Franz Humer has told Roche he will not stand for re-election as Chairman of the company’s board of directors next year.

The 67-year-old announced his decision at Roche’s annual general meeting that he intends to end his 28-year association with the Swiss-based company when his term ends in 2014.

He said that Roche is in “excellent shape and well positioned to meet future challenges” and now is a “good time to hand over to a successor”.

Roche will now nominate Humer’s replacement this autumn. The Board has said the new chair will also serve as Non-Executive Chairman, continuing the separation of the offices of chair and CEO.

Humer joined the company in 1995 as Head of the Pharmaceuticals Division and a member of the Board of Directors. Prior to that, he worked as the UK general manager for Schering Plough Corporation and in similar high ranking positions for Glaxo. He became Roche Chairman in 2001, after being appointed CEO two years earlier.

“I am looking forward to the next 12 months, and I intend to perform my duties as Chairman with enthusiasm and drive,” he added.

Humer is the third high-profile chair to confirm his departure this year. Dr Daniel Vasella called time on his association with Novartis back in January, followed by Mats Pettersson’s announcement last month that he was departing Lundbeck.

Glenmark Generics (Europe) Ltd (GGEL) has launched a generic version of Glaxo’s successful anti-malaria drug Malarone in the UK, following the revocation of Glaxo’s patent.

The High Court determined that Glaxo could not block the launch of generic atovaquone proguanil, with the presiding judge saying the case was “obvious”.

The drug brought Glaxo £17.76m in the UK in 2012, a sizeable market that Glenmark is set to undercut.

Malarone is indicated for the prevention and treatment of acute, uncomplicated p.falciparum malaria, especially in patients resistant to treatment. It is recommended by the UK’s Malaria Reference Laboratory.

The mosquito that transmits malaria is not found in the UK, but prevention and treatment in people travelling to tropical regions can be necessary.

Rahul Garella, Glenmark’s Senior Vice President Europe, said: “Atovaquone proguanil is a well-established treatment for malaria. Doctors, pharmacists and consumers, in particular travellers, need to be made aware that there is now a first-class quality generic option available which can offer a more competitive solution.”

GGEL is based in the UK and sells, directly and through distribution partners, in the UK, Ireland, Germany, the Netherlands, Denmark and Sweden, with more than 300 generic drugs approved for sale in Europe.

It is the European arm of Glenmark Generics Ltd (GGL), which aims to be a leading global supplier of generic drugs and active ingredients. GGL is a subsidiary of the Glenmark Pharmaceuticals group, based in India.

GSK will table a hostile $2.6bn takeover bid for Human Genome Sciences after refusing to participate in its strategic review process.

Instead, Glaxo intends to press ahead with its $13 per share offer to HGS’ shareholders, despite the company’s board having previously rejected the same offer.

The bid offers a premium of 81% of HGS’s share price in mid-April, GSK says, and the pharma giant now hopes to evolve its relationship with the Maryland-based firm.

The two are in partnership for the diabetes drug Benlysta. GSK says it “values the long relationship” it has with HSG and would prefer to conduct takeover “on a friendly basis in a timely fashion”.

HSG rejected Glaxo’s initial $13 per share offer on the grounds it undervalued its potential and instructed Wall Street advisors to search for potential suitors, sources claim.

But GSK say their decision not to participate in the review process and to target HGS’s shareholders is unnecessary as there is “clear and strategic logic” to the combination of the companies.

It added that a month has passed since its original offer and that “provides a reasonable amount of time” for HGS to complete its review process.

GSK says it continues to believe that it has made a “full and fair offer” which provides “immediate liquidity” to shareholders in HSG.

Novo Nordisk expects to appoint Dr Göran Ando as its new chairman next year after its existing chair Sten Scheibye was elected to the board of the Novo Nordisk Foundation.

Mr Scheibye is expected to become Chairman of the Foundation’s board in 2013 and has since become a non-independent director of the Novo Nordisk board.

The outgoing chair said Dr Ando has “impressed all of us with his expertise and insights” since he joined the leadership committee in 2005.

The experienced Dr Ando has been re-elected to Novo’s board of directors several times, most recently this year, during his seven year stay on the committee.

The 63-year-old has previously held senior positions at Pharmacia, now Pfizer, and at Glaxo. He has served as Vice Chairman of the Board since 2006.

