AMAG Pharmaceuticals (AMAG)

[TheFinalCD]

AMAG FDA CRL "cannot be approved" = http://ih.advfn.com/p.php?pid=nmona&article=60752360&symbol=AMAG

[Nolerman]

I'm not familiar with this company....how big is this for the company? Is this a blockbuster/business essential?

[Nolerman]

I'm not familiar with this company....how big is this for the company? Is this a blockbuster/business essential?

[Nolerman]

I'm not familiar with this company....how big is this for the company? Is this a blockbuster/business essential?

[surf1944]

2:01AM AMAG Pharma receives notice of 3-month extension of PDUFA date for supplemental NDA for Feraheme for broader IDA indication (AMAG) 19.54 : Co announces the FDA has extended its review of a supplemental new drug application for Feraheme injection for intravenous use. The sNDA seeks to expand the indication for Feraheme beyond the current indication for the treatment of iron deficiency anemia in adult patients with chronic kidney disease to include all adult patients with IDA who have failed or cannot tolerate oral iron treatment. The new prescription drug user fee act action date has been set for January 21, 2014.

[surf1944]

8:47AM AMAG Pharma announces its European commercial partner, Takeda Pharmaceutical (TKPYY), has submitted a type-II variation to the European Medicines Agency for Rienso (ferumoxytol) (AMAG) 19.55 : Co announced that its European commercial partner, Takeda Pharmaceutical (TKPYY), has submitted a type-II variation to the European Medicines Agency for Rienso (ferumoxytol). The submission requests EMA approval to expand the indication for ferumoxytol beyond the current indication for the treatment of iron deficiency anemia in adult patients with chronic kidney disease to include all adult patients with IDA who have a history of unsatisfactory oral iron therapy or in whom oral iron cannot be used. If approved for this indication, we believe that Rienso could provide a new treatment option for iron deficiency anemia patients who cannot tolerate or do not respond to oral iron therapy."

[surf1944]

8:30AM AMAG Pharma: Ferumoxytol results in significant hemoglobin increases in Adult Iron deficiency anemia patients with abnormal uterine bleeding who had failed or could not tolerate oral iron therapy (AMAG) 23.37 : Co announced that a new sub-group analysis from IDA-301, a phase III, randomized, placebo-controlled clinical trial, will be presented today at the first poster session of the American College of Obstetrics and Gynecology annual meeting in New Orleans, Louisiana. In the full IDA-301 study, 608 adult patients with iron deficiency anemia who had failed or could not tolerate oral iron were treated with ferumoxytol and 200 received placebo, with the demographics and all baseline parameters well balanced between the two treatment groups. The sub-group analysis being presented today at ACOG is based on 344 patients in IDA-301 with abnormal uterine bleeding (AUB), the most frequent underlying cause for IDA in this study, with 260 AUB patients randomized to ferumoxytol and 84 to placebo.

The primary efficacy endpoint of this study for FDA is the proportion of subjects who achieved a > 2.0 g/dL increase in hemoglobin at any time from baseline to week 5; the primary efficacy endpoint for European Union (EU) regulators is the mean change in hemoglobin from baseline to week 5. In the AUB subgroup analysis, 87.3% of ferumoxytol-treated patients achieved an increase of > 2.0 g/dL in hemoglobin compared to 3.6% of patients who received placebo, meeting the protocol defined measure of superiority (p<0.0001). The mean change in hemoglobin in ferumoxytol-treated AUB patients was 2.8 g/dL, compared to no increase (0.0 g/dL) in AUB patients receiving placebo (p<0.0001). These results paralleled those in the total study population.

In the AUB sub-group, the rate of reported adverse events (AEs) was higher among ferumoxytol-treated patients (47.7%) than in patients that received placebo (46.4%), although no new safety signals, outside those described in the current FDA-approved label for ferumoxytol, were observed in this study.

[surf1944]

6:02AM AMAG Pharma announces positive preliminary results from an extension study evaluating the safety and efficacy of repeat dosing with ferumoxytol in patients with persistent or recurring iron deficiency anemia, regardless of the underlying cause; achieved a statistically significant mean increase in hemoglobin from baseline to week five (AMAG) 20.15 : Co announced positive preliminary data from the IDA-303 study. IDA-303 is a single arm, open-label extension study that evaluated the safety and efficacy of repeat dosing with ferumoxytol in patients with persistent or recurring iron deficiency anemia regardless of the underlying cause and a history of unsatisfactory oral iron therapy or in whom oral iron could not be used. Patients were eligible to enroll in the IDA-303 extension study after they completed IDA-301, which was a double-blind, placebo-controlled trial that randomized patients to receive either a one gram intravenous course of ferumoxytol or placebo, the results of which were previously reported by the company and presented at the American Society of Hematology annual meeting in December 2012.

The primary efficacy endpoint of the extension study was the mean change in hemoglobin from baseline to week five following the first course of ferumoxytol. The 151 patients who received their first course of therapy in IDA-303 achieved a statistically significant mean increase in hemoglobin from baseline to week five of 2.6 g/dL. This change was consistent with the 2.7 g/dL increase in hemoglobin reported for ferumoxytol-treated patients in both the IDA-301 and IDA-302 studies. The first secondary endpoint was the mean change in hemoglobin from baseline to week five for each subsequent course of ferumoxytol after treatment course one. The group of patients receiving a second (n=244) and third (n=69) course of treatment with ferumoxytol in IDA-303 included patients who had received ferumoxytol in IDA-301 and patients who had received their first course of ferumoxytol in IDA-303.

No new safety signals were observed with repeat dosing of ferumoxytol and the types of reported adverse events (AEs) were consistent with those seen in both the previously reported IDA and CKD phase III studies, and those contained in the approved U.S. package insert for Feraheme; no hypersensitivity reactions or hypotension were reported in the IDA-303 study.

[surf1944]

8:49AM AMAG Pharma announces FDA acceptance of supplemental new drug application for Feraheme label expansion to include iron deficiency anemia patients who cannot take oral iron; Both studies achieved their primary efficacy endpoints (AMAG) 17.82 : Co announced that the FDA has accepted for review the company's supplemental new drug application for Feraheme Injection for Intravenous use, which was submitted to the FDA in December 2012. The sNDA requests FDA approval to expand the indication for ferumoxytol beyond the current indication for the treatment of iron deficiency anemia in adult patients with chronic kidney disease to adult patients with IDA who have failed or could not take oral iron treatment. Under the Prescription Drug User Fee Act guidelines, the sNDA is subject to a 10-month review by the FDA. With the acceptance of the submission, the FDA has set October 21, 2013 as a target date for completion of their review.

The sNDA submission is based on data from a global phase III program that evaluated the use of ferumoxytol in a broad range of adult IDA patients, all of whom had failed or could not take oral iron treatment. More than 1,400 patients were enrolled in the two phase III clinical trials, known as IDA-301 and IDA-302. Both studies achieved their primary efficacy endpoints, with statistically significant improvements in hemoglobin from baseline to the 35-day endpoint of the studies. Adverse events and serious adverse events commonly associated with ferumoxytol and other IV iron therapies, including hypersensitivity reactions, were reported in both studies. No new safety signals, outside of those described in the current Feraheme label, were observed with ferumoxytol treatment in these studies.

