Showing posts with label Generic. Show all posts
Showing posts with label Generic. Show all posts

Tuesday, October 14, 2008

Athersys Announces Initial Patient Dosing of MultiStem(r) in Phase I Acute Myocardial Infarction Trial

Athersys, Inc. today announced the presentation of data from its ongoing phase I clinical trial of MultiStem(r) for individuals following acute myocardial infarction (AMI). Marc Penn, M.D., Ph.D., Director of the Bakken Heart-Brain Institute at the Cleveland Clinic and co-principal investigator of the study, presented summary data yesterday at the annual Transvascular Cardiovascular Therapeutics conference (TCT) in Washington, D.C. where he described the AMI program and the successful administration of MultiStem in the first patient enrolled at the Cleveland Clinic. Dr. Penn reported that MultiStem was delivered safely and tolerated well by the patient following administration.

The phase I clinical trial is an open label, multi-center dose escalation trial evaluating the safety and maximum tolerated dose of single dose administration of allogeneic MultiStem following an AMI. Following standard treatment, enrolled patients receive MultiStem delivered via a Cricket(tm) Micro-Infusion Catheter, a proprietary device developed and manufactured by Mercator Medsystems (San Leandro, CA). The Cricket catheter enables rapid and efficient delivery of MultiStem into the region of damage in the heart.

Athersys has evaluated the safety and ability of MultiStem to improve heart function in multiple animal models, including well-validated preclinical models of AMI. Based on this preclinical work, the Company believes that MultiStem may be administered safely and has the potential to improve heart function in patients following severe heart attacks.

William Lehmann, President and Chief Operating Officer at Athersys, commented, ``We are excited about the potential of MultiStem to provide benefit in multiple diseases and conditions, and we look forward to providing additional information about this phase I clinical trial and other studies as we move our programs ahead.''

Athersys is jointly developing MultiStem for AMI with Angiotech Pharmaceuticals, Inc.

About MultiStem(r)

MultiStem is a proprietary non-embryonic stem cell product that may be derived from bone marrow or other tissue sources, and has the demonstrated ability to form a wide range of cell types. In addition, based on extensive preclinical work conducted by the Company and its collaborators, Athersys believes MultiStem has the potential to deliver benefit through several mechanisms, including the production of multiple therapeutic proteins and factors produced in response to inflammation and tissue damage. Athersys believes that MultiStem represents a unique ``off-the-shelf'' stem cell product based on its apparent ability to be used without tissue matching or immunosuppression and its capacity for large scale production.

About Athersys, Inc.

Athersys is a biopharmaceutical company engaged in the discovery and development of therapeutic product candidates designed to extend and enhance the quality of human life. In addition to its lead product candidate, ATHX-105, the Company is developing other orally active pharmaceutical product candidates for the treatment of metabolic and central nervous system disorders. Athersys is also developing MultiStem(r), a patented, adult-derived ``off-the-shelf'' stem cell product platform for multiple disease indications, including damage caused by myocardial infarction, bone marrow transplantation/oncology support, ischemic stroke and other indications.

Contact:

Athersys, Inc.
William (B.J.) Lehmann, J.D., President and Chief Operating
Officer
(216) 431-9900
bjlehmann@athersys.com

In-Site Communications
Lisa M. Wilson
(917) 543-9932
lwilson@insitecony.com

Source: Athersys, Inc.

Sunday, October 12, 2008

Galea Life Sciences, Inc. Accepts Settlement and Prepares New Form 10 Registration Statement

Galea Life Sciences Inc. announced today that the company has accepted an offer of settlement with the U.S. Securities and Exchange Commission (SEC) in connection with an administrative proceeding instituted pursuant to Section 12(j) of the Securities and Exchange Act of 1934. This will result in revocation of the registration of each class of GLSN securities, and therefore, halt trading of the Company's stock.

The company intends to file a new Form 10 registration statement with the SEC. The company's stock will begin trading on the OTC Bulletin Board, if and when the company clears SEC comments on the Form 10, and FINRA has accepted the Company's stock for quotation.

