New cholesterol drugs on the horizon


The new candidate reduced "bad" LDL cholesterol by 40-72% in the trial

Sanofi has reported Phase II data for a new drug candidate for lowering cholesterol levels in patients already taking statins. Over an 8-12 week period, the candidate reduced low density lipoprotein (LDL) cholesterol - so-called ’bad’ cholesterol - by 40-72%, compared with 5% for placebo treatment. The 183 patients in the trial all had high levels of LDL cholesterol despite taking atorvastatin (the generic name for Pfizer’s Lipitor). The candidate (SAR236553/REGN727) is a monoclonal antibody, administered by injection, that targets the PCSK9 enzyme. If approved, it would be a first-in-class drug. It was created by US drugmaker Regeneron - which started working with Sanofi in this area in 2007, and in 2009 signed a $160 million (£100 million) licensing deal.

Meanwhile, Amgen has reported Phase I data for its own monoclonal antibody PCSK9 inhibitor (AMG145), also aimed at lowering cholesterol levels in patients taking statins. In a 51 patient study, AMG145 reduced LDL cholesterol by up to 75% when taken every two weeks over a six week period by patients already taking ’low to moderate’ doses of statins. The reductions in LDL cholesterol levels were lower for patients taking high doses of statins. 
Andrew Turley

Sanofi grabs polymer surgical gel company

Sanofi has bought Pluromed, a US medical device company that makes a polymer product for temporarily blocking blood vessels during surgery. The LeGoo mixture is liquid at room temperature but rapidly forms a gel when warmed by the body, creating a firm plug and halting blood flow. It was approved in the US in October 2011. The key ingredient is a poloxamer, a polymer comprising three distinct ’blocks’ of repeating monomers, a hydrophobic block of polypropyleneglycol sandwiched between two hydrophilic blocks of polyethyleneglycol. In addition to LeGoo, Pluromed makes Backstop, a product designed to prevent kidney stones slipping in the wrong direction during their removal. Pluromed says the market for its products is worth over $2 billion (£1.3 billion). The companies have not released financial details of the deal. 

GSK sells batch of familiar brands for €470 million

GlaxoSmithKline (GSK) has sold another chunk of its over-the-counter products portfolio. Specifically Belgian Omega Pharma has agreed to pay €470 million (£391 million) for rights to the Lactacyd, Abtei, Solpadeine, Zantac, Nytol and Beconase brands, which generated sales of £185 million for GSK in 2011. Under the terms of the deal, Omega will get the manufacturing site in Herrenberg, Germany, which employs 110 people. GSK says that it is still planning to offload weight loss brand Alli (orlistat). 

First generic Lexapro

US authorities have approved the first generic version of Lexapro (escitalopram) tablets for treating depression and anxiety. Lexapro tablets are marketed in the US by Forest, which developed escitalopram in partnership with Danish drugmaker Lundbeck. The generic version will be marketed by Israeli generics giant Teva, which has a 180 day period of exclusivity. Escitalopram has been a controversial drug for Lundbeck and Forest owing to its similarity to another Lundbeck drug: citalopram. The underlying molecule is chiral - citalopram is a 50:50 racemic mixture. Escitalopram, which was developed years later, is the S enantiomer only. Lundbeck was granted a separate patent for the latter, but critics said this was unreasonable given the similarity and accused the company of unfairly extending a period of exclusivity for a single drug.

Shire buys anaemia drug company for $325m

Shire has signed a $325 million deal to buy US biotech FerroKin BioSciences. Shire will pay $100 million upfront and make further payments totalling up to $225 million if and when prearranged drug development milestones are reached. For this, Shire will get access to FBS0701, an iron chelator in Phase II trials for treating patients with too much iron in their blood after multiple transfusions. This situation typically arises in patients with anaemia and cause problems. Under normal conditions the body is very slow to clear excess iron and this means it can accumulate in organs, including the heart and the liver, where it causes damage. 

Abbott renamed AbbVie

US healthcare giant Abbott has renamed the branded drugs part of its business following its decision to split that unit from the medical devices unit - creating two separate organisations. The new pharma company, to be launched by the end of 2012, will be called AbbVie, while the medical devices company - which will include the generic drugs and food supplements portfolio - will inherit the existing Abbott name. Richard Gonzalez, currently executive vice president for global pharmaceuticals, will become chief executive and chair of AbbVie. 