“I am very pleased that Göran Ando is prepared to take over the chair in 2013 and thereby ensure a smooth transition,” said Sten Scheibye.

Sten Scheibye was first elected to the Novo board in 2003. He became vice chair a year later and was appointed Chairman in 2006.

Generic manufacturer Mylan has agreed a $17.5 million deal with Pfizer for the exclusive rights to develop, manufacture and commercialise a portfolio of respiratory products.

As part of the deal, Mylan will have licensing rights to Pfizer’s generic equivalent to GSK’s Advair and Seretide.

Heather Bresch, Mylan President, says the agreement offers a “significant opportunity for our generics business”.

The agreement will also see Mylan retaining staff at Pfizer’s respiratory inhalation development team at Discovery Park in Sandwich, Kent. Other former Pfizer staff will be located in Cambridge.

Under the terms of the agreement Mylan will have rights to Pfizer’s dry powder inhaler (DPI) technology platform, as well as the opportunity to negotiate on existing compounds during different stages of their development in the Pharma giant’s pipeline.

Mylan will have to pay the costs for any remaining development and commercialisation for the transferred products. Additional payments will also be made once the deal is completed, depending on the regulatory and commercial success of the portfolio.

Advair Diskus and Seretide Diskus are inhaled fixed-dose combinations of Fluticasone Propionate and Salmeterol which are delivered via a DPI and used to treat asthma and COPD.

On completion of the deal, Mylan with gain the exclusive commercialisation rights for Seretide in the US, Canada, Australia and New Zealand, as well as in the EU and European Free Trade Association countries. The two companies will have the co-promotion rights to the product in the rest of the world.

GlaxoSmithKline (GSK) has agreed to pay $3 billion to settle US criminal and civil investigations into whether the company illegally marketed drugs and other matters.

The investigations include a Department of Justice review of the UK company’s controversial diabetes drug Avandia, which has been linked to heart risks.

The settlement follows clampdowns since the late 1990s in the US on unfair pharmaceutical industry practices that may have prioritised sales targets over payer and patient interests, such as marketing drugs for unapproved uses.

Andrew Witty, CEO of GSK, said: “This is a significant step toward resolving difficult, longstanding matters which do not reflect the company that we are today.

“In recent years, we have fundamentally changed our procedures for compliance, marketing and selling in the US to ensure that we operate with high standards of integrity.”

Mr Witty said that the company has put in place a new bonus system for US sales, which no longer focuses on individual sales goals, but is now based on selling competency, customer evaluations and overall performance of the sale representative’s business unit.

Federal prosecutors began investigating GSK in 2004, into whether the company promoted drugs for unapproved indications, and into cases where the company may have potentially influenced doctors.

The inquiry involved nine of the company’s best-selling products from 1997 to 2004, including lung therapy Advair.

Gbola Amusa, an analyst at UBS AG in London, said: “This news essentially draws a line under a 10-year legal saga.”

Both civil and criminal settlements are expected to be finalised in 2012.

Sanofi is expected to overthrow Pfizer’s nine-year reign as the world’s biggest drug maker, according to new research.

The French pharmaceutical company is expected to retain the top spot until at least 2016, with Pfizer falling to third place behind Novartis due to the loss of Lipitor’s US patent protection, according to EvaluatePharma (see figure one).

The report says that Sanofi’s numerous acquisitions over the last decade have contributed largely to the company’s success, gaining $20 billion after it bought out Genzyme.

Sanofi’s mergers over the last decade have contributed a great deal to its current position, starting with its $30 billion deal with Synthélabo in 1999.

It is expected that the company will retain its top position until at least 2016, mainly thanks to sales of enzyme replacement therapies through its acquisition of Genzyme.

Also, the company’s addition of Cerezyme and Myozyme blockbuster drugs will help fill the gap left by Lovenox, Taxotere, and Plavix, which loses US patent protection in 2012.

Pfizer’s $68 billion buyout of Wyeth in 2009 helped fill the gap left by Lipitor, but it will be difficult to replace the drug’s global sales figure of $13.4 billion seen in 2008, which set the record as the biggest selling medicine.

Following its loss of US patent protection in November 2011, Lipitor sales are estimated to shrink to $2 billion by 2016.