Paul Zuromski, President of Galea Life Sciences, Inc. said, ``We agreed to these sanctions as the most expeditious way to move our company forward. During this time we will continue to execute our business plan. As we work toward filing the Form 10 registration statement, we intend to keep our shareholders informed.''

About Nutraplete(tm)

Nutraplete is the first therapeutic dietary supplement designed specifically for people living with HIV/AIDS. It is a multi-nutritional supplement, designed to address AIDS Wasting Syndrome. It works in conjunction with antiviral therapies and assists patients in the adherence and tolerance of drug treatments. Nutraplete is a ``functional food'' that encourages the restoration of lean body mass, can inhibit pro-oxidative stress, and improves immune function. Nutraplete is distributed exclusively in the U.S. by Allion Healthcare, Inc.under its MOMS Pharmacy trade name. http://www.momspharmacy.com. For more information: http://www.nutraplete.com

About Galea Life Sciences, Inc.

Galea Life Sciences, Inc. identifies and acquires new and innovative nutraceutical products and dietary supplement companies with outstanding growth potential. The Company's focus is in the emerging scientific field of advanced nutritional supplements designed to support traditional medical treatments and therapies.

Contact:

Galea Life Sciences Inc.
Paul Zuromski, President
877-576-8872

Source: Galea Life Sciences

American CareSource Holdings, Inc. (ANCI) President and Chief Executive Officer to Ring the NASDAQ Stock Market Closing Bell

What:
David Boone, President and Chief Executive Officer of American
CareSource Holdings, Inc. (ANCI) will preside over the Closing Bell
to commemorate the company's listing on The NASDAQ Stock Market on
September 29, 2008.

Where:
NASDAQ MarketSite - 4 Times Square - 43rd & Broadway - Broadcast Studio

When:
Thursday, October 9, 2008 at 3:45 - 4:00 p.m. ET

Contacts:
Melody Carey
mcarey@rxir.com

NASDAQ MarketSite:
Robert Madden
646.441.5045
Robert.Madden@NASDAQOMX.com

Feed Information:

The Closing Bell is available from 3:50 p.m. to 4:05 p.m. on AMC-3/C-3 (ul 5985V; dl 3760H). The feed can also be found on Ascent fiber 1623. If you have any questions, please contact Robert Madden at (646) 441-5045.

Radio Feed:

An audio transmission of the Closing Bell is also available from 3:50 p.m. to 4:05 p.m. on uplink IA6 C band / transponder 24, downlink frequency 4180 horizontal. The feed can be found on Ascent fiber 1623 as well.

Webcast:

A live Webcast of the NASDAQ Closing Bell will be available at: http://www.nasdaq.com/about/marketsitetowervideo.asx

Photos:

To obtain a hi-resolution photograph of the Market Close, please go to http://www.nasdaq.com/reference/marketsite_events.stm and click on the market close of your choice.

About American CareSource Holdings, Inc. (ANCI):

American CareSource Holdings, the first national, publicly traded ancillary care network services company, offers a comprehensive national network of approximately 2,500 ancillary service providers at over 25,000 sites. The Company's ancillary network and management provides a complete outsourced solution for a wide variety of healthcare payors and plan sponsors including self-insured employers, indemnity insurers, PPOs, HMOs, third party administrators and both federal and local governments. For additional information, please visit http://www.anci-care.com.


Source: The NASDAQ OMX Group, Inc.

American Shared Hospital Services to Develop Proton Beam Radiation Therapy Facility at Long Beach Memorial Medical Center

AMERICAN SHARED HOSPITAL SERVICES, a leading provider of turnkey technology solutions for advanced radiosurgical and radiation therapy services, announced today that it and Dr. A.M. Nisar Syed & Associates, a leading radiation oncology group, have agreed to provide a Monarch 250TM proton beam radiation therapy (PBRT) facility at Long Beach Memorial Medical Center (LBMMC) in Long Beach, California.

Currently under development by Still River Systems, Littleton, Massachusetts, the Monarch 250 is a single-treatment-room system incorporating proprietary technology that dramatically reduces the cost of implementing proton beam radiation therapy.

