Key Developments For Biomarin Pharmaceutical Inc.
Biomarin Pharmaceutical Inc. (BMRN.O) (Nasdaq)
BioMarin Pharmaceutical, Inc. Announces Particles Detected In Vials From Genzyme's Plant Not Expected To Impact Aldurazyme or Naglazyme
BioMarin Pharmaceutical, Inc. announced that Genzyme notified the Company that, in rare circumstances, it has detected foreign particles in some products filled at the Allston Landing facility. To ensure that patients are not exposed to foreign particles during product administration, Genzyme has issued a 'Dear Doctor' letter to all physicians treating patients with enzyme replacement products that it markets, including Aldurazyme. The letter states that foreign particles have been found in some vials filled at Genzyme's Allston Landing facility and reminds physicians, as a preventive measure, to use a 0.2-0.22 micron filter during administration. For Aldurazyme, this is essentially a reminder as the Aldurazyme approved product label has always recommended the use of a 0.22 micron filter when administering the drug. Accordingly, BioMarin does not expect this letter to have any substantial effect on the usage of Aldurazyme, or on the Company's financials. Due to a mutual decision by BioMarin and Genzyme, BioMarin has been transitioning Aldurazyme production to other fill finish facilities. The last fill finish of Aldurazyme at Allston Landing was in September 2008.
United States Patent Office Issues Patent To BioMarin Pharmaceutical, Inc. Covering Approved Administration of Kuvan With Food
BioMarin Pharmaceutical, Inc. announced that the United States Patent and Trademark Office has issued a patent covering the approved administration of Kuvan (sapropterin dihydrochloride) with food for the treatment of phenylketonuria (PKU). The patent expires in 2024.
BioMarin Pharmaceutical, Inc. Narrows FY 2009 Revenue Outlook To A Range In Line With Analysts' Estimates; Raises FY 2009 Net Profit Outlook
BioMarin Pharmaceutical, Inc. updated its fiscal 2009 outlook and expects revenues of $313-$327 million, compared to the previous range of $311-$336 million, GAAP net loss of $8-$4 million, compared to the previous range of $12-$6 million and non-GAAP net profit of $39.8-$43.8 million, compared to previous range of $35.4-$41.4 million. According to Reuters Estimates, analysts were expecting the Company to report revenues of $325 million and non-GAAP net loss of $11 million for the same period.
Aceras BioMedical LLC Sells Huxley Pharmaceuticals Inc. To BioMarin Pharmaceutical, Inc.
Rodman & Renshaw Capital Group Inc. announced that its affiliate, Aceras BioMedical LLC (Aceras), has sold Huxley Pharmaceuticals Inc. (Huxley), a portfolio company, to BioMarin Pharmaceutical, Inc. Huxley was established by Aceras in August 2008 with a focus on developing therapeutic products for rare diseases of the nervous system. Under the terms of the agreement, BioMarin paid Huxley stockholders $15.0 million. An additional $7.5 million is payable upon the achievement of regulatory milestones. Further, Huxley stockholders may also receive up to an additional $36 million in milestone payments if certain annual, cumulative sales and U.S. development milestones are met. Aceras owned 95% of Huxley's stock at the time of the transaction.
BioMarin Pharmaceutical, Inc. Acquires Huxley Pharmaceuticals, Inc.
BioMarin Pharmaceutical, Inc. announced that it has acquired Huxley Pharmaceuticals, Inc. (Huxley), which has rights to a form of 3,4-diaminopyridine (3,4-DAP), amifampridine phosphate, for the rare autoimmune disease Lambert Eaton Myasthenic Syndrome (LEMS). Under the terms of the agreement, BioMarin paid Huxley stockholders $15.0 million upfront and will pay an additional $7.5 million upon final European Commission approval of amifampridine in LEMS, which is expected in late 2009 or early 2010. Additionally, Huxley stockholders are eligible to receive up to approximately $36.0 million in milestone payments if certain annual, cumulative sales and U.S. development milestones are met. In addition, successful development of multiple sclerosis will result in milestone payments to EUSA.
