Watson Receives US FDA Approval for RAPAFLO(TM) (silodosin) for the Treatment of Benign Prostatic Hyperplasia (BPH)

Watson Pharmaceuticals, Inc, a leading specialty pharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has approved RAPAFLO(TM) (silodosin), the company's new alpha blocker for the treatment of the signs and symptoms of BPH.

BPH is the number one reason patients visit urologists and is characterized by urination problems, including decreased urine flow, more frequent urination and nocturia. The U.S. BPH market is growing and currently exceeds $2 billion annually, of which $1.7 billion is attributed to alpha blockers.

"RAPAFLO's approval is the most important milestone for the Company's Brand division thus far," said Paul Bisaro, Chief Executive Officer of Watson. "RAPAFLO is a novel product that provides strong efficacy and an exceptional safety profile for patients managing their BPH. RAPAFLO provides an excellent long term opportunity for Watson and will be the foundation for future growth of our urology franchise."

Today's approval is based on data from two Phase 3, 12-week, randomized, double-blind, placebo-controlled, multi-center studies as well as a 40 week open label study. In the two Phase 3 studies, 923 patients (mean age 64.6 years) were randomized to receive either RAPAFLO 8 mg once-daily or placebo. In the two trials, 8 mg once-daily RAPAFLO for 12 weeks resulted in significant and rapid relief of BPH symptoms, compared with placebo, as measured by the International Prostate Symptom Score (IPSS). IPSS includes irritative (frequency, urgency, and nocturia), and obstructive (hesitancy, incomplete emptying, intermittency, and weak stream) symptoms. RAPAFLO also has been proven to significantly improve Qmax scores (maximum urine flow rates) as early as two hours following first dose and at 12 weeks of treatment.

"We are pleased we received approval for RAPAFLO so quickly which demonstrates, among other things, the high quality of our clinical and regulatory groups," said Mr. Bisaro. "With our oxybutynin gel NDA under consideration with the FDA and plans to file our Trelstar® 6 month application later this year, Watson is in a unique position to introduce products within the next 12 to 18 months that treat the top three conditions in urology."

About RAPAFLO

RAPAFLO is an effective, selective alpha-1 adrenergic receptor antagonist. RAPAFLO binds with high affinity to the alpha (1A) receptors concentrated in the prostate, causing the smooth muscles in these tissues to relax and resulting in improved urine flow and a reduction in BPH symptoms. The binding affinity for the alpha (1B) receptors that cause smooth muscle relaxation and blood pressure effects is significantly lower, thereby maximizing target organ activity for treating BPH and minimizing the potential for side effects and interactions with other therapies.

In clinical trials, RAPAFLO demonstrated strong efficacy with minimal effects on the cardiovascular system, and clinical studies have shown that RAPAFLO does not cause any meaningful prolongation of the QT interval. The most common drug-related side effect was retrograde ejaculation (orgasm with reduced semen), a direct reflection of the product's selective binding properties. In targeting the 1A receptors, organ-specific activity is maximized, and cardiovascular effects are minimized. Rates of discontinuing therapy due to retrograde ejaculation were low. The second most commonly- reported adverse event was dizziness. The incidence of treatment-related dizziness was low and only slightly higher among RAPAFLO than placebo-treated patients.

Recently presented data demonstrate that RAPAFLO can also be administrated in combination with medications for erectile dysfunction with no symptomatic effects on blood pressure or heart rate.

RAPAFLO was originally developed by Kissei Pharmaceutical Co., Ltd. in Japan and licensed to Watson for the US, Canada and Mexico markets.

About Watson Pharmaceuticals, Inc.

Watson Pharmaceuticals, Inc., headquartered in Corona, CA, is a leading specialty pharmaceutical company that develops, manufactures, markets, sells and distributes generic and specialty brand pharmaceutical products. Watson pursues a growth strategy combining internal product development, strategic alliances and collaborations and synergistic acquisitions of products and businesses.

The mission of Watson Urology is to offer products and services that improve the quality of patients' lives, and satisfy the needs of physicians who specialize in the diagnosis, management, and treatment of urological disorders. By advancing education and support for urological diseases, we are creating the differences that make life more livable.

In the U.S., the Watson Urology portfolio includes: RAPAFLO(TM); Oxytrol®; TRELSTAR® LA; TRELSTAR® Depot; Androderm®; ProQuin® XR, under a co-promotion agreement with Depomed, Inc.; and AndroGel®, under a co-promotion agreement with Solvay Pharmaceuticals, Inc. The Watson portfolio also includes a number of products under development including: a six-month formulation of TRELSTAR® (triptorelin pamoate for injectable suspension), for the treatment of advanced prostate cancer; oxybutynin topical gel, for overactive bladder and Uracyst(TM), for cystitis.

