The pharmaceutical industry’s reputation in the last twelve months has declined worldwide, a new survey has found.

Only a third of patient groups now believe that pharma has an ‘excellent’ or ‘good’ reputation, figures from PatientView’s independent 2012 annual review show. In 2011, 42% of respondents had the same opinion.

A global survey of some 600 international, national and regional patient groups showed that 66% of respondents felt the industry needed to do more to improve its corporate image and its relationship with patients.

Respondents were quizzed on their impression of 29 of the largest global pharmaceutical companies, including Pfizer, AstraZeneca, Boehringer Ingelheim and Roche.

Up to half of responses claimed that pharma had a ‘poor’ record in 2012 for its pricing policies. Nearly the same amount (48%) also claimed that the industry had a ‘poor’ record for being transparent over the last twelve months.

There was also a marked change in opinions of the way pharma manages adverse news about its products – down 29% compared to the 2011 results; of whether it has ethical marketing practices – a fall of 23% on the 2011 data; and of its relationship with the media – down 19% on last year’s results.

But the survey was not all bad news for pharma. As part of the study, respondents were asked to provide feedback on six key indicators that influence corporate reputation: patient-centeredness; patient information; patient safety; useful products; transparency; and integrity. Lundbeck topped the charts after it received the highest ranking overall and moved up three places on 2011’s chart – see below.

Gilead Sciences, which jumped from 10^th in 2011 to 2^nd last year, and Eli Lilly, which improved from 18^th to 9^th place, also had reason to celebrate.

The first proven drug for prevention of HIV infection has been recommended for FDA approval by an expert panel.

Truvada from Gilead Sciences, an oral combination therapy used since 2004 to treat HIV infection, may shortly be available as a preventative therapy.

The panel emphasised that the drug is less effective in women than in men, and must not be used in place of other preventative strategies.

Adherence was also highlighted as an issue, since Truvada is ineffective if not taken every day.

Truvada was recommended for prescription to people at high risk of HIV infection, including gay and bisexual men and heterosexual couples with one HIV-positive partner.

The medication is a combination of two anti-HIV drugs, Emtriva and Viread. Its off-label use to prevent HIV infection is already widespread.

In 2010, a three-year study by the US government found that daily doses of Trevada together with condom use reduced the risk of HIV infection by 42% in gay and bisexual men. In 2011, a similar study found that it reduced infection by 75% in heterosexual couples where one partner was HIV-positive.

The drug’s value is contested among people working to control HIV infection, due to concerns that Trevada will give people who are not compliant with the need for condom use and/or daily dosage a false sense of security.

While the cost of widespread prescription is not a factor in whether the FDA grants marketing approval for Trevada, it will clearly affect its uptake by health workers relative to other strategies.

Novartis is expected to overtake Pfizer and become the biggest manufacturer of prescription medicines by 2018, according to new consensus data.

Research by EvaluatePharma estimates Novartis will record sales of more than $50bn in six years’ time, with its eye care business Alcon and generic unit Sandoz driving growth.

But the outlook is not good for US-based companies with only Pfizer remaining in the top five by 2018 and Sanofi, GSK and Roche maintaining a strong presence.

Data found that despite generic competition on Diovan and Glivec and disappointment from key projects such as Gilenya and its new respiratory franchise, Novartis is expected to record annual growth between 2011 and 2018 of 1.2%.

This is in contrast with AstraZeneca whose annual sales are expected to drop from $32.4bn in 2011 to $22.1bn in 2018 representing a negative growth of 5.3%.

Gilead Sciences is expected to experience the biggest increase in annual growth of the top fifteen companies with data showing sales will rise from $8.1bn to $15.7bn at a rate of 9.9% per year.

Novo Nordisk is also forecast to enter the top 15 ranked companies for the first time due to an increasing demand for its diabetes medicines. Annual growth is expected to be 7% until 2018 with sales totalling nearly $20bn.

One of the biggest casualties, data found, will be Eli Lilly. The Indianapolis research-based company currently claims to be the 10th biggest pharmaceutical company in the world. But Lilly fails to make the top 15 companies after research found a drop in sales will see it fall to 17th place by 2018. But researchers did note that Lilly’s Alzheimer’s candidate, solanezumab, could reverse the trend if it successfully enters the lucrative market.

Lilly will be replaced in the list by German healthcare giant Bayer, which also enters the top 15 global companies for the first time, with annual sales of around $16.5bn by 2018 boosted by Xarelto.

The combination of two oral drugs from Gilead Sciences and Bristol-Myers Squibb (BMS) has the potential to offer a faster cure for hepatitis C.

Gilead’s GS-7977 and BMS’s daclatasvir, taken daily for six months, cured almost all patients in a phase II clinical trial while sparing them the side-effects of interferon.

However, the lack of a partnership between the two companies could delay patient access to the drug combination.

The companies said that all 88 trial participants who took the two-drug combination had undetectable virus levels after four weeks, and 84 had undetectable virus levels four weeks after the end of the 24-week trial.

The most common side-effects of the combination were fatigue, headache and nausea; the non-ribavirin treatment group also showed low phosphorus and high cholesterol levels.

Gilead also reported two 12-week phase II trials: one where GS-7977 and ribavirin cured 22 of 25 hepatitis C patients (with undetectable virus levels a month after the trial end); and and one where GS-7977, ribavirin and interferon cured 90% of patients.

