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I agree that's why I took a starter position.
This is good news.
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.
A friend reviewed the different phases on research and patents that could make SPHRY pps much higher over the next few years.
Hello there. Nice to see a new face. I have high hopes for Starpharma. The information I've read is very encouraging.
Hello there. Nice to see a new face. I have high hopes for Starpharma. The information I've read is very encouraging.
A friend filled me in on the long term potential of SPHRY....Started with a small position and will be adding the remainder of 2015
Kinda quiet here
Starpharma Holdings Announces Update on VivaGel Condom Launch Timing in Japan
BY NewsBites
— 12:01 AM ET 12/05/2014
AUSTRALIAN COMPANY NEWS BITES
SOURCED FROM INFORMATION LODGED WITH THE AUSTRALIAN STOCK EXCHANGE
Starpharma Holdings (SPHRF) announced that the planned launch timing of the VivaGel condom in Japan would be delayed following a review of the specific category of medical device classification by the Japanese regulatory authorities. The regulatory status of the VivaGel condom in other regions where the product is approved for sale (Australia and NZ) or is undergoing regulatory review is not affected and does not rely upon the Japanese classification or approval process. Since receiving regulatory certification for the VivaGel condom in Japan earlier in 2014, Okamoto Industries has been actively undertaking launch preparations for the product with a view to launching the product shortly.
Source: Morningstar (MORN)
Starpharma Holdings Announces Marketing Clearance for VivaGel Condom in New Zealand
BY NewsBites
— 12:01 AM ET 11/28/2014
AUSTRALIAN COMPANY NEWS BITES
SOURCED FROM INFORMATION LODGED WITH THE AUSTRALIAN STOCK EXCHANGE
Starpharma Holdings (SPHRF) announced the completion of the regulatory requirements to allow for marketing of the VivaGel condom in New Zealand under the brand Lifestyles Dual Protect. The Company's commercial partner, Ansell (ANSLF), along with their New Zealand distributor, EBOS Group (EBOSF) plan to launch the Lifestyles Dual Protect condom in the New Year having obtained market clearance for New Zealand.
Source: Morningstar (MORN)
Starpharma Holdings Responds to ASX Price Query, No New Information
BY NewsBites
— 12:01 AM ET 11/17/2014
AUSTRALIAN COMPANY NEWS BITES
SOURCED FROM INFORMATION LODGED WITH THE AUSTRALIAN STOCK EXCHANGE
Starpharma Holdings (SPHRF) responded to an ASX share price query stating that it is not aware of any information which, if known, could be an explanation for the recent trading in its securities. The company confirmed that it is in compliance with the ASX listing rules. In relation to ASX's query regarding earnings, the Company has not provided earnings guidance for the 6 month period ending on 31 December 2014 and notes that, given the phase of development of the Company, it does not consider that a change in earnings would explain the recent trading and there has been no apparent relationship between the share price and the announced earnings. The Company has a strong cash position as previously announced and has recently released a number of positive announcements.
Source: Morningstar (MORN)
Starpharma Holdings to Launch VivaGel Condom
BY NewsBites
— 12:01 AM ET 10/02/2014
AUSTRALIAN COMPANY NEWS BITES
SOURCED FROM INFORMATION LODGED WITH THE AUSTRALIAN STOCK EXCHANGE
Starpharma Holdings (SPHRF) announced the inclusion of the VivaGel condom in the Australian Register of Therapeutic Goods, the final step ahead of market launch in Australia. The company's partner in innovating and bringing this product to market, Ansell (ANSLF) has made the necessary preparations, including manufacture of launch supplies, and will launch the VivaGel condom under the LifeStyles Dual Protect name in Australian retail outlets during October 2014.
Source: Morningstar (MORN)
Starpharma raising $23m for clinical programs
Starpharma (ASX:SPL) has raised $18 million, through a placement, to help fund the company’s clinical and commercialisation programs. The company plans to follow this up with an up-to $5 million share purchase plan at $0.65 per share. Part of the proceeds from the capital raising will be used to support the completion of phase III trials of Starpharma’s VivaGel for the prevention of recurrent bacterial vaginosis (BV), and regulatory and commercialisation activities for VivaGel for symptomatic relief of BV. Funds will also be used to help advance chemotherapeutic candidate DEP docetaxel from phase I into phase II trials, as well as to advance other development programs, the company said. Starpharma CEO Dr Jackie Fairley said the capital raising has attracted “strong interest” from the company’s existing institutional shareholders. “We also have welcomed several new local and international funds as shareholders in Starpharma for the first time,” she said. The company last month revealed that spending on its development programs had reduced its cash position to $24 million as of the end of FY14, from $33.8 million at the end of the prior financial year. Starpharma (ASX:SPL) shares were trading 6.34% lower at $0.665 as of around 2.30 pm on Monday.
Starpharma Holdings Trading Halted, Pending Company Announcement
BY NewsBites
— 12:01 AM ET 09/18/2014
AUSTRALIAN COMPANY NEWS BITES
SOURCED FROM INFORMATION LODGED WITH THE AUSTRALIAN STOCK EXCHANGE
The securities of Starpharma Holdings (SPHRF) will be placed in trading halt session state, at the request of the company, until the earlier of the commencement of normal trading on Monday, 22 September 2014 or when the announcement is released to the market.
Source: Morningstar (MORN)
Intriguing Biotech Stocks from Australia
http://www.equities.com/editors-desk/stocks/healthcare/intriguing-biotech-stocks-from-australia
Another company moving up the price charts is Starpharma Holdings Ltd. (SPL:ASX). It has a dendrimer-based delivery technology that delivers established chemotherapy drugs using a scaffold that makes them soluble, more efficacious and safer. Dendrimers are a very special type of spherical polymer that can be manufactured with a high degree of precision and consistency to have specific physical and chemical properties.
The company has terrific preclinical data. In relation to safety, Starpharma has shown, in animal models, that combining its scaffold with a well-known cancer drug such as docetaxel significantly reduces a side effect called neutropenia (diminished white blood cell count). Chemotherapy wipes out a lot of white blood cells, and this leaves patients highly susceptible to infections. A lot of cancer patients develop neutropenia while on chemotherapy, and many get infections and die as a result. But neutropenia is a short-term condition. It occurs within three days of the chemotherapy. The white blood cell count usually returns to normal in seven or eight days. However, for those seven or eight days, patients are very vulnerable, and preventing neutropenia will end up saving lives.
The Starpharma technology is currently in a Phase 1 dose escalation trial. It is starting to hit doses typically used in the clinic, at which point one would normally see a high level of neutropenia and hair loss. None of the patients in the trial so far have shown either. It is in very early days, but Starpharma is a very exciting company. There are a couple of companies in the U.S.— BIND Therapeutics Inc. (BIND) and Cerulean Pharma Inc. ($CERU) —trying to do the same type of thing. I have looked extensively at their results, and while they show positive data in terms of efficacy, as far as I can tell, they have not shown a major benefit in terms of reducing the devastating side effects of the chemotherapy.
