Protalix BioTherapeutics is an Israeli pharmaceutical company that manufactures a plant-based enzyme,
taliglucerase alfa, which has received
U.S. Food and Drug Administration
The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food ...
approval for the treatment of
Gaucher disease
Gaucher's disease or Gaucher disease () (GD) is a genetic disorder in which glucocerebroside (a sphingolipid, also known as glucosylceramide) accumulates in cells and certain organs. The disorder is characterized by bruising, fatigue, anemia, low ...
.
Corporate history
Protalix BioTherapeutics was established in 1993. It was founded by Yoseph Shaaltiel, who received his Ph.D. in
Plant Biochemistry
Plant physiology is a subdiscipline of botany concerned with the functioning, or physiology, of plants. Closely related fields include plant morphology (structure of plants), plant ecology (interactions with the environment), phytochemistry (bio ...
from the
Weizmann Institute
The Weizmann Institute of Science ( he, מכון ויצמן למדע ''Machon Vaitzman LeMada'') is a public research university in Rehovot, Israel, established in 1934, 14 years before the State of Israel. It differs from other Israeli univ ...
in Israel and served in the Biology Department of the
Israel Defense Forces
The Israel Defense Forces (IDF; he, צְבָא הַהֲגָנָה לְיִשְׂרָאֵל , ), alternatively referred to by the Hebrew-language acronym (), is the national military of the Israel, State of Israel. It consists of three servic ...
' Biological and Chemical Center. One of the earliest and largest investors in the company was
Phillip Frost. Protalix has two Nobel Prize winners (Chemistry) in its Scientific Advisory Board,
Roger Kornberg Ph.D and Prof.
MD. Aaron Ciechanover.
In its early days Protalix operated out of a warehouse in the town of
Qiryat Shemona
Kiryat Shmona ( he, קִרְיַת שְׁמוֹנָה, ''lit.'' Town of the Eight) is a city in the Northern District of Israel on the western slopes of the Hula Valley near the Lebanese border. The city was named after the eight people, includi ...
in northern Israel. On July 19, 2005, Protalix Biotherapeutics announced the closing of a $5.3 million private placement of its series C preferred stock. Protalix entered into a partnership agreement with
Teva Pharmaceutical Industries
Teva Pharmaceutical Industries Ltd. (also known as Teva Pharmaceuticals) is an Israeli multinational pharmaceutical company with headquarters in Tel Aviv, Israel. It specializes primarily in generic drugs, but other business interests include ...
in 2006 for the development of two proteins and in 2009 signed a collaboration agreement with
Pfizer
Pfizer Inc. ( ) is an American multinational pharmaceutical and biotechnology corporation headquartered on 42nd Street in Manhattan, New York City. The company was established in 1849 in New York by two German entrepreneurs, Charles Pfizer ...
for the development and commercialization of its taliglucerase alfa treatment. Also in 2009, Protalix reported that
Frost & Sullivan
Frost & Sullivan is an American business consulting firm. It offers market research and analysis, growth strategy consulting, and corporate training. It has about 45 offices in the Americas, Africa, Asia and Europe; the principal office is in San ...
presented the company with its 2009 European Orphan Diseases
Market Product Innovation of the Year Award. In 2011 Protalix announced that the U.S. Food and Drug Administration had approved the company's manufacturing facility in
Karmiel
Karmiel ( he, כַּרְמִיאֵל) is a city in northern Israel. Established in 1964 as a development town, Karmiel is located in the Beit HaKerem Valley which divides upper and lower Galilee. The city is located south of the Acre-Safed road, f ...
.
Protalix initially became a public company through a
reverse merger
A reverse takeover (RTO), reverse merger, or reverse IPO is the acquisition of a public company by a private company so that the private company can bypass the lengthy and complex process of going public. Sometimes, conversely, the public compan ...
process with Orthodontix, a company which was at the time traded
"over the counter" on the
NASDAQ
The Nasdaq Stock Market () (National Association of Securities Dealers Automated Quotations Stock Market) is an American stock exchange based in New York City. It is the most active stock trading venue in the US by volume, and ranked second ...
.
This merger was completed on December 31, 2006, and is notable as one of the largest reverse mergers executed, valuing the joint entity at almost $1 billion. It subsequently applied for a listing on the AMEX, and sold 10 million shares in a public offering.
