Industry news, April 2012

Business roundup



PHARMACEUTICAL

A pill to keep you off the pints?

Phase III trials of Selincro (nalmefene) tablets show that it outperforms placebo treatment when used to help patients with alcohol dependence to reduce their alcohol consumption. The developer of the drug candidate, Danish drug maker Lundbeck, ran three trials looking at the number of heavy drinking days (HDDs) per month and the total alcohol consumption (TAC) per day. In one trial (Esense 1), patients taking Selincro tablets reduced their mean number of HDDs from 19 to 7 days per month and their mean TAC from 84 to 30g per day over the first six months. Patients taking a placebo also substantially reduced their alcohol consumption but to a lesser extent. They reduced their mean number of HDDs from 20 to 10 days per month and their mean TAC from 85 to 43g per day over the first six months. Nalmefene is an opioid receptor antagonist - it is designed to bind to the receptor and effectively deactivate it so that it cannot be triggered by the natural opioids produced during drinking. It is similar in structure and reactivity to another drug, naltrexone, that has been marketed for the treatment of alcohol problems for several years.

Lundbeck bought the rights to nalmefene from Finnish biotech Biotie in a deal worth up to €84 million (?74 million) in upfront and milestone payments plus royalty on sales. Lundbeck will be responsible for manufacturing and registration of the product - in December 2011 it submitted an application for marketing approval to the EU authorities. 

Andrew Turley

 

AstraZeneca takes on FDA over Seroquel

AstraZeneca has launched a legal attack on 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. The patent for the drug has run its course, having expired 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 2011 global sales.

 

Biocon break up

Pfizer 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 resources in this area. 
The US FDA has issued draft guidance to industry on this issue - but a lot of uncertainty still remains. 

 

The (pharma) apprentice

GlaxoSmithKline (GSK) says that it will recruit 40 apprentices across its UK sites in August as part of a new scheme aimed at 16-24 year olds. The company already recruits apprentices into engineering roles but it will diversify its approach to include IT, R&D laboratory support, manufacturing, supply chain and artwork design. Apprenticeships will last between two and four years depending on the discipline and combine on-the-job training with study modules. 

 

’Caffeine inhaler’ manufacturer warned

The FDA has warned a US company marketing a ’caffeine inhaler’ for making false or misleading statements about the product. The company, Breathable Foods, says its ’AeroShot’ device is designed to provide ’breathable energy’. But it also says that the product should be consumed through swallowing - and these two claims contradict each other. ’A product cannot be intended for both inhalation and ingestion,’ the FDA said. ’Caffeine is not normally inhaled into the lungs and the safety of doing so has not been well studied,’ it added. 

 

Fabrazyme site up and shipping product

US biotech and Sanofi subsidiary Genzyme has begun shipping Fabrazyme (agalsidase beta) doses from a new manufacturing plant. Does this mean Genzyme might soon put its much discussed manufacturing problems behind it? The drug, an enzyme replacement therapy used to treat Fabry disease, has been in chronically short supply since the company was hit with a viral contamination problem at its primary manufacturing plant in 2009. Supplies of Cerezyme (imiglucerase) for the treatment of Gaucher’s disease were similarly affected, leading to significant loss of sales. The new site is in Framingham, Massachusetts. 

 

More money for GSK boss Witty

The total remuneration for GlaxoSmithKline (GSK) boss Andrew Witty more than doubled in 2011 to ?6.8 million, up from ?3.7 million in 2010, because of his excellent performance. But the remuneration committee says (in the 2011 annual report) that this still leaves him 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 with his peers.

 

Japan vaccine venture 

GSK and Japanese drug maker Daiichi Sankyo are to form a 50:50 ?100 million (?800,000) joint venture that they say will be ’the number one vaccines company in Japan’. The two companies will move the rights associated with their existing vaccines portfolios into the new company, Japan Vaccine Co, which will market vaccines against a wide range of infectious diseases in Japan. Historically, Japan has been slow to approve vaccines, but as the country struggles under the weight of burgeoning healthcare costs it has become more positive towards vaccines, which arguably offer greater potential to save money through disease prevention as opposed to treatment. 