- See more at: http://www.equities.com/editors-desk/stocks/healthcare/intriguing-biotech-stocks-from-australia#sthash.vrUH4CSZ.dpuf
Starpharma : CBCD Congratulates Starpharma (SPHRY) on the Development of Its Virus Killing Condom
08/18/2014 | 12:01am US/EasternRecommend:
0
Rochester, NY (PRWEB) August 18, 2014
"Infected with the genital herpes virus (HSV-2)? The CBCD recommends taking Novirin or Gene-Eden-VIR." - Greg Bennett, CBCD
The Center for the Biology of Chronic Disease (CBCD) congratulates Starpharma, an Australian biomedical company, on the development of "a condom coated with a special gel that has been able to deactivate as much as 99.9 percent of viruses in laboratory testing." (1) The antiviral gel is called VivaGel and is designed to deactivate or destroy HIV, the herpes virus and the human papillomavirus (HPV), and will be marketed in Australia under the brand name LifeStyles Dual Protect. (1) So far, the condoms are only approved by the Australian health authorities. The CBCD looks forward to seeing a reduction in HPV, HSV, and HIV diagnoses in the Australian public, and to the introduction of these condoms to the American market. However, the CBCD reminds the public that approval of these condoms for American markets by the FDA may take time. Until then, the CBCD recommends two natural, safe and effective, HSV-2 remedies that are backed by clinical studies.
Click to learn more about genital herpes symptoms.
The Center for the Biology of Chronic Disease (CBCD) recommends that people infected with the genital herpes virus (HSV-2) take Novirin or Gene-Eden-VIR. The formula of these natural antiviral products was tested by Hanan Polansky and Edan Itzkovitz from the CBCD in two clinical studies that followed FDA guidelines. The studies showed that the Novirin and Gene-Eden-VIR formula is effective against the herpes simplex virus, and other viruses. The clinical studies were published in the peer reviewed, medical journal Pharmacology & Pharmacy, the first, in a special edition on Advances in Antiviral Drugs. Study authors wrote that, "individuals infected with the HSV … reported a safe decrease in their symptoms following treatment with Gene-Eden-VIR." (2) The study authors also wrote that, "we observed a statistically significant decrease in the severity, duration, and frequency of symptoms." (2)
Both products can be ordered online on the Novirin and Gene-Eden-VIR websites.
Novirin and Gene-Eden-VIR are natural antiviral dietary supplements. Their formula contains five natural ingredients: Selenium, Camellia Sinesis Extract, Quercetin, Cinnamomum Extract, and Licorice Extract. The first ingredient is a trace element, and the other four are plant extracts. Each ingredient and its dose was chosen through a scientific approach. Scientists at polyDNA, the company that invented and patented the formula, scanned thousands of scientific and medical papers published in various medical and scientific journals, and identified the safest and most effective natural ingredients against latent viruses. To date, Novirin and Gene-Eden-VIR are the only natural antiviral products on the market with published clinical studies that support their claims.
Even though the new condoms from Starpharma are coated with an antiviral gel, the CBCD reminds the public that genital herpes can be transmitted even when using condoms. As the CDC notes on its website, while condom use can reduce the risk of herpes transmission, "outbreaks can occur in areas that are not covered by a condom." (See the CDC, last updated February 13, 2013) (3)
What current treatments are available for herpes infections?
"Two types of antiviral treatments against HSV are available: topical and oral. The treatments include penciclovir, acyclovir, famciclovir, and valaciclovir. However, their effectiveness is limited. For instance, a meta-analysis of five placebo-controlled and two dose comparison studies evaluated the effect of aciclovir, famciclovir or valaciclovir on symptoms. The meta-analysis showed that oral antiviral therapy decreases the duration and the associated pain of an outbreak by merely one day." (2). There are also natural antiviral products that studies show to be safe and effective in reducing herpes symptoms. Two of these products are Novirin and Gene-Eden-VIR.
"There are currently no FDA approved antiviral coated condoms against the genital herpes virus. Research shows that most drugs against HSV-2 only reduce outbreaks by one day. Thus, we recommend that infected individuals take Novirin or Gene-Eden-VIR, which are designed to help the immune system target the latent HSV-2." - Greg Bennett, CBCD
Interested individuals can view the two published studies on the Novirin and Gene-Eden-VIR formula here: http://www.scirp.org/journal/PaperInformation.aspx?PaperID=36101#.U-x7BeOSz90 and http://www.scirp.org/journal/PaperInformation.aspx?PaperID=44234.
To learn more about Novirin, visit http://www.novirin.com and about Gene-Eden-VIR, visit http://www.gene-eden-vir.com.
References:
(1) NYDailynews.com - Condoms armored with virus-killing lubricant will soon be available. Published July 24, 2014.
nydailynews.com/life-style/health/condoms-virus-killing-lube-article-1.1878467
(2) Polansky, H. Itzkovitz, E. Gene-Eden-VIR Is Antiviral: Results of a Post Marketing Clinical Study. Published in September 2013. http://www.scirp.org/journal/PaperInformation.aspx?PaperID=36101#.U-x7BeOSz90
(3) CDC.com - Genital Herpes - CDC Fact Sheet. Last updated on February 13, 2013.
cdc.gov/std/herpes/stdfact-herpes-detailed.htm
Read the full story at http://www.prweb.com/releases/2014/08/prweb12095579.htm
Global Contraceptives market will grow at 5.90% CAGR over the period 2013-2018.
Recently, pharmaceutical companies have introduced new products into their portfolios or diversified their contraceptive drugs and devices. This trend has been primarily supported by several prominent deals or partnerships to develop or introduce new products with better efficacy and safety profiles. These strategic decisions will help companies to generate revenue and acquire a significant share of the Global Contraceptives market.
Some of the major acquisitions in this space include Conceptus Inc. by Bayer, Warner Chilcott plc by Actavis, Uteron Pharma SA by Watson Pharmaceuticals Inc., and Barr Pharmaceuticals Inc. by Teva Pharmaceutical Industries. Some of the other prominent deals include Bayer and USAID partnering to make Microgynon, an oral contraceptive and Starpharma Holdings licensing agreement with Okamoto Industries Inc. for the VivaGel-coated condom.
http://www.live-pr.com/en/global-contraceptives-market-will-grow-r1050431385.htm
Starpharma To Launch Anti-Viral Condoms
Tech & Pharma
August 1, 2014
The first of its kind, the VivaGel® condom incorporates an antiviral compound to reduce the risk of exposure to viruses such as HIV, HSV and HPV
AsianScientist (Aug. 1, 2014) – Starpharma has received Conformity Assessment Certification for the VivaGel® condom by the Australian Therapeutic Goods Administration (TGA). This TGA certification is similar to CE certification of devices (CE Mark) in Europe.
