Alex Philippidis Senior News Editor Genetic Engineering & Biotechnology News

These newcomers are on the rise.

2013 wasn’t technically a blockbuster year for new drugs, since no treatment launched last year reached the magic billion-dollar benchmark. But one drug came close, and at least two other 2013 launches started strongly enough to suggest that they may become blockbusters this year.

Overall, sales figures for 2013 launches were a tale of two tiers—over $100 million by at least four new drugs, and another 14 launches whose sales fell around the same range as the new drugs launched during 2012. That adds up to just 18 best sellers. The number would have been at least 20, but companies declined to disclose sales for several additional 2013 launches—Johnson & Johnson’s Invokana for type 2 diabetes in adults; Kynamro, marketed by Sanofi and Isis Pharmaceuticals for a rare form of high cholesterol, homozygous familial hypercholesterolemia; Bayer HealthCare’s pulmonary hypertension drug Adempas; and two Boehringer Ingelheim launches, Striverdi Respimat for chronic obstructive pulmonary disease (COPD) and Gilotrif/Giotrif, the company’s first entry into the oncology market.

Why the silence? Isis’ COO/CFO Lynne Parshall told analysts in March of this year that Kynamro sales were off to a “slow start,” with both companies saying that more reps would be hired to jumpstart sales. J&J has included Invokana as one of several new products that it said enjoyed “strong sales” last year, without furnishing a figure. The closest to an actual number is one widely-quoted estimate, by Wells Fargo analyst Lawrence Biegelson, projected that Invokana would generate $122 million in first-year 2013 sales.

J&J was more forthcoming with one of the soon-to-be blockbusters, the chronic hepatitis C treatment Olysio/Sovriad. In April, J&J trumpeted its $354 million in first-quarter 2014 sales—and also tucked inside its quarterly earnings announcement that the drug racked up global 2013 sales of $23 million.

Another new drug that could not make the list is the Biogen Idec/Genentech (Roche) drug Gazyva (obinutuzumab), an anti-CD20 monoclonal antibody as is the companies' Rituxan (rituximab). While Roche reported CHF 3 million ($3.369 million) for Gazyva, Biogen Idec reported only a combined $1.1 billion in sales for both drugs in 2013, not breaking out Gazyva sales.

Following is a list of 18 drugs launched in 2013, and whose companies furnished 2013 sales information, allowing for ranking. Drugs are listed by trade name (U.S./Europe where it varies), generic name, 2013 sales, company or companies marketing the drug, indication, and date of FDA and/or European Commission approval. 


#18. Lemtrada (alemtuzumab)

2013 sales: $2.773 million (€2 million)10

Marketer(s): Genzyme, a Sanofi Company, and Bayer HealthCare

Indication(s): Monoclonal antibody that selectively targets CD52, indicated for relapsing remitting multiple sclerosis (RRMS) in adults, with active disease defined by clinical or imaging features

Date of FDA approval: On April 30, 2014, Sanofi released data linking patients treated three years with Lemtrada to a slowing of brain atrophy and reductions in new MS lesions, following FDA rejection on December 30, 2013

Date of European Commission approval: September 17, 201310


#17. Osphena (ospemifene)

2013 Sales: $4.887 million (¥ 500 million)

Marketer(s): Shionogi

Indication(s): Estrogen agonist/antagonist indicated for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause

Date of FDA approval: February 27, 2013

European Medicines Agency accepted its marketing authorization application on March 13, 2013.


#16. Opsumit (macitentan)

2013 Sales: $5.688 million (CHF 5 million)

Marketer(s): Actelion Pharmaceuticals

Indication(s): Endothelin receptor antagonist indicated for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) to delay disease progression

Date of FDA approval: October 22, 2013

Date of European Commission approval: December 20, 2013


#15. Breo Ellipta/ Relvar Ellipta (fluticasone furoate and vilanterol inhalation [FF/VI] powder)

2013 Sales: $13.492 million (£8 million)

Marketer(s): GlaxoSmithKline and Theravance2

Indication(s): Combination of fluticasone furoate, an inhaled corticosteroid, and vilanterol, a long-acting beta2-adrenergic agonist (LABA), indicated in U.S. only for long-term, once-daily, maintenance treatment of airflow obstruction and for reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD). Indicated in Europe for COPD in adults with a FEV1<70% predicted normal (post-bronchodilator) with an exacerbation history despite regular bronchodilator therapy, and additionally for regular treatment of asthma in adults and adolescents aged 12 years and older where use of a combination medicinal product (long-acting beta2-agonist and inhaled corticosteroid) is appropriate.

Date of FDA approval: Of COPD indication, May 10, 2013

Date of European Commission approval: Of COPD and asthma indications, November 18, 2013


#14. Imbruvica (ibrutinib)

2013 Sales: $13.6 million3

Marketer(s): Pharmacyclics and Janssen Biotech (Johnson & Johnson)

Indication(s): Kinase inhibitor indicated for the treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy, and for chronic lymphocytic leukemia (CLL) who have received at least one prior therapy.

