Protalix BioTherapeutics said today it has sold its 40%-share in the collaboration agreement for the marketed Type 1 Gaucher disease treatment ELELYSO™ (taliglucerase alfa) to its commercialization partner Pfizer, which will also take a 6% equity stake in Protalix. The deals are valued at a total $46 million.
Protalix said it will use the proceeds to “aggressively” advance its clinical pipeline and execute a new strategy of developing “clinically superior” biologics.
Pfizer will now be responsible for all expenses, and will be entitled to all revenues, globally for ELELYSO—except in Brazil, where Protalix will be responsible for all expenses and retain all revenues.
Under the companies’ initial collaboration agreement, Pfizer and Protalix shared revenues and expenses for the development and commercialization of ELELYSO on a 60/40% basis globally, excluding in Israel and Brazil.
“The funds we are receiving from the overall transaction, totaling $46 million, will yield a strong pro forma cash balance for the company of approximately $80 million as of September 30, 2015 enabling us to aggressively push our clinical pipeline forward and concentrate on our new strategy of developing clinically superior biologics,” Protalix President and CEO Moshe Manor said in a statement.
Headquartered in Carmiel, Israel, Protalix is focused on developing and commercializing recombinant therapeutic proteins through its ProCellEx® plant cell-based protein expression system. The company’s pipeline includes compounds designed to treat addressing Fabry disease, immune and inflammatory diseases, cystic fibrosis and Gaucher disease—as well as additional programs in initial research phases.
Earlier this year, Protalix reported positive interim Phase I/II results for the Fabry disease compound PRX-102, a chemically modified version of the recombinant alpha-Galactosidase-A protein. The company also reported promising Phase I results for the recombinant anti-tumor necrosis factor PRX-106, an orally-administered anti-inflammatory treatment.
Protalix said the $46 million will consist of $36 million cash for its share in the collaboration agreement and rights for Israel, plus $10 million that Pfizer has agreed to invest in Protalix, in exchange for 5,649,079 of its common stock shares subject to terms referenced under the stock purchase agreement.
Protalix also said it stands to gain up to $12.5 million in annual payments it will no longer have to make to Pfizer in return for the pharma transferring full commercialization rights in Brazil.
“We look forward to expanding the availability of ELELYSO and our successful patient support programs to the Gaucher patient community globally,” added Michael Goettler, Pfizer’s global commercial officer for its Global Innovative Pharma Business.
ELELYSO is a long-term enzyme replacement therapy that first won FDA approval in 2012 as an injection treatment for Type 1 Gaucher disease in adults. The indication was expanded last year to include pediatric patients.
The ELELYSO collaboration was launched in 2009, when Pfizer paid $60 million upfront to develop and commercialize Protalix ‘s lead Gaucher disease enzyme replacement therapy. Protalix could potentially receive another $55 million in regulatory milestones.
In 2012, Protalix handed responsibility for new clinical trials to Pfizer, with the pharma agreeing in return to pay Protalix $8.3 million tied to achieving undisclosed near-term clinical development milestones.