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News Release
Acorda  Therapeutics Announces Completion of Neuronex, Inc. Acquisition

 Diazepam Nasal Spray, Pre-NDA Stage Epilepsy Product, Added to Acorda’s Neurology Pipeline 

ARDSLEY,  N.Y.--(BUSINESS WIRE)--Dec. 21, 2012-- Acorda
Therapeutics, Inc. (Nasdaq:  ACOR) today announced that the Company has completed the acquisition of  Neuronex, Inc., a privately held company developing a nasal spray formulation  of diazepam. Under the terms of the agreement, Acorda paid $6.8 million to  Neuronex to complete the acquisition. 

“Diazepam  Nasal Spray is an important addition to our pipeline and aligns with our core  strategy to develop and commercialize products that offer unique benefits to people  with neurological diseases,” said Ron Cohen, M.D., Acorda’s President and  CEO. “This product leverages our existing sales, marketing and medical  organizations, which have proved highly successful in
bringing novel  neurological therapies to market.” 
 
Diazepam  Nasal Spray is a proprietary formulation of diazepam that Acorda is  developing as a treatment for the management of selected, refractory patients  with epilepsy, on stable regimens of antiepileptic drugs (AEDs), who require  intermittent use of diazepam to control bouts of acute repetitive seizures  (ARS). Currently, the only approved outpatient treatment option for people  who experience this type of seizure activity is DIASTAT® AcuDialTM  (diazepam rectal gel), a rectally administered gel formulation of  diazepam. The nasally administered formulation potentially offers patients  and caregivers a more practical and socially acceptable treatment option. 

“There  are up to 175,000 people in the U.S. who suffer from acute repetitive  seizures despite being on stable regimens of antiepileptic medications. These  seizures can occur at any time and have a profound impact on a person’s  life,” said Enrique Carrazana, M.D., Acorda’s Chief Medical Officer. “As an  epileptologist, I am very excited that we are developing a product which, if  approved, will represent a major contribution to patient care.” 
 
In  addition to the closing payment to Neuronex, Acorda will provide additional  payments of up to $18 million based on achievement of certain regulatory and  manufacturing-related milestones, and up to $105 million based on specified  sales milestones. Tiered upper single-digit to lower double-digit  royalty-like earnout payments on sales will be paid if the product
is  approved. In addition, Acorda will assume responsibility for regulatory and  sales milestone payments of up to $11 million and single-digit royalties to  third parties, based on existing Neuronex licensing agreements. 
 
Acorda  made an initial option payment of $2.0 million to Neuronex in the first  quarter of 2012, and provided $1.5 million in ensuing quarters to support  certain research and development activities conducted by Neuronex prior to  completing the acquisition. 
 
Acorda  plans to submit a 505(b)(2)-type New Drug Application (NDA) for Diazepam  Nasal Spray to the U.S. Food and Drug Administration (FDA) in 2013. A  505(b)(2) application allows for an NDA that relies on medical literature and  FDA’s finding of safety and effectiveness for a previously approved drug  product.


About Epilepsy and Acute Repetitive Seizures (ARS)

Epilepsy  is a neurological condition that produces seizures affecting a variety of  mental and physical functions. Seizures are symptoms of abnormal brain  activity, and occur when a brief, strong surge of electrical activity affects  part or all of the brain. The Centers for Disease Control and Prevention  (CDC) estimates that approximately 2.3 million Americans have active 
epilepsy. 

Acute  repetitive seizures (ARS) are characterized by recognizable, recurring  episodes of seizure clusters.



About 
Acorda Therapeutics
Acorda  Therapeutics is a biotechnology company focused on developing therapies that  restore function and improve the lives of people with MS, spinal cord injury  and other neurological conditions. 

Acorda  markets
AMPYRA®(dalfampridine) Extended  Release Tablets, 10 mg, in the United States as a treatment to improve  walking in patients with multiple sclerosis (MS). This was demonstrated by an  improvement in walking speed. AMPYRA is marketed outside the United States as  FAMPYRA®(prolonged-release fampridine tablets) by Biogen Idec  under a licensing agreement from Acorda. AMPYRA and FAMPYRA are manufactured  under license from Alkermes Pharma Ireland Limited. 