"Widely regarded as the optimal radiation treatment for a wide variety of cancers, proton beam radiation therapy is the most significant advance in radiation oncology in a generation. In partnership with an illustrious group of radiation oncologists, AMS is taking the lead in making this advanced therapy available to cancer patients at LBMMC," said Ernest A. Bates, M.D., Chairman and CEO of American Shared Hospital Services. "Subject to approval by the Board of Directors of LBMMC and FDA clearance of the Still River PBRT device, we and our partners hope to begin treating patients at this single-treatment-room facility by 2011."

Terry A. Belmont, CEO of Long Beach Memorial Medical Center, said, "With its many clinical advantages over traditional radiation therapy, we expect proton beam radiation therapy to capture a significant share of the radiation oncology market in the years ahead. As an industry leader, we are excited that LBMMC will become only the second medical center in Southern California to make PBRT available to cancer patients."

AMS previously has announced contracts to place PBRT devices at Tufts Medical Center in Boston and Orlando Regional Healthcare (with professional services to be provided exclusively by M.D. Anderson Cancer Center Orlando).

About Long Beach Memorial Medical Center

Long Beach Memorial Medical Center has been providing compassionate care and offering the latest state-of-the-art technology for more than 100 years. Long Beach Memorial is the region's first choice for comprehensive care in virtually every medical and surgical specialty and has been recognized as one of the nation's premiere medical centers. Long Beach Memorial Medical Center’s Todd Cancer Institute is one of the region’s most prestigious and successful cancer centers. At the forefront of cancer management are the divisions of Radiation Oncology, Gynecologic Oncology, Breast Oncology, Thoracic Oncology, Gastrointestinal Oncology, Genitourinary Oncology and Pediatric Oncology.

About AMS

American Shared Hospital Services provides turnkey technology solutions for advanced radiosurgical and radiation therapy services. AMS is the world leader in providing Gamma Knife radiosurgery equipment, a non-invasive treatment for malignant and benign brain tumors, vascular malformations and trigeminal neuralgia (facial pain). The Company also offers the latest IGRT and IMRT systems, as well as its proprietary Operating Room for the 21st Century® concept. Through its equity investment in Still River Systems, AMS also plans to complement these services with the Monarch 250TM proton beam radiation therapy (PBRT) system, which has not yet been approved by the FDA.

Contact:

American Shared Hospital Services
Ernest A. Bates, M.D., 415-788-5300
Chairman and Chief Executive Officer
e.bates@ashs.com
or
Berkman Associates
Neil Berkman, 310-826-5051
President
info@berkmanassociates.co
or
Long Beach Memorial Medical Center
Rick Damrel, 562-933-2889
Public Relations Manager
rdamrel@memorialcare.org

Source: American Shared Hospital Services

Providence's LogistiCare Subsidiary Receives Notice of Award for $17.4 Million South Carolina Transportation Contract

The Providence Service Corporation today announced that its LogistiCare subsidiary, the nation's largest coordinator of non-emergency transportation (NET) services, has received a notice of award from the State of South Carolina to provide transportation services to the South Carolina Department of Social Services for 28 counties under the state's Family Independence Program.

Services under the contract, valued at $17.4 million annually, should begin November 3, 2008 and contain annual renewal options that run through October 31, 2012. The award is subject to finalized contracts and various processing procedures and should be additive to earnings in 2009.

"We are extremely pleased to be able to serve South Carolina's Family Independence Program," said John Shermyen, LogistiCare's CEO. "South Carolina is committed to helping families become self sufficient and transportation is key to their access of program services and employment and training opportunities. We look forward to working with the state and our transportation providers to help make a difference in the lives of these families."

The Company also announced an additional social services contract award with the state of Michigan in the amount of $1.0 million annually. The Michigan award, while small, is notable because it is an " off-season announcement" as social services contracts traditionally are awarded to begin service July 1, the beginning of the state fiscal year . This contract is expected to take effect in January 2009.

