Actonel® provides low incidence of vertebral fracture in osteoporosis patients through 7 years
EurekAlert, Public release date: 19-Jun-2003
Contact: Terri Pedone
Hill and Knowlton
PHILADELPHIA (June 19, 2003) – In a long-term clinical trial of Actonel® (risedronate sodium tablets), a low incidence of new vertebral fractures was maintained over 7 years of treatment. The new study, presented today at ENDO 2003, the 85th annual meeting of The Endocrine Society (ENDO), examined the long-term safety profile and sustained efficacy of Actonel in the treatment of postmenopausal osteoporosis.
"Osteoporosis is treated over a number of years, so long-term protection against fractures is critical," said Jean-Marc Kaufman, M.D., PhD, Unit for Osteoporosis and Metabolic Bone Disease, Ghent University Hospital, Belgium. "This is the longest clinical trial of risedronate to date, and it provides reassurance that the fracture benefits and favorable safety profile of risedronate are sustained over 7 years."
The study measured fracture incidence in 2 groups of postmenopausal women. One group received Actonel 5 mg daily for 7 years; the other received placebo for 5 years and was then switched to Actonel 5 mg daily for 2 years. For those women treated with Actonel for 7 years, the annualized incidence of new vertebral fractures for years 0-3, 4-5, and 6-7 was 4.7 percent, 5.2 percent, and 3.8 percent, respectively. These data suggest a sustained benefit of Actonel over 7 years of therapy. In the 5-year placebo/2-year Actonel group, the annualized incidence of new vertebral fracture dropped to 3.8 percent during years 6-7 while taking Actonel, down from an incidence of 12.3 percent experienced during years 4-5 on placebo. The incidence of new vertebral fractures in these patients was reduced during years 6 and 7 to a level comparable to those of the treatment group during the 7 years of the study.
Adverse events in years 6-7, including upper gastrointestinal adverse events, were similar to those in patients taking placebo during the first 5 years of the study.
This study was the second 2-year extension of an original 3-year placebo-controlled study with Actonel 5mg daily for the treatment of postmenopausal osteoporosis. This open-label extension study evaluated a total of 164 women: 83 patients received Actonel 5 mg daily for 7 years; 81 patients received placebo for 5 years and then were treated with Actonel 5 mg daily for 2 years. The original placebo group was switched to active therapy during years 6 and 7 for ethical reasons. Throughout the 7 years of the study, all patients received 1,000 mg daily calcium and, if baseline levels were low, up to 500 IU Vitamin D daily. The objective of the study was to evaluate the safety and tolerability of 7 years of Actonel treatment.
Osteoporosis is a skeletal disorder characterized by reduced bone strength predisposing a person to an increased risk of fracture. According to the National Osteoporosis Foundation, 1.2 million women suffer osteoporotic fractures in the U.S. each year. Risk factors for osteoporosis and subsequent fractures include loss of estrogen production, advanced age, preexisting fractures, and low bone mineral density. Studies show that among postmenopausal women with osteoporosis who experience a spinal fracture, one out of five will suffer their next spinal fracture within just one year, potentially leading to a fracture cascade.
Preventive measures, such as not smoking, maintaining a balanced diet supplemented with calcium and vitamin D, and engaging in weight-bearing exercise like walking, can reduce an individual's chances of developing osteoporosis. However, in some people these preventive measures may not be enough, and medications like Actonel may be beneficial.
About Actonel® (risedronate sodium tablets)
Actonel is developed by Procter & Gamble Pharmaceuticals and co-marketed by Procter & Gamble Pharmaceuticals and Aventis. Actonel 35 mg Once-a-Week and Actonel 5 mg daily are indicated for the prevention and treatment of osteoporosis in postmenopausal women. Actonel 5 mg daily is also indicated for the prevention and treatment of glucocorticoid-induced osteoporosis (GIO) in men and women either initiating or continuing systemic glucocorticoid treatment (greater than or equal to 7.5 mg/d prednisone or equivalent) for chronic diseases.
In clinical trials, Actonel was generally well tolerated. Actonel is contraindicated in patients with hypocalcemia, known hypersensitivity to any component of this product, or inability to stand or sit upright for at least 30 minutes. Hypocalcemia and other disturbances of bone and mineral metabolism should be effectively treated before starting Actonel therapy. Actonel is not recommended for use in patients with severe renal impairment (creatinine clearance < 30 mL/min).
Bisphosphonates may cause upper gastrointestinal disorders such as dysphagia, esophagitis and esophageal or gastric ulcer. Patients should pay particular attention to the dosing instructions, as failure to take the drug according to instructions may compromise clinical benefits and may increase the risk of adverse events.
