"We continue discussions with outside partners that address the commercial potential of Ampion™ in multiple world markets....
Regulatory Exclusivity and IP protection:
The Company believes that Ampion™, a low molecular weight fraction of human serum albumin with anti-inflammatory properties, will be identified as a “reference product” upon FDA approval of their BLA. Reference products are granted 12 years of exclusivity under the PHS Act, 42 U.S.C. § 262(k)(7). Specifically, FDA is not permitted to approve an application for a biosimilar or interchangeable product until 12 years after the date of the first licensure of the reference product.
The existing Ampion™ portfolio has patent coverage in all major jurisdictions throughout the world (U.S., Europe, Australia, Brazil, Canada, China, Eurasia, Hong Kong, India, Indonesia, Israel, Japan, Korea, Mexico, Malaysia, New Zealand, Philippines, Singapore, South Africa) for pharmaceutical compositions and methods of treating a range of conditions. The portfolio includes 125 issued patents and 85 pending applications throughout seven primary patent families having expiration dates that extend to 2035."
There could be many regional deals with upfront and sales related escalating double digit royalties IMO. The patent portfolio is TRULY world wide!
"The refusal of the real is the number one dogma of our time" Rene Girard
Recent AMPE News
- Ampio Pharmaceuticals Received Audit Opinion with Going Concern Explanation • PR Newswire (US) • 04/03/2024 06:33:00 PM
- Ampio Announces Voluntary Delisting and SEC Deregistration • PR Newswire (US) • 03/25/2024 09:00:00 PM
- Form EFFECT - Notice of Effectiveness • Edgar (US Regulatory) • 03/05/2024 05:15:29 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 02/28/2024 08:49:00 PM
- Form S-8 POS - Securities to be offered to employees in employee benefit plans, post-effective amendments • Edgar (US Regulatory) • 02/28/2024 08:48:05 PM
- Form S-8 POS - Securities to be offered to employees in employee benefit plans, post-effective amendments • Edgar (US Regulatory) • 02/28/2024 08:47:17 PM
- Form POS AM - Post-Effective amendments for registration statement • Edgar (US Regulatory) • 02/28/2024 08:46:20 PM
- Form RW - Registration Withdrawal Request • Edgar (US Regulatory) • 02/28/2024 08:45:20 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 02/15/2024 02:31:23 PM
- Ampio Provides Update on Results from Pre-IND Enabling Studies • PR Newswire (US) • 02/14/2024 10:45:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 01/25/2024 09:31:28 PM
- Form 424B5 - Prospectus [Rule 424(b)(5)] • Edgar (US Regulatory) • 01/25/2024 09:18:53 PM
- Form 424B5 - Prospectus [Rule 424(b)(5)] • Edgar (US Regulatory) • 01/24/2024 10:16:26 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 01/11/2024 09:20:20 PM
- Ampio Provides Litigation Update - Reports Settlement in Principle of Certain Pending Legal Actions • PR Newswire (US) • 01/11/2024 09:15:00 PM
- Form S-1 - General form for registration of securities under the Securities Act of 1933 • Edgar (US Regulatory) • 12/21/2023 09:25:42 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 11/14/2023 09:10:40 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 11/02/2023 01:30:24 PM
- Ampio Pharmaceuticals to Present at the Emerging Growth Conference • PR Newswire (US) • 10/31/2023 01:00:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 10/27/2023 06:10:26 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 10/06/2023 06:56:04 PM
- Ampio Selects Ascendia Pharmaceuticals, Inc. to Provide CDMO Services to Support Clinical Development of OA-201 • PR Newswire (US) • 10/05/2023 08:30:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 10/04/2023 08:15:24 PM
- Ampio Pharmaceuticals to Present at the Emerging Growth Conference • PR Newswire (US) • 09/26/2023 01:15:00 PM
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