Dates of FDA approval: For MCL indication, November 13, 2013; for CLL indication, February 12, 2014.

Seeking European Commission approval for adults with relapsed or refractory CLL / small lymphocytic leukaemia (SLL) or relapsed or refractory MCL.3


#13. Mekinist (trametinib)

2013 Sales: $16.865 million (£10 million)

Marketer(s): GlaxoSmithKline

Indication(s): Kinase inhibitor indicated as a single agent and in combination with dabrafenib for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations as detected by an FDA-approved test; indicated in combination with Tafinlar (dabrafenib) for patients with advanced melanoma that is unresectable or metastatic

Date of FDA approval: May 29, 2013; FDA approval of Mekinist-Tafinlar combination came on January 10, 2014

European Commission approval: September 2, 2013


#12. Olysio / Sovriad (simeprevir)

2013 Sales: $23 million4

Marketer(s): Johnson & Johnson

Indication(s): Hepatitis C virus (HCV) NS3/4A protease inhibitor indicated for the treatment of chronic hepatitis C (CHC) infection as a component of a combination antiviral treatment regimen

Date of FDA approval: November 22, 2013; positive opinion by European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) March 20, 2014

European Commission decision expected later this year.


#11. Tafinlar (dabrafenib)

2013 sales: $26.984 million (£16 million)

Marketer(s): GlaxoSmithKline

Indication(s): Kinase inhibitor indicated as a single agent for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation as detected by an FDA-approved test; indicated in combination with Mekinist (trametinib) for patients with advanced melanoma that is unresectable or metastatic

Date of FDA approval: May 29, 2013; FDA approval of Tafinlar-Mekinist combination came on January 10, 2014

Date of European Commission approval: September 2, 2013


#10. Gattex / Revestive (teduglutide [rDNA origin]) for injection

2013 Sales: $31.8 million

Marketer(s): NPS Pharmaceuticals

Indication(s): Glucagon-like peptide-2 (GLP-2) analog indicated for the treatment of adult patients with Short Bowel Syndrome who are dependent on parenteral support

Date of FDA approval: December 21, 2012

Date of European Commission approval: August 30, 20125


#9. Tivicay (dolutegravir)

2013 sales: $32.044 million (£19 million)

Marketer(s): GlaxoSmithKline (GSK) and Viiv, a venture whose shareholders include GSK, Pfizer, and Shionogi

Indication(s): Human immunodeficiency virus type 1 (HIV-1) integrase strand transfer inhibitor indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and children aged 12 years and older and weighing at least 40 kg

Date of FDA approval: August 12, 2013

Date of European Commission approval: January 21, 2014


#8. Farxiga /Forxiga (dapagliflozin)

2013 Sales: $33 million ($23 million Bristol-Myers Squibb + $10 million AstraZeneca)

Marketer(s): AstraZeneca and Bristol-Myers Squibb6

Indication(s): Sodium-glucose cotransporter 2 (SGLT2) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes

Date of European Commission approval: November 12, 2012; European Commission approval for dapagliflozin-metformin combination (Xigduo) came on January 22, 2014

Date of FDA approval: January 8, 2014


#7. Iclusig (ponatinib)

2013 Sales: $45.2 million7

Marketer(s): Ariad Pharmaceuticals

Indication(s): Kinase inhibitor indicated for adult patients with T315I-positive chronic myeloid leukemia (CML) (chronic phase, accelerated phase, or blast phase) or T315I-positive Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL); also indicated for treatment of adult patients with chronic phase, accelerated phase, or blast phase chronic myeloid leukemia or Ph+ ALL for whom no other tyrosine kinase inhibitor therapy is indicated

Date of FDA approval: December 14, 2012; indications revised December 2013

Date of European Commission approval: July 3, 2013


#6. Juxtapid / Lojuxta (lomitapide)

2013 Sales: $48.5 million

Marketer(s): Aegerion Pharmaceuticals

Indication(s): Microsomal triglyceride transfer protein inhibitor indicated as an adjunct to a low-fat diet and other lipid-lowering treatments, including LDL apheresis where available, to reduce low-density lipoprotein cholesterol (LDL-C), total cholesterol (TC), apolipoprotein B (apo B), and non-high-density  lipoprotein cholesterol (non-HDL-C) in patients with homozygous familial hypercholesterolemia (HoFH)

Date of FDA approval: December 21, 2012

Date of European Commission approval: July 31, 2013


#5. Xofigo (alpharadin or radium Ra 223 dichloride)

2013 Sales: $55.246 million8

Marketer(s): Launched by Algeta, acquired earlier this year by Bayer for NOK 16.2 billion (about $2.6 billion)9

Indication(s): Alpha particle-emitting radioactive therapeutic agent indicated for the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease

