A small biopharmaceutical company in Palma, Laminar Pharma, has achieved a breakthrough in the main drug market in the world by business volume, that of oncology in the US The Balearic firm has received the designation of orphan drug (used in rare or infrequent diseases) for its experimental LAM561 therapy against glioma, a type of tumor that originates in the brain.
The United States Medicines Agency (FDA) thus facilitates the path to treatment of the Balearic company because there is no effective therapy against a pathology with high mortality a few months after diagnosis.
This company was founded in 2006 by Pablo V. Write, Professor of Cell Biology at the University of the Balearic Islands, as spin-off from that educational center. Among its investors is the Matutes family and the pharmaceutical company Praxis, in addition to around 800 small investors.
The company recognizes that the orphan drug designation provides its therapy with a number of benefits to facilitate development and approval for commercialization in the US, such as free counseling, elimination of approval fees and a faster path to commercialization. In Europe it has also received the go-ahead to follow this path.
Laminar’s business plan includes what to expect the approval of this drug in 2023. The company has already completed phases I and II of clinical trials and is developing phase III (the last one before authorization) in various countries. In Europe, it is advancing with a study in adults and in the United States at a pediatric level for glioma, a lethal disease without effective treatment.
It is a milestone for a Spanish company to enter the US cancer market, the largest with a business volume of around $ 100 billion according to data from the biotech Balearic Islands, which estimates the market for glioma in adults at 1.4 billion. Only another national firm, PharmaMar, has managed to carry out two anti-tumor drugs of its own research before, specifically the drugs Yondelis and Zepzelca.
Laminar holds open a financing round, until November 2, in a model of crowdfunding of small investors to advance these studies. It has also received funding from the American Dana-Farber Foundation, linked to Harvard University.
This designation as an orphan drug is granted to pathologies with low prevalence, serious and without effective current treatment. The American agency thus recognizes that previous trials are sufficient to consider LAM561 as a therapy with potential beneficial for glioma patients.
This medicine is a synthetic derivative of oleic acid. The biopharma is specialized in the development of therapies against pathologies that present alterations of the lipid membrane, a thin sheet that covers all the cells of the body, what the company calls melitherapy.
The company is currently conducting studies with hospital patients in Spain, France, Italy, Israel and the United Kingdom, in addition to pediatric trials in the United States.
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