Monday, June 30, 2003
Actonel® provides low incidence of vertebral fracture in osteoporosis patients through 7 years
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Health
EurekAlert, Public release date: 19-Jun-2003
Contact: Terri Pedone
terri.pedone@aventis.com
908-243-6578
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.
Study Details
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.
About Osteoporosis
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.
About Aventis
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 koenigs.pm@pg.com
Mercosur Leaders Agree to Expand, Strengthen Trade Ties
<a href=www.voanews.com>VOA News, 19 Jun 2003, 10:07 UTC
The heads of the four main countries that make up South America's Mercosur trading bloc have agreed to expand economic and political ties in an effort to create a common market by 2006.
The presidents of Argentina, Brazil, Paraguay, and Uruguay made the pledge Wednesday as they wrapped up their bi-annual summit in Asuncion.
Their counterparts from associate member nations Bolivia and Chile also took part in the discussions. Venezuelan President Hugo Chavez attended the talks as a special guest. Reports indicate he would like to see Venezuela become a full member of the group.
The South American leaders want to strengthen Mercosur to counter what they say is U.S. dominance in talks on a proposed Free Trade Area of the Americas. Work on the hemispheric trade zone is expected to be completed by 2005.
The planned zone is a top U.S. policy priority for Latin America and would stretch from Alaska to Argentina. Thirty four nations, excluding Cuba, would be part of the zone.
The Mercosur leaders also agreed to intensify efforts to merge with the Andean Community - which comprises Bolivia, Colombia, Ecuador, Peru, and Venezuela.
Brazil lowers interest rate to 26%
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brazil
The Miami Herald, Posted on Thu, Jun. 19, 2003
BY KEVIN G. HALL
khall@krwashington.com
RIO DE JANEIRO, Brazil - Brazil's central bank slightly lowered its overnight basic lending rate Wednesday for the first time in 11 months and the first time since President Luiz Inacio Lula da Silva took office Jan. 1.
In a sign that the Brazilian government is regaining investors' confidence, the bank's monetary policy committee reduced the interest rate, called the Selic, by half a percentage point, to 26 percent.
Brazil's overnight lending rate remains the third-highest in the world, trailing only Turkey and Venezuela.
Brazil had raised interest rates five times since October, the month Lula was elected, the final time in February under his presidency.
The higher rates were aimed at inducing foreign investors to keep their money in Brazil despite fears that Lula, a critic of U.S.-backed economic policies, would abandon the free-market reforms his predecessor had adopted.
Wednesday's action is unlikely to quiet what has become the first major controversy of Lula's government. An avowed leftist, Lula spooked financial markets after his victory. Since taking office, he has been ultra-orthodox in managing the economy.
Economic analysts in Brazil think interest rates should fall further, given that the currency has been stable for months against the dollar.
''It is very clear there was enough space to cut up to 2 points on interest rates,'' said Daniel Tha, an analyst with economic consultant Global Invest in Curitiba.
High interest rates are slowing South America's largest economy, which isn't expected to grow by more than 2 percent this year.
Lula took office promising a ``confidence shock.''
But Tha and other analysts complain that the high interest rates stifle consumer spending and hurt the stock market, because investors won't gamble on stocks if they can earn 26 percent on government bonds and other debt instruments.
''They are forgetting to look at the real economy, where people are hurting,'' Tha said.
In a speech Tuesday, Lula asked Brazilians to be patient about the economy and his promise of new jobs.
''We have spent six months fixing the house, conquering the confidence [of investors] that was needed,'' he said.
Inflation in May was at a 17.2 percent annual rate, the highest since 1996. The central bank predicts 7.76 percent inflation over the next 12 months.
Earlier this month, Brazil sold international investors $1.25 billion in 10-year bonds. The government said it was a clear sign that Wall Street saw healthy long-term prospects for Brazil.
Big grant to oil firm shrouded in secrecy-- Citgo will not discuss the $15.7 million it got in federal port security aid.
The Philladelphia Enquirer, Posted on Thu, Jun. 19, 2003
By Jennifer Lin
Inquirer Staff Writer
Last week, after the U.S. Department of Homeland Security awarded long-awaited and highly competitive grants for port security projects, many in the maritime trade were baffled by the windfall for Citgo Petroleum Corp.
The odds of anyone's getting a grant were no better than one in five. Even then, most of the winners were awarded less than $1 million. But Citgo, the profitable U.S. subsidiary of the Venezuelan national oil company, hit the jackpot: a $13.5 million grant to upgrade security at its refinery in Lake Charles, La.
That's more than the combined 24 grants for the Delaware River port system.
More than the nine grants for Los Angeles, the busiest container port in the country.
More than the 17 grants for every other private business or port authority in Louisiana.
So why did one company get so much money, and where is it going?
The Homeland Security Department won't say, citing security concerns.
Neither will Citgo.
"We will not discuss any of the items that the money will be used for," said Kent Young, a spokesman for Citgo at the company's U.S. headquarters in Tulsa, Okla. "That was a condition of our application, that it be held in confidence."