About LogistiCare

LogistiCare is the nation's leading Medicaid transportation management solution. Proprietary software, innovative management strategies, and a proven record of creating budget stability and quality improvements for our clients distinguish LogistiCare as the leader in its field. From its corporate office just outside Atlanta and its numerous state- based operations nationwide, LogistiCare manages a national network of more than 1,100 transportation companies that provide more than 17 million trips to customers annually. LogistiCare's clients have included state Medicaid agencies, school boards, transit authorities, hospital systems and many of the nation's largest managed care organizations.

Source: The Providence Service Corporation

Watson Pharma says Rapaflo reduced prostate enlargement symptoms, was well tolerated in trials

Watson Pharmaceuticals Inc. on Monday reported results from four late stage trials of its drug candidate silodosin, saying the drug was well tolerated and reduced symptoms of prostate enlargement.

Watson presented results from the studies at two American Urological Association conferences. It said the drug reduced the symptoms of prostate enlargement and increased urine flow in two late stage trials, and two safety trials showed the drug did not increase blood pressure.

The company also announced that the marketing name for silodosin will be Rapaflo.

In two pooled trials, Watson said patients who took Rapaflo experienced significant improvement compared with those who took a placebo after 12 weeks. In the third trial, patients continued taking the drug once per day for nine months, approximately 28 percent of patients suffered a drug-related side effect. None of those side effects were termed serious.

In the fourth trial, the company tested Rapaflo in combination with two common treatments for erectile dysfunction. Watson said the regimen caused no changes in blood pressure, heart rate or dizziness.

Results were presented at the New England and Mid Atlantic AUA conferences.

In morning trading, Watson shares dipped 49 cents to $28.31.

Watson Notified of OXYTROL(R) Patent Challenge

Watson Pharmaceuticals, Inc., a leading specialty pharmaceutical company, today confirmed the receipt of a Paragraph IV Certification Notice Letter relating to an Abbreviated New Drug Application (ANDA) submitted to the U.S. Food and Drug Administration (FDA) by a generic filer requesting approval to market and sell a generic version of OYXTROL® (Oxybutynin Transdermal System). In its Notice Letter, the filer alleges that patents covering OXYTROL are invalid, unenforceable and/or will not be infringed by their manufacture, use or sale of the product described in its ANDA.

Watson currently is reviewing the Notice Letter and, by statute, has 45 days to initiate a patent infringement lawsuit against the filer. Such a lawsuit would automatically prevent the FDA from approving the ANDA until the earlier of a district court decision or 30 months from Watson's receipt of the Notice Letter.

Source: Watson Pharmaceuticals, Inc.

Watson Pharma says patent on Oxytrol overactive-bladder patch is being challenged

Drugmaker Watson Pharmaceuticals Inc. said Wednesday the patent on its overactive bladder patch Oxytrol is being challenged.

Watson said it has received a paragraph IV certification letter, which means a rival has asked the Food and Drug Administration to approve a generic version of the drug. In such challenges, filers state that the patents protecting a branded drug are invalid, unenforceable, or that a generic version won't infringe on those patents.

Now that it has received the letter, Watson has 45 days to file a patent lawsuit against the company that submitted the application. Starting a lawsuit would automatically prevent the FDA from approving the generic for the next 30 months, or until a district court rules on the validity of the patent, whichever happens first.

The company did not say if it is preparing to file such a lawsuit.

The product is formally called the oxybutynin transdermal system. Watson is also developing an oxybutynin gel. The company said early in 2008 that it has completed late-stage testing of the product.

In aftermarket trading, Watson shares rose 13 cents to $29.10. The stock finished at $28.97.

Caraco Pharmaceutical Laboratories, Ltd. Reaches Agreement with Labor Union

Caraco Pharmaceutical Laboratories, Ltd. (Amex: CPD - News) announced today that members of the Local 3, Service Employees International Union, CTW, have ratified a new labor agreement covering approximately 400 production and packaging employees at all of Caraco's facilities. The new four year agreement will be effective through September 21, 2012. It replaces the agreement originally set to expire September 12, 2008.

