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Starpharma : Additional US Patent Granted for VivaGel BV
10/13/2015 | 07:06pm US/Eastern
Microsoft Word - 151014 US BV Patent grant Final
Additional US Patent granted for VivaGel® BV
Melbourne, Australia; 14 October 2015: Starpharma (ASX: SPL, OTCQX: SPHRY) today announced the granting of a patent by the US Patent Office for VivaGel® related to the prevention of recurrence of bacterial vaginosis (BV). The patent's term is to 2032 providing an extension of seven years over granted VivaGel® patents. Additional term may also be available subject to timing of regulatory approval.
This US patent builds on the company's VivaGel® patent portfolio that underpins the VivaGel® BV products. The VivaGel® patent portfolio comprises granted patents in key markets, including in Europe where the product recently received marketing approval for the topical treatment and rapid relief of BV, including symptomatic relief of vaginal odour and discharge.
The current market for the management of BV and associated symptoms is estimated to be in excess of US$1 billion globally, with significant areas of unmet need for BV sufferers, especially women with recurrent BV.
Bacterial vaginosis is the most common vaginal infection worldwide affecting millions of women annually. It is associated with an increased risk of pre-term births, miscarriage, and transmission and acquisition of STIs, including genital herpes and HIV/AIDS.
Recurrence of BV has been estimated to occur in around 60% of women treated for BV, and there is currently no approved therapy available for prevention. As well as being an effective treatment for the relief of BV symptoms, ongoing use of VivaGel® BV was shown in a phase 2 clinical study to reduce recurrence of BV. A phase 3 clinical trial programme for VivaGel® BV for prevention of recurrent BV is progressing well in North America, Europe and Asia.
Discussions regarding commercial rights for VivaGel® BV are underway with a number of potential partners. This patent grant will extend the value of this product opportunity for both Starpharma and its partners.
Starpharma Chief Executive, Dr Jackie Fairley, commented: 'The grant of this new patent is confirmation of the innovation that VivaGel® brings to the bacterial vaginosis field. The patent is one of several in the VivaGel® portfolio and further enhances the commercial value of VivaGel® BV.'
Starpharma Holdings Limited (ASX:SPL, OTCQX:SPHRY), located in Melbourne Australia, is an ASX 300 company and is a world leader in the development of dendrimer products for pharmaceutical, life science and other applications.
Starpharma's underlying technology is built around dendrimers - a type of synthetic nanoscale polymer that is highly regular in size and structure and well suited to pharmaceutical and medical uses. Starpharma has three core development programs: VivaGel® portfolio, DEP™ drug delivery, and agrochemicals with the Company developing a number of products internally and others via commercial partnerships.
Starpharma's lead products are based on VivaGel® (SPL7013, astodrimer sodium), a proprietary dendrimer which has antimicrobial properties. VivaGel® formulated as a water based gel and delivered vaginally now has EU regulatory approval for topical treatment and rapid relief of bacterial vaginosis (BV) and is under clinical development for the prevention of recurrent
BV. Starpharma has also signed separate licence agreements with Ansell Limited (ASX:ANN) and Okamoto Industries. Inc., (TSE: JP3192800005) to market a value-added, VivaGel® condom. The VivaGel® condom is available for purchase in Australia under Ansell's Lifestyles® Dual ProtectTM brand. Ansell manufactures and sells leading condom brands worldwide, including LifeStyles®,
ZERO® and SKYN®. Okamoto is the market leader for condoms sold in Japan, which is the world's second largest condom market.
In the wider pharmaceutical field, Starpharma has both partnered and internal programs in Drug Delivery. A number of dendrimer- enhanced, or DEP® versions of existing drugs are under development. The most advanced of these is DEP® docetaxel, a dendrimer-enhanced version of docetaxel (Taxotere®), which is in clinical development in patients with solid tumours. In preclinical studies DEP® docetaxel has shown significant tumour-targeting and superior anti-cancer effects across a range of important cancer types including breast, prostate, lung and ovarian tumour, when compared to Taxotere® (docetaxel). AstraZeneca has signed a licensing agreement with Starpharma for the use of its DEP® drug delivery platform in the development and commercialisation of an AstraZeneca oncology compound, with potential for follow on compounds directed at a defined family of targets.
In agrochemicals Starpharma has a series of partnerships with leading industry players including global leader Adama (formerly Makhteshim Agan) as well as internal programs including an enhanced version of glyphosate (the active ingredient in Roundup®). For more information please visit: www.starpharma.com
Media: Buchan Consulting
Rebecca Wilson
Mob: +61 417 382 391
rwilson@buchanwe.com.au
Starpharma:
Dr Jackie Fairley, CEO
Nigel Baade, CFO and Company Secretary
+61 3 8532 2704
investor.relations@starpharma.com
Forward Looking Statements
This document contains certain forward-looking statements, relating to Starpharma's business, which can be identified by the use of forward-looking terminology such as 'promising', 'plans', 'anticipated', 'will', 'project', 'believe', 'forecast', 'expected', 'estimated', 'targeting', 'aiming', 'set to', 'potential', 'seeking to', 'goal', 'could provide', 'intends', 'is being developed', 'could be', 'on track', or similar expressions, or by express or implied discussions regarding potential filings or marketing approvals, or potential future sales of product candidates. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no assurance that any existing or future regulatory filings will satisfy the FDA's and other authorities' requirements regarding any one or more product candidates nor can there be any assurance that such product candidates will be approved by any authorities for sale in any market or that they will reach any particular level of sales. In particular, management's expectations regarding the approval and commercialization of the product candidates could be affected by, among other things, unexpected trial results, including additional analysis of existing data, and new data; unexpected regulatory actions or delays, or government regulation generally; our ability to obtain or maintain patent or other proprietary intellectual property protection; competition in general; government, industry, and general public pricing pressures; and additional factors that involve significant risks and uncertainties about our products, product candidates, financial results and business prospects. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described herein as anticipated, believed, estimated or expected. Starpharma is providing this information as of the date of this document and does not assume any obligation to update any forward-looking statements contained in this document as a result of new information, future events or developments or otherwise.
