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SOCMA News Gilead Sciences to acquire Pharmasset, Inc for $11 billion Gilead Sciences, Inc and


SOCMA reiterates opposition to Safe Chemicals Act


SOCMA, in a statement submitted to a US Senate environmental panel, has provided support for a bipartisan look at the country’s chemical control law, but has reiterated its opposition to the Safe Chemicals Act. The statement was submitted to a jointly-held legislative hearing on the Toxic Substances Control Act (TSCA) before the full Senate Committee on Environment and Public Works and the Subcommittee on Superfund, Toxics, and Environmental Health. “There is broad stakeholder agreement that TSCA needs to be modernised, but the Safe Chemicals Act is not workable. It fails to adequately consider its impact on innovation or balance chemical safety with continued manufacturing in the US”, said SOCMA President Lawrence D. Sloan. “Ultimately the Safe Chemicals Act will have to consider how the costs and delays associated with increased data submission will impact US jobs. Right now, there has been insufficient discussion about this important issue.” Sloan added that the


Environmental Protection Agency has a unique opportunity to exercise its existing authority and carry out the law as it was intended.


SOCMA has also said it is disappointed that the committee continues to overlook the voice of the industry’s small and medium- sized chemical manufacturers by failing to invite this sector to testify, and that the speciality batch manufacturers sector could be particularly impacted if production of certain chemicals is shifted to developing countries. It stated that for a bipartisan bill to advance, Congress should avoid dismantling the aspects of TSCA that have worked well.


10 sp2 November/December 2011


Pharmasset, Inc have signed a definitive agreement under which Gilead will acquire Pharmasset for $137 per share in cash. The transaction, which values Pharmasset at about $11 billion, was approved by Pharmasset’s Board of Directors. Gilead plans to finance the transaction with cash on hand, bank debt and senior unsecured notes. The company expects the transaction, when completed, to be dilutive to Gilead’s earnings through 2014 and accretive in 2015 and beyond. The transaction is expected to close in the first quarter of 2012.


Pharmasset currently has three clinical-stage product candidates for the treatment of chronic hepatitis C virus (HCV) advancing in trials in various populations. The company’s lead product candidate, PSI-7977, an unpartnered uracil nucleotide analogue, has recently been


advanced into two Phase 3 studies in genotype 2 and 3 patients. A third Phase 3 study in genotype 1 patients will be initiated in the second half of 2012, the design of which is dependent on the outcome of Phase 2 studies which are evaluating PSI-7977 in various combinations in genotype 1- infected patients. If successful, this strategy could lead to an initial US regulatory approval of PSI-7977 in 2014.


PSI-938, an unpartnered guanosine nucleotide analogue, is being tested in a Phase 2b interferon-free trial as


monotherapy and in combination with PSI-7977 in subjects with HCV of all viral genotypes. Mericitabine (RG7128), a cytidine nucleoside analogue, is partnered with Roche and is being evaluated in three Phase 2b trials. Roche is responsible for all aspects of the development of mericitabine.


BMS and Dako in pharmacodiagnostics collaboration


Bristol-Myers Squibb and Dako have entered into a broad framework agreement on the development of


pharmacodiagnostic tests intended to identify patients more likely to benefit from treatment with investigational drug candidates under development by Bristol-Myers Squibb. The agreement builds on a


New Mastersizer 3000 particle size analyser from Malvern Instruments


Malvern Instruments has introduced the Mastersizer 3000 laser diffraction particle size analyser, which has an extended dynamic range from 0.01 to 3,500 microns, thus delivering wet and dry measurements across the milli-, micro- and nanometer size ranges.


The design of the optical core gives the indtrument a small footprint system,and it also includes a novel dry powder


collaboration begun in 2008. Pharmacodiagnostics are increasingly in demand with the recognition that personalised medicine may provide a way to improve patient care and manage health care costs by targeting treatments to individuals more likely to benefit from specific therapies.


Dako, based in Denmark, is a


Gilead’s research and development portfolio includes seven compounds in various stages of clinical development for the treatment of HCV. Pegylated interferon in combination with ribavirin is currently part of the standard of care treatment for patients with chronic hepatitis C. Gilead is focused on advancing multiple compounds with different mechanisms of action and resistance profiles in


combinations that will support delivery of an all-oral regimen that would eliminate the need for pegylated interferon. Three separate all-oral Phase 2 studies are currently ongoing, and the company expects clinical data from these studies to become available in 2012 and early 2013. Pharmasset’s compounds are complementary to Gilead’s existing HCV portfolio: Gilead says the transaction will help advance its effort to develop an all-oral treatment for HCV.


specialist in tissue-based cancer diagnostics and has extensive experience of developing diagnostic tests in collaboration with pharmaceutical companies. The company supplies reagents, instruments and software to hspitals and research laboratories to make precise diagnoses and determine the most effective treatment for cancer. The company is owned by a private equity fund, EQT.


dispersion unit. The system is suited for a wide range of particle sizing applications for which laser diffraction is now the technique of choice. Intuitive software gives operator-independent analysis


and offers data generation tailored to individual needs, with a broad range of presentation options. For further information visit www.malvern.com/ms3000


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