Healthcare Industry News: steatohepatitis
News Release - January 10, 2011
Raptor Pharmaceutical Hires Patrick Reichenberger to Lead Commercial Development of DR Cysteamine for Nephropathic CystinosisContracts in Place for Cambrex Corporation and Patheon, Inc. to Manufacture Active Pharmaceutical Ingredient and Commercial Product, Respectively
NOVATO, Calif., Jan. 10, 2011 (Healthcare Sales & Marketing Network) -- Raptor Pharmaceutical Corp. ("Raptor" or the "Company") (Nasdaq:RPTP ) announced today the appointment of Patrick Reichenberger to the newly created position of Vice President, Commercial Operations. Additionally, Raptor has engaged Cambrex Corporation (NYSE:CMB ) for the manufacturing of the active pharmaceutical ingredient ("API"), cysteamine bitartrate, and Patheon, Inc. (TSX:PTI ) to produce the commercial product, DR Cysteamine.
A 20-year industry veteran with significant expertise in commercial operations and product-launch management, Mr. Reichenberger will lead the development and management of Raptor's sales and marketing efforts along with its commercial manufacturing, supply and distribution programs. Prior to joining Raptor, Mr. Reichenberger served as Senior Director of Commercial Development at XOMA, LLC. In this role, he led XOMA's commercial development department with particular emphasis on XOMA 052, an anti-IL1 antibody for diabetes, cardiovascular disease, and Behcet's Uveits, an orphan disease.
Prior to XOMA, Mr. Reichenberger was in charge of marketing, sales and distribution at Questcor Pharmaceuticals where he developed patient access and reimbursement programs supporting the successful commercial re-launch of H.P. Acthar(R) Gel for the treatment of infantile spasms, an ultra-orphan, pediatric disease. Prior to Questcor, he led commercial and strategic marketing for brands at Genentech, Athena Neurosciences, and Parke-Davis, where he assisted in the launch of Lipitor(R).
"The addition of Patrick is particularly appropriate at this time as we work towards a potential commercial launch of DR Cysteamine for nephropathic cystinosis in 2012. His hands-on commercial development expertise will be central to our efforts to build the necessary commercial infrastructure and capability for the near term and as the Company grows in later years." stated Christopher M. Starr, Ph.D., Chief Executive Officer of Raptor.
Mr. Reichenberger stated "My experience in building commercial infrastructures around orphan therapeutics, especially Acthar(R) Gel, is particularly applicable to Raptor's nephropathic cystinosis program. I am encouraged by the enthusiastic patient and foundation support for Raptor's DR Cysteamine program, and I look forward to working to create a sound patient access program ready for commercial launch. While developing and implementing such a program for nephropathic cystinosis is my top priority at Raptor, I am also very excited about the entire Raptor pipeline. I am impressed with the commercial opportunities at Raptor with a near term program in an orphan indication for nephropathic cystinosis and mid-stage programs in other indications, including Huntington's Disease and NASH. I'm pleased to have the opportunity to use all of my capabilities, from long-term strategic planning to practical marketing and sales, in this position."
Ted Daley, President of Raptor stated "We are very pleased to welcome Patrick to lead our commercial efforts. The addition of Patrick to our leadership team, along with our recently established long-term manufacturing agreements with Cambrex and Patheon, are significant milestones in the continued advancement of our DR Cysteamine programs. Both Cambrex and Patheon have significant expertise working with cysteamine bitartrate. Cambrex has provided us with cysteamine bitartrate for all our clinical studies and, for over 10 years, has been one of the few API manufacturers worldwide that is capable of providing a commercial source of pharmaceutical-grade cysteamine bitartrate. Patheon developed Raptor's DR Cysteamine microbead formulation and currently manufactures our clinical drug supply. We look forward to employing their combined expertise and capabilities in our commercial manufacturer."
About Nephropathic Cystinosis
Nephropathic cystinosis is an inborn metabolic error characterized by the abnormal transport of cystine, an amino acid, out of the lysosomes. Failure to treat nephropathic cystinosis can cause serious health consequences, including renal failure and resultant kidney transplant, growth failure, rickets, photophobia and blindness. Symptom onset typically occurs within the first year of life, when cystine crystals accumulate in various tissues and organs, including the kidneys, brain, liver, thyroid, pancreas, muscles and eyes.
