Boehringer Ingelheim has breached the ABPI Code of Practice over the promotion of its type 2 diabetes drug Trajenta.

The Prescription Medicines Code of Practice Authority (PMCPA) ruled that Boehringer had breached five different clauses of the Code in a medical journal before Trajenta was granted a marketing authorisation.

The PMCPA deemed that Clauses 2, 3, 7, 9 and 12 of the industry’s rule book had all been breached.

As a result, Boehringer was the subject of a public reprimand in advertisements in the BMJ, The Pharmaceutical Journal and The Nursing Standard.

In total, Boehringer was found to have breached nine different parts of the Code: Clause 2 – Bringing discredit upon, and reducing confidence in, the pharmaceutical industry; Clause 3.1 – Promoting a medicine before the grant of a marketing authorisation.

Four aspects of Clause 7 – Information, claims and comparison – were breached, along with two aspects of Clause 9 – High Standards, Format, Suitability and Causing Offence, Sponsorship – and Clause 12.1 – Disguising promotional materials.

The FDA has delayed making a decision on whether to approve the use of Eliquis (apixaban) for the prevention of stroke and systemic embolism in patients with atrial fibrillation.

Further data supplied by Pfizer and Bristol-Myers Squibb on patient trials after the original application will take an additional three months to review, the Agency has said.

Pfizer and BMS said in a joint statement they will continue to work closely with FDA during the review period.

Eliquis is not yet approved in any country for the prevention of stroke and systemic embolism in patients with atrial fibrillation.

It faces competition from Boehringer’s Pradaxa (dabigatran) and J&J’s Xarelto (rivaroxaban) for the indication.

Industry analysts predict all three have the potential to become ‘blockbuster’ brands as doctors and patients search for an alternative to warfarin.

Eliquis was approved in May 2011 by the European Union as a treatment option for the prevention of blood clots in patients who have undergone hip or knee replacement surgery.

BernsteinResearch analyst Dr Timothy Anderson forecasts total sales of Eliquis to reach $395 million this year, rising to $2.5 billion in 2015 and $3.7 billion by 2020.

German pharmaceutical giant Boehringer Ingelheim (BI) is building a new $65m R&D facility at its US headquarters in Ridgefield, Connecticut.

The new facility, according to BI, will undertake “production of active pharmaceutical ingredients used in early development activities”.

While not employing new staff, the new R&D site – which will replace a smaller current site – will support the company’s research activity in the region.

This development follows another new building project in Ridgefield commenced by BI in August: a $42m drug safety assessment site for non-clinical safety studies, scheduled for completion in 2013.

The two new buildings represent a total investment of more than $100 million in the Connecticut operation.

Jim Baxter, BI’s Senior VP of Development for US Operations, said that the company’s investment in new buildings shows its commitment to supporting and developing its US research base: “When they say the site is critical to BI’s future, they mean it.”

Boehringer Ingelheim has invested more than $350 million in the US in 2011, with new projects in Iowa, Missouri and Ohio and the acquisition of a business from Amgen in California.

Boehringer Ingelheim is to work with Pantheon to develop two projects worth over $18 million involving combination drugs to treat type II diabetes.

Mark Kontny, Chief Scientific Officer at Pantheon, said: “I am very gratified that Boehringer Ingelheim recognises our expertise in formulating, scaling and successfully launching complex formulations such as these molecules. It is this kind of support and recognition that has enabled us to develop our market leading position in pharmaceutical development services.”

The projects are set to span over a three year period.

Patheon is a global provider of pharmaceutical services, manufacturing at ten facilities and nine development centres across North America and Europe.

NICE has requested more information from Boehringer Ingelheim on Pradaxa (dabigatran) for the prevention of stroke and systemic embolism in people with atrial fibrillation (AF).

The Institute’s independent Appraisal Committee is seeking clarification on a number of areas, in particular over its cost effectiveness, during preliminary recommendations.

Dr Gillian Leng, NICE Deputy Chief Executive and Chief Operating Officer for NHS Evidence, says a “more plausible set of assumptions” during Pradaxa’s use in clinical practice is needed.

Pradaxa has a UK marketing authorisation for the prevention of stroke and systemic embolism in patients aged 75 years with AF who have had a previous stroke, heart attack or systemic embolism.

It is also authorised for people with AF over 65 who have diabetes, coronary heart disease or hypertension.

NICE says that Pradaxa “may have potential benefits” for people with AF, and that evidence has shown it to be more clinically effective than warfarin, but additional information on its cost to the NHS is required.

“In particular it (NICE’s Appraisal Committee) is seeking clarification on the cost effectiveness of the licensed regimen, in which people aged under 80 years begin treatment with dabigatran 150mg twice daily, and at age 80 years switch to dabigatran 110mg twice daily,” said Dr Leng.

Final guidance is now expected to be published in December.

Boehringer Ingelheim has posted net sales of €6.4 billion in the first six months of 2011 resulting in a 4% growth when compared to the same period the year before.

Sales were boosted by the new launches of the anticoagulant Pradaxa and diabetes treatments Twynsta and Tradjenta which accounted for 60% of revenue.

Professor Andreas Barner, Chairman of the Board of Managing Directors, says Boehringer’s Value through Innovation vision “proves itself sustainably as the basis of our company.”

Overall, prescription medicines net sales amassed €4.9 billion in the first half of 2011 and turnover of the Consumer Healthcare Business was up 11% to €667 million.

Following strong sales in emerging markets, the company’s Human Pharmaceuticals’ net sales increased by 12% to €890 million.

“For Boehringer Ingelheim the first half of business year 2011 is characterised in turnover terms by successful new launches,” said Hubertus von Baumbach, Member of the Board of Managing Directors responsible for Finance.

“A good earnings position overall has enabled us to activate again higher investment in research and development, even though further burdensome interventions by the legislators in price-setting for prescription medicines have had a negative effect.”

Pradaxa, a novel, direct thrombin inhibitor was approved across Europe for the prevention of stroke and systemic embolism in patients with atrial fibrillation (AF). Outside of the EU, it has already been granted approval in the USA, Canada, Japan and other countries on four continents.

Professor Barner also added that several new substances from the company’s own research and development had made further progress and a number of new biological and chemical active ingredients were transferred from the preclinical stage to clinical development.