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Executives

David Arkowitz - Chief Financial Officer, Chief Business Officer

Dr. Brian Pereira - President, CEO

Kristen Galfetti - Senior Director of Investor Relations

Analysts

Soham Pandya - ThinkEquity

Adam Walsh - Jefferies & Company

Robin Karnofysk - Bear Stearns

Chris Raymond - Robert W. Baird & Co.

Marshall Urist - Morgan Stanley

Subhash Desai - Delaware Street Capital

Malini Chatterjee - Kay Street Capital

Andrew Berens - Merrill Lynch

AMAG Pharmaceuticals Inc. (AMAG) Q1 2008 Earnings Call April 25, 2008 8:00 AM ET

Operator

Good morning. My name is Laurie and I will be your conference operator. At this time I would like to welcome everyone to the AMAG first quarter financial results conference call. All lines have been placed on mute to prevent any background noise. (Operator Instructions) I will now the turn the call over to Kristen Galfetti, Senior Director of Investor Relations; please go ahead.

Kristen Galfetti

Thank you, Laurie. Good morning; I would like to welcome everyone to our fist quarter 2008 earnings results conference call. Today we will be discussing our financial results, business highlights and development program. Our call today will reference the press release we issued this morning which is posted on our website at www.amagpharma.com.

The agenda for our call will be as follows. First David Arkowitz, our Chief Financial Officer and Chief Business Officer will discuss our financial results for the quarter, next our President and CEO, Dr. Brian Pereira will follow with a brief discussion of the Company’s accomplishments and steps that we are taking to become a commercial biopharmaceutical Company. This will be followed by a question-and-answer period.

Before proceeding with this call please be reminded that any statements we made during the course of this conference call that are other than the historical facts including statements regarding our financial condition, cash position, liquidity development program, commercial plan, launch plan, the expected US launch of Ferumoxytol in the first quarter of 2009, our ability to liquidate our auction rate security investments, the impact of current auction rate securities and liquidity on our operations and business plans and our intent to initiate addition clinical programs in patients with iron deficiency anemia in 2008.

Our forward-looking statements made pursuant to the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. We want to emphasize that these forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those discussed in such forward-looking statements.

Such risks and uncertainties include the possibility that we may not be able to obtain the necessary regulatory approvals in order to market and sell Ferumoxytol or we may not obtain such approvals in a timely manner, the fact that we have limited sales and marketing expertise, uncertainties regarding our ability to successfully compete in the intravenous iron replacement market, uncertainties regarding our ability to obtain favorable coverage, pricing and reimbursement for Ferumoxytol if approved, uncertainties regarding our ability to manufacture sufficient quantities of Ferumoxytol to meet demand if approved, uncertainties relating to our patents and proprietary rights and other risks identified in our Securities and Exchange Commission filings.

Any forward-looking statements that we make today must be considered in light of these factors. The assumption’s on which we base any forward-looking statements and our perception of the factors influencing those assumptions are highly likely to change overtime. However, our Company policy is to provide forward-looking statements only at certain points in the year, such as during the calls like this one. We do not plan to otherwise update such statements. Actual results may differ materially.

I will now turn the call over to our Chief Financial Officer and Chief Business Officer, David Arkowitz.

David Arkowitz

Thank you Kristen and good morning everyone. Today we reported un-audited, consolidated financial results for the first quarter of 2008. Total revenues were $0.6 million as compared with total revenues of $0.9 million in the same period in 2007.

Total operating costs and expenses for the first quarter of this year were $13.3 million, an increase of $4.2 million compared to the same period in 2007. The increase quarter-over-quarter was primarily due to increased selling, general and administrative expenses as the company prepares for the expected US launch of Ferumoxytol in the first quarter of 2009.

We reported a net loss of $9.3 million or $0.55 per basic and diluted share for the first quarter of this year compared to a net loss of $10.2 million, or $0.72 per basic and diluted share for the same period in 2007.

