NEBIDO


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BERLIN, Nov. 27 /PRNewswire-FirstCall/ -- Schering AG (NYSE: SHR; FSE: SCH) received approval in Finland, the first European country, for Nebido(TM), a new type of depot preparation for the treatment of hypogonadism (testosterone deficiency) in men. Following the European Mutual Recognition Process, Schering expects approval for Nebido(TM) to follow in more European countries in the course of 2004. In addition, Schering plans to apply for approval in Latin American countries and Canada next year.

"Requiring only four injections per year, Nebido(TM) represents a major improvement for men suffering from testosterone deficiency. Previously, patients received on average 22 injections per year. Additionally the unique formulation of Nebido(TM) allows for a blood level of testosterone within the physiological range and is therefore more compatible with the patients needs," said Dr. Philip Smits, Head of Gynecology & Andrology at Schering AG. Hypogonadism is an indication of an impaired testes function. There are various causes for reduced testosterone production, which result in a lowering of the concentration of this most important male sexual hormone in the blood. Due to the many functions of this hormone, testosterone deficiency can lead to considerable health problems and severely impair quality of life. Testosterone deficiency may be caused by a variety of factors. Most often it is the result of congenital disturbances of the hormonal feedback regulation or of a disease of the testes; occasionally it may be due to a decrease in gonadal function in older age.

Schering AG is a research-based pharmaceutical company. Its activities are focused on four business areas: Gynecology & Andrology, Diagnostics & Radiopharmaceuticals, Dermatology as well as Specialized Therapeutics for disabling diseases in the fields of the central nervous system, oncology and cardiovascular system. As a global player with innovative products Schering AG aims for leading positions in specialized markets worldwide. With in-house R&D and supported by an excellent global network of external partners, Schering AG is securing a promising product pipeline. Using new ideas, Schering AG aims to make a recognized contribution to medical progress and strives to improve the quality of life: making medicine work

This press release has been published by Corporate Communication of Schering AG, Berlin, Germany.
 


Indevus Licenses U.S. Rights to NEBIDO(R) from Schering AG, Germany
Friday July 29, 9:03 am ET

LEXINGTON, Mass.--(BUSINESS WIRE)--July 29, 2005--Indevus Pharmaceuticals, Inc. (NASDAQ: IDEV - News) today announced that it has licensed exclusive U.S. rights from Schering AG, Germany (NYSE: SHR - News) to market NEBIDO®, a long-acting injectable testosterone preparation for the treatment of male hypogonadism. NEBIDO, which was recently approved and launched in Europe, is the first injectable product for treating hypogonadism requiring dosing only once every three months.
Under the terms of the agreement, Indevus will be responsible for the development and commercialization of NEBIDO in the United States. Schering will be responsible for manufacturing and supplying commercial product to Indevus. Indevus will make up to $30 million in up-front, regulatory milestone, and commercialization milestone payments, including $7.5 million up-front and $5.0 million upon approval of the product. Following approval of the product, Indevus will pay to Schering a percentage of net sales to cover both the supply of finished product and royalties.

"Our acquisition of rights to NEBIDO in the U.S. is a major step in the execution of our corporate strategy. Leveraging and building on our existing franchise in urology has been our highest priority since the launch of SANCTURA®," said Glenn L. Cooper, M.D., chairman, president and chief executive officer of Indevus. "NEBIDO is an exciting late-stage product which will complement our sales and marketing effort with SANCTURA.

"NEBIDO will be the first three-month testosterone preparation in the growing market for testosterone replacement therapies," said Dr. Cooper. "Based on the benefits of its once every three months dosing regimen, NEBIDO has the potential to offer an attractive treatment option to the millions of men who suffer from hypogonadism."

NEBIDO has been clinically proven to reduce symptoms and prevent consequences associated with testosterone deficiency. NEBIDO has been shown to achieve steady state levels of testosterone in the body for three months, thereby reducing or eliminating the variability in serum levels of testosterone found with short-acting injectable agents. Based on the substantial data package available from Schering, as well as certain additional ongoing studies, Indevus currently anticipates filing a New Drug Application with the FDA in the second half of 2006.

