AstraZeneca takes on FDA over Seroquel – Pfizer ditches Indian insulin biosimilars deal – And UK launches CCS competition

PHARMACEUTICALAstraZeneca has launched a legal attack against the US Food and Drug Administration (FDA) to overturn a recent court ruling allowing generic versions of antipsychotic Seroquel (quetiapine fumarate) onto the US market by the end of the month. The patent for the drug has run its course and will expire on 26 March. But the company claims that it has ‘regulatory exclusivity’ with respect to ‘important clinical trial data’ which won’t expire until 2 December 2012. Seroquel is a huge part of the AstraZeneca portfolio – it generated $4.3 billion (£2.7 billion) in global sales in 2011.

PHARMACEUTICALPfizer has ditched its $350 million deal with Indian drug maker Biocon to develop insulin biosimilars. All rights licensed to Pfizer will bounce back to Biocon, and the two companies will ‘move forward independently’. Biosimilars can be thought of as ‘copies’ of biologics in the same way that generics are copies of traditional small molecule drugs. The key difference is the degree of complexity, which has caused concern among regulators and by association companies looking to invest time and resources in this area. The US FDA has issued draft guidance to industry on this issue – but a lot of uncertainty remains.

CHEMICALBASF has invested $13.5 million in Allylix, a US renewable speciality chemical company, through its venture capital wing. Allylix has developed fermentation processes for making a range of chemicals, primiarily terpenes and their derivatives, from renewable raw materials and for use in several industries, including the flavour, fragrance, food ingredients and cosmetics industries. It says that terpenes and their derivatives are difficult to make by chemical synthesis and until now have only been made using natural resources that are in limited supply.

PHARMACEUTICAL – German drug maker Boehringer Ingelheim opened a €12 million (£10 million) veterinary R&D site in Shanghai, China. The site, which boasts 70 ‘scientific workplaces’, will focus on vaccines against swine and poultry diseases and provide jobs for local scientists. The company says that local R&D capacity is important in China to shorten development times and to provide solutions to customers faster as new pathogens continue to emerge.

PHARMACEUTICAL – The total remuneration for GSK boss Andrew Witty more than doubled in 2011 to £6.8 million, up from £3.7 million in 2010. But despite this the remuneration committee says (in the 2011 annual report) he is underpaid: there remains a ‘significant competitiveness gap’ between what Witty receives each year and what his peers at other big pharma companies get. His remuneration for 2011 was made up of £1 million in salary plus a £2 million bonus and £3.7 from a performance share plan. The committee says that he is performing well and therefore the company should boost his salary 4% and his performance share plan from 500% to 600% of his salary – although this will still leave Witty in the bottom quartile when compared to his peers.

CHEMICAL – The UK government has launched a £20 million competition to inspire innovation in carbon capture and storage (CCS) technology. It is inviting bids based on better and cheaper CCS components and systems for pilot scale demonstration. It says that the CCS industry could be worth £6.5 billion per year by the late 2020s.

Andrew Turley

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