that helped usher in newer inflammatory joint disease therapies and widening the choices offered to patients.
2013, Januvia, Merck & Co.
Merck’s Januvia helps to stop the increase of disease on a global basis by tackling what is considered a pandemic issue-type 2 diabetes-putting it on Pharm Exec’s map for 2013 Brand of the Year. Januvia (sitagliptin), a first-in-class dipeptidyl peptidase-4 (DPP-4) inhibitor, also works as a fixed-dose combination with metformin HCL, known as Janumet, to help lower blood sugar levels in adult patients with type 2 diabetes. In 2013, Seven years after its approval, Januvia/Janumet’s sales were growing by 15% in the US and 25% outside of North America. The combined diabetes franchise generated $5.7 billion in revenue in 2012, making it Merck’s top selling drug in history.
Januvia continues to be a best-seller, totalling $6 billion in sales last year, a 2% increase from 2015. Aiding the drug’s continued momentum was the release of data from a cardiovascular outcomes trial in 2015. Results showed that there were no signs pointing to Januvia being a risk for heart failure. Analysts estimate sales of the drug will increase around 10% by 2020. Merck’s patent for Januvia expires in 2022.
In 2014, Pharm Exec decided to highlight two brands, wanting to equally recognize the power of brand consistency and the clinical and marketing achievement of repurposing older drugs for new indications in rare disease. Teva’s Copaxone, on the market for 17 years at the time, was chosen for its consistent track record in fighting MS, and doing so with virtually no serious side effects emerging. Weeks into its 1997 launch, Copaxone became the most prescribed treatment for patients with relapsing-remitting MS. Its 40-milligram treatment regimen reduced the number of injections from seven a week to three.
The future of Copaxone is uncertain as Teva is currently dealing with a mountain of debt, following last year’s acquisition of Allergan’s generics business, and the loss of four patents for the drug. Previously, when Copaxone generics were made for the daily injection, 20-milligram dose, Teva could convince patients to switch to the improved 40-milligram Copaxone; now, the switch to a generic 40-milligram version may put a substantial dent in Teva’s annual overall sales of $20 billion.
Also chosen in 2014 was Korlym, a repurposed medicine targeting Cushing’s syndrome, a rare metabolic disorder caused by the overproduction of cortisol, a metabolic hormone. Two years earlier, Korlym was approved by the FDA as the first-ever treatment for adults with endogenous Cushing’s syndrome. The drug was picked in part for its advancement in treating a condition that is difficult to diagnose. The pathology of Cushing’s can still be unfamiliar to physicians and can be confused with other, less fatal conditions. Korlym decreases the dangerous side effects of the excess production of cortisol, especially high blood sugar, which can lead to diabetes.
The drug includes a warning label to women that it would terminate pregnancy. Mifepristone, the active ingredient in Korlym, has been used for years, in combination with misoprostol, to bring about abortion.
2015, Sovaldi, Harvoni, Gilead Sciences
Gilead’s one-two punch of oral treatments, Sovaldi and Harvoni, represented a medical breakthrough, curing the liver-ravaging hepatitis C virus (HCV). First-to-launch, Sovaldi, used in combination with ribavirin or interferon, offered a new lease on life for HCV patients, with an over 90% trial-certified efficacy rate. Sovaldi was the first approved all-oral treatment for genotypes 2 and 3 of the virus. Patients with genotype 1 endured shorter treatment time, in combination with interferon, minimizing side-effects with older medicines.
Harvoni, approved in 2014, has a shortened duration to cure and a higher efficacy rate than its predecessor, at 95%. The drug filled in the gaps, combining Sovaldi and ledipasvir, a second inhibitor, without the need for interferon or ribavirin.
The drop in sales of the breakthrough duo (Sovaldi posted $10.3 billion in US sales in 2014) amid healthcare access, pricing, and sustainability issues is well documented. In 2016, year-end sales reached $3.2 billion, down from $4.9 billion in 2015. This was also due to Gilead’s newer HCV drug, Epclusa, launched in 2016.
Nevertheless, the company has built on its HCV innovators with expanded indications. In the last two years, the FDA approved Harvoni in patients with genotypes 4, 5, and 6 for chronic HCV as well as patients co-infected with HIV. Harvoni and Sovaldi were also approved for chronic HCV infection in adolescents without cirrhosis or with compensated cirrhosis.
2016, Opdivo, Bristol-Myers Squibb
Last year’s Brand of the Year went to BMS’s innovative immuno-oncology drug Opdivo, which has launched in three key cancer fields since 2015-melanoma, lung, and renal. Designed to trigger the immune system to attack cancer cells and prevent or slow their growth and spread in the body, Opdivo,a PD-1 Inhibitor, has demonstrated overall survival benefits for patients-and is predicted to impact the head and neck cancer market as well.
Commercially, Opdivo pushed ahead of immunotherapy rival Keytruda in the advanced squamous non-small cell lung cancer space (NSCLC). Pharm Exec recognized Opdivo’s achievement in bridging personalized care and diagnostics in tandem to offer patients better diagnostics for future treatments.
Opdivo boosted BMS’s sales by $835 million in 2016. The FDA has since approved the drug for patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN). It was recommended for approval in the same indication by the European Commission by the Committee for Medical Products for Human Use (CMPH), marking the first positive recommendation from CMPH for a PD-1 inhibitor for SCCHN.
In February, Opdvio was approved in the US for intravenous use to treat patients with locally advanced or metastatic urothelial carcinoma (mUC), a type of bladder cancer. Opdivo’s early run of success, however, has not been without its setbacks. In August 2016, it was revealed that the drug did not meet the primary endpoint in its Phase III trial as a first-line treatment for advanced NSCLC. Upon news of the failure, BMS’s pre-market trading dropped almost 20% that day. While some analysts predict Merck’s Keytruda may overtake Opdivo in sales in the coming years, BMS says it is determined to evaluate the failed bid as first-line therapy and continue to test Opdivo-including in combination with older immunotherapy Yervoy-for NSCLC indications.
Pharm Exec EAB members do note Keytruda’s potential edge going forward, due to its application across numerous tumor types and lines of therapy, and its combination approaches and synergies with biomarker testing. In March, Keytruda was approved for treatment of adult and pediatric patients with refractory classical Hodgkin lymphoma, or those who have relapsed after three or more previous types of therapy.