Starpharma’s marketing partner, Ansell, plans to launch the VivaGel® condom under their brand LifeStyles Dual Protect™ in the coming months, following listing on the Australian Register of Therapeutic Goods.
The VivaGel® condom is the only condom of its type, providing barrier protection and incorporating a proprietary antiviral compound (VivaGel®) in the lubricant, which contains 0.5% astodrimer sodium. VivaGel® is intended to help reduce the risk of exposure to viruses that cause STIs, having been shown in laboratory studies to inactivate up to 99.9 percent of HIV (human immunodeficiency virus), HSV (herpes simplex virus) and HPV (human papillomavirus).
Extensive international consumer research conducted in condom users confirms a high level of consumer interest in the VivaGel® condom concept with more than 80 percent of participants surveyed rating the product as very interesting and more than 90 percent indicating they would buy it.
Starpharma has a licensing agreement that provides marketing rights to Ansell for the VivaGel® condom in countries outside of Japan. In Japan, Starpharma has licensed the product to Okamoto Industries, Inc. Okamoto is Japan’s leading marketer of condoms with approximately 60 percent of the Japanese condom market, the second largest global market next to the US.
The TGA Conformity Assessment Certification was achieved after examination by TGA of the evidence of conformity of the VivaGel® condom to the Essential Principles for medical devices, which set out the requirements relating to the safety and performance of products.
Achievement of this regulatory milestone for the VivaGel® condom follows Starpharma’s announcement in March 2014 of regulatory certification of the VivaGel® condom in Japan. Regulatory processes are ongoing in a number of other markets and this TGA approval will support some of these.
——–
Source: Starpharma; Photo: Victor/Flickr/CC.
Disclaimer: This article does not necessarily reflect the views of AsianScientist or its staff.
http://www.asianscientist.com/tech-pharma/starpharma-launch-anti-viral-condoms-2014/
Things are heating up!
http://atlanta.cbslocal.com/2014/07/22/hiv-killing-condom-could-launch-in-next-few-months/
PRESS RELEASE
July 14, 2014, 5:35 a.m. EDT
FDA Grants Special Protocol Assessment (SPA) Agreement for Starpharma Phase 3 Recurrent BV Trial
MELBOURNE, Australia, Jul 14, 2014 (BUSINESS WIRE) -- Starpharma Holdings Ltd (asx:SPL) (otcqx:SPHRY) today announced that the US Food and Drug Administration (FDA) has granted Special Protocol Assessment (SPA) agreement on the design and planned analyses of the phase 3 clinical studies of the VivaGel® bacterial vaginosis (BV) product for the prevention of recurrent BV.
The favourable SPA outcome provides a binding agreement from the FDA that the phase 3 clinical study design, endpoints, statistical analyses and other aspects of the planned studies adequately address objectives in support of a US regulatory submission for approval of the product.
The granting of SPA agreement by the FDA follows the earlier agreement of the European Medicines Agency (EMA) on the design of the phase 3 studies.
Starpharma will now commence its two pivotal phase 3 clinical trials of VivaGel® for the prevention of recurrent BV at sites in North America, Europe and Asia.
The two phase 3, double-blind, randomised, placebo-controlled trials will be identical in design and will compare the rate of BV recurrence in women using VivaGel® to the rate of recurrence in women using a placebo gel during a 16 week treatment period. Approximately 600 women will be recruited into each study.
Starpharma Chief Executive Officer, Dr Jackie Fairley, said: “Receiving agreement on the SPA is an important and very positive development as it effectively eliminates the US regulatory risk associated with clinical development, by specifying upfront the FDA’s agreed trial design. This significantly reduces overall development risk for VivaGel®. SPA agreement from the FDA is protected by US law and gives Starpharma certainty and confidence that the studies will support a regulatory submission for the approval of VivaGel® for the prevention of recurrent BV in the US.”
VivaGel® (SPL7013, astodrimer sodium) is a non-antibiotic agent formulated as a vaginally applied gel for prevention of BV recurrence. It is also being developed for the management of BV symptoms, which include unpleasant vaginal odour and discharge, and regulatory submissions to support the symptomatic relief indication are also planned for 2HCY14.
There are no approved products for the prevention of recurrent BV and so VivaGel® will be a world-first therapy for this troublesome condition. Bacterial vaginosis affects around 1 in 3 women and recurs in approximately 50 per cent of women within 12 months.
In the previous exploratory phase 2 clinical trial, more than 80 per cent of women receiving 1% VivaGel® remained BV-free at 16 weeks and the product also provided protection against the occurrence of BV symptoms. Formal market research with both patients and clinicians and from Key Opinion Leaders strongly supports the demand for a product such as VivaGel® in the management of BV.
About BV
Bacterial vaginosis is the most common cause of vaginal infection for women of childbearing age affecting around 30% of women in the US. It is a highly recurrent condition with 50-60% of sufferers having it recurrently. Bacterial vaginosis is caused by an imbalance of naturally occurring bacterial flora (the usual bacteria found in a woman's vagina). Smoking and the use of some hygiene products are linked to a higher risk of developing BV.
BV results in unpleasant and embarrassing symptoms such as odour and vaginal discharge. It has been linked to still birth, pregnancy complications, pelvic inflammatory disease, and lower rates of fertility. It also is associated with increased susceptibility of women to HIV and other STIs, and an increased risk of transmission of HIV from women to men.
SOURCE: Starpharma Holdings Ltd
Buchan Consulting
Rebecca Wilson, +61 417 382 391
rwilson@buchanwe.com.au
or
Starpharma
Dr Jackie Fairley, +61 3 8532 2704
Chief Executive Officer
Nigel Baade
CFO and Company Secretary
Investor.relations@starpharma.com
www.starpharma.com
Copyright Business Wire 2014
Starpharma: VivaGel Condom Receives TGA Device Certification - Launch Preparations to Follow
Starpharma (SPL.AX) (SPHRY) today announced achievement of a major milestone with the receipt of Conformity Assessment Certification for the VivaGel® condom by the Australian Therapeutic Goods Administration (TGA). This TGA certification is similar to CE certification of devices (CE Mark) in Europe.
Starpharma’s marketing partner, Ansell (ANN.AX) plans to launch the VivaGel® condom under their brand, LifeStyles Dual Protect™, in the coming months, following listing on the Australian Register of Therapeutic Goods (ARTG). TGA certification will also support certain regulatory processes in other markets.
