Company Overview
| Company Name |
ANTHERA PHARMACEUTICALS INC |
| Company Address |
25801 INDUSTRIAL BOULEVARD, SUITE B
HAYWARD, CA 94545 |
| Company Phone |
(510) 856-5600 |
| Company Website |
www.anthera.com |
| CEO |
Paul F. Truex |
| Employees (as of 12/31/2011) |
38 |
| State of Inc |
DE |
| Fiscal Year End |
12/31 |
| Status |
Priced (7/20/2012) |
| Symbol |
ANTH |
| Exchange |
Nasdaq National Market |
| Share Price |
$1.00 |
| Shares Offered |
33,000,000 |
| Offer Amount |
$33,000,000.00 |
| Total Expenses |
$56,460.00 |
| Shares Over Alloted |
0 |
| Shareholder Shares Offered |
-- |
| Shares Outstanding |
74,074,419 |
| Lockup Period (days) |
180 |
| Lockup Expiration |
1/16/2013 |
| Quiet Period Expiration |
8/29/2012 |
| CIK |
0001316175 |
We estimate that the net proceeds of the sale of 33,000,000 shares of common
stock that we are offering will be approximately $30.8 million, or
approximately $35.5 million if the underwriters exercise their over-allotment
option in full, based on the public offering price of $1.00 per share and
after deducting underwriting discounts and commissions and estimated offering
expenses that we must pay.
We intend to use the net proceeds from this offering for general corporate
purposes. We may also use a portion of the net proceeds to acquire or invest
in complementary businesses, products and technologies. Although we have no
specific agreements, commitments or understandings with respect to any
acquisition, we evaluate acquisition opportunities and engage in related
discussions with other companies from time to time.
As of the date of this prospectus supplement, we cannot specify with
certainty all of the particular uses of the proceeds from this offering.
Accordingly, we will retain broad discretion over the use of such
proceeds.
Pending use of the proceeds as described above or otherwise, we intend to
invest the net proceeds in short-term interest-bearing, investment-grade
securities.
Our industry is highly competitive and subject to rapid and significant
technological change. Our potential competitors include large pharmaceutical
and biotechnology companies, specialty pharmaceutical and generic drug
companies, academic institutions, government agencies and research
institutions. We believe that key competitive factors that will affect the
development and commercial success of our product candidates are efficacy,
safety and tolerability profile, reliability, convenience of dosing, price
and reimbursement.
Many of our potential competitors, including many of the organizations
named below, have substantially greater financial, technical and human
resources than we do and significantly greater experience in the discovery
and development of product candidates, obtaining FDA and other regulatory
approvals of products and the commercialization of those products.
Accordingly, our competitors may be more successful than we may be in
obtaining FDA approval for drugs and achieving widespread market acceptance.
Our competitors' drugs may be more effective, or more effectively marketed
and sold, than any drug we may commercialize and may render our product
candidates obsolete or non-competitive before we can recover the expenses
of developing and commercializing any of our product candidates. We
anticipate that we will face intense and increasing competition as new
drugs enter the market and advanced technologies become available. Finally,
the development of new treatment methods for the diseases we are targeting
could render our drugs non-competitive or obsolete.
Company Description
We are a biopharmaceutical company focused on developing and commercializing
products to treat serious diseases associated with inflammation and autoimmune
diseases. We currently have one Phase 2 clinical program, blisibimod, which
targets elevated levels of B-cell activating factor, or BAFF,
which has been
associated with a variety of B-cell mediated autoimmune diseases, including
systemic lupus erythematosus, or lupus, lupus nephritis, vasculitis,
rheumatoid arthritis, idiopathic thrombocytopenia purpura, IgA nephropathy,
and others.
Blisibimod
Blisibimod (formerly referred to as A-623) is a peptibody antagonist of the
BAFF cytokine that is initially being developed as a treatment for systemic
lupus erythematosus, or lupus. BAFF, also known as BLyS, is a tumor necrosis
family member and is critical to the development, maintenance and survival
of B-cells. Although the cause of lupus is still not completely understood,
B-cell activation and autoantibody production are known to be central to the
process. Evidence has emerged that over-expression of BAFF plays an important
role in this disease process. In preclinical studies, transgenic mice created
to over-express BAFF begin to exhibit symptoms similar to lupus. In addition,
treatment of these same mice with BAFF antagonists appears to ameliorate the
disease.
We recently completed a Phase 2b clinical study with blisibimod for the
treatment of lupus in July 2010 called PEARL-SC. In June 2012 we announced
that initial results from the Phase 2b PEARL-SC study support the initiation
of a differentiated Phase 3 registration plan with a selected dose of
blisibimod in patients with severe systemic lupus erythematosus. In a
predefined Phase 3 target population of severely ill, seropositive lupus
patients, defined as those patients having a SELENA-SLEDAI score of greater
than ten, or SS ³ 10, and currently receiving background corticosteroid
medication, a more pronounced effect was seen in the 200mg weekly dose group
demonstrating a 13.8% treatment difference compared to placebo at 24 weeks.
In this subgroup, planned for Phase 3 studies, separation of clinical response
occurred as early as week eight and was sustained through week 44. The
pre-specified primary efficacy endpoint, clinical improvement at 24 weeks
in the SLE responder index for the pooled blisibimod dose groups versus
pooled placebo, was not met due to a lack of clinical efficacy in the 100mg
weekly and 200mg monthly dose groups. All doses of blisibimod demonstrated
consistent serological response including reductions of B-cells, ds-DNA and
improvements in complement.
In July 2012 we announced additional clinical data from the PEARL-SC clinical
study suggesting the potential for greater treatment effects for blisibimod
versus placebo in patients with a SS>10 and who achieved reductions of SS of
seven points, or SRI-7, and eight points, or SRI-8. We anticipate
discussing this new SRI-7 and SRI-8 data, and all other efficacy data, as a
basis for two phase 3 studies with the US FDA in the third quarter of 2012.
Blisibimod was safe and well-tolerated at all dose levels with no meaningful
imbalances in serious adverse events. We may also study blisibimod in other
B-cell mediated autoimmune diseases such as nephritis, IgA nephropathy,
vasculitis or idiopathic thrombocytopenia purpura. We are actively pursuing
various partnerships with major pharmaceutical and biotech companies to
develop and commercialize blisibimod for both lupus and additional
indications.
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We were incorporated in Delaware on September 9, 2004 as Anthera
Pharmaceuticals, Inc. Our corporate headquarters are located at 25801
Industrial Boulevard, Suite B, Hayward, California 94545 and our telephone
number is (510) 856-5600. Our website address is www.anthera.com.