BPH treatments-Global Update

What is BPH?
The prostate is a gland about the size of a walnut that is only present in men. It is located just below the bladder and surrounds the urethra. One of its main functions is to produce an important liquefying component of semen, which allows the sperm to move freely. An enlarged prostate is caused by an overgrowth of prostate cells, and leads to a constriction of the urethra. This in turn reduces the flow of urine, making it increasingly difficult to empty the bladder.


BPH is very common, affecting about one-third of men aged 50+, and may be treated with drugs and surgery. As any treatment can have unwanted effects, however, some men with mild symptoms opt for “watchful waiting”, where no treatment is undertaken, but they are closely monitored. If symptoms deteriorate, it is then possible to opt for treatment.

Current drug treatments
Two main classes of drugs are prescribed for BPH: alpha-blockers and 5-alpha-reductase inhibitors.


Alpha-blockers (or alpha-1 antagonists) work by relaxing the muscles at the neck of the bladder and in the prostate. In this way they reduce the pressure on the urethra and so help increase the flow of urine. They do not cure BPH but help to alleviate some of the symptoms. Around 60% of men find symptoms improve significantly after 2-3 weeks of treatment with an alpha-blocker, which are also used for hypertension. Common side-effects include tiredness, dizziness and headaches.

Major drugs in this class include:

tamsulosin – marketed by developer Astellas as Harnal, and licensor Boehringer Ingelheim as Flomax or Alna. Abbott will co-market Flomax in the US until the end of 2005
alfuzosin – sanofi-aventis’ Xatral. A long-acting version is available as UroXatral/Xatral OD
doxazosin – Pfizer’s Cardura
and terazosin – Abbott’s Hytrin
5-alpha-reductase inhibitors inhibit production of the hormone dihydrotestosterone, produced from testosterone, which contributes to prostate enlargement. Merck & Co’s Proscar (finasteride) is the main drug of this type for BPH, although it is now being challenged by a newer product, GlaxoSmithKline's Avodart (dutasteride). Proscar was first launched in the US in 1998 and is also used for the treatment of male-pattern baldness.

Unlike alpha blockers, 5-alpha-reductase inhibitors are able to reverse BPH to some extent and so may delay the need for surgery. Potential side-effects of finasteride, however, include a reduced sex drive and difficulty in maintaining an erection. In addition, it takes several months of treatment before any benefit is noticed.

Certain plant-based products are also used in the treatment of BPH and there is some evidence that an extract of saw palmetto (Serenoa repens) can be beneficial. Pierre Fabre markets this plant extract as Permixon, and it was the sixth best-selling product in the class for the 12 months to June 2005, according to IMS.

Tamsulosin dominates the market
The major compound used in the treatment of BPH is the alpha-1 antagonist tamsulosin, originally developed by Yamanouchi (now Astellas). In the 12-month period to the end of June 2005, tamsulosin had almost half the G4C BPH market. It was first launched in Japan in 1993 as Harnal, and in 1994, Yamanouchi licensed it out to BI for co-marketing in certain European countries and in North and South America. Astellas co-markets with BI in France, Italy and Greece. BI mainly sells it as Flomax, which is also co-promoted in the US by Abbott, though this agreement is due to cease at the end of 2005. Astellas claims that tamsulosin has high selectivity for the lower urinary tract, making it better suited to BPH therapy than previous alpha-1 antagonists.


Global BPH therapy sales (G4C therapy class)



Source: IMS MIDAS Quantum

Behind tamsulosin in terms of sales is Merck & Co's Proscar, the leading 5-alpha-reductase inhibitor, with an 18% market share. Its share has fallen since 2001, perhaps because of the launch of GSK’s similar product, Avodart, which hit the major markets in 2003. Avodart was number five in the G4C class for the 12 months to June 2005, with a 4% share, but 150% fixed-rate US dollar growth. Number four in the class was sanofi-aventis' Xatral, with 10% of the market.

The top five products together accounted for 80% of the BPH market. The remainder is mainly made up by plant-based products such as Pierre Fabre's Permixon and older alpha-1 antagonists. Also, the alpha-1 adrenergic antagonist, naftopidil, is used for BPH in Japan. Originally developed by Roche, it is sold by Asahi Chemical and Akzo Nobel in Japan as Flivas and Avishot, but development outside Japan has stopped.

New products in R&D

Various new compounds for BPH are in research and development. In addition, some compounds marketed for other indications are in trials for BPH, notably Lilly Icos’ tadalafil, which is marketed for erectile dysfunction as Cialis.

