PEACHMAN
5 years ago
More Great news SPHRY
https://starpharma.com/news/425
VivaGel® BV has been launched in Europe by Mundipharma, under the brand name Betadine BVTM
Betadine BVTM will be available Over-The-Counter, without prescription
Mundipharma is rolling out Betadine BVTM throughout Europe during the year
European launch triggers a milestone payment of US$0.5M (A$0.72M)
Starpharma is eligible to earn total milestones up to US$24.7M, plus revenue share, for all territories under Mundipharma’s licence
Regulatory activities are underway for multiple countries across other Mundipharma regions
Melbourne, Australia; 27 June 2019: Starpharma (ASX: SPL, OTCQX: SPHRY) today announced that VivaGel® BV has been launched in Europe under the brand name Betadine BVTM. The product has been launched in several countries in Europe, including Germany, with further roll-out in additional European countries during the year.
Betadine BVTM will be available over-the-counter (OTC), without the need to see a doctor or obtain a prescription. Europe is the second region to launch VivaGel® BV and represents a large commercial opportunity with access to more than 260 million women.
VivaGel® BV (Betadine BVTM) is a novel, non-antibiotic therapy for treatment and prevention of bacterial vaginosis (BV). BV is the most common vaginal condition worldwide and twice as common as thrush. VivaGel® BV (Betadine BVTM) is an Australian innovation –invented, fully developed and taken through to commercialisation by Starpharma.
BV is a troublesome and often recurrent condition that causes unpleasant vaginal odour and discharge symptoms that have significant social impacts for women. BV has also been associated with a range of other serious reproductive health-related medical problems.
Betadine BVTM is being marketed by Mundipharma, a leading global pharmaceutical company which owns the successful international brand BETADINE®. Mundipharma is one of the largest privately-owned pharmaceutical companies in the world employing over 8,600 people.
The launch of Betadine BVTM in Europe triggers a milestone payment of US$0.5M (A$0.72M) to Starpharma. Starpharma is eligible to earn total milestones up to US$24.7M, plus revenue share, for all territories under Mundipharma’s licence.
Dr Jackie Fairley, Starpharma CEO, commented: “We are delighted to achieve another territory launch of VivaGel® BV this year, and our first with Mundipharma. Europe represents a very important market for VivaGel® BV and we’re delighted that our breakthrough product will be available to millions of European women who suffer from BV. Mundipharma have a excellent track record in the OTC space and a leading position in feminine care with their successful international brand BETADINE®. We look forward to working with Mundipharma on further registrations and launches across the globe”.
Raman Singh, Mundipharma CEO, commented: “We are delighted to launch Betadine BVTM in Europe. This product represents a true innovation in the management of bacterial vaginosis (BV). It sits well under the BETADINE® brand, which has emerged as a powerful brand platform for consumer healthcare products, trusted by women globally.”
Starpharma’s and Mundipharma’s marketing and regulatory teams continue to work actively together on further launches of VivaGel® BV in Europe and also in other regions, such as Asia. Regulatory activities are underway for multiple countries across Mundipharma’s regions.
Download ASX Announcement: VivaGel® BV launched in Europe (PDF, 70kb)
PEACHMAN
5 years ago
›› FDA meeting to discuss VivaGel® BV
approval in the US
In preparation for the upcoming meeting with the FDA, Starpharma
has completed and submitted a comprehensive package of
information, including further analyses of existing clinical data for
VivaGel® BV. A meeting with the FDA is expected to occur in the
second week of April 2019, subject to final confirmation of availability
of all parties. The meeting will be attended by senior representatives
of Starpharma as well as internationally recognised KOLs in the area
of BV, and the Company’s expert FDA regulatory consultants.
Since receiving the FDA’s request for confirmatory clinical data,
Starpharma has undertaken a comprehensive program with a view
to expediting approval, which has included extensive regulatory
advice from FDA experts and specialist US legal counsel. The
information submitted for the meeting, which includes additional
statistical analyses of existing data, was prepared in consultation
with, and following input from Starpharma’s team of expert FDA
consultants, including former senior FDA personnel, KOLs and
statisticians. These analyses provide further support for the approval
of VivaGel® BV.
The meeting is expected to clarify what confirmatory data will be
required for approval and whether the requirement can be satisfied
by additional analyses of existing clinical data, or whether this will
require the generation of new confirmatory clinical data. Starpharma
will be in a position to provide additional information following the
FDA meeting, once the outcomes of the discussion at the meeting
have been confirmed in writing.
Requests for additional data from the FDA are not unusual among
New Drug Applications. In 2016, almost 40% of NDAs submitted
were not approved in the first instance and additional data were
requested. A longer-term review between 2001 and 2015 showed
that 44% of NDAs were not approved upon first round review.