Source: Watson Pharmaceuticals, Inc.

Swaggers turn to shudders a year after market high

Just a year ago, investors were swaggering as the stock market surged to an all-time high. Now, almost everyone on Wall Street and Main Street seems to be shuddering amid a frightening reversal of fortune that has erased $8.3 trillion in shareholder wealth in the past 366 days.

"We aren't dealing with a fundamental economic issue any longer," said James Paulsen, chief investment strategist for Wells Capital Management. "We are dealing with fear. And that doesn't respond to economic medicine."

That hasn't stopped the U.S. government from trying to find a remedy.

In a series of moves aimed at avoiding the mistakes that culminated in the Great Depression nearly 80 years ago, the government already has committed to spend more than $1 trillion to prop up ailing banks and other lenders during the past month of turmoil.

But none of it seems to be working, which only seems to be scaring people even more, especially after the nation's leaders spent nearly two weeks painting a gloomy picture of the economic outlook to persuade Congress to approve a $700 billion bailout of the banks.

"I think right now there are just some very powerful negative images that are alive in many people's minds -- images of the Depression, images of people selling apples," said George Loewenstein, a behavioral economist at Carnegie Mellon University. "The images of the downside are just so salient in people's minds, and nobody has presented an upside image yet."

Some investors, like software engineer Sandeep Bhanote, are trying their best not to be spooked.

"Fear is the most dangerous emotion. It can really do the market a lot of harm when maybe it is not necessary to be afraid," Bhanote said Thursday at a coffee shop near the New York Stock Exchange.

The quarterly 401(k) statements that are starting to arrive in the mail will only serve as another grim reminder of the financial carnage. And it has gotten worse since the quarter ended in September, with the Dow Jones industrial average tumbling every day so far this month.

In this week alone, the Dow Jones has plummeted by 17 percent, bringing the total decline to 39 percent since the stock market's most famous bellwether peaked at 14,164.53 on Oct. 9 a year ago.

The downturn translates into a paper loss of $8.3 trillion, based on figures measured by the Dow Jones Wilshire 5000 Composite Index, which tracks 5,000 U.S.-based companies' stocks and represents almost all stocks traded in America.

There are some logical reasons why stocks aren't worth as much as they were a year ago.

For starters, the U.S. economy appears to be in a recession for the first time since 2001. To make matters worse, this contraction looks like it could be particularly painful, with home prices in their steepest slide since the Great Depression and banks in their shakiest condition since the savings-and-loan crisis of the 1980s and early 1990s wiped out thousands of federally insured institutions.

"It's not just psychology," Santa Clara University finance professor Meir Statman said of the stock market sell-off. "There are some things happening in the world that are pretty scary. We have every right to be scared."

And some economic doomsayers still think it could get a lot worse.

"The economy has been in terrible shape for a long time. It was built on an illusion before this," said Mike Stathis, an investment consultant who wrote a book called "America's Financial Apocalypse." "I think people are starting to recognize what's coming, so why wait around for it to get worse?"

Major mutual fund companies like The Vanguard Group, Fidelity Investments and T. Rowe Price all reported sharp increases in phone calls this week as some individual investors bailed out of the market and others sought words of reassurance.

"It's consistent with the climate we're in. Obviously in times of significant market volatility, investors are interested in our thoughts about what they should be doing," Fidelity spokesman Vin Loporchio said. "We try to reinforce our message about long-term investing."

Paulsen said he believes the U.S. government has sounded even more alarms by announcing one different approach to the financial crisis after another in recent weeks.

"It made them seem scared and it made them seem like they didn't know what they were doing," he said. "I think we have reached a point where the Treasury and the Federal Reserve have to just stop and send out this message: 'We have done enough and we think it's going to work.'"

When the government first announced its $700 billion proposal to buy back money-losing mortgages from banks on Sept. 19, the stock market surged. Since then, the Dow Jones has plummeted 25 percent.

Until they get some credible words of reassurance, investors are likely to be on edge -- much like a soldier suffering from post-traumatic stress, said Michal Ann Strahilevitz, a marketing professor at Golden Gate University in San Francisco who studies investor psychology.

"We've been so traumatized over the past few weeks that every little thing that happens, we overreact," she said.

With more gloom seemingly around every corner, investors run the risk of pulling their money out of stocks just when the market may be poised to bounce back. The 39 percent decline from the Dow Jones' high already exceeds the drop experienced in the typical bear market, suggesting it may be not much longer before the sell-off bottoms out.

When investors act purely on emotion, there is greater chance of them sabotaging their financial goals, said Stuart Ritter, a certified financial planner at T. Rowe Price.

"The opposite side of irrational exuberance is irrational pessimism, and neither one is a good path to your financial goals," Ritter said.