At March 31, 2008 our cash, cash equivalents and investments totaled $276 million, which is a decrease of approximately $11 million from our December 31, 2007 balance. Excluding stock option proceeds, our cash burn for the quarter was $8.9 million. Our cash burn over the 12 month period ending March 31, 2008 was approximately $26 million.

I would now like to provide some additional information regarding our auction rate securities. First I will just remind everyone that our auction rate securities are only those that are direct obligations of municipalities, are not structured investment vehicles, mortgage-backed securities or other esoteric structured products. As I reported at our last earnings call as of February 19, 2008, our auction rate securities balance was approximately $81 million. Since mid February of this year we’ve experienced continued auction failures.

Our auction rate security balance as of March 31, 2008 using the par value of these securities was approximately $72 million, which includes more than $2 million that has since been redeemed by certain issuers. Because of the auction failures since mid February there has been limited and insufficient observable market information to determine the fair value of these securities.

We’ve estimated the fair value using discounted cash flow analysis by incorporating assumptions that market participants would use in their estimates of fair value. As a result we are recording a temporary impairment relating to our auction rate securities in the first quarter of this year in the amount of $3.6 million or approximately 5% of par. Therefore, our auction rate securities balance as of March 31, 2008 is $68.8 million. We do not believe that any of our auction rate securities are presently at risk of default and we continue to receive interest payments in accordance with their terms.

All of our auction rate securities are AAA-rated by either S&P/Moody's or Fitch and over 95% of these holdings are collateralized by student loans guaranteed by the US Government under the Federal Family Education Loan Program or FFELP with the rest guaranteed or collateralized by municipalities and further backed by bond insurance companies.

Given the credit quality in collateral securing our auction rate securities, we currently believe that we will ultimately be able to liquidate our investments without significant loss. It could however take some time before the capital markets settle down and as a result we will be classifying the auction rate securities that have not been called by the issuer and long-term investment as of March 31, 2008.

As of March 31, 2008, in addition to our auction rate securities we had over $200 million in cash and other investments held primarily in the form of US Government debt, corporate debt, commercial paper and money market funds. Therefore, we continue to believe that the current liquidity challenges, that our auction rate securities will not materially impact our ability to fund our operations and execute our business plans. I’ll now turn the call over to Brian for his comments.

Brian Pereira

Thank you, David. During the past quarter we advanced our New Drug Application or NDA review process with an NDA orientation presentation to the FDA, in February 2008. Under PDUFA core orientation presentations provide companies an opportunity to meet with the FDA and highlight key aspects of their filings. We are pleased with our interactions with the agency to-date and remain on track for our potential US launch of Ferumoxytol in the first quarter of 2009.

Earlier this month we presented additional positive results from our Ferumoxytol pivotal studies at the National Kidney Foundations Spring Clinical Meetings. Two posters were presented that add to the body of positive data derived from our Phase III clinical studies conducted over the years. The first poster presented pooled results from our three open-label multicenter, randomized Phase III efficacy and safety study and included 875 patients with all stages of chronic kidney disease.

When the results were stratified by the state of CKD, Ferumoxytol treatment produced approximately a 1 gram per deciliter increase in hemoglobin from base line to day 35 for each stage. The second poster presented peritoneal analysis results of Phase III randomized double-blind placebo-controlled crossover safety study.

Overall, the 12.5% adverse event rate of patients on peritoneal dialysis who received Ferumoxytol was lower than the 20.5% following placebo and the 5.0% drug related adverse event rates following Ferumoxytol administration were similar to the 7.7% following placebo administration. Overall more than 1,700 patients and healthy volunteers have been treated with Ferumoxytol in 11 clinical studies administering over 2800 dozes of Ferumoxytol. We think that the efficacy and safety results that we have presented at several prestigious medical meetings speak for themselves.

