Watch out for the new SSRI demon Vilazodone (Merck)

[Guest guest]

http://www.bioexchange.com/news/news_page.cfm?id=20855

NEW HAVEN, Conn., Sept. 23 /PRNewswire-FirstCall/ -- Genaissance

Pharmaceuticals, Inc. (Nasdaq: GNSC - News) today announced that it

has acquired an exclusive worldwide license from Merck KGaA to

develop and commercialize a small molecule compound. The compound,

vilazodone, is a selective serotonin reuptake inhibitor (SSRI) and a

5HT1A partial agonist. In Phase II clinical trials for depression,

the compound has shown signals of efficacy and a favorable side

effects profile in the more than 1,000 patients exposed to the

compound.

During the first half of 2005, Genaissance intends to commence

enrollment for a Phase II clinical trial that will include

pharmacogenomic characterization of patients. Genaissance will apply

its HAP Technology and clinical genetics experience and leverage

the existing knowledge of the genetics of depression and response to

antidepressants, especially to SSRIs. The primary goal of the

clinical trial will be to find genetic markers that can be used to

identify a population of patients who will respond to the drug.

" As compared to the traditional drug development process, we see this

agreement as representing a compelling value-creation template for

Genaissance, " said Rakin, President and Chief Executive Officer

of Genaissance. " In this instance, as opposed to traditional drug

development, a relatively modest investment should determine within

two years whether a Phase II compound can proceed to late stage

pivotal clinical testing. Moreover, the compound has a novel

mechanism of action with potentially superior claims for what is

currently a $13 billion market in the U.S. We are also pleased to

have a partner of the caliber of Merck KGaA and that they have

elected to become a stockholder in Genaissance. "

" This is an innovative approach for the further development of one of

our compounds that allows Merck to be in the forefront of

pharmacogenomic developments with a leading company in this dynamic

new field, " said Merck Chairman Bernhard Scheuble. " At the same time,

Merck can continue to focus its R & D resources on its main therapeutic

areas of Oncology and CardioMetabolic Care. "

Under the terms of the agreement, Merck KGaA is entitled to receive

up to EUR 36 million worth of common shares of Genaissance for the

initial license fee and milestone payments up to the first commercial

sale, based on a trailing average of the closing price of the stock

prior to the relevant payment dates. The license fee consisted of

369,280 shares, 84,000 of which were issued upon the execution of the

letter of intent in April 2004. Merck KGaA will also receive

royalties on all product sales and a share of all sub-licensing

income from any third party.

" There is great potential to differentiate vilazodone from other

drugs targeted for depression and anxiety, " said Carol R. , M.D.,

Vice President, Medical Affairs of Genaissance. " Not only is its

mechanism of action unique, but a pharmacogenomic-based drug should

specifically target the problem of poor overall efficacy of current

first-line treatments for depression. Since approximately 50% of

patients do not achieve initial relief of their depression, switching

and discontinuation rates are very high and patient and physician

satisfaction are low. By using genetics to target vilazodone, we

believe that patients will achieve a satisfactory response and stay

with the drug. "

In any given year, 9.5% of the U.S. population, or about 18.8 million

American adults, suffer from a depressive illness(1). Depressive

illnesses interfere with normal functioning and cause pain and

suffering not only for those affected, but also for those who care

about them(2). Sales of products for the treatment of depression

represent one of the largest therapeutic categories in the world. In

2003, sales of depression treatments were $13.2 billion in the U.S.

alone, with forecasts estimating that the U.S. market will grow to

$22.9 billion by 2013 with a compounded annual growth rate of 5.7%(3).

Genaissance will host a conference call and audio webcast to discuss

matters mentioned in this release today, September 23rd, at 2:00

p.m., Eastern Time. To participate in this call, dial 719-457-2679,

confirmation code 880744, shortly before 2:00 p.m. The audio webcast

can be accessed at: http://www.genaissance.com. A replay of the call

will be available starting at 5:00 p.m., Eastern Time, through

midnight on Monday, September 27th. The replay number is 719-457-

0820, confirmation code 880744.

About Merck KGaA

Merck is a global pharmaceutical and chemical company with sales of

EUR 7.2 billion in 2003, a history that began in 1668, and a future

shaped by 28,300 employees in 56 countries. Its success is

characterized by innovations from entrepreneurial employees. Merck's

operating activities come under the umbrella of Merck KGaA, in which

the Merck family holds a 74% interest and free shareholders own the

remaining 26%. The former U.S. subsidiary, Merck & Co., has been

completely independent of the Merck Group since 1917.

About Genaissance

Genaissance Pharmaceuticals, Inc. is developing innovative products

based on its proprietary pharmacogenomic technology and has a revenue-

generating business in DNA and pharmacogenomic products and services.

The Company's product development strategy is focused on in-licensing

drug candidates with promising clinical profiles and finding genetic

markers to identify a responsive patient population. This strategy

enables Genaissance to leverage existing clinical data and, thus,

reduce the costs and risks associated with traditional drug

development and increase the probability of clinical success and

commercialization. Genaissance intends to use this strategy to build

a late-stage, proprietary candidate drug pipeline. The Company's lead

product, vilazodone for depression, is in Phase II of development.

Genaissance also markets its proprietary FAMILION Test, designed

to detect mutations responsible for causing Familial Long QT and

Brugada Syndromes, two causes of sudden cardiac death. For more

information on Genaissance, visit our website at:

http://www.genaissance.com.

