More news on NEBIDOs approval

[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. 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

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.

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