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Progenika CEO Sees No 'Major Impact' After Grifols Acquires Majority Stake in Firm


Spanish genetic testing firm Progenika Biopharma will continue to pursue its business objectives after Barcelona-based plasma products manufacturer Grifols acquired a 60 percent stake in the firm for for €37 million ($48.4 million), according to its CEO.

Antonio Martinez told BioArray News this week that the transaction, disclosed last week, will "not have a major operational impact" on the privately held 13-year-old firm. Martinez said that he will continue to serve as Progenika's president and CEO, and that the change "will only affect some members of our board."

Moreover, the company's objectives are the same as before the acquisition, which he said will "help to consolidate the company" and its current R&D programs as Grifols has "important financial resources."

Grifols claims to be the third largest global producer of plasma medicines. The firm, which employs more than 11,000, reported 2012 sales of €2.6 billion. Since 2010, Grifols has held global distribution rights, outside of Mexico, to Progenika's BloodChip blood genotyping test, which Grifols said in a statement enables the "availability of donor-recipient compatible blood units," and "increases transfusional safety."

According to Progenika, the BloodChip is used to genetically characterize blood group antigens of both blood donors and recipients. It relies on an array-based assay to determine more than 60 clinically relevant blood group phenotypes from the ABO, RHD, RHCE, Kell, Kidd, Duffy, MNS, Colton, Diego, and Dombrock systems.

Progenika offers several other genotyping arrays, including chips for lipoprotein lipase deficiency, familial hypocholesterolemia, and pharmacogenetics, with focused PGx arrays available for breast and colon cancer. Though the company is an Affymetrix-certified service provider, it manufactures its menu of arrays in house.

It is the expansion of a separate line of blood-typing assays called IDCore, though, that will be among the Progenika's "main objectives" in coming years, Martinez said. The firm currently offers IDCore and IDCore+ assays, which screen for 23 and 33 low-frequency antigens, respectively. Progenika claims that the assays, which are run on Luminex's 100/200 instrument, enable users to predict mild to severe transfusion reactions, hemolytic disease in newborns, fetal anemia, and alloimmunization in multi-transfused patients.

Martinez said that Progenika in April will launch IDCore XT, a new, simplified version of the assay with content selected from both the IDCore and IDCore+ panels, plus other clinically relevant antigens. When IDCore XT launches, the older IDCore products will be discontinued, Martinez said.

The IDCore XT assay will be available first for research use only, but the company hopes to secure a CE-IVD mark for the test by year end. The assay has also been submitted to the US Food and Drug Administration for pre-market approval, he said. It is here that Grifols' "important financial resources" will aid Progenika.

"As you can imagine, PMA is a large process," said Martinez. "This is a product for blood transfusion, a high risk product, so the clinical study is expensive, and Grifols will provide us with resources that we did not have before."

Another area of focus is Progenika's line of Promonitor enzyme-linked immunosorbant assays, Martinez said. Commercialized via Progenika's Proteomika subsidiary, Promonitor enables the determination of the circulating level of anti-TNFα biologics in plasma, and detects and measures the levels of any patient-produced antibodies targeting the drug itself, the company said.

To date, Proteomika has developed and launched CE-marked kits for monitoring patients treated with infliximab (Remicade), adalimumab (Humira), etanercept (Enbrel), and rituximab (Mabthera). Martinez said that Proteomika's focus is on autoimmunity, and that the firm will introduce Promonitor assays for three additional drugs by the end of the year, though he declined to name the compounds.

Among its other offerings, Proteomika has also commercialized PneumoArray, a microarray-based test for typing Streptococcus pneumoniae.

Finally, Progenika intends to move its LipoChip test for FHL to the Roche GS Junior next-generation sequencing platform. Martinez said that the firm hopes to achieve a CE-IVD mark for an NGS-version of LipoChip in May. The current version of the LipoChip screens for 250 mutations in three genes, making sequencing a "very good platform" for the product, as Progenika's chips have "limited capacity," Martinez said.

He added that the firm is considering moving other array products to sequencing, but did not elaborate.

Progenika is headquartered in Derio, Spain. The firm, which employs 130, also maintains a Medford, Mass.-based subsidiary and reference laboratory called Progenika Inc., as well as another subsidiary in Mexico (BAN 11/1/2011).