AstraZeneca pulls Targacept depression deal

AstraZeneca is ditching TC-5214, a drug candidate it licensed from US pharma company Targacept in 2009 under a deal worth up to $740 million, $200 million of which AstraZeneca paid up front. The two companies were interested in using TC-5214, an enantiomer of mecamylamine, as a treatment for depression. But recent trials have returned poor results, and AstraZeneca now says that it is not going to pursue marketing approval for the drug candidate. The move will cost the company $50 million in intangible assets. 

Shire signs $190m neuro deal

Irish pharma major Shire has signed a $190 million deal with Heptares for rights to AdenosineA2A antagonists discovered by the company. Adenosine A2A is a G-protein coupled receptor (GPCR) involved in regulating dopamine in the brain. There is evidence that inhibiting the receptor may be useful in the treatment of central nervous system disorders. Shire says that this is the first time a ’structure based’ drug discovery approach has been applied - from the outset - to a GPCR drug target. 

Seroquel patent row

The legal tug of war over the right to sell generic versions of Seroquel (quetiapine) tablets continues. In the latest round, a US court has ruled that the patent for the extended release formulation, sold by AstraZeneca as Seroquel XR tablets, is valid and has been infringed by several generic manufacturers. AstraZeneca is now facing generic erosion of its blockbuster Seroquel brand - the patent for quetiapine expired a few days ago. But the patent for the Seroquel XR formulation, which patients take less frequently compared with the original formulation, offers the possibility of maintaining some exclusivity until 2017. Only a week ago, AstraZeneca lost out in a UK court, which ruled the patent invalid. The Seroquel brand is an important part of the AstraZeneca portfolio - it generated $4.3 billion (£2.7 billion) in global sales in 2011.

Illumina continues to frustrate Roche

Swiss pharma company Roche is struggling to get its hands on Illumina, the gene sequencing company it made a $5.7 billion hostile bid for back in January. Since then, it has upped the bid 18% to $6.7 billion, but the Illumina board has held firm. Roche has now sent a second letter direct to shareholders encouraging them to tender their shares and vote in as board members a group of candidates nominated by Roche. Illumina is one of the forerunners in the race to technology that would enable an entire genome to be sequenced in just one day. 

EMA backs public access to clinical data

The European Medicines Agency (EMA) has given its support for free and public access to all clinical trial data associated with approved treatments. In a perspective published in the journal PLoS Medicine (DOI:10.1371/journal.pmed.1001202), regulators at the EMA say that it is ’neither desirable nor realistic to maintain the status quo of limited availability of regulatory trials data’. Clinical trial data should not be thought of as ’commercial confidential information’ and drug companies and regulators should not have a monopoly on crunching the data, they add. But appropriate measures would have to be put in place to first maintain patient confidentiality and prevent misuse of data by rival companies. 

Valeant moves to Montreal

Canadian pharma company Valeant is planning to move its global headquarters from Mississauga, Ontario to Montreal, Quebec. In addition, the company says that it will establish an R&D centre for consumer dermatology in Laval, Quebec. The move will make Valeant the only big pharma company to have its global headquarters in Quebec. 

Takeda buys gout company for $800m

Japanese drug maker Takeda has signed an $800 million deal to buy privately owned US company URL Pharma. URL Pharma is a pharmaceutical company with 2011 calendar year revenues of nearly $600 million. The top URL brand is Colcrys (colchicine) for treating and preventing gout, a condition caused by high levels of uric acid in the blood leading to the formation of crystals in joints, tendons and surrounding tissues. Colcrys products generated sales of over $430 million in 2011. URL employs about 500 people. 

Amgen signs up hypocalcaemia company for $315m

US biotech Amgen has signed a deal to buy privately owned drug development company KAI Pharmaceuticals for $315 million. The move will give Amgen access to KAI-4169, a Phase/nbsp II drug candidate for treating secondary hyperparathyroidism in patients on dialysis with chronic kidney disease. Secondary hyperparathyroidism is excessive secretion of parathyroid hormone by the parathyroid glands in response to hypocalcaemia, a disorder often seen in patients with chronic kidney disease. KAI-4169 is a peptide agonist of the calcium sensing receptor, which affects calcium levels by modulating the release of parathyroid hormone. 

