Lilly launches Cialis in China

April 2nd, 2007

Eli Lilly & Co., maker of impotence drug Cialis, hopes that Chinese couples who might resort to traditional aphrodisiacs or divorce court to resolve sexual problems will seek marital bliss with its own remedy.

The U.S. drugmaker launched a marketing campaign for Cialis in the world’s most populous country on Thursday with the release of a survey showing that 45 percent of middle-aged Chinese couples had experienced erectile dysfunction problems.

Since only one-third of those couples had thought about seeking treatment, Lilly believes that efforts to boost awareness of the problem would increase sales of Cialis, whose long-lasting effects have given it the nickname “the weekender.”

“This drug is effective, because men are like light bulbs. They can be turned on and off easily. Women are like irons, they need a long time to heat up, but also a long time to cool down,” said psychologist Qiu Xiaolan, brought in as part of Lilly’s media campaign to educate the public.

Cialis, which has been distributed to 5,000 Chinese pharmacies this month, is effective for up to 36 hours, longer than rival drugs on the market, Lilly says.

“It’s a longer window of opportunity,” Eli Lilly China President Jorg Ostertag told a news briefing.

About 35 million Chinese men suffer from some form of erectile dysfunction, Lilly said. Nearly 10 percent of these will eventually look for some sort of treatment, mainly in pharmacies.

FAMILY HARMONY

Erectile dysfunction is common among men with diabetes, high blood pressure and high cholesterol levels, and has historically been treated in China with traditional medicines containing herbs or animal parts such as tiger penis and rhinoceros horns.

“Erectile dysfunction has become a serious issue. It not only threatens men’s health, but also challenges family relationships and harmony,” Ostertag said.

A local court in south China granted a divorce to a woman who remained a virgin after four years of marriage due to her husband’s apparent sexual dysfunction, Xinhua news agency reported in October.

More than 10 percent of divorce cases center on sexual dysfunction, Xinhua quoted a judge with the court in south China’s Guangxi Zhuang Autonomous Region as saying.

The Supreme People’s Court has ruled that sexual dysfunction that cannot be cured is proper grounds for divorce, Xinhua said.

Industry estimates for China’s market for impotence drugs range from 500 million yuan to as much as 2 billion yuan a year ($65 million to $260 million).

Cialis, although growing faster globally than Viagra, still lags its rival, which was launched in China by Pfizer, the world’s largest drugmaker, in 2000.

Levitra, an impotence drug developed jointly by Bayer AG, GlaxoSmithKline Plc and Schering-Plough Corp., is also available in China.

Pfizer does not disclose sales figures for Viagra in China but global revenues from of the drug rose 1 percent to $1.7 billion last year.

Worldwide sales of Lilly’s Cialis jumped 30 percent to $971 million.

Viagra OTC

February 17th, 2007

Well… it had to happen. Finally, Viagra will be available over the counter in the UK. Just walk onto Boots the chemist, pay your £50, have a few quick checks… blood pressure etc. Then you get 4 pills. If you want a refill however - you have to do a follow up at the docs. (Or you could of course just go here and buy twice the number of pills of genuine Pfizer Viagra at half the price.)

Boots to sell Viagra over the counter

February 17th, 2007

The impotence drug Viagra will go on sale this week for the first time without prescription at three branches of a high street chemist.

Boots’s decision to sell the drug over the counter from Wednesday at three of its stores in Manchester coincides with Valentine’s Day and National Impotence Day. If the pilot scheme is successful, it will be extended to branches throughout Britain.

Customers will have to reveal their medical history to a pharmacist, and have their blood pressure, cholesterol and glucose levels tested, before they can purchase the packet of four diamond-shaped blue tablets for £50.

Viagra available on high street without prescription in trial run

The impotence drug Viagra will go on sale this week for the first time without prescription at three branches of a high street chemist.

Boots’s decision to sell the drug over the counter from Wednesday at three of its stores in Manchester coincides with Valentine’s Day and National Impotence Day. If the pilot scheme is successful, it will be extended to branches throughout Britain.