In clinical trials, the overall incidence of adverse events with Actonel 5 mg daily was comparable to placebo. The most commonly reported adverse events regardless of causality were infection (primarily upper respiratory, placebo 29.7 percent vs. Actonel 5 mg 29.9 percent), back pain (23.6 percent vs. 26.1 percent), and arthralgia (21.1 percent vs. 23.7 percent).
In a one-year clinical trial comparing Actonel 35 mg Once-a-Week and Actonel 5 mg daily, the overall incidence of adverse events with the two dosing regimens was similar. The most commonly reported adverse events regardless of causality were infection (Actonel 35 mg 20.6 percent vs. Actonel 5 mg 19.0 percent), arthralgia (14.2 percent vs. 11.5 percent) and constipation (12.2 percent vs. 12.5 percent). Please visit www.actonel.com for full prescribing information for Actonel.
About The Alliance for Better Bone Health
The Alliance for Better Bone Health was formed by Procter & Gamble and Aventis in May 1997 to promote bone health and disease awareness through numerous activities to support physicians and patients around the globe.
About Procter & Gamble
Two billion times a day, P&G brands touch the lives of people around the world. Some of the nearly 300 P&G brands consumers know and use with confidence in over 160 countries around the world include: Pampers®, Tide®, Ariel®, Always®, Whisper®, Pantene®, Bounty®, Pringles®, Folgers®, Charmie®, Downy®, Lenor®, Iams®, Crest®, Olay®, and Clairol Nice 'n Easy®. Some of P&G Pharmaceuticals leading prescription products include Actonel® (risedronate sodium tablets), Asacol® (mesalamine), and Macrobid® (nitrofurantoin monohydrate macrocrystals). The P&G community consists of nearly 102,000 employees working in almost 80 countries worldwide. Please visit www.pg.com for the latest news and in-depth information about P&G and its brands.
Aventis is dedicated to treating and preventing disease by discovering and developing innovative prescription drugs and human vaccines. In 2002, Aventis generated sales of € 17.6 billion (US $16.6 billion), invested € 3.1 billion (US $3 billion) in research and development and employed approximately 71,000 people in its core business. Aventis corporate headquarters are in Strasbourg, France. The company's prescription drugs business is conducted in the U.S. by Aventis Pharmaceuticals Inc., which is headquartered in Bridgewater, New Jersey. For more information about Aventis in the U.S., please visit: www.aventis-us.com.
Copies of this release are available on the Procter & Gamble Pharmaceuticals Web site at www.pgpharma.com, on the Aventis Pharmaceuticals U.S. Web site at www.aventis-us.com, or by calling 1-800-207-8049.
For P&G: All statements, other than statements of historical fact included in this news release, are forward-looking statements, as that term is defined in the Private Securities Litigation Reform Act of 1995. In addition to the risks and uncertainties noted in this news release, there are certain factors that could cause actual results to differ materially from those anticipated by some of the statements made. These include: (1) the achievement of expected cost and tax savings associated with changes in the Company's organization structure; (2) the ability to achieve business plans, including growing volume profitably, despite high levels of competitive activity, especially with respect to the product categories and geographical markets in which the Company has chosen to focus; (3) the ability to manage and maintain key customer relationships; (4) the achievement of growth in significant developing markets such as China, Turkey, Mexico, the Southern Cone of Latin America, the countries of Central and Eastern Europe and the countries of Southeast Asia; (5) the ability to successfully manage regulatory, tax and legal matters, including resolution of pending matters within current estimates; (6) the ability to successfully implement, achieve and sustain cost improvement plans in manufacturing and overhead areas; (7) the ability to successfully manage currency (including currency issues in Latin America), interest rate and certain commodity cost exposures; (8) the ability to manage the continued political and/or economic uncertainty in Latin America (including Venezuela) and war in the Middle East, as well as any political and/or economic uncertainty due to terrorist activities or war (including Korea); and (9) the successful acquisition, transition, integration, and operation of the Wella business. If the Company's assumptions and estimates are incorrect or do not come to fruition, or if the Company does not achieve all of these key factors, then the Company's actual results might differ materially from the forward-looking statements made herein.
For Aventis: Statements in this news release other than historical information are forward-looking statements subject to risks and uncertainties. Actual results could differ materially depending on factors such as the availability of resources, the timing and effects of regulatory actions, the strength of competition, the outcome of litigation, and the effectiveness of patent protection. Additional information regarding risks and uncertainties is set forth in the current Annual Report on Form 20-F of Aventis on file with the Securities and Exchange Commission.