Male hypogonadism is an increasingly recognized medical condition characterized by a reduced or absent secretion of testosterone from the testes. Reduced testosterone levels can lead to health problems and impair quality of life. Common effects of hypogonadism include decreased sexual desire, muscle loss and weakness, as well as an increased risk of osteoporosis. According to Easton Associates, LLC it is estimated that 4 to 5 million men in the U.S. have hypogonadism. Of this group, only about 5% are currently treated with testosterone replacement therapy. Based on IMS data, sales for testosterone replacement therapies in the U.S. were approximately $450 million in 2004.

"Hypogonadism has a profound impact on the quality of life for millions of men. The market is highly under-treated and is expected to grow by more than 10% annually which represents an attractive opportunity for NEBIDO," said John Tucker, chief sales and marketing officer for Indevus. "In addition, our market research indicates that physicians and patients currently using other methods of treatment may be willing to switch to NEBIDO because of the many benefits of three-month dosing, including compliance, convenience, and the maintenance of steady serum levels of testosterone for three months."

The Company intends to discuss the acquisition of rights to NEBIDO on its quarterly earnings call scheduled for August 9, 2005. Call details will be made available prior to the conference call.

Indevus Pharmaceuticals is a biopharmaceutical company engaged in the acquisition, development and commercialization of products targeting certain medical specialty areas, including urology and infectious diseases. The Company currently markets SANCTURA® for overactive bladder and has multiple compounds in clinical development, including PRO 2000 for the prevention of infection by HIV and other sexually transmitted pathogens, pagoclone for stuttering, aminocandin for systemic fungal infections, and IP 751 for interstitial cystitis.

Except for the descriptions of historical facts contained herein, this press release contains forward-looking statements that involve risks and uncertainties that could cause the Company's actual results and financial condition to differ materially from those anticipated by the forward-looking statements. These risks and uncertainties are set forth in the Company's filings under the Securities Act of 1933 and the Securities Exchange Act of 1934 under "Risk Factors" and elsewhere, and include, but are not limited to: dependence on the success of SANCTURA® and SANCTURA XR(TM); the early stage of products under development; uncertainties relating to clinical trials, regulatory approval and commercialization of our products, particularly SANCTURA and SANCTURA XR; risks associated with contractual agreements, particularly for the manufacture and co-promotion of SANCTURA and SANCTURA XR; dependence on third parties for manufacturing and marketing; competition; need for additional funds and corporate partners, including for the development of our products; failure to acquire and develop additional product candidates; history of operating losses and expectation of future losses; product liability and insurance uncertainties; risks relating to the Redux-related litigation; limited patent and proprietary rights; dependence on market exclusivity; valuation of our Common Stock; risks related to repayment of debts; risks related to increased leverage; and other risks.



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YEAH - our only competitors are weekly injections, testim, androgel. Physicians will actually get PAID to have the nurse inject the patient. COOL.
 






Testosterone preparation for intramuscular injection in male hypogonadism
Composition: Each ampoule contains 1000 mg testosterone undecanoate in a 4-ml solution for injection (250 mg testosterone undecanoate/ml).

Nebido® is the first 3-monthly injectable testosterone preparation for the treatment of male hypogonadism. Nebido® offers long-lasting testosterone levels in the eugonadal range. It reliably and significantly improves all symptoms associated with hypogonadism.

With Nebido® testosterone levels remain constantly - for up to 14 weeks - in the eugonadal range, avoiding unphysiological peaks and troughs. Patients value the consistent, reliable efficacy and the long duration of effect, which mean they are not dependent on taking frequent medication. Consequently, Nebido® is believed to become the standard preparation for long-term treatment.

Nebido® is injected deeply into the gluteal muscle. Following administration, testosterone undecanoate is gradually released from the depot and is cleaved by serum esterases into testosterone and undecanoic acid. An increase of serum testosterone concentrations above basal values can already be measured the very next day after injection.

Nebido® will be introduced in Europe, starting in Finland and Germany, autumn 2004. Other European countries will follow in 2005. Launches in Latin American and Asian will start 2005.
 


Well, Tucker & Co. finally came thru, but let's face the facts, this isnt a block buster and won't make the company much revenue...3 yrs and counting, get your resumes together boys and girls...
 


