Oxygen Biotherapeutics Signs Agreement to Acquire Phase 3, FDA Fast Track Product to Pursue Potential $600 Million Cardiovasc...
October 21 2013 - 4:45PM
Business Wire
Phyxius Pharma’s Experienced
Management Team Brings Exclusive Rights to Levosimendan with FDA
Fast Track Status and Agreed Protocol to Begin Phase 3
Trial
Oxygen Biotherapeutics, Inc., (NASDAQ:OXBT) a developer of
oxygen-carrying therapeutics, today announced it has signed a
Definitive Agreement (“Agreement”) to acquire certain assets of
Phyxius Pharma, a privately-held biopharmaceutical company focused
on the development and near-term commercialization of levosimendan
to prevent and treat cardiac surgery patients at risk for
developing low cardiac output syndrome (LCOS), a significant unmet
medical need addressing an estimated $600 million market in the
U.S. According to the terms of the Agreement, Oxygen
Biotherapeutics will acquire the exclusive rights to develop and
commercialize levosimendan in North America, as well as integrating
three key Phyxius Pharma executives into the Company’s management
team. The transaction is valued at approximately $4.8 million in
stock as of October 18, 2013, based on Oxygen Biotherapeutics
issuing an aggregate of approximately 3.4 million shares of its
common stock and securities convertible into common stock to
Phyxius Pharma’s stockholders in a private placement. Upon closing
of the transaction, Phyxius Pharma Co-Founder and CEO, John Kelley
is to become CEO of Oxygen Biotherapeutics.
Ladenburg Thalmann & Co. Inc., a subsidiary of Ladenburg
Thalmann Financial Services Inc. (NYSE MKT:LTS) acted as a
financial advisor for the transaction.
“Upon closing of this transaction, Oxygen Biotherapeutics will
be a Company that has a clear path to commercialization with a
Phase 3 asset addressing a $600 million market. With Fast Track
status and an agreed study protocol under the Special Protocol
Assessment (SPA), we expect we are one trial away from approval,”
said Michael Jebsen, Oxygen Biotherapeutics’ Interim CEO and CFO.
“This acquisition and management transition is designed to offer us
a tremendous opportunity to enhance shareholder value. We are
thrilled that an industry veteran of Mr. Kelley’s stature will be
taking the helm at Oxygen Biotherapeutics.”
Phyxius Pharma Co-Founder and CEO John Kelley commented, “We
look forward to concluding this transaction and swiftly moving
forward on our product development path. By bringing these specific
levosimendan rights with an SPA and Fast Track status to Oxygen
Biotherapeutics, we’re creating synergies by building a portfolio
of indications for the acute care hospital setting. My team and I
have spent much of our careers bringing products through the
approval process, generating revenues and building value at other
public pharmaceutical companies. We look forward to contributing
here at Oxygen Biotherapeutics.”
Levosimendan is licensed from Finland-based Orion Corporation, a
global healthcare company. The drug is currently approved in 53
countries to treat acute decompensated heart failure, a critical
heart disease condition. This asset purchase Agreement brings to
Oxygen Biotherapeutics not only the exclusive rights in North
America to develop and commercialize levosimendan for the specific
indication of prevention and treatment of LCOS, but also the FDA’s
approval of Fast Track status for a Phase 3 trial, and the FDA’s
SPA which represents agreement with the Phase III clinical trial’s
study protocol. The FDA has provided guidance that a single
successful trial will be sufficient to support approval of
levosimendan in this indication.
According to the scientific literature, LCOS occurs in 5-10% of
cardiac surgery patients, and can increase death after surgery by
14-fold. There is no drug currently approved for the prevention or
treatment of LCOS. The Phase 3 clinical trial will study if
levosimendan administered before and during surgery will reduce the
incidence of LCOS and associated morbidity and mortality. There is
substantial scientific evidence for the use of levosimendan in
cardiovascular surgery, with over 25 published articles in peer
reviewed journals and evidence of mortality reduction in some
cardiac surgery trials of more than 50%.
Upon closing of the asset purchase, three key Phyxius Pharma
executives and co-founders will join Oxygen Biotherapeutics. John
Kelley is to become CEO of Oxygen Biotherapeutics. Mr. Kelley has
37 years of experience as a global pharmaceutical executive. He was
formerly President, COO, and Director of NASDAQ-listed The
Medicines Company, a provider of medical solutions to hospitals.