[surf1944]

AMAG Pharmaceuticals, Inc. to Present at Upcoming Healthcare Conferences
Press Release: AMAG Pharmaceuticals, Inc. – Thu, Feb 21, 2013 4:05 PM EST

LEXINGTON, Mass.--(BUSINESS WIRE)--
AMAG Pharmaceuticals, Inc. (AMAG) today announced that William Heiden, AMAG’s chief executive officer, will participate in the RBC Capital Markets Global Healthcare Conference on Tuesday, February 26, 2013 at 9:30 am ET in New York and the Cowen and Company 33rd Annual Healthcare Conference on Monday, March 4, 2013 at 2:50 pm ET in Boston. The presentations will include a company overview and business update, followed by a question and answer session with investors.
A live webcast of the presentations will be accessible through the Investors section of the company’s website at www.amagpharma.com. Following the conferences, the webcasts will be archived on the AMAG Pharmaceuticals, Inc. website until April 4, 2013.

[surf1944]

11:16AM AMAG Pharma announces new data from ferumoxytol pivotal Phase 3 broad iron deficiency anemia program presented at ASH (AMAG) 14.44 +0.02 : Co announced that new data from two pivotal phase III clinical trials were presented at the American Society of Hematology's (ASH) annual meeting in Atlanta, Georgia. The phase III trials evaluated the use of ferumoxytol in subjects with iron deficiency anemia (IDA), regardless of the underlying cause of the anemia, who had failed or could not tolerate oral iron treatment. New data from an investigator-initiated study evaluating a one gram 15-minute infusion of ferumoxytol are also being presented at ASH; the current approved dosing of ferumoxytol is two 510 mg injections, three to eight days apart. Two poster sessions highlighted the safety and efficacy data from each of the phase III clinical trials: IDA-301 and IDA-302. In addition, an oral presentation contained patient-reported outcome data from IDA-301, which demonstrated a direct correlation between the rise in hemoglobin and improvement in patient-reported measures of fatigue. Data from these two clinical trials will be the foundation for AMAG's supplemental new drug application (sNDA) in the United States.

[surf1944]

AMAG Pharmaceuticals, Inc. Announces that Feraheme Abstracts for the American Society of Hematology Annual Meeting are Now Available
Business WirePress Release: AMAG Pharmaceuticals, Inc. – Tue, Nov 6, 2012 9:00 AM EST

LEXINGTON, Mass.--(BUSINESS WIRE)--

AMAG Pharmaceuticals, Inc. (AMAG) today announced that four abstracts containing new data on treatment with Feraheme® (ferumoxytol) Injection for intravenous (IV) use in patients with iron deficiency anemia with a history of unsatisfactory oral iron therapy will be presented at the 2012 Annual Meeting of the American Society of Hematology (ASH) taking place December 8-11, 2012 in Atlanta, Georgia.

The following abstracts have been accepted for presentation and are now available on the ASH website at www.hematology.org:

“Ferumoxytol Treatment Results in Robust Hemoglobin Increases in Iron Deficiency Anemia Patients with a History of Unsatisfactory Oral Iron Therapy in a Phase III, Randomized, Placebo-Controlled Trial” (Vadhan-Raj, et. al.)
Session Name: 102. Regulation of Iron Metabolism: Poster II; Date: Sunday, December 9, 2012
Presentation Time: 6:00 PM - 8:00 PM; Location: Georgia World Congress Center, Hall B1-B2

“Potential New Treatment Option for Iron Deficiency Anemia Patients with a History of Unsatisfactory Oral Iron Therapy- Results of a Phase III, Randomized, Open-Label, Active-Controlled Trial of Ferumoxytol” (Hetzel, et. al.)
Session: 102. Regulation of Iron Metabolism: Poster II; Date: Sunday, December 9, 2012
Presentation Time: 6:00 PM-8:00 PM; Location: Georgia World Congress Center, Hall B1-B2

“Efficacy of Total Dose Administration (TDI) of 1012 Mg of Ferumoxytol Over 15 Minutes for the Treatment of Iron Deficient Anemia” (Auerbach, et. al.)
Session Name: 102. Regulation of Iron Metabolism: Poster III ; Date: Monday, December 10, 2012
Presentation Time: 6:00 PM - 8:00 PM; Location: Georgia World Congress Center, Hall B1-B2
“Ferumoxytol Treatment Demonstrates Significant Improvements in Fatigue and Health-Related Quality of Life in Iron Deficiency Anemia Patients with a History of Unsatisfactory Oral Iron Therapy” (Vadhan-Raj, et. al.)
Session Name: 901. Health Services and Outcomes Research: Benign hematology - iron metabolism, hemoglobinoapthies and coagulation;
Session Date: Monday, December 10, 2012; Session Time: 10:30 AM - 12:00 PM; Presentation Time: 11:15 AM; Room: Georgia World Congress Center, C211-C213

About Feraheme (ferumoxytol)

In the United States, Feraheme® (ferumoxytol) Injection for Intravenous (IV) use is indicated for the treatment of iron deficiency anemia in adult chronic kidney disease (CKD) patients. Feraheme received marketing approval from the US Food and Drug Administration on June 30, 2009 and was commercially launched by AMAG in the US shortly thereafter. Ferumoxytol received marketing approval in Canada in December 2011, where it will be marketed by Takeda as Feraheme®, and in the European Union in June 2012 and Switzerland in August 2012, where it will be marketed by Takeda as Rienso®. For additional product information, please visit www.feraheme.com.

[surf1944]

8:16AM AMAG Pharma announces Rienso receives Swiss Marketing Authorization for the treatment of iron deficiency anemia in adult patients with chronic kidney disease (AMAG) 15.00 : Co announces that the Swiss Agency for Therapeutic Products has granted marketing authorization in Switzerland for ferumoxytol, an intravenous iron therapy to treat iron deficiency anemia in adult patients with chronic kidney disease. Ferumoxytol was approved for the same indication in the EU in June 2012, and in the US and Canada under the brand name Feraheme in June 2009 and December 2011, respectively. AMAG's partner, Takeda Pharmaceutical (TKPYY), is responsible for commercialization of ferumoxytol in Switzerland, the EU and Canada, among other territories. Takeda plans to launch ferumoxytol in Switzerland under the brand name Rienso. AMAG is entitled to receive tiered, double-digit royalties on product sales in the licensed territories. AMAG has sole commercial rights for Feraheme in the US.

[surf1944]

6:00AM AMAG Pharma announces positive preliminary results from its phase III study evaluating Feraheme compared to placebo in patients with iron deficiency anemia; Feraheme achieves superiority on all primary efficacy endpoints (AMAG) 15.85 : Co reported preliminary results from the second phase III study from its global registrational program for Feraheme (ferumoxytol) in patients with iron deficiency anemia (IDA) regardless of the underlying cause. Feraheme demonstrated superiority on all primary efficacy endpoints evaluated in this study. The efficacy and safety of Feraheme in this study were comparable to that reported earlier this year in the IDA-302 study, the phase III IDA study comparing Feraheme to iron sucrose. In the IDA-301 study, Feraheme demonstrated robust efficacy, achieving superiority on both primary efficacy endpoints. Patients treated with Feraheme achieved a statistically significant mean increase in hemoglobin at week five of 2.7 g/dL, compared to a mean increase of only 0.1 g/dL in patients who received placebo; importantly, these data are consistent with the 2.7 g/dL increase in hemoglobin reported in the IDA-302 study. In addition, a = 2.0 g/dL increase in hemoglobin at any time from baseline to week five was achieved in a statistically significantly greater proportion, 81.1%, of patients treated with Feraheme in this study, compared with only 5.5% of patients who received placebo; these data are also consistent with the data from IDA-302, in which 84.0% of Feraheme-treated patients achieved a = 2.0 g/dL increase in hemoglobin. Further, a statistically significant improvement in fatigue, as assessed by patient reported outcome measures, was demonstrated at week five in Feraheme-treated patients. No new safety signals were observed with Feraheme and the types of reported adverse events (AEs) were consistent with those seen in both the previously reported IDA phase III study and the CKD phase III studies, and those contained in the approved U.S. package insert for Feraheme. Overall, AEs were reported in both study arms with AEs reported in 49.2% of Feraheme-treated patients, compared to 43.0% of patients who received placebo. AMAG is planning to submit a supplemental new drug application for the broad IDA indication to the FDA by year-end 2012.

