Approvals In Brief
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Tercica's Increlex measures up: Tercica will launch its extreme short stature therapy Increlex in January with a 30-member sales force following approval Aug. 30 with seven-year orphan drug exclusivity, the firm says. Increlex (mecasermin [rDNA origin]) is labeled for "long-term treatment of growth failure in children with severe primary IGF-1 deficiency (primary IGFD) or with growth hormone (GH) gene deletion who have developed neutralizing antibodies to GH." If and when competitor Insmed's SomatoKine (mecasermin rinfabate) is approved, FDA will decide a battle between the firms for orphan drug exclusivity in the extreme short stature market, Tercica predicts. SomatoKine, which has an Oct. 3 user fee date, is intended to treat growth hormone insensitivity syndrome, an indication encompassed by severe primary IGFD...
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Licensing In Brief
Chiron deal offers Novartis vaccine entry: Chiron's Sept. 5 rejection of a $4.5 bil. Novartis cash takeover proposal could lead to a sweetened bid for the company. Novartis, which has owned a 42% stake in Chiron since 1995, would gain rapid entry into the global vaccine market by acquiring the firm's remaining shares. Chiron offers influenza, meningococcal, travel, pediatric and other vaccines (1see related brief). The proposed deal also would give Novartis anti-cancer and anti-infective molecules to complement its existing oncologic portfolio and infectious disease pipeline. Chiron's anti-infective portfolio includes tifacogin, in late-stage development, and certain ex-U.S. rights to Cubist's Cubicin (daptomycin). Chiron markets Proleukin (aldesleukin) for metastatic melanoma and metastatic renal cell cancer. Under the acquisition proposal, announced Sept. 1, Novartis offered $40 per Chiron share - a modest 9.8% premium to its Aug. 31 closing price of $36.44...
Licensing In Brief
Chiron deal offers Novartis vaccine entry: Chiron's Sept. 5 rejection of a $4.5 bil. Novartis cash takeover proposal could lead to a sweetened bid for the company. Novartis, which has owned a 42% stake in Chiron since 1995, would gain rapid entry into the global vaccine market by acquiring the firm's remaining shares. Chiron offers influenza, meningococcal, travel, pediatric and other vaccines (1see related brief). The proposed deal also would give Novartis anti-cancer and anti-infective molecules to complement its existing oncologic portfolio and infectious disease pipeline. Chiron's anti-infective portfolio includes tifacogin, in late-stage development, and certain ex-U.S. rights to Cubist's Cubicin (daptomycin). Chiron markets Proleukin (aldesleukin) for metastatic melanoma and metastatic renal cell cancer. Under the acquisition proposal, announced Sept. 1, Novartis offered $40 per Chiron share - a modest 9.8% premium to its Aug. 31 closing price of $36.44...