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Generic Drug Opportunity Assessment : Asenapine (Saphris)

  • January 2014
  • -
  • Greystone Research Associates

Greystone Research has identified a branded drug that represents an attractive opportunity for generic drug companies that utilize the provisions under Section 505(j)(2)(A)(vii)(IV) as part of their ANDA-filing strategy. Details of our findings are contained in an insightful assessment, the highlights if which are presented below.

The Brand

Asenapine (Saphris) is a psychotropic agent indicated for the treatment of psychological disorders, including schizophrenia and bipolar disorder. The drug is supplied as a sublingual tablet. The brand drug owner is Merck and Co. Merck acquired Saphris as part of its 2009 acquisition of Schering-Plough. Schering-Plough acquired the then-development stage drug via its acquisition of Organon Biosciences in 2007. In 2010, asenapine, sold under the brand name Sycrest, received marketing approval in the EU for the treatment of bipolar I disorder in adults. In 2010, Merck and H. Lundbeck A/S announced a worldwide commercialization agreement for Sycrest sublingual tablets (5 mg, 10 mg). Under the terms of the agreement, Lundbeck paid a fee and makes product supply payments in exchange for exclusive commercial rights to Sycrest in all markets outside the United States, China and Japan. Merck’s sales of Saphris were $166 million in 2012 and $120 million in 2011.

The Drug

Saphris currently competes in a global market valued at approximately $13 billion annually. This therapeutic market consists of about a dozen unique APIs that are supplied in a variety of dosage form, primarily oral tablets. Several sustained injectable drugs have entered the market in the past few years. These drugs are designed to reduce the dosing frequency as a way of improving compliance and safety for schizophrenic patients.

The Market

Schizophrenia occurs in 1 percent of the general population, but it occurs in 10 percent of people who have a first-degree relative with the disorder, such as a parent, brother, or sister. People who have second-degree relatives (aunts, uncles, grandparents, or cousins) with the disease also develop schizophrenia more often than the general population. The risk is highest for an identical twin of a person with schizophrenia. He or she has a 40 to 65 percent chance of developing the disorder.

Therapeutic Sector P (IV) Activity

Recent Paragraph (IV) activity in the psychotropic drug segment has been limited, reflecting the life cycle stage of important branded drugs in this space. We epect activity to increase beginning in 2015 as several branded drugs reach the stage where challenges from generic drug sector participants is likely.

The Opportunity

Saphris had global revenue of US $ 166 million in 2012. We are forecasting revenue of $245 million in 2015. The drug competes with more than twenty product (brand + generic), including Risperdal Consta (Alkermes); Invega Sustenna (Ortho-McNeil Janssen); and Zyprexa Relprevv (Eli Lilly). The current ‘best’ retail price for Saphris is $370 for a prescription of 30 10 mg orally disintegrating tablets. This equates to a one-month supply based upon drug label guidelines. The annual retail cost is $4,440.

Generic Revenue Opportunity

We are predicting that the ANDA first-filer entering the market in will capture of the total global market for asenapine drugs for the treatment of schizophrenia in calendar year. The majority of sales will come during the 180-day exclusivity period, at a price approximate- ly of the brand price.

Report Highlights

Saphris – The Brand
Asenapine – The Product
Asenapine – The Market
Asenapine – The Opportunity
Manufacturing and Sourcing
Saphris Patents and Exclusivity
Therapeutic Class P4 Certifications
Generic First-to-File Revenue Opportunity
Business Risk Assessment
First-to-File – Probabilistic Scenario

Table Of Contents

Generic Drug Opportunity Assessment : Asenapine (Saphris)

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