The VivaGel® condom is a world-first product based on innovative Australian technology. It is the only condom of its type, providing barrier protection and incorporating a proprietary antiviral compound (VivaGel®) in the lubricant.
LifeStyles Dual Protect™ condoms to be marketed by Ansell will carry the VivaGel® brand and Starpharma will receive royalties based on sales.
Ansell President & General Manager, Sexual Wellness Global Business Unit, Peter Carroll, said:
“Ansell looks forward to rolling out its marketing and sales campaign to support the launch of LifeStyles Dual Protect™ over the coming months with the first product expected to be available on shelves soon.
“Our partnership with Starpharma is a great example of two highly innovative Australian businesses working together to bring to market a ground-breaking new sexual health product. New product development is central to Ansell’s business strategy and this highly innovative product is exciting for both companies.”
Ansell is a global leader in protection solutions, manufacturing and marketing condoms across the world and ranked number two globally. In Australia, Ansell’s share of the condom market is around 70%. The global branded condom market is estimated to be worth approximately $1.1 billion.
So glad I stumbled on to this company. In addition to their HIV killing condom, they work with AstraZeneca on Cancer treatments.
Oncology agreement with AstraZeneca expanded A second, expanded agreement with AstraZeneca in the field of
cancer medicine using Starpharma’s proprietary DEP™
technology is a strong validation of the interest in the Company’s
drug delivery technology. The agreement follows an earlier
agreement with AstraZeneca to access Starpharma’s delivery
technology. The new agreement will see the application of
Starpharma’s technology to a cancer drug, from AstraZeneca’s
pipeline.
“As a leading discovery-led company this alliance represents
an exciting collaboration with an Australian-based company to
combine the oncology treatments of tomorrow that AstraZeneca is
developing using innovative delivery mechanisms,” said Mark
Fladrich, Managing Director, AstraZeneca Australia.
Under the new agreement, AstraZeneca will provide funding
for a pre-clinical stage cancer research program to be
conducted jointly.
http://www.starpharma.com/assets/asxannouncements/140612_Shareholder_Update_JUNE_1.pdf
Starpharma’s dendrimer a potential viral conjunctivitis treatment
https://www.otciq.com/otciq/ajax/showFinancialReportById?id=104259
Melbourne Australia; 24 April 2013 - Starpharma Holdings Ltd (ASX: SPL; OTCQX:
(excerpt)
SPHRY) today released its Appendix 4C – Quarterly Cashflow report for the period ended 31 March 2013.
The cash balance at 31 March was $35.9 million following the receipt of a $5.4 million R&D tax incentive refund. This represents a net increase of $2.7 million on the previous quarter.
https://www.otciq.com/otciq/ajax/showFinancialReportById.pdf?id=103015
Dendrimers improve anticancer efficacy in lung metastasis model
Melbourne Australia; 4 March 2013 – Starpharma Holdings Ltd (ASX:SPL;OTCQX:
SPHRY) today announced the results of an animal study which shows that a dendrimerbased formulation of doxorubicin was substantially more efficacious in treating secondary tumours of breast cancer (metastases) in lungs than the drug alone.
The study involved a dendrimer formulation of the widely used cancer drug doxorubicin delivered via intra-tracheal administration, and was substantially more efficacious than doxorubicin alone in treating lung metastases of breast cancer.
The study was conducted as part of an ARC (Australian Research Council) funded collaboration with Monash Institute of Pharmaceutical Sciences (MIPS). It utilised a rat model which uses lung-resident secondary tumours (or metastases) derived from breast cancer cells. Lung metastases are particularly difficult to treat with conventional chemotherapeutic drugs, leading to a mortality rate of approximately 85% within 5 years, and existing treatments may often be considered palliative in nature. Commonly used treatments include doxorubicin, either alone or in combination with other agents.
In addition to the improvement in efficacy, the study also found that the dendrimerdoxorubicin formulation tended to remain in the lungs rather than passing into the body of the animal. This distribution pattern also creates the potential for reduced side effects, which are a significant problem with many cancer drugs, including doxorubicin.
Dr Jackie Fairley said: “The combination of Starpharma’s dendrimers, an existing cancer drug and direct lung administration appears to yield a substantially more efficacious agent for treating lung metastases than the drug alone. Given the clinical management of lung metastases is an area of significant medical need, and current drugs often provide poor results, this finding has the potential to create a valuable and important application for Starpharma’s proprietary dendrimer formulations.”
Starpharma has recently filed a new patent based on these results as a precursor to further discussions with commercial partners.
Results and Methods
This rat lung metastasis model is intended to replicate the situation in humans in which breast cancer cells separate from the primary breast tumour and “metastasize” or spread, seeding new tumours to multiple points throughout a lung.
Figure 1 shows results from the study in which rats with lung-resident tumours derived from breast cancer cells were treated with either saline (left panel), intravenous doxorubicin (centre panel), or intra-tracheal dendrimer-doxorubicin (right panel). [Note: results from intratracheal delivery of doxorubicin alone could not be generated as this route of administration proved too toxic for the drug in the absence of dendrimer.]Saline Control Intravenous doxorubicin (no dendrimer)Intratracheal (IT) dendrimerdoxorubicinFigure 1 – Rat Lungs: Bioluminescent Images and Gross Pathology The figure shows both the gross appearance of the rat lungs and bioluminescent images of the chest at the end of the experiment (day 18-21).
The degree of luminescence indicates the extent of tumour tissue within the rat’s lungs (top), and a photograph of the exterior of the lungs (bottom) is also shown. As can be seen by both gross appearance of the lungs and the bioluminescent images, the extent of lung metastases was greatly reduced in the intra-tracheal dendrimer-doxorubicin group compared with other treatment groups (intravenous doxorubicin and a saline control).
To conduct the study, rats were dosed with breast cancer cells by tail vein injection (Day 0). These tumour cells had been transfected with the luciferase gene allowing imaging of resultant tumours by a technique known as bioluminescent imaging. Following administration, breast cancer cells migrated to the lungs, lodged there and began to replicate, initially without treatment. From Day 7 different treatment formulations were administered to the rats twice a week for two weeks. At the end of the experiment (day 18-21, depending on the extent of tumour growth) all rats were sacrificed and an assessment Degree of luminescence indicates the extent of tumour tissue within the rat’s lungPage 2 of 4was made of their lung pathology and degree of metastasis using both visual inspection of the gross pathology and bioluminescent imaging.
Work is now underway to further explore these findings, including examination of the effect of dosage in metastatic models and the testing of other dendrimer drug combinations. Starpharma is also investigating potential explanations for this finding including the observation that its dendrimer nanoparticles appear to be selectively concentrated in tumour tissue and within the lymphatic system - which plays an important role in tumour spread.