[surf1944]

AMAG Receives EU Approval For Iron Drug With Phase III Results Expected Soon

AMAG Pharma (AMAG) is a specialty pharmaceutical company focused on the development and commercialization of FERAHEME (ferumoxytol) as an intravenous drug for the treatment of iron deficiency anemia (IDA).

Today, the Company announced European Union approval for the drug (brand name RIENSO in EU) for the treatment of adults with IDA due to chronic kidney disease (CKD). The drug will be marketed by EU partner Takeda (TKPYY.PK) and approval triggered a $15 million (M) milestone payment in addition to another $15M due upon first sales of the drug in Europe along with double-digit royalties.

In addition, AMAG is conducting a pivotal Phase III clinical trial (IDA-301) (ClinicalTrials.gov ID NCT01114139) to support a planned Supplemental New Drug Application seeking expanded FDA approval for treatment of IDA regardless of the underlying cause (current approval is for patients with CKD). In March, AMAG reported the first Phase III study (IDA-302) met both primary efficacy endpoints w/ no safety issues and results are expected from the fully enrolled second pivotal Phase III trial in the near-term (mid-2012).

Below is a summary of the most recently reported financials for AMAG.

AMAG reported total revenue during 1Q12 was $15.5M including $13.6M in net sales of FERAHEME compared to $13.4M and $10.9M, respectively, in the year-ago periods.
AMAG reported total FERAHEME demand was 26,600 grams-representing a 30% increase from 1Q11 and a 10% increase from 4Q11.
AMAG reported a net loss during 1Q12 of ($12.4M) vs. ($22.3M) in the year-ago period
As of 3/31/12, AMAG reported cash and equivalents of $218M which equates to over $10/share in cash w/ no debt and a projected cash balance at year-end of $225-230M based on $33M in milestone payments from Takeda for commercialization in the EU ($30M) and Canada ($3M).
As of 4/27/12, AMAG reported 21.4M shares of common stock outstanding.
AMAG expects net sales of FERAHEME to be $53-57M which excludes ex-U.S. double-digit royalties from Takeda.
AMAG expects $40-45M in research and development (R&D) and $50-55M in selling, general and administrative (SG&A) expenses in 2012.

Despite a recent rebound in shares of AMAG over the past few weeks from fresh 52-week lows in the mid-$12s to current levels around $15/share; the Company has generated some positive momentum with the EU approval announced today and has a strong balance sheet with over $10/share in cash now and by year-end in addition to pending double-digit royalties from Takeda for sales of RIENSO in Europe.

With positive Phase III results likely in the second Phase III trial in the near-term; I expect shares of AMAG to continue the recent upside momentum in the coming weeks; although longer term success for the company will depend on continued sales growth for FERAHEME/RIENSO to achieve profitability. Thanks to a strong balance sheet, AMAG has more than adequate time and resources to devote to marketing and R&D (i.e. the planned sNDA filing) to make this happen.

Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.

http://seekingalpha.com/article/678601-amag-receives-eu-approval-for-iron-drug-with-phase-iii-results-expected-soon?source=yahoo

[mlkrborn]

AMAG Pharma announces realignment of operating cost structure to focus on continued Feraheme growth and business development activities (AMAG) 14.89 -0.16 : Co announced a number of changes to its operating expenses that further align its cost structure with the company's focus on advancing Feraheme and expanding its product portfolio with commercial stage assets. First, AMAG is moving to an outsourced manufacturing model and intends to divest the company's manufacturing facility in Cambridge, MA. Additionally, the company's global phase III broad iron deficiency anemia (IDA) clinical program for Feraheme, which will support an sNDA filing later this year, will conclude this year. Along with the natural attrition of external development costs associated with the conclusion of the IDA development program, AMAG is reducing internal development expenses to match the reduced activities at this time, and will continue to adapt development resources to meet the company's future development needs. By year-end 2012, AMAG expects to reduce its workforce by approximately 45 positions. The company expects to incur approximately $1.0 million in charges associated with the restructuring, which will be spread over the remainder of 2012, with $0.5 million expected to be recognized in the second quarter of 2012. The company may provide updated 2012 financial guidance when it reports second quarter financial results.

[mlkrborn]

Euro marketing: $15
AMAG Pharma: Rienso (ferumoxytol) receives European Marketing Authorization for the treatment of iron deficiency anemia in adult patients with chronic kidney disease; triggers $15 mln milestone payment to co (AMAG) 15.28 +0.84 : Co announced that the European Commission has granted marketing authorization for ferumoxytol, an intravenous iron therapy to treat iron deficiency anemia in adult patients with chronic kidney disease. The marketing authorization is valid in the current European Union Member States as well as in Iceland and Norway, and is based on data obtained from an extensive clinical development program. Takeda Pharmaceutical Company (TKPPY), AMAG's partner in Europe, plans to launch ferumoxytol in Europe under the brand name Rienso in 2012. The EU marketing authorization triggers a $15 million milestone payment to AMAG from Takeda; the first commercial sale of Rienso in Europe will trigger another $15 million milestone payment to AMAG. Additionally, AMAG is entitled to receive tiered, double-digit royalties on sales of Rienso in the licensed territories.

[surf1944]

9:33AM AMAG Pharma announces a positive CHMP opinion for the approval of ferumoxytol in Europe for the treatment of iron deficiency anemia in adult patients with chronic kidney disease (AMAG) 15.44 +0.18 : Co announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for the approval of ferumoxytol, an intravenous (IV) iron therapy, for the treatment of iron deficiency anemia (IDA) in adult patients with chronic kidney disease (CKD). In the European Union, ferumoxytol will be marketed as Rienso by AMAG's partner, Takeda Pharmaceutical Company Limited. European approval and the subsequent first commercial sale of ferumoxytol in Europe would trigger $30 mln in milestone payments to AMAG from Takeda. Additionally, AMAG is entitled to receive tiered, double-digit royalties on sales of ferumoxytol in licensed territories. Upon EU Commission approval, Takeda is planning to launch Rienso in the second half of 2012.

[surf1944]

Allos Eyed by Spectrum Pharma
ZacksBy Zacks Equity Research | Zacks – Mon, Apr 9, 2012 12:15 PM EDT

Recently, Allos Therapeutics, Inc. (NasdaqGS:ALTH - News) and Spectrum Pharmaceuticals (NasdaqGS:SPPI - News) inked a deal whereby the latter agreed to acquire the former for $1.82 per share in cash, in addition to one contingent value right (:CVR). The offer price represents a premium of 27% to Allos’ closing price on April 4, 2012. Spectrum Pharma intends to finance the deal through its available cash balance in addition to a revolving credit line from Bank of America.

Per the terms of the deal, Spectrum Pharma will initiate a tender offer to buy the entire outstanding shares of Allos for the above mentioned purchase price. The CVR, which will not be traded in the public domain, makes each Allos shareholder eligible to receive a further 11cents per share in cash depending on the conditional European approval and achievement of certain milestones of its sole marketed drug, Folotyn.