As we have mentioned, we anticipate initiating additional clinical programs in patients with iron deficiency anemia in 2008. Many patients experience iron deficiency anemia as a result of a variety of debilitating conditions other than CKD. We plan to commence program in women with abnormal uterine bleeding or AUB and also in patients with iron deficiency anemia caused by multiple disease conditions including cancer.

We are currently discussing the AUB study protocol with the FDA and are on track to initiate that program middle of this year. Study designs for the program addressing iron deficiency anemia due to multiple disease conditions is also under development and is subject to further discussions with the agency. We planned to initiate that program in the second half of this year. We look forward to sharing additional data details with you at our analyst and investor day on June 5.

As we have said in the past, our plan is to market and sell Ferumoxytol ourselves in the US. We continue to be on track with our launch preparation activities and have completed the hiring of most senior and middle level management positions across the commercial operations at medical affairs groups. We are about to embark on hiring our frontline sales managers for our US field force over the next several months. In addition we have begun hiring our medical science liaison team. We plan on hiring a field sales force of approximately 80 members during the second half of this year.

In May, we will be launching a non-product specific disease state advertising campaign in major nephrology medical journals. The intent of this campaign is to educate those who treat CKD patients on the importance of early and frequent testing of iron status as a critical part of optimal anemia management in patients. This advertising campaign will also further strengthen AMAG image as an emerging leader in the field of nephrology.

Market research indicates a significant opportunity to increase the use of IV iron in the nephrology office setting. Approximately 30% of US nephrologists stock and administer IV iron to CKD patients in their offices, compared to 70% that stock and administer ESAs. This was not surprising considering that the current approved IV iron preparations can be cumbersome and inconvenient for patients and providers. The insufficient testing of iron levels by a nephrologists is an important factor contributing to the under utilization of IV iron in the office setting. Our advertising campaign will help address this issue.

Our manufacturing scale of efforts are also on track, as we hire production and quality control staffs as we build Ferumoxytol inventory at our commercial scale GMP manufacturing facility. They are also engaged in negotiations with respect to agreements for second source manufacturing to augment the Ferumoxytol commercial supply that we will be manufacturing at our facility. I am happy to announce that we now have over 100 employees at AMAG which is an important milestone for the company and reflective of the growth opportunity we see in the marketplace for treating iron deficiency anemia.

While we plan to commercialize Ferumoxytol for CKD in the US ourselves, we continue to evaluate opportunity for Ferumoxytol in markets outside the US. The commercial attractiveness of these markets varies greatly and is driven by pricing and reimbursement, patient access to dialysis and the role of iron in local treatment protocols. For those markets that we consider to be attractive we are evaluating the best way to enter that including partnerships, distributorships and collaborations.

In addition as we build our commercial organization in support of the anticipated launch of Ferumoxytol in the US for CKD, we are focused on leveraging our renal expertise and investment. As a result we are working to expand our renal franchise through business development activity. We look forward to updating you on our progress on commercialization brands for Ferumoxytol outside the US and our business development efforts through the year.

Finally we strengthened our Board of Directors in the first quarter by adding Dr. Joseph Bonventre in February. Dr. Bonventre is the Director of the Renal Division at the Brigham and Women's Hospital and is the Robert H. Ebert professor of Medicine at Harvard Medical School and Professor of Health Sciences and Technology at the Massachusetts Institute of Technology. We are excited to have someone with world class academic reputation, strong scientific and medical advice report experience and longstanding leadership roles in the American Society of Nephrology joining our Board.

As you have seen in our press release today we will be hosting an analyst and investor day in New York on Friday June 5 this year. Invitations will be sent out shortly and we will be webcasting the presentation with slides. At this analyst day we will highlight Ferumoxytol’s opportunity in CKD patients, our commercial plans for launch and discuss our plans for additional trials this year. We have invited industry experts to speak and in addition we plan to showcase the depth of our management team. We are very excited with what we have organized for the day and we hope that many of you will be able to join us.

