October 13, 2015
By Mark Terry, BioSpace.com Breaking News Staff
Karmiel, Israel-based Protalix Biotherapeutics, Inc. announced today that it was selling its share of a collaboration deal back to Pfizer Inc.
Under the original deal, Pfizer took 60 percent and Protalix took 40 percent of revenues and expenses for the development and commercialization of ELELYSO, except in Israel and Brazil. Under the amendment, Pfizer gets 100 percent of all expenses and revenue globally, except for Brazil.
In August 2014, the U.S. Food and Drug Administration (FDA) approved ELELYSO (taliglucerase alfa) in pediatric patients for the treatment of Type 1 Gaucher disease.
Gaucher disease is an inherited lysosomal storage disorder that affects about 10,000 people worldwide. Possible symptoms include enlarged liver and spleen, various bone diseases, easy bruising, and anemia.
As part of the amendment, Protalix will receive a total of $46 million, which the company intends to use to advance its clinical pipeline. It will receive $36 million in cash and Pfizer will acquire 5,649,079 company shares for about $10 million. Also, Pfizer will turn over full commercialization rights in Brazil, which will free up about $12.5 million that Protalix was paying Pfizer annually.
“We look forward to expanding the availability of ELELYSO and our successful patient support programs to the Gaucher patient community globally,” said Michael Goettler, global commercial officer, Global Innovative Pharma Business at Pfizer, in a statement. “This amended agreement underscores Pfizer’s long-standing commitment to serving the needs of patients living with rare diseases.”
Protalix focuses on developing and commercializing recombinant therapeutic proteins using its proprietary ProCellEx protein expression system. ELELYSO is the company’s sole marketed product. It currently has PRX-102 in Phase I/II development for Fabry Disease, PRX-106, an oral antiTNF molecule for cancer treatment which completed a Phase I clinical trial, PRX-110, for potential treatment of Cystic Fibrosis, which is expected to start a Phase I trial by the end of 2015, and PRX-112 for Gaucher disease, which completed Phase I clinical trials in Israel.
Protalix has been on a mild downward trend for the last year, although it took a short hop recently. Shares traded on Oct. 17, 2014 for $2.65, dropped to $2.24 on May 20, 2015, and to $1.33 on Aug. 24. On Oct. 2 shares traded for $1.03 and are currently trading for $1.15.
Zacks Investment Research gives the company a “strong buy” rating with a one-year consensus target price of $2.30. In a research note on Oct. 7, analysts at Jefferies Group changed the company’s price objective from $2.60 to $2.30, which would still be an upside of 103.54 percent from its price on Oct. 9.