"We are pleased that the members of the Local 3, Service Employees International Union, CTW, have ratified this agreement as our employees are extremely important to Caraco's strategy and continued growth," said Daniel H. Movens, Caraco's Chief Executive Officer.

This press release should be read in conjunction with our Form 8-K, which provides more detailed information on the labor agreement.

Detroit-based Caraco Pharmaceutical Laboratories, Ltd., develops, manufactures, markets and distributes generic and private-label pharmaceuticals to the nation's largest wholesalers, distributors, drugstore chains and managed care providers.

Source: Caraco Pharmaceutical Laboratories, Ltd.

Isolagen to Present at the JMP Securities Healthcare Focus Conference

Isolagen, Inc. announced today that Declan Daly, Chief Executive Officer, will present at the JMP Securities Healthcare Focus Conference on Monday, October 6, 2008 at 3:30 p.m. (EST) at Le Parker Meridien hotel in New York, New York.

The presentation will be webcast live and can be accessed on the Isolagen website, www.isolagen.com, on the investors page. A replay will be available approximately three hours after the presentation and will be archived on the company's website for 90 days.

About Isolagen, Inc.

Isolagen(TM), Inc. is an aesthetic and therapeutic company committed to developing and commercializing scientific advances and innovative technologies. The company's technology platform includes the Isolagen Process(TM), a cell processing system for skin and tissue rejuvenation which is currently in clinical development for a broad range of aesthetic and therapeutic applications including wrinkles, acne scars, burns and periodontal disease. Isolagen also commercializes a scientifically-advanced line of skincare systems through its majority-owned subsidiary, Agera® Laboratories, Inc.

Source: Isolagen, Inc.

Pro-Pharmaceuticals' Pre-NDA Meeting Scheduled with FDA

Pro-Pharmaceuticals, Inc. today announced that a pre-New Drug Application (“NDA”) meeting with the U.S. Food & Drug Administration (“FDA”) is scheduled for December 22nd for DAVANAT® under Section 505 (b)(2) to be co-administered with 5-Fluorouracil (5-FU) to treat late-stage colorectal cancer patients.

“Our goal is to commercialize DAVANAT® and to generate revenue in 2009,” said Theodore Zucconi, Ph.D., President, Pro-Pharmaceuticals, Inc. “In pre-clinical and clinical studies, DAVANAT® has improved efficacy and reduced toxicity of chemotherapies and biologics. We also are working on potential licensing agreements and have regional agreements in place to market DAVANAT® internationally.”

The Company is using DAVANAT®, a galactomannan, to obtain more timely and efficient marketing approval of new formulations of previously approved therapeutics which incorporate the Company’s proprietary drug through Section 505 (b)(2). The FDA has approved galactomannans for other uses, such as oral or topical delivery. The Company is seeking approval for co-administration of DAVANAT® (a galactomannan) with 5-FU for intravenous injection for the treatment of advanced colorectal cancer.

About DAVANAT® DAVANAT®, a new chemical entity, is a proprietary carbohydrate compound that is administered with chemotherapies and biologics to treat cancer. DAVANAT®'s mechanism of action is based on binding to lectins. DAVANAT® targets specific lectin receptors (Galectins) on cancer cells. Current research indicates that Galectins affect cell development and play important roles in cancer, including tumor cell survival, angiogenesis and tumor metastasis.

Pro-Pharmaceuticals, Inc. – Advancing Drugs Through Glycoscience®

Pro-Pharmaceuticals is engaged in the discovery, development, and commercialization of carbohydrate-based, targeted therapeutics for advanced treatment of cancer, liver, microbial, and inflammatory diseases. Initially, the product pipeline is focused on developing targeted therapeutics to treat cancer. The Company’s technology also is being developed to explore the treatment of liver and kidney fibrosis. The Company is headquartered in Newton, Mass.

Contact:

Pro-Pharmaceuticals, Inc.
Anthony D. Squeglia, 617-559-0033
squeglia@pro-pharmaceuticals.com

Source: Pro-Pharmaceuticals, Inc.