 

Set prices quicker

EU member states will get less time to set prices and create reimbursement plans for new drugs under proposals from the European Commission. Currently, state authorities get 180 days in which to make their decisions. This is to be reduced to 120 days for unique drugs and just 30 for generics - in a bid to get new drugs to patients faster. Commission vice president Antonio Tajani said: ’Our proposal will lead to substantial savings for public health budgets, for example by allowing earlier market entry of generic products. It also creates a more predictable environment with greater transparency for pharmaceutical companies, thus improving their competitiveness.’ 

 

Jobs to go at Merck KGaA

German chemical and pharma company Merck KGaA is talking about job cuts over the next two years as part of new ’efficiency measures’. The company says that it has started a consultation with employees, but it has yet to decide where the axe will fall. Merck KGaA suffered a major setback recently when its oral multiple sclerosis (MS) candidate cladribine failed to deliver in the clinic and the company chose to drop it to focus on other areas. 

 

$1.35bn autoimmune deal 

Abbott has signed a $1.35 billion deal with Belgian drug maker Galapagos for GLPG0634, a Janus kinase 1 (JAK1) inhibitor that Galapagos is developing for treating rheumatoid arthritis and other autoimmune diseases. Abbott will pay $150 million up front and a further $200 million if Phase II trials show the candidate is successful. After that, Galapagos could receive up to $1 billion in additional payments as and when key milestones are passed. 

 

EMA backs orlistat

The European Medicines Agency (EMA) says that the benefits of weight loss drug orlistat outweigh the risks. The organisation, which controls drugs in the EU, launched an investigation into the drug - marketed on prescription as Xenical by Roche and over the counter as Alli by GlaxoSmithKline - in August  2011 following reports of liver problems. Orlistat has been on the market in the EU since 1998. Generic versions are now available.

 

Enzymes for rare disease treatment

GlaxoSmithKline is to pay up to $300 million (?190 million) for rights to enzyme replacement therapies for lysosomal storage diseases under development at Canadian biotech Angiochem. GSK will pay $31.5 million in cash up front. The rest will come in research funding and fees for successful disease targets. Angiochem is focused on drugs that can cross the blood-brain barrier, something many drugs struggle to do. Once in the central nervous system, the active agent should help to restore enzyme function. Lysosomal storage diseases are rare disorders caused by genetic variations that cause deficiencies of vital enzymes. They include, Tay-Sachs disease, Fabry disease and Hunter syndrome. 

 

$440m HCV deal

Novartis has signed a $440 million deal for rights to hepatitis C virus (HCV) candidate EDP-239 from privately owned US drug discovery firm Enanta. EDP-239 is a small molecule candidate that targets a non-structural viral protein that is essential for viral replication - a protein called NS5A. Enanta will receive $34 million up front and later receive up to $406 million if and when milestones are passed.

 

Caprelsa approved in EU

AstraZeneca has won European marketing approval for anticancer drug Caprelsa (vandetanib) for treating medullary thyroid cancer (MTC). AstraZeneca says Caprelsa is the first drug approved in Europe for treating advanced MTC. It was approved in the US in April 2011. The drug is a kinase inhibitor - it blocks the blood supply to the tumour through the VEGF (vascular endothelial growth factor receptor) pathway and reduces the growth and survival of the tumour through the EGFR (epidermal growth factor receptor) pathway. 

 

QNexa recommended

Weight loss drug candidate QNexa (phentermine, topiramate) has won recommendation from a US Food and Drug Administration (FDA) expert committee, taking it one step nearer to becoming the first new weight loss drug to be approved in the US for over a decade. The committee voted 20 to 2 in favour of recommending QNexa from US biotech Vivus. QNexa was turned away by the FDA in October 2010. The FDA said at the time that more safety data were needed to assess whether the benefits outweighed the risks. 

 

Pharma plans in the US

US president Barak Obama is threatening hundreds of thousands of jobs with ’short-sighted’ plans, according to the Pharmaceutical Research and Manufacturers of America (PHRMA), which has responded to the 2013 budget proposal with disappointment. The organisation, which represents research orientated pharmaceutical companies in the US, is particularly worried about ’mandatory rebates in Medicare Part D’ and plans to ’reduce data protection’ for biologics. Obama is looking to save $364 billion over the next decade through ’payment innovations and other reforms’ at the Department of Health and Human Services. 

Meanwhile, the Food and Drug Administration has requested a 17%, $654 million, increase in its budget, an increase that would take the budget to $4.5 billion in the 2013 presidential proposal. Most of that increase, 98%, would come from fees paid by the pharma industry - and the lion’s share, $364 million, would be for regulation of generics and biosimilars. A further $253 million would fund food safety. 