Hepatitis C is a chronic blood-borne infection than can cause life-threatening liver damage. No complete oral treatment for the infection currently exists.

In 2011, Vertex and Merck introduced oral medications that increased the cure rate from 60% to 80% – but these need to be used alongside alpha interferon, which is injected weekly for up to a year and has flu-like side-effects.

As yet Gilead and BMS have not agreed to collaborate in order to bring the new combination therapy to market.

Dr Douglas J. Manion, a Senior VP at BMS, said the company was “keen” to work with Gilead but the latter was “unwilling to engage in that collaboration.”

Norbert W. Bischofberger, Executive VP for Research and Development at Gilead, said the company wanted to wait for further clinical trial data: “We told them it’s too early to jump wildly into this collaboration.”

In particular, he noted, Gilead wanted to establish whether the combination of GS-7977 with the generic ribavarin would be as clinically effective as using daclatasvir. If so, not only would the combination be cheaper, but Gilead could increase its profits by using its own ribavarin.

Finally, Bischofberger observed that if no collaboration took place, doctors would still be able to use GS-7977 and daclatasvir together.

Biopharmaceutical company Celgene has appointed Dr David Gillen as their new UK and Ireland Medical Director.

The appointment aims to reinforce the company’s commitment to its portfolio of products and use the experience of Dr Gillen to enhance its pipeline.

Samantha Pearce, Celgene General Manager in the UK and Ireland, says the new Medical Director is “one of the most well respected and experienced medical leaders” in the UK pharma industry.

Dr Gillen worked within the NHS as a physician for seven years before joining Pfizer’s R&D unit. In 2010, he joined Gilead Sciences as the Head of International Medical Affairs. “I am delighted to be appointed as Medical Director at Celgene and look forward to working with the team in an area that I’m passionate about,” he commented. “This is a very exciting time as Celgene’s portfolio expands and I can’t wait to build on the excellent work that’s already being undertaken.”

The Marketing Authorisation Application for Gilead Sciences Quad single-tablet regimen for the treatment of HIV-1 has been validated by the EMA.

The application is supported by results from two Phase III studies which demonstrated the tablet’s safety and efficacy data and by clinical data for the individual components of the Quad and Chemistry, Manufacturing and Controls (CMC) information.

Norbert Bischofberger, Executive Vice President, Research and Development and Chief Scientific Officer, Gilead Sciences, says Gilead is working with the regulator “to bring this new single-tablet regimen to physicians and patients as quickly as possible”.

The regimen contains elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate and was submitted to the EMA in November 2011. The submission to the FDA was made in October 2011.

Gilead’s first single-table regimen, Atripla, was approved in the EU in 2007. Its second single-tablet regimen, Eviplera – which combines its Truvada and Tibotec Pharmaceutical’s rilpivirine – was approved in the EU in November 2011.

“Based on the safety and efficacy data from the Phase 3 pivotal studies, we believe the Quad single-tablet regimen has the potential to be a convenient treatment option for patients new to HIV therapy,” said Norbert Bischofberger.

The FDA has approved a once-per-day combined pill by Gilead and Johnson & Johnson for the treatment of HIV in the US.

Complera has been approved as a first-line treatment for patients who have not been previously treated for HIV.

The pill combines Gilead’s drug Truvada (emtracitabine and tenofovir) and Johnson & Johnson’s Edurant (rilpivirine).

Both drugs are already approved as part of a drug cocktail or combination HIV therapy, but the combined pill is now approved as a stand-alone regimen.

Further manufacturing, development and marketing are set to be headed by Gilead in the EU, Canada, Brazil, Australia and New Zealand.

Complera is the second once-per-day drug intended for untreated HIV, approved in 2006. The first was Atripla, which is marketed by Gilead and Bristol-Myers Squibb.

Gilead Sciences has become the first pharmaceutical company to sign a licence agreement with the Medicines Patent Pool to improve the access of HIV medicines to developing countries.

The agreement will see generic versions of HIV and Hepatitis B treatments available at lower costs and in easier to use formulations without the delays which currently occur.

Ellen ‘t Hoen, Executive Director of the Medicines Patent Pool, says the agreement is a “milestone in managing patents for public health”.

The World Health Organization estimates that as many as 15 million people currently require HIV treatment, and expects that figure to double within the next five years.

The landmark licence will allow generic versions of Gilead’s products to enter the market shortly after they have been launched in western markets.

The agreement allows for the production of tenofovir, emtricitabine, cobicistat, and elvitegravir, as well as a combination of these products in a single pill known as the “Quad”. The development and other combinations that include these medicines will also be made available.

Gregg Alton, Executive Vice President, Corporate and Medical Affairs for Gilead Sciences, says the company hopes to see the Pool become an “effective mechanism” for increasing important treatments in “resource-limited parts of the world”.

The Pool, established in July 2010 with the support of UNITAID, aims to collaborate with other pharmaceutical companies to expand global access to quality, low-cost antiretroviral therapies through the licensing of patents.

Philippe Douste-Blazy, Chair of the UNITAID Executive Board, said: “I salute this first important step by Gilead and urge other pharmaceutical companies to place their intellectual property at the service of global public health.”