John Dorfman, portfolio manager of the Dorfman Value Fund, is preparing for a rally after the United States picks its next president in the Nov. 4 election. "I see a lot of bargains out there," Dorfman said.

Even the generally pessimistic Stathis hasn't given up all hope. As more investors fled the market late Thursday, he bought 900 shares of Pfizer Inc.

AP Business Writers Dave Carpenter in Chicago, Candice Choi in New York, Mark Jewell in Boston and David Pitt in Des Moines, Iowa and AP Writer Colleen Long in New York contributed to this story.

AstraZeneca gets FDA approval for extended-release version of bipolar disorder drug

Drug developer AstraZeneca said Friday the Food and Drug Administration approved an extended-release version of the bipolar-disorder drug Seroquel.

The new version of the drug, called Seroquel XR, is approved as a once-daily treatment for bipolar mania, biopolar depression and mixed biopolar episodes. The previous version of the drug had to be taken twice-daily for bipolar mania and is not approved for mixed episodes.

Seroquel XR is also approved as a long-term treatment for bipolar I disorder.

Shares of AstraZeneca fell 35 cents to $36.20 in morning trading.

American Academy of Pediatrics Point-of-Care Resource Will be Available on a Free Trial Basis For Pediatricians and Pediatric Residents

The American Academy of Pediatrics (AAP) is introducing a revolutionary, next-generation point-of-practice resource to the nation’s pediatricians this week as the organization holds its annual National Conference & Exhibition.

The Web-based resource is called Pediatric Care Online™, and it is receiving high praise for ease-of-use and the assembly of immediate knowledge it makes available in the office and through mobile devices.

“It is fast and easy to navigate, and every hit is rewarding,” said Michael Severson, MD, FAAP, who has more than 25 years experience in pediatrics. “Pediatric Care Online is going to be very valuable not only because of the amount and quality of information that it brings together in one place, but also because it’s interactive and there when you need it. If you’ve ever wished for a point-of-care resource that you didn't have, this service probably offers it.”

Through a three-year sponsorship by Mead Johnson Nutritionals, most pediatricians can enroll for a free three-month trial period, while pediatric residents can sign up for a free trial of one year.

At the heart of Pediatric Care Online’s content are three of the AAP’s most relied-upon practice resources: the new AAP Textbook of Pediatric Care, which is the standard reference of its kind; content from the AAP’s Red Book®, which provides detailed information on more than 200 childhood infectious diseases; and Bright Futures, the organization’s comprehensive health supervision guidelines.

Homepage content is provided in an easy-to-use format that also enables quick access to an interactive periodicity schedule, patient handouts, forms and tools, an antimicrobial therapy guide, clinical calculators, algorithms and a visual library.

If all of that seems like a lot, that was the intent, according to Tom McInerny, MD, FAAP. “One of our most important goals is to provide materials to pediatricians in the way they want to use them at point-of-care,” McInerny said. “We’re confident that Pediatric Care Online will do that while also helping them implement best practices.”

The service’s mobile features are particularly appealing to residents on the go as well as practice-based pediatricians who would rather reach for their handheld device than leave the patient to use an office-based computer.

Amy Jost, MD, chair of the AAP Section on Medical Students, Residents and Fellowship Trainees, said that she’s looking forward to using the mobile interface in the hospital. “In addition to being a resource for information you know you can trust, it will undoubtedly be a great time-saver and a tool that helps provide patient care more efficiently,” she said.

Mobile features include an interface that will allow users of Internet-capable devices to search the Website. In addition, the service offers a broad range of content that can be downloaded to handhelds that do not have Internet access. Downloads are compatible with Palm, Windows Mobile, and Pocket PC devices. Downloadable content includes the Point-of-Care Quick Reference, Bright Futures, the Bright Futures Pocket Guide, Pediatric Drug Lookup, Interactive Periodicity Schedule, Signs & Symptoms Search, Antimicrobial Therapy Guide and Pediatric Care Updates.

The American Academy of Pediatrics is an organization of 60,000 primary care pediatricians, pediatric medical subspecialists and pediatric specialists dedicated to the health, safety and well-being of infants, children, adolescents and young adults. Learn more at www.aap.org.

Mead Johnson Nutritionals is a world leader in nutrition, dedicated to helping provide infants and children with the best start in life. Mead Johnson Nutritionals is a Bristol-Myers Squibb Company. Bristol-Myers Squibb is a global biopharmaceutical and related health care products company whose mission is to extend and enhance human life.


Contact:

AAP:
Debbie Linchesky, 847-434-7084
dlinchesky@aap.org

Source: Mead Johnson Nutritionals

Wyeth Wins Philadelphia Diet Drug Trial Involving Claim of PPH

Wyeth announced today that the jury in the case of Danny Crowder (Individually and as Administrator of the Estate of Edna Faye Crowder) v. Wyeth in the Philadelphia Court of Common Pleas found in favor of Wyeth.

