ADVFN Logo

We could not find any results for:
Make sure your spelling is correct or try broadening your search.

Trending Now

Toplists

It looks like you aren't logged in.
Click the button below to log in and view your recent history.

Hot Features

Registration Strip Icon for discussion Register to chat with like-minded investors on our interactive forums.

FUM Futura Medical Plc

39.10
0.30 (0.77%)
Last Updated: 11:42:11
Delayed by 15 minutes
Share Name Share Symbol Market Type Share ISIN Share Description
Futura Medical Plc LSE:FUM London Ordinary Share GB0033278473 ORD 0.2P
  Price Change % Change Share Price Bid Price Offer Price High Price Low Price Open Price Shares Traded Last Trade
  0.30 0.77% 39.10 38.60 39.90 40.00 39.10 39.60 122,938 11:42:11
Industry Sector Turnover Profit EPS - Basic PE Ratio Market Cap
Pharmaceutical Preparations 0 -5.85M -0.0194 -20.57 119.98M

Futura Medical PLC MED2002 Regulatory Update (6256G)

31/05/2017 7:00am

UK Regulatory


Futura Medical (LSE:FUM)
Historical Stock Chart


From Mar 2019 to Mar 2024

Click Here for more Futura Medical Charts.

TIDMFUM

RNS Number : 6256G

Futura Medical PLC

31 May 2017

For immediate release 31 May 2017

Futura Medical plc

("Futura" or the "Company")

MED2002 Regulatory Update

Futura Medical plc (AIM: FUM), the innovative healthcare company focused on advanced transdermal technology, is pleased to provide the following update on its discussions with US and UK regulatory authorities on the clinical trial requirements and regulatory pathway for MED2002, the Company's topical gel for erectile dysfunction ("ED").

Summary and Highlights

-- Written responses received from regulators (the US FDA and the UK MHRA) on regulatory pathway for MED2002

-- Responses support the Company's expectations, including on timing for regulatory submissions for marketing authorisations, anticipated in Q2 2019 following data from studies to be initiated in Q4 2017

-- Recommendations to evaluate at higher doses to optimise efficacy across the spectrum of all ED patients, as well as to obtain limited additional safety data

The planned Phase III programme follows the successful clinical results announced on 7 September 2016, confirming MED202 had met its primary endpoint and showed efficacy, safety and speed of onset. MED2002's rapid onset of action means that it has the potential to be the world's fastest-acting treatment for ED.

James Barder, Futura's Chief Executive, commented: "We are delighted by the constructive feedback provided on the remaining development pathway for MED2002, our topical gel for ED, from both the US and UK regulatory authorities. We believe that to have the remaining development programme aligned with the authorities' suggestions, and with no expected impact on overall timelines, this is an excellent outcome and should provide reassurance for shareholders and prospective licence partners alike. We look forward to updating shareholders further on the development and commercialisation of a product that has the potential to be the world's fastest-acting treatment for ED."

Further details on the regulatory feedback and the Company's development strategy for MED2002 are provided below:

Futura confirms that it has now received written responses following constructive meetings with the US Food & Drug Administration ("FDA") and the UK's Medicines and Healthcare products Regulatory Agency ("MHRA"). There was a broad consensus from both regulatory authorities on the development pathway for MED2002 which validates the Company's previously disclosed target of making regulatory submissions in US and certain EU territories in H1 2019.

Both the FDA and MHRA confirmed filing routes by which the Company can make use of the extensive pre-existing safety data on the active ingredient in MED 2002, glyceryl trinitrate ("GTN"), which has already been approved in other indications and is well characterised. A limited amount of additional data will be required to confirm that the unique application of the MED2002 gel to the penis and the limited transference of the active ingredient to the sexual partner do not present a safety issue. As anticipated, MED2002's US filing will be via a 505(b)(2) investigational new drug application and in Europe via an Article 8.3 of Directive 2001/83/EC (as amended).

The authorities gave their support in principle to the Company's proposal to conduct a pivotal Phase III, placebo controlled, parallel group, multi-centre clinical study. In addition, they urged the Company to evaluate higher doses in addition to those originally proposed of 0.2% and 0.4% to optimise efficacy across the spectrum of all ED patients. The strategy of providing a range of dose strengths is already followed by existing oral ED treatments.

The Company intends to adopt this recommendation and will conduct two Phase III studies, but with differing dosage protocols to address the suggestions made by authorities whilst optimising the chances of clinical success. The studies will also include a cohort of ED patients taking other medication containing nitrates, as these patients are currently contraindicated from taking existing oral ED treatments.

The authorities also gave their support to Futura's proposal to conduct a pharmacokinetic safety study to compare GTN blood plasma levels of MED2002 with existing GTN drugs to support the proposed abridged filings and confirm the expected low level of GTN transference to the sexual partner. The latter was evidenced through the extremely low side effect profile observed in women in the Company's earlier study which concluded in 2016.

The timelines for the remaining study programme remain in line with those outlined in the Company's preliminary results announced on 23 March 2017, with the studies expected to begin with first patient recruitment in Q4 2017 and regulatory submissions for marketing authorisation expected to be made in Q2 2019. A further regulatory meeting with the MEB, the Netherlands regulatory authority, is also planned ahead of recruitment of the first patient into the ongoing clinical trial programme.

For further information please contact:

 
 Futura Medical plc 
 James Barder, Chief Executive              Tel: +44 (0) 1483 685 670 
 Email to: james.barder@futuramedical.com   www.futuramedical.com 
 
 N+1 Singer (Nominated Adviser 
  and Broker) 
 Aubrey Powell / Liz Yong                   Tel:+44 (0) 20 7496 3000 
 
 For media enquiries please contact: 
 
   Buchanan 
 Mark Court / Sophie Cowles /               Tel: +44 (0) 20 7466 5000 
  Stephanie Watson 
 

Notes to Editors

Futura Medical plc

Futura Medical is a pharmaceutical group that develops innovative products for consumer healthcare. The Company is developing a portfolio of products and its strategy is to license their manufacture and distribution to major pharmaceutical and healthcare groups. Futura is based in Guildford, Surrey, and its shares trade on the AIM market of the London Stock Exchange. www.futuramedical.com

This information is provided by RNS

The company news service from the London Stock Exchange

END

MSCSDUESSFWSEII

(END) Dow Jones Newswires

May 31, 2017 02:00 ET (06:00 GMT)

1 Year Futura Medical Chart

1 Year Futura Medical Chart

1 Month Futura Medical Chart

1 Month Futura Medical Chart

Your Recent History

Delayed Upgrade Clock