Indevus Pharmaceuticals, Inc. (IDEV) Licenses U.S. Rights To NEBIDO(R) From Schering AG, (SHR) Germany
Friday, July 29, 2005
LEXINGTON, Mass.--(BUSINESS WIRE)--July 29, 2005--Indevus Pharmaceuticals, Inc. (NASDAQ: IDEV) today announced that it has licensed exclusive U.S. rights from Schering AG, Germany (NYSE: SHR) to market NEBIDO(R), a long-acting injectable testosterone preparation for the treatment of male hypogonadism. NEBIDO, which was recently approved and launched in Europe, is the first injectable product for treating hypogonadism requiring dosing only once every three months. Under the terms of the agreement, Indevus will be responsible for the development and commercialization of NEBIDO in the United States. Schering will be responsible for manufacturing and supplying commercial product to Indevus. Indevus will make up to $30 million in up-front, regulatory milestone, and commercialization milestone payments, including $7.5 million up-front and $5.0 million upon approval of the product. Following approval of the product, Indevus will pay to Schering a percentage of net sales to cover both the supply of finished product and royalties.

Provided by: BioSpace.com
 


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Testing in Humans
Number of Patients Length Purpose Percent of Drugs Successfully Tested*
Phase 1 20-100 Several months Mainly safety 70 percent
Phase 2 Up to several hundred Several months to 2 years Some short-term safety but mainly effectiveness 33 percent
Phase 3 Several hundred to several thousand 1-4 years Safety, dosage, effectiveness 25-30 percent
* For example, of 100 drugs for which investigational new drug applications are submitted to FDA, about 70 will successfully complete phase 1 trials and go on to phase 2; about 33 of the original 100 will complete phase 2 and go to phase 3; and 25 to 30 of the original 100 will clear phase 3 (and, on average, about 20 of the original 100 will ultimately be approved for marketing).
 








Indevus Shares Jump on Nebido Outlook
Monday March 12, 3:40 pm ET
Indevus Pharmaceuticals Shares Rise on Analyst Outlook for Nebido Sales

NEW YORK (AP) -- Shares of biopharmaceutical company Indevus Pharmaceuticals Inc. jumped Monday after Leerink, Swann & Co. reaffirmed a positive rating for the company, citing the outlook for testosterone replacement therapy Nebido.
The maker of urological, gynecological and men's health conditions treatments saw shares rise 34 cents, or 5.2 percent, to $6.86 on the Nasdaq Stock market in afternoon trading. Shares of Indevus have traded between $4.25 and $8.06 over the last 52 weeks.

The Lexington, Mass-based company is currently conducting late-stage studies for Nebido, a treatment of hypogonadism or a testosterone replacement therapy.

Analyst Gary Nachman reaffirmed a "Outperform" rating with a valuation between $9 and $11, citing the drug candidate's positive prospects for the marketplace.

"Once available, Nebido is projected to change physicians' prescribing habits with testosterone replacement therapy dramatically," he wrote in a note to investors. "In aggregate, Nebido is projected to be used 51 percent of the time as first-line therapy and 21 percent of the time as second-line therapy, and replace gels as the dominant TRT product." Nebido is a long-acting injectible testosterone therapy.

The outlook is based on a Leerink Swann survey of physicians. The market itself is likely to expand, with the number of patients treated with testosterone replacement therapy jumping by 20 percent over the next two years, he wrote.

He expects the drug to garner 6 percent of the market share in 2008, with a midyear launch, 15 percent in 2009 and 20 percent in 2010. That equals $36 million, $99 million and $145 million in sales respectively for each of those years, he wrote.

"Based on the survey results, we believe there is significant upside potential to those forecasts," he said.


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2008 mid-year launch................nice !!!!!!!!!!!!

Hello ESSP.............go baby go...........
 


Indevus Shares Jump on Nebido Outlook
Monday March 12, 3:40 pm ET
Indevus Pharmaceuticals Shares Rise on Analyst Outlook for Nebido Sales

NEW YORK (AP) -- Shares of biopharmaceutical company Indevus Pharmaceuticals Inc. jumped Monday after Leerink, Swann & Co. reaffirmed a positive rating for the company, citing the outlook for testosterone replacement therapy Nebido.
The maker of urological, gynecological and men's health conditions treatments saw shares rise 34 cents, or 5.2 percent, to $6.86 on the Nasdaq Stock market in afternoon trading. Shares of Indevus have traded between $4.25 and $8.06 over the last 52 weeks.