 

CHEMICAL

Fresh row over consumer chemicals

A new study suggests that harmful chemicals are present in a wide range of consumer products - including products marketed as safer alternatives. The researchers tested for 66 chemicals linked to hormonal changes or asthma in 84 products - including types of shampoo, sunscreen and laundry detergent - and found 55 of them. The potentially harmful chemicals showed up in all 42 conventional products analysed and in 32 out of the 43 alternatives. Furthermore, in many instances the chemicals were not listed on the product labels. But the report - commissioned by US non-profit the Silent Spring Foundation (SSF) - has been criticised by the American Chemistry Council (ACC), which represent the US chemical industry. The ACC accuses the SSF of stoking fears based on unfounded claims highlighting in particular the role of exposure levels in toxicity.

 

BPA and heart disease?

Further research into whether there is a link between heart disease and bisphenol A (BPA) has stoked widespread media interest. Much of the considerable public interest in BPA - which is used in the production of certain types of plastic - has focused on hormones and its potential to cause reproductive or developmental problems. But there is some evidence to suggest that people exposed to higher levels of the controversial chemical may have a higher risk of coronary artery disease. The researchers involved in the most recent study looked at BPA levels in the urine of healthy people over a 10 year period. 

 

Salt slip up 

A food scare relating to salt (sodium chloride) is developing in Europe, according to news reports. Specifically, Polish authorities have launched legal action against three companies that allegedly sold salt for de-icing winter roads as salt for human consumption. The Polish inspectorate has taken 555 samples for testing from a range of foods including: bread and other bakery products; sauerkraut; pickled onions; a wide variety of spices; beetroot; horseradish pickles; and pickled cucumbers. 

 

Reach products list

For the first time, the European Chemicals Agency (ECHA) has published a list of real products on the EU market that contain at least one substance of very high concern (SVHC) as defined by the Reach (registration, evaluation, authorisation and restriction of chemicals) regulation. It based the list on data gathered from notification and registration dossiers submitted by chemical  companies. Under the Reach regulation, companies must notify the ECHA before December 2012 if they intend to sell a product that contains an SVHC. The majority of notifications submitted so far relate to phthalates, typically found in plastic products, and HBCDD, a brominated flame retardant found in many construction products.

 

Clariant to hire 500...

Swiss chemical group Clariant has started work on a new €100 million (?83 million) R&D site in Frankfurt, Germany. The new site will provide jobs for 500 researchers, who will focus on functional materials, energy efficiency and renewable raw materials. Clariant is planning to centre its R&D activity in H?chst, Germany. 

 

...and make eco jeans  

Swiss chemical company Clariant has been awarded the EU ’flower’ label for its environmentally friendly denim production process. The company says this is a first for denim production - the label signifies that all stages of production - from raw materials to finished article - have met stringent requirements. In conventional denim production, the fabric passes through 10 to 14 vats of dyes and other chemicals. Clariant says that using its process, which incorporates new dyes, this sequence can be reduced to a single step. It says that if the process were adopted in the production of just 25% of the pairs of jeans produced globally, it would save 62 million cubic metres of water per year and 220 million kWh of energy. 

 

End of the road for lead chromate 

BASF has said it will stop making lead chromate pigments by the end of 2014. The company says that it has for a long time offered a wide range of alternatives but that customers in the coatings industry have so far resisted change. Lead chromate has a long history as a pigment compound, but both lead and hexavalent chromium are toxic and therefore unsuitable for many applications. Its use will be banned from 2015 without special authorisation as part of the Reach (registration, evaluation, authorisation and restriction of chemicals) regulation, which affects how chemicals of all kinds are marketed in the EU. 

 

Solvay drops Pipelife

Solvay has agreed to sell its 50% stake in plastic pipe firm Pipelife to Austrian construction products company Wienerberger - which owns the other 50% - for €257 million in cash and assumed debt. Solvay is changing in the wake of its €3.4 billion merger with Rhodia in April 2011. In January, it said it was planning to create a new ’energy services’ business. Pipelife is based in Vienna, Austria. It employs 2600 people, and in 2011 it generated total sales of €800 million. 

 

Formic acid for de-icing?