Additional Contact Info: Paula Koenigs Procter & Gamble 513-622-3923 email@example.com
America a sweet pill for Indian firms
By: Amriteshwar Mathur
May 26, 2003
For US pharmaceutical companies this may be a bitter pill to swallow. Indian pharmaceutical companies are giving US multinationals, who dominated global research, a run for their own money.
Indian pharma companies are spreading their wings both in USA and in Latin America. And surprisingly it is the quality of the Indian drugs that is appealing to consumers globally.
During the last five years, the share of Indian applications to United States Food and Drugs Administration (USFDA) for selling bulk actives has risen from 1.8 per cent to 6.2 per cent of all such applications received by the drug regulator. Quality is high and some Indian products have found a place in the WHO lists of essential drugs.
Says Shahina Mukadam, pharma analyst, Motilal Oswal Securities, “with its numerous FDA filings companies like Indian companies have demonstrated their ability to successfully contest and win against giants like Glaxo Plc which is essential to survive in US markets.”
Even in Latin America, Indian pharma exports have climbed to $1400 million in 2002-03 from $980 million in 2001-02. But it is the $16 billion Latin American domestic market, that Indian pharmaceutical companies are targeting through joint ventures and by setting up manufacturing bases.
The rush has started. Alembic Ltd. is planning to join hands with certain US based formulators to expand its bulks drugs business. As a first step in this direction, Alembic has filed four drug master files with the USFDA with more applications for the next two-three years.
Glenmark Pharmaceuticals has set up a wholly owned subsidiary Glenmark Pharmaceuticals USA, Inc, based in Princeton, New Jersey, to make further inroad into the US market. Dr Reddy`s Laboratories has filed an Abbreviated New Drug Application (ANDA) with the USFDA for ondansetron hydrochloride tablets and for fexofenadine HC1 tablets.
Ranbaxy Laboratories Ltd., which is ranked eight in the US market has received a tentative approval from the USFDA to make and sell a variety of drugs.
Says Dipak Chattaraj, president Ranbaxy Pharmaceuticals Incorporation (USA), “this further helps strengthens our expanding product portfolio and our commitment to bring generic alternatives into the US healthcare system. The approval is yet another testimony to our strong intellectual and regulatory expertise.”
Even in Latin American companies like Ranbaxy, Dr Reddy’s, Aurobindo Pharma and Hetero Drugs have set up plants in countries like Venezuela, Chile and Brazil.
The reason Latin Americans perceive Indian drugs as better in quality compared to Chinese drugs, and so they are looking for supply tie-ups with Indian firms.
Researchers win top designation--Immunologists in London are on par with those at Harvard and the Mayo Clinic.
ELAINE SMITH, London Free Press Reporter 2003-05-24 03:06:35
London's immunology researchers are now on par with those at Harvard and the Mayo Clinic.
A team of scientists from the Robarts Research Institute, the Lawson Health Research Institute and the University of Western Ontario landed a prestigious international research designation aimed at accelerating the discovery of treatments for immune system disorders.
"We are among what I would call a unique crowd," said Dr. Joaquin Madrenas, a Robarts physician and scientist and UWO professor who spearheaded the drive to become Canada's only FOCIS Centre for Clinical Immunology and Immunotherapeutics.
"This is a very important club, a very prestigious club whose members have the keenest minds in the world in immunology," added Dr. David Hill, scientific director of LHRI. "This is to be celebrated. We're a member of this club on merit."
The researchers involved in the collaborative effort represent four medical departments and eight clinical divisions at the three institutions.
"It's a virtual centre," said Madrenas. "That's the beauty of it. The institutions represented will continue to support the researchers, but we'll foster communication and interaction and drop the usual barriers."
The researchers will concentrate on immune-mediated diseases such as rheumatoid arthritis and multiple sclerosis.
"One in every four hospital admissions is related to an immune disorder, so both from a clinical and a financial point of view the implications are significant," said Madrenas.
The centre's projects will have a research component, a care component (for example, a patient registry for clinical trials) and an education component, such as a Web presence, which will allow for community involvement.
In the coming months, the centre network will have funding available for such items as the implementation of clinical trials and for assistance by young researchers.
The FOCIS centres selected by the Federation of Clinical Immunology Societies are confined to 22 in the U.S. -- places such as Stanford and Yale -- and eight more worldwide, including England, Italy and Venezuela.
"Here in London, we're finding treatments, cures and ways to affect people throughout the world," Mayor Anne Marie De Cicco told an audience at Robarts where the announcement was made. "We know how to come together in a strategic way."