We believe our continued progress as we have discussed today along with our experience management team and strong cash balance provide a firm foundation to successfully launch Ferumoxytol in the US and to develop additional indications. We look forward to updating you on our progress at the upcoming analyst investor day and over the coming months. This completes my prepared comments. We will now turn the call back to the operator to conduct the question-and-answer session of this call.

Question and Answer Session

Operator

(Operator Instructions) Your first question comes from the line of Soham Pandya of ThinkEquity.

Soham Pandya - ThinkEquity

Great, thanks for taking my question. Brian just a couple of quick question; you mentioned about learning more about the European strategy maybe the partnerships or distribution agreement, can you give us an update on the filing for Europe?

Brian Pereira

Soham as we have mentioned in the past, European markets are fragmented and vary in attractiveness widely. We are at this point of both following our own registration strategy in the Europe, while having business development discussions with both broad-based European players as well as country specific European players. I will be able to share a little more about the time lines and plans at the analyst day in June.

Soham Pandya – ThinkEquity

Okay, fair enough and then just from our understanding then typically what agency or what division within the FDA handles IV iron review? Is there a specific division that historically has been associated with reviewing these agents?

Brian Pereira

Yes there is. The division of hematology and medical imaging which is a consolidated division, it’s a change from the past. It reviews all IV irons and erythropoietic agents among the other things.

Soham Pandya – ThinkEquity

So it’s not the renal or cardiac division typically that’s involved here?

Brian Pereira

No.

Soham Pandya – ThinkEquity

Okay and then one last question. There seems to be lot of confusion on the street with respect to treatment of iron deficiency anemia versus prevention of iron deficiency anemia? Just can you highlight the strategy that you are employing and what is done with respect to prevention? Is that something or prevention or maintenance protocol? How was that used in the real world setting?

Brian Pereira

I would be happy to address that Soham; I'm glad you asked the question. Iron deficiency anemia is common in CKD patients particularly those in hemodialysis and most of these patients are best treated with IV iron. The challenge with respect to episodic treatment versus chronic maintenance therapy with IV iron actually lies in the test for iron. The available tests that the transfer and saturation inheritance are at that fair for the diagnosis of iron deficiency but are notoriously unable to detect iron overload and its chronic preemptive therapy is fraught with the risk of iron overload which cannot be detected hence registration studies are designed to treat iron deficiency not prevent it. In the Ferumoxytol development program both non-dialysis and dialysis patients in whom iron deficiency anemia re-emerge after the first course of Ferumoxytol, we are allowed to re-enter the study and receive additional doses of Ferumoxytol. I would like to emphasize that there is a difference between regulatory requirements for product approvals and clinical use. Sponsors work with the agency to construct a development program that meets the regulatory requirements for approval. What happens in clinical practice is determined by the decisions made by individual physicians or dialysis organizations. As I have said in the past our proposed label seeks to treat iron deficiency anemia and not prevented and as such represents an episodic treatment paradigm consisted with the clinical use. Current IV irons do not have chronic therapy included in their label nor do labels include maintenance storing information. In our efficacy trials patients with iron deficiency received our targeted 1 gram therapeutic dose and as I said earlier in this statement after 35 days of follow-up for the primary and secondary end points all the way up to the completion of enrollment in trials, patients who met the criteria for iron deficiency anemia could and did receive a second course of Ferumoxytol. I hope that answers your question.

Operator

Your next question comes from the line of Adam Walsh of Jefferies & Company.

Adam Walsh - Jefferies & Company

Brian, can you elaborate a little bit and give some more detail on the orientation meeting that went on between your management team and the agency on the Ferumoxytol filing? Can you just discuss specifically, exactly what members of the FDA were present at the meeting; was it the actual division or reviewer members that will review the Ferumoxytol application and also was the scope of the development program in terms of the clinical trials you ran, was that discussed as part of the meeting, that’s my first? Thanks.