Barr Will Host An Earnings Conference Call on November 6, 2008 to Discuss the Results for the Third Quarter of Calendar 2008

Barr Pharmaceuticals, Inc. today announced that the Company will host a Conference Call at 8:30 AM Eastern time on Thursday, November 6 to discuss earnings results for the third quarter of calendar 2008, ended September 30, 2008. The number to call from within the United States is (800) 230-1059 and (612) 288-0337 Internationally. A replay of the conference call will be available from 10:30 AM Eastern time on November 6 through 11:59 PM Eastern time on November 13 and can be accessed by dialing (800) 475-6701 in the United States or (320) 365-3844 Internationally and using the access code 961801.

The Conference Call will also be Webcast live on the Internet. Investors and other interested parties may access the live webcast through the Investors section, under Calendar of Events, on Barr's website at www.BarrLabs.com.

Log on at least 15 minutes before the call begins to register and download or install any necessary audio software.

About Barr Pharmaceuticals, Inc.

Barr Pharmaceuticals, Inc. is a global specialty pharmaceutical company that operates in more than 30 countries worldwide and is engaged in the development, manufacture and marketing of generic and proprietary pharmaceuticals, biopharmaceuticals and active pharmaceutical ingredients. A holding company, Barr operates through its principal subsidiaries: Barr Laboratories, Inc., Duramed Pharmaceuticals, Inc. and PLIVA d.d. and its subsidiaries. The Barr Group of companies markets more than 120 generic and 27 proprietary products in the U.S. and approximately 1,025 products globally outside of the U.S.

Helicos Ships Genetic Analysis System To Stanford University

Helicos BioSciences Corporation today announced the shipment of a Helicos™ Genetic Analysis System to Stanford University for use in research.

The unique ability of the Helicos Genetic Analysis System to obtain sequence information from individual DNA molecules couples unparalleled throughput and scalability with an unbiased view of DNA and RNA that is critical for accelerating research.

About Helicos BioSciences

Helicos BioSciences is a life science company focused on innovative genetic analysis technologies for the research, drug discovery, and diagnostic markets. Helicos' proprietary True Single Molecule Sequencing (tSMS)™ technology allows direct measurement of billions of strands of DNA, enabling scientists to perform experiments and ask questions never before possible. Helicos is a recipient of the $1,000 genome grant and is committed to providing scientists the tools to unlock the era of genomic medicine. The company's corporate headquarters are located at One Kendall Square, Building 700, Cambridge, MA 02139, and its telephone number is (617) 264-1800.

Contact:

Investor Relations Contact:
Helicos BioSciences Corporation
Justine Alonzo, 617-264-1822
Investor Relations
InvestorRelations@helicosbio.com
or
Media Contact:
Ruder Finn Public Relations
Rachel Spielman, 212-583-2714 (office)
646-872-2985 (cell)
spielmanr@ruderfinn.com

Source: Helicos BioSciences Corporation

Watson Announces Positive Data for Its Investigational Oxybutynin Topical Gel for the Treatment of Overactive Bladder at SUNA's Annual Conference

Watson Pharmaceuticals, Inc, a leading specialty pharmaceutical company, announced today that investigators presented clinical pharmacokinetic data on oxybutynin chloride topical gel (OTG), its investigational therapy for overactive bladder (OAB).

Previously, the efficacy and safety of OTG were demonstrated in a Phase 3 multi-center, double blind, placebo-controlled study. The study showed that daily treatment of a 1g dose of OTG for 12 weeks was superior to placebo at relieving OAB symptoms, based on patient urinary diaries, which demonstrated a reduction in incontinence episodes and urinary frequency, and an increase in void volume. Secondary endpoints indicated a significant positive effect of OTG treatment on quality-of-life. Treatment was well tolerated in the study with no treatment-related serious adverse events.

"A topical oxybutynin gel is a convenient option for treating OAB that is easy to use and offers a way to improve treatment compliance among patients," said Diane K. Newman, RNC, MSN, CRNP, FAAM, lead author and Co-Director of the Penn Center for Continence and Pelvic Health, Division of Urology, University of Pennsylvania. "Transdermal drug delivery through a topical gel is a widely accepted and effective technology in urology. Our data confirm that this particular gel can fit nicely into a busy woman's daily regimen, including showering and sunscreen use, without compromising efficacy."

