Bremelanotide Presentation at Bio Investor Forum

Carl Spana, CEO and President of Palatin Technologies, recently spoke at the Bio Investor Forum in San Francisco to provide some current news about Bremelanotide (breem-oh-LAN'-oh-tyd) along with other Palatin research projects.

Following is a summary of what was said about Bremelanotide during that presentation.

[Caveat: every attempt was made to transcribe the audio presentation accurately. However some mistakes may have occurred and the presentation is no longer available for reference on the Palatin Technologies website)]


Issues with Current Treatments

There is still a clear - and growing - unmet need for erectile dysfunction (ED) solutions and that marketplace accounts for sales worth around $3 billion in 2006 with a projected growth rate of 10% annually.

Presently over 50% of ED patients stop therapy, and only ~30% of patients in the younger age group fill more than 4 times per year. So there are a lot patients coming in for treatment but many are leaving the therapies currently available.

Why is this happening? Among other reasons it's partly because of the cost, but also due to the "variability in response" to existing treatments. In other words, men can experience some anxiety because there's often no clear "sign" with some treatments that they'll be ready to perform when the time comes. And that anxiety complicates an already existing problem even further.

Bremelanotide (formerly PT-141) differs from existing treatments as it "pharmacologically" causes the release of nitric oxide and vasal dilation occurs, whereas other products are enzyme inhibitors.

Tests show Bremelanotide has been effective with a broad range of patients over six studies that have included home studies as well.


Female Sexual Dysfunction

And in regards to Female Sexual Dysfunction (FSD), Bremelanotide has a chance to become the leader in the field since there is no approved competition.

Palatin Technologies' CEO stated that FSD is a huge demographic and that over 40% of women experience some form of FSD as they age. He also mentioned he has had discussions with OB/GYNs and sexual psychologists who stated women are actively seeking help for this, as there are no good options right now. Female Sexual Dysfunction is a problem that can cause emotional problems and create stress in a relationship.

Some phases of Bremelanotide tests have now been completed with both pre-menopausal and postmenopausal women, resulting in very similar and favorable results. Subjects have reported an increase in physical arousal and desire.


Recent Bremelanotide Test Results

Phase 2B of the program was a dose ranging study with all types of ED patients. Single intranasal doses were grouped into: placebo (benchmark), 5mg, 7.5mg, 10mg, 12.5mg, and 15 mg using a disposable dispenser (see image). After analyzing the result, Palatin Technologies will have the optimum dose for their phase 3 trials.

Notably, it was reported the results of the 2B study will be released soon and will support their Phase 3 development program.

It was also mentioned that Bremelanotide was co-administered (parallel and flex dosing) with a PDE5 inhibitor in those most recent tests, and that combination was described as being "synergetic" - which describes the "interaction of two or more drugs such that their combined effect is greater than the sum of the individual effects seen when each drug is given alone".

Unlike some other options, this one allowed the patients to actually feel the drug working... the beginning of arousal best described as similar to the "anticipation" you'd feel as a teenager. This in turn builds confidence, addressing the aforementioned problem of performance anxiety that can happen with alternative treatments.

He also indicated a fairly rapid onset of effects (within 15 to 20 minutes), erection quality was high, and there were no problems when combined with food or drink.

Bremelanotide side effects remain the same as described previously:

• facial flush,
• nausea,
• postnasal drip,
• and after taste.

However I've seen anecdotal evidence that this flushing effect (redness in the face) is much less evident after the first experience. And the after taste can be simply masked with breath mints or candy, so I would think the finished product can address that easily enough.


Other Details Mentioned in the Presentation

- 2007/2008 will include pivotal trials and safety evaluation with the end of 2008 being the submission for approval (production and sales, I assume).

- Bremelanotide is a 60/40 venture between Palatin and King Pharmacology for the North American market and both companies are actively involved. Palatin will be looking for partnerships in other parts of the world during 1st half 2007.


"Can I Buy Bremelanotide Now..?"

I have heard various reports of people experimenting with Bremelanotide type concoctions with a myriad of results - real or perceived. And there have been some people who have spent considerable money buying products advertised as 'Bremelanotide' with no results at all...

So I'll be scouring around to figure out if there are any current variations or substitutes for Bremelanotide available and will report back to "Bremelanotide Bulletin" subscribers if I find conclusive proof something exists.

There's only one available product I've seen so far that features a University of Illinois study along with links to reputable news sites like CNN, WebMD, and Time Magazine (which I've mentioned in previous Bulletins). It doesn't work exactly like Bremelanotide, but according to the U of I study it does have some desirable effects... :)

So while you're waiting for Bremelanotide to become available to buy online or at your local pharmacy, you might want to consider clicking here to learn more about that product since it is available now.