Latest News For 'Generic Pharmacy'
September 20th, 2007
When Eli Lilly and Co. thought about how to market its erectile-dysfunction drug in Italy, the answer seemed natural: hold a series of tango workshops to help couples revive their passions.
As a professional couple danced on stage, Lilly and its partners in medical associations provided counselors and medical experts to talk to consumers about sexual health problems.
How Cialis plays in Europe is important to Lilly, which recently won approval to market a one-a-day version of the erectile-dysfunction drug there. The company also hopes to get U.S. approval later this year.
Neither Viagra nor Levitra is sold in once-daily doses, which could give Lilly an edge.
The once-a-day version will be marketed for men who anticipate having sex two or more times a week, without confining it to a limited time. The current dosage of Cialis works for about 36 hours. Viagra and the other major erectile-dysfunction drug, Levitra, work for about four hours.
Cialis trails rival Viagra in the U.S., but it’s the leader in 22 nations, from France to Mexico, in the $3 billion worldwide market for erectile dysfunction.
The pills all work the same way, by blocking an enzyme in men’s bodies, allowing men to get and maintain an erection.
Doctors say they expect Cialis’ once-a-day version to catch on. “The baby boomer population is growing. I think a certain patient group could benefit. They want to take it now and be ready whenever,” says Dr. Ronald Suh, who works at Urology of Indiana.
Some analysts say the once-a-day version could increase Lilly sales, but only modestly. But it could provide a steadier revenue stream than the current dosage of Cialis, which men take sporadically.
“Giving consumers more options is a positive step, but I don’t think it’s going to be a game-changing development for Lilly or the erectile-dysfunction market, at least in the short run,” says Jason Fox, a drug analyst at H&R Block in Detroit.
Source:http://www.app.com/apps/pbcs.dll/article?AID=/20070918/LIFE11/709180345/1006/LIFE
September 14th, 2007
UK biopharmaceutical company Vernalis on Sept. 13th announced that a diet drug it is developing similar to Acomplia (rimonabant), V24343, had produced “striking weight loss” in patients in two small phase I clinical trials, with one patient losing 24 pounds in just over two weeks.
The Vernalis drug, like Acomplia, is a CB-1 receptor antagonist that acts by targeting the CB-1 receptor in the brain and suppressing a person’s appetite. Vernalis said its drug produced weight-loss results that compared “very favorably” with results for rimonabant.
Average weight loss after 16 days was 1 pound for the overweight and mildly obese patients given a placebo, 6 pounds for those on a 5 mg dose of V24343 and 11 pounds for those on a 100 mg dose.
But Vernalis said results for V24343 from its early trial showed “a markedly reduced propensity for neurological adverse events” and “a lower propensity to induce nausea and GI disturbance.”
While Acomplia has been approved and is on sale in Europe, developer Sanofi-Aventis pulled back its application in the United States after it was unanimously thumbed down by an FDA advisory committee concerned over side-effects that included suicidal thoughts and behavior.
Vernalis said the concerns over “risks associated with depression, may be relevant to this class of drug. However, the question as to whether or not other CB-1 antagonists can achieve similar or improved efficacy without major side effects remains open.”
Pharmaceutical giants Merck and Pfizer are far ahead of Vernalis in exploring this, with drugs that target the CB-1 receptor already in large phase III trials.
Vernalis CEO Simon Sturge, nevertheless, said his company was “very excited by these preliminary results which, if confirmed over longer studies, will be of significant benefit to overweight and obese patients.
“We stated from the outset of this trial that it is our intention to seek a partner for this program, a process which is enhanced by such promising data,” he added.
Source: http://www.acompliareport.com
August 13th, 2007
Erectile dysfunction after surgery to remove the prostate (radical prostatectomy) has traditionally been attributed to nerve damage that theoretically should heal over time. But it can take as long as two years for the nerves to recover enough for a man to have an erection without the aid of drugs or devices.
By that time, other damage may have occurred, according to an article in the latest issue of Perspectives on Prostate Disease.
