Shareholder Update January 2019
In this issue:
>> FDA requests further data for VivaGel® BV approval in the US
>> Launch of VivaGel® BV in multiple territories
>> VivaGel® BV licensed to ITF Pharma in the US
>> VivaGel® condom approved in Japan
>> Clinical trials for internal DEP® products progressing well
>> Patent published for AstraZeneca-DEP® drugs: DEP® Bcl2/xL inhibitors show compelling efficacy & synergy in combination
>> DEP® docetaxel & DEP® cabazitaxel outperformed both gemcitabine & Abraxane®
>> SPL7013 eye drops for viral conjunctivitis
>> Partnering activities
>> Macquarie initiates coverage of Starpharma
>> Outlook
Download: Shareholder Update January 2019 (pdf file, 557kb)
VivaGel® condom receives final regulatory approval in Japan
Melbourne, Australia; 2 January 2019: Starpharma (ASX: SPL, OTCQX: SPHRY) today announced that the VivaGel® condom has received final regulatory approval and is now able to be marketed in Japan, following the completion of the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) review of the product’s medical device classification and associated data. This final approval follows on from the previously granted regulatory certification, which was attained for the VivaGel® condom.
US FDA requests further data for VivaGel® BV approval
Melbourne, Australia: Starpharma today received advice from the US FDA that it will require confirmatory clinical data prior to approving VivaGel® BV for treatment of bacterial vaginosis (BV) and the prevention of recurrent BV (rBV).
Starpharma’s $142M+ US license deal for VivaGel® BV featured in Proactive Investors
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Online investor portal Proactive Investors highlighted Starpharma’s VivaGel® BV US license deal with ITF Pharma, worth $142 million plus escalating double digit royalties. The piece noted ITF Pharma’s strong pedigree in women’s health and their high-calibre team. |
To read the article, click here.
Starpharma’s US license for VivaGel® BV covered by Biotech Dispatch
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Biotech Dispatch featured the news that Starpharma had signed a sales and marketing license agreement for VivaGel® BV for the US market with ITF Pharma. The piece highlighted that upon launch, VivalGel® BV will be ITF Pharma’s top priority women’s health product. |
To read the article, click here.
US VivaGel® BV licensed for A$142M milestones, plus royalties
Melbourne, Australia: Starpharma and ITF Pharma today announced they have signed a licence for the sales and marketing rights to VivaGel® BV in the United States. Starpharma will be eligible to receive up to US$101M (A$142M) in regulatory approval and commercialisation milestones in addition to attractive tiered royalties on sales.
US patent granted for SPL7013 eye drops for conjunctivitis
Melbourne, Australia: Starpharma (ASX: SPL, OTCQX: SPHRY) today announced that the US Patent and Trademark Office has granted a patent for SPL7013 ophthalmic drops for viral conjunctivitis. The patent has been granted with broad claims for treating and preventing microbial infections of the eye, including adenoviral conjunctivitis, bacterial conjunctivitis and other eye infections. The patent term is to 2033.
AGM - Chairman address and CEO presentation
Melbourne, Australia: Attached is the Chairman’s address together with the CEO’s presentation to the Annual General Meeting of Starpharma Holdings Limited (ASX: SPL, OTCQX: SPHRY), to be held at 3.00pm today.
DEP® docetaxel and DEP® cabazitaxel outperform in human pancreatic cancer model
Melbourne, Australia: Starpharma today announced that its proprietary DEP® docetaxel and DEP® cabazitaxel products, which are both currently in the clinic, showed significant efficacy and safety benefits over gemcitabine (Gemzar®) alone, Abraxane® (Nab-paclitaxel) alone and in combination, in a human pancreatic cancer model. These impressive efficacy results were despite the fact that these standard pancreatic cancer treatments, gemcitabine and/or Abraxane® showed limited activity in this model.
Quarterly Cashflow Report
Melbourne, Australia: Starpharma (ASX: SPL, OTCQX: SPHRY) today released its Appendix 4C – Quarterly Cashflow Report for the period ended 30 September 2018