Shire Pharmaceuticals said that TKT Therapeutics – the US firm it agreed to buy in April [[22/04/05d]] – had announced positive results from a clinical trial of an investigational therapy for the treatment of a rare genetic disorder known as Hunter syndrome. Both companies’ share prices shot up on the news as investors seemed to regain confidence in their stocks, as well as the proposed takeover.
Specifically, patients in the pivotal Phase III clinical trial who received TKT’s treatment, which is currently known as iduronate-2-sulfatase or I2S, showed a statistically significant improvement compared to those taking placebo, with the study reaching its main goal. TKT, which expects to present the full data at a medical meeting later on in the year, says that the results will form the basis of regulatory dossiers for both the European and US regulators, which it hopes to file in the fourth quarter.
Hunter syndrome, also known as MPS II, is a rare, life-threatening genetic disorder with no available treatment. As the disease progresses, a variety of symptoms appear including, enlarged liver and spleen, and heart failure.
In a statement, Shire’s chief executive, Matthew Emmens, said: “We are very pleased that the announcement of the… study results from TKT are positive and that they plan to file the product license applications in the US and Europe as targeted, in the fourth quarter of 2005. [Enzyme replacement therapy] product development is lower risk than other new chemical entities. This lower risk profile is one of the reasons why TKT is such an attractive fit for Shire.”
The deal still remains subject to shareholder approval, as well as regulatory approvals and satisfaction of other customary closing conditions, but is still expected to close some time during the summer.