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Pfizer & the search for the new Viagra equivalent

Source: http://www.thebusiness.co.uk

Drug companies spend billions of pounds chasing "the next big thing" – the wonder pill that will change the world and earn millions for its creators. Viagra, discovered by chance by pharmacists seeking a treatment for angina, is just such a drug.

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Pfizer, the US colossus that holds the patent, earned $1.6bn (£800m; E1.2bn) from Viagra sales last year. This is big money, even in an industry known for its blockbuster earnings.

But standing still is a recipe for disaster and Pfizer risks squandering Viagra's legacy. With fake Viagra flooding the internet and British rival, GlaxoSmithKline (GSK), working on a gel that could be widely available in chemists by 2009 (unlike Pfizer's little blue pill, which requires a doctor's prescription), Pfizer is playing a desperate game of catch up.

As The Business revealed last week, the company is discussing an over-the-counter version of Viagra aimed at boosting sales and seeing-off challenges from rivals such as GSK.

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One specialist US pharmaceutical company has also conducted research into a spray version of Viagra, all part of the drive to explore new markets and make Pfizer's trophy drug appeal to as wide a customer base as possible.

The worldwide market for erectile dysfunction will be worth more than $6bn by 2012. Over 150m men are thought to suffer mild to moderate impotence and would be attracted by a drug available in pharmacies without the need for an embarrassing visit to the doctor. It is too important an opportunity to let pass for any major pharmaceutical company worthy of the name.

Yet for Pfizer, grappling with a messy internal restructuring, it is starting to look dangerously like a case of too little, too late.

Viagra has been on sale since 1998; yet it is only now, with the worldwide patent for Viagra due to expire between 2011-2013, that the company is looking at plans for a non-prescription version of its wonder drug. For so successful a company, with 14 of the world's 25 best-selling medicines and $51bn in annual sales, this is inexcusable.<

Shareholders and financial analysts should take Pfizer's man-agement to task for allowing complacency to cloud their judgement.

Instead of presenting investors with a bold, articulate plan for taking Viagra to the next level, Pfizer has shown signs of bunker mentality. Its reaction to our report that it was researching new versions of Viagra spoke volumes.

After, at first, refusing to comment on "speculative reports", stock market reaction to our story on its ground-breaking initiatives forced Pfizer last Wednesday night to confirm that it has indeed considered a number of options for Viagra, including an over-the-counter version. Our story was subsequently followed-up extensively in the international media.

While no company likes to see commercially-sensitive information about potential new products leaked to the market, Pfizer was wrong to stick its head in the sand.

It should have taken the opportunity to trumpet its advances in research and development, sending a clear signal to investors that it is on the offensive, rather than fighting a rearguard action.

Investors respond well to a bold, assertive strategy. Instead, Pfizer's churlish reaction reflects the malaise that has gripped the company and which threatens to distract it from the real business of maximising value from its drugs line-up. Its management clearly needs to get a grip, fast.

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That grip may have appeared in the combative shape of Jeffrey Kindler, appointed chairman and chief executive of Pfizer in July last year. But he needs to act quickly.

The company's full-year results, due on 22 January, are likely to make unpleasant reading. Analysts predict that fourth-quarter sales will be down by 11% on the previous year.

Net income during the fourth quarter is estimated to have slumped by a quarter from the same three month period of 2005 to $2.79bn.

Kindler is poised to outline his strategic vision for the world's biggest drugs company, including shedding up to 7,000 jobs on top of earlier cuts and rethinking the way Pfizer develops, makes and markets medicines. He has reshuffled his senior team, cut the US sales force by a fifth and raised Pfizer's dividend by 21% to placate restless shareholders.

His strategy appears to be to contain spending by keeping research-and-development costs flat while radically trimming spending on marketing and manufacturing. Kindler's next move is likely to be cutting jobs in the company's international sales force.

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Like many big pharmaceutical companies, Pfizer is struggling to bring enough new products down the development pipeline to compensate for future loss of patents. It spends $8bn a year on research and development, more than any competitor, but has yet to find its next money-spinner.

Lipitor, the cholestrol-lowering drug that accounts for close to a quarter of Pfizer's sales, comes off-patent in 2010, with no obvious new blockbuster to fill the vacuum. The company was recently forced to cease trials of Lipitor's potential successor, a cholesterol drug called torceptrapib, after some patients died. The setback, disclosed last month, sent Pfizer's shares sliding 11% to $24.90.

Pfizer's worldwide revenues were down by 2% in 2005 to $51.3bn and are projected by Bank of America to see a further 5.1% decline to $48.7bn for 2006.

The company depends on six drugs for half its revenues: Lipitor for $12.1bn; blood pressure treatment Norvasc (worth $4.7bn); anti-depressant Zoloft ($3.3bn); the antibiotic Zithromax ($2bn); anti-inflammatory Celebrex ($1.7bn); and Viagra ($1.6bn).

Viagra's market share faces increasing challenges from prescription drugs such as Eli Lilly's Cialis, a Viagra-style treatment whose effects last up to 36 hours, compared to four hours for Viagra. Another prescription-only competitor, Levitra, developed by GSK, Bayer Healthcare and Schering-Plough, has made in-roads into Pfizer's territory, claiming a market share of 12.1%.

