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The Class of 2012 for New Molecular Entities and Biologics
Leader of the pack
Eisai's two NME approvals were for Belviq (lorcaserin hydrochloride) and Fycompa (perampanel). Belviq is a serotonin 2C receptor agonist indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management. Belviq was developed by Arena Pharmaceuticals, a Zofingen, Switzerland-based company, for which it granted exclusive marketing and distribution rights to Eisai for most of North and South America. Fycompa is a noncompetitive AMPA glutamate receptor antagonist indicated as an adjunctive therapy for treating partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy aged 12 years and older.
Forest Laboratories received approval for two NMEs in 2012: Linzess (linaclotide), developed with Ironwood Pharmaceuticals, and Tudorza Pressair (aclidinium bromide), developed with Almirall. Linzess is a guanylate cyclase-C agonist for treating irritable bowel syndrome or chronic idiopathic constipation. Tudorza Pressair is an anticholinergic indicated as a long-term maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease.
Roche/Genentech also had two new drug approvals, one for a NME, Erivedge (vismodegib), and one for a BLA, Perjeta (pertuzumab). Erivedge is a hedgehog pathway inhibitor for treating metastatic basal-cell carcinoma or locally advanced basal-cell carcinoma that has recurred following surgery or for pateints who are not candidates for surgery or radiation. Perjeta is a HER2/neu receptor antagonist indicated in combination with trastuzumab and docetaxel for treating patients with HER2-positive metastatic breast cancer.
Sanofi received approval for its NME Aubagio (teriflunomide) and its BLA Zaltrap (ziv-aflibercept). Aubagio is a pyrimidine synthesis inhibitor for treating patients with relapsing forms of multiple sclerosis. Zaltrap is a recombinant fusion protein, which acts as a soluble receptor that binds to vascular endothelial growth factor-A (VEGF-A), VEGF-B, and placental growth factor and is used to treat metastatic colorectal cancer. Sanofi partnered with the biopharmaceutical company Regeneron Pharmaceuticals for Zaltrap.
The generic-drug company Teva had two approvals, one for its NME Synribo (omacetaxine mepesuccinate), a drug to treat leukemia, and a BLA for tbo-filgrastim, which was approved as an original BLA and not as a biosimiliar to Amgen's Neupogen (filgrastim), which is a previously approved biologic. Tbo-filgrastim is a human granulocyte colony-stimulating factor produced by recombinant DNA technology for reducing neutropenia in patients with non-myeloid malignancies.
Approvals constitute a mixed bag for other large companies. Merck & Co. gained one new drug approval in 2012 for Zioptan (tafluprost ophthalmic solution), a prostaglandin analog indicated for reducing elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. Bayer received FDA approval for Stivarga (regorafenib), a kinase inhibitor for treating metastatic colorectal cancer. Eli Lilly's subsidiary Avid Radiopharmaceuticals received approval for the radioactive diagnostic agent, Amyvid (florbetapir F-18). Takeda Pharmaceutical and Affymax received approval for Omontys (peginesatide acetate), an erythropoiesis-stimulating agent to treat anemia.
Equally important in evaluating R&D productivity is seeing which companies did not receive FDA approval for NMEs or new biologics (excluding vaccines). Through Nov. 20, 2012, GlaxoSmithKline, Novartis, AstraZeneca, Bristol-Myers Squibb, and Abbott were among the large companies without a NME or original BLA FDA approval this year. As the industry waits for 2012 to come to a close, it has yet to be seen if their late-stage candidates under review will get the FDA nod this year.
Patricia Van Arnum is a executive editor of Pharmaceutical Technology, 485 Route One South, Bldg F, First Floor, Iselin, NJ 08830 tel. 732.346.3072, firstname.lastname@example.org