Products
Protalix has been using cultured plant cells to manufacture biopharmaceuticals. As of 2017, Protalix has one FDA approved product sold by Pfizer in the U.S. and currently developing four products:
* Taliglucerase alfa (Elelyso) – a recombinant
glucocerebrosidase
β-Glucocerebrosidase (also called acid β-glucosidase, D-glucosyl-N-acylsphingosine glucohydrolase, or GCase) is an enzyme with glucosylceramidase activity () that is needed to cleave, by hydrolysis, the beta-glycosidic linkage of the chemical g ...
enzyme produced from
transgenic
A transgene is a gene that has been transferred naturally, or by any of a number of genetic engineering techniques, from one organism to another. The introduction of a transgene, in a process known as transgenesis, has the potential to change the ...
carrot cell cultures. Known also as ''Elelyso'', taliglucerase won approval from the
U.S. Food and Drug Administration
The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food ...
in May 2012 as an
orphan drug
An orphan drug is a pharmaceutical agent developed to treat medical conditions which, because they are so rare, would not be profitable to produce without government assistance. The conditions are referred to as orphan diseases.
The assignment of ...
for the treatment of Type 1
Gaucher's disease
Gaucher's disease or Gaucher disease () (GD) is a genetic disorder
A genetic disorder is a health problem caused by one or more abnormalities in the genome. It can be caused by a mutation in a single gene (monogenic) or multiple genes (polyg ...
. Protalix has licensed global development and commercialization rights for ''Elelyso'' to Pfizer, except for Brazil, where Protalix retains full rights. Brazil has the third largest number of Gaucher patients identified worldwide, after the U.S. and Israel. The Brazilian National Health Surveillance Agency, known as ANVISA, granted regulatory approval for ''Elelyso'' (Uplyso) to treat adults with Gaucher disease in March 2013, and extended that approval to children in December 2016.
* Alidornase alfa (PRX-110) – proprietary plant cell-expressed recombinant form of human deoxyribonuclease I (DNase I), that Protalix has designed, through chemical modification, to be resistant to inhibition by actin. DNase I is part of current Cystic Fibrosis therapy, intended to reduce sputum viscosity that accumulates in the lungs of Cystic Fibrosis patients, which exposes patients to recurrent infections and compromises lung function. AIR DNase (alidornase alfa), developed to make mucus in the lungs of cystic fibrosis patients less sticky, showed remarkably good results in 2017.
* Pegunigalsidase alfa (PRX-102) – plant cell culture expressed and a chemically modified version of the recombinant alpha-Galactosidase-A protein. Protein sub-units are covalently bound via chemical cross-linking using PEG chains, resulting in a more active and stable molecule than the current available versions. Protalix is currently conductin
Phase 3 clinical trial for PRX-102for the treatment of Fabry Disease following a successful meeting with
U.S. Food and Drug Administration
The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food ...
. Protalix announced positive results from its clinical trial for PRX-102. Pegunigalsidase alfa is being developed to replace Fabrazyme and interim data shows potential superiority in efficacy.
* OPRX-106 – plant cell-expressed recombinant human tumor necrosis factor receptor II fused to an IgG1 Fc domain (TNFRII-Fc), in development for oral administration. If successful, OPRX-106 will be the first ever oral enzyme treatment as currently there are no other oral enzyme treatments available.
* PRX-105 – a recombinant human
Acetylcholinesterase
Acetylcholinesterase (HGNC symbol ACHE; EC 3.1.1.7; systematic name acetylcholine acetylhydrolase), also known as AChE, AChase or acetylhydrolase, is the primary cholinesterase in the body. It is an enzyme
Enzymes () are proteins that a ...
, produced from genetically modified cell line of tobacco cells (Nicotiana tabacum), which can be used as a counter-measure against
nerve agents
Nerve agents, sometimes also called nerve gases, are a class of organic chemicals that disrupt the mechanisms by which nerves transfer messages to organs. The disruption is caused by the blocking of acetylcholinesterase (AChE), an enzyme that ...
attack. PRX-105 completed exploratory Phase I clinical trials.
See also
*
List of companies of Israel
This is a list of notable companies in Israel.
A
* Adallom
* AdExtent
* Aeronautics Defense Systems
* Africa Israel Investments
* Ahava
* Aladdin Knowledge Systems
* Allot Communications
* Alvarion
* Am Oved
* Amdocs
* Amit, Pollak, Matalo ...
*
TA BlueTech Index
The TA BlueTech Index is a stock market index all capitalised information technology and biotechnology companies listed on the Tel Aviv Stock Exchange (TASE). The index was launched on 3 April 2011 as the TA BlueTech-50 Index and replaced by the ...
*
Velaglucerase alfa
References
External links
{{Authority control
Biotechnology companies of Israel
Pharmaceutical companies of Israel
Pharmaceutical companies established in 1993
Companies listed on the Tel Aviv Stock Exchange
Companies listed on NYSE American