Please login to the form below

Not currently logged in
Email:
Password:

Shire eyes 6 product launches by end of 2006

British firm reports a third-quarter net loss after TKT acquisition charges

British-based Shire Pharmaceuticals said it aims to launch six new products by the end of 2006, after reporting a third-quarter net loss of $624.2m (£352m) due to higher costs of developing new drugs and charges related to its recent acquisition of US biotech Transkaryotic Therapies (TKT).

The company said potential 2006 launches for NRP104 and Daytrana for attention deficit hyperactivity disorder (ADHD) and I2S for Hunter syndrome, a rare hereditary disorder, could bump up marketing costs to $700m next year from $640m in 2005.

However, analyst Frances Cloud at Nomura described the chances of the firm launching six products in the next 14 months were "quite unrealistic".

"In the projections, it is assumed that the Food and Drug Administration (FDA) will approve everything outright on or before the PDUFA [Prescription Drug Users Fee Act] date," she said. "By looking at average statistics coming out of the FDA itís pretty clear that the FDA does not approve things by the PDUFA dates. It very often issues an approvable letter and asks for new data."

Shire also said it would continue to protect its best-selling ADHD drug, Adderall XR, from generic competition. It has filed lawsuits against Barr Pharmaceuticals and Impax Laboratories, alleging that their respective products infringe one of Adderall XRís patents.

Cloud said that of all Shireís new products, NRP104 had the most potential to be a big-selling drug: "It will replace Adderall if it gets to market."

In the nine months to September 30, Shire made a pre-tax profit of $430m ($344m) on turnover of $1.13bn ($989m).

30th September 2008

Share

PMEA Awards 2020

COVID-19 Updates and Daily News

Featured jobs

PMHub

Add my company
Branding Science

We are Branding Science Partners in thinking which inspires change in healthcare Branding Science are an award-winning global pharmaceutical market...

Latest intelligence

What’s in it for me? How to engage, motivate and support staff with internal training at OPEN Health
...
Environmental impact of in-person vs. virtual meetings
Although it will be tempting to resume in-person activities in the same capacity as before, we need to weigh the pros and cons of virtual vs. in-person vs. hybrid events...
US biosimilars
The US celebrates five years of biosimilars on the market – a look to the past, present and future
Why the success of biosimilars in the US has been mixed...

Infographics