LAVAL, QC, Aug. 13, 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 second quarter ended June 30, 2014.
- Completed targeted enrollment of 230 patients for KIACTA™ Phase III Confirmatory Study in AA amyloidosis;
- KIACTA™ Phase III Confirmatory Study on track to conclude in 2016, with more than 50% of the targeted number of events linked to the deterioration of kidney function having been reached;
- Recommendation of the Data and Safety Monitoring Board to continue the KIACTA™ Phase III Confirmatory Study as per protocol, based on its review on April 15, 2014;
- Presented an update on the KIACTA™ Phase III Confirmatory Study's progress at the XIVth International Symposium on Amyloidosis in Indianapolis on April 28, 2014;
- Amendment to the KIACTA™ asset sale and license agreement in relation to the share of proceeds from a potential divestiture of KIACTA™;
- BELLUS Health's clinical development partner, Auven Therapeutics, engaged Lazard as a financial advisor to explore the sale of KIACTA™;
- License agreement for the development of KIACTA™ in sarcoidosis entered into by Auven Therapeutics with Mount Sinai Hospital;
- Concluded the quarter with a cash position of $13.1 million, which should enable the Company to finance its operations beyond the end of the Phase III Confirmatory Study for KIACTA™.
"During the second quarter, momentum continued to build in the KIACTA™ program through the completion of targeted enrollment in the Phase III Confirmatory Study for AA amyloidosis and the addition of a second rare disease indication," said Roberto Bellini, President and Chief Executive Officer of BELLUS Health.
Phase III Confirmatory Study for KIACTA™
During the second quarter of 2014, the KIACTA™ Phase III Confirmatory Study completed its targeted enrollment of 230 patients from more than 70 sites in 30 countries. Total enrollment will be increased 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 50% 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.
Patients completing the KIACTA™ Phase III Confirmatory Study will be offered to continue in an extended program, for which the first patients were enrolled during the second quarter of 2014.
On April 28, 2014, Auven Therapeutics and BELLUS Health presented an update on the study's progress at the XIVth International Symposium on Amyloidosis ("ISA") in Indianapolis. The ISA is the largest international conference focused on amyloid diseases.
As part of the Phase III Confirmatory Study, there are periodic meetings of the Data Safety Monitoring Board ("DSMB"), which independently assesses the safety of KIACTA™ throughout the study. Based on its last review on April 15, 2014, the DSMB recommended that the study continue as per protocol.
KIACTA™ is partnered with global private equity firm Auven Therapeutics. Auven Therapeutics is conducting the KIACTA™ study and funding 100% of the development costs of KIACTA™, 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.
Amendment to the KIACTA™ asset sale and license agreement
In May 2014, Auven Therapeutics and BELLUS Health agreed upon modified terms to the KIACTA™ asset sale and license agreement in relation to the share of proceeds from a potential divestiture of KIACTA™, particularly in the envisaged scenario of a KIACTA™ sale before the completion of its Phase III study. Assuming that total divestiture transaction proceeds reach a pre-determined threshold, the parties will share aggregate proceeds equally. Auven Therapeutics retains certain preference rights on exit proceeds related to Auven Therapeutics' aggregate investment in KIACTA™ up to the date of the sale. The amendment to the agreement provides more flexibility to divest KIACTA™ at the most opportune moment for stakeholders, whether that proves to be in the short term or after the conclusion of the KIACTA™ Phase III Confirmatory Study.
Engagement of financial advisor to explore the sale of KIACTA™
In May 2014, Auven Therapeutics and BELLUS Health announced that Auven Therapeutics had engaged Lazard as a financial advisor to explore the sale of KIACTA™. As the Phase III KIACTA™ study in AA amyloidosis neared completion of its enrollment, it was determined that a potential sale prior to the completion of the study would provide the acquirer with the opportunity to have input into the regulatory process for approval of KIACTA™ worldwide, and would facilitate the manufacturing, marketing and sales preparations for a global launch of the drug.
License Agreement with Mount Sinai for KIACTATM in 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.
Auven Therapeutics intends to conduct a Phase II (proof-of-concept) clinical trial to evaluate KIACTA™'s effectiveness and safety to treat certain medical manifestations of sarcoidosis. The Phase II trial is expected to begin in 2015. 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.
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 sometimes debilitating chronic disease.
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.
Shigamab™'s proof-of-concept testing for treatment of sHUS in mouse models is currently underway.
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
June 30, 2014
| Three months ended
June 30, 2013
|(in thousands of dollars, except per share data)|
|Research and development expenses||(369)||(245)|
|General and administrative expenses||(847)||(1,136)|
|Net finance income||28||104|
|Net loss attributable to shareholders||(737)||(867)|
|Basic and diluted loss per share||(0.02)||(0.02)|
The Company's full consolidated financial statements and accompanying management's discussion and analysis for the three and six-month periods ended June 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 June 30, 2014, compared to $383,000 for the corresponding period the previous year. Revenues mainly consist of revenue recognized for accounting purposes from the asset sale and license agreement and the service agreement entered into with Auven Therapeutics in 2010 in relation to KIACTA™.
- Research and development expenses amounted to $369,000 for the three-month period ended June 30, 2014, compared to $245,000 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. (Thallion) in August 2013.
- General and administrative expenses amounted to $847,000 for the three-month period ended June 30, 2014, compared to $1,136,000 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 an expense reduction in relation to VIVIMIND™'s operations following its divestiture in October 2013.
- Net finance income amounted to $28,000 for the three-month period ended June 30, 2014, compared to $104,000 for the corresponding period the previous year. The decrease is mainly attributable to the depreciation of the Canadian dollar vs. the US dollar in the current quarter, compared to an appreciation of the Canadian dollar vs. the US dollar in the corresponding quarter the previous year.
As at June 30, 2014, the Company had available cash, cash equivalents and short-term investments totalling $13,088,000, 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 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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