- Pipeline of rare disease projects continues to progress on track -
LAVAL, QC, Nov. 5, 2014 /CNW/ - BELLUS Health Inc. (TSX: BLU) ("BELLUS Health" or the "Company"), a drug development company focused on rare diseases, today reported its financial and operating results for the third quarter ended September 30, 2014.
- More than 60% of the required events to conclude the Phase III Confirmatory Study for KIACTA™ in AA amyloidosis have been reached; the study is on track to conclude in 2016;
- The exploratory sale process for KIACTA™, initiated in May of this year with financial advisor Lazard, continues;
- Shigamab™ proof of concept studies, performed in collaboration with the Uniformed Services University of the United States Department of Defense, demonstrated prevention of toxicity of Shiga toxin type 2 in a lethal sHUS mouse model;
- Concluded the quarter with a cash position of $12.7 million, which should enable the Company to finance its operations beyond the end of the Phase III Confirmatory Study for KIACTA™.
"As the Phase III study for KIACTA™ continues to advance, we are moving closer to providing patients with a safe and effective therapy for AA amyloidosis," said Roberto Bellini, President and Chief Executive Officer of BELLUS Health. "Concurrently, we have gained ground with our pipeline of other rare disease assets, including KIACTA™ for sarcoidosis, clinical stage Shigamab™ for sHUS and a research-stage project for AL amyloidosis."
KIACTA™ for AA Amyloidosis
During the third quarter of 2014, the KIACTA™ Phase III Confirmatory Study continued its progress in more than 70 sites in 30 countries, following the completion of its targeted enrollment of 230 patients in the second quarter of 2014. Total enrollment will be extended beyond 230 patients as eligible patients who were in pre-screening and screening at the time the target was reached are also being given the opportunity to enroll in the study. The study is designed to confirm the safety and efficacy of KIACTA™ in preventing renal function decline in patients diagnosed with AA amyloidosis, an orphan indication resulting in renal dysfunction that often leads to dialysis and death.
The Phase III Confirmatory Study is an event-driven trial that will conclude when 120 patients have experienced an event linked to deterioration of kidney function. To date, more than 60% of the required events have been reached, and based on the current event rate, the KIACTA™ Phase III Confirmatory Study is expected to conclude in 2016.
KIACTA™ is partnered with global private equity firm Auven Therapeutics. Auven Therapeutics is conducting the KIACTA™ study and funding 100% of the development costs, including the Phase III Confirmatory Study and other related activities, which total costs are currently estimated to be in excess of US$60 million. Overall proceeds from potential future revenue of KIACTA™ will be shared between Auven Therapeutics and BELLUS Health based on a pre-agreed formula included in the asset sale and license agreement, and assuming that total divestiture transaction proceeds reach a pre-determined threshold, the parties will share aggregate proceeds equally.
A process to explore the sale of KIACTA™ prior to the completion of the study was initiated in May 2014 with the engagement of financial advisor Lazard by Auven Therapeutics. This initiative provides more flexibility to divest KIACTA™ at the most opportune time for stakeholders, whether that is in 2014 or after the conclusion of the KIACTA™ Phase III study.
KIACTA™ for Sarcoidosis
In May 2014, Auven Therapeutics and BELLUS Health announced that Auven Therapeutics had entered into a license agreement with Icahn School of Medicine at Mount Sinai Hospital, New York, under which Auven Therapeutics obtained rights to develop KIACTA™ (eprodisate) as a treatment for chronic sarcoidosis, a rare inflammatory condition that affects the lungs. There is no cure for sarcoidosis, and treatment options are limited and can have serious adverse effects. Obtaining the rights to move KIACTA™ into a second indication further expands its commercial potential and may help patients with this debilitating chronic disease.
Auven Therapeutics intends to conduct a Phase II (proof-of-concept) clinical trial to evaluate KIACTA™'s effectiveness in treating certain medical manifestations of sarcoidosis. The Phase II trial is expected to begin in 2015, for which a clinical study protocol is currently being developed. All costs in relation to the development of KIACTA™ in sarcoidosis will be borne by Auven Therapeutics. Proceeds from potential future revenue of KIACTA™, including the rights to KIACTA™ for sarcoidosis, are subject to the proceeds sharing agreement between Auven Therapeutics and BELLUS Health.
Shigamab™ is a monoclonal antibody therapy being developed for the treatment of Hemolytic Uremic Syndrome related to Shiga toxin-producing E. coli ("STEC") bacterial infections ("sHUS"), which principally affects the kidneys and often leads to acute dialysis, and in certain cases chronic kidney disease and death, primarily in children.
