The UK’s Shire Pharmaceuticals this morning confirmed it is in talks with generics company Barr Laboratories over the ADHD drug Adderall XR (amphetamine salts controlled release). The statement from Shire follows market rumours over the past couple of days, which has triggered a heavy trading in the firm’s stock on the London Stock Exchange, and a jump in share price from £6.39 on Wednesday to £6.81 at close yesterday.
Barr is one of several generic drugmakers planning to manufacture copy-cat versions of Adderall XR – the shining star of Shire’s pipeline, sales of which leapt 43% to $205.4 million during the second quarter [[29/07/05f]]. The US company was the first off the starting blocks in 2003 [[10/01/03b]], and was closely followed by Impax Laboratories [[05/01/04d]], Colony Pharmaceuticals [[03/12/04d]] and Teva [[09/06/05e]]. Shire has filed lawsuits against both Barr and Impax and has been expecting these cases to go to trial in January and February 2006 respectively. Shire has chosen not to sue either Colony or Teva.
“Shire confirms that there have been very preliminary discussions with Barr,” Shire said in a statement, adding: “Shire continues to review all options with respect to this litigation, and has not ruled out the possibility of settling this litigation or entering into an agreement with Barr that would result in Barr’s ability to launch a generic version of Adderall XR prior to 2018. Given the very preliminary nature of the discussions, it is not possible to form any judgement as to the likelihood of reaching any agreement with Barr.”
- Meanwhile, Barr has received an approvable letter in the USA for its extended-cycle oral contraceptive Seasonique (levonorgestrel/ethinyl estradiol). The Food and Drug Administration has requested more data to support the dosing regimen, which involves 84 days’ combination therapy, followed by seven days of oestrogen alone. Barr says it plans to meet with the drug regulator during the coming month to discuss how to proceed.