This article is provided to FT.com readers by Pharmawire—a news service focused on providing insight into the most price sensitive issues in the global pharmaceutical market. www.pharmawire.com
--------------------------------------------------------------------------------------------------------
Theravance, a Californian biopharmaceutical company, is in discussions to partner its Phase II gastrointestinal (GI) motility dysfunction compound TD-5108, CEO Rick Winningham told Pharmawire.
However, despite being in discussions, NASDAQ-listed Theravance would rather wait until after receiving QTc study data on TD-5108, which should be later this year. He would not give a specific date for when this data would be announced.
The company recently completed enrollment in a thorough QTc study. According to press releases, Theravance’s preliminary review of the electrocardiogram data from the study implied there were problems with the conduct of the study, which meant the study will need to be repeated in order to generate scientifically valid results.
Still, GSK has shown great interest in Theravance. In February, GlaxoSmithKline and Theravance announced the expansion of the Horizon program into development of a next-generation combination treatment for patients with chronic obstructive pulmonary disorder (COPD).
When asked if GSK could acquire Theravance, Winningham said the board is looking at options to increase shareholder value in the short, medium and long term. He noted that GSK’s standstill agreement with Theravance expires in September 2008. Theravance has a solid partnership with GSK and its Japanese partner Astellas, he said.
Theravance raised USD 130m in January, and is unlikely to be in a vulnerable cash position, said Winningham. He added the company has been ”judicious” with the management of its cash.
Meanwhile, Theravance has lost about two months of business, based on the cancellation of the planned 27 February review of Astellas partnered telavancin – a bactericidal, once-daily injectable for the treatment of complicated skin and skin structure infections (cSSSIs) caused by Gram-positive bacteria, including resistant pathogens such as methicillin-resistant Staphylococcus aureus (MRSA). This allows the FDA time for further evaluation of study site monitoring and study conduct to ensure data integrity in the ATLAS Phase III program for the treatment of complicated skin and skin structure infections (cSSSI).
The company said at the time, the FDA indicated that due to study monitoring issues at a single study site managed by the primary contract research organization for the ATLAS program, the agency intends to evaluate additional sites, and that additional questions could arise after further evaluation.
Winningham said the clinical monitoring at a single site gave motivation to look at other clinical sites. The one site in question was in relation to an investigator who enrolled 50 patients, and some patients deviated from the protocol, he added.
Theravance has a USD 637m market cap.
--------------------------------------------------------------------------------------------------------
For more information or to inquire about a trial please email sales@pharmawire.com or call Americas: +1 212-500-1384 or Europe: + 44 (0)20 7059 6251
