Active Pharmaceutical Ingredient Watch

03 March 2003 00:00  [Source: ICB Americas]

APHTON Corp.'s G17DT (anti-gastrin) immunogen in combination with cisplatin and 5-FU for use in stage IV gastric cancer has been granted fast track status by the Food and Drug Administration (FDA).

BIOMARIN Pharmaceutical Inc. and Genzyme General report that the Commit-tee for Proprietary Medicinal Products (CPMP) of the European Union has recommended approval for Aldura-zyme (laronidase), an enzyme replacement therapy to treat mucopolysaccharidosis I.

BIOVAIL Corp. has received FDA approval for hypertension drug Teveten HCT, a combination of the angiotensin II receptor blocker, eprosartan mesylate, and diuretic, hydrochlorothiazide.

CEPHALON Inc. lowered guidance for the first quarter of 2003 to 20 cents per diluted share, versus JPMorgan estimates of 35 cents per share, on a major increase in selling, general and administrative (SG&A) expenses. Cephalon reiterated full year 2003 product sales of $650 million to $660 million. Separately, Cephalon posted underlying fourth quarter earnings of 41 cents per share, 4 cents above Morgan Stanley estimates, on strong product sales of $139 million, driven by Actiq (oral transmucosal fentanyl citrate), up 113 percent, to $44 million and Gabitril (tiagabine). 

ELI LILLY and Company and 3M have suspended clinical trials of genital herpes drug resiquimod on preliminary Phase III data that suggest the dosing will not achieve adequate efficacy.

INTERMUNE Inc. narrowed its fourth quarter loss to 81 cents per share, or $25.6 million, 12 cents lower than Morgan Stanley estimates, on higher than expected sales of Actimmune (interferon gamma-1b), and lower SG&A expenses.

INTROGEN Therapeutics Inc. has received orphan drug status by the FDA for Advexin, an adenoviral p53 gene therapy, in Phase III clinical trials for head and neck cancers.

IVAX Corp. was one of four companies to receive FDA approval for its generic version of AstraZeneca PLC's 10 mg and 20 mg breast cancer drug Nolvadex (tamoxifen). Barr Laboratories, Mylan Laboratories and Teva Pharmaceutical Industries also received approvals. 

LA JOLLA Pharmaceutical Company reports that an initial assessment of Phase III trial data of lead drug candidate Riquent to treat lupus renal disease failed the primary end point. Riquent is designed to arrest the production of antibodies to double-stranded DNA (dsDNA).

MEDAREX Inc. and ACTELION Ltd. are rumored to be potential bidders to acquire Oxford Glycosciences PLC (OGS), according to West LB Panmure analyst Emma Palmer. On March 4, holders of OGS American Depository Receipts will vote on the Cambridge Antibody Technology Group PLC proposal. 

QLT Inc. has suspended new patient accrual in Phase III studies of tariquidar to treat non-small cell lung cancer, pending a  three month interim safety and efficacy analysis. Tariquidar, a small molecule inhibitor of the P-glycoprotein pump, treats multidrug resistance in cancer. Xenova Group PLC licensed the rights to tariquidar in North America in 2001.

ROCHE will make a year's supply of the HIV drug Fuzeon (enfuvirtide) available at roughly  19,000 ($20,000) to European Union members that elect to undertake a special access program.

SCHERING-PLOUGH Corp. reports that the CPMP has recommended approval of Remicade (infliximab) to treat ankylosing spondylitis.

ICIS Copyright © Reed Business Information 2009

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