Phase 2 Antiviral for the Treatment of
Diseases Caused by Human Papillomavirus Strengthens
Pipeline
Conference Call Today at 9:00 A.M.
EST
Biota Pharmaceuticals (Nasdaq:BOTA) (the "Company") announced today
that it has entered into a definitive agreement to acquire Anaconda
Pharma, a privately-held biotechnology company based in Paris,
France. Anaconda Pharma's lead candidate is AP611074, a patented,
direct-acting antiviral in development for the treatment of
condyloma, or anogenital warts, as well as the orphan disease
recurrent respiratory papillomatosis (RRP), both of which are
caused by human papillomavirus (HPV) types 6 and 11. Anaconda
Pharma has successfully completed a Phase 2a clinical trial of
AP611074 5% gel demonstrating biological activity with a
significant reduction in the surface area of condyloma while
exhibiting favorable local skin tolerability.
"We're very enthusiastic about the global market opportunity for
AP611074, and believe it is uniquely positioned to significantly
improve the treatment paradigm for anogenital warts, the most
frequent viral sexually transmitted disease worldwide, and RRP, a
condition in which tumors grow in the respiratory tract," stated
Dr. Joseph Patti, president and chief executive officer of Biota.
"We are encouraged by both the positive efficacy data as well as
the favorable local skin tolerability profile observed in the
proof-of-principle Phase 2a clinical trial. We are looking forward
to the initiation of a randomized, placebo-controlled,
double-blind, Phase 2b trial in patients with anogenital warts in
the second half of 2015."
"We believe that Biota's antiviral clinical development
capabilities and experience, along with its financial resources,
will enhance and accelerate the development of AP611074," stated
Dr. Marta Blumenfeld, chief executive officer of Anaconda Pharma.
"We are delighted to unite forces with Biota as AP611074 advances
into a robust Phase 2b clinical trial later this year."
Under the terms of the agreement, at closing all of Anaconda
Pharma's outstanding shares will be acquired for 3.5 million shares
of Biota common stock and $8.0 million in cash, subject to certain
closing and post-closing adjustments. Biota will fund the cash
portion of the purchase price with cash on hand. The transaction
also includes additional contingent financial consideration of up
to $30.0 million, which is based on the successful achievement of
certain future clinical and regulatory milestones, plus a royalty.
Closing of the transaction, which is expected to occur by the end
of April 2015, is subject to approval of the French Ministry of
Finance and Economics and other customary conditions.
Stifel, Nicolaus & Company, Incorporated is acting as
exclusive financial advisor to the Company. Dechert LLP is acting
as legal counsel to the Company in connection with this
transaction.
Conference Call and Webcast Information
Biota Pharmaceuticals will host a conference call today via a
webcast and conference call at 9:00 a.m. EST. To access the
conference call, please dial (877) 312-5422 (domestic) or (253)
237-1122 (international). A live audio webcast of the call and the
archived webcast will be available in the Investors section of the
Biota website at http://www.biotapharma.com.
About Condyloma (Anogenital
Warts)
Condyloma infections with human papillomavirus (HPV) represent
the most frequent viral sexually transmitted disease in adults
worldwide. In the United States, approximately one to two percent
of sexually active adults between the ages of 15 to 49 develop
condyloma as the primary clinical manifestation of HPV infection.
Currently available treatments for anogenital warts typically are
divided into two categories, ablative/destructive therapies and
topical therapies. Existing topical therapies are associated with
significant mucosal toxicities manifesting as erosions and
ulcerations, which can result in therapy discontinuation. Ablative
options can be painful, scarring and can lead to sexual
dysfunction. Another significant limitation with current therapies
is a high incidence of recurrence after successful primary
treatment. One reason postulated for frequent genital wart
recurrence is the lack of robust antiviral activity with the
immunomodulatory therapies. Condyloma represents a significant
burden to the health care system with an estimated 385,000 initial
visits to physician offices in 2008 and $200 million in direct
costs annually in the United States.
