Latest news about Nebido

[Guest guest]

Nebido is a testosterone undecanoate injection that has a long half life and

can be injected every three months. I have used it and love it. But I can

see that they will price it like the current gels (Testim or Androgel) which I

think is crazy...

The FDA did not approve the product due to caughs they saw in the study, and it

is requiring a new study. As

many of you know, certain patient that use injectable testosterone get a

caugh right after the injection due to an anaphylactic reaction. I have had it

and it goes away in minutes.

From the company's last conf call with shareholders:

_http://seekingalpha.com/article/107971-indevus-pharmaceuticals-inc-f4q08-qtr-

end-09-30-08-earnings-call-transcript?page=2_

(http://seekingalpha.com/article/107971-indevus-pharmaceuticals-inc-f4q08-qtr-en\

d-09-30-08-earnings-call-trans

cript?page=2)

Let me start with the regulatory path forward for NEBIDO, which is foremost

on the minds of all our stakeholders. As you know, FDA issued an approvable

letter for NEBIDO in June. The one sticking point against approval was FDA¢s

concern about rare reports of injection related cough reactions. In our NDA,

we estimated the incidence of cough reactions based on post-marketing

surveillance data in Europe but by one in 15,000 injections. FDA¢s position on

the

approvable letter that was that we would need a prospective clinical trial for

them to be convinced that this is an accurate quantification of the incidence

of serious cough, and I would emphasize it is only the serious cases that

are of concern to them.

They couldn¢t get comfortable with our assessment of risk since the

estimation of the incidence of any drug reaction based on spontaneous adverse

event

reporting is fraught with assumptions and potential error. So, our initial

assessment which we communicated to our investors immediately after getting FDA

feedback was that we would need to do a new prospective trial. If we needed

to do that it would delay approval by at least two years.

Now fortunately our partner Bayer Schering has been willing and able to

devote the internal resources necessary to provide us at a very timely fashion

with safety data on a large number of patients who have been participating in

several ongoing European prospective Phase IV trials of NEBIDO. The original

NDA included clinical data on about 4000 injections. The European Phase IV

trials include approximately 10,000 additional injections.

FDA was able to rapidly accommodate a formal meeting with us to review the

approvable letter and the potential path forward. At that meeting both sides

came to the clearly amended [ph] agreement that the combined Indevus and Bayer

Schering Phase II, III, and IV clinical database involving approximately

14,000 injections from about 2600 patients would enable FDA to conclude their

risk benefit assessment.

I also have further positive news to report to you today. We now believe

there is only a single serious case of cough reaction in those 14,000

injections, which gives an incidence consistent with our expectations and

unequivocally

defines serious cough reactions as rare. Said differently, there have been

zero cases of serious cough reaction among the approximately 10,000 additional

injections from the Bayer Schering Phase IV studies.

At the FDA meeting, we also came to an agreement on how to characterize the

handful of patients in post-marketing surveillance where the physician

reported the cough reaction as an anaphylactic or anaphylactoid reaction.

Although

we believe these cases are probably the same oil-based cough reactions as the

other cases we have agreed to describe the potential for rare anaphylactoid

reactions in the label and to educate physicians on proper injection

techniques and risk mitigation for cough for anaphylactoid reactions. Based on

our

discussions with the FDA, we do not believe that NEBIDO will have a black box

warning or any kind of a restricted distribution system.

Post approval we have agreed to conduct the large simple 10,000 patient

safety study using commercially sold products. Recall that we have not seen a

single serious case of cough reaction to date using our 3 cc 750 milligram

formulation. The European dosage formulation is 4 cc 1000 milligram. This

prospective post-marketing study will enable us to get incidence data on the 3

cc

product and possibly the incidence will be even lower given the lower injection

volume but this remains to be seen.

Right now, we anticipate being able to resubmit the NDA with the new Bayer

Schering data by the end of the first calendar quarter next year with a

standard 6-month approval clock we anticipate launching NEBIDO early in the

fourth

quarter of 2009. We continue to be very comfortable with our NEBIDO pricing

assumptions on par with gels, which currently sell for about $2500 per year

therapy. We remain confident that NEBIDO can still capture the lion¢s share of

the $300 million price adjusted injectable market. We also remain quite

encouraged by the opportunity to capture significant share in the $620 million

topical gel and patch market.

Furthermore, the overall testosterone market continues to exhibit robust

double-digit growth as physicians become more aware of undiagnosed hypogonadism

and adopt routine testosterone screening.

Among key opinion leaders and other physicians with an interest in

hypogonadism there was disappointment when NEBIDO launch was delayed.

Physicians who

actively prescribe testosterone products continue to early await the highly

differentiated therapy so they can offer patients an alternative to daily gel

usage or frequent injectibles.

Regards,

Vergel

powerusa dot org