BELLUS Health Inc BLUSD

BLU - Summer Launch 2011 VIVIMIND

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https://www.bellushealth.com/en/newsroom/?rkey=1905113408&view=96347-2&Start=0&htm=0

Strategic Partnerships and Products Update
KIACTA™ (eprodisate)
On April 29, 2010, BELLUS Health entered into an asset sale and licence agreement with global pharmaceutical fund Celtic Therapeutics regarding KIACTA™, an investigational product candidate being developed for the treatment of AA amyloidosis, a life-threatening orphan disease. Pursuant to the agreement, Celtic Therapeutics acquired and licensed worldwide rights related to KIACTA™ (eprodisate) for upfront payments of US$10 million, and is assuming all costs related to the confirmatory phase III clinical trial and other development activities, estimated at an additional US$25 million. Celtic Therapeutics intends to conduct an auction process for the commercialization rights of KIACTA™ upon completion of the confirmatory phase III clinical trial, the overall proceeds of which are expected to be shared equally between the parties.
The global confirmatory phase III clinical trial for KIACTA™ was initiated on December 14, 2010. The trial is designed to confirm the safety and efficacy of KIACTA™ in preventing renal function decline in patients diagnosed with AA amyloidosis. It will involve approximately 230 patients enrolled from approximately 72 sites in 30 countries worldwide. Enrolment has commenced and is estimated to be completed in mid-2012. The confirmatory phase III clinical trial is the last key step before applications for regulatory approval for KIACTA™ can be filed. It is currently estimated that the trial will be completed in 2014.
VIVIMIND™
In September 2010, Health Canada issued a Natural Health Product Number for VIVIMIND™, thereby granting formal authorization for sale of VIVIMIND™ in Canada. VIVIMIND™ is BELLUS Health's patented nutraceutical product that has been shown to protect the hippocampus, the area of the brain associated with memory and learning.
In October, 2010, BELLUS Health and FB Health LLC ("FB Health") entered into a license and supply agreement pursuant to which the Company granted FB Health exclusive distribution rights for VIVIMIND™ inItaly. FB Health launched VIVIMIND™ and made the product available to Italian consumers in January, 2011.
In early January, 2011, BELLUS Health and Advanced Orthomolecular Research Inc. ("AOR") entered into a share purchase agreement with respect to BELLUS Health's wholly-owned subsidiary OVOS Natural Health Inc. ("OVOS"), whereby AOR acquired all issued and outstanding shares of OVOS. The Company and AOR also entered into a Canadian license and supply agreement pursuant to which the Company granted AOR exclusive distribution rights for VIVIMIND™ in Canada. AOR is responsible for all marketing, distribution and sales activities of VIVIMIND™in Canada and is expecting to launch the product across the country in the summer of 2011.
Finally, in April, 2011, BELLUS Health signed an exclusive license and distribution agreement with Agahan Ayandeye Pars Inc. ("Agahan Group") pursuant to which the Company granted the Agahan Group exclusive distribution rights for VIVIMIND™ in Egypt, United Arab Emirates, Pakistan, Iran and certain other Gulf states of strategic importance to the Agahan Group. The Agahan Group intends to proceed rapidly with obtaining regulatory approval for VIVIMIND™ in the countries where it has exclusive distribution rights, following which it will move quickly to launch the product through prescribing physicians and direct-to-consumer pharmacy sales.
These three partnerships represent approximately $2 million in upfront and guaranteed payments to BELLUS Health and up to $7.5 million in potential milestone payments. All partnerships also provide for BELLUS Health to supply VIVIMIND™'s active ingredient in powder form at a pre-agreed transfer price, which represents approximately 15% of the sales value.
BELLUS Health continues to actively pursue arrangements to distribute VIVIMIND™ in other markets.
NRM8499 Prodrug Candidate
In January, 2011, BELLUS Health completed the phase I clinical trial for NRM8499, a prodrug of tramiprosate intended for the treatment of Alzheimer's disease, which affects more than 30 million patients worldwide. The phase I clinical trial investigated the safety, tolerability and pharmacokinetic profile of NRM8499 as compared to tramiprosate in a group of 67 young and elderly healthy subjects. Results of the trial showed a solid potential for pursuing NRM8499 for the treatment of Alzheimer's disease. The phase I clinical trial data demonstrated that NRM8499 was safe and well tolerated at the intended therapeutic dose. Moreover, the gastrointestinal tolerability and pharmacokinetic profile of tramiprosate, with regards to the inter-individual variability in drug systemic exposure, were meaningfully improved with NRM8499 when compared to the administration of an equivalent dose of tramiprosate. The Company is currently seeking a potential partnership to pursue the development process of NRM8499.
BELLUS Health's burn rate to approximately 
.35 million per month by the end of the second quarter of 2011.
As at February 22, 2011, the Company had available cash and cash equivalents of $8.4 million. Based on current projections, the Company does not expect any additional financing to be required until the end of the second quarter  of 2013.