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Sepracor

 
Wikipedia: Sepracor
 
Sepracor, Inc.
Type Public (NASDAQSEPR)
Founded 1984
Headquarters Marlborough, Massachusetts
Key people Timothy J. Barberich, Chairman;
Industry Pharmaceuticals
Products Lunesta, Xopenex, Brovana
Employees 1,325 (2009)[1]
Website http://www.sepracor.com

Sepracor, Inc. (NASDAQSEPR) is a pharmaceutical company founded in 1984 by Tim Barberich (President, CEO). It was originally located in Princeton, New Jersey and then re-located to Marlborough, Massachusetts.[2]

Contents

History

The company's initial focus was on the development of single isomers and active metabolites. This concept allowed Mr. Barberich and Doug Reedich, PhD, JD (Chief Patent Council) to generate an impressive patent estate that served the company well for many years. Therapeutically, Sepracor's products were focused on the treatment of central nervous system and respiratory disorders, under the direction of Gunnar Aberg, PhD (VP of Research and Development) and John McCullough, PhD (Director of Research). The primary source of its revenue is the approximately $600 million annually from its Xopenex franchise of drugs, launched under the marketing leadership of John Simon, with the direct involvement of Medical Communications, under Dean Handley, PhD. It is available as a multi-dose inhaler (MDI) or nebulized (UDV) form. However, the insomnia drug Lunesta, which was discovered by Tom Jerussi, PhD, approved by the U.S. Food and Drug Administration (FDA) in December 2004 and launched in April 2005 under the marketing leadership of Tim Healy, is on pace to exceed $1 billion in annual sales.[citation needed] In addition, on February 13, 2006, Sepracor filed a new drug application (NDA) for Brovana, patented by Gunnar Aberg and John Morley, PhD (also launched under John Simon) to treat Chronic Obstructive Pulmonary Disease (COPD). All of the launch drugs were manufactured under the leadership of Walter Piskorski.[citation needed]

In recent developments, the company executed a 20% layoff in early 2009[3] and then got word Lunesta would be going generic in 2012 thanks to 9 ANDA generic filers including Teva-Barr, Dr. Reddy and Roxane. The recent bad news underlines Sepracor’s broad exposure to generic competition as both Xopenex inhalation solution and Lunesta brands will fall silent almost exactly at the same time in Q3-2012, leaving Omnaris, Alvesco, Brovana and Stedesa to fill in the revenue gaps.[citation needed]

Beneficiaries, partners, and subsidiaries

Acadia Pharmaceuticals

On January 11, 2005, Sepracor partnered to advance a joint muscarinic-1 receptor agonist program for neuropathic pain.

Schering-Plough

In December 1997 Schering-Plough obtained exclusive worldwide rights to Sepracor's patents relating to desloratadine, discovered and patented by Drs. Gunnar Aberg, John McCullough, Emil Smith and Dean A. Handley. In January 2002, Schering-Plough launched the product as Clarinex for the treatment of seasonal allergic rhinitis (SAR).

Sanofi-Aventis

Sepracor earns royalties from patents relating to fexofenadine which is marketed as Allegra by Sanofi-Aventis. Fexofenadine is a nonsedating antihistamine for the treatment of allergic rhinitis. In December 1993, Sepracor licensed the United States patent for the use of fexofenadine to Hoechst Marion Roussel (HMRI). HMRI developed the drug and launched it in late 1996 as Allegra brand fexofenadine hydrochloride.

Sepracor Canada (Nova Scotia) Ltd.

Sepracor Canada (Nova Scotia) Ltd. is a 50,000-square-foot (4,600 m2) facility located in Windsor, Nova Scotia, Canada. Sepracor Canada is a pilot and commercial plant operation and the commercial manufacturing site since launch for levalbuterol HCl, the active ingredient in XOPENEX; eszopiclone, the active ingredient in LUNESTA; and arformoterol tartrate, the active ingrediant in Brovana.

GlaxoSmithKline

On September 11, 2007, Sepracor signed a marketing deal with British pharmaceutical company GlaxoSmithKline over the rights to sell Lunesta in Europe.[4] If all stipulations are met, Sepracor is expected to receive approximately 155 million dollars in compensation for supplying the drug.[4] Currently, Lunesta, known as Lunivia in Europe, is under review by the European Union's equivalent of the U.S. Food and Drug Administration for regulatory purposes.[4]

Nycomed

On January 28, 2008, Sepracor and Nycomed announced an exclusive development, marketing and commercialization agreement for ciclesonide in the United States.[5]

BIA 2-093

In 2008, Bial agreed with Sepracor that its antiepileptic BIA 2.093 would be produced in Sepracor's facilities and supervised by Bial. [6]

Omnaris and Alvesco

The company recently acquired Omnaris and Alvesco for $150M upfront and an addition $280M in potential milestones. Alvesco revenues for Q4'08 were -$0.3 million because returns from the "stocking" in Q3'08 exceeded the demand in Q4'08. The company disclosed a 2009 forecast of $25-$40M for Omnaris and $10-15M for Alvesco; yielding a combined total of $35M-$55M in year 2 of a launch. However, revenues continue to be dismal, prompting criticisms and concerns over the purchase price relative to minuscule income.

2009 layoffs and stock incentive plan

The company announced its second layoff in 16 months. This layoff was attributed to a “challenging economic time for the country and the pharmaceutical industry”, stated Mr. Adams, current CEO of Sepracor. However, Adams accepted a large pay increase to $6.5 million annually, and was the seventh highest paid CEO in Massachusetts in 2007. Furthermore, the management has awarded top executives with a new 2009 stock incentive plan which will allow executives to receive a maximum of 500,000 shares per year. The exact number of shares for each executive will be determined by the board compensation committee; however, typical grants for a company this size are 50,000 to 125,000 for each executive and could be a mixture of restricted stock as well as stock options (Rising Star Equity, LLC. – by Stan M. Goldmen, April 13, 2009).

See also

References

External links


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