Attached files
| file | filename |
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| 8-K - BIOMIMETIC THERAPEUTICS, INC. | v190026_8k.htm |
| EX-99.2 - BIOMIMETIC THERAPEUTICS, INC. | v190026_ex99-2.htm |
| EX-99.1 - BIOMIMETIC THERAPEUTICS, INC. | v190026_ex99-1.htm |
Contact:
Kearstin
Patterson
Corporate
Communications
615-236-4419
(office)
615-517-6112
(mobile)
kpatterson@biomimetics.com
BioMimetic
Therapeutics, Inc. Releases Clinical Update Including Positive 52-Week Data
from
North American Pivotal Trial
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·
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Final
Augment Study Data Further Confirms Non-Inferiority with
Autograft
|
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·
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Positive
EU Augment Trial Results Consistent with Canadian, North American
Studies
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·
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New
Economic Study Provides Valuable Insight into the Cost Burden Related to
the Use of Autograft in U.S.
Hospitals
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Franklin, Tenn. – July 7, 2010
- BioMimetic Therapeutics (NASDAQ:
BMTI) will report today the final, one year results of its North American
Pivotal Study comparing Augment Bone Graft to autograft in foot and ankle fusion
surgery. The presentation of the data by Dr. Timothy Daniels,
associate professor of orthopedic surgery at the University of Toronto and St.
Michaels Hospital, will take place at the American Orthopaedic Foot and Ankle
Society (AOFAS) summer meeting. As previously reported, the trial met its
pre-specified primary endpoint of non-inferiority of Augment to autograft at six
months, and the Company’s Premarket Approval (PMA) application for Augment was
recently accepted by the FDA.
In Dr.
Daniels’ presentation, he will report the entire 52-week data set, highlighting
key 52-week endpoints, which demonstrate that out of 16 secondary endpoint
measures at the 52-week time point, 15 were statistically significant for
non-inferiority. Further, Augment compared favorably to autograft
with clinical healing rates of 87.8% and 88.3%, and a therapeutic failure rate
of 7.3% and 8.0%, respectively. Importantly, safety outcomes favored the Augment
treatment group, which had fewer complications and infections compared to
patients treated with autograft.
The
Company is also reporting the results of the European Union (EU) Augment foot
and ankle fusion study, which included 108 patients at 11 clinical centers in
Europe. This study demonstrated only a seven percent revision rate,
which is consistent with the therapeutic failure rate observed in the U.S.
pivotal trial for Augment and autograft (7.3-8.0%) and Canadian registration
trial (10%), and a safety profile that was consistent with all other studies of
Augment to date.
Additionally,
during the AOFAS meeting earlier this morning, Dr. Nicholas Abidi, a practicing
orthopedic surgeon at Santa Cruz Orthopaedic Institute, presented for the first
time the results of a recently completed study that quantifies the direct
medical costs of harvesting autograft in foot and ankle fusion
procedures. The study concluded that the cost of harvesting autograft
is between $1,100 and $2,400 depending on the harvest site, excluding the cost
of treating complications associated with the harvest procedure.
“We are
very pleased with the consistently positive results of all studies related to
Augment’s clinical performance. We are also encouraged by the results
of Dr. Abidi’s economic study which provides valuable insight into the cost
burden in U.S. hospitals related to the use of autograft, the current standard
of care,” commented Dr. Samuel Lynch, president and CEO of BioMimetic
Therapeutics. “The 52 week data from the Augment North American
pivotal clinical trial demonstrate that patients treated with Augment have just
as good an outcome after one year, and a favorable safety profile, compared to
patients treated with autograft. And, the patients treated with
Augment have the added benefits of not having the additional pain and risk of a
procedure to harvest the autograft from another bone in their body. The European
trial further confirms the clinical benefits and safety of Augment, and brings
the total number of patients who have been safely treated with the product
candidate to over 500. Finally, the autograft cost study confirms the
significant cost of autograft harvesting and will provide us with valuable
economic data as we formulate our strategy for commercial launch of
Augment.”
The
detailed results of all clinical studies reported today are included below, and
slides from the presentations will be filed as a Form
8-K. Additionally, the Company will host a conference call on July 7,
2010 at 10:30 a.m. EDT to discuss the information presented. Drs.
Timothy Daniels and Sheldon Lin, both clinical investigators in the Augment N.A.
clinical trial, will join management on this call. Further details
regarding the call are provided at the conclusion of this press release and on
the Company’s website.
Detailed Analyses of All
Reported Study Findings
Augment
Pivotal Trial 52 Week Data Summary
Dr.