However, pipeline products such as rheumatoid arthritis (RA) pills tofacitinib and Eliquis are expected to boost Pfizer’s drug sales after 2016, which will help retain the company’s position in the top-five pharmaceutical companies.

Merck’s four-year outlook is seen as bleak despite its takeover of Schering-Plough for $41 billion in 2009, with only 1% annual sales growth predicted, conceding to European companies GlaxoSmithKline and Roche to overtake the company.

EvaluatePharma predicts that Johnson & Johnson’s recent pipeline successes will benefit the company in the coming years, despite its drugs arm being substantially smaller than the five biggest pharma companies.

It is thought that Novartis will be Sanofi’s closest competition over the next few years, with strong sales growth from Gilenya and Tasigna due to Diovan’s loss of patent protection next year.

Figure 1:

Life Technologies is to join GlaxoSmithKline (GSK) Biologicals in developing a diagnostic to be used with a GSK cancer immunotherapy.

Life will develop a multi-gene qPCR-based molecular in vitro diagnostic assay for GSK’s MAGE-A3 cancer immunotherapy candidate designed to identify patients likely to benefit from the treatment.

Kim Caple, Head of Molecular Diagnostics at Life Technologies, said: “Life Technologies' platform technologies, such as qPCR, are allowing biological knowledge to be applied in multiple markets, including companion diagnostics.”

MAGE-A3 is currently being evaluated in two clinical trials, MAGRIT and DERMA, evaluating safety for patients with non-small cell lung cancer whose melanoma has invaded lymph nodes.

Under the terms of the agreement, Life Technologies and GSK will develop and commercialise the qPCR-based test to detect MAGE-A3 positive patients most likely to benefit from MAGE-A3 ASCI. 

Based in California, Life Technologies is a global biotechnology company that manufactures both molecular diagnostic and research use only products.

GSK has posted underlying sales growth of 6% for the third quarter of 2011 after turnover in its pharmaceuticals and vaccines division increased 3% to £5.7 billion.

Group sales outside Europe and the US were up 17% to £2.8bn driven by underlying growth in Japan (+57%), emerging markets (11%) which offset a decline in Europe of 4%.

Andrew Witty, CEO, says the results show the company is delivering on its strategy and pinpointed towards its breadth and mix product and geographic portfolio helping to combat economic volatility.

The company recorded a 14% rise in turnover in its vaccine division despite a decline in sales of pandemic related products.

Operating profit for the Group grew 3% in line with sales growth with profit in the vaccines and consumer healthcare divisions able offset a small decline in pharmaceuticals.

Sales in Japan were boosted by the strong performance of Cervarix and Avodart following its launch in the country. Growth in dermatologicals and vaccines saw sales rise in emerging markets with profits also increasing in the Asia Pacific region by 8% reflecting favourable operating leverage.

But the news was not as good in the US in Q3 where the loss of pandemic related products, Avandia and Valtrex, saw sales fall by 1%. A decline was also recorded in Europe where the loss of Avandia, pandemic related products and austerity price cuts resulted in a 5% loss.

Glaxo now predicts it’s on course to post full sales growth for the year and larger than expected profit margins in 2012, despite the ongoing pricing pressure and economic weakness it faces.

GSK has been fined three billion South Korean won ($2.6 million) for conspiring with Dong-A Pharmaceutical over drugs sales, a Fair Trade Commission (FTC) official has said.

The FTC claims that GSK offered Dong-A the exclusive rights to sell the products Zofran (pictured)and Valtrex in 2000.

But in return, the FTC says, if the Seoul-based pharmaceutical company pulled a generic version of Zofran it introduced in 1998 or ever produce or sell medication that could compete against Zofran and Valtrex.

Kim Jun-Ha, a FTC official involved in the case, says the two “shared benefits” which should have gone to consumers after GSK made wrongful gains of around 16 billion won.

“With the cheaper generics made by Dong-A taken off the market, the financial burden on patients and on the government's health insurance budget has increased,” Kim said.

GSK's South Korean unit says the decision is “very regrettable” and “inappropriate” and will appeal against the decision.

“We simply exercised our legitimate patent rights,” a statement said.

The anti-trust agency also fined Dong-A Pharmaceutical $2.1 billion won for its part in the collusion, it added.