Dianne Cunningham, Ontario's minister of training, colleges and universities, added congratulations on behalf of the province.
"This is a scientific first for London, for Ontario and for Canada," she said.
"We don't brag enough. I'm looking forward to the day we're announcing a new treatment for an immune-related disorder as a result of this FOCIS designation."
Medical care on the other side of the world
Oconomowoc OnlineAmy Glasheen, staff writer May 12, 2003
Imagine a city on the other side of the world, where people don't have the money or the medicine to receive the treatment they need for HIV or AIDS. Such a city is anything but imaginary. In one city in India, a conservative estimate has more than 250,000 people stricken with the disease.
Think India is far away? Bryan Sauer will tell you differently. He spent four months providing medical care in India. The medical challenges that residents faced left a lasting impression on the Oconomowoc native.
Sauer, a 1994 graduate of Oconomowoc High School, completed medical school at the University of Wisconsin-Madison in May and took the year off. He spent the time traveling to places such as Venezuela and Belize. He also was a substitute teacher.
During the year off, he also spent from January to April in India, working with local people infected with various diseases, such as HIV, malaria and tuberculosis.
This was the third time he had traveled to the country, having spent 10 weeks there during each summer in 1998 and 1999.
Sauer stayed in the city of Thane, approximately 35 kilometers (about 22 miles) from the city of Mumbai, formerly called Bombay. He also did village work in Dolkhamb, which is about 75 kilometers (46 miles) from Thane.
Sauer spent time at Lok Hospital, also located in Thane. The hospital's first phase of construction was completed in 1997 and has been added onto since.
"After getting my M.D. in May, I took a year off basically to spend this extended time in India to work at this hospital and help out," Sauer said.
This hospital is a Christian hospital, in a country where the predominant religion is Hinduism, Sauer said. The government in India has persecuted a number of Christians, Sauer added.
"I think the success and safety of the hospital is a testament to the prayers and support of so many around the world," he said. Sauer added that the hospital was built and updated through donations from people in the United States, United Kingdom and India.
Sauer said that surgeon Stephen Alfred, whom Sauer met through a friend in college, started the hospital. Alfred is a native of India.
While he was there, Sauer also helped with Jeevan Sahara Kendra HIV initiative, which he said means "Center of Life and Help."
"HIV has a very negative stigma, especially in India," Sauer said. "A lot of people find out they have HIV and they're left by the wayside. Their families disown them and they have nothing ... they live in the slums."
He said that the purpose of Jeevan Sahara Kendra is to "bring dignity to these people and help them to die with dignity."
The HIV/AIDS initiative was started less than a year ago, Sauer said. A couple of volunteers and paid staff visit their contacts stricken with the disease.
Sauer said they had approximately 100 contacts with HIV or AIDS that they visited. The initiative is in the initial stages, Sauer said and plans are under way for a support institution where people can be treated for diseases associated with HIV and AIDS.
Without proper medicines, people in India with HIV die much faster than someone with the proper treatments, Sauer said.
"During the four months I was there, at least six to seven patients we had contact with died," Sauer said.
Seeing the way some people lived was difficult, Sauer said.
"I can't imagine having HIV in a country where is little education (about the disease) and then to not have the family support," he said. "That has to be hard."
While seeing different diseases not commonly experienced in this part of the world, such as malaria, was a medical benefit for Sauer, he said helping people was the main reason he was there.
"The people all over were very welcoming," Sauer said. "Ninety-nine percent of the people that you meet are such kind-hearted people and so content with what they have."
The people did everything they could to make him feel welcome, Sauer said.
"I went to one family where we had chicken, and Stephen (Alfred, a surgeon friend) said they probably only have chicken twice a year at their house," Sauer said, due to the families not having a lot of money to buy meat.
He added many of the children enjoyed seeing their pictures on Sauer's digital camera immediately after he took them.
Working in another country didn't provide as big a language barrier that some would think.
"A lot of the communication was based on nonverbal communication," he said.
With all the time he has spent in India, Sauer said that it's a fascinating country. He said one of the hardest parts to see is the poverty-stricken areas.
"It's hard to see people living on the street, people begging," he said.
Although he was an 18-hour plane ride away from Oconomowoc, family wasn't far away. Sauer said that his sister, Julie, paid him a visit during this last trip and his twin brother, Cary, visited him during his summer trip in 1999.
Next month, Sauer will head to the University of Virginia for his residency in internal medicine. His brother is already there for a residency in pediatrics.
Sauer said he could see himself traveling again to use his medicine once he's completed his residency. He said he probably wouldn't make it back to India during his residency.