The Harvard Medical School bulletin notes that when the penis is flaccid for long periods of time, it is deprived of a lot of oxygen-rich blood. Recent research suggests that this low oxygen level causes some muscle cells in the penis’s erectile tissue to lose their flexibility. The tissue gradually becomes more like scar tissue, interfering with the penis’s ability to expand when it’s filled with blood.
Therefore, the traditional advice given to men—to wait for erectile function to return on its own—may not be adequate. Simply put, erections seem to work on a use-it-or-lose-it basis. To prevent the secondary damage that may occur if the penis goes too long without erections, researchers now think it’s better to restore erectile function soon after prostate removal. Treatment options include using a vacuum pump device or taking erectile dysfunction drugs by mouth or by injection into the penis.
According to Dr. Marc Garnick, editor in chief of Perspectives on Prostate Disease and a Harvard oncologist, “Although the evidence supporting this ‘penile rehabilitation’ isn’t perfect, you may want to ask your doctor about the options. Such early intervention may help increase the odds that you will regain erectile function.”
Also covered in the 48-page report:
- Alternative therapies for prostate cancer
- Handling a prostate cancer relapse
- Surgical options for benign prostatic hyperplasia
August 10th, 2007
A Des Moines woman who asked the Polk County Jail to lock her up so she can quit smoking is looking at smoking cessation programs and methods.Viewers’ e-mails have been pouring in to KCCI about Jodi Perkins.The Polk County Jail said they wouldn’t take her, but many people from around the country offered suggestions for Perkins to try.
“I do look at it as a life-or-death situation. Just last week, two people that I know were diagnosed with lung cancer and that has really hit home and scared me,” Perkins said.
Many told Perkins to try a prescription drug called Chantix. The Mayo Clinic e-mailed Perkins inviting her to try its residential treatment program.Perkins’ co-workers recommended she try laser treatment.”They laser your ears, nose and hands, and they shoot endorphins into you. So I already e-mailed them because it sounded like the best idea so far,” she said.Perkins said she is desperate to quit the habit. She said she has tried prescription pills, gum, nicotine patches to no avail.”I got stronger and stronger patches and then I went to wearing multiple patches while smoking and that didn’t faze me,” she said.She said she wishes she knew at 16 what she knows today.”Absolutely don’t pick up that first cigarette and don’t take it. Don’t take it because somebody said it was cool and don’t hang around with people who do,” she said.Perkins contacted the Mayo Clinic about its offer. She has a week of vacation time next week and is hoping to participate in the program at that time.
August 6th, 2007
The Co-operative Group is moving into the generic drugs industry with the construction of a factory in China in partnership with a Chinese pharmaceutical company.The group today announced that it had signed a joint venture with Tasly Group China, one of the country’s top three drug companies.
It has taken a 60% stake in the venture which will employ up to 200 people and is expected to begin production of a range of generic drugs within a year. Total investment for the project is £20m.
John Nuttall, managing director of the healthcare division of the Co-op, said the new factory would make well-established generic medicines as well as newer generic versions of drugs that have recently come off-patent. These will be brought back to the UK to supply the Co-op’s 600 pharmacies.
Mr Nuttall said the group planned to sell the generics it makes in Europe and was interested in going into the US. The drugs will not have the Co-op brand but another to be decided.
This is the group’s first move into drug manufacturing and its first venture in China. The generics industry is a lucrative one, as more and more blockbuster drugs come off patent, providing profitable opportunities for companies to copy them.
Global blockbusters such as Pfizer’s Viagra are reaching the end of their patent, and by 2009, $80bn worth of blockbuster drug patents will expire.
Mr Nuttall said the move would give the group control over its source of supply and would help improve margins. He said the Co-op had chosen China because of the wide experience of its partner Tasly in making drugs as well as lower production costs.
Frances Cloud, a generics analyst at Nomura Code Securities, said this was the first Chinese deal of its kind. She said an Indian company would normally do this kind of deal.
China has been criticised recently for the lack of safety of some of its products. The head of the country’s food and drug administration was executed last month after he was found guilty of accepting bribes from companies to approve their products without the necessary checks. Some of the drugs were blamed for several deaths.
Mr Nuttal said the Co-op had management control of the joint venture, adding that any drugs that came into the UK had to adhere to strict guidelines set by the MHRA, the UK’s drugs regulator. “We’ve got a very high degree of confidence that the products will comply with UK standards.”