The deal, expected to close in the second quarter of this year, is valued (the upfront portion) at $108 million after deducting Allos’ cash balance of $97.8 million at the end of 2011. The deal, cleared by the Boards of both companies, is expected to boost Spectrum Pharma’s earnings in the final quarter of the year.

We remind investors that Folotyn is available in the US for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (:PTCL). The drug is under review in the EU for the indication.

The deal, which is expected to result in savings in the range of $40 -$50 million for Spectrum Pharma in the first year following its closure, is a smart strategic move by Spectrum Pharma as it will further strengthen its product portfolio.

Currently, Spectrum Pharma’s product portfolio comprises two FDA approved products-Fusilev (advanced metastatic colorectal cancer and for rescue in osteosarcoma (a form of bone cancer) patients following treatment with a high-dose of chemotherapy drug, methotrexate) and Zevalin (for treating patients suffering from non-Hodgkin’s lymphoma). The addition of Folotyn will further strengthen the oncology portfolio at Spectrum Pharma. Management at Spectrum Pharma stated that both Zevalin and Folotyn target the same set of doctors for treating different cancer forms. This makes the deal all the more sound strategically.

We note that, last year, the proposed merger between Allos and AMAG Pharma (NasdaqGS:AMAG - News) was called off following insufficient shareholder votes for the deal. However, we expect the deal between Spectrum Pharma and Allos to go through since it makes more strategic sense than the failed deal. AMAG’s sole marketed product, Feraheme, for treating patients suffering from iron deficiency anemia, is an underperformer with nothing to indicate that sales would have improved had the merger materialized.

Our Recommendation

Currently, we have an Outperform Recommendation on Allos. The company carries a Zacks #1 Rank (short-term “Strong Buy” rating). We are Neutral on Spectrum Pharma in the long run. Spectrum Pharma carries a Zacks #3 Rank (short-term “Hold” rating).
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[Penny Roger$]

~ Monday! $AMAG ~ Earnings posted, pending or coming soon! In Charts and Links Below!

~ $AMAG ~ Earnings expected on Monday *
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One or more of many earnings sites has alerted this security has or will be posting earnings on or around the day of this message.








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[surf1944]

AMAG Pharmaceuticals, Inc. (AMAG) – Call activity on the biopharmaceutical company today might have looked bullish at first glance, particularly earlier in the session when shares in the name were still positive on the day. AMAG’s shares rose 1.8% to an intraday high of $15.98 this morning, but have since slipped into negative territory, down 0.30% at $15.65 as of 1:50 p.m. One investor positioning for shares in AMAG to continue to decline appears to have initiated a synthetic put on the stock. The trader likely sold 148,800 shares of the underlying at $15.6297 each and purchased 2,300 in-the-money calls at the May $15 strike for a premium of $2.40 apiece. The long calls offer upside protection should the stock rally ahead of expiration, while gains on the short stock may amass if the price of AMAG’s shares continues to slide. AMAG Pharmaceuticals was cut to ‘underweight’ from ‘neutral’ with a reduced share price target of $12.00 from $20.00 at JPMorgan on Monday. The biopharmaceutical company reports fourth-quarter earnings ahead of the opening bell one month from today.

http://seekingalpha.com/article/321696-tuesday-options-briefs-ibb-amag-aone?source=yahoo

[mlkrborn]

AMAG Pharma hires financial advisor as it explores all opportunities to enhance stockholder value (AMAG) 16.00 : Co announces that it has hired Jefferies & Company as a strategic advisor. Jefferies will assist the company in identifying and evaluating various strategies to enhance stockholder value and leverage AMAG's core assets - Feraheme Injection for Intravenous use, AMAG's commercial and drug development infrastructure, and the company's balance sheet, which had more than $250 million in cash and investments, and no debt, as of September 30, 2011.

[mlkrborn]

AMAG $15

"1:07AM AMAG Pharma reports positive data from the FIRST Trial, a head-to-head comparison trial of Ferumoxytol compared to iron sucrose (AMAG) 15.55 : Co announces positive new data from the FIRST head-to-head trial comparing Feraheme(R) (ferumoxytol) Injection for intravenous (IV) use to iron sucrose in patients with iron deficiency anemia and chronic kidney disease. Overall, this randomized controlled clinical trial demonstrated that ferumoxytol 1.02 g, delivered as two injections of 510 mg within 5 3 days, had a favorable safety profile and comparable efficacy to 1 g of iron sucrose dosed as 100 mg or 200 mg over 5 to 10 injections given over 2 to 2.5 weeks. Safety and efficacy data in the poster include: Patients treated with ferumoxytol had lower overall rates of adverse events (48% vs. 65%), related adverse events (10% vs. 16%), and adverse events leading to drug discontinuation (1% vs. 5%) compared to patients treated with iron sucrose. Serious adverse events, related SAEs, and AEs of special interest were similar between the two treatment groups. Ferumoxytol-treated patients had a comparable increase in hemoglobin at Week 5 from baseline compared with patients treated with iron sucrose, however, higher Hgb values were observed at all time points following treatment through Week 5 in ferumoxytol-treated patients compared to patients treated with iron sucrose. More ferumoxytol-treated patients (50%) achieved a >=1 g/dL increase in Hgb compared with patients treated with iron sucrose (42%). Ferumoxytol-treated patients had a faster time to response (28.5 days vs. 32.9 days) than did patients treated with iron sucrose. "

[surf1944]

7:43AM AMAG Pharma beats by $0.20, beats on revs (AMAG) 13.75 : Reports Q3 (Sep) loss of $0.78 per share, $0.20 better than the Capital IQ Consensus Estimate of ($0.98); revenues rose 4.1% year/year to $17.6 mln vs the $16.09 mln consensus. Additionally, Dr. Pereira has resigned from his position as president, CEO and a director of the co, effective immediately. He will remain a key strategic advisor to the co on certain matters. Co promoted Frank Thomas, the co's CFO, to the position ofCOO and appointed him as the interim president and CEO. The co has concurrently launched a search for a permanent chief executive officer. Co also implemented , a broad restructuring plan to align operating expenses with near-term revenue projections for Feraheme Injection for Intravenous use. The plan, including an approximate 25% reduction in positions, is expected to decrease the co's operating expenses, excluding cost of goods sold, by $20-25 mln in 2012 as compared to 2011. Finally, co's Board is committed to the evaluation of all strategic options to enhance stockholder value, while management focuses on strategies to increase Feraheme revenues.

[surf1944]

8:22AM AMAG Pharma: MSMB files revised preliminary consent solicitation statement to replace the Board of Directors of AMAG Pharmaceuticals (AMAG) 13.63 : MSMB Capital Management announced that it has filed an amended preliminary Consent Solicitation Statement with the SEC that seeks, among other things, to remove each of the current directors of AMAG and replace them with MSMB's nominees. MSMB amended its filing to increase the number of nominees to include Richard Brewer and David Gryska, each of whom have extensive management experience in the healthcare industry.

