NEBIDO

If the PFUDA date is June 28, 2008, why did Ed say that we were not launching it until late Q4 2008?

 

The conference call said that Nebido would be price 2400. per year. This is suppose to be comparable to the year costs of gels.

I thought the gels were 150.00 per month. This would be 450. for 3 months.
Nebido will be 600. for 3 months.

Is my info incorrect?

 

http://biz.yahoo.com/cc/3/87833.html

Did you listen to the conference call?
Here are the highlights I noticed;

Cooper brags about the early approval of XR. What's the point? XR is still not being launched until Jan. 2008.

He states that Allergan has "loafty goals" for XR. That's doesn't sound promising. They will probably have their reps in the offices every other day to promote XR. Allergan is doing "quite significant preparation" and is responsible for issuing all additional information on XR.

Nebido PFUDA June 28, 2008. All endpoints were met. Doing additional studies at higher dosages. They are holding firm on the $2400.00 per year cost for Nebido. He says that this is comparable to the yearly costs of the gels. He thinks it will capture the "lion's share of the injectible market".

Valstar to launch sometime in 2008.

Supperlin LA has surpassed their expectations. 114 units have been implanted. $14,000 per unit.

He thinks that Vantas will capture Viadur's business when Bayer exits the arena. International opportunities for Vantas.

Expanding the oxtiteitide studies.

Still working on Pagaclone - maybe a deal in 2008.

PRO2000 still on track. Data by end of 2008.

1 million dollars for IP 751 to a Sanofi spinoff.

 

Yes.

 

Only 5% of gel patients pay cash so their co-pay is $25. nebido will have to get formulary coverage which it probably won't becaue the gel is less expensive because after the initla work up the cost is all on the patient. Nebido will require 4 office visits and 4 injections which means more money. In addition the short acting depo is cheap and those patients wont pay cash especially $2400 a year. This is not going to be an easy sell at all.

 

Bad news coming on Nebido Ladies and Gents....you heard it here first

 

News Re: Approval of NEBIDO? or Pricing? Rumor that NEBIDO will NOT be approved for another year. Anyone else hear this??

 

More trials will be needed.

 

TRANSLATION: we are not launching this product this year - maybe next. At least we still have XR, oh yeah and VANTAS (goodie)!

 

Is Denise C. gone? Who is in charge of Nebido?

 

Indevus Pharmaceuticals Provides Update on NEBIDO(R) NDA Status

Company Expects FDA to Request Additional Safety Study Prior to Approval
LEXINGTON, Mass., June 4, 2008 /PRNewswire via COMTEX News Network/ -- Indevus Pharmaceuticals, Inc. (Nasdaq: IDEV) today announced that based on a recent discussion with the U.S. Food and Drug Administration (FDA) regarding the NDA filing for NEBIDO(R), the Company expects the FDA to formally request that the Company provide additional safety data prior to approving NEBIDO. The Company currently believes that an additional study will be required in order to supply the necessary data. The Company expects to re-file for approval of NEBIDO in approximately 18 months followed by a 6 month FDA review. The Company will finalize the requirements and initiate the study following the receipt of formal communication from the FDA which the Company expects to receive by the original June 27, 2008 PDUFA date.
The Company believes the requirement for additional data relates to a reaction immediately following the injection and is a known rare complication of oil-based depot injections. The reaction is believed to be the result of a small amount of the oily solution immediately entering the vascular system from the injection site and may be due to improper injection technique. The phenomenon is characterized by short-term reactions involving an urge to cough, coughing episodes or a shortness of breath. In rare cases the reaction has been classified as serious or the patient experiences other symptoms such as dizziness, flushing or fainting.

The Company believes that the FDA's safety concern is derived from spontaneous post-marketing adverse event reports of the NEBIDO 1000 mg (4ml) dose. In the Indevus U.S. clinical trials, which included a total of approximately 500 patients, there was a single, non-serious, instance of this phenomenon with the 750 mg (3ml) dosage of NEBIDO. The patient did not require medical intervention and the event resolved without issue within 10 minutes. This patient has continued to receive regular injections without further incident. Because estimations of the true frequency of these events are difficult to determine from post-marketing reports on patients having received the 1000 mg (4ml) NEBIDO dose, FDA has asked for new data to more precisely calculate the incidence of the occurrence prospectively, as well as methods or procedures to mitigate the incidence with the 750 mg (3ml) dosage.

Glenn L. Cooper, M.D., chairman and chief executive officer of Indevus stated, "We are very surprised and disappointed by the position the FDA is taking regarding the safety profile of NEBIDO given the large European experience. Rare coughing reactions have been well-described in the European product labeling of NEBIDO. We believe the information available on these cases indicates these reactions resolved without consequences and that our proposed labeling for NEBIDO in the U.S. adequately addressed this issue. We intend to vigorously pursue the approval of NEBIDO and will allocate the resources necessary to conduct an additional study to satisfy the concerns of the FDA. From our verbal discussion with the FDA, we are not aware of any other approvability issues."