The Lexington, Mass-based company is currently conducting late-stage studies for Nebido, a treatment of hypogonadism or a testosterone replacement therapy.

Analyst Gary Nachman reaffirmed a "Outperform" rating with a valuation between $9 and $11, citing the drug candidate's positive prospects for the marketplace.

"Once available, Nebido is projected to change physicians' prescribing habits with testosterone replacement therapy dramatically," he wrote in a note to investors. "In aggregate, Nebido is projected to be used 51 percent of the time as first-line therapy and 21 percent of the time as second-line therapy, and replace gels as the dominant TRT product." Nebido is a long-acting injectible testosterone therapy.

The outlook is based on a Leerink Swann survey of physicians. The market itself is likely to expand, with the number of patients treated with testosterone replacement therapy jumping by 20 percent over the next two years, he wrote.

He expects the drug to garner 6 percent of the market share in 2008, with a midyear launch, 15 percent in 2009 and 20 percent in 2010. That equals $36 million, $99 million and $145 million in sales respectively for each of those years, he wrote.

"Based on the survey results, we believe there is significant upside potential to those forecasts," he said.


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2008 mid-year launch................nice !!!!!!!!!!!!

Hello ESSP.............go baby go...........



I DOUBT IT! Problems with the trials will come to the surface soon. Excursions above normal makes the FDA very nervous. NOlibidio won't see the market until late 09 if it ever does!
 


I DOUBT IT! Problems with the trials will come to the surface soon. Excursions above normal makes the FDA very nervous. NOlibidio won't see the market until late 09 if it ever does!

This comment is almost identical to some comments a few weeks ago on the Auxilium board saying that Nebido goes above the norm and this make the FDA very concerned...Go back to the Auxilum board.....if you know your facts to be true you wouldn't be worried about the info on our board. You know you are going to get your a_ _ kicked. Compliance is one of the main concerns with the gel users and you know it. To not have to put that stinky crap on everyday will be a relief. Nurses can't wait to inject Bubba only once a quarter instead of 3-4 times a quarter.

Your time at Auxilium is limited.
 




Indevus Announces Submission of New Drug Application
Seeking Approval for NEBIDO to Treat Male Hypogonadism
LEXINGTON, Mass., Aug 28, 2007 /PRNewswire-FirstCall via COMTEX News Network/ -- Indevus Pharmaceuticals, Inc. (Nasdaq: IDEV) today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for NEBIDO(R) (testosterone undecanoate) intramuscular injection, a long-acting testosterone therapy intended to treat male patients with primary and secondary hypogonadism. Each 1000 mg injection of NEBIDO would only need to be provided once every 12 weeks, as compared to the current injectable therapies which typically require an injection every two to three weeks.
The NDA submission follows the June 2007 announcement of positive results from the Company's Phase III pharmacokinetic trial for NEBIDO. In addition to the data from this U.S. trial, the NDA includes the results of the European clinical trials database (originally generated by the Company's partner, Bayer Schering Pharma AG, Germany) which has formed the basis for the approval of NEBIDO in over 75 countries to date.

The U.S. testosterone therapy market is currently estimated to be in excess of $550 million. Of the approximately 340,000 men currently receiving therapy, approximately 130,000 utilize the existing injectable therapies that must be given every two to three weeks.

The NDA contains data from six clinical studies in which over 400 patients received at least one dose of NEBIDO, with over 300 of these patients treated for more than one year. In total, over 3,000 injections of NEBIDO have been given to hypogonadal males during the clinical development program. In addition, the NDA includes post-marketing data from safety reporting through June 2007, reflecting the world-wide experience from over 260,000 injections of NEBIDO.

"The submission of the NEBIDO NDA is a very important milestone for the Company," said Glenn L. Cooper, M.D., chief executive officer and chairman of Indevus. "We strongly believe that NEBIDO can greatly improve the treatment options for men who suffer from hypogonadism."

Phase III Pharmacokinetic Trial

In June 2007, the Company announced positive results of its Phase III pharmacokinetic trial with NEBIDO. The purpose of the trial was to evaluate NEBIDO under U.S. Food and Drug Administration (FDA) pharmacokinetic guidelines for the approval of testosterone therapy products for male hypogonadism. The trial met its primary endpoints: a responder analysis based on the average testosterone concentrations during the steady-state dosing interval and an outlier analysis based on the maximum testosterone concentrations during the steady-state dosing interval.

