Executive Summary: The view from 2020: Scrip looks back at the most successful commercial launches of the decade.   

Source: Shutterstock  

Success is subjective, especially when it comes to new drugs that can change the lives of patients. Clinical success doesn't always translate to commercial success, but when pharma is firing on the right cylinders, medical breakthroughs are also big commercial winners.

Big blockbusters got harder and harder to launch in the last decade, as competition grew and drug developers focused on more challenging areas of drug development where the market was less tapped, such as in immuno-oncology and rare diseases. Also, launch trajectories lengthened as market access became more burdensome.

The best-selling drugs of the last decade were largely more mature franchises like AbbVie Inc.'s Humira (adalimumab), Celgene Corp.'s Revlimid (lenalidomide) and Roche's Herceptin (trastuzumab),  Avastin (bevacizumab) and Rituxan (rituximab), pointing to the challenging commercial dynamics for new drugs. A few new launches from the past decade were top 10 sellers in 2018, however: Regeneron Pharmaceuticals Inc.'s Eylea (aflibercept), Merck & Co. Inc.'s Keytruda (pembrolizumab) and Bristol-Myers Squibb Co.'s Opdivo (nivolumab). (Also see "Top 10 Drugs: Weighing Pharma's Golden Eggs" - Scrip, 6 Aug, 2019.)

Launching mega-blockbusters wasn't easy the last decade. Scrip looked back at 10 new drugs that hit the market between 2010 and 2019 and exceeded expectations in the first two years after launch, measuring launch success solely on revenues. 

Pfizer's Prevnar 13 (2010)

Pfizer Inc. acquired the pneumococcal vaccine Prevnar 13 with the 2009 acquisition of Wyeth and the 2010 launch delivered; the franchise has continued to be one of the company's top sellers. Prevnar 13 was a 13-valent vaccine initially approved to treat infants and children that was an advance over the already marketed seven-valent Prevnar vaccine. Prevnar 13 generated $2.4bn in sales in 2010 in addition to Prevnar's $1.25bn, as Prevnar 13 supplanted the older vaccine.

Prevnar 13 continued to be a long-term growth driver for Pfizer, eventually adding a big new market opportunity with a US Food & Drug Administration (FDA) approval for adults in 2016. In 2018, Prevnar 13 was Pfizer's top-selling product with revenues of $5.8bn. Now Pfizer is looking to continue its dominance in the category with the development of a 20-valent pneumococcal vaccine.

Regeneron's Eylea (2011)

Eylea (aflibercept) for wet age-related macular degeneration was the drug that powered Regeneron from an R&D specialist into a commercial biotech power player when it launched in November 2011. The company undercut the competition, Roche/Novartis AG’s Lucentis (ranibizumab), on price even though Eylea had a more convenient dosing regimen. (Also see "Regeneron Plays It Safe With Eylea, Aims To Undercut Lucentis" - Pink Sheet, 28 Nov, 2011.)

Eylea generated $838m in 2012, its first full year on the market, and the drug has proven its mettle over the long term. It generated $7.26bn in 2018 and $5.54bn in the first nine months of 2019. The problem for Regeneron now has become its dependence on the success of Eylea as the franchise matures. In pharma, a decade of success can start to become a double-edged sword.

Johnson & Johnson's Zytiga (2011)

Johnson & Johnson succeeded in getting the first oral androgen inhibitor for metastatic prostate cancer to market ahead of the competition, and it paid off. Zytiga (abiraterone) was approved by the FDA in April 2011, more than a year ahead of Medivation Inc./Astellas Pharma Inc.'s Xtandi (enzalutamide), which was approved by the FDA in August 2012.

The head start, including a rapid global expansion, was a leg up in terms of the early commercial trajectory. Zytiga generated $301m the year it launched and $961m in its first full year in 2012. Xtandi, when it launched, had to fight the headwinds of a rival, and generated only $445.2m in its first full year on the market in 2013. Zytiga went on to be a big seller for J&J through the rest of the decade, with $3.9bn in revenues in 2018, but the entry of a generic version in the US in late 2018 has begun to erode the drug’s sales.

