Wyeth Acquires Thiakis

Posted on December 18, 2008 @ 06:24 am

Wyeth has acquired Thiakis Limited, a privately held biotechnology company based in the United Kingdom. Thiakis' lead product candidate, TKS1225, is being studied for the treatment of medical obesity and other co-morbidities. TKS1225 and related compounds are synthetic versions of the natural gastrointestinal peptide oxyntomodulin.

Wyeth is paying approximately $30 million for Thiakis, with potential milestone payments of as much as $120 million. Thiakis was founded in 2004.

"This acquisition is evidence of our commitment to develop and bring to market innovative, high-value medicines that have the potential to address significant unmet needs in critical therapeutic areas such as metabolic disorders," said Mikael Dolsten, M.D., Ph.D., president, Wyeth Research. "Thiakis' R&D program fits well with our goal of addressing the medical burden of obesity in a targeted manner using biologic-based therapies."

"As we take this important step with Wyeth, we are certain we have chosen the right company to follow through on our vision and commitment to develop and commercialize important new therapies that help address the growing worldwide medical epidemic of obesity," says John Burt, D.Phil. ACMA, chief executive officer and co-founder of Thiakis.

GSK Licenses PER.C6 from DSM, Crucell

Posted on December 18, 2008 @ 05:17 am

GlaxoSmithKline has signed a license agreement with DSM Biologics and Crucell, allowing GSK to research a recombinant protein on the PER.C6 platform. Financial terms of the agreement were not disclosed.

"We are very pleased to enter into this collaboration with GSK," said Ronald Brus, Crucell's chief executive officer. "This agreement further underscores the potential of our PER.C6 production technology for generating recombinant proteins."

"The PER.C6 production technology continues to surpass our expectations as a robust manufacturing platform with its ever extending and global reach into the Research and Development departments of major healthcare players," Karen King, president of DSM Biologics, commented. "This agreement with GSK brings us closer to our mission of making the PER.C6 technology a gold standard for industry use."

Pfizer, Auxilium in EU Bio-Pact

Posted on December 18, 2008 @ 05:15 am

Auxilium Pharmaceuticals and Pfizer have entered into a strategic alliance for the development, commercialization and supply of Xiaflex, a novel, first-in-class, biologic for the treatment of Dupuytren's contracture and Peyronie's disease. Pfizer will receive exclusive rights to commercialize Xiaflex in the 27 member countries of the EU and 19 other European and Eurasian countries. In addition, Pfizer will be primarily responsible for regulatory activities for Xiaflex in these countries.

Pfizer will make an up-front payment of $75 million to Auxilium and as much as $410 million in milestone payments, with $150 million tied to regulatory milestones and $260 million based on sales milestones. Auxilium will receive increasing tiered royalties based on sales of Xiaflex in Pfizer's territories.

Auxilium will remain primarily responsible for the global development of Xiaflex and will be responsible for all clinical and commercial drug manufacturing and supply. Pfizer will share clinical development costs for certain trials required for the EU and be responsible for all discretionary development within the countries for which it has exclusive rights to commercialize Xiaflex. Pfizer will have a right of negotiation to obtain exclusive rights to commercialize Xiaflex pipeline indications in its territories.

Auxilium has completed Phase III trials for Xiaflex in Dupuytren's contracture and expects to file a biologics license application (BLA) in the U.S. for the treatment of Dupuytren's contracture in early 2009. Pfizer expects to file Xiaflex for approval for the treatment of Dupuytren's contracture in Europe in 2010. Xiaflex is also being evaluated in a Phase IIb trial for Peyronie's disease, with top-line data expected in late 2009.

"Today, Pfizer and Auxilium have forged a compelling partnership and together we believe we have the opportunity to offer the first, effective non-surgical treatment for two diseases," said Armando Anido, chief executive officer and president of Auxilium. "With the strength of Pfizer's commercialization and development organization, this relationship greatly enhances our ability to effectively introduce this potentially groundbreaking technology for the treatment of Dupuytren's contracture and Peyronie's disease in Europe."