BASF says that formic acid salts are becoming popular as de-icing agents for roads and paths in several Northern European countries, where they are displacing the more familiar gritting material: sodium chloride salt. Formic acid already has a wide range of applications including as a leather tanning agent, an industrial cleaner and an animal feed preservative. The company, which makes up to 255,000 tonnes of formic acid per year, says that the approach is more environmentally friendly - and more efficient. In addition, it says they can be used as a preventative measure when icy conditions are on the way. 

 

150 chemical alternatives

In a bid to reduce exposure to long chain perfluorinated chemicals (LCPFCs), which are toxic and known to bioaccumulate, the US chemical industry has developed over 150 alternatives. In 2006, eight chemical companies signed up to an Environmental Protection Agency (EPA) programme to reduce the amount of perfluorooctanoic acid (PFOA) and related chemicals in process emissions and products on a global basis by 95% by 2010 and to work toward eliminating them entirely by 2015. Interim results show that Daikin, DuPont, 3M and Solvay Solexis reached the 2010 goal. 

 

Battery technology buy-in continues at BASF

German chemical giant BASF has made strong moves into the market for advanced batteries and their associated technology. Specifically, it has struck a deal to buy the electrolytes for high performance batteries business of German chemical and pharma group Merck KGaA. The deal includes the electrolyte formulations marketed under the Selectilyte brand and electrolytes for lithium ion batteries, as well as the Merck research portfolio for novel electrolytes and additives. In addition BASF has bought Ovonic, a US company specialising in nickel-metal hydride (Ni-MH) battery technology. BASF says that Ovionic is ’the inventor of the Ni-MH technology as it is used today’ and that all the major producers of Ni-MH batteries have signed licensing deals with the company. In January, BASF paid $50 million (?30 million) for a stake in privately owned US company Sion Power, which specialises in lithium-sulfur (Li-S) batteries.

 

IN BRIEF

Four strain flu vaccine

AstraZeneca has won US approval for FluMist Quadrivalent - the first flu vaccine approved by the Food and Drug Administration (FDA) that combines four strains. The most comprehensive vaccines available at the moment contain only three strains. The four strain vaccine, developed at AstraZeneca subsidiary MedImmune, includes two type A strains and two type B. 

 

New animal R&D site in China 

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. 

 

FDA revises statin advice

The FDA has changed (slightly) its view of statins, a frequently prescribed group of drugs for treating high cholesterol of which avorstatin, marketed as Lipitor by Pfizer, is arguably the best known. Specifically, the agency says that it has received reports of cognitive problems, including memory loss and confusion, and hyperglycaemia. There is also evidence that patients taking statins may have increased risk of type 2 diabetes. 

 

Surfactants for better breathing

The US FDA has cleared Surfaxin (lucinactant) to be marketed for the prevention of respiratory distress syndrome (RDS), a breathing disorder that affects premature infants. US biotech Discovery Labs, which is developing Surfaxin, says it is ’the first synthetic, peptide-containing surfactant approved for use in neonatal medicine’. The company is planning to launch it in the US in late 2012. RDS results in a lack of surfactants in the lungs, which makes breathing difficult and can cause the lungs to collapse. 

 

Evonik evicts colourants

German chemical company Evonik has sold its colourants business to US investment firm Arsenal Capital Partners. The companies have not disclosed financial details of the deal. In 2011, the Evonik colourants business generated sales of €130 million and employed 300 people at sites in the US, Canada, Brazil, Australia, China, Malaysia and the Netherlands. 

 

$100m solar deal 

DuPont and Chinese solar energy company Yingli have signed a $100 million deal covering photovoltaic materials. Yingli will buy a range of DuPont products including Solamet photovoltaic metallisation pastes and protective backsheets made from Tedlar polyvinyl fluoride film. DuPont generated $1.4 billion in photovoltaic sales in 2011. The company plans to reach $2 billion in sales by 2014. 

 

Huntsman opens new tech site 

US chemical company Huntsman has officially opened its $40 million Asia Pacific Technology Center in Shanghai, China. The centre will focus on materials that help to save energy and forms part of the existing technology campus opened in September 2008, which will eventually house up to 400 technical experts. 

 

Biggest UK uni spin-out fund? 

Venture capital firm MTI has established what it says will be the largest investment fund dedicated to UK university spin-outs. The Orion Fund has ?100-150 million to spend in collaboration with three universities: the University of Manchester, the University of Edinburgh and University College London. Previous funds established by MTI have invested heavily in graphene technology.