Daniels’ review of the Augment pivotal trial provides data for the 52-week
visit, which is the final patient visit in the trial, comparing these data with
the 24-week data that had been previously reported. A total of 18
secondary study endpoints are reported in the results, including radiographic,
clinical, functional and pain outcomes along with four key safety
outcomes. While the Company has previously reported on the primary
endpoint of the study, the percent of patients fused at 24 weeks, the updated
secondary endpoint data provide valuable information related to the final
patient outcomes and further support the study hypothesis that Augment is
non-inferior to autograft in the treatment of these fusions.
Of 16
secondary endpoint measures at the 52-week time point, 15 were statistically
significant for non-inferiority; this conclusion reinforces the 24-week study
findings, which showed 14 of these 16 endpoints were statistically significant
for non-inferiority. Comparing the 24-week and 52-week data, two
endpoints went from not significant at 24 weeks to significant at 52 weeks,
while one endpoint went from significant at 24 weeks to not significant at 52
weeks.
An
additional secondary endpoint appearing for the first time in this data table is
the 36-week CT fusion analysis. This endpoint did not meet
statistical significance for non-inferiority, in part because a number of
patients that had successful fusion by six months did not return for their
nine-month CT scans. The patients that missed their nine month CT
scans were counted as failures even though (1) no patient in either
group that was evaluated as “fused” at 24 weeks and returned for their nine
month CT scans was determined to be “not fused” at 36 weeks; (2) bone growth in
both Augment and autograft patients equally progressed on plain film radiographs
from 24 to 52 weeks; and (3) clinical and functional outcomes also continued to
improve equally in both groups from 24 to 52 weeks. In fact, at the
52 week time point, X-ray assessments for fusion of the full complement of
joints (three aspects) showed statistical significance for non-inferiority in
Augment patients, though non-inferiority was not demonstrated for the same
endpoint at 24 weeks.
“As a
clinician, a successful surgical outcome and patient safety are my primary
concerns,” said Dr. Daniels, commenting on the study results. “If you
consider that this patient population included a high percentage of patients
with a risk factor for poor healing, the study results are quite
impressive. I don’t think there is any question that this trial
accomplished what it set out to prove, that Augment is non-inferior with
autograft in clinical effectiveness and offers real benefits for patients by
reducing pain and potential complications relative to autograft.”
EU
Foot & Ankle Trial Data Summary
As noted
above, the Company also reported the results of the Augment foot and ankle
fusion study conducted in 11 high volume foot and ankle clinical centers in the
EU. The design of this study was based on the Company’s previously
reported Canadian trial. In summary, this study demonstrated only a
seven percent revision rate, which is consistent with the therapeutic failure
rate observed in the North American pivotal trial for Augment and autograft
(7.3-8.0%) and Canadian registration trial (10%). Detailed results of
the trial are outlined in the table below, which compares the results of the EU
trial with the previously reported 60 patient, single-arm Canadian
trial.
The goal
of the EU study was to collect additional safety and clinical utility data that
would, along with the results of the North American and Canadian trials, support
regulatory and reimbursement applications in the EU, as well as provide an
opportunity for leading EU surgeons to gain experience with the
product. All patients were evaluated based on a study endpoint of
nine months, similar to the Canadian trial. The Company expects to
submit the data, along with North American trial data, to European regulatory
authorities later this year in order to to gain marketing approval in the
EU.
Evaluating
the Cost of Autograft
Additionally,
Dr. Nicholas Abidi, a practicing orthopedic surgeon at Santa Cruz Orthopaedic
Institute and an investigator in the Company’s Augment North American Clinical
Study, presented a paper during the AOFAS meeting this morning
entitled Economic
Evaluation of the Direct Healthcare Costs of Harvesting Autogenous Bone Graft
in Foot and Ankle Surgery. The paper presented the results of a
recently completed study led by Dr. Abidi, and supported by the Company, which
sought to evaluate the costs affiliated with the bone graft harvest procedure in
foot and ankle fusion surgery.
The study
analyzed billing and cost data for medical resources directly attributable to
harvesting autograft from 10 hospitals and orthopedic centers located across the
U.S. Average direct medical costs ranged from $1,100 to $2,400 per
patient, dependent upon the location of the harvest site and individual hospital
charge/cost structure. These conclusions do not include the
incremental costs resulting from significant complications associated with the
harvest procedure. Further, it is impossible to quantify the cost of
the pain and additional risk experienced by patients having autograft
harvested.