In addition, Young preemptively said the terms of the grant award would not be available through the open-records provision of the federal Freedom of Information Act (FOIA). "It is my understanding that it is not subject to FOIA," Young said.
The secrecy shrouding the Citgo grant points to a larger problem with the billions in taxpayer money being directed to fight the war on terrorism, according to Gary Bass, executive director of OMB Watch, a nonprofit government watchdog group in Washington that tracks budget issues.
"This administration equates secrecy with security," Bass said. "It's our firm belief that access to information will actually make us feel safer. Once the public knows what steps are being taken, there's not only a better feeling about security, there's accountability to assure that we are safer. We can verify that various steps have been taken."
Mark Hatfield, a spokesman for the Transportation Security Administration (TSA) of the Homeland Security Department, defended the confidentiality of the grants because of the sensitive nature of the projects.
"You don't want to tell people where the hole is before you have it plugged," Hatfield said.
The size of the Citgo award also raised eyebrows among other oil companies, as well as port officials, because of the fierce competition for scare federal dollars for port security. For the latest round of port funding, the Homeland Security Department received 1,112 applications for the $245 million to be handed out.
Some maritime groups that lost out in grants were dismayed to see one company get so much.
"There are so many things that are not getting funded," said Doug Dillon, executive director of the Tri-State Maritime Safety Association, a nonprofit group in Newport, Del., that did not get funding for a project to increase vessel tracking on the Delaware River.
While the nation's airports have ramped up security since 9/11, the 361 seaports across the country have not received the same level of federal support for security improvements. Many lawmakers and maritime officials believe that the nation's port system is the weak link in homeland security.
With ports, the two biggest threats are terrorists using shipping containers to plant bombs, or sabotaging refineries or tanker ships.
The government's own concern about the vulnerability of chemical plants and refineries was evident in the large number of port security grants going to private companies in those sectors.
In distributing $245 million last week in port security funding, the Homeland Security Department directed 15 percent of the money to refineries, tank terminals and pipelines.
Citgo received the most money, with grants totaling $15.7 million for facilities in Lake Charles; Paulsboro; Savannah, Ga.; and Corpus Christi, Texas.
Sunoco Inc. was second, with a combined $5.1 million in grants for plants in Philadelphia and the Houston area.
Hatfield, a TSA spokesman, said the process for awarding the grant money was strictly prescribed. The grants were determined by a committee made up of officials from TSA, the Coast Guard, and the Maritime Administration of the Department of Transportation.
"The awards are made strictly on the merits of the proposal," Hatfield said.
He said Citgo had conducted a security assessment of its Lake Charles refinery in December 2001 and again in April 2003. "They did the groundwork, and that put them further ahead," Hatfield said.
While not disclosing the specifics of the Citgo grant, he said the money would be used to control access to the company's refinery facilities. He added that under grant guidelines, the money could be used to buy such equipment as identification-card readers, lighting systems, or perimeter cameras.
Citgo, which earned $140 million in the first quarter of this year, had received a previous TSA grant in 2002 to buy a patrol boat and to build a boat ramp and boathouse for its Lake Charles facility. The company is part of Petroleos de Venezuela S.A., the national oil company of Venezuela.
In Lake Charles, the Citgo grant took many in the port community by surprise. Located in southwestern Louisiana, the port stretches 35 miles from the Gulf of Mexico up through the Calcasieu River Waterway to the city of Lake Charles.
In addition to Citgo, the region has two other refineries, plus river terminals for receiving liquefied natural gas, a volatile cargo that raises the security risk for the waterway.
Jim Robinson, director of navigation and security for the state-run Port of Lake Charles, said he knew nothing about the Citgo grant, other than its enviable size.
"I could contract a private security company to provide round-the-clock surveillance for the entire waterway for two years on that size of a grant," Robinson said. "But I doubt that's what they're going to spend it on."
Mercosur Presidents Agree to Expand, Strengthen Trade Bloc
<a href=www.voanews.com>VOA News
19 Jun 2003, 01:33 UTC
The leaders of South America's Mercosur trade bloc have agreed to strengthen and expand their economic and political ties to create a common market by 2006.
The presidents of Argentina, Brazil, Paraguay, and Uruguay made the pledge Wednesday as they wrapped up their bi-annual summit in Asuncion.
Their counterparts from associate member nations Bolivia and Chile also took part in the discussions. Venezuelan President Hugo Chavez attended the talks as a special guest.
The South American leaders want to boost Mercosur to counter what they say is U.S. dominance in talks on a proposed Free Trade Area of the Americas. Work on the hemispheric trade zone is expected to be completed by 2005.
The planned zone is a top U.S. policy priority for Latin America and would stretch from Alaska to Argentina. Thirty four nations, excluding Cuba, would be part of the zone.
The Mercosur leaders also agreed to intensify efforts to merge with the Andean Community - which comprises Bolivia, Colombia, Ecuador, Peru, and Venezuela. Peru and Venezuela have expressed an interest in Mercosur.