Alex Philippidis Senior News Editor Genetic Engineering & Biotechnology News
What new medicines are shaking things up?
You’ve seen GEN’s list of the top 20 best-selling drugs of 2012, but what brand new drugs have come out over the past year that are worth watching? Here are top 20 best-selling drugs that were approved and launched during 2012, ranked by their 2012 sales. Data on 2012 comes in most cases from the companies themselves, except where otherwise noted. Drugs are listed by both trade name and generic or active pharmaceutical ingredient name. Accompanying each listing is the marketer(s) of the drug, the drug’s indication, and date of FDA and/or European Commission approval.
#20. Qsymia® (phentermine and topiramate extended-release)
2012 sales: $2 million
Marketer(s): Vivus
Indication(s): Chronic weight management in adults with an initial body mass index (BMI) of30 kg/m2 or greater (obese) or 27 kg/m2 or greater (overweight) in the presence of at least one weight-related medical condition such as high blood pressure, type 2 diabetes, or high cholesterol. Should be used together with diet and exercise
Date of FDA approval: July 17, 2012
#18 (tie). Xeljanz® (tofacitinib citrate)
2012 sales: $3 million1
Marketer(s): Pfizer and Takeda
Indication(s): Moderately to severely active rheumatoid arthritis in adults who have had an inadequate response or intolerance to methotrexate. It may be used as monotherapy or in combination with methotrexate or other nonbiologic disease-modifying antirheumatic drugs (DMARDs).
Date of FDA approval: November 6, 2012
Date of Japan Ministry of Health, Labor and Welfare approval: March 25, 2013
#18 (tie). Signifor® (pasireotide)
2012 sales: $3 million2
Marketer(s): Novartis
Indication(s): Cushing’s disease in adult patients for whom pituitary surgery is not an option or has not been curative
Date of European Commission approval: April 25, 2012
Date of FDA approval: December 14, 2012
#17. Belviq® (lorcaserin hydrochloride)
2012 sales: $6 million3
Marketer(s): Arena Pharmaceuticals and Eisai
Indication(s): Chronic weight management in adult patients with an initial body mass index (BMI) of 30 kg/m2 or greater (obese), or 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, dyslipidemia, type 2 diabetes), in addition to diet and exercise
Date of FDA approval: June 27, 2012
#16. Aubagio® (teriflunomide)
2012 sales: $9.1 million (€7 million)4
Marketer(s): Sanofi (Genzyme)
Indication(s): Relapsing forms of multiple sclerosis
Date of FDA approval: September 12, 2012
#15. Fycompa® (perampanel)
2012 sales:$12 million5
Marketer(s): Eisai
Indication(s): Partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy aged 12 years and older
Date of European Commission approval: July 23, 2012
Date of FDA approval: October 22, 2012
#14. Tudorza™ Pressair™ (aclidinium bromide)
2012 sales: $12.2 million6
Marketer(s): Forest Laboratories
Indication(s): Long-term maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema
Date of FDA approval: July 23, 2012
#13. Voraxaze® (glucarpidase)
2012 sales: $14 million
Marketer(s): BTG International
Indication(s): Toxic plasma methotrexate concentrations (>1 micromole per liter) in patients with delayed methotrexate clearance due to impaired renal function
Date of FDA approval: January 17, 2012
#12. Bosulif® (bosutinib)
2012 sales: $15 million7
Marketer(s): Pfizer
Indication(s): Chronic, accelerated, or blast phase Ph+ chronic myelogenous leukemia (CML) in adult patients with resistance or intolerance to prior therapy
Date of FDA approval: September 4, 2012
Date of European Commission conditional approval: March 28, 2013
#11. Elelyso™ (taliglucerase alfa)
2012 sales: $18 million8
Marketer(s): Protalix BioTherapeutics and Pfizer
Indication(s): Long-term enzyme replacement therapy for adults with a confirmed diagnosis of Type 1 Gaucher disease
Date of FDA approval: May 1, 2012
Date of European Commission rejection: November 1, 2012, citing the EU market exclusivity until 2020 of a competing agent from Shire
#10. Linzess™ (linaclotide)
2012 sales: $19.2 million9
Marketer(s): Ironwood Pharmaceuticals and Forest Laboratories
Indication(s): Irritable bowel syndrome with constipation and chronic idiopathic constipation in adults
Date of FDA approval: August 30, 2012
#9. Erivedge® (vismodegib)
2012 sales: $30.9 million (CHF 29 million)10
Marketer(s): Roche (Genentech)
Indication(s): Advanced basal cell carcinoma in adults who cannot have surgery or radiation therapy
Date of FDA approval: January 30, 2012
