- US-based CEO aligns with Avita’s
increasing US orientation with BARDA contract, completed Phase 3
trial, imminent PMA submission, and pending US approval &
commercialization
- Mike Perry former Novartis Executive –
Prior SVP & Chief Scientific Officer of Business Development
and previous Chief Scientific Officer of Novartis’ Cell & Gene
Therapy Unit
- Adam Kelliher resigns after two years
of energetic service
The board of pioneering regenerative medicine company Avita
Medical Limited (ASX: AVH; OTCQX: AVMXY) has appointed Dr Michael
(Mike) Perry as its new Chief Executive Officer.
Dr Perry has been an Avita non-executive director since February
2013. His former executive role was Senior Vice President and Chief
Scientific Officer of Global Business Development and Licensing for
Novartis AG. From 2014-16 Dr Perry served as Chief Scientific
Officer of Novartis’ Cell and Gene Therapy Unit. Prior to that he
served as Vice President of the Inegtrated Hospital Care Franchise
and Global Head of Stem Cell Therapy for Novartis Pharmaceuticals
Corp, a US affiliate of Switzerland-based Novartis AG.
Dr Perry, based in the United States, has previously served as
the Global Head of R&D for the Bioscience Division of Baxter
Healthcare, President and CEO of Cell & Gene Therapy for
Novartis subsidiaries Systemix Inc. and Genetic Therapy Inc., Vice
President of Regulatory Affairs for Sandoz Pharma and Syntex Corp,
Director of Regulatory Affairs for Schering-Plough Corp, and
Chairman, CEO or CMO for several early stage biotech companies. He
also previously served as a venture partner with Bay City Capital,
LLC in San Francisco. He presently serves as a director of listed
companies Arrowhead Pharmaceuticals and AmpliPhi Biosciences Corp
and holds academic affiliations with the Gates Center for
Regenerative Medicine at the University of Colorado School of
Medicine and with the Houston Methodist Research Institute. Dr
Perry also serves as a director and operating partner of Bioscience
Managers Pty Ltd.
The board determined that Avita’s achievement of US-focused
milestones will largely drive company value and as such, a decision
was made to retain a US-based chief executive to optimize
shareholder value. London-based Mr Kelliher has elected not to
relocate to the US and has resigned from his position, but will
remain a consultant to the board of directors. Mr Lou Panaccio,
Chairman of Avita, stated, “We are most grateful to Mr Kelliher for
his significant contributions to Avita during his tenure. He
oversaw a diversity of critical company achievements; most notably
progress of our clinical programs, strategic capital raises and
continued progress on our BARDA contract. We are also appreciative
of the keen focus and energy he brings to his work, qualities we
are sure he will apply in his future endeavours.”
Major company regulatory and commercial milestones are
increasingly US-oriented including the US$62 million contract with
the US defense preparedness group BARDA for burns applications
using ReCell®. The BARDA contract includes US$27.9 million to
support FDA premarket approval requirements. Further, the company
has recently completed treatment of patients in its US pivotal
trial, which compares ReCell® in combination with meshed autograft
against conventional skin grafts. Positive results from the US
pivotal burns trial were released on 18 May. In the near term,
Avita intends to submit a PMA to the US FDA seeking approval of
ReCell® for use in patients with severe burns.
Mr Panaccio said he welcomes Dr Perry to the senior executive
role, “Mike’s expertise across the value chain in cell therapy
along with his experience in business development, regulatory
affairs and general management will be crucial to Avita’s future
success. These fundamental attributes complemented by his US
presence, will maximize Avita’s prospects as the company progresses
through PMA submission, FDA review and preparation for large-scale
product commercialization.”
The appointment is effective immediately.
ABOUT AVITA MEDICAL LIMITED
Avita’s patented and proprietary collection and application
technology provides innovative treatment solutions derived from the
regenerative properties of a patient’s own skin. Our medical
devices work by preparing a Regenerative Epithelial Suspension
(RES™), an autologous suspension comprised of the patients’
own skin cells and wound healing factors that are necessary to
regenerate natural healthy skin. This is then applied to the area
to be treated.
In all countries outside of Europe, our portfolio is marketed
under the ReCell® brand to promote skin healing in a wide
range of applications including burns, chronic wounds and
aesthetics.
ReCell® is TGA‐registered in Australia, and CFDA‐cleared in
China. In the United States, ReCell® is an investigational
device limited by federal law to investigational and compassionate
use.
In Europe, our portfolio of medical device products received
CE-mark approval as three tailored product presentations, with
three individual brand names. ReCell® is designed for the
treatment of burns and plastic reconstructive procedures;
ReGenerCell™ has been formulated for chronic wounds including leg
and foot ulcers; and ReNovaCell™ is tailored for aesthetic
applications including the restoration of pigmentation.
To learn more, visit www.avitamedical.com.
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
This letter includes forward-looking statements. These
forward-looking statements generally can be identified by the use
of words such as “anticipate,” “expect,” “intend,” “could,” “may,”
“will,” “believe,” “estimate,” “look forward,” “forecast,” “goal,”
“target,” “project,” “continue,” “outlook,” “guidance,” “future,”
other words of similar meaning and the use of future dates.
Forward-looking statements in this letter include, but are not
limited to, statements concerning, among other things, our ongoing
clinical trials and product development activities, regulatory
approval of our products, the potential for future growth in our
business, and our ability to achieve our key strategic, operational
and financial goal. Forward-looking statements by their nature
address matters that are, to different degrees, uncertain. Each
forward-looking statement contained in this letter is subject to
risks and uncertainties that could cause actual results to differ
materially from those expressed or implied by such statement.
Applicable risks and uncertainties include, among others, the
timing of regulatory approvals of our products; physician
acceptance, endorsement, and use of our products; failure to
achieve the anticipated benefits from approval of our products; the
effect of regulatory actions; product liability claims; risks
associated with international operations and expansion; and other
business effects, including the effects of industry, economic or
political conditions outside of the company’s control. Investors
should not place considerable reliance on the forward-looking
statements contained in this letter. Investors are encouraged to
read our publicly available filings for a discussion of these and
other risks and uncertainties. The forward-looking statements in
this letter speak only as of the date of this release, and we
undertake no obligation to update or revise any of these
statements.
Annexure A
Terms and Conditions of Employment
This annexure outlines the key terms and conditions of Dr.
Michael Perry’s employment as Chief Executive Officer of Avita
Medical Limited.
The Performance Related Bonuses are closely aligned with
shareholder returns.
- Salary
- Base annual salary of US $475,000
- Performance related bonuses
- Annual Short Term Incentive (‘STI’)
linked to specific company performance milestones. The STI target
is 70% of base salary. There is also a mechanism available at board
discretion to reward over-performance, capped to a maximum of 150%
of target STI.
- Long Term Equity Based Incentive
(‘LTI’) linked to continuous employment and share price milestones;
the structure and terms to be confirmed and advised separately and
will be subject to shareholder approval.
Avita Medical may terminate Mr. Perry’s employment by giving him
12 months notice and may elect to make a payment in lieu of all or
part of the notice period.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20170601006783/en/
Avita Medical LtdTim RooneyChief Financial OfficerPhone:
+ 1 (661)
367-9170trooney@avitamedical.comorAustraliaMonsoon
CommunicationsSarah KemterPhone: +61 (0)3 9620 3333Mobile: +61
(0)407 162 530sarahk@monsoon.com.auorUSAWestwicke
PartnersJamar IsmailPhone +1 (415)
513-1282jamar.ismail@westwicke.com
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