BELLUS Health Reports Results for Third Quarter Ended September 30, 2012, and Provides an Update on KIACTA(TM) Phase III Confirmatory Study

LAVAL, QC, Nov. 8, 2012 /CNW/ - BELLUS Health Inc. (TSX: BLU) ("BELLUS Health" or the "Company") today reported its financial results for the third quarter ended September 30, 2012.

Third Quarter 2012 Highlights

  • Recruitment continued for the Phase III Confirmatory Study for KIACTA™ for the treatment of AA amyloidosis, with more than 50% of patients recruited to date;
  • Entered into a partnership with Asclepios Bioresearch (UK) Limited that is expected to provide approximately $4 million for the development of BLU8499, BELLUS Health's drug candidate for the treatment of Alzheimer's disease;
  • Entered into a licence and distribution agreement with Lifenergy Biotech Corp. for VIVIMIND™ in Taiwan.

"The progress we made with our commercial and clinical assets during the third quarter further diversifies and strengthens BELLUS Health," said Roberto Bellini, President and Chief Executive Officer of BELLUS Health. "While KIACTA™ remains the focal point of our product pipeline, we believe we can also create additional shareholder value by advancing BLU8499 and VIVIMIND™ in the coming quarters."

Phase III Confirmatory Study for KIACTA™ (eprodisate)

During the third quarter of 2012, recruitment continued for the Phase III Confirmatory Study for KIACTA™, for the treatment of AA amyloidosis, an orphan indication resulting in renal dysfunction that often rapidly leads to dialysis and death. The study will involve approximately 230 patients enrolled from more than 70 sites and 25 countries worldwide.

As of November 8, 2012, there are 119 patients enrolled in the Phase III Confirmatory Study, and based on the current recruitment rate, it is expected that patient recruitment will be completed in the first half of 2014. As the Phase III Confirmatory Study is an event-driven study that will end when 120 events linked to deterioration of kidney function have occurred, it is currently expected that the study will reach 120 events in 2017. BELLUS Health is actively working with its partner Celtic Therapeutics Inc. (Celtic Therapeutics) to explore means and actions to accelerate both recruitment and study end. Celtic Therapeutics is funding 100% of the ongoing development costs of KIACTA™ including the Phase III Confirmatory Study and other related activities. The total cost of the development activities of KIACTA™ is currently estimated to be in excess of US$50 million. Celtic Therapeutics and BELLUS Health are expected to share the overall proceeds from the future revenues of KIACTA™ approximately equally.

The Data Safety Monitoring Board, which independently assesses the safety of KIACTA™ throughout the Phase III Confirmatory Study, met for a second time on October 19, 2012, and based on its review, recommended to continue the study as per protocol.

Patients completing the Phase III Confirmatory Study will be offered to continue in an open label extension study (OLES). The first patients are expected to be enrolled in the OLES in the second half of 2013.

BLU8499

During the third quarter of 2012, the Company entered into a partnership with Asclepios Bioresearch (UK) Limited (Asclepios) for the development of BLU8499 (formerly named NRM8499), BELLUS Health's drug candidate for the treatment of Alzheimer's disease. Under the terms of the agreement, Asclepios will fund all Phase IIa enabling activities and has committed to a second tranche of additional capital for the conduct of a Phase IIa clinical trial in mild Alzheimer's disease patients. The total investment and commitment by Asclepios towards the development of BLU8499 is expected to be approximately $4 million. Under the terms of the agreement, BELLUS Health will earn study management fees equal to 15% of direct development costs and will also be reimbursed for certain intellectual property costs. During the third quarter of 2012, the Company received a payment of $201,000. According to the agreement, it is expected that the two parties will share the overall proceeds from the future monetization of BLU8499 approximately equally.

The Phase IIa clinical trial is currently expected to be initiated in the first half of 2014. The trial is expected to focus on patients with mild Alzheimer's disease and an apoE4 positive genotype. BELLUS Health will form a joint steering committee with Asclepios to oversee the program's development efforts.

VIVIMIND™

In September 2012, BELLUS Health entered into a licence and distribution agreement with Lifenergy Biotech Corp. (Lifenegy), pursuant to which BELLUS Health granted Lifenergy exclusive distribution rights for VIVIMIND™ in Taiwan. Lifenergy expects to launch VIVIMIND™ in 2013.

VIVIMIND™ is a natural health product designed to protect memory function. The Company currently has distribution agreements with partners in several countries, including Italy, Canada, Taiwan, Greece, and certain countries in the Middle East.

Summary of Financial Results
All currency figures reported in this press release are in Canadian dollars, unless otherwise specified. Comparative per share data for 2011 have been retrospectively adjusted to reflect the consolidation of the Company's common shares.