"We believe this unanimous verdict was supported by the evidence," says Bob Nicholas, an attorney from Reed Smith, who represented Wyeth. "While Mrs. Crowder's death was tragic, the medical evidence clearly demonstrated that her condition was unrelated to the diet drugs she used over ten years ago."

The trial began on September 29, 2008 before The Honorable Gary S. Glazer. The plaintiff alleged the wrongful death of Mrs. Crowder caused by Primary Pulmonary Hypertension (PPH) as a result of her use of the diet drug Pondimin®, a drug once marketed by Wyeth. The Court had earlier ruled that plaintiff could not pursue punitive damages in this case.

The plaintiff was represented by the Clark Burnett law firm of Houston, Texas.

Wyeth is one of the world's largest research-driven pharmaceutical and health care products companies. It is a leader in the discovery, development, manufacturing and marketing of pharmaceuticals, vaccines, biotechnology products, nutritionals and non-prescription medicines that improve the quality of life for people worldwide. The Company's major divisions include Wyeth Pharmaceuticals, Wyeth Consumer Healthcare and Fort Dodge Animal Health.


Source: Wyeth

Healthcare Resources Available in Difficult Times

In these troubling economic times, people may be unable to make their healthcare a priority and may feel that they don't have the money to visit their doctor or fill a prescription. According to a survey by the National Association of Insurance Commissioners (NAIC) released in August 2008:(1)

-- Twenty-two percent of Americans say that they have cut back on the number of times they see a physician as a result of the weaker economy.

-- Eleven percent say they have cut back on the number of prescription drugs they take or the dosage of those medications to make the prescriptions last longer.

Ultimately, this neglect may lead to declining health across the country, both physically and mentally. Eli Lilly and Company has resources available that can help people manage their health, even if their financial concerns are becoming overwhelming.

Patient Assistance Programs

Lilly has patient assistance programs to help people meet their healthcare needs. Additional information is available at www.lillyforbetterhealth.com .

-- LillyMedicareAnswers(TM) is a patient assistance program that provides eligible Medicare recipients access to affordable Lilly medications outside of their Medicare Part D plan. To learn more or apply, go to www.lillymedicareanswers.com or call (877) RX-LILLY (1-877-795-4559).

-- Lilly Cares(TM) is a patient assistance program that provides access to Lilly products for legal U.S. residents regardless of their ability to pay. Through physicians, patients who are otherwise unable to obtain Lilly medications may qualify for free medicines. To learn more or apply, go to www.lillycares.com or call (877) RX-LILLY (1-877-795-4559).

-- The Partnership for Prescription Assistance (PPA) helps qualifying patients who lack prescription coverage receive the medicines they need through public or private programs. Many of these programs are offered by individual pharmaceutical companies. PPA is sponsored by the Pharmaceutical Research and Manufacturers of America (PhRMA), doctors, other health care providers, patient advocacy organizations and community groups. There is no cost to patients for PPA's services. To learn more, visit www.pparx.org or call (888) 4PPA-NOW (888-477-2669).

Guide Book to Better Health

A Healthy You! - America's Guide to Healthy Living is aimed at addressing the effects of poor health in the U.S. The free book is available in English and Spanish and includes an extensive listing of specific resources in each state where people can access useful programs and agencies in their area. The content is available online at www.lillyforbetterhealth.com, and Lilly has been distributing the book at health fairs and other events around the country.

Readers will find information on each one of these key measures and more. Chapters include: Exercise and Nutrition; Children's Health; Women's Health; Men's Health; Older Adults; Mental Health; Diabetes; Living Heart Healthy; Cancer Screening; Substance Abuse/Tobacco Cessation; Veterans Health; and Patient Assistance Programs.

About Eli Lilly and Company

Lilly, a leading innovation-driven corporation, is developing a growing portfolio of first-in-class and best-in-class pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers - through medicines and information - for some of the world's most urgent medical needs. Additional information about Lilly is available at www.lilly.com .

Lilly is constantly seeking answers to the world's most pressing health needs, but it can't be done alone. Through www.lillyforbetterhealth.com, Lilly provides information about the health challenges facing our society and potential solutions for those challenges. Recognizing that these programs won't solve every health problem that exists, Lilly hopes they demonstrate ways to improve patient care while at the same time potentially reducing health care costs without restricting a patient's or physician's access to medications.

1 Weakening U.S. Economy Takes Toll on Americans' Health. Available at http://www.naic.org/Releases/2008_docs/economy_health_toll.htm.

C-LLY

(Photo: http://www.newscom.com/cgi-bin/prnh/20081010/CLF071 )

(Logo: http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO )


Source: Eli Lilly and Company