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.”

Eli Lilly saw global revenue fall by 4% in the first quarter of 2012 after sales of its atypical antipsychotic drug Zyprexa decreased by more than half due to generic exposure.

Revenues totalled $5.6 billion as sales increased by 41% in China but flat lined in the US and decreased outside America by 9% after Zyprexa lost exclusivity in all major markets bar Japan.

John C. Lechleiter, Lilly’s Chairman, President and CEO, says the Q1 figures represent a “solid start” to the year and despite the Zyprexa losses “demonstrated strong underlying growth in other products and key regions”.

Lilly expects to lose in the region of more than $3bn in Zyprexa sales but still record revenue this year between $21.8bn and 22.8bn.

It hopes the reduction in revenue generated by Zyprexa will be offset by growth in other key brands such as Cymbalta, Humalog, Humulin and newer products including Effient and Axiron.

In the first three months of the year, Cymbalta generated sales of $1.1 billion, an increase of 23% on the same period in 2011. Alimta sales were up 5% to $606.8m, Humalog generated $590.3m and revenue for Cialis, Humulin, Forteo, Strattera and Effient also increased.

But it was the 56% loss of sales on Zyprexa which saw global revenue fall as the former blockbuster totalled $562.7m in Q1. Sales of Evista also dropped 4% to $256.2m in the quarter.

The Indianapolis-based company’s total operating expenses increased by 3% compared with the 2011 Q1 after it continued its R&D-based strategy.

“We strongly believe that our innovation-based strategy will enable Lilly to return to steady growth following a period of multiple patent expirations,” said John C. Lechleiter.

Global revenue increased 5% in 2011 at Eli Lilly to $24.2 billion after the company saw demand increase but net income fall 14% to $4.3bn.

Agreements to supply generic versions of Zyprexa and Gemzar helped reduce the impact after the two lost patent exclusivity and saw revenue in the US increase by one per cent to $12.9bn. Revenue outside the US increased 11% to $11bn.

Lilly says total revenue was reduced by approximately $410 million due to the impact of the US healthcare reforms and now predicts to lose billions of dollars in 2012 due to generic competition for Zyprexa.

In 2011, total operating expenses increased 8% and R&D expenses were up 3% to just over $5bn. Lilly also paid $316.4m in relation to severance costs after its restructuring.

Its operating income was down 15% to $5.5bn compared to 2010 after an increase in R&D charges as part of its diabetes collaboration with Boehringer Ingelheim, coupled with clinical trial costs, restructuring and lower gross margin per cent.

The loss of patent exclusivity on antipsychotic treatment Zyprexa saw global sales drop 8% to $4.6bn. Zyprexa lost its patent protection in the US in October, resulting in sales decreasing by 13%. Outside the US, where exclusivity was also lost in the majority of markets, sales fell 3% to $2.45bn. But in Japan, where its patent still stands, sales reached $540m.

Gemzar also suffered at the hands of generic competition for the first time as sales decreased by 61% to $452.1m. But the news was better for Alimta, Humalog, Cialis, Humulin, Evista, Forteo and Strattera, which all recorded improved sales in 2011.

Lilly also received royalties of $409.2 million from Erbitux, an increase of 6% on 2010; $422.7m from Byetta, a 2% loss compared with 2010; and $302.5m from sales of Effient.

But Lilly now anticipates that revenue will fall to between $21.8bn and $22.8bn next year after an expected decline of more than $3bn in Zyprexa sales due to its exposure to generic competition. It hopes the loss in revenue will be partially offset by growth in Cymbalta, Cialis, Humalog, Humulin and Forteo, as well as continued improvement in its newer products such as Effient, Axiron and Tradjenta.

Japan and Emerging Markets are expected to continue to post strong underlying growth. But overall revenue in these markets is also expected to be hit by pricing actions in Japan and the impact of patent expirations, including Zyprexa, in a number of countries in these regions.

Eli Lilly expects to lose $3bn in 2012 after its psychotic disorder drug Zyprexa lost its patent protection in a number of major markets.

But the company still expects to generate revenue of between $21.8bn and $22.8bn next year due to the growth of its key franchises and new products such as Effient, Axiron and Tradjenta.

John C. Lechleiter, Chairman, President and CEO, said 2012 is an “important year” for the company and revealed Lilly had been preparing for the loss of Zyprexa’s exclusivity to return to sustained growth in 2014.

Zyprexa’s exclusivity ended in most markets outside of Japan at the end of last year. Lilly hopes brands such as Cymbalta, Cialis, Humalog, Humulin and Forteo will offset the lost revenue generated by Zyprexa and has invested in its pipeline and brands with long standing exclusivity, and attempted to improve productivity levels to fund R&D and future growth.

“First and foremost, we are replenishing and advancing our pipeline,” said Mr Lechleiter. “We've successfully rebuilt our mid- to late-stage pipeline to position Lilly for growth post-2014, with 12 assets now in Phase III, exceeding our goal of 10 by the end of 2011. We continue to revamp our discovery efforts to ensure a more sustainable flow of innovation for the long-term.

“Second, we're investing to drive growth in the key brands that don't lose patent protection during this period and in our countercyclical growth engines that don't have the same cycle of patent expirations as our US and European pharmaceutical businesses. These include Japan, select emerging markets and our animal health business. Third, we continue to drive productivity gains across our business to fund the R&D necessary to fuel our future growth, recapitalise our physical assets and maintain our dividend at least at its current level.”

