Cynapsus Or Acorda - Whose Market Is It For Parkinson's Disease?
Michael Hagan • 35 Comments
Michael Hagan • 35 Comments
Fri, May 20, 6:58 AM
- Acorda Therapeutics (NASDAQ:ACOR) pulls the plug on developing PLUMIAZ (diazepam) Nasal Spray for the treatment of seizure clusters in patients with epilepsy. Its decision was based on ongoing clinical studies that failed to demonstrate the product candidate's bioequivalence to Valeant Pharmaceuticals' (NYSE:VRX) Diastat AcuDial (diazepam rectal gel), a requirement for the refiling of the New Drug Application (NDA). The specific issue was lower-than-expected mucosal absorption of diazepam in epileptics compared to studies in healthy volunteers.
- The company is in communication with investigators to discontinue all clinical trials and will assist in the transition of study participants. The data will be presented as a future medical conference.
- Acorda originally submitted its NDA in 2013 but received a Complete Response Letter (CRL) in May 2014 citing the need for three more clinical trials. Its plan was to refile the NDA in Q1 2017.
- Shares are down 3% premarket on average volume.
- Previously: Acorda Therapeutics projects Plumiaz NDA filing in early 2017 (May 27, 2015)
Tue, Mar. 15, 5:40 PM
Fri, Mar. 11, 4:07 PM
- Acorda Therapeutics (ACOR -7.8%) states the USPTO's Patent Trial & Appeals Board (PTAB) is launching an inter partes review (IPR) of the company's '685, '703, '437, and '826 patents. A ruling is expected within a year.
- Acorda notes the patents are 4 of the 5 Orange Book-listed patents applying to its AMPYRA multiple sclerosis drug, and are set to expire between 2025 and 2027.
- Shares fell to $32 in afternoon trading following the announcement, hitting their lowest levels since October.
Tue, Jan. 19, 6:58 AM
- Acorda Therapeutics (NASDAQ:ACOR) makes an all-cash tender offer of €0.2946 per share on the Nasdaq Helsinki index for Biotie Therapies (NASDAQ:BITI). The offer price per ADS is €23.5680 or $25.60 based on a dollar/euro exchange rate of 1.0864, representing a 94% premium over Friday's close of $13.20.
- Acorda CEO Dr. Ron Cohen says, "Our acquisition of Biotie positions Acorda as a leader in Parkinson's disease therapeutic development, with three clinical-stage compounds that have the potential to improve the lives of people with Parkinson's. Tozadenant, Biotie's most advanced clinical program, is a promising therapy being developed to reduce daily OFF time. Adenosine A2a receptor antagonists may be the first new class of drugs approved for the treatment of Parkinson's in the U.S. in over 20 years. Tozadenant is a compelling opportunity with potential market exclusivity to 2030. We are targeting an NDA filing by the end of 2018."
- The deal also includes Phase 2-stage SYN-120 for Parkinson's dementia, BTT1023 for primary sclerosing cholangitis and Selincro for the reduction of alcohol consumption (marketed by Lundbeck A/S in certain European countries).
- Update: Over 97% of Biotie's shares were tendered in the deal.
Aug. 25, 2015, 9:19 AM| Aug. 25, 2015, 9:19 AM | 7 Comments
Aug. 24, 2015, 5:36 PM
Aug. 24, 2015, 5:35 PM
- Acorda Therapeutics (NASDAQ:ACOR) +24.3% AH after the U.S. Patent and Trademark Office denies a patent challenge against the company from Kyle Bass' Coalition For Affordable Drugs of ACOR's multiple sclerosis drug Ampyra.
- The board declines to begin a review of the patent, which expires in 2025; the decision is not subject to appeal.
- Ampyra is the only prescription medicine indicated to help improve walking in adults with MS.
Sep. 24, 2014, 12:46 PM
Sep. 24, 2014, 9:20 AM
Sep. 24, 2014, 8:51 AM
Jun. 17, 2014, 12:50 PM
Mar. 6, 2014, 5:40 PM
Feb. 28, 2014, 5:40 PM
Jan. 13, 2014, 11:12 AM
- Shares of Acorda Therapeutics (ACOR +4.2%) are higher in morning trading after the company provided preliminary financial results in connection with the JPMorgan Healthcare Conference.
- Q4 and FY Ampyra net sales: $84M and $302M, respectively.
- 2014 Ampyra net sales guidance: $328-335M.
- 2014 opex guidance: R&D, $60-70M; SG&A, $180-190M.
- 2014 Zanaflex guidance and ex-U.S. Fampyra revenue: $25M
Oct. 14, 2013, 3:40 PM
- Acorda Therapeutics (ACOR -8.4%) falls despite reporting what the company calls "positive" results for a dalfampridine-ER proof-of-concept study in patients with post-stroke deficits.
- The treatment was "was well-tolerated and improved walking, as measured by the Timed 25-Foot Walk test." (PR)
- RBC's Michael Yee says that while the post-stroke data "is interesting," it is "not as compelling versus the MS indication."
- Speaking of the MS indication, Yee says "scripts look a bit mediocre tracking a tad shy of Q3 consensus, and overall new scripts are down too."
- Nevertheless, RBC says "expectations are pretty low and ... the stock is pretty cheap at $1.1B EV or ~3x sales plus all potential upside from label expansion or pipeline."
Jul. 5, 2013, 5:30 PM
Acorda Therapeutics, Inc. engages in the identification, development and commercialization of novel therapies that improve neurological function in people with multiple sclerosis, spinal cord injury and other disorders of the nervous system. The company's two main products are Ampyra and... More
Country: United States
Other News & PR