Dr. Cooper continued, "Despite this disappointment we remain committed to our strategic direction. VANTAS(R) and SUPPRELIN(R) LA are both growing franchises that we will devote additional effort to promoting and we intend to extend our SANCTURA XR(TM) sales force co-promotion agreement with Allergan by the full six months available to us. In addition, this summer we anticipate receiving approval to launch VALSTAR(TM) for bladder cancer and intend to initiate the Phase III clinical program for our octreotide implant with an anticipated 2010 launch date for acromegaly. We will also continue to aggressively pursue business development opportunities."

 

UPDATE 1-Indevus testosterone drug hits safety snag, shrs crash
Wed Jun 4, 2008 9:19am EDT

Indevus Pharmaceuticals Inc (IDEV.O: Quote, Profile, Research) said U.S. health regulators would ask for more safety data before approving its injectable testosterone drug, Nebido, sending its shares crashing 68 percent.

The decision on approval of the drug was set to be taken later this month, but will now be delayed by about two years as the company plans to conduct another safety study and re-apply for approval in around 18 months, which would be followed by six months of review.

Indevus, which has not yet received a formal request for additional data from the U.S. Food and Drug Administration, had previously applied for approval in August last year.

Nebido treats male hypogonadism, a disorder in which testicles do not produce enough of the male sex hormone testosterone.

Indevus said FDA's concerns were related to a reaction immediately following injection of the drug, which could lead to coughing, shortness of breath, and in some cases dizziness, flushing or fainting.

The company said it believes the concerns stem from the post-marketing adverse event reports of the 1000 mg, or 4ml, dose of the drug, sold in Europe by German company Bayer Schering Pharma AG (SCHG.DE: Quote, Profile, Research). Indevus owns the U.S. rights to Nebido.

"We are very surprised and disappointed by the position the FDA is taking regarding the safety profile of Nebido given the large European experience. Rare coughing reactions have been well-described in the European product labeling of Nebido," Indevus Chief Executive Glenn Cooper said in a statement.

Cooper said the company will allocate resources to conduct the additional safety study.

Shares of the Lexington, Massachusetts-based company fell to $1.31 before the bell. They closed at $4.10 Tuesday on Nasdaq. (Reporting by Varsha Tickoo in Bangalore; Editing by Himani Sarkar)

 

Indevus Pharma Slides on FDA Delay
Adam Feuerstein
06/04/08 - 09:55 AM EDT

Efforts by Indevus Pharmaceuticals IDEV to land U.S. approval for a long-acting testosterone have been delayed by two years, news that sent the stock falling to a new 52-week low Wednesday morning.

The Lexington, Mass.-based specialty pharmaceutical firm revealed that the U.S. Food and Drug Administration has asked for additional safety data on Nebido, a long-acting injectable testosterone.

Indevus will be required to conduct a new clinical trial to collect the safety data, which the biotech company estimates will take 18 months to complete. The FDA was expected to issue its approval decision on Nebido later this month, so the delay pushes the timeline for the product's approval out two years.

Indevus shares slumped $2.72, or 66%, to $1.38 in recent trading Wednesday morning. Before today, the stock had traded only as low as $3.91in the last 52 weeks and as high as $8.22 in the same time.

Nebido is an every-three-month injectable testosterone for the treatment of male hypogonadism, the failure to produce adequate amounts of the male reproductive hormone.

Current testosterone treatments are administered via creams, gels or more frequent injections.

According to Indevus, the FDA's safety concerns centers around an adverse reaction to the Nebido injection that can cause patients to cough or suffer shortness of breath. This short-term reaction was seen in only one patient out of 500 patients enrolled in the Indevus clinical trials.

"We are very surprised and disappointed by the position the FDA is taking regarding the safety profile of Nebido given the large European experience," said Indevus CEO Glenn Cooper, in a statement. "Rare coughing reactions have been well described in the European product labeling of Nebido. We believe the information available on these cases indicates these reactions resolved without consequences and that our proposed labeling for Nebido in the U.S. adequately addressed this issue."

Nebido is approved for use in Europe, where is it marketed by German drug firm Bayer.

Critics of the FDA have long complained that the agency is not doing enough to safeguard patients from drug safety problems. This has led the agency to ramp up its drug safety monitoring efforts and take a harder line on drug safety issues on products under review.

The Nebido setback is a severe blow for Indevus, which was counting on the drug's approval later this month. The company has about $60 million in the bank and is burning about $15 million a quarter.

Other companies competing in the testosterone replacement market are Repros Therapeutics RPRX and Auxillium Pharmaceuticals AUXL.

Indevus also owns Sanctura, an overactive bladder drug that is marketed in the U.S. by Allergan AGN.

 

Hey, just wanted to drop back in and say "I told you so". To the poster above I ask who's ass you gonna kick now bitch!