Customers will have to reveal their medical history to a pharmacist, and have their blood pressure, cholesterol and glucose levels tested, before they can purchase the packet of four diamond-shaped blue tablets for £50.

Until now, men wishing to take Viagra have been able to obtain it on prescription by appointment with a GP. Others use the less reliable method of obtaining the drug over the internet.

The drug will be available to men aged between 30 and 65. Boots claims that only 10% of the estimated 3 million men in Britain who suffer from impotence are being treated.

The drug works by relaxing the blood vessels and increasing the blood flow to the penis, helping users to overcome erectile dysfunction for around four hours. Boots already sells weight-loss drugs and treatments for balding under the same arrangement - known as a patient group direction.

Men will be asked to have a consultation with a private doctor, at a further cost of £37.50, if they wish to buy regular supplies of Viagra. If given the all-clear, they will be able to buy packs of four tablets for £21.25, which is comparable with prices on the internet.

A Boots spokeswoman said: “There are a number of safety checks in place to ensure correct supply. People will have to go through a thorough consultation with a pharmacist. They would then need to see a doctor to have a full medical examination before getting an ongoing supply.

“Erectile dysfunction can be a marker for an underlying medical condition and so we are keen to take this extra step.”

It is estimated that Viagra, manufactured by Pfizer, is taken by 27 million men worldwide, including around 900,000 in Britain. Viagra has faced strong competition from rival drugs such Cialis, manufactured by Eli Lilly, which can work for 36 hours.

Exercising regularly and preventing heart disease and diabetes can safeguard your sex life.

February 3rd, 2007

A study published in today’s issue of the American Journal of Medicine calculates that more than 18 million American men over age 20 are affected by erectile dysfunction, the inability to maintain or achieve an erection.
Almost 90 percent of the studied men with dysfunction had at least one risk factor for heart disease, such as diabetes, hypertension, poor cholesterol levels or smoking. They also were less likely to have had strenuous exercise within the month prior to the study.
With such a strong link between sexual problems and lifestyle, health providers are hoping men will make changes.
“This may be a powerful motivator for male patients who may be at risk for cardiovascular disease or who have diabetes,” said Elizabeth Selvin, lead author and a faculty member in the Johns Hopkins Bloomberg School of Public Health’s Department of Epidemiology. “It’s another reason to get off the couch and exercise and eat well.”
Researchers culled data from 2,126 participants in the National Health and Nutrition Examination Survey. Men who reported being “sometimes able” or “never able” to get and keep an erection were labeled as having erectile dysfunction, while men who reported being “always or almost always able” or “usually able” were not.
The prevalence of erectile dysfunction was 18 percent. Men 70 and older were more likely to suffer from erectile dysfunction, compared to 5 percent of men between ages 20 and 40.
Almost half of all men in the study with diabetes also had erectile dysfunction.
Steven N. Gange, a urologist at Western Urological Clinic in Salt Lake City, said he believes from other studies that the number of men with the condition is much higher.
“This is actually a much lower number than I’m comfortable with,” Gange said.
The diabetes findings make sense to him. “Diabetes ultimately does become a vascular disease, and smoking and aging are also risk factors,” he said.
Erectile dysfunction can be the first sign of a vascular disease in otherwise seemingly healthy males. Recently, Gange saw a 33-year-old smoker who wasn’t responding to Viagra, Cialis or Levitra, popular drug treatments that increase blood flow to the penis. Gange recommended he see a cardiologist.
Blake Hamilton, a urologist with University Health Care in Salt Lake City, said men may seek medical help for sexual problems before other health issues because it affects their lives so negatively.
“Men often put things off,” he said. “But a lot will go to the doctor for erectile dysfunction. It’s important to make the connection between” erectile dysfunction and cardiovascular disease.
Brent Muhlestein, director of cardiology research at LDS Hospital in Salt Lake City, says cardiologists should ask their patients about erectile dysfunction.
They also need to be very careful when prescribing the three treatment drugs, because they can be dangerous for patients on nitroglycerin. Since both types of drugs can cause blood pressure to drop, when coupled, they can lead to plummeting blood pressure, heart attacks and even death.
“We have to learn when it’s safe and not safe to let patients with heart disease use Viagra or other similar medications,” Muhlestein said. “A lot of men ask for it because it’s very distressing to them.”
He also thinks more men might be willing to become healthier if they understand all the ways it can improve their lives.
“One thing I have done is tell patients not only can you prevent yourself from having a heart attack or stroke in the future, but it will also probably help your sex life to last longer,” he said. “Sometimes that catches their attention.”