[surf1944]

1:50AM AMAG Pharma: MSMB Capital announces that ISS recommends that AMAG shareholders vote against the Allos (ALTH) Transaction (AMAG) 13.24 : MSMB Capital Management announced today that it was pleased to learn that ISS Proxy Advisory Services recommends that its clients holding AMAG vote AGAINST the proposed acquisition of Allos Therapeutic. In its October 8, 2011 report, ISS stated: "The AMAG board has effectively proposed that its shareholders accept 39% dilution in exchange for an asset that, based on the company's own stand-alone financial projections, would not achieve breakeven adjusted EBIT through at least 2027...The $2.44 implied offer value of AMAG shares is substantially higher than the upper end of range, suggesting Allos shareholders are getting an excellent price - and AMAG shareholders may be overpaying...As the strongly negative market reaction, the 13D filings from large shareholders, and the evidence that AMAG may be overpaying for an asset whose potential its current owners cannot unlock without AMAG's help, all argue against the transaction - and the stand-alone alternative is relatively strong, with little apparent operating risk if the deal falls through - A VOTE AGAINST THE PROPOSED TRANSACTION IS WARRANTED."

[surf1944]

With third-party suitor out, AMAG merger fight heats up

http://www.bizjournals.com/boston/news/2011/10/10/amag-merger-fight-heats-up.html?ana=yfcpc

[mlkrborn]

Activist Fund Manager Ups Stake in Amag Pharma to Stop Merger With Allos
By Adam Feuerstein 10/10/11 - 10:46 AM EDT


Allos Therapeutics Inc.| ALTH
DOWN


LEXINGTON, Mass. (TheStreet) --Hedge fund manager Martin Shkreli has taken a 5.8% ownership stake in Amag Pharmaceuticals(AMAG_), an escalation of his effort to wrest control of the struggling drug maker and stop a planned merger with Allos Therapeutics(ALTH_).

Shkreli must still demonstrate that he has the funds necessary to make good on his previously announced $18-a-share offer for Amag. But Shkreli's purchase of 1.25 million Amag shares -- disclosed for the first time in a regulatory filing Friday night -- may persuade on-the-fence shareholders to accept his proposals and reject Amag's plans to merge with Allos.

Amag is fighting a two-front war at the moment. First, it must secure the support of a majority of its shareholders at an Oct. 21 vote to complete the Allos merger. Second, Amag is being force to fend off Shkreli's activism, including a proposal seeking shareholder approval to remove six of the seven directors on Amag's board and replace them with five MSMB nominees who would put a stop to the Allos merger.

Adage Capital Management and Palo Alto Investors, owners of 17.5% and 15% of Amag, respectively, are still said to be opposing the Allos merger because of concerns about the financial and strategic rationale behind the deal, according to sources familiar with the situation.

Amag will have a very difficult time completing the Allos merger without the support of Adage and Palo Alto. Whether the two largest Amag shareholders also support Shkreli's efforts to shake up Amag's board is not clear, but killing off the Allos merger will almost certainly provoke significant changes at Amag.

"Voting no on the Allos deal is a referendum against Amag's management team," said an Amag shareholder who asked not be identified but is voting to stop the Allos merger.

If the current Amag board survives, directors will face tremendous pressure to fire Amag CEO Brian Pereira and put the company up for sale. For all intent and purpose, a sale of Amag will really be a simple auction of the company's only asset Feraheme, an injectable iron replacement therapy for anemia in patients with chronic kidney disease.

[mlkrborn]

Now AMAG being approached by a private capital group to be purchased @$14?.

[mlkrborn]

AMAG shareholder is so pissed of AMAG's acqusition of ALTH, it wants AMAG to scrap the deal and buy AMAG.
Amag Pharma receives unsolicited acquisition offer
Amag Pharma receives $381 million unsolicited acquisition offer from MSMB Capital Management
ap

Companies:
o Allos Therapeutics, Inc.
o AMAG Pharmaceuticals, Inc.

Related Quotes
Symbol Price Change
ALTH 1.75 -0.03
Chart for Allos Therapeutics, Inc.
AMAG 15.90 +1.51

Tom Murphy, AP Business Writer, On Wednesday August 3, 2011, 11:32 am

INDIANAPOLIS (AP) -- Amag Pharmaceuticals Inc. shareholder MSMB Capital Management is so disappointed by the drugmaker's recently announced plan to buy Allos Therapeutics that it wants to scrap that deal and buy Amag outright.

The hedge fund said Wednesday it has offered to buy shares of Lexington, Mass.-based Amag it doesn't already own for $18 each in cash. The offer, worth about $378 million, represents a 25 percent premium over the stock's closing price Tuesday of $14.39. MSMB Chief Investment Officer Martin Shkreli told The Associated Press his firm owns less than 5 percent of Amag and had recently increased its stake. He declined to be more specific.

Shares of Amag jumped nearly 9 percent, or $1.25, to $15.64 in late Wednesday morning trading. Allos Therapeutics shares fell 4 cents, or more than 2 percent, to $1.74.

Amag makes Feraheme for the treatment of iron deficiency anemia in adults with chronic kidney disease. Last month, it announced a plan to buy drugmaker Allos Therapeutics Inc. of Westminster, Colo., for about $268 million in stock in a deal designed to bolster its commercial portfolio and cuts costs.

That proposal left Shkreli surprised and disappointed, according to an Aug. 2 letter he sent to Amag's board of directors. Shkreli told the board he felt they overpaid for Allos, and he didn't like the stock-for-stock combination.

"It's not a healthy transaction," he said in a brief phone interview. "If you've been a shareholder for a long time, and you're waiting for a premium price, you didn't get it with this transaction."

Amag said in a brief statement it would carefully consider the unsolicited MSMB offer, but a company spokesman declined additional comment.

Amag's share price has tumbled about 24 percent since closing at $19.07 July 19, the day before it announced the Allos deal. Shkreli noted that the company's stock has not responded well, and the MSMB offer gives shareholders an alternative to the "poorly viewed" Allos transaction.

Under terms of that deal, Allos stockholders will get 0.1282 shares of Amag stock for each share of Allos. Amag shareholders will own about 61 percent of the combined company, while Allos stockholders will have 39 percent.

Amag will nominate five of the nine members of the new company's board, and its CEO, Dr. Brian J.G. Pereira, will serve as CEO of the new company. Michael Narachi will remain chairman. The combined company will be based in Lexington.

Shkreli said MSMB is prepared to raise its price if that is warranted and if it receives the time and access it needs to conduct due diligence on Amag. MSMB requested that Amag respond by Aug. 15 and said its offer is contingent on an agreement being reached before Sept. 1. It added that its offer is not subject to any financing condition.

"It is imperative that the company be sold now, the transaction with Allos terminated and further erosion of stockholder value be prevented," Shkreli wrote.

[surf1944]

1:36AM AMAG Pharma receives unsolicited proposal from MSMB Capital Management to acquire all outstanding stock for $18 per share in cash (AMAG) 14.39 : Co announces the receipt of an unsolicited proposal from MSMB Capital Management to acquire all of co's outstanding stock for $18 per share in cash. Co's Board of Directors will carefully consider and evaluate the MSMB proposal in due course and will inform AMAG stockholders of its position

[surf1944]

4:08PM AMAG Pharma appoints Frank Thomas as Executive Vice President and CFO (AMAG) 14.89 +0.08 : Co announced the appointment of Frank Thomas to the position of Executive Vice President and CFO. Mr. Thomas will be responsible for the co's finance, accounting, treasury and corporate communications functions and will report directly to Brian Pereira, M.D., President and CEO. During his 19-year career, Mr. Thomas has held a variety of senior executive roles in the life sciences industry. From 2008 to 2011, Mr. Thomas served as Senior Vice President, COO and CFO for Molecular Biometrics.