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 presentation 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.
Feedback on VivaGel® BV from US clinicians and patients has been
extremely positive. We are looking forward to a productive and
informative meeting with the FDA. Starpharma is committed to
working with the FDA to secure approval with minimal delay to
make VivaGel® BV available to US patients as soon as possible.
Dr Jackie Fairley, CEO of Starpharma
Michael Scofield
8 years ago
http://www.thestreet.com/story/13498233/1/adama-licenses-starpharmas-priostar-dendrimer-technology-for-the-development-and-commercialization-of-a-novel-24-d-product-for-the-us-market.html
MELBOURNE, Australia and TEL-AVIV, Israel, March 17, 2016 /PRNewswire/ --
Starpharma (ASX:SPL; OTCQX: SPHRY) and Adama today announced the licensing by Adama of Starpharma's Priostar ® dendrimer technology for the development and commercialization of an enhanced, proprietary 2,4-D herbicide for the US market. 2,4-D is one of the top three herbicides sold world-wide, with global sales in 2014 estimated by Phillips McDougall to be around US$680 million. The US market in 2014 was worth approximately US$115 million, and has been projected by the US Department of Agriculture to grow by more than 70% by 2020.
(Logo: http://photos.prnewswire.com/prnh/20140402/679073 )
Adama has already commenced development of a novel and unique 2,4-D product containing the Priostar ® dendrimer technology, which is expected to provide better flexibility and weed control benefits to the grower, as well as improved safety. This will allow for on-target application, thus benefiting the environment by reducing the amounts of product required.
Under the license, Starpharma will receive royalties on sales of the proprietary Adama Priostar ®-improved 2,4-D products. In addition to the US, the agreement also includes a mechanism to expand the license into additional territories.
Sami Shabtai, Head of Innovative Development at Adama, commented, "As a farmer-centric company, Adama constantly strives to bring new and innovative solutions to farmers that will simplify their lives. The innovative nature and superior performance of the Priostar ® formulations fit well with our strategy to deliver simple and efficient solutions to farmers to help them grow. This is yet another step in the evolution and differentiation of our offering, as we continue to introduce unique mixtures and formulations to the market."
Dr. Jackie Fairley, CEO of Starpharma, said, "We enjoy a positive relationship with Adama, and their extensive trials of Priostar ®-improved 2,4-D formulations have led to this license agreement. With Adama's strong, proven record of innovative product development, we are very pleased to have them as commercial partners for Priostar ®-improved 2,4-D products. In addition, we continue to explore other Priostar ® product opportunities with Adama."
About Starpharma ' s Priostar® dendrimer technology:
Starpharma's Priostar® dendrimer technology offers formulation and efficacy benefits in crop protection applications including:
Improved efficacy
More concentrated formulations to reduce transport costs;
Reduction in solvent requirements; and
Increased adhesion, to reduce losses due to rain run-off, and the need for multiple applications.
About Adama
Adama is one of the world's leading crop protection companies. We strive to Create Simplicity in Agriculture - offering farmers effective and efficient products and services that simplify their lives and help them grow. With one of the most comprehensive and diversified portfolios of differentiated, high-quality products, Adama's 4,900 people reach farmers in over 100 countries across the globe, providing them with solutions to control weeds, insects and disease and improve their yields. For more information, visit us at http://www.adama.com and follow us on Twitter at @AdamaAgri.
About Starpharma Holdings Limited
Starpharma Holdings Limited, an Australian ASX 300 company, is a world leader in the development of novel products based on dendrimers, a type of synthetic nanoscale polymer that is highly regular in size and structure, for pharmaceutical, life science and other applications. Starpharma has three core development programs: VivaGel ® portfolio, DEP™ drug delivery, and agrochemicals with a number of products being developed internally and externally via commercial partnerships. Partners include AstraZeneca, Ansell, and Okamoto, as well as other named and undisclosed partnerships with leading global companies in pharmaceuticals and agrochemicals. For more information please visit: http://www.starpharma.com
Contact at Adama:Nina ZoukelmanPublic Relations ManagerEmail: nina.zoukelman@adama.com Contact at Starpharma: Buchan Consulting Rebecca WilsonMob: +61-417-382-391 rwilson@buchanwe.com.auGabriella Hold+61-3-9866-4722 ghold@buchanwe.com.au Starpharma:Dr Jackie Fairley, Chief Executive Officer Nigel Baade, CFO and Company Secretary+61-3-8532-2704 investor.relations@starpharma.com http://www.starpharma.com
SOURCE Starpharma and ADAMA
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