WALTHAM, Mass., July 22, 2015 (GLOBE NEWSWIRE) -- AMAG Pharmaceuticals, Inc. (Nasdaq:AMAG) announced today that it has entered into an agreement that grants AMAG an exclusive option to acquire the rights to an orphan drug candidate at the conclusion of a Phase 2b/3a clinical trial. Digoxin immune fab (DIF) is a polyclonal antibody being developed for the treatment of severe preeclampsia in pregnant women. AMAG will make an upfront payment of $10 million from cash on hand to Velo Bio, LLC (Velo), a privately held life-sciences company, for the option to acquire global rights to the DIF program.
Preeclampsia is a serious multi-system disorder that presents in the second or third trimester of pregnancy, and is associated with new onset hypertension and in many cases excess protein in the urine and end organ dysfunction that may endanger both the mother and baby. Severe preeclampsia affects approximately 1% of pregnancies and is characterized by more difficult-to-control hypertension and the potential for end organ damage that is severe enough to require immediate delivery of the baby in order to stop disease progression in the mother. It is one of the leading causes of maternal death in the United States and is responsible for approximately 20% of premature births in the nation each year.
"Despite the significant health consequences of severe preeclampsia to at-risk mothers and their babies, there are currently no FDA-approved treatment options available for these patients," said Julie Krop, M.D., AMAG's chief medical officer and senior vice president, clinical development and regulatory affairs. "The development and eventual approval of DIF for the treatment of severe preeclampsia could have a significant impact on the lives of these pregnant women and their babies and would nicely complement AMAG's growing portfolio of maternal health products."
Elevated levels of endogenous digitalis-like factor (EDLF) have been found in the placental and maternal circulation of the majority of patients with preeclampsia, and the degree of elevation is correlated with disease severity. DIF is thought to bind to these factors, causing a decrease in serum EDLF levels and inhibition of their activity. A prior placebo-controlled Phase 2 study in 51 pregnant women with severe preeclampsia validated DIF's mechanism of action and was suggestive of clinical benefit in both mothers and their babies. DIF has been granted both orphan drug and fast-track review designations by the U.S. Food and Drug Administration (FDA) for the use in the treatment of severe preeclampsia. DIF has four issued patents, the longest of which provides protection through 2032.
"AMAG has built a strong maternal health business platform that has the ability to reach many at-risk pregnant women and their physicians, making them an ideal partner for our DIF program," said Stephen Butts, chief executive officer of Velo. "We believe the compound has demonstrated early potential to help address this very serious health complication of pregnancy."
Under the option agreement, Velo will complete a dose ranging study and a Phase 2b/3a clinical study. Following conclusion of the DIF Phase 2b/3a study, AMAG may exercise, extend or terminate the acquisition option. If AMAG exercises its option to acquire DIF, it would pay an option fee and a potential U.S. approval milestone, totaling up to $75 million. AMAG would also be responsible to pay any additional costs in pursuing FDA approval beyond the planned Phase 2b/3a clinical trial, as well as up to $250 million in sales milestone payments and single-digit royalties. The sales milestones are payable at annual product sales starting at $100 million up to $900 million. AMAG anticipates that results from the pivotal Phase 2b/3a study could be available as early as 2018.
"This is another example of our disciplined financial approach – in this case making measured investments at key value inflection points in an important development stage product like DIF, which will serve to expand our maternal health business and aid pregnant women in areas of high unmet need, such as severe preeclampsia," said William Heiden, chief executive officer of AMAG.
About AMAG Pharmaceuticals, Inc.
As a high-growth specialty pharmaceutical company, AMAG Pharmaceuticals, Inc. uses its business and clinical expertise to bring medical therapies and other innovations to market that provide clear benefits and improve people's lives. Based in Waltham, MA, AMAG has a diverse portfolio of products in the areas of maternal health, anemia management and cancer supportive care. AMAG continues to work to expand the impact of these and future products for patients by delivering on its aggressive growth strategy, which includes organic growth, as well as the pursuit of products and companies that align with AMAG's existing therapeutic areas or those that could benefit from its proven core competencies. For additional company information, please visit www.amagpharma.com.
About Velo Bio, LLC
Velo Bio, LLC, a privately held life-sciences company, is a joint venture between Glenveigh Pharmaceuticals and QuatroBio. Glenveigh, a Chattanooga, TN-based company formed by maternal fetal medicine specialist David Adair, M.D., is focused on developing treatments for complicated pregnancies and is the originator of the DIF program for preeclampsia. QuatroBio, located in Morrisville, NC, is led by Moise Khayrallah, Ph.D. and Stephen Butts, entrepreneurs with a track record of drug development success. Most recently, Dr. Khayrallah and Mr. Butts founded Aerial BioPharma, where they successfully developed ADX-N05 (now JZP-110), which was acquired by Jazz Pharmaceuticals in 2014. Prior to Aerial, they founded Neuronex, acquired by Acorda in 2012, and Addrenex, acquired by Shionogi in 2009.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Any statements contained herein which do not describe historical facts, including, among others, statements regarding beliefs that the development and eventual approval of DIF for the treatment of severe preeclampsia could have a significant impact on the lives of pregnant women and their babies and would nicely complement AMAG's growing portfolio of maternal health products; beliefs that DIF study data suggest a clinical benefit in both mothers and their babies; expectations regarding patent protection; expectations that AMAG's maternal health business platform will be able to reach many at-risk pregnant women and their physicians, which in turn make AMAG an ideal partner for Velo's DIF program; beliefs that the compound has demonstrated early potential to help address severe preeclampsia; expectations regarding the option arrangement and the timing of clinical study results; beliefs that AMAG is taking a disciplined financial approach and making measured investments at key value inflection points in DIF; the characterization of DIF as an important development-state product; beliefs about the efficacy and behavior of DIF; expectations that DIF could serve to expand AMAG's maternal health business and aid pregnant women in areas of high unmet need; beliefs that AMAG is a high-growth specialty pharmaceutical company; and AMAG's plans to continue to expand the impact of its product portfolio by delivering on its aggressive growth strategy are forward-looking statements which 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, among others, AMAG's ability to further expand its product portfolio and realize the anticipated benefits of its business development activities, AMAG's ability to enter into and succeed in markets in which it has no or limited prior experience and such other risks identified in AMAG's Securities and Exchange Commission (SEC) filings, including AMAG's Annual Report on Form 10-K for the year ended December 31, 2014 and subsequent filings with the SEC. AMAG cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. AMAG disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements.
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Source:AMAG Pharmaceuticals, Inc.