The  Company also markets
ZANAFLEX CAPSULES® (tizanidine hydrochloride)  and Zanaflex tablets, a short-acting drug for the management of spasticity.  Acorda also receives sales royalties on tizanidine hydrochloride capsules, an  authorized generic version of ZANAFLEX CAPSULES distributed by Watson  Pharmaceutics, Inc. under its agreement with Acorda.

Acorda  has an industry-leading pipeline of novel neurological therapies. The Company  is developing Diazepam Nasal Spray for treatment of certain epileptic  seizures. It is also studying AMPYRA to improve a range of functional  impairments caused by MS, as well as its use in other neurological  conditions, including cerebral palsy and post-stroke deficits. In addition,  Acorda is developing clinical stage compounds AC105 for acute treatment of  spinal cord injury and GGF2 for treatment of heart failure. GGF2 is also  being investigated in preclinical studies as a treatment for neurological  conditions such as stroke and spinal cord injury. Additional development  programs include rHIgM22, a remyelinating monoclonal antibody for the  treatment of MS, and chondroitinase, an enzyme that encourages nerve  plasticity in spinal cord injury.


Forward-Looking tatements
This  press release includes forward-looking statements within the meaning of the  Private Securities Litigation Reform Act of 1995. All statements, other than  statements of historical facts, regarding management's expectations, beliefs,  goals, plans or prospects should be considered forward-looking. These  statements are subject to risks and uncertainties that could cause actual  results to differ materially, including our ability to successfully market  and sell Ampyra in the U.S.; third party payers (including governmental  agencies) may not reimburse for the use of Ampyra or our other products at  acceptable rates or at all and may impose restrictive prior authorization  requirements that limit or block prescriptions; the risk of unfavorable  results from future studies of Ampyra or from our other research and  development programs, including Diazepam Nasal Spray (“DZNS”) or any other  acquired or in-licensed programs; we may not be able to complete development  of, obtain regulatory approval for, or successfully market DZNS or other  products under development; the occurrence of adverse safety events with our  products; delays in obtaining or failure to obtain regulatory approval of or  to successfully market Fampyra outside of the U.S. and our dependence on our  collaboration partner Biogen Idec in connection therewith; competition,  including the impact of generic competition on Zanaflex Capsules revenues;  failure to protect our intellectual property, to defend against the  intellectual property claims of others or to obtain third party intellectual  property licenses needed for the commercialization of our products; failure  to comply with regulatory requirements could result in adverse action by  regulatory agencies; and the ability to obtain additional financing to  support our operations. These and other risks are described in greater detail  in Acorda Therapeutics' filings with the Securities and Exchange Commission.  Acorda Therapeutics may not actually achieve the goals or plans described in  its forward-looking statements, and investors should not place undue reliance  on these statements. Forward-looking statements made in this press release  are made only as of the date hereof, and Acorda Therapeutics disclaims any  intent or obligation to update any forward-looking statements as a result of developments occurring after the date of this press release. 
 
Source:  Acorda Therapeutics, Inc.
Acorda  Therapeutics, Inc.
  Jeff Macdonald,
914-326-5232
jmacdonald@acorda.com


 
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    • 2020 News Releases >
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      • Aerial BioPharma JZP-110 Dec
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      • Target PharmaSolutions Nov
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      • Arrivo BIoVentures
      • Contego Medical
    • 2015 News Releases >
      • Contego Medical
      • AMAG Pharmaceuticals Announces Further Expansion of Maternal Health Portfolio
      • Chapel Hill’s Achelios reports promising test results
    • 2014 News Releases >
      • Jazz Pharmaceuticals Announces Acquisition From Aerial Biopharma Of Rights To A Late Stage Investigational Compound
      • Aerial Hears a Cool Jazz $400M Wake-Up Call
    • 2013 News Releases >
      • TBJ 2013 Life Sciences Awards winners revealed
      • Aerial Biopharma Announces Closing of Second Tranche of Series A
    • 2012 News Releases >
      • Acorda Therapeutics Announces Completion of Neuronex, Inc. Acquisition
      • Aerial Biopbarma Receives FDA Orpban Drug Designation
      • A new migraine drug taken by skin? How Achelios could make it happen
      • Acorda 4Q profit climbs; company buying Neuronex
      • Addrenex Founders Sell Neuronex
    • 2011 News Releases >
      • Lookout Capital Announces Investment In EnviCor
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