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Six of the seven companies on this list focus on cancer drug development, with eye disorders, inflammation, and myelofibrosis among other treatment specialties. [© ArtFamily - Fotolia.com]
Focus: Discovering, developing, and commercializing small molecule drugs for “serious” unmet medical needs.
Key products and pipeline: Lead product Jakafi® (ruxolitinib), a JAK1 and JAK2 inhibitor, is currently approved in the U.S. for intermediate or high-risk myelofibrosis. Pipeline includes three additional Jakafi indications—polycythemia vera (Phase III), pancreatic cancer (Phase II), and solid/hematologic tumors (Phase I/II)—and five compounds, including INC280 (formerly INCB28060) for solid tumors, for which worldwide rights have been licensed to Novartis (Phase II); INCB24360 for metastatic melanoma and ovarian cancer (both Phase II); and INCB39110 for myelofibrosis, rheumatoid arthritis, and psoriasis (all Phase I/II).
Why attractive: Incyte has built on its successful 2012 launch of Jakafi for myelofibrosis, with the drug generating $102.4 million for the first half of 2013, more than double the year-ago number of $49 million. In August, Incyte raised its range of projected annual sales for Jakafi, to between $220 million and $230 million, a change from $210 million to $225 million. The company’s pipeline has wowed partners and investors: Ruxolitinib for pancreatic cancer showed overall survival of 42% vs. 11% for placebo, in results released August 21. Earlier this year, Incyte captured a $25 million milestone payment from Novartis once it formally launched the Phase II trial for INC280 in April, under a 2009 agreement that could land Incyte more than $1 billion. Phase III data for the polycythemia vera indication for Jakafi is expected early next year.
Focus: Rapid development of therapies for “serious” diseases with limited treatment options.
Key products and pipeline: Xtandi® (enzalutamide, formerly MDV3100) capsules for metastatic castration-resistant prostate cancer (mCRPC). Medivation and Astellas Pharma are jointly responsible for commercialization and development of Xtandi in the U.S, while outside the U.S., Astellas oversees development and commercialization, paying Medivation a tiered royalty ranging from the low teens to the low twenties on aggregate net sales. Pipeline includes several new indications for Xtandi including prechemotherapy CRPC (one ongoing Phase III trial, and two Phase II trials), neoadjuvant therapy (Phase II), and breast cancer (a Phase II study in advanced, androgen receptor positive triple-negative breast cancer that began enrollment in June).
Why attractive: Xtandi successfully launched last year, and has generated $161.5 million in net sales for the first half of 2013. In June, Xtandi won marketing approval from the European Union for adult men with mCRPC whose disease has progressed on or after docetaxel therapy. The EU approval triggered a $15 million milestone payment from Astellas to Medivation. By year’s end, Medivation expected to release promising additional data on Xtandi for prechemo CRPC, and eventually compete head on with Johnson & Johnson mCPRC drug Zytiga.
Focus: Discovering, developing, manufacturing, and commercializing medicines for serious medical conditions that include eye diseases, colorectal cancer, and a rare inflammatory condition, with developmental drugs in other areas of high unmet medical need including hypercholesterolemia, oncology, rheumatoid arthritis, allergic asthma, and atopic dermatitis.
Key products and pipeline: Arcalyst (rilonacept), marketed to U.S. patients since 2008 for Cryopyrin-Associated Periodic Syndromes (CAPS) including familial cold autoinflammatory syndrome (FCAS) and Muckle-Wells Syndrome (MWS) in adults and children 12 and older; Eylea® (aflibercept), launched in 2011 for neovascular (wet) age-related macular degeneration (AMD), with a second indication, macular edema following central retinal vein occlusion, approved by FDA in 2012. Regeneron collaborates with Bayer HealthCare on development of Eylea. Also last year, Regeneron joined Sanofi in obtaining FDA approval for Zaltrap® (ziv-aflibercept) Injection for intravenous infusion for macular edema following central retinal vein occlusion.
Pipeline consists of more than a dozen drug candidates and/or indications including four in Phase III: Eylea for diabetic macular edema (DME) and branch retinal vein occlusion (BRVO); sarilumab (REGN88) for rheumatoid arthritis; and alirocumab (REGN727) for LDL cholesterol reduction.
Why attractive: In a word, Eylea. The drug enjoyed a very successful launch, with U.S. sales more-than-doubling in the first half of 2013, up 103% to $644 million. Total worldwide sales stood at $805 million, versus $318 million in 1H 2012. Twice this year, Regeneron has raised its estimated full-year Eylea net sales forecast—most recent after the second quarter, when the company upped its projection to between $1.3 billion and $1.35 billion.
Morningstar’s Karen Andersen, however, told GEN: “I think Regeneron is not as likely to be acquired, given the stability of their relationship with Sanofi and the financial structure of their collaboration.” Earlier this year she told Reuters another factor boding against an acquisition was the doubling of its share price since mid-2012.
Focus: Developing and commercializing innovative, empowered antibody-based therapies for the treatment of cancer.
Key products and pipeline: Adcetris® (brentuximab vedotin) for relapsed Hodgkin lymphoma (HL) and relapsed systemic anaplastic large-cell lymphoma (sALCL), approved as the first in a new class of antibody-drug conjugates (ADCs) by FDA in 2011 and HealthCanada this year. Adcetris was developed with Millennium: The Takeda Oncology Company, which has worldwide exclusive rights except in the U.S. and Canada, which are held by Seattle Genetics. The drug is in more than 20 ongoing clinical trials, including four Phase III studies—post-transplant HL relapse prevention; relapsed CD30-positive cutaneous T-cell lymphoma; Frontline HL (+ chemotherapy); and Frontline CD30-positive mature T-cell lymphomas (+ chemotherapy). An additional five indications are the subject of Phase II studies. The pipeline also has six additional compounds in preclinical phases through Phase I.
Why attractive: Adcetris has delivered net product sales of $69.7 million from January–June, just above $69.2 million a year earlier. However, collaboration revenue doubled to $55.3 million and royalty revenues from Adcetris jumped nearly five-fold, to $5.9 million from $1.2 million in 1H’12.
The company is also well-viewed for its rich pipeline, as well as its crafting of ADC licensing agreements with 12 biopharmas—including giants like AbbVie, Bayer, Genentech, GSK, and Pfizer—which have generated more than $225 million for the company. In the most recent such deal in June, Seattle Genetics netted $20 million in up-front and option exercise fees for worldwide rights to its auristatin-based ADC technology with antibodies to several oncology targets, with up to $500 million in milestone payments possible.
Seattle Genetics says it’s more focused on expanding use of Adcetris than on finding a buyer: “We have a great trajectory in the future," CEO Clay Siegall told Reuters, adding: “I believe that our big shareholders are supportive of that. I don't have any pressure on me to try to run out and do some deal.”
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