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Biotech / Medical : VPHM - Viropharma Inc -- Ignore unavailable to you. Want to Upgrade?

To: sjemmeri who wrote (2410)	12/16/2008 1:15:31 PM
From: Thomas Kirwin	Respond to of 2557

Akorn, Inc. Responds to FDA Draft Guidance for Industry on Bioequivalence Recommendation for Vancomycin HCl Tuesday December 16, 7:00 am ET LAKE FOREST, Ill.--(BUSINESS WIRE)--Akorn, Inc. (NASDAQ: AKRX) today provided the following response regarding FDA’s draft guidance on vancomycin hydrochloride (HCl) capsules. The Food and Drug Administration (FDA) has posted draft guidance for establishing bioequivalence (BE) for vancomycin HCl capsules. Under the guidance, the FDA is currently recommending in vitro dissolution studies only for test formulations that are qualitatively and quantitatively the same as the reference listed drug with respect to inactive ingredients. This FDA draft guidance when finalized, will allow the introduction of affordable, safe and effective generic vancomycin capsules. Arthur S. Przybyl, Akorn’s President and CEO, stated, “We applaud this FDA draft guidance on vancomycin HCl capsules. The FDA’s position supports our belief that in vitro dissolution studies are sufficient to determine the bioequivalence of vancomycin capsules. Akorn encourages the public to respond positively to this draft guidance within the 60 day time frame. We look forward to generic FDA approvals for vancomycin capsules that will effectively help reduce the cost of public health.”

To: sjemmeri who wrote (2410)	9/20/2010 3:28:13 PM
From: sjemmeri	Read Replies (1) \| Respond to of 2557

ViroPharma initiated with a Buy at Caris & Company 9:19 AM ET 9/17/10 \| Briefing.com . Caris & Company initiates VPHM with a Buy and price target of $18 saying they expect upside to Cinryze revenue in 2011 and beyond as it continues to penetrate the prophylactic HAE market, driving EPS well above consensus in 2011-15. Although Vancocin generics may arrive near term, they project fewer entrants could result in EPS upside of $0.14-1.00+ in 2011. They expect VPHM to continue its skillful business development activities, and a sizable transaction could result in substantial EPS accretion longer term.