Maxine Vaccine interviews two directors at Bona Pharma who are brightening the grey landscape of medical sales.

I’m soaking up the cosmetically enhanced atmosphere of Battersea’s Vauxhall Tavern when the leaders of Bona Pharma flounce subtly into view.

Managing Director Julian and Sales Director Sandy have brought style and verve to the strait-laced world of the pharma industry.

“We beat that Adele to the first name only thing,” Sandy assures me. “She copied our shoes as well.”

Reassuringly, they follow industry convention in one respect: they never get a round in. I order four happy hour cocktails (two for me, one each for them), and the Q&A begins.

Pf: “These are hard times for the pharmaceutical industry. The leading drug companies have all fallen over the patent cliff. How can they drag themselves up again?”

Julian: “Trolling reps everywhere, Sophie Hipgrave is your guide – follow her through the hazardous forest of fashion choices to the emerald city of fantabulosa.”

Sandy: “Most pharma is a work of performance art in the medium of naff. The industry needs to learn that pinstripe is not the only suit.” (Shudders.)

The duo have recently returned from an antipodean business trip. We debate the relative merits of their Bushwackers and my Brandy Alexander. Maybe some day we’ll design a head-to-head clinical trial.

Pf: “Is it fair to say that your marketing has ensured Bona Pharma has a strong rep in the outback?”

Julian: “Yes indeed. We miss him though.”

Pf: “Bona Pharma is known for its niche products. What success stories did 2012 bring you?”

Sandy: “We did well with our erectile dysfunction drug abonafil. But there was one customer who claimed it had worked a bit too well. The poor omi sued us for causing him to suffer from priapism. Though it had boosted his call rates no end.”

Julian: “Didn’t stand up in court.”

Pf: “Of course, the market is changing radically, even in the UK. How has Bona Pharma responded to the shift of healthcare into the community?”

Julian: “Well, I have a check-up once a week. He’s got an extended visa.”

Sandy: “Very extended at certain times. Never vada’d the like.”

Pf: “One question our readers will be keen to hear your answer to. How useful are recruitment companies to pharma?”

Sandy (sadly): “Elton John syndrome. Great voice, nante riah.”

Pf: “What one thing about pharma would you change?”

Julian: “Its name. Every farmer I’ve met has been into market penetration in quite the wrong way.”

Another round of happy hour cocktails – my expense account covers a multitude of gins – and then it’s time for the final question.

Pf: “In an era when Parliament is voting to legalise gay marriage, is there still any need for an underworld gay dialect designed to keep secrets and spread rumours?”

Sandy: “This is pharma, dear. Secrets and rumours are the world.”

The erectile dysfunction drug market is shaped by the parallel needs of consumers and industry, with both demanding faster and more reliable performance. Maxine Vaccine explores the fine line between medicine and desire.

This week’s most exciting drug news was the FDA approval for Stendra (avanfil) from Vivus: an erectile dysfunction drug that can take full effect within 15 minutes.

Stendra is the youngest and studliest member of the Viagra family (PDE5 inhibitors), all of which have generic names ending in ‘fil’. Whether that is a play on ‘phile’ (lover) or, more crudely, on ‘fill’ is a question for chemists. It definitely has nothing to do with Phil Mitchell.

The greater speed of action of Stendra prompted urologist Dr Ira Sharlip to make the slightly double-edged comment: “Quick onset of action is important to men.” He added that Stendra would appeal predominantly to ED sufferers “whose opportunities for sexual activity are more casual”.

The new kid in town has the classic side-effects of the PDE5 inhibitor family: headache, lack of sensation, insomnia. But it doesn’t have the rare side-effect observed with Viagra of blue-tinged vision – about which Dr Sharlip said:

“Blue vision with Viagra is uncommon and at worst annoying. Most men who get the blue vision with Viagra don’t care about it.”

Perhaps it just reinforces their sense of living in a blue movie.

But is the impatience of male patients to get it on resonating with the sales professional’s hard-on for the next customer – leaving the clinician as the odd one out in the commercial three-way?

Let’s be honest about this. ED drugs restore reliable sexual functionality to men in whom age and/or circulatory problems have made such functionality unreliable or impossible. They are clinically suitable for men who are in late middle age or old age or have certain medical conditions.

They are not clinically suitable for young and healthy men who want to have more sex for longer, to have sex while drunk or stoned, or to be able to make porn films or imagine they are doing so. Yet that is the natural ‘market’ driven by their brand positioning as performance-enhancing products rather than as medicines helping to restore normality.

The ambiguity of the Viagra brand – is it a medical product or a consumer sex aid? – is reflected in the online market that exists for stolen pills or counterfeit versions of the drug. Just how big is that market? Well, this week it was reported that British fraudster Martin Hickman has been ordered to pay back £14.4 million earned by selling fake Viagra online.