Brian Pereira

Adam, the NDA orientation meeting is where companies are provided the opportunity to meet with the entire review team including the leadership of the FDA for 90 minutes to review the filing and highlight key aspect of the application including product attributes, efficacy, safety results and any other issue considered important by the agency. The agency leadership and review team get an opportunity to ask questions from the sponsors team at this meeting. Having said that we don’t comment on which specific members of the agency were there at the meeting of what exactly was discussed.

Adam Walsh - Jefferies & Company

Okay, fair enough and then Brian maybe you could just touch briefly on -- I would like to get your thoughts on the JC articles on the use intravenous iron in oncology; if you had an opportunity to see those, can you just give us your thoughts and what you might have learned from those in terms of Ferumoxytol development in that indication? Thanks.

Brian Pereira

I mean, I am glad you point out to the recent publication on the use of intravenous iron in oncology. The field of oncology has for the last decade and a half been completely focused on the use of erythropoietic agents for the treatment of anemia and largely ignore the other side of the coin, that’s iron deficiency. As the article highlight many patients with cancers have extensive surgery, have bad mucositis and GI disturbances which prevent absorption of iron, have multiple blood test and procedures and are very likely to be iron deficient. A few of those voices in the field have been using iron successfully and showing that patients who get adequate iron with or without erythropoietic agents and to have a better clinical outcome. So, I guess this article just confirms our belief that there is an opportunity in patients with cancer and hence that’s one of the indications that we are pursuing; having said that, given all of the tumultuous occurrences in the ESA use in oncology, we are working closely with the agency with respect to the construction and rollout of clinical trials in this field.

Adam Walsh - Jefferies & Company

Just as a follow-up to that Brian in your dialogue with the agency, do you see any, indication that there might be special trial designs that you might have to implement in order to pursue the oncology indication based on what were seeing with the ESA franchises? Thanks.

Brian Pereira

That’s an important question Adam. As you know that the challenge is in designing the right trial with the right combination of iron and ESA. It’s still too early for us to share information with you as to where exactly the agency is heading with respect our clinical development program. Over the ensuing months we will be able to share a little more with you once we nail down the final study design and the patient numbers.

Operator

Your next question comes from the line of [Robin Karnofysk] of Bear Stearns.

Robin Karnofysk - Bear Stearns

Just a couple of questions; first in the EU if you do decide to pursue a launch in the EU, would you have to additional studies and then my second question is, thinking ahead of the launch since launch preparations are already underway, what kind of things are you doing potentially begin having interactions with dialysis centers; I know there is a lot of contracting dialysis centers, so how are you thinking about penetrating that market segment?

Brian Pereira

Well, Robin let me take the first question. As to the EU, our clinical development and regulatory team have initiated discussions with the agencies in the EU. I think we will have to wait for the outcome of those discussions to see whether our package as we have is adequate for EU filing or there are specific peculiarities of the EMEA requirement that we will have to address. As you know we’ve submitted of fully electronic filing with the FDA in the US. That gives us a lot of flexibility in moving things around in terms of the structure in the EU. If the EU requires additional studies, we will address those once we have completed; our discussions with the agency and once we have a greater granularity and information on that we’ll be delighted to share that with you. On the second piece of what are our preparations for launch, we are going through the classical launch preparations including starting off as you will see shortly, an unbranded program wherein we are educating nephrologists on the challenges of iron deficiency, both in dialysis but particularly in non-dialysis patients. At the National Kidney Foundation Meetings this year, this month in fact we had had a medical affairs booth, we had a lot of material that also provided two of the participants as well at the symposium of with leading authorities discussing the unmet needs with respect to iron deficiency anemia in CKD patients. With respect to our interactions with the dialysis chain, we have to be careful to behave within the confines of compliance guidelines and that restricts the amount of discussions and the scope of discussions that we can have with dialysis agency and we are early in our commercial light setting a standard that we will not be embarrassed in the years to come.

Robin Karnofysk - Bear Stearns

And I guess I have one additional question. You mentioned you might be interested in expanding your renal franchisee in your business development; can you just elaborate a little bit or, maybe give a little bit more detail on maybe the timing for the types of opportunities.