The work was conducted as part of an on-going collaboration between Starpharma and Professor Chris Porter, Dr Lisa Kaminskas, and their colleagues at MIPS. The collaboration is funded through the ARC linkage scheme and is exploring a range of novel applications of dendrimers as drug delivery systems. Data generated under this program also supports Starpharma’s in-house oncology program including its proprietary dendrimer-docetaxel formulation being developed for intravascular use and due to enter the clinic later this year.
Starpharma’s internal oncology program sits alongside a number of partnered drug delivery programs (including for a range of indications with Lilly, GSK and AstraZeneca), and Starpharma’s development programs and commercial relationships based on VivaGel®in BV (bacterial vaginosis) and as a condom coating (licensed to Ansell and Okamoto)
Starpharma presenting at Bell Potter LifeScience Conference
https://www.otciq.com/otciq/ajax/showFinancialReportById.pdf?id=93602
Starpharma’s new formulations demonstrate
further improvement in crop protection
New dendrimer-glyphosate formulations demonstrate improved efficacy and rain-fastness
Higher loading formulations and soil penetration achieved
Dendrimers applicable to a wide range of agrochemical products
Melbourne, Australia; 30 October 2012: Starpharma Holdings Ltd (ASX:SPL;OTCQX: SPHRY) today announced that its new agrochemical dendrimer formulations have shown further improved features compared to commercially available products. Starpharma has conducted a whole range of new studies in its internal agrochemical program including with its lead program, an enhanced reformulation of the best-selling herbicide glyphosate (marketed under a variety of trade names including Roundup®.
The new dendrimer glyphosate reformulations have confirmed previously reported higher efficacy than existing marketed glyphosate formulations. The significance of these new results is in the potential to further broaden the conditions under which the Starpharma glyphosate formulation is effective, such as in adverse environments.
In addition to the improved efficacy referred to above, Starpharma has also recently shownits formulations to be more rain-fast compared to glyphosate formulations without dendrimer. Starpharma’s dendrimer formulations demonstrated up to a 150%-250% improvement in efficacy when rain was applied four hours after treatment with the test formulations. Glyphosate has global sales of approximately US$5 billion annually and as an off-patent chemical represents the largest opportunity for an enhanced formulation in the US$44 billion* agrochemical market.
“In addition to improving major products such as glyphosate, there are crop protection products with sales of more than $5 billion which will come off patent in the next 4-5 years. This creates a significant commercial opportunity for Starpharma’s dendrimers to deliver improved, proprietary formulations to this large and growing market,” said Dr Jackie Fairley, Chief Executive Officer.
Other recent formulation activities at Starpharma have been targeted at improving the loading of commercially important crop protection products. Using formulations that include dendrimers, Starpharma has increased the loading of one important herbicide by 50% more than formulations currently available in the market. High loading formulations generally have Page 2 of 3an improved cost of goods by reducing transport and handling costs and are sought after by both farmers and crop protection companies.
Soil penetration is also important for the performance of some crop protection products to ensure that they reach their targets. In laboratory studies using imidacloprid, a US$1BN product, Starpharma has shown that its dendrimers can tailor how this important insecticide moves by either increasing or decreasing percolation through a substrate. Common uses of imidacloprid include termite control and the control of other soil inhabiting insects.
In addition to its internal programs Starpharma continues to advance existing agrochemical partnerships, and in August announced a new Crop Protection Agreement with Nufarm. Nufarm is one of the world’s leading crop protection companies with sales in excess of A$2billion. Starpharma’s agrochemicals program has been assisted by funding under the Victorian Government’s Small Technology Industries Uptake Program (STIUP), and research is also ongoing in partnership with a number of global agrochemical companies.
*CropLife US, Phillips McDougal data
https://www.otciq.com/otciq/ajax/showFinancialReportById.pdf?id=93402
Nice position!
Sorry, I didn't know anyone was interested.
Starpharma Holdings Limited : Starpharma's VivaGel Phase 3 trials 60% enrolled
http://www.4-traders.com/STARPHARMA-HOLDINGS-LIMIT-8864716/news/Starpharma-Holdings-Limited-Starpharma-s-VivaGel-Phase-3-trials-60-enrolled-14354837/
Starpharma closer to VivaGel approval in Europe and US
The terms of Starpharma's (ASX:SPL) phase III trial for its VivaGel bacterial vaginosis treatment have now been endorsed by both the European EMA and the US FDA.
Dylan Bushell-Embling (Australian Life Scientist)23 November, 2011 12:15Comments
Starpharma (ASX:SPL) has gained the support of the European Medicines Agency for its phase III trials for its VivaGel bacterial vaginosis treatment.
The EMA has accepted the terms of Starpharma's proposed phase III trial of the VivaGel treatment, indicating that positive results would lead to the product being cleared for sale in the major market.
The US FDA agreed to the clinical trial program in October indicating that, pending successful trial results, VivaGel is on the road to approval in the world's two biggest pharmaceutical markets.
Melbourne-headquartered Starpharma plans to conduct two sets of placebo-controlled phase III trials in parallel from early next year. Around 220 patients will be involved, with the primary goal being clinical cure of bacterial vaginosis symptoms.
The company secured funding for the trials through an oversubscribed $32 million institutional placement, which closed last week. Around $16 million of this will be put towards the trials.
Starpharma CEO Jackie Fairley said that in light of the capital raising, the company plans to add more trial sites than originally planned. After the phase III trials are completed, the company plans to seek partners for the product.
The company already has a prospective agreement with Ansell to develop a VivaGel-coated condom, to take advantage of another potential use for the vaginal microbicide as an inhibitor of the transmission of STIs including HIV and genital herpes
The condom product is expected to launch within 18 months. Startpharma has advised it expects royalties from this product to be worth over $100 million. The company has a similar agreement with Okamoto.
Starpharma (ASX:SPL) shares rose 1.77% on Tuesday to $1.150, in high-volume trading relative to recent weeks.
Starpharma Holdings Limited : Cleansing Statement
Notice under section 708A(5)(e) of the Corporations Act 2001 Melbourne, Australia; 21 November 2011:
Starpharma Holdings Limited (ASX:SPL, OTCQX:SPHRY) (Starpharma) is pleased to announce that it has issued 29,767,442 fully paid ordinary shares (Shares) to institutional, sophisticated and professional investors in accordance with the private placement announced to ASX on 16 November 2011.
Starpharma gives notice under section 708A(5)(e) of the Corporations Act 2001 (Cth) (Corporations Act) that:
• Starpharma issued the Shares without disclosure to investors under Part 6D.2 of the
Corporations Act.
• As at the date of this notice, Starpharma has complied with:
o the provisions of Chapter 2M of the Corporations Act as they apply to Starpharma;
and
o section 674 of the Corporations Act.
• As at the date of this notice, there is no information that is "excluded information" within the meaning of sections 708A(7) and 708A(8) of the Corporations Act.