Clinical Data Presented at SUNA

The data presented at the Society of Urologic Nurses and Associates (SUNA) Annual Conference are from three open-label, randomized studies in healthy men and women which showed that showering one hour or later, or the application of sunscreen 30 minutes before or after OTG application did not significantly alter the absorption and systemic blood levels of OTG. The data also found limited transference of the drug when treated people came into contact with their untreated partner.

The new abstract included data from three open-label, randomized studies conducted in healthy men and women. In the showering study, participants received OTG for 35 days. Every seven days, starting at day 14, subjects either didn't shower or showered at 1, 2, or 6 hours after dosing. At the time points tested, showering did not have a meaningful impact on delivery of the drug into the bloodstream.

In the sunscreen study, participants received OTG alone, or 30 minutes before or after applying sunscreen. All three application regimens resulted in similar oxybutynin absorption and time to maximum blood plasma concentration (Tmax).

In these studies, OTG demonstrated good safety and tolerability. No treatment-related adverse events were observed, and no skin reactions to the gel application site were exhibited. In addition, there were no significant changes in vital signs among any of the trial participants between pre- and post-study evaluations.

"We are very excited about the new data, which further point to the outstanding convenience and ease-of-use of OTG, our topical gel formulation of oxybutynin, for patients suffering from OAB," said Edward Heimers, Jr., Executive Vice President and President of Watson's Brand division. "Through products like OTG, Watson continues to work to meet the highest standards of safety and efficacy while offering novel treatment solutions that allow patients to focus on enjoying their lives."

About Oxybutynin Topical Gel (OTG)

OTG is a clear, rapid-drying, odorless formulation of oxybutynin hydrochloride that is under development for the treatment of OAB with symptoms of urge urinary incontinence, urgency and frequency. It is designed to deliver a consistent dose of oxybutynin through the skin over a 24-hour period to help decrease urinary urgency and the frequency of incontinence episodes in patients with OAB. A one-gram (approx. 1 mL) dose of 100mg/g OTG, applied once daily, delivers about 4mg oxybutynin each day.

About Watson Pharmaceuticals, Inc.

Watson Pharmaceuticals, Inc. 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: 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. In addition to oxybutynin topical gel, the Watson portfolio includes a number of products under development including: Rapaflo(TM)(silodosin), a product for the treatment of benign prostatic hyperplasia; and a six-month formulation of TRELSTAR® (triptorelin pamoate for injectable suspension), for the treatment of advanced prostate cancer and Uracyst(TM), for cystitis.

Source: Watson Pharmaceuticals, Inc.

Watson Pharmaceuticals reports new data on effectiveness of overactive bladder gel

Watson Pharmaceuticals Inc. on Wednesday presented updated information on the effectiveness of its experimental topical gel to treat overactive bladder syndrome.

New data from three studies of men and women showed the gel remained effective after both showering and the application of sunscreen.

A prior study by Watson showed the gel, which contains oxybutynin chloride, was more effective at controlling overactive bladder than placebo, based on fewer incontinence episodes reported by patients.

Shares of Watson Pharmaceuticals fell 15 cents to $25.45 in morning trading.

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.

Mylan Announces $500 Million of Floating Rate Debt Swapped to Fixed Rates

Mylan Inc. announced today that it has completed $500 million of interest-rate swaps to fix the interest rate of a portion of its term loan borrowings to take advantage of the recent decline in medium term dollar interest rates. The swaps serve to fix the interest cost on this debt through year-end 2010 at a rate of 6.03%. The company has now executed $2 billion of interest rate swaps at a weighted average rate of 6.55%.

Additionally, the company reconfirmed its previous guidance of a full-year 2008 weighted average cost of financing of approximately 6.5%.

"We believe we have put in place a capital structure that is ideal for this difficult credit environment," said Mylan Vice Chairman and CEO Robert J. Coury. "With protection against short-term interest rate fluctuations, no significant near-term debt maturities, a current cash balance in excess of $700 million, a committed undrawn revolving credit facility and no requirement to access the credit markets, Mylan could hardly be in a stronger position to deal with the current economic climate."

