Bradley Pharmaceuticals Enters Into Agreement With BioSante Pharmaceuticals for Estradiol Transdermal Gel
08 Novembre 2006 - 1:45PM
PR Newswire (US)
FAIRFIELD, N.J., Nov. 8 /PRNewswire-FirstCall/ -- Bradley
Pharmaceuticals, Inc. (NYSE:BDY) announced today that the Company
has entered into an agreement with BioSante Pharmaceuticals
(AMEX:BPA) to market BioSante's estradiol transdermal gel,
Bio-E-Gel(R)* (estradiol), in the United States. The US Food and
Drug Administration (FDA) accepted the New Drug Application for
review in April of this year and set the PDUFA date for
mid-December. Bradley Pharmaceuticals plans to market Bio-E-Gel(R)
through its Kenwood Therapeutics division and plans to introduce it
in 2007, pending approval by the FDA. The licensing of Bio-E-Gel(R)
represents another milestone in the execution of the Bradley's
strategic plan to increase shareholder value by expanding the
Company's product offerings, with particular attention to therapies
with intellectual property protection. An issued patent, plus
pending patents, cover Bio-E-Gel(R) and other gel formulations into
2017. Bio-E-Gel(R) is expected to be prescribed for the treatment
of moderate- to-severe hot flashes in menopausal women and is
expected to be available at three dosage levels. Bradley believes
this product offers the possibility of becoming an important
alternative to estrogen therapies currently on the market. Market
research data shows the estrogen therapy market to be approximately
$1.3 billion in the US, with the transdermal segment expected to
grow to more than $300 million over the next several years.
Bio-E-Gel(R) will compete most directly with patches and other gel
products in the transdermal segment of this market. In
consideration, Bradley paid BioSante and its licensor for
Bio-E-Gel(R) an aggregate of $3.5 million. In addition, Bradley
agreed to pay regulatory milestones between $10.0 million and $10.5
million, a royalty on net sales and sales-based milestones.
Bio-E-Gel(R) will be marketed to the OB/GYN physician community and
complements other products in the Kenwood portfolio promoted to the
same physician audience. There are approximately 14,000 OB/GYN
physicians in the United States who account for the majority of
prescriptions in the estrogen therapy market. Bradley President and
CEO, Daniel Glassman, stated, "Our Kenwood Therapeutics division
has been building a presence in the OB/GYN market for several
years. We are extremely pleased to be adding Bio-E-Gel(R) to our
product portfolio. We believe, with FDA approval, Bio-E-Gel(R) will
offer significant advantages that will be clearly recognized by
both prescribing physicians and their patients." Mr. Glassman
further stated, "This product, along with the in-licensing
agreement with MediGene AG for Polyphenon(R) E Ointment, 15%,
continues our plan for in-licensing Phase II and Phase III drugs
with long term-intellectual property protection, developing these
products and bringing to market brands that fill unmet needs. These
important actions continue to fulfill the promise that we set
forward in our initiatives to increase shareholder value." BioSante
President and CEO, Stephen M. Simes, stated, "We believe Bradley is
an excellent partner to market Bio-E-Gel(R) in the United States.
Their sales and marketing expertise and established relationships
with this physician audience will be invaluable in capturing a
share of the US estrogen therapy market. We look forward to a
successful launch in 2007." * Bio-E-Gel(R) is the current working
name of the product, but the product may be commercialized under a
new trade name. Please visit Bradley Pharmaceuticals web site at:
http://www.bradpharm.com/ Bradley Pharmaceuticals common stock is
listed on the NYSE under the symbol BDY. Bradley Pharmaceuticals,
Inc. was founded in 1985 as a specialty pharmaceutical company and
markets to niche physician specialties in the U.S. and 38
international markets. Bradley's success is based upon
strategically expanding from an Acquire, Enhance and Grow to an
In-License, Develop and Bring to Market business model: In-license
phase II and phase III drugs with long-term intellectual property
protection; Develop these products and submit completed clinical
studies to the FDA for NDA approvals and commercialization; Bring
to Market these patent-protected brands to fill unmet needs and
leverage Bradley's marketing and sales expertise to increase
shareholder value. Bradley Pharmaceuticals is comprised of Doak
Dermatologics, specializing in therapies for dermatology and
podiatry; Kenwood Therapeutics, providing gastroenterology, OB/GYN,
respiratory and other internal medicine brands; and A. Aarons,
which markets authorized generic versions of Doak and Kenwood
therapies. Important announcement: Bradley Pharmaceuticals will
present at the Pointe Capital Small Cap Ideas Institutional
Investor Conference, to be held at The Princeton Club of New York,
15 West 43rd Street, New York, NY, December 4, 2006, at 8:35 AM.
Bradley Pharmaceuticals will participate in a panel discussion at
the RBC Capital Markets 2006 Healthcare Conference, to be held at
The Westin New York at Times Square, New York, NY, December 13-14,
2006. Bradley Pharmaceuticals will present at the Wachovia
Securities Small and Mid-Cap Healthcare Conference, January 30,
2006, at 8:30 AM at the Langham Hotel in the Timberlay Room, Boston
MA. Bradley Pharmaceuticals will present at the Raymond James &
Associates 28th Annual Institutional Investors Conference, to be
held at the Hyatt Regency Grand Cypress in Orlando, FL, March 4-7,
2007. Safe Harbor for Forward-Looking Statements This release
contains "forward-looking statements" within the meaning of the
Private Securities Litigation Reform Act of 1995. Forward-looking
statements include statements that address activities, events or
developments that Bradley expects, believes or anticipates will or
may occur in the future, such as sales and earnings estimates,
other predictions of financial performance, timing of payments on
indebtedness, launches by Bradley of new products, market
acceptance of Bradley's products, timing and repurchases of shares
of common stock, and the achievement of initiatives to enhance
corporate governance and long-term shareholder value.
Forward-looking statements are based on Bradley's experience and
perception of current conditions, trends, expected future
developments and other factors it believes are appropriate under
the circumstances and are subject to numerous risks and
uncertainties, many of which are beyond Bradley's control. These
risks and uncertainties include Bradley's ability to: estimate
sales; comply with the restrictive covenants under its credit
facility; refinance its credit facility, if necessary; access the
capital markets on attractive terms or at all; favorably resolve
the pending SEC informal inquiry and file required financial
statements with the SEC in a timely manner; remediate its material
weaknesses in its internal controls; maintain sales of its
products; successfully acquire, develop, integrate, or sell new
products, including POLYPHENON(R) E Ointment and Bio-E-Gel (R)
(when and if approved by the FDA) and the products incorporating
the delivery systems to be developed by Polymer Science; or
effectively react to other risks and uncertainties described from
time to time in Bradley's SEC filings, such as fluctuation of
quarterly financial results, estimation of product returns,
chargebacks, rebates and allowances, concentration of customers,
reliance on third party manufacturers and suppliers, litigation or
other proceedings (including the pending class action and
shareholder derivative lawsuits), government regulation, stock
price volatility and ability to achieve strategic initiatives to
enhance long- term shareholder value. Further, Bradley cannot
accurately predict the impact on its business of the approval,
introduction, or expansion by competitors of generic or
therapeutically equivalent or comparable versions of Bradley's
products or of any other competing products. In addition, actual
results may differ materially from those projected. Bradley
undertakes no obligation to publicly update any forward-looking
statement, whether as a result of new information, future events or
otherwise. DATASOURCE: Bradley Pharmaceuticals, Inc. CONTACT:
Anthony Griffo, Investor Relations of Bradley Pharmaceuticals,
Inc., +1-973-882-1505, ext. 313 Web site: http://www.bradpharm.com/
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