Ben Rogers
Company Secretary
Starpharma Holdings Limited (ASX:SPL, OTCQX:SPHRY) is a world leader in the development of
dendrimer technology for pharmaceutical, life-science and other applications. SPL has two operating companies, Starpharma Pty Ltd in Melbourne, Australia and DNT, Inc in the USA. Products based on
SPL's
dendrimer technology are already
on the market in the form of diagnostic elements and
laboratory reagents through licence arrangements with partners including Siemens and Merck KGaA.
The Company's lead pharmaceutical development product is VivaGel® (SPL7013 Gel), a vaginal microbicide designed to prevent the transmission of STIs, including HIV, genital herpes and bacterial vaginosis. Starpharma has a licence agreement with Ansell Limited to develop a VivaGel®-coated condom, and a licence agreement with Okamoto Industries Inc in relation to the VivaGel®-coated condom for the Japanese market. Okamoto is the market leader for condoms sold in Japan, the world's second largest condom market.
Starpharma also has agreements in place with Lilly, Elanco, Stiefel Laboratories (a GSK Company), and Siemens Healthcare as well as many research collaborations with some of the world's leading organisations in the fields of pharmaceuticals, drug delivery, cosmetics and agrochemicals.
A dendrimer is a type of precisely-defined, branched nanoparticle. the medical, electronics, chemicals and materials industries.
Dendrimers have applications in
American Depositary Receipts (ADRs): Starpharma's ADRs trade under the code SPHRY (CUSIP number
855563102). Each Starpharma ADR is equivalent to 10 ordinary shares of Starpharma as traded on the Australian Securities Exchange (ASX). Starpharma's ADRs are listed on International OTCQX, a premium market tier in the U.S. for international exchange-listed companies.
Media: Buchan Consulting
Rebecca Wilson
Mob: +61 417 382 391
rwilson@buchanwe.com.au
Starpharma and the FDA in agreement on BV treament phase 3
http://dev.starpharma.com/assets/asxannouncements/111010_SecuresFDA_agr_BV_tmt_Ph3.pdf
Starpharma Commences Bacterial Vaginosis Prevention Study of VivaGel(R)
MELBOURNE, Australia, Aug. 15, 2011 /PRNewswire-Asia/ -- Starpharma Holdings Limited (ASX: SPL, OTCQX: SPHRY) today announced the commencement of its Phase 2 study of VivaGel® for the prevention of bacterial vaginosis (BV), following receipt of ethics approval.
The prevention of BV is the second area of investigation of the VivaGel® product for this condition. In May 2011, Starpharma announced the positive results of its first study of VivaGel® for the treatment of BV, which showed that the product successfully treated patients suffering the illness, with very high levels of patient acceptability. Further discussions with the US Food and Drug Administration (FDA) and other regulators on the development of VivaGel® for the treatment of BV will occur over the next few months, with Phase 3 studies for BV treatment expected to commence in late 2011 or early 2012.
This new phase of the program will investigate the ability of VivaGel® to prevent recurrence of BV, which clinicians identify as a major unmet need. The trial will be conducted in women with a prior history of recurrent BV, and the product will be used every second day.
The study will be conducted under an investigational new drug application (IND) at sites in US and will enroll approximately 200 women. Clinical trial sites have been fully assessed, and the first patient is expected to be enrolled later this month, following final initiation of sites. The primary objective of the study is to determine the efficacy of two strengths of VivaGel® (1% and 3%) compared with a placebo gel in preventing recurrence of BV. Whilst the duration of use of the product in this study is 16 weeks, it is intended that women would use the product as a long-term prevention tool if proven effective.
The global market for topical BV treatments alone is estimated at approximately US$350M. Starpharma's modeling suggests the addressable global market for prevention of recurrence of BV is potentially in excess of $1 billion, due to the long term usage associated with such a product.
Dr Jackie Fairley, Chief Executive Officer of Starpharma, said:
"There are currently very few proven options for women who wish to prevent recurrence of BV. Clinical experts in this field have repeatedly expressed the need for products to prevent the recurrence of this condition and so the commencement of this program is an important step in the development of VivaGel® and the management of the condition."
"In addition to the obvious unmet market need for the recurrence indication, we were very encouraged by the results obtained in our Phase 2 BV treatment trial of VivaGel® reported in May, and the implications of these results for recurrence. These included high rates of cure and rapid resolution of symptoms together with excellent patient acceptability," she said.
BV is caused by a disruption to the delicate balance of the vaginal bacteria, so that the bacteria that help maintain a normal healthy vagina are reduced and harmful bacteria overgrow. The symptoms of BV include vaginal irritation, discharge and odour that are unpleasant and disrupt and interfere with a woman's relationships and general quality of life. Relapse, or recurrence, of BV is extremely common following treatment with existing antibiotics, and long-term use of these existing products is not recommended.
BV is associated with serious health consequences such as pelvic inflammatory disease and pre-term births. Several studies have also found an association between BV and acquisition of HIV, with one study indicating that more than 30% of HIV infections in women could be prevented if BV was successfully treated. In addition, a recent study showed men were three times more likely to contract HIV from their female partners if the women also had BV in the three months before the men became infected.
VivaGel® is also being developed as a topical microbicide for the prevention of HIV and genital herpes and as a condom coating. Prevention of human papillomavirus is also under assessment.
A copy of the Clinical Trial Summary is attached as Appendix A.
ABOUT STARPHARMA
Starpharma Holdings Limited (ASX:SPL, OTCQX:SPHRY) is a world leader in the development of dendrimer technology for pharmaceutical, life-science and other applications. SPL has two operating companies, Starpharma Pty Ltd in Melbourne, Australia and DNT, Inc in the USA. Products based on SPL's dendrimer technology are already on the market in the form of diagnostic elements and laboratory reagents through licence arrangements with partners including Siemens and Merck KGaA.
The Company's lead pharmaceutical development product is VivaGel® (SPL7013 Gel), a vaginal microbicide designed to prevent the transmission of STIs, including HIV, genital herpes and bacterial vaginosis. Starpharma has a licence agreement with Durex® condom manufacturer Reckitt Benckiser to develop a VivaGel® -coated condom, and a licence agreement with Okamoto Industries Inc in relation to the VivaGel® -coated condom for the Japanese market. Okamoto is the market leader for condoms sold in Japan, the world's second largest condom market.
Starpharma also has agreements in place with Lilly, Elanco, Stiefel Laboratories (a GSK Company), and Siemens Healthcare as well as many research collaborations with some of the world's leading organisations in the fields of pharmaceuticals, drug delivery, cosmetics and agrochemicals.
Dendrimer: A type of precisely-defined, branched nanoparticle. Dendrimers have applications in the medical, electronics, chemicals and materials industries.
