BioMarin+Pharmaceutical

= BioMarin Pharmaceutical =

toc BioMarin Pharmaceutical ||
 * ~ Company Name ||
 * ~ Year founded || 1997 ||
 * ~ Headquarters || Novato, CA, USA ||
 * ~ Number of Locations || 5 ||
 * ~ Key People || Jean-Jacques Bienaimé ||
 * ~ Total Revenue || $315.7 Million (2009) ||
 * ~ Employees || More than 700 worldwide ||
 * ~ website || [|www.bmrn.com] ||

The Strategy of this company is to providing rapid access to treatment for patients with serious unmet medical needs, Optimizing powerful biology with demonstrated potential and development clarity, Accelerating approval process, Strategic pipeline development

History
**-** BioMarin Forms Strategic Alliance With Serono for the Development and Commercialization of Phenoptin and Phenylase - BioMarin Receives FDA Approval For Naglazyme - Phenoptin For PKU Receives FDA Fast Track Designation - Naglazyme Receives European Union Approval - BioMarin And Alliant Pharmaceuticals Establish North American Licensing Agreement For Orapred - Positive Results From Phase 3 Diet Study Of Phenoptin For PKU - BioMarin Submits NDA For Kuvan For PKU - BioMarin Files IND For PEG-PAL For The Treatment Of PKU - Kuvan Approved By FDA; Launched Immediately In The U.S. - BioMarin Re-Acquires Rights To Kuvan In Canada From Merck Serono - Biopten (Sapropterin Dihydrochloride) Approved by Japanese Ministry of Health for the Treatment of PKU - Results of First Interim Efficacy Analysis for Riquent Phase 3 ASPEN Trial: Continuation of the Trial is Futile - BioMarin’s Clinical Trial Application for GALNS for Morquio A Syndrome Accepted by the MHRA - BioMarin Appoints Dr. Henry J. Fuchs as Senior Vice President and Chief Medical Officer - Naglazyme Approved by Brazil’s National Health Surveillance Agency
 * ** March of 1997 -** BioMarin Pharmaceutical Inc. Founded (with a $1.5 million investment from Glyko Biomedical Ltd.)
 * **December of 1997** - BioMarin initiated the first clinical trial of Aldurazyme® (laronidase) for the treatment of mucopolysaccharidosis I (MPS I)
 * **September 1998** - BioMarin/Genzyme LLC Formed to Support the Development and Commercialization of Aldurazyme
 * **July 1999** - BioMarin Becomes a Publicly Traded Company (Nasdaq/SWX:BMRN)
 * **2000** - BioMarin Initiates Clinical Trial of Naglazyme for MPS VI
 * **2003** - Aldurazyme for MPS I Approved and Launched in the Unites States and Europe
 * **February 2004 -** BioMarin Advances Phenoptin for PKU into Phase 2 Development
 * **June 2004** - BioMarin Files Marketing Applications for Naglazyme in the United States and Europe
 * **April 2005** - BioMarin Initiates Phase 3 Clinical Study of Phenoptin for PKU
 * **May 2005** - BioMarin Acquires Rights to 6R-BH4 for the Treatment of Cardiovascular Indications
 * **June 2005** - BioMarin Launches Naglazyme In The United States
 * **August 2005** - BioMarin Files New Drug Application For Orapred ODT
 * **January 2006** - BioMarin Establishes Commercial Operations In Europe
 * **March 2006** - Positive Results From Phase 3 Clinical Study Of Phenoptin For PKU
 * **July 2006** - Phase 2 Clinical Study Of 6R-BH4 In Poorly Controlled Hypertension Initiated
 * **August 2006** - Orapred ODT Launched By Alliant Pharmaceuticals
 * **October 2006** - Aldurazyme Receives Marketing Approval In Japan
 * **December 2006** - Positive Results From Phase 3 Extension Study Of Phenoptin For PKU
 * **January 2007** - Phase 2 Clinical Study Of 6R-BH4 In Peripheral Arterial Disease Initiated
 * **February 2007** - Results From Phase 2 Clinical Study Of 6R-BH4 In Poorly Controlled Hypertension
 * **May 2007** - BioMarin Initiates Phase 2a Clinical Study Of 6R-BH4 In Sickle Cell Disease
 * **June 2007** - BioMarin Initiates Expanded Access Program For Kuvan In The U.S.
 * **July 2007** - Kuvan Receives Priority Review Status From FDA
 * **August 2007** - BLA For Naglazyme Submitted To Japanese Ministry Of Health
 * **September 2007** - Exclusive Rights To Kuvan Data Licensed To Asubio Pharma
 * **November 2007** - MAA For Sapropterin For Hyperphenylalaninemia Submitted To EMEA
 * **December 2007** - BioMarin And IGAN Collaborate On Development Of Enzyme Therapy To Treat IgA Nephropathy
 * **January 2008** - BioMarin and Genzyme Restructure Aldurazyme 50/50 Joint Venture
 * **March 2008** - Naglazyme Approved by Japanese Ministry of Health
 * **May 2008** - BioMarin Initiates Phase 1 Clinical Study of PEG-PAL in PKU
 * **June 2008** - BioMarin Announces Program for ERT for Treatment of MPS IVA - Morquio A Syndrome
 * **July 2008** - BioMarin and Summit plc Sign Worldwide Licensing Agreement for Duchenne Muscular Dystrophy Program
 * **September 2008** - Kuvan Receives Positive Opinion from CHMP for European Approval
 * **October 2008** - Positive Results from Study of 6R-BH4 in Sickle Cell Disease
 * **November 2008** - BioMarin Initiates Clinical Program for Morquio A Syndrome (MPS IVA)
 * **December 2008** - Kuvan Approved By EMEA for Use in Europe
 * **January 2009** - BioMarin & La Jolla Pharmaceutical Sign Worldwide Development and Commercialization Agreement for Riquent
 * **February 2009** - Results From Phase 2 Clinical Study of 6R-BH4 in Peripheral Arterial Disease Not Statistically Significant
 * **March 2009** - BioMarin Receives Notice of Allowance for Once Daily Dosing Patent for Kuvan
 * **April 2009** - BioMarin Initiates Phase I/II Clinical Trial for GALNS for Morquio A Syndrome (MPS IVA)
 * **June 2009** - Kuvan Receives Priority Review Status From Health Canada
 * **September 2009** - BioMarin Initiates Phase II Clinical Study of PEG-PAL in PKU
 * **Octuber 2009** - BioMarin Acquires Huxley Pharmaceuticals, Inc.
 * **November 2009** - FDA Grants Orphan Drug Designation for 3, 4-DAP for LEMS

Products
is an enzyme replacement therapy for the treatment of mucopolysaccharidosis VI (MPS VI) is an enzyme replacement therapy for the treatment of mucopolysaccharidosis I (MPS I) is the first and only FDA-approved medication for PKU to reduce blood Phe levels in patients with hyperphenylalaninemia (HPA) due to tetrahydrobiopterin (BH4-) responsive PKU
 * [|Naglazyme®]
 * [|Aldurazyme®]
 * [|Kuvan®]

Pipeline


All references on this page can be found at: [|www.bmrn.com] (visited on April 19th 2010)
 * References:**

by Núria Lopes, nº66696, MBiotec

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