The investigation – one of the biggest ever undertaken by the MHRA – uncovered more than 30 bank accounts scattered around the world, with customers across Europe served via a website hosted in Germany but run by Hickman from his Staffordshire home.

The pharmaceutical industry makes no money from counterfeit drugs – and indeed, it loses custom since those customers will not seek prescriptions. But the question the industry has to ask itself is: does its brand positioning create images and expectations that help to drive a black market in fake drugs?

Remember: a sales rep can do it all night, but only a key account manager can make your breakfast in the morning.

Maxine’s views are not necessarily those of Pharmaceutical Field.

A new, more rapid-acting erectile dysfunction (ED) drug that is currently being assessed by the EMA has gained FDA approval.

Stendra (avanafil) from Vivus can take effect within 15 minutes, phase 3 clinical trials with over 1350 patients have shown.

The newest addition to the class of ED drugs that includes Viagra, Levitra and Cialis, Stendra is targeted more at patients who engage in casual sex.

The FDA approval is the first gained by US company Vivus, which has licensed the US marketing rights to Stendra from Mitsubishi Tanabe Pharma of Japan.

Stendra will be available in three doses, all of which have been shown to provide statistically significant improvements in erectile and sexual function.

Like other phosphodiesterase type 5 (PDE5) inhibitors, Stendra improves penile blood flow – but it offers a faster action than its rivals.

The drug’s side-effects are characteristic of PDE5 inhibitors: headache, flushing and cold symptoms. However, Stendra clears the body more rapidly than other drugs in its class.

Dr. Ira Sharlip, Professor of Urology UC San Francisco, commented: “Quick onset of action is important to men.” He noted that Stendra was likely to appeal most to ED sufferers “whose opportunities for sexual activity are more casual”.

A marketing authorisation application for Stendra was accepted by the European Medicines Agency (EMA) on March 26.
“The unique profile of avanafil, including its onset of action and highly selective profile, make it an attractive treatment alternative for the more than 20 million European men suffering with ED,” said Francesco Montorsi, Director of the Urology Research Institute in Milan, Italy.

“The comprehensive results from the development program suggest avanafil, if approved, could effectively compete in the $4 billion worldwide ED market.”

The FDA has approved Eli Lilly’s Cialis (tadalafil) to treat men with signs and symptoms of Benign Prostatic Hyperplasia (BPH) and Erectile Dysfunction (ED).

The drug works by inhibiting the phosphodiesterase type 5 enzyme (PDE5), helping to produce vascular relaxation and increase blood flow to the penis. These enzymes are also found in the prostate and bladder, where problems can occur with BPH.

Claus Roehrborn, Chairman of the Department of Urology at The University of Texas Southwestern Medical Centre, said: “Since many men who have ED also experience the signs and symptoms of BPH, a single medication approved to treat both may be a significant therapeutic option for men and physicians.”

The approval totals three indications: both ED and signs and symptoms of BPH separately, as well as for men who have both conditions.

Dave Ricks, Lilly USA President, said: “These additional indications for Cialis reinforce our commitment to providing medical innovation in the area of men's health.”

“We're encouraged that Cialis provides a new treatment option for men affected by both ED and the signs and symptoms of BPH,” commented Mr Ricks.

The FDA clearance was based on clinical research gathered from three placebo-controlled efficacy and safety studies involved 1,989 men.

BPH is a condition where the prostate enlarges, which can cause urinary problems. Approximately 50% of men between 40-70 years old suffer from erectile dysfunction. Several studies have shown that many men with ED also experience the symptoms of BPH.

The first orodispersible tablet to treat erectile dysfunction (ED) has been launched in the UK.

Bayer’s Levitra (vardenafil) has been designed to offer convenience and discretion and rapidly dissolves on the tongue in seconds without the need for water.

Marc van Unen, Business Unit Head General Medicine, Bayer, says the tablet has been designed to “remove the known barriers” associated with ED.

An estimated 2.3 million UK men suffer from ED, yet only one in 10 receive treatment and four in 10 men regard presently available therapies as inconvenient.

The new formulation was approved by the European Commission in September 2010 and is the first and only ED medication to be available in the convenient orodispersible formulation. Its packaging also includes more than 1000 anti-counterfeiting measures with the aim to reduce the amount of fraudulent replicas.

“Bayer is committed to men’s health and is continuously striving to develop new and innovative treatment options for people living with erectile dysfunction, which is becoming more prevalent in the UK but is still undertreated,” said Marc van Unen.

“It is hoped that ultimately, the advantages of the new product and its discreet packaging, which includes 120 anti-counterfeiting measures, will reduce the growing numbers of patients purchasing counterfeit pills online and lead to improved patient satisfaction and treatment outcomes in ED overall.”