The interest-rate swaps lock in a fixed rate for a significant portion of Mylan's borrowings under its term loan facility. Mylan currently has $4.1 billion outstanding under this facility, which the company used to finance the acquisition of Merck KGaA's generics business. Of this amount, $1.25 billion is denominated in Euros, which has benefited Mylan as the dollar has strengthened against the Euro. Of the remaining $2.85 billion, which is denominated in dollars, $2 billion has been converted to a fixed rate, leaving approximately $850 million subject to short-term fluctuations of LIBOR interest rates.

The company has the option to reset the term of its variable rate borrowings under its term loan facility for as long as six months. It most recently reset the interest rate for these borrowings during the last week in September. Further, Mylan continues to have an ability to enter into additional fixed rate swaps should medium term interest rates continue to decline.

In September, the company successfully issued $575 million -- comprising $463.5 million in net proceeds after fees and the cost of an associated bond hedge -- in seven-year convertible notes paying interest at 3.75%. This permitted the company to fully repay the $300 million outstanding balance under its $750 million committed revolving credit facility, which had been accruing interest at a 5.0% rate at the time of repayment.

The company faces no major maturities on its term loans for at least six years, or until 2014, and on its other borrowings until 2012. None of the company's borrowings permit the lenders to require early payment, and they are not affected in any way by changes in the company's stock price.

"We believe that the recent disproportionate decline in Mylan's stock price is unrelated to the company's business operations or fundamentals," said Mylan Chief Financial Officer Edward J. Borkowski. "Rather, we believe the decline has been driven by the need for certain institutions to meet capital requirements and by unwarranted concern regarding our capital structure."

Mylan Inc., which provides products to customers in more than 140 countries and territories, ranks among the leading diversified generic and specialty pharmaceutical companies in the world. The company maintains one of the industry's broadest -- and highest quality -- product portfolios, supported by a robust product pipeline; owns a controlling interest in the world's second largest active pharmaceutical ingredient manufacturer; and operates a specialty business focused on respiratory and allergy therapies.

Source: Mylan Inc.

Watson Pharmaceuticals receives FDA approval for drug to treat urinary problems from BPH

Watson Pharmaceuticals Inc. said late Wednesday the Food and Drug Administration approved its drug Rapaflo for the treatment of urinary problems.

The drug is approved as a treatment for BPH, or benign prostatic hyperplasia, which has symptoms including decreased urine flow and more frequent urination.

Watson plans to launch the drug in early 2009. It estimates the U.S. market for all BPH drugs at about $2 billion annually.

Shares of Watson closed at $24.63 Wednesday.

Mylan completes rate swap, switching $500 million to fixed rates in term loans

Drug developer Mylan Inc. said Thursday it completed $500 million of interest rate swaps in a move meant to take advantage of a decline in medium-term interest rates.

The move is partly a response to what the company calls "abnormal trading activity" in its stock. Shares have dipped 25 percent from a closing price of $10.27 on Friday. The stock finished at $7.73 Wednesday.

The swap fixes the interest rate portion of Mylan's term loan and reduces the amount of its short-term LIBOR rate borrowings to about $850 million, the company said.

"We believe we have put in place a capital structure that is ideal for this difficult credit environment," said Mylan Vice Chairman and Chief Executive Robert J. Coury in a statement.

The interest-rate swaps lock in a fixed rate for a significant portion of Mylan's borrowings under its term loan, the company said. It currently has $4.1 billion outstanding under that facility, which the company used to finance the buyout of Merck KGaA's generics business. Of that amount, $1.25 billion is denominated in Euros, $2 billion has been converted to a fixed rate, and $850 million is subject to short-term fluctuations of LIBOR interest rates.

Mylan said it faces no major maturities on term loans for at least six years, or until 2014, and on its other borrowings until 2012.

Mylan shares advanced 52 cents, or 6.7 percent, to $8.25 in premarket activity.