Talacotuzumab

May 17, 2017 By Mark Terry , BioSpace.com Breaking News Staff Johnson & Johnson decided to show its pipeline muscle. In meeting with industry analysts, the company indicated it expects to have 10 new products approved between 2017 and 2021 that have blockbuster potential—annual sales of $1 billion each. And if that wasn’t enough, they have more than 50 line extensions on existing and new medicines planned. “With a growing core business of differentiated medicines and a strong line-up of innovative products expected to launch or the next five years, we are leading the industry in advancing the health of patients around the world,” said Alex Gorsky, J&J’s chairman and chief executive officer , in a statement. “Our pharmaceutical business will continue to be a significant driver of innovation and growth for Johnson & Johnson. With our proven global commercial capabilities and robust pipeline, we are well-positioned to continue delivering strong, long-term, sustainable growth.” Since 2011, the company and its subsidiary, Janssen Pharmaceutical Companies , has received approval by the U.S. Food and Drug Administration (FDA) for 11 new molecular entities (NMEs). The company’s portfolio is spread amongst five core areas—Immunology, Infectious Diseases & Vaccines, Neuroscience, Cardiovascular & Metabolism, and Oncology. It’s planning to add a sixth area, Pulmonary Arterial Hypertension, when it completes the acquisition of Actelion, which should close this quarter. Joaquin Duato , the company’s worldwide chairman for pharmaceuticals, has indicated that J&J hopes to see its branded drug market maintain a 5 percent annual growth through 2020, despite downward pressure on drug pricing. At this point, they’re hoping for three approvals this year and four more in 2018. “These new drugs,” writes John Carroll , for Endpoints News , “are one leg of the company’s three-leg strategy for growing revenue, with a promise that it can improve significantly on existing drugs—like Stelara, Invokana and Xarelto—while beefing up a new core focus on pulmonary arterial hypertension through the Actelion buyout.” The first two drugs that have already been filed are guselkumab for psoriasis and sirukumab for rheumatoid arthritis. The next nine are: • Apalutamide (ARN-509) — the company acquired it when it bought Aragon. It’s for pre-metastatic prostate cancer. • Esketamine — an intranasal version of ketamine for treatment-resistant depression. • Talacotuzumab (JNJ-560222473/CSL362) — for acute myeloid leukemia. • Erdafitinib — an FGFR inhibitor for solid tumors. • Niraparib — for prostate cancer, approved earlier this year in the U.S. as Zejula. • Imetelstat — for myelofibrosis. John Carrol notes, “Geron revealed a few weeks ago that J&J’s review of the data from two studies of its drug imetelstat warranted continued work in myelodysplastic syndromes and myelofibrosis. But the pharma giant JNJ is still reserving the right to quit if the data doesn’t hold up later in the year. That’s not a big vote of confidence.” • Pimodivir (JNJ-3872) — acquired with Vertex in 2014, for influenza A. • Lumicitabine (JNJ-1575) — for respiratory syncytial virus (RSV). • JNJ-7922 (lrexin-2 antagonist) — for adjunctive treatment for major depressive disorder. Johnson & Johnson, of course, is offering this up optimistically as a done deal, but in reality, some of these drugs may not make it past Phase III. Carrol writes, “It’s important to remember that the success rate for Phase III drugs is about 50 percent, and payers have been radically altering the landscape for new drug prices.” On the other hand, J&J has an R&D budget of $7 billion annually, so the company clearly wants investors updated on what’s going on with its spending.