Phase III Study Design

The Phase III pharmacokinetic trial was a randomized open-label (unblinded) study that included the evaluation of the pharmacokinetics of NEBIDO dosed as either 1000 mg every 12 weeks or as 750 mg every 12 weeks, both via intramuscular injection. The primary endpoints included a responder analysis (based on guidelines provided from the FDA for average testosterone concentrations over the steady state dosing interval) and an outlier analysis (based on the maximum testosterone concentrations during the steady state dosing interval). Specifically, a responder was defined (per the FDA) as a patient who, at steady-state conditions, had an average concentration of serum total testosterone (Cavg) within the normal range (300 to 1000 ng/dL). The primary response endpoint was met if at least 75% of patients achieved a Cavg within this normal range. FDA also provided guidelines related to maximum testosterone (Cmax) levels, including thresholds that no patient should exceed a testosterone concentration of 2500 ng/dL, no more than 5% of patients should exceed a concentration of 1800 ng/dL, and no more than 15% of patients should exceed a concentration of 1500 ng/dL.

In addition, secondary outcomes included measurements evaluating the general health and well-being of the patients by questionnaires and assessment tools.

Phase III Study Findings

The trial randomized a total of 237 male hypogonadal patients (117 patients treated in the 1000 mg dose arm and 120 patients treated in the 750 mg dose arm). The patient completion rate of all 5 injections with NEBIDO was over 80%, demonstrating very high treatment compliance for a one-year study. Reasons for discontinuation were similar between the treatment groups.

Of the 97 patients in the 1000 mg arm receiving their steady-state injection, 94% had a Cavg over the course of the 12-week period that was within the normal range, demonstrating that treatment with NEBIDO successfully maintained therapeutic testosterone levels in hypogonadal men with injections given only once every 12 weeks (just 4 to 5 times per year). Further, no patients in the 1000 mg arm exceeded a testosterone concentration of 2500 ng/dL; four of 97 (4.1%) patients had a peak level over 1800 ng/dL; and 11 of 97 (11.3%) patients had a peak level exceeding 1500 ng/dL. The duration of time any patient had a concentration over these Cmax thresholds was brief.

Of the 102 patients in the 750 mg arm receiving their fourth injection, 86% had a Cavg within the normal range. No patients in the 750 mg arm exceeded a testosterone level of either 2500 ng/dL or 1800 ng/dL, and only four of 102 (3.9%) patients had a peak level exceeding 1500 ng/dL. For those few patients exceeding the 1500 ng/dL threshold, the duration of time above the threshold was brief.

Both treatment arms demonstrated improvements from baseline in key secondary clinical outcome variables.

Both doses of the drug were well-tolerated as indicated by the analysis of the safety measurements collected and the persistence with study treatment. Further, the spectrum of adverse events reported were comparable to other injectable hypogonadism treatments reported in the literature. There were no significant adverse changes in laboratory parameters with NEBIDO treatment.

About NEBIDO

NEBIDO(R) is a long-acting depot preparation of testosterone undecanoate, developed for the treatment of male hypogonadism. NEBIDO is expected to be the first three-month testosterone preparation available in the U.S. in the growing market for testosterone therapies. Indevus acquired U.S. rights to NEBIDO from Bayer Schering Pharma AG, Germany in July 2005.

About Hypogonadism

Male hypogonadism is an increasingly recognized medical condition characterized by a reduced or absent secretion of testosterone from the testes. Reduced testosterone levels can lead to health problems and significantly impair quality of life. Common effects of hypogonadism include decreased sexual desire, muscle loss and weakness, as well as an increased risk of osteoporosis. Today, there are an estimated four to five million men in the U.S. who suffer from hypogonadism. Of this group, less than ten percent are currently receiving treatment with testosterone therapy.
 