 

Ooooh, right again/

 

Maybe I should be a stock picker....man I have my shit together>

 

Don't Get Your Drug Approved in Europe First
By Brian Orelli June 5, 2008 Comments (3)
1
Recommendation

Editor’s note: An earlier version of this article indicated that Indevus sold Nebido in Europe, which is not the case. The Fool regrets this error.

You'd think that a drug's prior approval in Europe would help its case for approval with the FDA. You'd think. But Indevus Pharmaceuticals (Nasdaq: IDEV), thanks to European sales of long-acting testosterone Nebido, will be further delayed in its hoped-for comeback.

The drug developer announced yesterday that the FDA will likely make it run a safety study. This will push back any approval of Nebido for sale in the U.S. by about two years. Apparently, this came about because of reports in Europe that some patients had adverse reactions to the drug, sold by Bayer Schering. A short-term coughing episode occurs when a small amount of the oily solution containing the drug enters the bloodstream immediately after injection. There was only one occurrence of the side effect in an earlier U.S. clinical trial, and that person has since received additional shots without complication, so it's certainly not a common issue.

Like Indevus, I'm a little surprised by the FDA's move. The agency could have just as easily approved the drug with a warning label, as is the case with the European version of the drug.

Indevus' stock was walloped yesterday -- down 70% -- and the company now has a market cap of a bit more than $100 million. That seems rather low for a drug developer with five drugs on the market, even if those drugs are only expected to bring in revenue in the mid-$60 million range this fiscal year.

Investors are most likely worried about how Indevus will make it for those two more years before Nebido is on the market. The company only had about $60 million on its balance sheet at the end of the quarter, but it's gained another $7 million up front for licensing the European rights to its prostate cancer treatment, Vantas, to Orion, with up to $14 million more coming. With a burn rate previously projected in the high tens of millions of dollars per quarter, Idevus will now need to cut costs and raise cash pretty soon.

With the stock trading so low right now, dilutive financing through a secondary stock offering isn't really a good option. The best choice for getting more cash might be to sell off the royalty stream it gets from Allergan (NYSE: AGN) for its overactive-bladder drug, Sanctura. Other drug developers in need of cash -- like Rule Breakers picks CV Therapeutics (Nasdaq: CVTX) and Vertex Pharmaceuticals (Nasdaq: VRTX) -- have recently pursued that approach, with considerable success.

 

http://www.fool.com/investing/high-growth/2008/06/05/dont-get-your-drug-approved-in-europe-first.aspx

 

Does this mean layoffs? Or downsizing of upper management?

 

Indevus and FDA Agree on Path Forward for NEBIDO(R)
Existing European Data Will Be Used for NDA Resubmission

LEXINGTON, Mass., Sept. 26 /PRNewswire-FirstCall/ -- Indevus Pharmaceuticals, Inc. (Nasdaq: IDEV) announced today that it has reached agreement with the U.S. Food and Drug Administration (FDA) with regard to the additional data and risk management strategy that will lead to re-submission (complete response) of the New Drug Application (NDA) for NEBIDO(R) in the first quarter of calendar 2009. The re-submission database will include experience from over 14,000 injections in more than 2,600 patients, all of which come from existing clinical trials conducted in the U.S. and post-marketing studies that have been conducted in Europe. FDA stated that the number of patients and the number of injections of testosterone undecanoate from these studies appear to provide an adequate size database to determine the precise incidence of serious post-injection, oil-based reactions.

Indevus and FDA also agreed on an education plan to minimize the risks associated with the clinical use of testosterone undecanoate intramuscular injection, namely, to reduce the incidence and/or severity of the serious oil- based reactions. Further, Indevus and FDA agreed to obtain skin-testing data to characterize an allergic component to the drug or any of its excipients in certain patients. Indevus has also agreed to conduct a large, simple post- marketing study of the safety of NEBIDO in approximately 10,000 patients.

"We are very pleased that we can provide to FDA additional data from existing clinical trials to satisfy FDA's desire to understand the incidence of these rare oil-based reactions, without the need to conduct new clinical trials prior to resubmission or approval," stated Glenn L. Cooper, M.D., chairman and chief executive officer of Indevus. "FDA also agreed with our outline of the proposed risk mitigation plans that included appropriate labeling description of intramuscular injection technique, adequate labeling information regarding allergic and oil-based reactions, and the commitment to conduct a large, simple post-marketing study. Risk mitigation plans are now commonly added to approval of new drugs and our agreed plans are consistent with FDA's new initiatives for the management of safety of new drugs. Given a six month FDA review time, assuming approval, we will be in a position to launch NEBIDO with our sales force in the fourth quarter of calendar 2009. We remain enthusiastic about the marketplace opportunity for a long-acting injectable testosterone therapy and we expect the introduction of NEBIDO to have a significant positive impact on the Company's business plan."