  Three-months ended
September 30, 2012
Three-months ended
September 30, 2011
  (in thousands of dollars, except per share data)
Revenues 484 745
Research and development
expenses, net
(223) (185)
General and administrative
expenses
(768) (718)
Finance income 281 3,065
Finance costs (60) (2,662)
Net (loss) income (286) 245
Net (loss) income attributable to
owners of the Company
(256) 245
Basic (loss) earnings per share (0.01) 0.03
Diluted loss per share (0.01) (0.06)
 
The Company's full consolidated financial statements and accompanying management's
discussion and analysis for the three- and nine-month periods ended September 30, 2012,
will be available shortly on SEDAR at www.sedar.com and on the Company's web site at
www.bellushealth.com.

  • For the three-month period ended September 30, 2012, net loss attributable to the owners of the Company amounted to $256,000 ($0.01 per share), compared to a net income of $245,000 ($0.03 per share) for the corresponding period the previous year. The increase in net loss in the current quarter is primarily due to lower revenue recognized for accounting purposes in relation to the agreements entered into with Celtic Therapeutics in 2010 for the development of KIACTA™.
  • Revenues amounted to $484,000 for the three-month period ended September 30, 2012, compared to $745,000 for the corresponding period the previous year. Revenues mainly consist of revenue from the asset sale and license agreement as well as the service agreement entered into with Celtic Therapeutics for KIACTA™. The decrease in revenues is primarily due to lower revenue recognized for accounting purposes, as described above.
  • Finance income amounted to $281,000 for the three-month period ended September 30, 2012, compared to $3,065,000 for the corresponding period the previous year. The decrease is mainly attributable to finance income in relation to the decrease in the fair value of the embedded conversion option liability on the 2009 Notes in the amount of $3,034,000 recorded in the three-month period ended September 30, 2011.
  • Finance costs amounted to $60,000 for the three-month period ended September 30, 2012, compared to $2,662,000 for the corresponding period the previous year. The decrease is primarily due to a reduction in accretion expense following the settlement of convertible instruments as part of the strategic partnership, financing and capital reorganization that occurred in the second quarter of 2012.

As at September 30, 2012, the Company had available cash and cash equivalents of $19.1 million.

About BELLUS Health

BELLUS Health is a development-focused healthcare company focusing on products that provide innovative health solutions and address critical unmet medical needs. The Company's lead program is KIACTA™, a novel drug candidate currently in a Phase III Confirmatory Study for the treatment of AA amyloidosis, an orphan indication resulting in renal dysfunction that often rapidly leads to dialysis and death. KIACTA™ is partnered with global private equity firm Celtic Therapeutics. AA amyloidosis affects approximately 35,000 to 50,000 individuals in the United States, Europe and Japan.

About AA Amyloidosis

AA amyloidosis is a deadly condition that progresses from chronic inflammatory diseases such as rheumatoid arthritis. The disease causes a protein called amyloid A to accumulate in major organs, particularly the kidneys, which leads to organ dysfunction, failure, and eventually death.

There is currently no available treatment for AA amyloidosis and it is estimated that approximately 35,000 to 50,000 patients are living with the disease in the United States, Europe and Japan. Independent research conducted by the Frankel Group in 2009 suggests that peak annual revenues of $400 million to $600 million are achievable.

Because patients diagnosed with AA amyloidosis tend to quickly progress to a costly regimen of dialysis, healthcare payers are anxious to find alternative treatments for this deadly condition. KIACTA™ has been granted Orphan Drug designation or its equivalent in the United States and Europe, which would provide seven and ten years of market exclusivity, respectively, as well as a reduction in application and review fees.

Forward Looking Statements

Certain statements contained in this news release, other than statements of fact that are independently verifiable at the date hereof, may constitute forward-looking statements.  Such statements, based as they are on the current expectations of management, inherently involve numerous risks and uncertainties, known and unknown, many of which are beyond BELLUS Health Inc.'s control. Such risks include but are not limited to: the ability to obtain financing immediately in current markets, the impact of general economic conditions, general conditions in the pharmaceutical and/or nutraceutical industry, changes in the regulatory environment in the jurisdictions in which the BELLUS Health Inc. does business, stock market volatility, fluctuations in costs, and changes to the competitive environment due to consolidation, achievement of forecasted burn rate, achievement of forecasted clinical trial milestones, and that actual results may vary once the final and quality-controlled verification of data and analyses has been completed. In addition, the length of KIACTATM Phase III Confirmatory Study is dependent upon many factors including clinical sites activation, patients enrollment rate, patients drop-out rate and occurrence of worsening events. Consequently, actual future results may differ materially from the anticipated results expressed in the forward-looking statements. The reader should not place undue reliance, if any, on any forward-looking statements included in this news release. These statements speak only as of the date made and BELLUS Health Inc. is under no obligation and disavows any intention to update or revise such statements as a result of any event, circumstances or otherwise, unless required by applicable legislation or regulation. Please see the Company's public fillings including the Annual Information Form of BELLUS Health Inc. for further risk factors that might affect the Company and its business.

 

SOURCE: BELLUS Health Inc.

For further information:

Adam Peeler
TMX Equicom
416-815-0700 ext. 225 | apeeler@equicomgroup.com