Mr. Kelley currently serves on the Board of Directors of
NASDAQ-listed Acorda Therapeutics. Michael Jebsen, Oxygen
Biotherapeutics’ current Interim CEO and CFO, will remain serving
as the CFO.
Also joining Oxygen Biotherapeutics are Doug Randall, who will
serve as head of business and commercial operations. Mr. Randall is
the former VP, Commercial Operations at The Medicines Company and
was previously VP of Diabetes Marketing and VP of Primary Care
Sales at Sanofi Aventis. Douglas Hay, PhD, will join as head of
regulatory affairs. Dr. Hay was former VP of Global Regulatory
Affairs at The Medicines Company and previously VP of Regulatory
Roles at Shire and Bristol Myers Squibb. Initially, one director
designated by Phyxius Pharma stockholders will be appointed to
Oxygen Biotherapeutics’ Board of Directors, while another designee
will be appointed to the Board following stockholder approval of
the transaction.
In connection with the acquisition, Oxygen Biotherapuetics will
issue to Phyxius’ stockholders in a private placement an aggregate
of approximately 3.4 million unregistered shares of common stock
and securities convertible into common stock. These securities will
be issued as follows at closing:
• Common stock in an amount equal to 15% of
Oxygen Biotherapeutics’ outstanding common stock prior to closing;
and
• Convertible preferred stock that, following
approval of the transaction by Oxygen Biotherapeutics’
stockholders, will automatically convert into common stock in an
amount equal to the remaining transaction consideration.
Approximately 11% of these shares of common stock will vest
immediately upon stockholder approval, while the remainder will
vest upon achievement of specified performance milestones.
The closing of the transaction is expected to occur during the
third quarter of the Company’s fiscal year, but remains subject to
customary closing conditions. Stockholder approval is not required
and will not be sought for the consummation of the acquisition;
however, following the closing, Oxygen Biotherapeutics intends to
seek stockholder approval for the full issuance of the securities
contemplated in the transaction. A more complete description of the
terms and conditions of the acquisition will be available in the
Form 8-K to be filed by the Company with the Securities and
Exchange Commission (the “SEC”) subject to NASDAQ approval. This
press release is neither an offer to sell nor a solicitation of an
offer to buy any of the Company's securities. No offer,
solicitation, or sale will be made in any jurisdiction in which
such offer, solicitation, or sale is unlawful. The terms and
conditions of the transactions described in this press release are
qualified in their entirety by reference to the transaction
documents, which will be filed with the SEC on Form 8-K.
About Oxygen Biotherapeutics, Inc.
Oxygen Biotherapeutics, Inc. is developing medical products that
efficiently deliver oxygen to tissues in the body. The company has
developed a proprietary perfluorocarbon (PFC) therapeutic oxygen
carrier called Oxycyte® that is currently in clinical and
preclinical studies for intravenous delivery for indications such
as traumatic brain injury, decompression sickness and stroke. The
company is also developing PFC-based creams and gels for topical
delivery to the skin for dermatologic conditions and potentially
wound care. In addition, the Company has commercialized its
Dermacyte® line of skin care cosmetics for the anti-aging market.
Dermacyte is now out-licensed to Valor Cosmetics of
Switzerland.
Caution Regarding Forward-Looking Statements
This news release contains certain forward-looking statements by
the Company that involve risks and uncertainties and reflect the
company’s judgment as of the date of this release. The
forward-looking statements are subject to a number of risks and
uncertainties, including, but not limited to, the likelihood of the
consummation of the Phyxius transaction, as well as the successful
integration of Phyxius into the Company, delays in new product
introductions and customer acceptance of these new products, and
other risks and uncertainties as described in our filings with the
Securities and Exchange Commission, including in the current Form
10-Q filed on September 17, 2013, and our annual report on Form
10-K filed on June 26, 2013, as well as other filings with the SEC.
The company disclaims any intent or obligation to update these
forward-looking statements beyond the date of this release. This
caution is made under the safe harbor provisions of the Private
Securities Litigation Reform Act of 1995.
IRTH CommunicationsRobert Haag, 1-866-976-IRTH (4784)Email
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