[mlkrborn]

AMAG and ALTH merge with stox deal.. Both down. AMAG drops 14% on merger deal with Allos
Stories You Might Like


By Val Brickates Kennedy

AMAG ALTH

BOSTON (MarketWatch) -- Shares of AMAG Pharmaceuticals /quotes/zigman/107237/quotes/nls/amag AMAG -13.95% dropped 14% to $16.46 on Wednesday following news that it plans to merge with Allos Therapeutics /quotes/zigman/81880/quotes/nls/alth ALTH -1.94% in an all-stock deal valued at around $686 million. Following the merger, AMAG shareholders will hold a 61% stake in the new company, while Allos stockholders will have 39%. The combined company will be headquartered in Lexington, Mass., and will be renamed "to reflect its strategic focus," the companies said. The deal is expected to close in the fourth quarter. Shares of Allos were down 1%.

[surf1944]

AMAG Pharmaceuticals Announces Update to Feraheme® Label

Press Release Source: AMAG Pharmaceuticals, Inc. On Tuesday June 21, 2011, 5:05 pm EDT

LEXINGTON, Mass.--(BUSINESS WIRE)-- AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG - News) today announced that the company has updated the product label for Feraheme® (ferumoxytol) Injection for Intravenous (IV) use. This update is based on the U.S. Food and Drug Administration’s approval of the company’s Label Supplement submission, which included additional post-marketing safety data. Feraheme is indicated for the treatment of iron deficiency anemia in adult chronic kidney disease (CKD) patients.

The updated product label, also called a package insert includes, among other things:

Modifications to the Contraindications section removing “evidence of iron overload” and “anemia not caused by iron deficiency.”
Modifications to the Hypersensitivity Reactions language of the Warnings and Precautions section to include:
The following revised text: “serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, have been reported in patients receiving Feraheme,” and
A decrease in the observation period to monitor patients for signs and symptoms of hypersensitivity during and following Feraheme administration from 60 minutes to 30 minutes.

“We are pleased that the post-marketing safety data support reverting back to a 30-minute monitoring period following Feraheme administration,” commented Brian J.G. Pereira, MD, President and Chief Executive Officer of AMAG Pharmaceuticals, Inc. “The dosing schedule of Feraheme allows for a full course of IV iron to be delivered in two doses, just three to eight days apart. This dosing schedule, combined with the revised observation period, supports the differentiation of Feraheme in the marketplace.”

About AMAG Pharmaceuticals, Inc.

AMAG Pharmaceuticals, Inc. is a biopharmaceutical company focused on the development and commercialization of a therapeutic iron compound to treat iron deficiency anemia. For additional company information, please visit www.amagpharma.com.

About Feraheme

In the United States, Feraheme® (ferumoxytol) Injection for Intravenous (IV) use is indicated for the treatment of iron deficiency anemia in adult chronic kidney disease (CKD) patients. Feraheme received marketing approval from the U.S. Food and Drug Administration on June 30, 2009 and was commercially launched by AMAG in the U.S. shortly thereafter. For additional product information, please visit www.feraheme.com.

Important Safety Information About Feraheme

Indication and contraindications

Feraheme is indicated for the treatment of iron deficiency anemia in adult patients with chronic kidney disease. Feraheme is contraindicated in patients with known hypersensitivity to Feraheme or any of its components.

[surf1944]

12 Undervalued Stocks With Significant Levels of Insider Buying

http://seekingalpha.com/article/276856-12-undervalued-stocks-with-significant-levels-of-insider-buying?source=yahoo

2. AMAG Pharmaceuticals, Inc. (AMAG): Diagnostic Substances Industry. Market cap of $361.41M. Price/cash ratio at 1.52. Net insider purchases over the last 6 months at 991150 shares, equal to 7.68% of the company's 12.91M share float. The stock is a short squeeze candidate, with a short float at 7.76% (equivalent to 8.65 days of average volume). The stock has had a couple of great days, gaining 8.58% over the last week.

[surf1944]

Label Update for AMAG's Feraheme

Zacks Equity Research, On Friday June 24, 2011, 6:10 pm EDT

AMAG Pharmaceuticals Inc. (NasdaqGS: AMAG - News) recently announced a label update for its lead drug Feraheme. Feraheme is an injectable drug for intravenous use as an iron replacement therapy for the treatment of iron deficiency anemia (IDA) in adult patients suffering from chronic kidney disease (CKD).

The label was updated following approval by the US Food and Drug Administration (FDA) of the company's Label Supplement submission which included additional post-marketing safety data.

AMAG modified its Warnings and Precautions section to revise the language used to describe the hypersensitivity reactions. The revised label mentions that fatal and life-threatening serious hypersensitivity reactions, including anaphylactic-type reactions, have been reported in patients who have received Feraheme.

The Contraindications section was also modified to remove language relating to evidence of iron overload and anemia not caused by iron deficiency. Finally the observation time of the patients for signs and symptoms of hypersensitivity following administration of Feraheme was decreased to 30 minutes from 60 minutes.

The observation time was earlier increased from 30 minutes to 60 minutes during a previous label update in November 2010. The label was also updated in November to describe events like life-threatening hypersensitivity reactions and clinically significant hypotension that have been reported following administration of Feraheme in the post-marketing environment.

The company had then inserted a new section to the label entitled Adverse Reactions from Post-Marketing Spontaneous Reports. Importantly, the FDA did not require the inclusion of a black box warning.

We believe that the decrease in observation period is a positive development, which combined with the faster dosing schedule of Feraheme, will help differentiate the drug from other competing therapies in the market. Feraheme competes with existing intravenous/IV iron replacement therapies like American Regent Inc.’s Venofer.

Our Recommendation

We currently have a Neutral recommendation on the stock. The recommendation is supported by a Zacks #3 rank (short term “Hold” rating). We prefer to remain on the sidelines until more visibility is obtained on Feraheme’s progress despite the improving monthly trend in provider demand.

[surf1944]

AMAG Pharma AMAG Ladenburg Thalmann Neutral $18.50 » $20

Read more: http://www.breifing.com/investor/calendars/upgrades-downgrades/#ixzz1QlTrucoZ

[momentum74]

17.03 Bought some here .Pincher chart trading near cash of 15.00 for a trade.
http://stockcharts.com/h-sc/ui?s=AMAG&p=D&b=5&g=0&id=p15284084450

[surf1944]

AMAG Pharmaceuticals, Inc. Q2 2010 Earnings Call Transcript

http://seekingalpha.com/article/217181-amag-pharmaceuticals-inc-q2-2010-earnings-call-transcript?source=yahoo

[surf1944]

6:32AM AMAG Pharma and Takeda announce acceptance of submission of Feraheme marketing authorization application to the European Medicines Agency (AMAG) 35.66

[surf1944]

AMAG Pharma shares fall on weak 1Q results
AMAG Pharmaceuticals shares fall following lower-than-expected 1st-quarter results

On Wednesday April 28, 2010, 2:06 pm EDT
NEW YORK (AP) -- Shares of AMAG Pharmaceuticals Inc. fell Wednesday after the biotechnology company reported a wider first-quarter loss and weaker revenue than Wall Street expected.

The stock shed $3.42, or 9.3 percent, to $33.36 in afternoon trading. Shares earlier reached a 52-week low of $31.90. They have ranged from $33.11 to $58.23 over the past year.

On Tuesday, the company said it lost $23.1 million, or $1.15 per share, on revenue of $13.3 million during the quarter. Analysts polled by Thomson Reuters, on average, had forecast a loss of 85 cents per share on revenue of $16.8 million.

The bulk of the company's revenue comes from Feraheme, which treats iron deficiency anemia in chronic kidney disease patients.

Jefferies & Co. analyst Eun K. Yang reaffirmed a "Hold" rating on the stock with a $32 price target, citing the lower-than-expected Feraheme sales and wider-than-expected first-quarter loss.

