ELN » Topics » (A) Marketed products

This excerpt taken from the ELN 20-F filed Feb 26, 2009.
Marketed Products
 
Twenty-three (23) products incorporating EDT technologies are currently marketed by EDT licensees, and EDT receives royalties and, in some cases, manufacturing fees on these, including:
 
         
Licensee
 
Product
 
Indication
 
Abbott Laboratories
  TriCor® 145   Cholesterol
Merck & Co., Inc. 
  Emend®   Nausea post chemo
Novartis AG
  Focalin XR®/Ritalin LA®   ADHD(1)
Wyeth
  Rapamune®   Anti-rejection
Victory Pharma
  Naprelan®   NSAID(2) — Pain
King Pharmaceuticals, Inc. 
  Avinza®   Chronic pain
Par Pharmaceutical Co., Inc. 
  Megace® ES   Cachexia
Acorda Therapeutics, Inc. 
  Zanaflex®   Muscle spasticity
 
 
(1) Attention Deficit Hyperactivity Disorder
 
(2) Non-Steroidal Anti-Inflammatory Drug


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This excerpt taken from the ELN 20-F filed Feb 28, 2008.
Marketed Products
 
22 products that incorporate EDT technologies are currently marketed by EDT licensees, and on which EDT receives royalties and in some cases manufacturing fees, including:
 
         
Licensee
 
Product
 
Indication
 
Abbott Laboratories
  TriCor®   Cholesterol
Merck & Co., Inc. 
  Emend®   Nausea post chemo
Novartis AG
  Focalin®/Ritalin®   ADHD(1)
Wyeth
  Rapamune®   Anti-Rejection
Victory Pharma
  Naprelan®   NSAID(2) — Pain
King Pharmaceuticals, Inc. 
  Avinza®   Chronic pain
Par Pharmaceutical Co., Inc. 
  Megace® ES   Cachexia
Acorda Therapeutics, Inc. 
  Zanaflex®   Muscle spasticity
 
(1) Attention Deficit Hyperactivity Disorder
 
(2) Non-Steroidal Anti-Inflammatory Drug


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This excerpt taken from the ELN 20-F filed Mar 30, 2006.
(A) Marketed products
 
Total revenue from marketed products increased to $174.5 million in 2004 from $154.2 million in 2003. The increase of 13% primarily reflected the growth in prescriptions and demand for Maxipime and Azactam, and initial sales of Tysabri. The basic patent on Maxipime expires in March 2007 and the basic patent on Azactam expired in October 2005. Two U.S. patents covering Maxipime formulations may provide patent protection until 2008. The expiration of these patents is expected to result in generic competition for these products, which could adversely impact future revenues. To date no Azactam generic has been approved.
 
As reported by IMS Health National Sales Perspectives, Maxipime prescription demand for 2004 increased by 14% over 2003, while revenues increased from $109.1 million to $117.5 million, or 8%. Azactam prescription demand for 2004 increased by 12% over the same period in 2003, corresponding to increased revenues from $45.1 million to $50.6 million. The difference between prescription and revenue growth rates is due to changing wholesaler inventory levels.
 
The FDA granted accelerated approval of Tysabri in late November 2004 for the treatment of patients in the United States with all forms of relapsing remitting MS. Revenue from Tysabri amounted to $6.4 million in 2004. The marketing and clinical dosing of Tysabri was voluntarily suspended in February 2005. On March 7-8, 2006, the PCNS Advisory Committee reviewed and voted unanimously to recommend that Tysabri be reintroduced as a treatment for relapsing forms of MS. On March 21, 2006, we and Biogen Idec were informed by the FDA that the agency would extend its regulatory review of Tysabri by up to 90 days in order to complete a full review of the


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Tysabri risk management plan. Under the revised timeline, we anticipate an action from the FDA about the reintroduction of Tysabri as a treatment for relapsing forms of MS on or before June 28, 2006.
 
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