“We
didn’t feel that the real costs affiliated with bone grafting were well
understood by either hospitals or payers,” stated Dr. Abidi. “Our study looked
at the direct costs affiliated with the time, effort, and materials involved in
this second surgery so that these stakeholders could more accurately compare the
cost of possible alternatives to autograft.”
52-Week
Augment Pivotal Study Results: Please See Accompanying Table
EU
Foot & Ankle Trial Summary; 36 Week Data; All Patients Were Treated with
Augment*
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EU Trial (n=108)
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Canadian Trial (n=60)
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Effectiveness
Outcomes
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||||||||
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Clinical
Healing
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84% | 88% | ||||||
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Revision
rate
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7% | 10% | ||||||
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SF-12
(Mean PCS)
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43.1 | 39.7 | ||||||
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Foot
Function Index (Mean Total)
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18.3 | 24.2 | ||||||
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AOFAS
Ankle-Hindfoot Scale
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73.4 | 64.1 | ||||||
| Safety Outcomes | ||||||||
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Device
related SAE’s
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0% | 0% | ||||||
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Infections
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3% | 8% | ||||||
*EU
results are compared to previously reported results from similar Canadian
clinical trial.
Conference Call and
Webcast
The
Company will host a conference call and audio webcast to discuss the 52 week
North American and EU data and autograft cost study at 10:30 a.m. EDT Wednesday,
July 7, 2010. Dr. Timothy Daniels and Dr. Sheldon Lin will be
available on the call.
The
conference call may be accessed on July 7, 2010 by dialing (877) 224-4059
(passcode: 83997359) for U.S. and Canada. The international dial in
number is (706) 902-2069, and the same passcode applies.
A live
webcast of the conference call will be available on the Investor Relations
section of BioMimetic’s website at www.biomimetics.com. The
webcast will be archived for at least 30 days following the call.
Slides
from the applicable presentations will be filed as a Form 8-K following the
AOFAS meeting today.
About BioMimetic
Therapeutics
BioMimetic
Therapeutics is a biotechnology company utilizing purified recombinant
human platelet-derived growth factor (rhPDGF-BB) in combination with tissue
specific matrices as its primary technology platform for promotion of tissue
healing and regeneration. rhPDGF-BB is a synthetic form of one of the
body's principal agents to stimulate and direct healing and regeneration.
The mechanism of action of this platform technology suggests it may be effective
in a broad array of musculoskeletal applications, including the repair of bone,
ligament, tendon and cartilage. Through the commercialization of this
technology, BioMimetic seeks to become the leading company in the field of
orthopedic regenerative medicine. In 2005, BioMimetic received marketing
approval from the FDA for its first product, GEM 21S®, as a grafting
material for bone and periodontal regeneration. Additionally, BioMimetic
Therapeutics has completed and ongoing clinical trials with its product
candidates Augment™ Bone Graft and Augment™ Injectable Bone Graft in multiple orthopedic
bone healing indications including the treatment of foot and ankle fusions and
the stimulation of healing of fractures of the wrist. In November
2009, BioMimetic received approval from Health Canada to begin marketing Augment
as an alternative to the use of autograft in foot and ankle fusion indications
in Canada. In May 2010, the Company’s Pre-Marketing Approval (PMA) application
for the approval of Augment Bone Graft was filed with the FDA.
GEM 21S is a trademark of
Luitpold Pharmaceuticals, Inc., who now owns this dental related product and
markets it through its Osteohealth Company in the United States and
Canada.
For
further information, visit www.biomimetics.com or
contact Kearstin Patterson, corporate communications, at
615-236-4419.
Forward-looking
Statements
This
press release contains "forward-looking statements" within the meaning of the
Private Securities Litigation Reform Act of 1995. These forward-looking
statements are based on the current intent and expectations of the management of
BioMimetic. These statements are not guarantees of future performance and
involve risks and uncertainties that are difficult to predict. There
are many important factors that could cause actual results to differ materially
from those indicated in the forward-looking statements. BioMimetic’s
actual results and the timing and outcome of events may differ materially from
those expressed in or implied by the forward-looking statements because of risks
associated with the marketing of BioMimetic’s product and product candidates,
unproven preclinical and clinical development activities, regulatory oversight,
and other risks detailed in BioMimetic’s filings with the Securities and
Exchange Commission. Except as required by law, BioMimetic undertakes no
responsibility for updating the information contained in this press release
beyond the published date, whether as a result of new information, future events
or otherwise, or for changes made to this document by wire services or Internet
services.
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