American Depositary Receipts (ADRs): Starpharma's ADRs trade under the code SPHRY (CUSIP number 855563102). Each Starpharma ADR is equivalent to 10 ordinary shares of Starpharma as traded on the Australian Securities Exchange (ASX). Starpharma's ADRs are listed on International OTCQX, a premium market tier in the U.S. for international exchange-listed companies, operated by OTC Markets Group Inc. (www.otcmarkets.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 health authorities' requirements regarding any one or more product candidates nor can there be any assurance that such product candidates will be approved by any health 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 clinical trial results, including additional analysis of existing clinical data, and new clinical 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.
APPENDIX A – CLINICAL TRIAL SUMMARY
Official Title:
A double-blind, multicenter, randomized, placebo-controlled, dose-ranging study to determine the efficacy and safety of SPL7013 Gel (VivaGel®) administered vaginally to prevent the recurrence of bacterial vaginosis
Identifying Codes:
Starpharma Protocol Number: SPL7013-014
Primary Objective:
To assess the efficacy of 1% and 3% SPL7013 Gel, used every second day for 16 weeks, in reducing the rate of recurrence of bacterial vaginosis (BV) in subjects with a history of recurrent BV
Primary Endpoint:
The recurrence of BV by or at the End of Treatment visit (Week 16)
Secondary Objectives:
To determine the safety and tolerability of 1% and 3% SPL7013 Gel used every second day for 16 weeks
To assess the acceptability of treatment with 1% and 3% SPL7013 Gel
To characterize the distribution of times to recurrence of BV in subjects with a history of recurrent BV when treated with SPL7013 Gel every second day for 16 weeks (vs. placebo)
Study Design:
Randomized, double-blind, multicenter, placebo-controlled, dose-ranging study of women with active BV and a history of recurrent BV. Recurrent BV is defined as a history of at least 3 episodes of BV in the past 12 months, including the current episode. The current diagnosis of BV is defined by the presence of at least 3 of the 4 Amsel criteria and subject-reported symptoms consistent with BV.
After receiving metronidazole for 7 days, eligible subjects will be randomized to receive 1% SPL7013 Gel, 3% SPL7013 Gel, or placebo gel every second day for 16 weeks followed by an 8-week follow-up period.
Sites:
The study will be conducted at sites in the US
Key Inclusion Criteria:
female, aged 18–45 years
history of recurrent BV, defined as at least 3 documented episodes in the previous 12 months (including the current episode) as indicated by subject's medical history and/or record of a prescription of medication to treat an episode of BV
current diagnosis of BV (ie, subject-reported symptoms consistent with BV (any vaginal discharge considered by the subject to be abnormal, and/or unpleasant vaginal odor) and at least 3 of 4 Amsel criteria)
non-pregnant
otherwise healthy, as determined by medical history
normal Pap smear at or documented within 24 months of screening
FOR FURTHER INFORMATION
Media:
Buchan Consulting
Rebecca Wilson
Mob: +61-417-382-391
rwilson@bcg.com.au
Starpharma:
Dr Jackie Fairley
Chief Executive Officer
+61-3-8532-2704
Ben Rogers
Company Secretary
+61-3-8532-2702
Ben.rogers@starpharma.com
SOURCE Starpharma Holdings Limited
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RELATED LINKS
www.otcmarkets.com
http://www.prnewswire.com/news-releases/starpharma-commences-bacterial-vaginosis-prevention-study-of-vivagelr-127724238.html
more good news as Starpharma is now working with Monsanto and their Roundup product.
PLUS Starpharma will this year start to get royalties from the Durex contracts. Said to be worth $35 Million
PLUS look at the big players now for SPL
UNILEVER
MONSANTO
Reckitt Benckiser that makes Durex condoms, scholl, Clearasil, Strepsils cough drops, Mucinex decongestant and Veet hair remover.
Siemens
Merck KGaA
Okamoto Industries in Japan
Lilly
Elanco
Stiefel Laboratories (a GSK Company)
PLUS a dozen more we dont even know about
I hold the stock and I bought more today on the slight dip
When USA Canada wake up tomorrow they will buy more
Starpharma brings its novel technology to leading cancer treatment
Starpharma (ASX:SPL) is conducting pre-clinical studies on popular chemotherapy treatment, docaetaxel, reformulated using the company’s dendrimer technology.
Tim Dean (Australian Life Scientist)29 June, 2011 13:14
Chemotherapy drugs are big business, and Melbourne-based Starpharma is looking to get involved by applying its dendrimer technology to reformulate and improve leading therapies.
The company announced today that it will be taking its dendrimer-based reformulation of the widely used docataxel into further pre-clinical studies as a lead candidate in its cancer drug delivery programme.
Docataxel is used to treat breast cancer, lung cancer and prostate cancer, and generated sales of €2.122 billion ($2.9 billion) last year.
Read our in-depth profile of Starpharma[1].
According to Starpharma, the dendrimer formulation of docataxel showed a 2000 to 8000-fold improvement in water solubility, which opens up the possibility of an improved formulation that doesn’t have the same pre-medication requirements and potential side-effects of the conventional formulation.
Greater water solubility has already been shown to improve other anti-cancer drugs, such as paclitaxel, which was reformulated by American nano-pharmaceutical developer Abraxis. In turn, Abraxis was acquired by Celegene for US$2.9 billion.
“The success seen with Abraxane highlights the significant commercial opportunity of reformulated proprietary chemotherapy agents which can result in improved patient outcomes, significant product sales and extended commercial life through new intellectual property filings,” said Starpharma CEO Dr Jackie Fairley.
“We believe a proprietary docetaxel-dendrimer formulation has a similar potential and as a result we are expanding our internal drug delivery program to fully explore this opportunity.”
Starpharma has also filed a new patent application with the United States Patent and Trademark Office, incorporating recent Docetaxel data.
On the back of the announcement, Starpharma (ASX:SPL) was up 7%, or 9c, to $1.38 as of 1pm today.
References
www.lifescientist.com.au/article/365421/ausbiotech_2010_biotech_profile_starpharma/
http://www.lifescientist.com.au/article/391884/starpharma_brings_its_novel_technology_leading_cancer_treatment/
I look at this and just want to cry. 500% gain in two years! Why, oh why, did I not hold? - The Spilled Milk Chronicles
The momentum continues. I wonder what secrets await?
VivaGel(R) Demonstrates Efficacy in Bacterial Vaginosis
http://ih.advfn.com/p.php?pid=nmona&article=47780812
this thing just keeps going....
10.25 close today. So much for my market timing acuity.
I sold for a nice profit at 7.75 a few weeks ago, but I am now second guessing myself for perhaps selling too soon. One has to wonder about the current run and if there are certain investors, in the know, accumulating.
