Shire has voluntarily withdrawn what it says are “a limited amount” of packages containing Daytrana, its attention deficit hyperactivity disorder patch, in the USA.
The UK drugmaker says that it is taking the step not due to safety and efficacy issues, but because of feedback from patients and caregivers who have experienced difficulty removing the release liner from some patches of Daytrana (methylphenidate transdermal system). The packages that have not been pulled were put on the market in the first quarter of 2007 by Shire and partner Noven using an enhanced process to improve ease of use of the patch, and the companies said current supply levels are sufficient to ensure that patients will have their Daytrana prescriptions at their local pharmacy with the new patch.
Some 700,000 Daytrana patches have been sold since the product received US approval in June last year and it had second-quarter 2007 sales of $19.9 million. Noven noted that based on preliminary information, the retail value of product being withdrawn is estimated to be in the range of $4-$6 million.
Shire warns US state over life sciences investment
Meantime, Shire has told legislators in Massachusetts that if they fail to act soon on a $1 billion package of proposals put forward by state governor Deval Patrick to boost the region’s life sciences industry, the company could move a major new manufacturing complex proposed for the Boston area to another state.
Shire is planning to construct the $210 million production and local headquarters complex at Lexington, with the creation of around 600 new jobs, but management have become frustrated by the legislature’s foot-dragging on Gov Patrick’s proposed Act Providing for the Investment In and Expansion of the Life Sciences Industry.
Gov Patrick announced the initiative at the BIO 2007 convention, held in Boston in early May, and he filed the bill with the Senate and House of Representatives on July 19. However, it is still in the House and has yet to reach the early stage of being assigned to a committee for review. Urging legislators to move forward with the bill, Shire has warned them that it is also being aggressively pursued by other states, including North Carolina, with big incentives to site the new complex within their regions.
Shire’s frustration with the bill’s slow progress has been echoed by regenerative medicine company Organogenesis, which pointed out that, because of Gov Patrick’s proposals, it had dropped plans to relocate to Rhode Island. Welcoming his “unprecedented commitment to both industry and academic institutions”, Organogenesis’ chief executive Geoff McKay had pointed out that regenerative medicine was both invented and pioneered in Massachusetts, and that the success of this new field was directly dependent on positive governmental policies.
However, leading legislators have responded to the companies’ complaints by claiming that the bill is expensive and extremely complex, not least its proposal to offer seven different tax breaks, and that it needs thorough examination in the committee process.