Biogen's Tecfidera (2013)

Biogen Inc.'s oral drug for multiple sclerosis, Tecfidera (dimethyl fumarate), was the star of the class when it launched in 2013. Tecfidera generated $876m in 2013 after launching in April of that year, positioning the drug as a rare first-year blockbuster. (Also see "Tecfidera Stands Out From The Pack Of 2013 Drug Launches" - Pink Sheet, 13 Jan, 2014.) By 2014, sales of Tecfidera had jumped to $2.9bn. Part of Biogen's launch strategy was to undercut Novartis' Gilenya (fingolimod), the first oral drug for multiple sclerosis, on price.  

Tecfidera has continued to be a mega-blockbuster for Biogen, generating $4.27bn in 2018, but as the franchise matures and the threat of generic competition looms, it is starting to become an overhang for Biogen, which is hoping to transition patients to its next-generation drug Vumerity. (Also see "Biogen Vumerity Receives Full US Approval, But GI Comparison With Tecfidera Must Wait " - Pink Sheet, 31 Oct, 2019.)

Gilead's Sovaldi (2013)

The introduction of Gilead Sciences Inc.'s Sovaldi (sofosbuvir) in 2013 wasn't a typical launch by any measure. Sovaldi broke boundaries, most importantly for patients, introducing a functional cure for many with hepatitis C, but for the industry it also broke drug pricing barriers and changed the way drug makers think about a typical launch curve. (Also see "Will Pricing For Gilead’s SovaldiSet A Ceiling In HCV, Lead To A Price War?" - Pink Sheet, 16 Dec, 2013.) Those lessons will be valuable to the industry as it wades ever deeper into gene therapy and potential one-time treatments that cure disease.

Sovaldi came in like a tiger and went out like a lamb, but for a time, the drug's commercial success surpassed anything the industry has seen before. In 2014, Sovaldi generated $10.28bn. A combination pill of sofosbuvir plus ledipasvir, Harvoni, generated another $2.13bn in 2014. Harvoni soon eclipsed sales of Sovaldi, generating $13.86bn in 2015, but as hepatitis C patients were cured and more competitors launched, Harvoni also faded, so that in 2018 sales were only $1.22bn. For Gilead investors, it was short, but sweet. (Also see "INFOGRAPHIC: Hepatitis C Market Still Has Room To Grow" - Scrip, 1 Aug, 2016.)

Merck & Co.'s Keytruda (2014)

A decade ago, industry watchers would have been surprised to hear Merck & Co. would become an immuno-oncology powerhouse with the best-selling cancer immunotherapy in the word. But that is what Merck did with Keytruda (pembrolizumab), which was approved in 2014 initially for metastatic melanoma. It was the second PD-1 inhibitor to reach the market behind Bristol-Myers Squibb's Opdivo (nivolumab), but it was the first to nab the biggest indication – lung cancer – and has continued to dominate in that space and a dozen others through consistent high-quality data readouts.

Keytruda generated $566m in 2015, its first full year on the market. In 2016, it generated $1.4bn. In 2018, those revenues grew to $7.2bn, outpacing Opdivo sales of $6.74bn and taking the lead in the fiercely competitive IO category. The launch of Opdivo certainly also stands out as a success, with the drug generating $942m in its first full year on the market in 2015. With potential new opportunities in areas like gastric cancer, bladder cancer and triple-negative breast cancer, Keytruda shows no signs of slowing down.

HIV: Gilead's Biktarvy (2018) and ViiV's Triumeq (2014)

Advances in combination regimens for HIV continue to deliver commercial rewards for the two leaders in the field, Gilead and ViiV Healthcare , a joint venture majority owned by GlaxoSmithKline. The two leaders are competing fiercely with newer, simpler regimens. (Also see "HIV Market Snapshot: Gilead's Biktarvy Set To Soar, But ViiV May Win In The End" - Scrip, 18 Apr, 2018.) 

Biktarvy, approved by the FDA in April 2018, combines the integrase inhibitor bictegravir, the nucleoside reverse transcriptase inhibitor Emtriva (emtricitabine) and the second-generation nucleoside reverse transcriptase inhibitor tenofovir alafenamide (TAF) in a single pill. Biktarvy generated $1.18bn in 2018 in eight months on the market and $3.17bn in the first nine months of 2019. The catch with the launch is that Biktarvy only fills some of the gap left by Gilead's declining mature HIV brands.

For ViiV, the launch of the dolutegravir franchise has pushed the company into a leadership position in HIV. Dolutegravir is an unboosted integrase inhibitor marketed alone as Tivicay and in combination as Triumeq in a co-formulation with the reverse transcriptase inhibitor abacavir and nucleoside analogue reverse transcriptase inhibitor Epivir (lamivudine). Tivicay launched in 2013 followed by Triumeq in 2014, and the drugs generated £1.32bn ($1.73bn) combined in 2015. In 2018, The Tivicay/Triumeq franchise generated £4.29bn ($5.61bn) combined.