Cialis has captured 24.6% of the main Western markets since its launch in 2003, with 52.7% growth from 2004 to 2005, and is now the most popular erectile dysfunction drug in France. Viagra's command of the market has collapsed from 95% several years ago to just 50% today. Continuing the trend, sales of Viagra fell by 1% in the nine months to September 2006.

Viagra's money-spinning status is under further attack from patent challenges to Viagra's active ingredient, sildenafil citrate, in developing countries such as China and Colombia.

Millions of men have bought fake Viagra over the internet – in addition to 23m genuine prescriptions for the drug – in spite of World Health Organisation warnings that counterfeit versions may contain dangerous chemicals or unsafe dosages.

The clearest indication that Pfizer was seriously considering a non-prescription version of its little blue pill emerged late last year when The Business was informed of new Viagra trials. Pfizer was testing the effects of Viagra on men who didn't suffer from erectile dysfunction [ED] and men with mild erectile dysfunction, we were told by a source; a clear hint that the company was seeking a wider outlet for its product.

On 2 January, Pfizer responded to our queries about these tests with an outright denial: "Pfizer is not and has not conducted any clinical trials assessing the effect of Viagra on erectile function in men not suffering from ED and has no plans to do so."

The Business has since traced two Pfizer-sponsored trials into the effects of Viagra, one on men with "normal" sexual functions and the other on men with mild erectile dysfunction, one in Israel, the other in Canada. Both trials are listed on the US government website www.clinicaltrials.gov and are actively recruiting participants.

Viagra's potential side effects include decreased vision, or loss of vision, and low blood pressure if taken with drugs called nitrates. Extending trials of the drug to include men with a "normal"

sexual function could be aimed at addressing such concerns and in satisfying the notoriously

cautious US Food and Drug Administration that the drug is safe to be sold over-the-counter. However, the scare stories of the late 1990s, where Viagra was linked to increased risk of heart attacks, appear to have faded.

Viagra is the most famous of the lifestyle drugs and the marketing campaign that accompanied its launch in 1998 succeeded in breaking down many of the taboos surrounding erectile dysfunction.

Before the arrival of the little blue diamond-shaped pill, the only options for treatment of erectile dysfunction involved injections or surgery. Within a month of Viagra's launch, doctors were writing 120,000 prescriptions a week, at $10 per pill. Pfizer's profits soared on the drug's success, with a 37% jump in net income for the financial quarter in which it was introduced.

The inaugural Viagra campaign featured Senator Bob Dole, one-time US presidential candidate who suffered from prostate cancer, closely associated with impotence. Iconic footballer Pele also endorsed the product. Once the scale of the potential market for Viagra became clear, Rafael Palmiro, a Texas Rangers baseball star, took over, and the message became more strident and pitched at younger men.

Nine years on, Viagra has entered the lexicon to the extent that any aphrodisiac product must now be written about in relation to it: herbal Viagra, gel Viagra or even female Viagra. The pill's everyday status brought erectile dysfunction products into the mainstream. New versions of this iconic product would give Pfizer a lucrative edge over competing over-the-counter products such as GSK's gel, developed with Futura Medical.

The gel, codenamed MED2002, is undergoing clinical trials and could be on the market by the end of 2009. It is based on a product that has been used to treat angina for more than 40 years and would be sold in single dose tubes. Like other impotence products, it causes dilation of the arteries and increased blood flow.

An over-the-counter version of Viagra will sell for less than prescription medicine; but its greater accessibility will boost revenues. While Pfizer's research chemists are continuing their quest for new outlets for Viagra, new delivery methods could be developed by specialists such as Novadel Pharma, based in New Jersey.

Novadel makes oral sprays that enable drug absorption through the oral mucosa and into the bloodstream. Novadel sources have told The Business that the company has researched a spray version of Viagra. While Novadel refuses to be drawn on the detail, it insists no product will come to the market in the near future and that no formal agreement has been signed with Pfizer.

Since our story last week, The Business has learnt that Novadel has made a patent application in the US for an oral spray formulation of various drugs including sildenafil, the active compound in Viagra. The application was filed in February 2005. Although the patent has yet to be granted, the move lends credence to our inside information that the company is researching the possibility of a Viagra Suhagra.

With billions of pounds at stake, it is unsurprising that Pfizer is being coy about its plans to develop Viagra. However, with its research-and-development teams yielding little in the way of new blockbusters, it has a commercial imperative - indeed, a duty to its shareholders - to exploit existing products to their full potential. A widely-available Viagra is a sure-fire winner, if Pfizer can clear the inevitable regulatory hurdles.

Yet there is no excuse for the length of time it has taken Pfizer to wake up to the extra potential of its popular drug. It is indicative of a company in disarray. Pfizer's new boss needs to inject a new sense of urgency - and of competitive pride - into this vast yet unwieldy company.

Without it, Pfizer faces years of decline as sharper rivals steal a march. It would take more than a little blue pill to remedy that.