PROTALIX BIOTHERAPEUTICS, INC. (PLX)

[Kronberg]

Protalix pharmaceutical companies
Protalix's commercialization agreement could grow to over $ 1 billion
As part of Protalix's agreement with Italian pharmaceutical company Casey, the company will invest $ 20 million in completing the product research. • In the event of success, Protalix will receive $ 760 million from Mexie for milestone and royalty payments of 15% -40%
Gali Weinreb 07/24/2018, 14:20
Moshe Manor - CEO of Protalix / Tamar Matzafi Moshe Manor - CEO of Protalix / Tamar Matzafi
Protalix company
( 0.484 + 1.89% )

( 175 + 0.11% )
Develops drugs rare diseases which it produces carrot cells, announced today (Tuesday) that it has signed an extension to its commercialization agreement with Italian pharmaceutical company Casey (Chiesi Farmaceutici) Faber product, so Casey will market the product not only in Europe but also the United States. Fabri Is a rare hereditary disease in which unwanted proteins accumulate in the various parts of the body, damaging the heart, blood vessels, kidney, and more.

Protalix's Fabri product is in Phase III clinical trials, which may be the last trial before marketing (since it is a rare disease drug, and the trials required for these drugs are few). Final results from this experiment are expected in 2020.


Protalix
Protalix
Under the US component of the agreement, Protalix from Casey will receive $ 25 million in advance. Casey will also invest another $ 20 million directly in completing the Fabry study according to the research needs (but not more than $ 7.5 million annually). In the event of success, Protalix will be able to receive another $ 760 million in milestone payments and a relatively high royalty rate of 15% -40% of product sales in the US Protalix will continue to be the producer of the product under this agreement.

Casey is a private Italian pharmaceutical company with a turnover of $ 2 billion. "We were looking for a company that was big but not too big, so that our product would not be buried with it," as happened in the past as part of the agreement for the company to commercialize its product, according to Moshe Manor, CEO of Protalix. For the treatment of Gaucher disease to the pharmaceutical giant Pfizer. "Our product is expected to be a leading product for Casey, especially in the US."

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Protalix has received $ 25 million in advance and $ 25 million in development investment, and Protalix will be able to receive an additional $ 320 million in royalties and royalties from the company. Between 15% and 30% of sales, Casey pays $ 95 million in advances and research funding, and up to $ 1 billion in milestones.

Manor: "The current agreement, which includes the advance and financing of the research, provides the company with all the cash it needs to operate until the results of all the clinical trials required in the suburban product are published." There are currently three trials: the peptide trial in the Fabri product compared to the product for Genzyme (owned by Roche), which is now the leading product in the market; A trial of the drug once a month instead of every two weeks, and another experiment to support the application for marketing in the European market. The three trials together include 130 patients.

Following Protalix's bond arrangement in 2017, it has convertible bonds of $ 40 million to repay in 2021, but assuming that the results of the Fabry tests are good, it can convert those bonds into shares or finance them through payments Milestones will be taken from Casey, so that if there is no disaster in terms of the results of the trial, Protalix will solve this problem with its debt.

"We believe that Protalix's Fabri product has the potential to change the market for treatment of the disease and are excited about the possibility of entrenching global rights," said Ogi Di Franceschett, CEO of Casey. The more we work with Protalix, the clearer the role that a product can have in this market. "

Protalix, which is traded at a value of NIS 208 million (down 40% in the past year), recorded $ 4.6 million in its first-quarter product in Gaucher disease, which it markets mainly in Brazil.

https://www.globes.co.il/news/article.aspx?did=1001247302