Brian Pereira

Sure. We look at business development at each two different spheres; one is geographical expansion and as we have mentioned in the past we continue to have discussions with key players in countries where the markets are attractive, both in established economies as well as in developing economies; we’ll update you more about that in the months ahead. On the additional product front we will have an established sales force in the nephrology space. We will have built relationships with both dialysis chains and nephrologists and so we are on the look out for our products or companies that could fix nicely into our Ferumoxytol and our nephrology’s franchise. Having said that when and what will happen, I cannot comment on that at this point in time, but will as soon as we will have more color to it.

Operator

Your next question comes from the line of Chris Raymond of Robert W. Baird.

Chris Raymond - Robert W. Baird & Co.

Thanks. Question was asked and answered, thanks.

Operator

(Operator Instructions) Your next question comes from the line of Marshall Urist of Morgan Stanley.

Marshall Urist - Morgan Stanley

So to follow-up on the business development question, I guess is there more opportunity in the sort of the pre-dialysis nephrologists space sort of given the limited number of drugs and certainly well represented from the commercial point of view in hemodialysis?

Brian Pereira

Good question Marshall. The reality is that not just pre-dialysis but the nephrology space outside of dialysis has largely seen very little innovation over the last couple of decades. Most innovation has been an injectable drugs in the dialysis because that was the biggest paying market, but as the dialysis market now becomes largely with most of the problems addressed and also with the potential for bundling in 2011, there are many, many emerging opportunities in nephrology outside of dialysis. That’s a very astute question.

Marshall Urist - Morgan Stanley

So, then are you looking to take on some development risk as you look at this or is it going to be something established that you might be able to move into the nephrology space?

Brian Pereira

We will evaluate product across the spectrum Marshall, from early development to advanced stage. We will evaluate the risk and benefit of a potential business development move based on the product attributes and how it’s fixing to our existing franchise.

Marshall Urist - Morgan Stanley

All right and then second question is on the trials for the new indication, so can you kind of speak to what’s the difference in some ways between the abnormal uterine bleeding and the other protocol that you are talking about in terms of sort of ease of settling on a protocol with the FDA? Is that the reason for the difference in timing or is it some other factor?

Brian Pereira

Well, the difference is that women with abnormal uterine bleeding could largely be considered healthy. The other indications, be it cancer or inflammatory bowel disease or what have you, would be folks who have a reasonably serious disease, so the risk profile of the trial and the number of patients required in the trials in these two conditions are going to be different and so will be construct of the study design. The most practically issue is that given as the fact that we are a little more advanced in terms of our discussions with the agency on women with abnormal uterine bleeding, that’s going to lead the way followed by the broader iron deficiency anemia, but the broad strategy for the Company Marshall is that we have demonstrated we believe the safety and efficacy Ferumoxytol in what one would consider the sickest group of patients, that’s CKD and dialysis. Our hope is to demonstrate the safety and efficacy in the healthiest group of patients, that’s women with abnormal uterine bleeding and disease to book ends fill the middle, that’s patients with cancer inflammatory bowel disease and so on who one would consider somewhere in between the sickest and the healthier patients.

Operator

Your next question comes from the line of Subhash Desai of Delaware Street Capital.

Subhash Desai - Delaware Street Capital

Hey guys thanks for taking my question. Two questions; the first one relates to the AUB and the cancer trial you are doing. Are you talking to the EMEA to incorporate their comments in the design so that the applications can be submitted simultaneously in the US and Europe?

