BioMarin Pharmaceutical Inc. (NASDAQ:BMRN)

Michael Scally MD

Doctor of Medicine
10+ Year Member
BioMarin Pharmaceutical Inc. (NASDAQ:BMRN)
Biomarin
BioMarin Pharmaceutical Inc.: NASDAQ:BMRN quotes & news - Google Finance

The company's product portfolio comprises four approved products and multiple clinical and pre-clinical product candidates.

Approved products include Naglazyme® (galsulfase) for mucopolysaccharidosis VI (MPS VI), a product wholly developed and commercialized by BioMarin; Aldurazyme® (laronidase) for mucopolysaccharidosis I (MPS I), a product which BioMarin developed through a 50/50 joint venture with Genzyme Corporation; KUVAN®(sapropterin dihydrochloride) Tablets, for phenylketonuria (PKU), developed in partnership with Merck Serono, a division of Merck KGaA of Darmstadt, Germany; and Firdapse™ (amifampridine phosphate), which has been approved by the European Commission for the treatment of Lambert Eaton Myasthenic Syndrome (LEMS).

Product candidates include GALNS (N-acetylgalactosamine 6-sulfatase), which is currently in Phase III clinical development for the treatment of MPS IVA, PEG-PAL (PEGylated recombinant phenylalanine ammonia lyase), which is currently in Phase II clinical development for the treatment of PKU, BMN-701, a novel fusion protein of insulin-like growth factor 2 and acid alpha glucosidase (IGF2-GAA), which is currently in Phase I/II clinical development for the treatment of Pompe disease, and BMN-673, a poly ADP-ribose polymerase (PARP) inhibitor, which is currently in Phase I/II clinical development for the treatment of genetically-defined cancers and BMN-111, a modified C-natriuretic peptide, which is currently in Phase I clinical development for the treatment of achondroplasia.


Drug trial gives hope to Pompe sufferer
Pompe Sufferer Gets Hope From Drug Trial | Stuff.co.nz


Maga JA, Zhou J, Kambampati R, et al. Glycosylation-independent lysosomal targeting of acid ?-glucosidase enhances muscle glycogen clearance in Pompe mice. Journal of Biological Chemistry. http://www.jbc.org/content/early/2012/11/27/jbc.M112.438663.abstract

We have used a peptide-based targeting system to improve lysosomal delivery of acid ?-glucosidase (GAA), the enzyme deficient in patients with Pompe disease. Human GAA was fused to the Glycosylation-Independent Lysosomal Targeting (GILT) tag, which contains a portion of insulin-like growth factor II (IGF-II), to create an active, chimeric enzyme with high affinity for the cation-independent mannose 6-phosphate receptor (CI-MPR). GILT-tagged GAA was taken up by L6 myoblasts about 25-fold more efficiently than was recombinant human GAA (rhGAA). Once delivered to the lysosome, the mature form of GILT-tagged GAA was indistinguishable from rhGAA and persisted with a half-life indistinguishable from rhGAA. GILT-tagged GAA was significantly more effective than rhGAA in clearing glycogen from numerous skeletal muscle tissues in the Pompe mouse model. The GILT-tagged GAA enzyme may provide an improved enzyme replacement therapy for Pompe disease patients.


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Background: Acid-?-glucosidase, an enzyme replacement therapy for Pompe disease, is poorly targeted to lysosomes when relying on phosphomannose residues.

Results: Fusing IGF-II to acid-?-glucosidase resulted in more efficient uptake and glycogen clearance from muscle of Pompe mice.

Conclusion: Enhanced binding to the CI-MPR enabled improved glycogen clearance in Pompe mice.

Significance: BMN 701 is now being tested for Pompe disease in human clinical studies.
 
Last edited:
Crunkhorn S. Trial watch: Enzyme replacement success in Phase III trial for rare metabolic disorder. Nat Rev Drug Discov 2013;12(1):12. http://www.nature.com/nrd/journal/v12/n1/full/nrd3929.html

BioMarin Pharmaceuticals has recently announced positive results from the Phase III trial (MOR-004) of its enzyme replacement therapy (ERT) BMN-100 — recombinant human N-acetylgalactosamine-6-sulphatase (GALNS) — for the treatment of mucopolysaccharidosis type IVA (MPS-IVA; also known as Morquio A syndrome). The study met both its primary and secondary end points, and the company plans to apply for marketing authorization in the first quarter of 2013.
 
[BUY] BioMarin Acquires Zacharon Pharmaceuticals
http://investors.bmrn.com/releasedetail.cfm?ReleaseID=731764

Lead Program Focused on the Oral Treatment of MPS III

Acquisition Augments Existing Analytical Capabilities and Expertise in Glycobiology


SAN RAFAEL, Calif., Jan. 7, 2013 (GLOBE NEWSWIRE) -- BioMarin Pharmaceutical Inc. (Nasdaq:BMRN) announced today that it has acquired Zacharon Pharmaceuticals, a private biotechnology company based in San Diego focused on developing small molecules targeting pathways of glycan and glycolipid metabolism.

Zacharon drug discovery projects include two ongoing lead optimization programs, inhibition of heparan sulfate synthesis for MPS III and other MPS disorders, and inhibition of ganglioside synthesis for diseases such as Tay Sachs and Sandhoff. Zacharon's proprietary SensiPro® platform is a powerful technology for analysis of specific carbohydrate structures and therefore the identification of candidate drugs to treat those conditions.
 
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