#8. Zaltrap® (ziv-aflibercept)
2012 sales: $32.3 million (€25 million)11
Marketer(s): Sanofi and Regeneron
Indication(s): Metastatic colorectal cancer in combination with 5-fluorouracil, leucovorin, irinotecan-(FOLFIRI) chemotherapy regimen
Date of FDA approval: August 3, 2012
Date of European Commission approval: February 5, 2013
#7. Stivarga™ (regorafenib)
2012 sales: $41.4 million (€32 million)12,13
Marketer(s): Bayer HealthCare and Onyx Pharmaceuticals
Indication(s): Metastatic colorectal cancer in patients who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if KRAS wild type, an anti-EGFR therapy
Date of FDA approval: September 27, 2012
#6. Stribild™ (elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate)
2012 sales: $57.536 million14
Marketer(s): Gilead Sciences
Indication(s): HIV-1 infection in adults who are antiretroviral treatment-naïve
Date of FDA approval: August 27, 2012
#5. Perjeta® (pertuzumab)
2012 sales: $59.7 million (CHF 56 million)15
Marketer(s): Roche (Genentech)
Indication(s): First-line treatment of HER2-positive metastatic breast cancer in patients who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease, in combination with Herceptin® (trastuzumab) and docetaxel
Date of FDA approval: June 8, 2012
Date of European Commission approval: March 5, 2013
#4. Kyprolis® (carfilzomib)
2012 sales: $64 million
Marketer(s): Onyx Pharmaceuticals
Indication(s): Multiple myeloma in patients who have received at least two prior therapies, including treatment with Velcade (bortezomib) and an immunomodulatory therapy
Date of FDA approval: July 20, 2012
#3. Inlyta® (axitinib)
2012 sales: $70.1 million16
Marketer(s): Pfizer
Indication(s): Advanced renal cell carcinoma after failure of one prior systemic therapy
Date of FDA approval: January 27, 2012
Date of European Commission approval: September 4, 2012
#2. Xtandi® (enzalutamide)
2012 sales: $71.5 million
Marketer(s): Medivation and Astellas Pharma
Indication(s): Metastatic, castration-resistant prostate cancer in men who have previously received treatment with docetaxel
Date of FDA approval: August 31, 2012
#1. Kalydeco™ (ivacaftor)
2012 sales: $171.6 million
Marketer(s): Vertex Pharmaceuticals
Indication(s): Cystic fibrosis (CF) in patients 6 years old and older who have at least one copy of the G551D mutation in the CF transmembrane conductance regulator (CFTR) gene
Date of FDA approval: January 31, 2012
Date of European Commission approval: July 23, 2012
Notes:
1 No sales figure announced by company; figure reported by Zacks Investment Research, though Xeljanz sales were reported at $18 million by EvaluatePharma.
2 No sales figure announced by company; worldwide sales figure reported by EvaluatePharma.
3 No sales figure announced by company; worldwide sales figure reported by EvaluatePharma.
4 Sales figure converted to USD via XE (www.xe.com) on April 4, 2013.
5 No sales figure announced by company; worldwide sales figure reported by EvaluatePharma.
6 Figure reflects value of initial trade stocking of the product as disclosed by Forest Laboratories in its January 15 announcement of fiscal year 2013 third-quarter results: http://investor.frx.com/press-release/corporate-news/forest-laboratories-inc-reports-fiscal-year-2013-third-quarter-earnings
7 No sales figure announced by company; figure reported by Zacks Investment Research; EvaluatePharma reported $7 million in Bosulif sales for 2012.
8 No sales figure announced by either company; worldwide sales figure reported by EvaluatePharma.
9 Figure reflects value of initial trade stocking of the product as disclosed by Forest Laboratories in its January 15 announcement of fiscal year 2013 third-quarter results: http://investor.frx.com/press-release/corporate-news/forest-laboratories-inc-reports-fiscal-year-2013-third-quarter-earnings
10 Sales figure converted to USD via XE (www.xe.com) on April 4, 2013.
11 Sales figure converted to USD via XE (www.xe.com) on April 4, 2013.
12 Sales figure converted to USD via XE (www.xe.com) on April 4, 2013.
13 Figure does not include Onyx’s 20% royalty received on Bayer’s global net sales of Stivarga in human oncology. For full-year 2012, Onyx reported receiving $8.3 million in royalty revenue.
14 Sales for 2012 furnished to thousandths by Gilead Sciences.
15 Sales figure converted to USD via XE (www.xe.com) on April 4, 2013.
16 No sales figure announced by company; figure reported by Zacks Investment Research, citing its Zacks Model; EvaluatePharma reported a 2012 sales figure for Inlyta of $70 million.