Choosing the right ED drug

February 3rd, 2007

If you’ve ever watched a prime-time television show, you’ve seen the ads for Viagra, Levitra or Cialis, drugs that treat erectile dysfunction drugs.

Those medications have helped millions of men have a normal sex life.

“Patients are able to converse much more freely amongst their friends, amongst their partners,” said Dr. Ajay Nehra of the Mayo Clinic.

Talking to a doctor about erectile dysfunction, or E.D., is the first step toward being treated successfully with the popular drugs.

“Erectile dysfunction is really synonymous with what we call endothelial dysfunction,” Nehra said.

Endothelial dysfunction is when the inner lining of the blood vessels don’t function properly, which means blood doesn’t flow as it should. It can be a complication of many issues including heart disease, diabetes, high blood pressure, prostate surgery or alcoholism.

Viagra, which has been on the market the longest, is fast-acting. It starts working within 1 to 2 hours and lasts from 6 to 12 hours.

Levitra is similar but it’s even faster. It works within 30 minutes and lasts 6 to 12 hours.

Cialis is a little different. It takes 3 to 4 hours to work and it lasts for 2 to 3 days.

All three drugs are safe for most men, but they can cause side effects including headache, stomachache and flushing. Cialis can also cause back or leg pain. So, the drug you choose depends on your lifestyle and your health.

E.D. drugs are effective for 50 to 60 percent of men who take them. Be sure you tell your doctors about any other medications you’re on before your prescribed any of these medicines.

Best way forward - try an ED starter pack and find out what works best for you!

Cialis Booms!

January 20th, 2007

Sales and profit of Cialis continued to show healthy gains in the fourth quarter, underscoring why Eli Lilly and Co. wants to buy out its longtime partner in the blockbuster product.

Fourth-quarter profit increased 63 percent, to $99.9 million, Lilly and its partner, Icos Corp. of Bothell, Wash., said Thursday after the markets closed.
The increase, in line with earlier guidance, was due, in part, to strong sales and lower marketing expenses. Fourth-quarter sales rose 28 percent from a year ago to $269.2 million. Cialis is the world’s No. 2 selling drug for erectile dysfunction, behind Pfizer’s Viagra.
Icos shareholders will vote on Lilly’s acquisition offer Thursday. Lilly is offering to pay $2.28 billion, or $34 a share, a price that one large Icos shareholder, New York hedge fund HealthCor Management, has criticized as too low, given the drug’s robust growth.
For the full year, the joint venture earned $320 million on sales of $971 million.
Lilly originally offered $32 a share in October, but raised the price by $2 a share, or 6.3 percent, after the bid came under attack.
Indianapolis-based Lilly and Icos market the drug in North America and Europe through a partnership. If Icos shareholders approve the deal, Lilly will get all the revenue. Most of Icos’ 700 employees are likely to lose their jobs after the sale is closed.

The Holy Grail - Flibanserin - Viagra for women… AT LAST!

January 9th, 2007

Flibanserin. Remember the name.

This new pill was being studied to fight depression but the drug company that produces it found something weird.

Somehow this pill is much more effective to boost a woman’s sex drive. Now, German drug-maker Boehringer Ingelheim boast it is the new viagra for women.