Major new compounds in R&D for BPH
Compound Mechanism of action Developer(s) Phase
silodosin alpha-1 adrenergic antagonist Kissei, Watson, Recordati Filed (Japan); III (USA)
lonidamine indazole-3-carboxylic acid Threshold III
lemuteporfin photosensitizer QLT II
NX 1207 unknown Nymox II
BXL 628 vitamin D3 analogue BioXell II


Source: IMS LifeCycle R&Dfocus /IMS Company Profiles

Of the new BPH compounds in development, the most advanced is Kissei and Watson's silodosin, which was filed for approval in Japan by originator Kissei in 2004. Watson has rights in the US, Canada and Mexico and Recordati holds European rights. It is in Phase III studies in the US with Watson, with an FDA filing forecast in 2008, and in Phase II trials in Europe.

Threshold is investigating lonidamine, an old compound (first patented in 1972), which was launched in 1987 by the Italian firm Angelini for the treatment of a variety of cancers, but was withdrawn in 2003, when Threshold acquired the regulatory dossier for the compound. Threshold initiated a European Phase III trial in BPH in August 2005.

QLT uses photodynamic therapy (PDT) to make lemuteporfin, a ‘light-activated’ drug. An instrument is put into the urethra to inject lemuteporfin into the prostate, and then another is used to shine light into the urethra and activate the therapy. When the cool laser light activates the lemuteporfin, the overgrown prostate tissue is destroyed.

BioXell announced in July 2005 the initiation of a Phase IIb trial of BXL 628 in BPH, to take place at 60 urology centres across Italy, enrolling more than 500 patients. BioXell is also planning to evaluate BXL 628 for an additional indication of non-bacterial chronic prostatitis. The company expects to initiate a proof-of-concept study in this indication by the end of 2005. BioXell has also confirmed that Phase IIa trials are ongoing, in Italy, in patients with over-active bladder.

In October 2005, Lilly and Icos announced positive results from a Phase II study of tadalafil in the treatment of lower urinary tract symptoms in men with BPH. The companies have a joint venture to develop tadalafil and are reported to be planning Phase III studies for this new indication. Lilly Icos notes that many men with BPH also suffer from erectile dysfunction, so it is well-poised to capitalise on Cialis’ existing marketing and promotional tactics.

This article was written by Susan Murray, Senior Editor of IMS Company Profiles.

To make any comments on this article, or to ask a question of the author, please contact the publisher. If you would like to submit an article, please contact the editors.

The opinions expressed in the articles published in this section do not necessarily reflect those of Pharmalicensing or Bridgehead International. No actions including proposals to or agreements with other companies should be taken by any reader without obtaining specific business or legal advice. Neither the publisher nor the authors accept any liability for any actions or activities undertaken by any reader or other third party as a consequence of these articles or for any errors or omissions therein.


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> Log in | Register BPH - a market due for enlargement as the population ages?
IMS Health (18 November 2005)


In the 12-month period to the end of June 2005, according to IMS, the global benign prostatic hypertrophy/hyperplasia (BPH) treatment market (G4C ATC therapy class) was worth almost $4 billion and grew by 12% in fixed-rate US dollar terms.

ZYFLAMEND reducing inflamation, including the prostate

COLUMBIA UNIVERSITY STUDY SUGGESTS BENEFITS OF ZYFLAMEND® IN THE EARLY TREATMENT OF PROSTATE CANCER
By nightsurfer
COLUMBIA UNIVERSITY STUDY SUGGESTS BENEFITS OF ZYFLAMEND® IN THE EARLY TREATMENT OF PROSTATE CANCER -. Tags: ZYFLAMEND, COX-2, COX-1, inhibitor, herbs, herbal, prostatecancer, prostate, cancer, PCa, treatment, prevention, edu, ...
Ma.gnolia: Recent Bookmarks - http://ma.gnolia.com/rss/full/bookmarks

ZYFLAMEND, a natural supplement, is reducing inflamation, including the prostate, prostatitis.

Prostate90 experience with patients corroborates the general and specific reduction of inflammation, especially when combined with 3T Cod Liver oil/day and 400MG Magnesium citrate (without calcium).

Lupron, etc Cause heart attacks?

Prostate cancer therapy may increase risk of death from heart ...
eMaxHealth.com - Hickory,NC,USA
Androgen deprivation therapy - one of the most common treatments for prostate cancer - may increase the risk of death from heart disease in patients over ...

BOSTON-Androgen deprivation therapy - one of the most common treatments for prostate cancer - may increase the risk of death from heart disease in patients over age 65, according to a new study by researchers at Dana-Farber Cancer Institute, Brigham and Women's Hospital and other institutions.

The study results were based on data from CaPSURE, a national registry of men with prostate cancer. Although the findings need to be confirmed in clinical trials, the study authors state that oncologists should weigh the benefits of androgen deprivation therapy, or ADT, against the risk of heart problems in older prostate cancer patients.

