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The ALDH2 deficiency product candidate is a proprietary oral formulationof a drug previously approved to treat another indication by intravenousadministration. Bennu plans to file an investigational new drug ("IND")submission to the Food and Drug Administration ("FDA") for the initiation of aPhase II clinical trial in 2008, subject to FDA approval of its IND.
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Through the establishment of Bennu, Raptor Pharmaceuticals Corp. will bestructured such that Raptor Pharmaceutical Inc. will drive research anddevelopment efforts, including preclinical studies, while Bennu will executethe clinical development of internal products and in-licensed candidates thatare: 1) new chemical entities in mid-to-late stage clinical development; 2)currently approved drugs with potential efficacy in additional indications;and 3) treatments that Bennu could repurpose or reformulate as potentiallymore effective or convenient treatments for their currently approvedindications.
"This corporate structure underscores Raptor's basic philosophy thatresearch and clinical development require different cultures and skills thatthrive optimally in their particular operating environments," stated Dr.Christopher M. Starr, Raptor's Chief Executive Officer. "We believe we cansuccessfully develop clinical stage products without losing our focus andpassion for new drug discovery. Our strategy ensures that the scientific anddrug discovery team at Raptor will continue to focus its energy on providing arobust pipeline of new drug candidates. Bennu will provide a clinicaldevelopment infrastructure through which Raptor's drugs will transition asthey evolve into the clinic and enable the company to in-license additionalclinical stage products."
"We are also very pleased to have Ted Daley join us as President ofBennu," continued Dr. Starr. "Ted is an experienced senior manager andseasoned entrepreneur with a successful track record of starting and buildingsuccessful companies. His knowledge and experience with Convivia's productswill enable an efficient transition of the ALDH2 deficiency program fromConvivia to Bennu and will help to advance the program through the clinic."
"I am excited to join the Raptor team," stated Mr. Daley. "The scientificdepth of the staff at Raptor along with their experience in bringing therapiesto market, coupled with the clinical and regulatory expertise we areassembling at Bennu, is a winning combination. The ALDH2 deficiency programwill be a key test of our ability to acquire and execute new clinical-phaseprograms."
"We plan to focus on Asia as the first market for our ALDH2 deficiencyproduct candidate. The high prevalence of this unmet medical need among Asianpopulations creates a particularly large commercial opportunity in this partof the world," continued Mr. Daley.
To optimize the development path of the ALDH2 deficiency productcandidate, Bennu has retained Pacific BioDevelopment, LLC, a drug developmentconsulting firm. Pacific BioDevelopment will