Ms Cloud questioned the group’s timing. “A year from breaking ground to actually having products coming out is rather short,” she said. Announcement of the venture comes after the recent merger of the Co-operative Group and United Co-operatives, which was completed at the end of last month.
The enlarged group is the world’s largest consumer co-operative with sales of more than £9bn, 4 million members and 87,500 employees. The Co-op is the third largest pharmaceutical chain in the country with annual sales of £450m and more than 33 million prescriptions dispensed every year.
August 2nd, 2007
Just how badly sales of diet drug Acomplia (rimonabant) have been set back by Sanofi’s inability to bring it to the U.S. market was dramatically illustrated July 25th when GlaxoSmithKline revealed initial launch results for over-the-counter diet pill alli (low-dose Xenical).
Sales of non-prescription alli totaled a surprising $156 million in the weeks after its U.S. launch in mid-June — a sales surge that dwarfs the monthly sales of Acomplia in all the countries where it is on the market in the European Union.
If most of the alli sales were to people initially buying a one-month supply of the over-the-counter diet pill, the sales figure would suggest that more than 1 million Americans decided to try these non-prescription weight-loss product in its first weeks on the market.
By contrast, in the European Union, where Acomplia was approved for sale last summer, somewhere between 100,000 and 200,000 are believed to have tried it over the course of a year.
Sanofi had initially hoped that Acomplia — which was to be sold in the United States as Zimulti — would be a blockbuster drug with sales that could even exceed $5 billion worldwide.
But without the U.S. market, it appears that Sanofi will be fortunate if sales in Europe and other countries where it has been approved total one-tenth of that.
Glaxo, in announcing sales results for alli as part of its report on second-quarter earnings, said its big advertising and promotion campaign paid off with more than 2.4 billion.
Glaxo also said that it had recorded more than 4.5 million visits to its website — myalli.com — making it the third-most visited website for any over-the-counter pharmaceutical product.
Acomplia is currently marketed in 13 European Union nations as well as in Argentina, Mexico and a handful of other countries.
July 31st, 2007
The city police and the Jakarta Food and Drugs Monitoring Agency announced Monday they had seized Rp 25 billion (US$2.75 million) worth of medicine distributed without permits during a series of raids over the past two months.
Five suspects were arrested and two others remained on the loose, the city police’s director of special crimes Sr. Comr. Sigit Sudarmanto said.
The confiscated medicines included over 15.6 million tablets, 46,000 capsules, 990 bottles, nine sacks of Chinese drugs and more than 13,000 other medical items.
Police also seized vaccines for diseases such as polio, measles and Hepatitis B, as well as food supplements, Calcium and vitamins C, B12, B1, B Complex.
The drugs were for treating infections, pain, allergies, respiratory illnesses, gastrointestinal illnesses, joint problems and sexual dysfunction.
“Some of the medicine may be genuine,” Sigit said.
An official at the agency, Heru Purwanto, said, “The originality of the medicines can only be determined by laboratory checks.”
Police alleged their preliminary investigation revealed the suspects were stockpiling, distributing and selling imported medicines and fake drugs as well as medical equipment, all without licenses from the National Food and Drugs Agency.
Heru urged the public to be cautious of fake drugs and to take a close look at the registration numbers and agency circle marks on medicine packages.
“The printed circle marks and registration numbers show that the medicines have passed the agency’s tests for quality and safety.”
There are three types of circle marks: red for prescribed drugs, blue for semi-prescribed drugs, and green for over-the-counter drugs.
There are also various types of registration number labeling, including “DKI” to indicate imported prescribed branded drugs, “DBL” indicating local over-the-counter drugs and “DTI” and “DTL” to indicate imported and local semi-prescribed branded drugs. For the generic drugs, the letter G is used instead of D on the label.
“The public should also be cautious about buying drugs that are much cheaper than the original prices,” he said.
“Unlicensed drugs can be as cheap as half the price of genuine ones,” he said, citing an example of the price of a blister packet of illegal Ponstan brand pain-killer, which costs as little as Rp 3,000. The official market price is around Rp 15,000.
