Bradley Pharmaceuticals, Inc. has entered into an agreement with BioSante Pharmaceuticals to market BioSante's estradiol transdermal gel, Bio-E-Gel (estradiol), in the US. 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 through its Kenwood Therapeutics division and plans to introduce it in 2007, pending approval by the FDA.
The licensing of Bio-E-Gel 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, covers Bio-E-Gel and other gel formulations into 2017.
Bio-E-Gel 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 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 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 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 US 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 to our product portfolio. We believe, with FDA approval, Bio-E-Gel will offer significant advantages that will be clearly recognized by both prescribing physicians and their patients." Glassman further stated, "This product, along with the in-licensing agreement with MediGene AG for Polyphenon E Ointment, 15 per cent, 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 fulfil 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 in the US. 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."