"You leave those people behind not knowing if you're going to go back for three years," Sauer said.
For Lucky Few, 'Recycled' HIV Drugs Keep Hope Alive
Mon Apr 14, 3:54 PM ET
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By E. J. Mundell
NEW YORK (Reuters Health) - Like many Americans living withHIV (news - web sites), New York writer and activist Mike Barr takes regularly scheduled, physician-sanctioned drug 'holidays,' giving his body a temporary break from the side effects of powerful anti-retroviral medications.
What's uncommon about Barr is how he disposes of drugs he has no use for during these treatment interruptions. Partnering with a Manhattan-based nonprofit agency called Aid For AIDS (news - web sites) (aidforaids.org), Barr and hundreds of like-minded patients across the US and Canada sort, ship and distribute these life-saving, 'recycled' drugs to HIV-positive individuals in the developing world.
"If I can take half as much therapy, and give the other half of that therapy to someone in South America or Haiti, then for the same amount of money two lives are being saved instead of one," he explained.
For hundreds of patients spread across Africa, the Caribbean and Central and South America, Aid For AIDS remains a vital lifeline, providing them with a reliable supply of medicines that would otherwise be financially out of reach.
And since many of those enrolled in the program are AIDS educators and activists in their local communities, their continued survival has a ripple effect, helping prevent the spread of HIV/AIDS in these countries.
"We don't pretend to solve the problem, but we're making it a little better for those who are making a real difference," explained Venezuelan-born Jesus Aguais, who started Aid For AIDS in 1996 with just three patients. That number is now 520 -- and growing.
With no advertising, the simple idea behind Aid for AIDS spread quickly via word of mouth through the HIV patient community in the United States and Canada, resulting in a steady supply of donated drugs.
"People for whatever reason -- they die, they change their regimen, they never took the medicine -- they give it to us," Aguais explained in an interview with Reuters Health.
After removing the donor's name from the label on the bottle, donated medicines are carefully inventoried and sorted as per the requirements of individual patients -- or "clients" as Aguais calls them -- in the developing world.
Every foreign patient who applies for assistance from Aid For AIDS must first undergo a careful medical assessment, because the program's small store of medicines is best spent on those who closely adhere to the strict treatment schedules HIV drug therapy requires.
Working via fax and email with doctors in the client's home country, Program Director Dr. Jaime Valencia reviews application forms that outline prospective clients' proof of HIV status, current medical history, and CD4 immune-cell blood counts.
Priority is given to AIDS activists and educators, "people who are making a difference in their countries," Aguais stressed. In this way, donated medicines do more than just keep individual patients alive -- they also help prevent new infections, as individuals helped by the agency spread the wordabout the dangers of HIV.
Once accepted into the program, clients must submit CD4 counts every six months so that Valencia can chart their progress and adherence to the medications. As often happens, specific medications can decline in effectiveness over time, but Valencia said the agency's drug inventory is usually flexible enough to accommodate changes in drug regimens.
"I have to talk with the client's doctor, telling him which medications we have available, and he chooses the (new) treatment for the patient," he explained.
Working out of a few small rooms in lower Manhattan, Aid For AIDS remains unique.
"There are other recycling programs," Aguais said, "but none of them work like we do. We have complete control over where these medicines go." Because there are currently no U.S. laws allowing or prohibiting the export of donated medicines, Aguais said it is important from a legal standpoint "to know who the patients are." He said abuse of the program (such as reselling donated medicines) is almost nonexistent, due to close bonds that have formed over time between the New York office and trusted doctors in the Americas and Africa.
Aid For AIDS also accepts non-HIV-related drugs and devices for distribution in the developing world. Walking into a room stacked floor-to-ceiling with donated medications, Aguais pointed to one pile in a corner.
"Here we are preparing 13 boxes so far of medical supplies," he said. "This is going to an indigenous area between Venezuela and Colombia called Guajira, the Guajira tribe. We send it to a hospital that we know is going to distribute it."
Lynn Shulman, director of communications with the pioneering AIDS outreach group Gay Men's Health Crisis, said initiatives like Aid for AIDS are desperately needed, "because it enables people with HIV/AIDS to have greater access to medications they need."
But money remains a problem. Although the medicines are donated, they still require storage, sorting and shipping.
"We always struggle for money," Aguais said. "Last year with a budget of $240,000 we sent over $5 million of HIV medicines abroad."
"We have proved, though, that things can be done -- and done well -- when you want to do it," he added. "I hope I can raise a million dollars this year. And instead of helping 500 people, help 5,000. If we help 5,000 of the right people, this will multiply into 20,000. This is how it happens."