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Monday, August 3, 2015
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Adma Biologics Inc., of Ramsey, N.J., said it submitted a biologics license application to the FDA seeking approval of RI-002, a specialty plasma-derived, polyclonal, intravenous immune globulin derived from human plasma containing naturally occurring polyclonal antibodies (e.g., Streptococcus pneumoniae, H. influenza type B, cytomegalovirus, measles, tetanus, etc.) as well as standardized, high levels of antibodies to respiratory syncytial virus. The drug demonstrated positive results in a phase III study in patients with primary immunodeficiency (PI), meeting its primary endpoint of no serious bacterial infections (SBI). Those results, included in the submission, more than meet the requirement specified by the FDA guidance of less than or equal to one SBI per patient-year, the company said. PI is a class of inherited genetic disorders that causes an individual to have a deficient or absent immune system due to either a lack of necessary antibodies or a failure of these antibodies to function properly. It affects roughly 250,000 people in the U.S.

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‘Titer’-ing on brink of BLA, Adma’s added endpoints encourage outcomes in RSV

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Recent outbreaks of respiratory syncytial virus (RSV) in Alabama, Arizona and Colorado children put renewed attention on the disease for which there is no approved therapy in adults, just as Adma Biologics Inc. reported more data from the pivotal phase III trial with RI-002 in primary immune defi ciency (PIDD) that included encouraging results in RSV and other pathogens.

“We’re unable to draw any conclusions about efficacy [against the specific infectious agents] from these increases in antibody titers, but it’s good to note that from the patients the trial was based on, we were able to generate this type of dose response, if you will,”
Adam Grossman, Adma’s CEO, told BioWorld Today. “We think it’s encouraging, and we think that clinicians, patients and payers want to know that, by infusing IVIG products, they’re getting this bump” in protection.

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at $10.05, fl at, analysts at Ladenburg Thalman set a $17.50 price target, Maxim Group went higher to $18 and Laidlaw & Co. forecast $20.

In December, Adma made known top-line data demonstrating that RI-002, a plasma-derived, polyclonal, intravenous immune globulin (IVIG) product, achieved its primary endpoint of preventing serious bacterial infections: zero, which is even below the FDA’s requirement of less than one per patient-year. The pharmacokinetic profile of total immunoglobulin G was consistent with the FDA’s guidance, too. (See BioWorld Today, Dec. 4, 2014.) Added results made RI-002’s picture even brighter. In the multisite study of 59 patients diagnosed with PIDD, researchers reported secondary endpoints that included a total of 93 days, or 1.66 days per patient per year lost from work or school due to infection, and one hospitalization due to an infection of only fi ve days duration in the entire study, with immunoglobulin G trough levels above those required by the FDA for IVIG products.

A marked increase in all of the measured specific antipathogen antibodies turned up, with the greatest increase, 5.3-fold, seen in the level of neutralizing antibody titers to RSV, which “offers an area of potential differentiation from other IVIG products and is in line with our expectations, based on the donorscreening profile,” wrote Ladenburg analyst Kevin DeGeeter in a research report. “However, we were surprised to learn that patients also reported a statistically signifi cant increase in antibody titers against two other common respiratory pathogens,” which means the compound “may have the potential to protect against a broad range of clinically important respiratory pathogens, which could strengthen the argument for premium pricing compared to other IVIG products.” Specifically, the findings showed an increase in H. infl uenzae antibodies and in S. pneumoniae antibodies.