Date of FDA approval: May 15, 2013

Date of European Commission approval: November 15, 2013


#4. Sovaldi (sofosbuvir)

2013 Sales: $139.435 million

Marketer(s): Gilead Sciences

Indication(s): Hepatitis C virus nucleotide analog NS5B polymerase inhibitor indicated for the treatment of chronic hepatitis C infection as a component of a combination antiviral treatment regimen

Date of FDA approval: December 6, 2013

Date of European Commission approval: January 16, 2014


#3. Kadcyla (ado-trastuzumab emtansine)

2013 Sales: $266.214 million (CHF 234 million)

Marketer(s): Genentech, a member of the Roche Group

Indication(s): HER2-targeted antibody and microtubule inhibitor conjugate indicated, as a single agent, for the treatment of patients with HER2-positive, metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination

Date of FDA approval: February 26, 2013

Date of European Commission approval: November 20, 2013


#2. Pomalyst / Imnovid (pomalidomide)

2013 Sales: $305 million

Marketer(s): Celgene

Indication(s): Thalidomide analogue indicated for patients with multiple myeloma who have received at least two prior therapies including lenalidomide and bortezomib and have demonstrated disease progression on or within 60 days of completion of the last therapy

Date of FDA approval: February 13, 2013

Date of European Commission approval: August 9, 2013


#1. Tecfidera (dimethyl fumarate)

2013 Sales: $876 million10

Marketer(s): Biogen Idec

Indication(s): Mechanism of therapeutic effect unknown; indicated for the treatment of patients with relapsing forms of multiple sclerosis

Date of FDA approval: March 27, 2013

Date of European Commission approval: February 3, 2014
























Non-U.S. currencies converted to U.S. dollars on May 2 via www.xe.com.

Notes:
1 Following approval by the European Commission in September, Lemtrada was launched in Germany in October. Lemtrada is also approved in Canada, Australia, several Nordic countries, and Mexico. In the U.S., however, Genzyme received a Complete Response Letter from the FDA in December 2013, for its supplemental Biologics License Application seeking approval for the treatment of relapsing forms of multiple sclerosis. Genzyme responded by saying it would appeal to the agency. The CVR milestone of U.S. approval of Lemtrada by March 31, 2014, was not met.
2 For 2013, Theravance recorded $1.9 million in royalty revenue from GSK as a result of the launch of Breo Ellipta in the U.S. and Relvar Ellipta in Japan.
3 Sales figure reported by Pharmacyclics; no figure furnished by Janssen. Janssen is responsible for approximately 60% of development costs and Pharmacyclics, 40% of development costs. The agreement includes a 50/50 net profit sharing arrangement for the commercialization of any products resulting from the collaboration including Imbruvica. The agreement with Janssen also provides for a $50 million annual cap of our share of development costs and pre-tax commercialization losses for each calendar year.
4 Olysio is on pace to become a blockbuster this year, having generated $354 million in sales during the first quarter of 2014—$291 million in the U.S., $62 million overseas. Some analysts have speculated that doctors are prescribing Olysio in combination with Gilead Sciences’ Sovaldi, which is also a potential blockbuster of 2014.
5 PDUFA date June 28, 2014, for sNDA submitted to FDA for label addition stating that patients on Gattex treatment beyond one year continue to achieve clinically meaningful reductions in parenteral support requirements, with some achieving complete independence.
6 In February 2014, Bristol-Myers Squibb completed the sale of its diabetes business to AstraZeneca, including all rights and ownership to Farxiga / Forxiga (dapagliflozin) and other products, for $2.7 billion, plus a $600 million milestone payment for U.S. approval of Farxiga on January 8, 2014. As part of the deal, AstraZeneca also agreed to make contingent regulatory and sales-based milestone payments of up to $800 million and royalty payments based on net sales through 2025.
7 Includes sales in the U.S. from January through October and in the EU from July through December. In October, Ariad halted commercial sales in the U.S. and halted the Phase III EPIC or “Evaluation of Ponatinib vs. Imatinib in Chronic Myeloid Leukemia” trial of iclusig for patients with newly diagnosed CML following an FDA hold after patients treated with Iclusig experienced increased blood clotting. In January 2014, U.S. commercial sales resumed after the company narrowed the drug’s intended patient sub-population and added a new boxed warning.
8 Disclosed as NOK 332 million by Norwegian-owned Algeta, which said its figure was “net sales as recognized by Bayer.” The figure is equivalent to the €41 million reported by Bayer for the drug in its 2013 annual report.
9 Algeta had been eligible for royalties and milestones based on Bayer's sales of Xofigo outside the U.S., and Algeta had been co-promoting Xofigo with Bayer in the U.S., until Bayer’s acquisition of Algeta.
10 Company said 2013 sales consisted of $864 million in the U.S. and $12 million in Canada and Australia.

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