A drug expert told The Sun: “It’s a very innovative pill. The company stumbled upon it without planning. This could be as popular with women as viagra is for men because it increases the woman’s sexual arousal.”

The drug is being processed by US authorities to get the necessary licences and should be on the shelves soon.

The drug industry is making miracles to make sure humans do not go extinct!

A Time and Place for everything - including Cialis!

January 9th, 2007

According to Satyrical Mick, enthusiasm in love is a wonderful thing However, an excess mixed with your first dose of Cialis can lead to… well… excess, and, so it seems, JAIL!

Here’s the story…

Eager to try out a new prescription for the erectile dysfunction drug Cialis, a couple in their fifties is facing indecent exposure charges after they were caught having sex on a balcony at a family resort in South Carolina. William McGinn, 57, and Patricia Scott, 53, were arrested Saturday afternoon when other vacationers at the Breakers Resort spotted them engaging in a variety of sex acts on their third-floor balcony, according to a Myrtle Beach Police Department report, an excerpt of which you’ll find below. One witness told cops that McGinn and Scott ignored requests that they take it inside, away from the view of guests, including children. When police confronted the couple, they claimed that onlookers were just “jealous,” adding that if other guests “did not want to see them, then they didn’t have to look.” McGinn told officers that he had just received his Cialis prescription and, “he and Scott were in love.” As she was being placed in a patrol car, Scott complained to one cop that she and McGinn were “just f**king” and “didn’t see the problem.” McGinn and Scott were booked into the Myrtle Beach Police Department jail, where the above mug shots were snapped.

A Penetrating Solution to ED

December 9th, 2006

If you’re squeamish look the other way.

Are you tired of taking little blue pills? Frustrated that Cialis will only last 36 hours?

Well, my friend, I’ve found just the solution you’re looking for.

Now you can banish ED for 6 months at a single stroke!

There is, of course, a catch… you have to to get an injection of some sort of genetic pap directly into you primary equipment.

Then again… who wouldn’t exchange 6 months of potency for a mere ’single subtherapeutic intracavernous injection of the human recombinant Maxi-K ion channel gene via a “naked DNA” plasmid vector (hMaxi-K)’ right into your dick!?

Well… me for one. What’s so hard about swallowing a pill I ask myself.

Anyway, it’s supposed to be safe and effective, so for those of you who suffer from ED spliced with a good dose of masochism… here’s the whole scholarly nine yards on it.

And given your penchant for pain you just might enjoy reading it!

—————>

The results of a phase 1 trial presented at the 11th World Congress of the International Society for Sexual and Impotence Research (ISSIR) in Buenos Aires, Argentina, suggest that a single subtherapeutic intracavernous injection of the human recombinant Maxi-K ion channel gene via a “naked DNA” plasmid vector (hMaxi-K) is safe in men with moderate to severe erectile dysfunction (ED),

“This is translational research; we actually made observations in the laboratory first and then tried to apply them to a clinical problem,” Arnold Melman, MD, told Medscape. Dr. Melman is affiliated with the Montefiore Medical Center and holds posts as professor and chairman of the department of urology at the Albert Einstein College of Medicine in New York City.

Dr. Melman and colleagues found that smooth muscle cells of the genitourinary system have four types of potassium channels that hyperpolarize the cell when open, blocking the inflow of calcium required for contraction. “The most common and the most active of these potassium channels was the Maxi-K channel,” Dr. Melman said.

The investigators created a “naked” DNA plasmid (hMaxi-K) by incorporating the cDNA necessary to produce the pore-forming subunit of the Maxi-K channel into a commercially available nonviral, double-stranded circular DNA. “We demonstrated that when we took this gene and put it into the penis, the [smooth muscle] cells took it up and produced the protein,” Dr. Melman explained.

The hMaxi-K injection increases the expression of the Maxi-K channel in a small percentage of penile smooth muscle cells, whose signal for smooth muscle relaxation upon neural stimulation is amplified by gap junctions, according to Dr. Melman. The relaxation-signal amplification eliminates the need for aggressive gene incorporation strategies (such as adenoviral or retroviral vectors) that are associated with increased risk of adverse immune responses and tissue inflammation, possibly precluding their use.