For Natural Prostate cures that work, without side effects See: www.prostate90.com

Prostatitis - Un-natural, ineffective treatments

Cholesterol drugs for prostatitis

About 3 weeks ago my dr put me 80mg of zocor because of my high cholesterol. Within 4 days i was unable to stand up and the cp symptoms went out of control Called her and she changed me to 20 mg of fluvastatin. the cp pain dropped significantly but still severe ...
sci.med.prostate.prostatitis - Feb 24, 06:03am by - 1 message - 1 author

For natural prostate treatments that work, see: www.prostatitis60daycure.com

When you should never treat prostate cancer

"When you should never treat prostate cancer"

Conventional treatments for prostate cancer, such as surgery to remove the prostate gland or radiotherapy, are dangerous. The good news, though, is that they may not be necessary for most men diagnosed with a low-grade of the disease.

Prostate cancer surgery can result in serious problems. These include incontinence and impotence.
Radiation treatment is not effective and can lead to major problems in your bladder and colon.
Unfortunately, few medical professionals in this country will admit there's a better way. But the British are making headway.

Researchers at the Institute of Cancer Research in England found something I've been telling you for years. They discovered that men whose cancer is detected early by a PSA screening are not likely to die from the disease. They are far more likely to die from something completely unrelated.

The study followed men between the ages of 55 and 59 with low-grade cancer. It showed that men in this age group have only a one in 100 chance of dying from the disease within 15 years. This was true even when they didn't receive any treatment at all. Treatments, such as surgery and radiation, are not likely to prolong survival in low-grade cases. Yet your urologist will jump to relieve you of your gland (and possibly your sex life) if cancer is present, no matter the grade.

The PSA test measures levels of prostate-specific antigen. Your prostate gland produces this protein.
Doctors believed for years that it provided an earlier detection. However, now we know that most elevated PSA levels are due to benign enlargement of the prostate.

The British researchers are testing a new technique for prostate cancer called Active Surveillance. This technique will help ensure that doctors give treatment only to men who will benefit. Men who have high-grade, advanced, prostate cancer, for instance, would be more likely to benefit from treatments.

As you can see, not all cancers are the same. All men will get prostate cancer. Should we go chopping and slicing on small chances that these cancers will be lethal? I think not. At last we're seeing some enlightenment in the medical industry. Too bad it's coming from Europe and hasn't had an effect in the U.S. yet. I predict it will be years before the sickness industry in this country looks itself in the mirror.

The chances you'll die from prostate cancer are slim, especially if you have the more common slow-growing cancer. If you're in this group, don't submit to surgery or radiation. There are plenty of alternatives that work well and don't have any negative side effects. You can find these on my website at www.secondopinionnewsletter.com .


Yours for better health and medical freedom, Robert Jay Rowen, MD

Prostatectomy Approaches Have Similar Continence Impact

Prostatectomy Approaches Have Similar Continence Impact
By David Douglas

NEW YORK (Reuters Health) Feb 14 - Open radical retropubic prostatectomy and laparoscopic radical prostatectomy to do not lead to significantly different rates of urinary incontinence postoperatively, Canadian researchers report in the February issue of the Journal of Urology.

"Recently," lead investigator Dr. Niels-Erik B. Jacobsen told Reuters Health, "laparoscopic and robotic prostatectomy have become popular among urologists and patients alike based on improved visualization, meticulous dissection and shortened convalescence. Critics of the laparoscopic technique question its oncologic efficacy and functional outcome."

Nevertheless, Dr. Jacobsen and colleagues at the University of Alberta, Edmonton note that numerous studies have demonstrated that the laparoscopic technique at a minimum provides comparable perioperative outcomes relative to the open approach in regard to postoperative blood loss, transfusion, analgesic requirements, hospitalization and convalescence.

To investigate whether there might be any advantage in regard to urinary incontinence, the researchers analyzed data prospectively obtained from 172 patients treated with open radical prostatectomy and 57 who underwent the laparoscopic procedure. All had clinically localized prostate cancer.

At 1 year, 13% of those who underwent the open procedure remained incontinent compared with 17% of those who underwent laparoscopic prostatectomy -- a nonsignificant difference. There were also no difference between groups in measures such as 24-hour urinary pad weight and urinary symptom scores.

Thus, continued Dr. Jacobsen, "the incidence and severity of incontinence 12 months postoperatively was similar between the two surgical groups. Functional equivalence was maintained despite the fact that the laparoscopic group represented our initial experience with this technically demanding procedure. We hypothesize that postoperative continence rates will improve -- and perhaps surpass open radical prostatectomy -- as our experience with laparoscopic or robotic prostatectomy expands."

In fact, he pointed out that he and his colleagues are currently comparing more recent groups of patients. "Until this data becomes available," he concluded, "we can assure our patients with prostate cancer who seek surgical treatment that the postoperative continence rates of laparoscopic prostatectomy are at the very least equivalent to that of open radical retropubic prostatectomy."

J Urol 2007;177:615-619.