Heru said, “The wide spread of unlicensed drugs is probably due to drug producers’ aim of accelerating the distribution process.”
Normally, a producer must wait a maximum of 100 days for laboratory testing before receiving a distribution license, Heru said.
The five-year term of registration of a drug officially costs between Rp 500,000 and Rp 1 million. Producers must re-register every five years.
July 26th, 2007
Smoking bans in public places have recently come into effect in several European countries, and Germany is set to join their ranks next month.
There has never been a better time to kick the habit, but smokers should be warned - without professional help the task is likely to be much harder. Statistics show that only 1-2 percent of smokers manage to quit on their own.
In Germany at least, smokers are vanishing fast, mainly because hardly anyone actually takes up the habit.
The number of young people who smoke fell this spring to a historic low, according to officials at Germany’s Federal Centre for Health Awareness in Cologne. The number of 12- to 17-year-olds who regularly light up has dropped to 18 percent, the figures show.
Failure to quit smoking by relying on sheer willpower alone usually means that the smoker is physically addicted.
“Nicotine is a very strong stimulant and one of the most dependency-inducing drugs,” said Karin Joder, a health scientist and psychologist from the northern city of Kiel. “Addiction occurs faster than with heroin or other drugs since nicotine influences the brain’s metabolism.”
The substance activates the brain’s reward mechanisms and releases “feel-good” chemicals. As a result, smokers who do not light up just feel bad.
Studies show that most habitual smokers only need to smoke one cigarette to find their emotional equilibrium. They have become so used to the kick unleashed by the substance that they are no longer consciously aware of its effect.
Smokers usually associate smoking a cigarette with a pleasant experience such as taking a break from work. Before long the brain learns to associate the two actions, telling the person “a pause for a cigarette feels good”.
The brain is unfortunately not adequately aware that the positive feedback is not a direct result of nicotine being inhaled.
Group therapy sessions with such promising titles as “How to finally quit smoking” are seen to be the most effective method of cessation. The group of smokers meets with a counsellor who guides the session. Initially, the aim is to analyse the smoking habits of those taking part.
“The idea is to make it clear to people that they are actually addicted,” said Karin Joder. In many cases this means destroying the illusions associated with the smoking habit.
The counsellor has little time for nicotine substitutes such as patches, sprays and other medicines.
These substances can reduce the craving and headaches, which usually occur as part of the nerve- wracking withdrawal symptoms although the smoker does realize that he no longer needs cigarettes and becomes more amenable to therapy.
Such substitute products are however ineffective in the long-term since they cannot diminish physical dependence and continue to provide the body with the nicotine it so craves.
The same applies to nicotine replacement therapy (NRT) medicines that are usually only available on prescription. Zyban (buspronion and Champix (varenicline) reduce the burning desire for nicotine but their side effects are undesirable.
Those observed in clinical trials include insomnia, panic attacks and dizziness. Vareniclin reduces the withdrawal symptoms and makes people taking it feel sick, if they do smoke a cigarette. The side effects include difficulty sleeping, flatulence, headaches and nausea.
According to expert Christian Kroeger at the Therapy Research Institute in Munich, such medicines are only really suitable for heavy smokers who are likely to experience severe physical and mental repercussions, if they simply give up smoking from one day to the other.
July 25th, 2007
The following is being issued by the AIDS Healthcare Foundation: AIDS Healthcare Foundation (AHF), is hosting a media availability all day today and Tuesday to comment upon a reckless new television advertising campaign for the erectile dysfunction drug, Viagra, premiering tonight during the NBC Nightly News. The campaign, titled, “Viva Viagra!” was created by Pfizer Inc., the world’s largest pharmaceutical company for its erectile- dysfunction drug Viagra (sildenafil citrate). The slick ad features 40-ish year-old men singing “Viva Viagra” to the tune of Elvis Presley’s immortal party anthem, “Viva Las Vegas!”
