QUOTE AND NEWS
newratings.com  Nov 22  Comment 
PARIS (dpa-AFX) - Acorda Therapeutics Inc. (ACOR) has decided to discontinue the development of Dalfampridine for treatment of post-stroke walking difficulties, following disappointing results from its trial, dubbed MILESTONE. Although the study...
Motley Fool  Nov 21  Comment 
Acorda's flagship drug flames out in a mid-stage trial, sending its shares downward on Monday.
GenEng News  Nov 21  Comment 
Acorda Therapeutics reports that a milestone clinical study did not show sufficient efficacy to support further development of dalfampridine to improve post-stroke walking difficulties (PSWD). “The study indicated there was activity related...
Benzinga  Sep 29  Comment 
  Intra-Cellular Therapies Inc (NASDAQ: ITCI) shares fell 63.4 percent to touch a new 52-week low of $15.49 after its lead product candidate, ITI-007, failed a late-stage study in schizophrenia. Apparently, the drug couldn't beat the...
Reuters  Sep 26  Comment 
* Arbitral Tribunal confirmed Acorda's redemption right regarding Biotie shares
Forbes  Sep 8  Comment 
Looking at options trading activity among components of the Russell 3000 index, there is noteworthy activity today in Ionis Pharmaceuticals Inc (NASD: IONS), where a total volume of 12,471 contracts has been traded thus far today, a contract...




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Acorda Therapeutics (NYSE: ACOR) is a biotechnology company specializing in therapies designed to improve the quality of life for multiple sclerosis (MS) patients. The company has two major products currently approved for sale. Acorda launched Zanaflex capsules in 2005 to relieve spasms in MS patients, and received FDA approval for Ampyra in 2010 to improve walking in MS patients. Ampyra is currently Acorda's biggest revenue generator, with $141 million in 2010 sales.

Ampyra is the driver of Acorda's revenue for the near-term future, and its sales growth as it ramps up to its peak potential will significantly impact Acorda's value. In addition, Acorda is pursuing patent extension opportunities that could protect it from generic competition for the next decade.

Business Growth

FY 2010 (ended December 31, 2010)

  • Net revenue more than tripled to $182 million.
  • Net loss decreased 86% to $11.8 million.

In 2010, revenue growth was driven by the approval of Ampyra by the FDA to improve walking in adults with multiple sclerosis (MS).[1] In 2010, its first year of commercial sales, Ampyra earned $141 million in revenue. Acorda's other major drug, Zanaflex, which is used to relieve spasms in MS patients, earned $55 million, a decrease of 6%.[2] For 2011, Acorda expects net revenue to increase to $205-230 million.[3]

Trends and Forces

Ampyra Sales Growth Will Define Acorda's Success

The FDA approval of Ampyra to treat MS has transformed Acorda's business. As sales for Ampryria ramp up to the $871 million that analysts expect for 2015, these sales will make up the vast majority of Acorda revenue.[4] In 2010, Ampyra garnered $141 million in sales and analysts expect as much as $230 million in sales for 2011. How Acorda ramps up sales of Ampyra and where peak sales fall relative to analyst estimates will impact Acorda's valuation.[5]

Acorda's Ability to Retain Patent Exclusivity for Ampyra will Impact Revenue

As a treatment for a rare disease, Ampyra has been granted 7 years of "Orphan Drug" exclusivity by the FDA for the treatment of MS. However, the major patents for Ampyra, which are necessary to prevent competitors from developing the drug for other disease markets, expire in 2011 and 2013. In 2010, Acorda applied for extensions on the patents, which would grant the company 5 additional years of exclusivity.[6] Acorda's ability to gain these extensions will impact its ability to prevent competition in markets outside of the MS field.

Competition

There are currently no generic versions of Ampyra, and FDA Orphan Drug regulations will prevent competition from entering the MS market until at least 2017.

References

  1. FDA Approves Ampyra to Improve Walking in Adults with Multiple Sclerosis
  2. ACOR 2011 10K
  3. Acorda Therapeutics Reports Fourth Quarter and Full Year 2010 Financial Results
  4. Acorda shares soar on possible patent extension of MS drug
  5. Acorda Pushes Sales of MS Drug
  6. Acorda Therapeutics Announces Filing Of Patent Extension Applications For AMPYRA
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