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TR-1: Standard form for notification of major holdings
NOTIFICATION OF MAJOR HOLDINGS (to be sent to the relevant issuer and to the FCA in Microsoft Word format if possible)i
1a. Identity of the issuer or the underlying issuer of existing shares to which voting rights are attachedii:
Ted Baker plc
1b. Please indicate if the issuer is a non-UK issuer (please mark with an "X" if appropriate)
Non-UK issuer
2. Reason for the notification (please mark the appropriate box or boxes with an "X")
An acquisition or disposal of voting rights
An acquisition or disposal of financial instruments
An event changing the breakdown of voting rights
x
Other (please specify)iii:
3. Details of person subject to the notification obligationiv
Name
Raymond Stuart Kelvin
City and country of registered office (if applicable)
London, UK
4. Full name of shareholder(s) (if different from 3.)v
Name
City and country of registered office (if applicable)
5. Date on which the threshold was crossed or reachedvi:
08/11/2019
6. Date on which issuer notified (DD/MM/YYYY):
08/11/2019
7. Total positions of person(s) subject to the notification obligation
% of voting rights attached to shares (total of 8. A)
% of voting rights through financial instruments
(total of 8.B 1 + 8.B 2)
Total of both in % (8.A + 8.B)
Total number of voting rights of issuervii
Resulting situation on the date on which threshold was crossed or reached
34.87%
44,566,689
Position of previous notification (if
applicable)
34.87%
8. Notified details of the resulting situation on the date on which the threshold was crossed or reachedviii
A: Voting rights attached to shares
Class/type of
shares
ISIN code (if possible)
Number of voting rightsix
% of voting rights
Direct
(Art 9 of Directive 2004/109/EC) (DTR5.1)
Indirect
(Art 10 of Directive 2004/109/EC) (DTR5.2.1)
Direct
(Art 9 of Directive 2004/109/EC) (DTR5.1)
Indirect
(Art 10 of Directive 2004/109/EC) (DTR5.2.1)
Ordinary Shares
GB0001048619
15,540,280
N/A
34.87%
N/A
SUBTOTAL 8. A
15,540,280
34.87%
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FDA Grants Braeburn's Citizen Petition Allowing BRIXADI (buprenorphine) Extended-Release Injection for Opioid Use Disorder to be Available in December 2020
Thu November 7, 2019 9:14 PM|PR Newswire
PR Newswire
PLYMOUTH MEETING, Pa., Nov. 7, 2019 /PRNewswire/ -- Braeburn Inc. is pleased to confirm that it will seek, and is eligible for, marketing approval for BRIXADI™ (buprenorphine) weekly and monthly extended-release injection for the treatment of OUD as of December 1, 2020. This follows from today's decision by the U.S. Food and Drug Administration (FDA) to grant Braeburn's Citizen Petition (filed in April 2019) and thereby revoke Indivior PLC's orphan designation for buprenorphine treatment for OUD. By revoking Indivior's orphan designation, Sublocade™ (buprenorphine extended-release) injection is not eligible for any period of orphan exclusivity.
"On behalf of patients and their families, we are grateful to the FDA for allowing additional treatment options to become available sooner," said Mike Derkacz, President and CEO of Braeburn. "BRIXADI weekly and monthly have been proven to allow healthcare providers to match a patient's current treatment regimen, addressing an important unmet patient need."
In a separate communication to Braeburn in response to the July 2019 U.S. District Court ruling, FDA re-affirmed its previous clinical exclusivity decision blocking BRIXADI from the U.S. market through November 30, 2020.
With the FDA revoking Indivior's orphan designation, BRIXADI is eligible for marketing approval on November 30, 2020, upon expiration of Sublocade's clinical exclusivity period.
Background
BRIXADI was tentatively approved by the FDA in December 2018 having met all required efficacy, safety and quality standards, but was ineligible for marketing due to a three-year clinical exclusivity period granted to Sublocade. Following the Tentative Approval, Braeburn filed court proceedings seeking to overturn the decision.
After a court hearing in July 2019, Chief Judge Beryl A. Howell ordered FDA to reconsider Braeburn's application for Final Approval of BRIXADI, including an expectation that FDA would more clearly define innovation standards and provide clarification regarding earlier FDA exclusivity decisions.
Braeburn separately filed a Citizen Petition with FDA in April 2019 requesting FDA to revoke Indivior's orphan designation and refuse to grant orphan exclusivity to Sublocade.
About BRIXADI (buprenorphine) Extended-Release Injection for SC Use (CIII)
BRIXADI is an extended-release weekly (8mg, 16mg, 24mg, 32mg) and monthly (64 mg, 96mg, 128mg) injection used for the treatment of moderate to severe OUD. BRIXADI is tentatively approved by FDA for patients who have initiated treatment with a single dose of a transmucosal buprenorphine p