"While its potential in non-dialysis remains, disappointing first-quarter sales suggests challenges it (Feraheme) faces in the competitive, pricing-sensitive intravenous iron market, with little advantages," Yang wrote in a note to investors.

[mlkrborn]

AMAG licenses Feraheme to Takeda in $280M deal


LEXINGTON, Mass.

AMAG Pharmaceuticals announced a licensing deal potentially worth $280 million Thursday to sell its anemia drug in some overseas markets.

Japanese drugmaker Takeda Pharmaceutical Co. bought the rights to market Feraheme in Europe, the Commonwealth of Independent States, Canada, Turkey, and the Asia-Pacific region excluding China, Japan, and Taiwan.

Takeda will pay AMAG $60 million upfront, and as much as $220 million if Feraheme advances through clinical development and regulatory review. AMAG will also get royalties of more than 10 percent on sales if the drug is approved.

The Commonwealth of Independent States is an alliance comprising most of the former Soviet Union. Its official members are Russia, Armenia, Azerbaijan, Belarus, Kazakhstan, Krygyzstan, Moldova, Tajikstan, and Uzbekistan.

Shares of AMAG Pharmaceuticals Inc. rose 3 percent, or $1.09, to $36 in premarket trading.

Feraheme is an intravenous drug intended to treat iron deficiency anemia. In the U.S., it is approved for use in patients with chronic kidney disease. The agreement covers all potential indications for the drug.

Under the deal, AMAG will be responsible for all clinical testing of Feraheme. It will handle regulatory filings in Europe and Canada. Takeda will handle those filings in the other countries covered by the agreement.

Feraheme was approved in the U.S. in July. AMAG plans to file for marketing approval in Europe in mid-2010.

[surf1944]

4:38AM AMAG Pharma and Takeda Pharma announce collaboration for Feraheme in all therapeutic indications in select ex-US territories, including Europe (AMAG) 34.91 : Co and Takeda Pharmaceutical jointly announce that the companies have entered into a license, development and commercialization agreement related to Feraheme (ferumoxytol) Injection for intravenous use in all therapeutic indications. Takeda receives an exclusive license to Feraheme for all therapeutic applications in 5 regions, including Europe, Canada, Turkey, the Commonwealth of Independent States and Asia Pacific countries, excluding Japan, China and Taiwan. AMAG receives a $60 million upfront payment and is eligible to receive up to $220 million in development and commercial milestones. Additionally, AMAG will receive tiered, double-digit royalties based on net sales of Feraheme in the licensed territories.

[surf1944]

Form 8-K for AMAG PHARMACEUTICALS INC.

26-Mar-2010

Other Events

Item 8.01 Other Events.
On March 25, 2010, AMAG Pharmaceuticals, Inc., or the Company, was served with a complaint, or the Complaint, naming the Company, its chief executive officer and its chief financial officer as defendants in a purported class action lawsuit, Silverstrand Investments v. AMAG Pharmaceuticals, Inc. et al (Case No. 10 Civ. 10470), filed in the United States District Court for the District of Massachusetts. The Complaint alleges violations by the Company and its chief executive officer and its chief financial officer of the Securities Act of 1933, as amended, in connection with the Company's January 2010 common stock offering.

The Company believes that the allegations are without merit and intends to vigorously defend against this action.

[surf1944]

2:24AM AMAG Pharma prices 3.6 mln common shares at $48.25/share (AMAG) 49.28 : The number of shares reflects an increase of 600,000 shares over the number of shares anticipated to be sold as previously announced.

[surf1944]

1:21AM AMAG Pharma announces preliminary Feraheme 4Q09 net product revenue estimates (AMAG) 40.44 : Co provides an update on the commercial launch of Feraheme Injection for intravenous use, including preliminary 4Q09 Feraheme net product revenues estimates, as well as an update on the co's international and label expansion efforts. The co will present further details at the 28th Annual J.P. Morgan Healthcare Conference. Commercial Launch of Feraheme: AMAG expects to report 4Q09 Feraheme net product revenues of between $12 and $13 mln (unaudited), including approx $1 million of the $11.5 million in previously deferred product revenues. The co expects that utilization of the remaining deferred product revenues from the launch incentive program, which were recorded during the third quarter of 2009, will increase going forward as each launch incentive program customer has now initiated a pilot program and begun to use Feraheme. These deferred revenues will be recognized when the purchases are utilized by these customers; no new deferred revenues are expected to be recorded during the fourth quarter of 2009. AMAG continues to expect that total operating expenses for 4Q09 will be higher than those reported for 3Q09, due primarily to increases in both research and development expenses and commercial spending.

[surf1944]

AMAG Pharma AMAG Robert W. Baird changed to Outperform $60 to $55

[surf1944]

AMAG 3Q loss narrows slightly on anemia drug sales
AMAG Pharmaceuticals 3rd-quarter loss narrows on boost from sales of anemia drug Feraheme

On 10:42 am EDT, Thursday October 29, 2009

Companies:Amag Pharmaceuticals, Inc.
CAMBRIDGE, Mass. (AP) -- Biotechnology company AMAG Pharmaceuticals Inc. said Thursday that its third-quarter loss narrowed on higher sales of the anemia drug Feraheme.

The company lost of $22.1 million, or $1.29 per share, compared with a loss of $23.6 million, or $1.39 per share, in the year-ago period. Revenue surged to $3 million from $260,000. The company launched Feraheme in July.

Analysts polled by Thomson Reuters, on average, expected a loss of $1.47 per share on revenue of $3 million.

Feraheme is specifically aimed at treating iron deficiency anemia in chronic kidney disease patients.

Shares of AMAG gained $3.24, or 9.4 percent, to $37.59 in morning trading.

[surf1944]

Short % of Float (as of 26-Aug-09)3: 27.70%
Shares Short (prior month)3: 4.73M

[surf1944]

AMAG Pharmaceuticals' Feraheme: The Next Billion Dollar Drug

On June 30, 2009, the FDA approved Feraheme for the treatment of anemia in chronic kidney disease (CKD), both in pre-dialysis patients and those undergoing dialysis. Feraheme, sold by AMAG Pharmaceuticals (AMAG), received a clean label without any black box warnings. Now that Feraheme has been approved, the key question for investors is what the market opportunity is and how quickly it will be achieved.

Background on Feraheme

Feraheme (generic name: ferumoxytol) was originally developed as an imaging agent. Iron, in order to be safely given, must be in a complex and not as a free metal. The free metal can cause a number of side effects including rash, wheezing, and anaphylaxis. Feraheme has the lowest free iron of any commercially available preparation (Balakrishnan, 2009). It is quite different from any other preparation because it is an iron oxide nanoparticle with a polyglucose sorbitol carboxymethylether coating.

Because of its low levels of free iron, Feraheme can be given much more rapidly than any other iron formulation. 510 mg can be given in a 17 second injection. (A standard dose of 1 gram of iron can thus be given in two office visits of a few minutes each.) In contrast, other iron preparations require 1 gram of iron to be given over 8-10 doses over 15-30 minutes each of injection time.

From an outpatient perspective, Feraheme is far more convenient and cost effective (when considering physician time, nursing time, and patient time) than any other iron preparation.