“Pfizer is clearly dovetailing off of the city of Las Vegas’ recent and enormously successful ‘What Happens in Vegas, Stays in Vegas’ campaign with its own new ‘Viva Viagra’ ad campaign,” said Michael Weinstein, AIDS Healthcare Foundation President. “Unfortunately, as far as Viagra is concerned, what happens in Vegas may NOT stay in Vegas when the use of Viagra as a party drug is encouraged with irresponsible ads like this-there is a real possibility of increased STD and HIV exposure a result of Pfizer’s encouragement of the reckless use of its ED drug, Viagra. ”
A Brief History and Background of Erectile Dysfunction (ED) Drugs, and Pfizer’s Advertising of Viagra
Viagra, the first erectile dysfunction drug on the market, was patented by Pfizer in 1996 and subsequently was approved for use in erectile dysfunction , on March 27, 1998, becoming the first pill approved to treat erectile dysfunction in the United States. It was offered for sale in the United States later that year, and quickly became a blockbuster drug for Pfizer: annual sales of Viagra in the period 1999-2001 exceeded $1 billion. Early advertisements for Viagra included television and print ads featuring septuagenarian and former Senator and Presidential candidate, Bob Dole (R, Kansas), who, as a spokesperson for Viagra, lent significant credibility and gravitas to Pfizer and the drug, particularly as he was widely-known to have suffered from, and undergone surgery for, prostate cancer.
With the introduction of two competing erectile dysfunction drugs in 2003, Eli Lilly & Company’s Cialis (tadalafil), and Bayer AG’s Levitra (vardenafil), Pfizer’s marketing of Viagra changed dramatically. One subsequent campaign for Viagra feature an attractive forty something year-old man sporting an impish grin and airbrushed devil’s horns on his head.
Earlier last year, AIDS Healthcare Foundation criticized Pfizer for running a holiday-themed print ad campaign that AHF believed promoted unsafe sex by encouraging the recreational use of Viagra on holidays such as New Year’s Eve and the Super Bowl. The ads, seen in The Wall Street Journal and The L.A. Daily News, among other publications, depicted a handsome, forty-ish male grinning knowingly at the camera with taglines, such as “What are you doing New Year’s Eve?” and “Be this Sunday’s MVP.” Pfizer continued this irresponsible advertising campaign to withdraw its previous ads, which inferred that men could re-capture their youthful vigor and become a devil-horned “wild thing” by taking Viagra.
AIDS Healthcare Foundation (AHF) is the nation’s largest oldest and largest non-profit HIV/AIDS healthcare, research, prevention and education provider, currently provides medical care, including lifesaving antiretroviral treatment, and/or services to more than 50,000 individuals in 15 countries worldwide in the US, Africa, Latin America/Caribbean and Asia.
July 23rd, 2007
Norwegian researchers have discovered that women who smoke are 59 percent more likely than non-smokers to have an early menopause. The researchers say smokers are more likely to begin the menopause before the age of 45 putting themselves at an increased risk of osteoporosis and heart disease. Dr. Thea F. Mikkelsen of the University of Oslo and her colleagues found that among 2,123 women 59 to 60 years old, those who currently smoked were 59 percent more likely than non-smokers to have undergone early menopause and for the heaviest smokers, the risk of early menopause was almost double.
The researchers also found that women who were smokers, but quit at least 10 years before menopause, were substantially less likely than current smokers to have stopped menstruating before age 45.
Mikkelsen and her team say evidence already exists which shows that smoking later in life makes a woman more likely to have early menopause, while smokers who quit before middle age may not be affected.
However the researchers went one step further and investigated whether exposure to second-hand smoke might also influence the timing of menopause.
They found that almost 10 percent of the women went through menopause before age 45 and of that number around 25 percent were current smokers, 28.7 percent were ex-smokers and 35.2 percent reported current passive exposure to smoke.
The women who had quit smoking at least a decade before menopause were 87 percent less likely than their peers who currently smoked to have gone through menopause early.
When they were compared with married women, widows were also at increased risk of early menopause, as were women who were in poor health.
In general the better educated women were less likely to go into menopause early, but they were also less likely to be smokers.
A good social life also appeared to cut the early menopause risk and the researchers found no link between coffee or alcohol consumption or passive exposure to smoke and early menopause risk.
Mikkelsen and her team say the earlier a woman stops smoking the more protection she derives with respect to an early onset of menopause.”
The research is published in the online journal “BMC Public Health.”
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