Results of laboratory studies showed that an injection of hMaxi-K could reverse diabetes-induced or age-related ED in animals for up to six months. After a public presentation of this preliminary work to the Recombinant DNA Advisory Committee of the Office of Biotechnological Activity at the National Institutes of Health, Dr. Melman and colleagues received investigational approval for hMaxi-K from the U.S. Food and Drug Administration (FDA) Center for Biologics and Research. The phase 1 trial was conducted at New York University and the Mount Sinai School of Medicine after institutional review board approval.

The FDA approval allowed testing of at least three levels of hMaxi-K dosing, in three patients per level. According to Dr. Melman, safety in humans was the primary concern at the 500-µg level. “The first level was one that really didn’t have an effect in animals — we’re increasing the dose sequentially to make it as safe as possible; when there are no adverse events in patients [at one level], you then go to the next level,” he said.

Results showed that intracavernous injection of 500 µg of hMaxi-K in three men with moderate to severe ED was safe. “There were no treatment-related adverse events,” Dr. Melman said, adding that the animal equivalent of the next dose to be tested (1000 µg) was also low but had been effective in laboratory studies.

“We are using the safest vector, which is naked DNA: it doesn’t cause allergic reactions, it doesn’t get integrated into the chromosomal apparatus…and [in animal models] the physiologic effect does seem to last a long time,” Dr. Melman said.

The science of ion channel gene transfer has been well accepted and its applications potentially affect millions of people, according to Dr. Melman. “All the major smooth muscle diseases are diseases that heighten contractility, including hypertension, asthma, irritable bowel, benign prostatic hyperplasia, and overactive bladder,” he pointed out. “These are all profound problems that together affect the majority of the population — compared with cancer, it’s another order of magnitude of morbidity.”

Dr. Melman and colleagues will also be seeking FDA approval for the investigative use of hMaxi-K in women with overactive bladder. “We’re using a very safe vector to treat local organ disease. If it works — and I think it will — it’s going to really be a giant step forward in medical therapy,” he said.

Dr. Melman pointed out that although ED drugs such as sildenafil (Viagra) and tadalafil (Cialis) are in use, “these work only in about 60% of people, they have side effects and some contraindications to using them, and you have to plan ahead — you have to take a pill to have sex,” he said.

“If hMaxi-K works in people the way it does in animals, [the effect of] a single treatment will last for a long duration,” concluded Dr. Melman. “It takes away the concept of having to plan ahead — patients want something safe that they can count on, and I think that’s what we have to offer here.”

The phase 1 study was funded by Ion Channel Innovations, LLC. Dr. Melman is a directing member of the company.

New Sex Drug targets heart not penis

December 9th, 2006

So Cialis, Viagra and Levitra all work in more or less the same way. They relax the muscles in the penis so that blood flows there more easily when the man is arroused. But all this assumes of course that the man is aroused i.e. interested in sex. The desire part is not an issue for most men so these drugs that target the wobbly equipment usually work just great. but what about the guys who just don’t get interested anymore. I remember some time back apomorphone was touted as the solution here, but results were very patchy and it seems to have faded away now.
So along comes bremelanotide (pronounced “BREE-ma-LAN-o-tide”) - the new kid on the block of sex meds. Does it work? Or will it got the way of apomorphine. Well here’s some info to start at least on the answer to that question…

Bremelanotide is being tested and developed, in part, in a laboratory at Concordia University in Montreal by neuroscientist Jim Pfaus.

Full-time college professor, part-time punk rocker, Pfaus is using rats to test whether this new substance, also called PT 141 - triggers desire.

Rats stand in for humans, because, like people, they’re social and they have a similar hypothalamus, the part of the brain that controls desire.

In his lab, Pfaus says he’s finding that bremelanotide seems to put rats in the mood.

