Sanofi has responded to protests against the withdrawal of its drug Campath by restoring access for a limited number of patients with multiple sclerosis (MS).

Campath (alemtuzumab) is approved for treatment of leukaemia but is prescribed off-label for treatment of MS.

To offset the effects of its withdrawal from the market, prior to a rebranding, Sanofi has agreed to make 201 vials available for MS patients in the UK.

In September 2012, Sanofi’s subsidiary Genzyme withdrew Campath to allow a new version, Lemtrada, to be licensed for treatment of MS in the UK.

This meant both that the drug’s price would increase by a factor of 15–20 and that a gap would be created in its availability.

There was widespread protest from doctors, including a letter to the Health Secretary from three specialists warning that patients could miss the window of ‘therapeutic opportunity’, with serious medical consequences.

One of the letter’s authors, Professor John Zajicek, commented that Sanofi’s approach was “morally corrupt”.

Genzyme has agreed to supply a further 201 vials of the drug for the patients of six specialists who were using it as a treatment for MS – however, it will not be available for new patients.

Professor Zajicek said the company’s response was “disappointing”, with Genzyme setting conditions that “don’t make sense”.

The decision to rebrand Campath was based on clinical trials that showed it to be more effective against MS than the current treatment, interferon beta-1a.

Researchers at the University of Cambridge said the drug had a “transformative” effect, and could be given to two-thirds of patients newly diagnosed with MS.

Genzyme stated that gaining regulatory approval for alemtuzumab as a treatment for MS was the best way to ensure patient access.

However, critics have predicted that its price as a licensed drug in this indication will be 15–20 times as high as its current price (which follows patent expiry).

Biotech company Genzyme has appointed Brendan Martin as General Manager for UK and Ireland, with responsibility for all commercial activities.

Brendan Martin joined Genzyme in 2002 and established its lysosomal storage disorders business in Ireland before becoming the company’s Business Unit Director in 2007 and Deputy General Manager for UK and Ireland in 2010.

He replaces Paul Drohan, who leaves Genzyme after 17 years to return to Canada and pursue other opportunities.

Robin Kenselaar, Head of Genzyme EMEA, said: “Brendan’s appointment as General Manager UK and Ireland comes at a key time for the business as it builds its multiple sclerosis franchise and continues to develop in rare diseases.

“In his Genzyme career to date, Brendan has shown he is a leader with the experience, energy, vision and commitment to patients needed to move us forward.”

Part of the Sanofi group, Genzyme in the UK focuses on rare inherited and immune diseases, with a commercial base in Oxford.

Its UK manufacturing facility in Haverhill in Suffolk is a major global distribution centre for the company’s products for genetic diseases.

Genzyme has been a leading global biotech company for 30 years.

Christopher Viehbacher, Sanofi’s CEO, has been selected by the European Federation of Pharmaceutical Industries and Associations (EFPIA) as its new president elect.

He will replace the outgoing Sir Andrew Witty in June 2013 and serve a two-year term.

Mr Viehbacher said he was “extremely honoured” by the designation which comes during the “midst of a crisis” in Europe.

The trade body’s new president has served as CEO of Sanofi since 2008 and also chairman of Genzyme since it was acquired by the French pharmaceutical company in 2011. He also served in a similar role as chair of the Pharmaceutical Research and Manufacturers of America (PhRMA) between December 2010 and April 2012.

“There’s a virtuous economic cycle of investing in education and then research and innovation,” said Mr Viehbacher. “The challenge Europe is currently facing is about managing to reduce government deficits and debt without smothering the opportunity for growth; to make sure that relevant pro-growth, pro-innovation strategies can be activated.”

Richard Bergström, EFPIA’s Director General, said the new president is “well placed” to take over the leadership of the group. “At this time, it is important to remind ourselves and others what is needed to sustain research based pharmaceuticals in Europe,” he said. “Chris was involved in the high-level group G10 Medicines and has shown his ability to engage with policy-makers world-wide. I look forward to working with him.”

Leading UK neurologists claim Sanofi’s decision to replace an off-label multiple sclerosis (MS) drug with a costlier licensed version “shows little regard for patients”.

The French pharma giant is withdrawing Campath (alemtuzumab) from unlicensed use as an MS treatment ahead of the regulatory approval of new version Lemtrada, which is expected to cost up to 20 times as much.

Three UK professors of neurology have written to Health Secretary Jeremy Hunt, saying the decision “has serious implications for vulnerable UK patients”.

Lemtrada is manufactured by US biotech company Genzyme, which Sanofi acquired in 2011.

Sanofi claims that off-label use of Campath, which has taken place since 1998, could put the approval of Lemtrada (expected in 2013) at risk.

It has allowed the continued use of Campath for treatment of leukaemia (its licensed indication) via patient access schemes.

However, French business journal Challenges argued that the withdrawal of Campath as an MS treatment was “dictated only by the logic of profit”.

The letter to the Health Secretary from professors Neil Scolding, Neil Robertson and John Zajicek says the withdrawal leaves patients who have started treatment stranded, while new patients may miss the “window of therapeutic opportunity”.

As the licensed version is expected to cost “15 to 20 times” as much, they comment, the decision “shows little regard for patients whose opportunity to alter the course of their disease is time-limited, and may represent an over-enthusiastic attempt by the parent company to profit from the current situation.”

Speaking to the Independent, Professor Zajicek called Sanofi’s approach “morally corrupt”.

However, a Genzyme spokesman argued: “Off-label use of alemtuzumab in MS has always been at the discretion of individual clinicians without reference to the company.”