Competition

There are four other competing irons on the market: Venofer (iron sucrose), Ferrlecit (sodium ferric gluconate), INFeD (low molecular weight iron dextran), and Dexferrum (high molecular weight iron dextran). The dextrans have a statistically significant higher level of adverse events, including fatal anaphylatic reactions, and are used much less often than Venofer or Ferrlecit. According to IMS, 2008 sales were:

Venofer: $359M
Ferrlecit: $152M
Infed: $37M
Dexferrum: $10M
Before Feraheme's approval, Venofer was the only iron approved for pre-dialysis, one of the reasons for its higher sales.

Impact from bundling

Starting in January 2011, it is likely that the Centers for Medicare and Medicaid Services (CMS) will begin to pay for dialysis patients using a so called "bundling" payment system. In this system, dialysis centers are reimbursed on a per patient basis and are thus have the incentive to keep costs as low as possible. It should be noted that this only affects the dialysis market and not pre-dialysis (which as we will see is larger).

When one factors in nursing and technician time, even in a bundled environment it is likely that Feraheme will be at least cost neutral if not cost beneficial. This is largely because of these ease of administration and the fact that patients can become iron replete much more quickly (in as short as 3 days) with Feraheme than other iron preparations. As discussed above, in the outpatient setting it is unmatched because of dramatic time (and hence cost) savings to physicians, nurses, and patients. (See Leerink-Swann report on AMAG dated June 26, 2009 for more on cost savings.)

Market size estimates

There are two current markets for Feraheme: CKD pre-dialysis patients and CKD dialysis patients. There are three future markets for Feraheme: vascular-enhanced MRI (VE-MRI) imaging, pediatric anemia, and generalized adult iron-deficiency anemia (IDA) from causes like heavy uterine bleeding, cancer, or gastrointestinal bleeding.

The wholesale acquisition costs (WAC) of Feraheme was announced to be $396.78 per vial. (Each vial contains 510 mg of iron.) This is approximately 40% higher than other IV irons. For the purpose of estimating market opportunity, it will be assumed that AMAG will negotiate supplier deals at a discount. To err on the side of being conservative, we will assume that each vial will be sold at $300, which is likely lower than will occur in practice.

The average dialysis CKD patient receives about 2.5 grams of iron each year. There are 354,000 dialysis CKD patients who are currently treated for iron deficiency (USRDS 2007 Annual Data Report). Most of these patients receive Venofer today. Given the cost savings of labor and nursing time, Feraheme should attain 50% market share. This is likely an underestimate, especially because for the next 1.5 years, dialysis clinics that use Feraheme will receive greater reimbursement due to the ASP + 6% structure that CMS currently employs.

Under these assumptions, peak sales in dialysis CKD patients will be:

$300 / vial * (5 vials / patient ) * 354,000 patients / year *

50% penetration = $265.5 million / year

There are approximately 1.6 million pre-dialysis patients who have iron-deficiency anemia. While this is 4.5 fold more patients than dialysis CKD patients, they require less iron than dialysis patients, only about 1-1.5 grams per year (we will conservatively use 1 gram in our estimates). In this market, Feraheme is the clear winner because of the tremendous savings to patients and physicians regarding time and labor costs. From a cost perspective, it has no real competition in this clinical setting besides oral iron, which is less efficacious and more uncomfortable for patients. Hence in this market we will hence assume 70% penetration:

Under these assumptions, peak sales in pre-dialysis CKD patients will be:

$300 / vial * (2 vials / patient ) * 1,600,000 patients / year *

70% penetration = $672M

VE-MRI is an interesting market, but more difficult to estimate. For many years, it has been clear that superparamagnetic iron oxide has been useful as a contrast agent (Kent, 1990). Nearly 30% of the 31 million annual MRI examinations use gadolinium (Colletti, 2008), which imparts the risk of renal toxicity (in particular nephrogenic systemic fibrosis). This has led to the search for other superparamagnetic agents without the toxicities of gadolinium. Iron also is superparamagnetic, and is a natural metal present in the body. However giving iron as a bolus has traditionally been restricted because of high levels of free iron, which can have a number of side effects such as rash, wheezing, and anaphylaxis. Feraheme elegantly solves these issues. Yet few details have been provided around Feraheme dosing in their clinical trial development plan. Given the present uncertainties regarding market size and dosing, no contributions of VE-MRI to peak sales will be factored.

Similar to the adult market, the current pediatric market is dominated by CKD patients. Pediatric patients are usually not treated with sufficient iron (Horl, 2007). Pediatric renal transplant patients are also commonly iron deficient (Kausman, 2004). Venofer and Ferrlecit are standard of care in pediatric patients today (Horl, 2007). It is unclear to what extent AMAG plans to develop this market, so for the purposes of estimating market size, it will be assumed to be negligible.

AMAG is in discussion with the FDA about running a phase 3 trial for generalized adult iron-deficiency anemia. This would include cancer patients, gastrointestinal bleeding patients, and women with abnormal uterine bleeding. These are much larger markets, totalling at least 4 million people in the United States. Due to administration advantages and cost savings, Feraheme is again the clear winner. It will be assumed that 20% market penetration will be achieved here, the main competitor being oral iron. (Neither Venofer or Ferrlecit are competitive due to administration inconvenience.) Assuming smaller needs of 1 gram of iron per year, similar to pre-dialysis patients, this yields:

$300 / vial * (2 vials / patient ) * 4,000,000 patients / year * 20% penetration = $480M

Because 20% is likely a low penetration estimate, this could obviously be dramatically higher.

Putting this together we have:

$265.5M + $672M + $480M = $1.4 billion

Factoring in Japan, Europe, India, China, and Latin America, a rough rule of thumb for estimating market size is that the the non-US markets in total are about the size of the US market. It will be assumed that AMAG will partner Feraheme in these markets, and receive 25% royalties.

Royalties then represent another 25% * $1.4 billion = $350M.

All told, using conservative assumptions throughout, peak sales should be:

$1.4 billion + $350M = $1.75 billion.

Time to adoption

Given the ASP + 6% reimbursement system, it is likely that many dialysis chains will adopt Feraheme for strong financial reasons within the next 3-6 months. Pre-dialysis adoption should occur even faster due to the lack of requisite contract agreements. Regarding generalized IDA, trial design discussions are underway with the FDA. It is likely that phase III trial would begin in early 2010, with submission by late 2010 and approval in 2011. Given time for sales and marketing efforts to reach their intended audience, peak sales could occur as early as 4-5 years from the present, or 2013-2014.

One element that should accelerate adoption is the renown of the AMAG management team. Their CEO Brian Perreira is a world leading nephrologist and former president of the National Kidney Foundation. Louis Brenner, Senior Vice President at AMAG, is a nephrologist and former business development head of Genzyme's renal division. Robert Brenner, another nephrologist, spent nine years at Amgen (AMGN), arguably the leading renal disease company in the world.

Impact from generics?

Watson recently announced that it may develop a generic version of Ferrlecit. Most analysts are skeptical if this will occur given the high trial costs (AMAG performed four phase III trials of Feraheme) and already low sales of Ferrlecit. Even if Watson did pursue this route, it would not be of relevance until 2011, and probably never gain relevance for the largest markets of pre-dialysis CKD and generalized IDA. Ironically, Watson had filed a Citizen's petition trying to block the entrance of generic competitors into the market. It will be of interest to watch how it now shifts its position for presumably financial reasons.

Conclusions

For patient investors, AMAG (market cap $775M as of close of market July 30, 2009) represents one of the best risk/reward profiles in the biotechnology space given the $1-2B market for Feraheme, an already approved drug.

Disclosure: The author's firm is long AMAG.

http://seekingalpha.com/article/153347-amag-pharmaceuticals-feraheme-the-next-billion-dollar-drug?source=yahoo