LONDON (Reuters) - The threat of generic copies of GlaxoSmithKline's (GSK.L) best-selling lung drug Advair finally making it to market in the United States hit confidence in the drug maker on Tuesday, sending the stock down more than 3 percent.
Fears of cheaper versions of the $8 billion-a-year seller being launched in the world's biggest market were fuelled by a draft guidance document from the Food and Drug Administration setting out the requirements for generic versions of the inhaled drug.
Bernstein analyst Tim Anderson said the requirements looked "fairly benign" for generic firms seeking to make copies that could be automatically substituted for Advair when patients have their prescriptions filled.
Citigroup said its worst-case scenario for an accelerated U.S. Advair sales decline, following the FDA document, could slice up to 5 percent off GSK's valuation.
http://finance.yahoo.com/news/gsk-shares-hit-advair-generics-082354075.html?l=1
Advair, which is marketed as Seretide outside the United States, is used to treat both asthma and chronic lung disease caused by smoking.
Although patents on the active ingredients used in the medicine have expired, it remains protected by U.S. patents on the Diskus inhaler device that run until 2016, after which copies may reach the market.
Up until now, many investors had assumed that fully substitutable generic versions of Advair were unlikely in the United States and instead generics would have to compete as separate brands. The FDA pathway to permitting "true" generics therefore represents a heightened threat.
Shares in GSK were down 3.3 percent at 15.85 pounds by 0805 GMT (3:05 EDT).
The uncertainty over Advair comes on the same day that a U.S. advisory panel is due to consider a new lung drug called Anoro from GSK and Theravance (THRX).
Recent THRX News
- Form 15-12G - Securities registration termination [Section 12(g)] • Edgar (US Regulatory) • 02/26/2024 02:00:55 PM
- Form EFFECT - Notice of Effectiveness • Edgar (US Regulatory) • 02/16/2024 05:15:06 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 02/14/2024 09:00:26 PM
- Form S-8 POS - Securities to be offered to employees in employee benefit plans, post-effective amendments • Edgar (US Regulatory) • 02/14/2024 07:26:12 PM
- Form POS AM - Post-Effective amendments for registration statement • Edgar (US Regulatory) • 02/14/2024 07:22:42 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 02/14/2024 03:44:05 PM
- Form SC TO-T/A - Tender offer statement by Third Party: [Amend] • Edgar (US Regulatory) • 02/14/2024 03:35:19 PM
- Theseus Pharmaceuticals Announces Closing of Tender Offer • PR Newswire (US) • 02/14/2024 01:30:00 PM
- Form SC 13G/A - Statement of acquisition of beneficial ownership by individuals: [Amend] • Edgar (US Regulatory) • 02/13/2024 05:36:57 PM
- Form SC 14D9/A - Solicitation, recommendation statements: [Amend] • Edgar (US Regulatory) • 02/07/2024 10:21:30 PM
- Form SC TO-T/A - Tender offer statement by Third Party: [Amend] • Edgar (US Regulatory) • 02/07/2024 10:15:51 PM
- Form SC 14D9/A - Solicitation, recommendation statements: [Amend] • Edgar (US Regulatory) • 01/30/2024 01:52:31 PM
- Form SC TO-T/A - Tender offer statement by Third Party: [Amend] • Edgar (US Regulatory) • 01/30/2024 01:23:43 PM
- Concentra Announces Calculation of Additional Price Per Share and Extension of Expiration Date for Tender Offer for Theseus Pharmaceuticals • Business Wire • 01/30/2024 01:00:00 PM
- Form SC 14D9 - Solicitation, recommendation statements • Edgar (US Regulatory) • 01/10/2024 02:47:20 PM
- Form SC TO-T - Tender offer statement by Third Party • Edgar (US Regulatory) • 01/10/2024 01:51:27 PM
- Form SC14D9C - Written communication relating to third party tender offer • Edgar (US Regulatory) • 12/22/2023 11:52:56 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 12/22/2023 11:36:08 AM
- Theseus Pharmaceuticals Enters into Agreement to Be Acquired by Concentra Biosciences for between $3.90 and $4.05 in Cash per Share Plus a Contingent Value Right • PR Newswire (US) • 12/22/2023 11:30:00 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 12/04/2023 11:30:30 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 11/27/2023 11:37:46 AM
- Theseus Pharmaceuticals Confirms Receipt of Unsolicited Expression of Interest from Foresite Capital, LLC and OrbiMed Advisors LLC and Unsolicited Proposal from Concentra Biosciences LLC • PR Newswire (US) • 11/27/2023 11:30:00 AM
- Form SC 13D/A - General statement of acquisition of beneficial ownership: [Amend] • Edgar (US Regulatory) • 11/24/2023 09:23:24 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 11/17/2023 09:01:52 PM
Axis Technologies Group and Carbonis Forge Ahead with New Digital Carbon Credit Technology • AXTG • Apr 24, 2024 3:00 AM
North Bay Resources Announces Successful Equipment Test at Bishop Gold Mill, Inyo County, California • NBRI • Apr 23, 2024 9:41 AM
Epazz, Inc.: CryObo, Inc. solar Bitcoin operations will issue tokens • EPAZ • Apr 23, 2024 9:20 AM
Avant Technologies Launches Advanced AI Supercomputing Network and Expansive Data Solutions • AVAI • Apr 23, 2024 8:00 AM
BestGrowthStocks.com Issues Comprehensive Analysis of Triller Merger with AGBA Group Holding Limited • AGBA • Apr 22, 2024 1:00 PM
Cannabix Technologies to Present Marijuana Breathalyzer Technology at International Association for Chemical Testing (IACT) Conference in California • BLO • Apr 22, 2024 8:49 AM