About Cysteamine and DR Cysteamine
DR Cysteamine is Raptor's proprietary enteric-coated, microbead oral formulation of cysteamine bitartrate designed to potentially reduce dosing frequency and gastrointestinal side effects associated with immediate-release cysteamine bitartrate, which is approved for sale by the FDA and EMA to treat nephropathic cystinosis, a rare, genetic lysosomal storage disease.
In December 2007, Raptor obtained an exclusive, worldwide license from the University of California, San Diego for the development DR Cysteamine for nephropathic cystinosis and cysteamine for other potential indications including Huntington's Disease, NASH and Batten Disease.
About Raptor Pharmaceutical Corp.
Raptor Pharmaceutical Corp. (Nasdaq:RPTP ) ("Raptor") is dedicated to speeding the delivery of new treatment options to patients by working to improve existing therapeutics through the application of highly specialized drug targeting platforms and formulation expertise. Raptor focuses on underserved patient populations where it can have the greatest potential impact. Raptor currently has product candidates in clinical development designed to potentially treat nephropathic cystinosis, non-alcoholic steatohepatitis ("NASH"), Huntington's Disease ("HD"), aldehyde dehydrogenase ("ALDH2") deficiency, and thrombotic disorder.
Raptor's preclinical programs are based upon bioengineered novel drug candidates and drug-targeting platforms derived from the human receptor-associated protein ("RAP") and related proteins that are designed to target cancer, neurodegenerative disorders and infectious diseases.
For additional information, please visit www.raptorpharma.com.
H.P. Acthar(R) Gel is a registered trademark of Questcor Pharmaceuticals.
Lipitor(R) is a registered trademark of Pfizer Inc.
FORWARD LOOKING STATEMENTS
This document contains forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements relate to future events or our future results of operation or future financial performance, including, but not limited to the following statements: that DR Cysteamine for nephropathic cystinosis will be approved for marketing and Raptor will require sales and marketing efforts and commercial manufacturing, supply and distribution programs; that Raptor will commercially launch DR Cysteamine in 2012; that Raptor will build a commercial infrastructure for the near term and that the Company will grow in later years; that Raptor will create a sound patient access program for nephropathic cystinosis, ready for commercial launch; that Raptor has mid-term commercial opportunities, including for Huntington's Disease and NASH; that DR Cysteamine will reduce dosing frequency and gastrointestinal side effects in nephropathic cystinosis patients; and that Raptor will be able to successfully develop DR Cysteamine or any of its other product candidates. These statements are only predictions and involve known and unknown risks, uncertainties and other factors, which may cause the Company's actual results to be materially different from these forward-looking statements. Factors which may significantly change or prevent the Company's forward looking statements from fruition include that Raptor may be unsuccessful in developing any products or acquiring products; that Raptor's technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; that Raptor is unable to retain or attract key employees whose knowledge is essential to the development of its products; that unforeseen scientific difficulties develop with the Company's process; that Raptor's patents are not sufficient to protect essential aspects of its technology; that competitors may invent better technology; that Raptor's products may not work as well as hoped or worse, that the Company's products may harm recipients; and that Raptor may not be able to raise sufficient funds for development or working capital. As well, Raptor's products may never develop into useful products and even if they do, they may not be approved for sale to the public. Raptor cautions readers not to place undue reliance on any such forward-looking statements, which speak only as of the date they were made. Certain of these risks, uncertainties, and other factors are described in greater detail in the Company's filings from time to time with the Securities and Exchange Commission (the "SEC"), which Raptor strongly urges you to read and consider, including Raptor's annual report on Form 10-K filed with the SEC on November 22, 2010, which is available free of charge on the SEC's web site at http://www.sec.gov. Subsequent written and oral forward-looking statements attributable to Raptor or to persons acting on its behalf are expressly qualified in their entirety by the cautionary statements set forth in Raptor's reports filed with the SEC. Raptor expressly disclaims any intent or obligation to update any forward-looking statements.
Source: Raptor Pharmaceutical
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