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Starpharma Holdings Ltd Release: Vivagel®-Coated Condom Approved For Marketing In Japan


3/14/2014 9:23:26 AM

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Melbourne, Australia; 14 March 2014: Starpharma (ASX: SPL, OTCQX: SPHRY) today announced that regulatory certification has been granted for marketing Starpharma’s VivaGel®-coated condom in Japan, the world’s second largest condom market.

VivaGel® is licensed to Okamoto Industries (TSE: JP3192800005) as a condom coating for the Japanese market. Okamoto is the market leader for condoms sold in Japan and has held this position for many years. Under Starpharma’s commercial licence agreement with Okamoto, Okamoto has exclusive Japanese marketing rights for the VivaGel®-coated condom. VivaGel®-coated condoms sold by Okamoto will carry the VivaGel® brand and Starpharma will receive royalties based on sales of these condoms.

“This receipt of the world’s first marketing approval for a VivaGel®-coated condom in Japan marks a major milestone for this product and for our strategically important partnership with Okamoto. We greatly appreciate Okamoto’s support and assistance in achieving this certification and we look forward to a long and mutually profitable commercial relationship” said Starpharma CEO, Dr Jackie Fairley.

“Following this certification Starpharma looks forward to the introduction of its innovative, patented VivaGel®-coated condom to this key market in partnership with Okamoto, one of the world’s leading condom companies,” she added. Okamoto is Japan’s leading marketer of condoms with approximately 60% share of the Japanese condom market. The value of the Japanese condom market has been estimated to be in the order of US$500 million. Okamoto, based in Tokyo, has total revenues of more than US$740 million and over 1,500 employees. In addition to its dominant position in the Japanese condom market, Okamoto also holds strong market positions in several other Asian markets, including Korea, Taiwan, Malaysia, Singapore and China.

Okamoto’s senior managing director Mr. Seiji Takeuchi said in January this year that condoms with functional coatings and gels represent the next wave of innovation in the Japanese condom market following on from a decades-long focus on condom thinness.

Following this initial VivaGel®-coated condom certification, Mr Takeuchi said, “We are very pleased to be in a partnership with Starpharma for this product.”

Starpharma has a separate licensing agreement with Ansell Limited (ASX: ANN) which provides marketing rights to a VivaGel®-coated condom in countries outside Japan and the company looks forward to further regulatory approvals under that partnership.

VivaGel®
Starpharma’s VivaGel® active (SPL7013) has both antibacterial and antiviral properties and in laboratory studies has been shown to kill 99.9% of HIV, HPV (human papillomavirus) and HSV-2 (genital herpes virus). VivaGel® is also being separately developed as an applicator-delivered vaginal product for the management of bacterial vaginosis.

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 uses. Starpharma has three core development programs: VivaGel® portfolio, drug delivery, and agrochemicals with the Company developing a number of products internally and others via commercial partnerships.

Starpharma’s lead product is VivaGel® (SPL7013 Gel), a gel-based formulation of a proprietary dendrimer. VivaGel® is under clinical development for the treatment and prevention of bacterial vaginosis (BV). Starpharma has also signed separate licence agreements with Ansell Limited (ASX:ANN) and Okamoto Industries Inc (Tokyo Stock Exchange) to market a value-added, VivaGel®-coated condom. Ansell manufactures and sells leading condom brands worldwide, including Lifestyles®, ZERO® and SKYN®. Okamoto is the market leader for condoms sold in Japan, the world’s second largest condom market.

In the wider pharmaceutical and life science fields, Starpharma has both partnered and internal programs in Drug Delivery. Drug Delivery partners include GSK, Lilly and AstraZeneca. 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 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).

In agrochemicals Starpharma has a series of partnerships with leading industry players including Nufarm (ASX:NUF) and Makhteshim Agan as well as internal programs including an enhanced version of glyphosate (the active ingredient in Roundup®).

Media:
Buchan Consulting
Rebecca Wilson
Mob: +61 417 382 391
rwilson@buchanwe.com.au

Starpharma:
Dr Jackie Fairley, Chief Executive Officer
+61 3 8532 2704

Nigel Baade, CFO and Company Secretary
Investor.relations@starpharma.com
www.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.

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