UN AIDS chief: Spread of HIV in E. Europe is scary
The Associated Press
Wednesday, November 24, 2010; 7:51 AM
VIENNA -- The U.N.'s top AIDS official says the spread of HIV in Eastern Europe and Central Asia is frightening.
The U.N. estimates that 1.4 million people were living with HIV in the region in 2009 - almost triple the number in 2000 - and that the Russian Federation and Ukraine account for nearly 90 percent of newly reported infections.
UNAIDS chief Michel Sidibe told reporters Wednesday that "we are scared" by what was happening and called for more access to prevention programs in the region.
He also warned that drug users have become transmitters of the virus because they don't have access to services and "have to go underground."
Starpharma expands partnership with Eli Lilly
29. September 2010 22:30
Starpharma Holdings Limited (ASX:SPL,OTCQX:SPHRY) today announced the signing of a collaborative research agreement with leading US pharmaceutical corporation Eli Lilly and Company.
The new agreement relates to a co-development program for one of Starpharma’s dendrimer-drug conjugates. Under the agreement Lilly will receive an option on the conjugate, will pay research fees to Starpharma and will conduct studies in animal models to advance the compound. The identity of the conjugate cannot be disclosed at this time due to confidentiality restrictions.
This latest announcement follows on from two previous agreements between the companies. In February 2010, Starpharma announced that its dendrimer drug delivery technology will be applied to enhance compounds in Lilly’s human pharmaceutical portfolio.
In May 2009 Starpharma and Lilly’s animal health division, Elanco, signed an agreement to develop new animal health products with enhanced properties.
“We are delighted that Lilly has chosen to expand the scope of its partnership with us once again,” said Dr Jackie Fairley, CEO Starpharma. “The agreement follows on from an initial evaluation in animal models of this conjugate by Lilly. Starpharma now looks forward to developing the compound as rapidly as possible with Lilly.”
www.starpharma.com
.49/share equates to $4.90 per ADR US (10 shares)
Orbis Acquires 2.5m Starpharma Holdings Shares
Orbis Investment Management has boosted its shareholding in Melbourne-based biotech company Starpharma Holdings (ASX: SPL) on the 25 August 2010, acquiring 2.5 million shares at prices ranging from $0.49 per share.
Orbis now holds 12.5% of Starpharma.
Starpharma is a market leader in the development of nanotechnology products for pharmaceutical, life-science and other applications.
Starpharma’s lead product is VivaGel®, a gel-based formulation of a nano-pharmaceutical under development as a vaginal microbicide to prevent the transmission of sexually transmitted infections, including HIV and genital herpes.
VivaGel® is at the expanded safety/Phase IIa stage of clinical development. VivaGel® has been granted Fast Track status by the US Food and Drug Administration (FDA), which will accelerate the clinical and regulatory process.
VivaGel® has been awarded US$20.3 million by the National Institutes of Health (NIH) to progress the development for HIV. The NIH has provided additional funding to develop VivaGel® against genital herpes.
VivaGel® Condom Patent Grant Extends Coverage
Melbourne | Posted on August 18th, 2010
The application will be granted on 20th August 2010 by the Russian patent office. Starpharma has also filed this patent in major markets including the USA, Canada, Europe, China, India and Japan.
Both the VivaGel® coated condom and the VivaGel® standalone gel are already protected by a portfolio of granted VivaGel® patents in major markets. This new patent family not only provides additional protection for the condom product but also extends the duration of coverage in each market for which it is granted. In the case of this grant in Russia it provides coverage for the coated condom until at least 2026.
"This is an important milestone in the commercialisation of the VivaGel® coated condom," said Dr Jackie Fairley, CEO Starpharma. "Although each patent office works according to slightly different criteria, we consider this successful grant to be a very encouraging sign more widely. Additionally, protection in Russia is very valuable in its own right as Starpharma's commercial partner SSL has the leading position in the Russian condom market."
SSL International plc (LSE:SSL) holds approximately 40% of the global branded condom market and is the owner of Durex®, the number one global condom brand.
In addition to the coated condom, Starpharma is also developing VivaGel® as a stand-alone vaginal microbicide to prevent the transmission of STIs, including HIV and genital herpes, and for the treatment of Bacterial Vaginosis.
Starpharma?
New Gel Sharply Reduces HIV Infections in Women
Margaret Besheer | Vienna20 July 2010
Photo: AP
Opening session of the International AIDS Conference in Vienna Austria, 18 July 2010
South African researchers have made a scientific breakthrough in the fight against AIDS, with a vaginal gel that significantly reduces a woman's risk of being infected with HIV, the virus that causes AIDS.
Since the epidemic began nearly 30 years ago, scientists have been searching for a vaginal microbicide that women could use to protect them from contracting HIV.
Now, two South African scientists with the Center for the AIDS Program of Research in South Africa, CAPRISA, say their clinical trials on 889 South African women show great promise. They will deliver the results of their two and half year study later Tuesday.
However, AIDS activists and researchers are already celebrating the news. UNAIDS Executive Director Michel Sidibe said the new gel is going to revolutionize HIV prevention for women.
"It is the first time we associate treatment products in the gels which can protect women up to 54 percent, which is amazing. Except for male circumcision, we never had, never, a prevention tool that can be controlled by women," said Sidibe.
Some 33 million people, worldwide, are infected with the HIV virus. About half of them are women. In Africa, more than 60 percent of new HIV infections are contracted by women and girls.
The new gel contains tenofovir, an antiretroviral drug that prevents HIV from growing in human cells. Dr. Kevin Decock, with the U.S. Centers for Disease Control, said the microbicidal gel could empower women in protecting their health.
"A microbicide is a product a woman can use vaginally. It is under a woman's control. It means a woman can use this intervention without requiring the male partner to take the initiative," Decock said.
Women apply the gel 12 hours before sexual intercourse and a second time, as soon as possible within 12 hours afterwards. Michel Sidibe said the simplicity of the gel will be the key to its appeal and effectiveness.
"This simplification is the revolution part. I called for a prevention revolution," Sidibe said. "I'm so convinced that to fight this epidemic we need prevention, prevention and prevention."
The South African study found that, in addition to reducing HIV infection by 39 percent, use of the gel also reduced the rate of infection of herpes simplex two by 51 percent. Women who have the herpes virus are more vulnerable to contracting HIV.
Health researchers stress that the gel is only a prevention against HIV and herpes, not a contraceptive.
UNAIDS and the World Health Organization will convene a group of AIDS specialists next month in South Africa to discuss the next steps. If additional trials go well, the drug could come to market in a few years.
Home Country News Release - Starpharma`s Bacterial Vaginosis Study gets FDA Clearance
https://www.otciq.com/otciq/ajax/showFinancialReportById?id=33949
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