Three out of four: Protlix also received marketing approval for its medicine for Fabry disease
The approval comes just after the company's stock was delisted from trading in Tel Aviv.
(Article published in Hbrew - Google translated, a non perfect translation.)
• MediWound and Gamida Cell also received marketing approvals for their drugs this year, after many
years of drought in obtaining approvals for Israeli drugs through new mechanisms
• BiolineRx is also awaiting the FDA's response.
Gali Vinrab 10.05.2023
The company Protelix, which produces drugs for rare diseases by engineering plant cells so that they express human proteins, has received marketing approval in the US for its drug for Fabry disease. Protelix is traded on the New York Stock Exchange at a value of 191 million dollars and in pre-opening trading the stock is up 17%. In March it was deleted The company's stock from trading in Tel Aviv. Even before that, it managed to rise nicely, in preparation for the possibility of receiving the approval. Its return in the last year on the New York Stock Exchange is 190%.
It is one of four Israeli companies that submitted innovative drugs to the FDA, the American Food and Drug Administration, for approval this year. This, after many years in which no innovative Israeli drug reached this status. Two companies have already received a positive answer: Gamida Sel, which is developing a drug that improves treatments for transplanting a new immune system in blood cancer patients, and Medivand, which has developed a drug against burns. Bioline, which is also developing a blood cancer treatment, is also waiting for the Authority's answer until the end of the year.
Protelix's drug is the only one that enters an existing market where it will compete head-to-head with Genzyme's drug Favrezyme. Genzyme's drug is produced in animal cells, while Protelix is the only one that produces it in plant cells. The entire market is estimated at about 2.2 billion dollars. Protelix has a marketing agreement in the US with the Chiesi company, which specializes in the field of rare diseases.
Protlix previously developed a drug for Gaucher's disease based on the same technology, and commercialized it to Pfizer. This drug generated revenue for the company, but due to delays in entering the market, it led to the fact that when it entered the market it was very competitive, and it was unable to take a significant place in the market, and Pfizer lost interest in it, and in the end the drug was not successful in the world market.
After learning this lesson, Protlix stated that it would only go to market with products that were superior to those already on the market. The Fabri product was designed to be better than existing products, and the company does state in its press release that it has a longer half-life. The studies conducted by the company were "non-inferiority" studies, and they did not establish that the half-life results in superiority of the product in terms of efficacy or safety.
That's why Protlix is conducting two follow-up trials for marketing purposes and obtaining insurance indemnity at the desired price. One trial was designed to support the claim that the product improves kidney function compared to Genzyme's product, and another trial was designed to support a treatment protocol according to which the injection is given once a month instead of once every two weeks.
The companies have not yet disclosed what the product's pricing will be compared to Genzyme's, but Protlix will probably not try to compete with an extremely low price, but will price it around the market price.
Amicus also competes in the American febrile market with the Galfold product, which can be swallowed and is only suitable for some patients. Outside of the USA, Shire (Takeda) also operates, which for a decade has not been able to get FDA approval.
The maximum revenue Protlix expects from the product is 150-200 million dollars per year. Protlix will produce the drug at the plant in Karmiel, where it also produces the drug for Gosha.
In the first quarter of this year, Protlix recorded revenues of 5.1 million dollars from the Ghosha product. At the end of the quarter, it had $33 million in cash. Upon approval, she is expected to receive a milestone payment from Casey.
The other two companies that received approvals from the beginning of the year, Medivand and Gamida Sel, did not, as a result, register significant increases in their shares over time. There is a difference between these two companies and Protelix: both companies market their products independently to markets where there are currently no other products, and they now need to invest in building a marketing system and educating the market, so they may require more time and significant investment before they reap the benefits of marketing their drugs . Protelix may have an easier path forward because it has already signed the deal with Casey. However, it is possible that some of these differences are already priced in the share price.