J&J hit by $1.1bn Risperdal fine

US healthcare giant Johnson & Johnson (J&J) has been hit by a $1.1 billion fine for illegal marketing of its anti-psychotic Risperdal (risperidone) products, according to BBC News. An Arkansas court concluded that in 2007 J&J and its subsidiary Janssen Pharmaceutica misled doctors about the side effects associated with risperidone, which include increased risk of stroke, obesity and diabetes. Janssen has already faced similar cases in Texas, Louisiana and South Carolina. 

Ista bought for $500 million


Bausch & Lomb has its eye on a lucrative market

US eye drug company Bausch & Lomb has signed a cash deal to buy US drugmaker Ista Pharmaceuticals for $9.10 per share, equivalent to $500 million (£310 million). Ista currently sells four products, including treatments for eye inflammation, pain brought on by cataract surgery, glaucoma and conjunctivitis. The two companies know each other well: Bausch & Lomb already manufactures most of the products Ista sells in the US. The deal follows a hostile bid from Canadian pharma company Valeant, which put forward a $7.50 per share cash deal, worth $410 million, in January but later took itself out of the bidding citing ’lack of progress’.


US demands chemical reporting for tobacco

Tobacco companies will have to report the amounts of harmful chemicals in their products under draft guidelines produced by the US Food and Drug Administration (FDA). There are more than 7000 chemicals in tobacco and tobacco smoke but the FDA has drawn up a list of 93 harmful or potentially harmful constituents (HPHCs) that tobacco companies will have to report for every tobacco product sold in the US. The FDA says that the move will help to ’prevent misleading marketing about the risks associated with tobacco products’. In addition, the FDA has produced draft guidelines for how companies can advertise tobacco products designed to be less harmful than conventional equivalents. Initially, reporting will focus on 20 HPHCs for which testing methods are accessible and well established, including benzene, toluene and formaldehyde. The FDA will make the information available to the public by April 2013.

Cytec pays $440m for UK materials company

US speciality chemical company Cytec has struck a deal to buy composite materials manufacturer Umeco for $440 million. Umeco makes lightweight bodywork for the civil and military aerospace industries, as well as Formula One cars and other high performance vehicles. The company is based in the UK and reported sales of £207 million in its most recent financial year. Cytec says that it is not expecting ’significant workforce reductions’ as a result of the move. 

ECHA launches chromium(vi) consultation

How should we regulate chromium(vi)? The European Chemicals Agency (ECHA) has launched a six month public consultation on this topic - with specific reference to leather products. Chromium(vi) is not used deliberately in leather production, but it can form by oxidation of chromium(iii). The move has been prompted by Danish authorities, who are worried about the levels of chromium(vi) in leather products that come into contact with skin such as shoes. The metal species can cause severe dermatitis through prolonged or repetitive contact of this kind. Therefore, the Danes have proposed a legal limit on the amount of chromium(vi) that can be found in finished leather products put on the market. They want to introduce a limit of 3mg/kg, which would rule out 30% of products currently on the market. 

US regulates legacy compounds

The US Environmental Protection Agency has proposed new rules that would force companies to report any new uses that arise in relation to a group of potentially harmful chemicals: polybrominated diphenylethers (PBDEs); benzidine dyes; a ’short chain chlorinated paraffin’; hexabromocyclododecane (HBCD); and di-n -pentyl phthalate (DNPP). These chemicals have been used in a range of consumer products and industrial applications, including: paints; printing inks; pigments and dyes in textiles; flame retardants in flexible foams; and plasticisers. And although most of them are no longer made or used in the US, they can still be imported in consumer goods or for use in new products. 

BASF looks to offload sports surface business

BASF says it is planning to sell its sports surfaces business, Conica, including the site at Schaffhausen in Switzerland. The business, which BASF bought from Degussa in 2006, makes materials for a wide range of sports surfaces including running tracks, gymnasium flooring and tennis courts. The growth opportunities for the business are outside Europe, says Tilman Krauch, head of the construction chemicals division. In addition, the business doesn’t link up well with BASF’s core activities. The Schaffhausen site employs 150 people. Of those, half work in the sports surfaces business. 

Lighter trains with Bayer composite

Bayer has launched a lightweight material designed to replace steel in railway locomotive and carriage construction. The company says that reducing weight has long been a key aim for automotive manufacturers, who are interested in reducing fuel consumption. But thanks to rising fuel costs, it is becoming important for companies that make trains as well. Bayer says that the sandwich polyurethane material, which it has demonstrated in a case study for housing diesel engines, is 35% lighter and 30% cheaper than steel and aluminium alternatives. The parts of the material are synthesised directly using a spray and press process. 