About Recurrent Respiratory Papillomatosis
(RRP)
HPV 6 and HPV 11 are also associated with RRP, a condition of
tumors or wart-like lesions of the upper respiratory tract,
particularly the larynx. The prevalence of this condition is
between one and seven per 100,000 persons. Juvenile-onset RRP
(JORRP) is usually diagnosed between the ages of one and four
years, is equally prevalent in both sexes, and is believed to be
acquired by newborns from their mothers during labor. Adult-onset
RRP (AORRP) has a broad peak of occurrence between ages 20 and 40
years, and is most frequent in males (2:1 ratio). Afflicted infants
and children with JORRP present with difficulty breathing or
swallowing and therefore the lesions can become life-threatening,
while adults usually present with hoarseness, chronic coughing or
breathing problems. A small percentage of afflicted patients go on
to have systemic disseminated disease which can invade the lungs
and become potentially lethal. Typically, RRP warts have to be
removed surgically. On average, in the United States, children
undergo 19.7 surgical procedures over their lifetime, with a mean
frequency of 4.4 procedures per year. In 20 percent of JORRP and
AORRP patients the disease will be more aggressive and can require
more than 40 surgical procedures during a lifetime. It is estimated
that 15,000 surgical procedures due to RRP are performed per year
in the United States, at a total cost of $150 million, and lifetime
costs per individual patient can reach up to $470,000.
About Biota Pharmaceuticals, Inc.
Biota Pharmaceuticals, Inc. is a company focused on the
discovery and development of products to treat serious viral
respiratory infectious diseases. The Company currently has two
late-stage product candidates: (i) laninamivir octanoate, which is
being developed as a one-time, inhaled treatment for influenza A
and B infections; and (ii) vapendavir, a potent, broad spectrum
capsid inhibitor of enteroviruses in development for the treatment
of human rhinovirus infected patients with underlying respiratory
illnesses, such as moderate-to-severe asthma and chronic
obstructive pulmonary disease (COPD). The Company is also
conducting IND-enabling studies with BTA-C585, an orally
bioavailable F protein inhibitor, in development for the treatment
of respiratory syncytial virus infections. For additional
information about the Company, please visit
www.biotapharma.com.
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of 1995
that involve known and unknown risks and uncertainties concerning
Biota's business, operations and financial performance. Any
statements that are not of historical facts may be deemed to be
forward-looking statements, including; the potential of AP611074 to
address viral sexually transmitted disease in adults worldwide; the
potential of AP611074 to address recurrent respiratory
papillomatosis; the timing of the initiation in the Phase 2b
clinical trial for AP611074 and the timing of approval of the
acquisition by the French Ministry of Finance and Economics.
Various important factors could cause actual results, performance,
events or achievements to materially differ from those expressed or
implied by forward-looking statements, including future clinical
data to support the continued development of AP611074 and its
potential of AP611074 to treat Recurrent Respiratory
Papillomatosis, obtaining approval of the transaction from the
French Ministry of Finance and Economics, the satisfaction or
waiver of other conditions to closing, the Company, the Food and
Drug Administration or a similar regulatory body in another
country, a data safety monitoring board, or an institutional review
board, delaying limiting or suspending the initiation of Phase 2b
or subsequent clinical development of AP611074 at any time for a
lack of safety, tolerability, antiviral activity, commercial
viability, regulatory or manufacturing issues, or any other reason
whatsoever; the Company's ability to secure, manage and retain
qualified third-party clinical research, data management and
contract manufacturing organizations upon which it relies to assist
in the design, development, implementation and execution of the
clinical development plan of AP611074, competition from existing
treatments or those in development and other cautionary statements
contained elsewhere in this press release and in the Company's
Annual Report on Form 10-K for the year ended June 30, 2014, as
filed with the U.S. Securities and Exchange Commission on September
30, 2014, and the Company's Quarterly Reports on Form 10-Q for the
quarter ended September 30, 2014 and December 31, 2014, as filed
with the U.S. Securities and Exchange Commission on November 7,
2014 and February 6, 2015. There may be events in the future that
the Company is unable to predict, or over which it has no control,
and the Company's business, financial condition, results of
operations and prospects may change in the future. The Company may
not update these forward-looking statements more frequently than
quarterly unless it has an obligation under U.S. Federal securities
laws to do so.
Biota is a registered trademark of Biota Pharmaceuticals,
Inc.
CONTACT: Joseph M. Patti, PhD
President and Chief Executive Officer of Biota
(678) 221-3352
j.patti@biotapharma.com
Sarah McCabe
Stern Investor Relations, Inc.
(212) 362-1200
sarah@sternir.com
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