Within the company’s forecast it also anticipates that gross margin as a percentage of revenue will be approximately 77%; operating expenses will be essentially flat compared to 2011 as a result of ongoing productivity efforts; marketing, selling and administrative expenses are expected to be flat to declining; R&D expenses will be between $5bn and $5.3bn and operating cash flows of approximately $800m will fund capital expenditures, as well as the company’s business development activity and its dividends.

“We remain on track to meet or exceed the mid-term minimum financial performance outlined this past June,” said Derica Rice, Lilly Executive Vice President, Global Services and Chief Financial Officer. “From now through 2014, on an annual basis we still expect revenue to be at least $20 billion, net income to be at least $3 billion, and operating cash flow to be at least $4 billion.”

Santa’s little helper Maxine Vaccine offers some festive thoughts on the good, the bad and the ugly in the world of pharmaceuticals.

This week’s most eye-catching pharma news is that the leader of a Texan counterfeit drugs outfit who smuggled thousands of fake Viagra and Cialis pills into the US from China and sold them online was jailed for 13 months and ordered to pay $140,000 in restitution to Pfizer and Eli Lilly.

In the USA, Viagra pills are sold legitimately for about $20 each – but the bogus pills were sold for half that. However, they probably did work in the most literal sense. Bill Donnelly, Pfizer’s chief of anti-counterfeiting for North America, commented that drug counterfeiters “are more likely to put too much active ingredient” so that “people will buy it again”.

What the counterfeiters ignore is the regulatory framework that ensures product safety and consistency. Given that Viagra can cause violent headaches and nausea, and is dangerous for anyone with a heart condition, only an idiot would take even the real thing without a prescription.

But there are quite a few idiots out there. Over four million counterfeit Viagra tablets were seized worldwide in 2010.

Of course, you’re not an idiot, and there won’t be any counterfeit drugs in your Christmas stocking. But this is a good time to reflect on what the pharma industry does well and what it’s capable of getting wrong.

This year we’ve seen progress towards the development of a vaccine against HIV infection, while the impact of anti-retroviral drugs has seen rates of HIV infection begin to fall worldwide.

Intensive R&D in the cancer therapy field has seen the evolution of a long-term condition treatment model for a disease that, in previous generations, had few survivors.

The UK government has highlighted the potential of stratified medicine, using genetic analysis to develop targeted drugs, to transform healthcare and create major commercial opportunities for UK life science companies.

While the swine flu vaccine may, in retrospect, have been overused, it’s good to know that the industry came up with a rapid solution to what could in theory have been a much greater problem.

So why do thousands of people click ‘like’ at every scandal story involving a pharma company? If pharma were a person its Facebook relationship status would vacillate between ‘single’ and ‘it’s complicated’. What’s wrong?

For a start, before the advent of ‘designer drugs’ every illegal drug on the black market was developed as a pharmaceutical product. Heroin, amphetamine, cocaine, barbiturates, tranquillisers – they were all on prescription once, and some of them still are. Addiction is something the industry, the medical professional and the public are still learning about.

The Verve song ‘The Drugs Don’t Work’ was indeed about chemotherapy, not narcotics – and there’s another reason drug companies are unloved. Drugs don’t always work, because people and their diseases are not predictable. Every patient is unique, and we ignore that at our peril. Medicine is not about spreadsheets and statistics, it’s about the human body – which nobody can control.

The trouble with drugs is that people see them as quick-fix solutions to problems that have complex causes. Instead of recognising that any drug can affect only certain narrow chemical parameters, increasing this and reducing that, shifting the balance of a complex dynamic system, we continue to look for ‘magic bullets’. That’s as much a problem with patients and doctors as with suppliers – but we get the blame, and we may sometimes deserve it.

The pharma industry’s future doesn’t lie in more blockbuster drugs, in corporate branding, or in NLP. It lies in consultation and the sharing of knowledge, in open innovation, in honest engagement between professionals with different areas of expertise. Only bad sales professionals try to get around the customer’s knowledge. Good sales professionals engage with it and add to it.

Drugs are imperfect. People are imperfect. All we can do is make connections, identify problems and work together towards solving them. The more we can do that, the less pain there will be.

Or maybe I’ve just opened the sherry a few days early.

Have a great Yuletide break and I’ll see you next year.

Profits at Eli Lilly fell 5% in the third quarter of 2011 to $1.24 billion despite revenue increasing nearly 10% to $6.15bn.

Strong sales performances by Cymbalta, Humalog, Forteo, Strattera, Cialis (pictured) and Alimta boosted revenue, although sales of Zyprexa and Gemzar were down after they faced generic competition for the first time.

John Lechleiter, CEO, Lilly, says that the company is “well-prepared” to meet the “challenges before us” as it prepares to face the loss of patent exclusivity on the two brands.

Zyprexa’s sales generated $1.18bn during the quarter, a decrease of 3% compared to the same time last year, after revenue dropped in the US by $563.2 million. It will lose its exclusivity in the US this month after the patent expired in Europe in September.

But with the introduction of cheaper generic copies, Lilly says it now expects a "rapid and severe decline in Zyprexa sales".

Sales in other divisions of the company boosted overall profits, especially in animal health where sales were up 28% compared with Q3 of 2010.

As a result in the drop in profits, Lilly did not raise its full-year profit forecast but Damien Conover, a financial analyst at Morningstar, said the “sales look reasonably good”.

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.