Latest Intelligence on Pharmaceuticals in North America

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Type Product title / description Pub Price
CommentWire
CommentWire

Somaxon: efficacy in the absence of commerciality

Somaxon has presented Phase III data at the American Psychiatric Association annual meeting in Washington DC which demonstrate that three doses of Silenor are efficacious and safe in elderly adults with chronic primary insomnia. Despite the positive trial data, the commercial potential of the drug will be limited substantially by generics and the absence of a marketing partner for Silenor.

Published By Datamonitor
08 May 2008
CommentWire
CommentWire

Solvay: a first for Creon

The approval of Solvay's pancreatic enzyme replacement treatment Creon should boost the therapy's sales in the shortterm. However, as it is only the first of four such therapies to be approved under new FDA guidelines, its direct competitors and the development of novel products will soon put a halt to this growth.

Published By Datamonitor
06 May 2009
CommentWire
CommentWire

Smallpox vaccination: planning to catch up

In response to the fear of bioterrorism, the US government has given states instructions on how to manage a smallpox outbreak. While the climate of worry over a biological attack has driven vaccine stockpiling - and useful revenues for pharma companies - the necessary strategy and infrastructure lags far behind.

Published By Datamonitor
27 Sep 2002
Expert View
Expert View

Slow growth in cardiovascular disease will be offset by prospects in diabetes

New Datamonitor research has revealed that pharmaceutical companies will struggle to profit from the cardiovascular disease market over the next decade, despite growing drug usage. Patent expiries and generic competition will have a major impact and Datamonitor expects only AstraZeneca and Novo Nordisk to generate positive sales growth in this sector out to 2018.

Published By Datamonitor
15 Mar 2010
CommentWire
CommentWire

SkyePharma: Flutiform back on track

Under a newly signed agreement, Kos Pharmaceuticals will have exclusive rights to market SkyePharma's Flutiform for adult and adolescent asthma in the US and possibly Canada. The US company will also be responsible for potential clinical development in COPD and pediatric asthma. Following a period of uncertainty over its future, with this deal Flutiform now seems on track for a US launch in 2009.

Published By Datamonitor
09 May 2006
CommentWire
CommentWire

Shire: good days ahead for Daytrana

Daytrana, Shire's methylphenidate transdermal system, has demonstrated statistically significant reductions in the symptoms of ADHD and proved generally well tolerated in two recent clinical trials. This encouraging data further points to the product's chances of commercial success, which are already strong given that it is predicted to become the market-leading stimulant by 2010.

Published By Datamonitor
26 May 2006
CommentWire
CommentWire

Shire: comeback conundrums

Canadian regulators have agreed to allow Shire's ADHD drug Adderall XR to return to the market following its temporary withdrawal earlier this year. This is good news for Shire as reinstatement of Adderall XR in Canada will help to re-establish both the drug's reputation and its share of the Canadian ADHD market. However, looking at the outlook for the drug in a wider context, it is no panacea.

Published By Datamonitor
26 Aug 2005
CommentWire
CommentWire

Shire: blockbuster and beyond for Vyvanse

Strong Q1 sales and significant velocity for its ADHD product Vyvanse suggest that Shire will be heralding a new blockbuster by the end of the year. Furthermore, with approval pending in European markets and investigations into additional psychiatric indications providing promising results, Vyvanse is set to deliver long-term sales growth.

Published By Datamonitor
30 Apr 2012
CommentWire
CommentWire

Shire: Adderall should recover from Canadian blow

Shares in the UK's third-biggest drug manufacturer Shire slumped on news of Adderall XR's withdrawal in Canada, prompted after Shire provided information about 20 sudden deaths in patients taking Adderall XR for ADHD. The withdrawal from Canada will cause even bigger problems for Shire if the FDA chooses to follow Health Canada's lead, but at present this seems unlikely.

Published By Datamonitor
10 Feb 2005
CommentWire
CommentWire

Shire/Noven: MTS back on track

The FDA has accepted for review Shire and Noven Pharmaceuticals' amended NDA for MTS for the treatment of pediatric ADHD. This is an important step not only for the two companies but also for the ADHD market, as MTS is expected to become the market-leading ADHD stimulant by 2010. However, further investment and a move into the adult market may be required to ensure this success.

Published By Datamonitor
28 Jul 2005

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