Brian Pereira

Our intent Subash is to do a global clinical study for both these indications and our regulatory team is evaluating all issues that -- we have to balance the competing, issues with respect to the EMEA versus the FDA because when one gets into both negotiating with two different agencies, we incur the risk of substantial delays. I think the key here is that once we pursue a broad label in the US that would be much easier to get into the EU because the EU has traditionally given broad label for iron. In fact all the IV irons in the European market has broad labels today. The second point of course as I mentioned earlier and I have repeated it; the US is by far the most attractive IV iron market today. If you look at IV iron sales globally, the US is in terms of dollar terms far and away the largest market, largely because a lot of genetic iron has a big play in EU. Having said that in the EU there isn’t a lot of IV iron use outside of nephrology, but as you know this is something that we are addressing.

Subhash Desai - Delaware Street Capital

The second question relates to the opportunities in the US in terms of the elderly since there is a large population of the elderly with the glomerular filtration rates, which are in the CKD category, what’s your strategy in addressing that market?

Brian Pereira

That’s a very astute observation. As you rightly pointed out, the vast majority of folks in the 60’s, 70’s, and 80’s -- I’m being a little careful not to call anybody elderly here; tend to have GFR’s which are below 60ml per minute, which by the definition of the KDOQI guidelines would be classified as chronic kidney disease. As you probably know we have presented an abstract showing the efficacy of Ferumoxytol across the age spectrum. Our marketing team is evaluating our commercial strategies to address this population. As we have said earlier, our first two layers of attack are hemodialysis and predialysis CKD. We will have to then or we will concurrently develop plans for addressing both the institutionalized and non- institutionalized folks with advancing age.

Operator

Your next question comes from the line of [Malini Chatterjee of Kay Street Capital].

Malini Chatterjee - Kay Street Capital

Just a very quick question; so your Ferumoxytol filing was to hematology and imaging and very recently towards the end of ’06 the division director of hematology and imaging George Mills retired. I am wondering if you guys have had the opportunity to talk to him and to seek his guidance in terms of your application package, I don’t know if you are going to divulge who is on your scientific advisory board, but it begs the question if you have spoken to this one very important person?

Brian Pereira

The broad statement Malini is that we are aware of who has been at the agency and who at the agency, who has left the agency, can provide us with sound input regarding our strategy. We have left no stone unturned in term of soliciting and involving former FDA experts in our clinical development program. Now, that’s as much as I can say. I cannot give you specifics, but you can be assured that we have left no stone unturned.

Operator

(Operator Instructions) Your next question comes from the line of Andrew Berens of Merrill Lynch.

Andrew Berens - Merrill Lynch

I would like to elaborate on your responses to Soham’s question. You indicated that there was a diversion between the regulatory requirements and the anticipated real world usage in dialysis; have you received acknowledgements from the agency that the suggested usage by the label for IDA and dialysis does not trigger the ICH recommended protocol?

Brian Pereira

Andy, that’s a good question. We have worked with the agency throughout our clinical development program to structure our clinical drug program based on what the agency believe is an appropriate registration strategy and we believe that the fact that we have completed a pre NDA meeting, our package has been acceptance to answer the question you have raised.

Andrew Berens - Merrill Lynch

So you are saying you actually have exceeded acknowledgements that they don’t require exposure data per the ICH guidelines?

Brian Pereira

Andy as I said earlier in response to many question asked in this call that we don’t discuss the specifics of our discussion with the agencies.

Andrew Berens - Merrill Lynch

Okay. Well is part of your strategy to try to convince the FDA that it’s not a chronic disease and that episodic acute treatment is acceptable?

Brian Pereira

Our strategy is to submit the most complete package to the agency that will give us the best chance of approval for the indication that we are seeking; treatment of iron deficiency anemia in CKD patients on dialysis and not on dialysis.

Operator

At this time there are no further questions. I will now turn the call to management for any final remarks.

Brian Pereira

Well thank you, very much for joining us on the call today. The 6th of June is just six weeks away and we look forward to updating you on all of the exciting things that are happening in the Company. Have a wonderful day.

Operator

Ladies and gentlemen thank you for participating in today’s AMAG first quarter financial results conference call. You may now disconnect.

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Source: AMAG Pharmaceuticals Inc. Q1 2008 Earnings Call Transcript
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