Pfizer's Ibrance (2015)

Pfizer's first-to-market CDK4/6 inhibitor Ibrance (palbociclib) launched in 2015 and quickly became a pillar of Pfizer's oncology portfolio. The drug, cleared initially under accelerated approval, is for patients with hormone receptor-positive/HER2-negative breast cancer. (Also see "First-Line Breast Cancer Approval Opens The Door For Pfizer’s Palbociclib" - Pink Sheet, 4 Feb, 2015.) Ibrance generated $723m in 2015 after launching in February that year, and $2.14bn in 2016, its first full year on the market.

Pfizer has successfully held onto the market lead even as new rival CDK4/6 inhibitors from competitors with deep pockets and oncology experience launched in 2017. Novartis's Kisqali (ribociclib) and Eli Lilly's Verzenio (abemaciclib) have failed to make big inroads against it. In the first nine months of 2019, Ibrance generated $3.68bn, becoming the company's top-selling drug behind Prevnar 13. 

Roche's Ocrevus (2017)

First-year blockbusters don't come around every day, but Roche's Ocrevus (ocrelizumab) joined the very selective club. Ocrevus has been one of the most successful commercial launches in modern pharma history, excluding hepatitis C and HIV drugs. (Also see "Roche's Ocrevus: A Rare First-Year Blockbuster" - Scrip, 1 Feb, 2018.) After launching in April 2017 for relapsing forms of multiple sclerosis, including primary progressive MS, Ocrevus generated $935m (CHF869m) in just nine months and CHF2.4bn ($2.4bn) in its first full year on the market.

Strong efficacy data supporting the approval and a smart pricing strategy helped power the launch. Roche priced Ocrevus at a 20% discount to other MS therapies on average, including the standard of care interferons. (Also see "Roche Set For Disruptive Entry To MS Market With 'Brave' Ocrevus Pricing Strategy" - Scrip, 29 Mar, 2017.) But Ocrevus is also one of the first new treatments for what had been an underserved population of patients with primary progressive MS, and filling that void has delivered returns for Roche.

GlaxoSmithKline's Shingrix (2017)

Despite the availability of a vaccine for shingles, Merck's Zostavax, GlaxoSmithKline's Shingrix overtook the market after launching in 2017 because of better efficacy data supporting the prevention of shingles. After securing FDA approval in October 2017, followed by a recommendation as the preferred shingles vaccine for adults 50 and older by the US Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices (ACIP), GSK had a big market opportunity to tap – more than 100m people in the US alone. Shingrix was approved in Europe in January 2018.

The big challenge for GSK has been manufacturing the vaccine at sufficient capacity to meet the demand, but the company executed well on a staged global launch. Shingrix generated £784m ($1.028m) in 2018 and £1.28bn ($1.68bn) in the first nine months of 2019, stepping in to fill an important void for GSK at the right time, when Advair was facing generic competition. (Also see "GSK Gets A Boost From Shingrix And Other New Drugs " - Scrip, 1 May, 2019.) Given that demand for Shingrix continues to outstrip supply, the vaccine will continue to be a big growth driver for GSK.

Honorable Mention: Biogen's Spinraza (2016)

The launch of Biogen's Spinraza (nusinersen) in late 2016 for spinal muscular atrophy blew investors away. The drug was the first treatment option for a devastating rare disease that affects children and babies in addition to adults, and Biogen succeeded commercially by finding the patients and by pricing the drug higher than investors and analysts expected: $750,000 for the first year and $375,000 in subsequent years. (Also see "A Year To Remember For US Drug Launches" - Scrip, 29 Dec, 2017.) 

The high price disgruntled payers, but didn't result in any significant pushback, given the severity of the disease and the limited patient population. Spinraza generated $883.7m in 2017, its first full year on the market, and $1.72bn in 2018. Spinraza has continued on a growth trajectory in 2019 but new competition in the form of Novartis's gene therapy Zolgensma could stunt the long-term growth prospects for Biogen’s drug. (Also see "Novartis's Zolgensma Finds Commercial Legs In A First For Gene Therapy" - Scrip, 22 Oct, 2019.)