FDA ACCEPTS NEW DRUG APPLICATION FOR NEBIDO®
SUBMITTED BY INDEVUS

LEXINGTON, MA, November 1, 2007 -- Indevus Pharmaceuticals, Inc. (NASDAQ: IDEV) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Company’s New Drug Application (NDA) for NEBIDO® , its long-acting injectable testosterone preparation for the treatment of male hypogonadism. The FDA Prescription Drug User Fee Act (PDUFA) target action date for NEBIDO is June 27, 2008. The NDA was submitted to the FDA by the Company on August 28, 2007.
The NDA contains data from six clinical studies in which over 400 patients received at least one dose of NEBIDO, with over 300 of these patients treated for more than one year. In total, over 3,000 injections of NEBIDO have been given to hypogonadal males during the clinical development program. In addition, the NDA includes post-marketing data from safety reporting through June 2007, reflecting the world-wide experience from over 260,000 injections of NEBIDO.

About NEBIDO
NEBIDO® is a long-acting depot preparation of testosterone undecanoate, developed for the treatment of male hypogonadism. NEBIDO is expected to be the first three-month testosterone preparation available in the U.S. in the growing market for testosterone therapies. Indevus acquired U.S. rights to NEBIDO from Bayer Schering Pharma AG, Germany in July 2005.

About Hypogonadism
Male hypogonadism is an increasingly recognized medical condition characterized by a reduced or absent secretion of testosterone from the testes. Reduced testosterone levels can lead to health problems and significantly impair quality of life. Common effects of hypogonadism include decreased sexual desire, muscle loss and weakness, as well as an increased risk of osteoporosis. Today, there are an estimated four to five million men in the U.S. who suffer from hypogonadism. Of this group, less than ten percent are currently receiving treatment with testosterone therapy.
About Indevus

Indevus Pharmaceuticals, Inc. is a specialty pharmaceutical company engaged in the acquisition, development and commercialization of products to treat conditions in urology and endocrinology. The Company’s approved products include SANCTURA® XR and SANCTURA® for overactive bladder, VANTAS® for advanced prostate cancer, SUPPRELIN® LA for central precocious puberty, and DELATESTRYL® to treat male hypogonadism. The Indevus development pipeline contains multiple compounds within the Company’s core therapeutic areas in addition to several partnered or partnerable programs. The most advanced compounds in development include VALSTAR® for bladder cancer, NEBIDO® for male hypogonadism, PRO 2000 for the prevention of infection by HIV and other sexually-transmitted pathogens, octreotide for acromegaly, and pagoclone for stuttering.
Forward Looking Statements
Except for the descriptions of historical facts contained herein, this press release contains forward-looking statements that involve risks and uncertainties that could cause the Company’s actual results and financial condition to differ materially from those anticipated by the forward-looking statements. These risks and uncertainties are set forth in the Company’s filings under the Securities Act of 1933 and the Securities Exchange Act of 1934 under “Risk Factors” and elsewhere, and include, but are not limited to: dependence on the success of SANCTURA®, SANCTURA® XR, NEBIDO® , VANTAS® and SUPPRELIN® LA; the early state of products under development; uncertainties relating to clinical trials, regulatory approval and commercialization of our products, particularly SANCTURA XR, NEBIDO, and VALSTAR®; risks associated with contractual agreements, particularly for the manufacture and co-promotion of SANCTURA and SANCTURA XR and the manufacture of NEBIDO, VANTAS, SUPPRELIN LA and VALSTAR; dependence on third parties for supplies, particularly for histrelin, manufacturing, marketing, and clinical trials; competition; need for additional funds and corporate partners, including for the development of our products; failure to acquire and develop additional product candidates; changes in reimbursement policies and/or rates for SANCTURA, VANTAS, SUPPRELIN LA, DELATESTRYL® and any future products; history of operating losses and expectation of future losses; product liability and insurance uncertainties; risks relating to the Redux-related litigation; the risk that the businesses of Indevus and Valera Pharmaceuticals, Inc. will not be integrated successfully during the period following the related merger; the risk that the cost savings and any other synergies from the merger may not be fully realized or may take longer to realize than expected; market acceptance for the merger and approved products; risks of regulatory review and clinical trials; disruption from the transaction making it more difficult to maintain relationships with customers, employees or suppliers; competition and its effect on pricing, spending, third-party relationships and revenues; reliance on intellectual property and having limited patents and proprietary rights; dependence on market exclusivity, valuation of our Common Stock; risks related to repayment of debts; risks related to increased leverage; general worldwide economic conditions and related uncertainties; the effect of changes in governmental regulations and other risks. Indevus undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.
 





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