Both the US FDA and the EMA have approved a second suite for filling and finishing products at Genzyme’s manufacturing plant in Waterford, Ireland.

The approval means Genzyme will almost double its ability to fill and finish Pompe disease treatments Myozyme and Lumizyme (alglucosidase alfa).

Bill Aitchison, Genzyme’s Head of Global Manufacturing Operations, said the approval is an “important milestone” for Genzyme as it aims to build a “robust manufacturing network”.

The manufacturing site employs more than 500 people and has been in operation for more than a decade. It is considered to be Genzyme’s centre of excellence for aseptic manufacturing and recently underwent a $150 million expansion earlier this year.

Genzyme now hopes to begin the process of securing further approval from the American and European health regulators to fill and finish additional products in the suite. The Sanofi company has the long-term aim to use the Irish plant as a filling and finishing platform across its portfolio of products.

An increase in sales at the ‘new Genzyme’ helped Sanofi’s business EPS grow by 7.2% as revenue topped €8.5bn in the first three months of 2012.

Sales of growth platforms, which include Genzyme, were €5.38bn and accounted for 63.2% of total sales, up from 59.2% in Q1 2011, despite global generic competition on Plavix and Aprovel.

Jérôme Contamine, Executive Vice President, Chief Financial Officer discusses the Q1 results.

An increase in sales at the ‘new Genzyme’ helped Sanofi’s business EPS grow by 7.2% as revenue topped €8.5bn in the first three months of 2012.

Sales of growth platforms, which include Genzyme, were €5.38bn and accounted for 63.2% of total sales, up from 59.2% in Q1 2011, despite global generic competition on Plavix and Aprovel.

Christopher Viehbacher, Sanofi CEO, said the “strong performance” in the first quarter was “driven by Genzyme, our growth platforms, and cost savings”.

However, Sanofi still expects profits to be down by around 12% to 15% on last year’s figures as a result of generic exposure of major brands.

Overall sales were up 7% compared to the same period last year after revenue in emerging markets increased by nearly a tenth (9.9%), and its pharmaceuticals division was boosted by increased sales in its diabetes and oncology businesses.

First quarter sales in pharmaceuticals reached €7.3bn, an increase of 8.8%, driven by the performance of diabetes drug Lantus which saw sales rise 17.2% to €1.1bn. But generic competition on Plavix, Lovenox and Taxotere hit sales, despite increased demand for Apidra, Eloxatin and Jevtana.

The ‘new Genzyme’ recorded sales of €400m in Q1 – up by 13.7%. Sales of Fabrazyme were up by half to €47m, with Cerezyme up by 5.8% to €149m and sales of Myozyme/Lumizyme also increasing by 17% to €112m.

Sanofi’s own generics business generated an increase of sales after the recent launch of the authorised generic Lovenox saw revenue grow by 6.5% to €439m.

Vaccine sales were down slightly (0.2%) to €617m after the delayed timing of supply of flu vaccines in the Southern Hemisphere. However, the news was better for Sanofi’s consumer health division as it achieved record sales of €805m.

Genzyme has submitted a marketing authorisation application to the EMA for its convenient oral teriflunomide for the treatment of relapsing forms of multiple sclerosis (MS).

The application is based on data from two pivotal Phase III studies. An additional three trials are also in progress making the treatment one of the longest in investigational MS therapy history.

Bill Sibold, Senior Vice President, Head of Multiple Sclerosis, Genzyme, says the application moves teriflunomide “one step to closer” to offering patients a new treatment option.

A similar application to market the medication in the US is currently under review by the FDA.

Teriflunomide is being studied in a large clinical programme that is expected to include more than 5,000 participants from more than 30 different countries. Five efficacy trials are now either completed or underway making it one of the largest and broadest of any MS agent under development.

“As an oral therapy with a promising clinical profile, teriflunomide is extremely well positioned to provide an alternative therapeutic option to patients who are currently taking injectable therapies,” said Bill Sibold. “Those injectable therapies make up approximately 80 percent of the MS market today.”

Lundbeck has decided to split its European market into two different regions: east and west.

The move follows the company’s planned future launch of new products which it hopes will build on the “foundation” of its business.

Marie-Laure Pochon, Executive Vice President for Commercial Operations, says the decision to divide its activities in the region has been made to “consolidate and strengthen our European organisation”.

The reorganisation will see João Rocha (pictured above) appointed as Regional Vice President for Region West to ead the commercial operations in the majority of Western European countries. Michael Quiqueran-Beaujeu (pictured below) will lead the company’s activities in Eastern Europe, as well as Turkey and Russia.

“With our new structure and the appointment of João Rocha and Michael Quiqueran-Beaujeu, who both bring with them many years of experience and impressive results, I am convinced that we have a set-up that gives us the optimal conditions for success in developing and expanding the Lundbeck business,” said Marie-Laure Pochon.

Mr Rocha takes on his new role after serving as the pharmaceutical company’s manager in Brazil and as Regional Vice President for Latin America. During his time working within the region, he has achieved impressive results, helping turn the antidepressant Lexapro into Brazil’s eighth best-selling drug.

Mr Quiqueran-Beaujeu joins Lundbeck from Genzyme, where he served as Senior Vice President and General Manager for Northern Europe. During his time at Genzyme, he helped the biotech company increase sales by 400% in less than four years.

French pharmaceutical giant Sanofi is looking to its drug pipeline, including products from the newly-acquired Genzyme business, to ensure the company’s growth in a year when patent expiries are forecast to cut its profits by 15%.

Sanofi CEO Chris Viehbacher reviews the company’s achievements in 2011 and its prospects for 2012 and beyond.

To read the full story, click here.