Given the peptide, female rats, he says, initiate sex four times more often than those who do not receive it.

And bremelanotide’s makers are betting it will work the same way on both men and women.

“It brings back your libido,” Pfaus said. “It doesn’t make it something that it wasn’t. It brings it back to where it probably was when you were having good sex.”

From Tanner Enhancer to Sex Driver

Bremelanotide didn’t start out as a drug for sexual dysfunction.

In fact, it was being developed as a tanning enhancer, until researchers noticed interesting side effects in the men involved in clinical trials.

“All treatments for sexual dysfunction, especially erectile dysfunction, have colorful stories about how they started,” said Carl Spana, CEO of Palatin Technologies, which holds the patent on bremelanotide. “In this particular one, young college men were given this drug in a Phase 1 study and got spontaneous erections.

Spana hopes his company has stumbled on the holy grail of sexual dysfunction.

And how does bremelanotide work?

Spana says it activates parts of the brain that are involved in regulating normal sexual function.

He says other products on the market, such as Viagra, Cialis and Levitra, “work by affecting peripheral blood flow, [rather than] the central nervous system.”

A First of a Kind for Women

Palatin Technologies, a biotech company in New Jersey, hopes to have bremelanotide on the market for men within a couple of years - and for women shortly after that.

If approved, it would be the first drug sold in the United States to specifically target lack of sexual desire in women.

It’s for those experiencing serious sexual problems - women who’ve gone through menopause or had a hysterectomy, for instance, and lost desire as a result.

Michael Perelman, a New York City sex and marriage therapist, screened women for Palatin’s human trials, and has kept an eye on the results.

“Some of the women put it in colorful language that I’m not comfortable using on television,” Perelman told ABC News’ “Nightline.”

“But what was said was that, ‘The quality of my orgasm was more the way it used to be, and I like that.’ ‘I had some thoughts about my husband.’ ‘I initiated sex with him for the first time even though I’ve thought about doing it for a long time.’ Those were some of the things that they said,” Perelman said.

If and when bremelanotide makes it to market, it will be administered as a single-use nasal spray.

That way, it goes straight to the brain and avoids being broken down in the digestive system.

Dr. Annette Shadiack, Director of Research at Palatin, says the results last six hours or eight hours, with the onset as early as 30 minutes.

Drug Abuse Concerns

But bremelanotide likely will encounter tough resistance on its way to receiving approval from the Food and Drug Administration.

One concern is abuse. Some young partyers have been known to mix Viagra with Ecstasy for recreational use.

“I think that there’ll be enormous sales over the Internet. I think that there’ll be sales in bars, on street corners,” said sexual psychologist Leonore Tiefer, associate clinical professor of psychiatry at the New York University’s School of Medicine. “Certainly when the thing is first approved, I think it will be widely misused.”

In 2004, Tiefer helped block FDA approval for Proctor & Gamble’s hormone patch Intrinsa, which was being touted as the female Viagra.

Besides the potential for abuse, she also worries about the overall impact of these sorts of drugs on the culture.

In particular, she’s worried about the way it will be marketed.

“It raises the bar on performance expectations. So that women, couples, will somehow feel that if arousal, orgasm, desire, is not a regular routine, every day, every week, womb-to-tomb kind of thing that there is something wrong with you,” Tiefer said.

“If women do go in with that message, their physician should clearly tell them that this is not what this is for,” said Palatin CEO Spana. “It’s for women who feel a real lack of desire, real lack of ability to get aroused.”

Back in his lab in Montreal, Pfaus says he thinks women should have the option, but he hopes bremelanotide will give women confidence, not doubt.

“Women don’t need another thing staring at them from a billboard telling them that they are not good enough,” Pfaus said.

“But I think that if the drug is available for people who actually have true desire disorders that are defined by a psychiatrist and a clinical psychologist, then we’re talking about a different group of people,” he said.

But Pfaus says critics should not be overly concerned about bremelanotide’s potency.

“This is not going to make people have orgies in the street,” he said.