Dow to close sites and cut 900 jobs

Dow has announced plans to close four plants, idle one plant and ditch 900 jobs in order to cut annual costs by $250 million (£160 million). Over the next two years, the company will close its plants at Estarreja in Portugal, Balatonfuzfo in Hungary and Charleston in Illinois, all of which make Styrofoam insulation products, plus its toluene diisocyanate plant in Camaçari, Brazil. In addition, it will idle its plant in Terneuzen, the Netherlands. The move will cost Dow $350 million in the short term. Chair and chief executive Andrew Liveris blamed ’changing and volatile economic conditions’, highlighting Western Europe in particular.

Meanwhile, the company is expanding R&D and striking new academic partnerships in other parts of the world. Dow has opened a new R&D site in Hwaseong in Gyeonggi Province, South Korea. The site has room for 300 researchers and will become the global hub for organic light-emitting diode (OLED) research at Dow. In addition to OLED research, the site will focus on lithography, display materials and advanced chip packaging. The company says that it has now invested more than $400 million in semiconductor, display and LED technology in Korea over the last decade. In addition, it is to partner with the University of Queensland in Australia to create the Dow Centre for Sustainable Engineering Innovation. Dow will provide $10 million towards the endeavour over the next six years for research into global issues of energy, water and sustainability. It says this is the first time it has signed such an agreement with an Australian university.

In brief

US approves imaging agent

A new drug for use in positron emission tomography (PET) to help evaluate whether a person has Alzheimer’s disease has been approved in the US. Amyvid injections contain florbetapir F-18, which binds to the amyloid plaques associated with Alzheimer’s disease and contains radioactive fluorine-18 for measuring the density of amyloid plaques in the brain using PET. The drug was developed by Avid Radiopharmaceuticals, which was bought by Eli Lilly in December 2010 in a deal worth up to $800 million. 

AstraZeneca signs Amgen deal 

AstraZeneca has signed a deal with US biotech Amgen for access to five monoclonal antibodies for treating inflammation (AMG 139, AMG 157, AMG 181, AMG 557 and brodalumab - also known as AMG 827). The deal will cost AstraZeneca $50 million upfront. Then, from 2012 to 2014, the company will pay 65% of costs. After that, the companies will split costs equally. 

£200m UK healthcare fund 

A £200 million biotechnology and life sciences research fund has been launched in the UK by the Wellcome Trust. The fund will invest in ’promising healthcare businesses’, typically at an early stage of their development. It will be led by Nigel Keen, who is chair of several technology companies in the healthcare and electronics industries, including Oxford Instruments, Laird and Bioquell. 

€40m pharma lobbying spend 

The pharma industry spends more than €40 million per year on EU lobbying, according to a report from two campaign organisations. In contrast, non-governmental public health organisations spend just €3.4 million per year. Corporate Europe Observatory and Health Action International looked at the entries made by pharmaceutical companies and their representatives in the EU lobby transparency register - a voluntary register of activities. 

DuPont opens US plant R&D site

DuPont has opened a $40 million plant genetics R&D site in the US. The site - in Johnston, Iowa - will create 400 jobs focused on the development of new genetically modified crop varieties. DuPont says that it will invest $10 billion globally in R&D focused on food, agriculture and nutrition by the end of 2020. 

Sony to sell chemicals business 

Electronics giant Sony is looking to sell its chemicals business - Sony Chemical & Information Device Corporation (SCID) - to Japanese state owned company the Development Bank of Japan. SCID makes a range of adhesive and optical materials for use in electronic and magnetic components for modern devices, such as smart phones and tablet computers. The two parties have not yet confirmed any financial terms of the deal. 

$144m for algae demo site 

US algae company Sapphire Energy has raised $144 million to build a commercial demonstration plant. The company makes ’green’ crude oil from algae and it says the plant, to be built in Luna County, New Mexico, will be the first commercial demonstration scale algae-to-energy plant. It has deals with German industrial gases and engineering company the Linde Group and US agricultural products giant Monsanto. 

Clariant opens battery site in Canada 

Swiss chemical company Clariant has opened a new plant in Canada for producing battery materials. Specifically, the plant will produce carbon coated lithium iron phosphate, an energy storage material used in modern batteries for a range of applications including electric vehicles. The move will create more than 50 new jobs in Quebec.