During the third quarter of 2014, in studies performed in collaboration with the Uniformed Services University of the United States Department of Defense, Shigamab™ was shown to prevent toxicity of Shiga toxin type 2 in a sHUS mouse model as measured by body weight loss, renal biomarkers and renal histopathology. Further studies are being conducted to evaluate Shigamab™ in the treatment of toxicity of Shiga toxin type 2.
Shigamab™ has been granted Orphan Drug designation or its equivalent in the United States and Europe, which provide for market exclusivity for a period of seven and ten years, respectively, once the drug is approved, as well as a reduction in application and review fees.
Summary of Financial Results
All currency figures reported in this press release are in Canadian dollars, unless otherwise specified.
| Three months ended
September 30, 2014
| Three months ended
September 30, 2013
|(in thousands of dollars, except per share data)|
|Research and development expenses||(406)||(321)|
|General and administrative expenses||(810)||(987)|
|Net finance income||53||129|
|Gain on acquisition||-||1,672|
|Net loss attributable to shareholders||(710)||1,039|
|Basic and diluted loss per share||(0.01)||0.02|
The Company's full consolidated financial statements and accompanying management's discussion and analysis for the three and nine-month periods ended September 30, 2014, will be available shortly on SEDAR at www.sedar.com and on the Company's website at www.bellushealth.com.
- Revenues amounted to $420,000 for the three-month period ended September 30, 2014, compared to $528,000 for the corresponding period the previous year. The decrease is mainly attributable to revenue recorded in the comparative period in relation to the agreement with Asclepios Bioresearch (UK) Limited for the development of BLU8499, which was terminated in October 2013.
- Research and development expenses amounted to $406,000 for the three-month period ended September 30, 2014, compared to $321,000 for the corresponding period the previous year. The increase is mainly attributable to expenses incurred in relation to the development of Shigamab™, which drug candidate was acquired through the acquisition of Thallion Pharmaceuticals Inc. in August 2013.
- General and administrative expenses amounted to $810,000 for the three-month period ended September 30, 2014, compared to $987,000 for the corresponding period the previous year. The decrease is mainly attributable to transaction costs recorded in the comparative period in relation to the acquisition of Thallion in August 2013 as well as a reduction of expenses in relation to VIVIMIND™, which was divested in October 2013.
- Net finance income amounted to $53,000 for the three-month period ended September 30, 2014, compared to $129,000 for the corresponding period the previous year. The decrease is mainly attributable to a lower increase in the fair value of the ABCP Notes compared to the previous year.
- Gain on acquisition amounted to $1,672,000 for the three-month period ended September 30, 2013, and is in relation to the acquisition of Thallion in August 2013. The gain on acquisition represents the difference between the fair value of the identifiable assets acquired and liabilities assumed and the consideration transferred.
As at September 30, 2014, the Company had available cash, cash equivalents and short-term investments totalling $12,687,000, compared to $15,297,000 as at December 31, 2013. Based on management's estimate, the current cash position should enable the Company to finance its operations beyond the end of the KIACTA™ Phase III Confirmatory Study.
About BELLUS Health (www.bellushealth.com)
BELLUS Health is a drug development company focused on rare diseases. It has a portfolio of rare disease assets including KIACTA™ in Phase III for AA amyloidosis, KIACTA™ for sarcoidosis, clinical stage ShigamabTM for sHUS and a research-stage project for AL amyloidosis. The lead program KIACTA™ is currently in a Phase III Confirmatory Study for the treatment of AA amyloidosis, an orphan indication resulting in renal dysfunction that often leads to dialysis and death. KIACTA™ is partnered with global private equity firm Auven Therapeutics.
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. A recent commercial assessment study conducted by Navigant Consulting on behalf of Auven Therapeutics and BELLUS Health indicated that there are approximately 13,000 diagnosed and addressable patients with AA Amyloidosis worldwide, of which an estimated 10,300 are in the U.S. and the EU5.
KIACTA™ has been granted Orphan Drug designation or its equivalent for the treatment of AA amyloidosis in the United States, Europe and Japan, which provide for market exclusivity for a period of seven to ten years once the drug is approved, 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, the impact of general economic conditions, general conditions in the pharmaceutical industry, changes in the regulatory environment in the jurisdictions in which the BELLUS Health Inc. does business, stock market volatility, fluctuations in costs, changes to the competitive environment due to consolidation, achievement of forecasted burn rate, potential payments in relation to indemnity agreements, 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 the KIACTATM Phase III Confirmatory Study is dependent upon many factors, including patient drop-out rate and occurrence of clinical endpoint events, and the sharing of proceeds between Auven Therapeutics and BELLUS Health Inc. from potential future revenue of KIACTA™ is dependent upon a number of factors, including the quantum of proceeds. 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 BELLUS Health Inc.'s public fillings including the Annual Information Form for further risk factors that might affect BELLUS Health Inc. and its business.
SOURCE: BELLUS Health Inc.
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