This press release contains forward-looking statements that involve a

number of risks and uncertainties. For this purpose, any forward-

looking statements contained in this press release that are not

statements of historical fact may be deemed forward-looking

statements, including, without limitation, statements about the

expected timing of clinical trials studying vilazodone, the potential

clinical benefits of vilazodone and the growth and development of

Genaissance's business and market opportunities. Important factors

that could cause actual results, events and performance to differ

materially from those referred to in such statements, include, but

are not limited to, whether vilazodone will advance in the clinical

trials process, including the timing of such clinical trials; whether

clinical trials will warrant continued product development; whether

and when, if at all, vilazodone will receive approval from the U.S.

Food and Drug Administration or equivalent regulatory agencies, and

for which indications; the extent to which genetic markers

(haplotypes) are predictive of clinical outcomes and drug efficacy

and safety; whether vilazodone will be successfully marketed; whether

Genaissance will be able to develop or acquire additional products;

the attraction of new business and strategic partners; the adoption

of our technologies by the pharmaceutical industry; competition from

pharmaceutical, biotechnology and diagnostics companies; the strength

of our intellectual property rights and those risks identified in our

Quarterly Report on Form 10-Q filed with the Securities and Exchange

Commission on August 16, 2004, and in other filings we make with the

Securities and Exchange Commission from time to time. The forward-

looking statements contained herein represent the judgment of

Genaissance as of the date of this release. Genaissance disclaims any

obligation to update any forward-looking statement.

(1) Robins LN, Regier DA (Eds). Psychiatric Disorders in

America, The

Epidemiologic Catchment Area Study, 1990; New York: The Free

Press.

(2) National Institute of Mental Health website

(http://www.nimh.nih.gov)

(3) IMS Healthcare website (http://www.ims-global.com)

[Guest guest]

http://www.bioexchange.com/news/news_page.cfm?id=20855

NEW HAVEN, Conn., Sept. 23 /PRNewswire-FirstCall/ -- Genaissance

Pharmaceuticals, Inc. (Nasdaq: GNSC - News) today announced that it

has acquired an exclusive worldwide license from Merck KGaA to

develop and commercialize a small molecule compound. The compound,

vilazodone, is a selective serotonin reuptake inhibitor (SSRI) and a

5HT1A partial agonist. In Phase II clinical trials for depression,

the compound has shown signals of efficacy and a favorable side

effects profile in the more than 1,000 patients exposed to the

compound.

During the first half of 2005, Genaissance intends to commence

enrollment for a Phase II clinical trial that will include

pharmacogenomic characterization of patients. Genaissance will apply

its HAP Technology and clinical genetics experience and leverage

the existing knowledge of the genetics of depression and response to

antidepressants, especially to SSRIs. The primary goal of the

clinical trial will be to find genetic markers that can be used to

identify a population of patients who will respond to the drug.

" As compared to the traditional drug development process, we see this

agreement as representing a compelling value-creation template for

Genaissance, " said Rakin, President and Chief Executive Officer

of Genaissance. " In this instance, as opposed to traditional drug

development, a relatively modest investment should determine within

two years whether a Phase II compound can proceed to late stage

pivotal clinical testing. Moreover, the compound has a novel

mechanism of action with potentially superior claims for what is

currently a $13 billion market in the U.S. We are also pleased to

have a partner of the caliber of Merck KGaA and that they have

elected to become a stockholder in Genaissance. "

" This is an innovative approach for the further development of one of

our compounds that allows Merck to be in the forefront of

pharmacogenomic developments with a leading company in this dynamic

new field, " said Merck Chairman Bernhard Scheuble. " At the same time,

Merck can continue to focus its R & D resources on its main therapeutic

areas of Oncology and CardioMetabolic Care. "

Under the terms of the agreement, Merck KGaA is entitled to receive

up to EUR 36 million worth of common shares of Genaissance for the

initial license fee and milestone payments up to the first commercial

sale, based on a trailing average of the closing price of the stock

prior to the relevant payment dates. The license fee consisted of

369,280 shares, 84,000 of which were issued upon the execution of the

letter of intent in April 2004. Merck KGaA will also receive

royalties on all product sales and a share of all sub-licensing

income from any third party.

" There is great potential to differentiate vilazodone from other

drugs targeted for depression and anxiety, " said Carol R. , M.D.,

Vice President, Medical Affairs of Genaissance. " Not only is its

mechanism of action unique, but a pharmacogenomic-based drug should

specifically target the problem of poor overall efficacy of current

first-line treatments for depression. Since approximately 50% of

patients do not achieve initial relief of their depression, switching

and discontinuation rates are very high and patient and physician

satisfaction are low. By using genetics to target vilazodone, we

believe that patients will achieve a satisfactory response and stay

with the drug. "

In any given year, 9.5% of the U.S. population, or about 18.8 million

American adults, suffer from a depressive illness(1). Depressive

illnesses interfere with normal functioning and cause pain and

suffering not only for those affected, but also for those who care

about them(2). Sales of products for the treatment of depression

represent one of the largest therapeutic categories in the world. In

2003, sales of depression treatments were $13.2 billion in the U.S.

alone, with forecasts estimating that the U.S. market will grow to

$22.9 billion by 2013 with a compounded annual growth rate of 5.7%(3).

Genaissance will host a conference call and audio webcast to discuss

matters mentioned in this release today, September 23rd, at 2:00

p.m., Eastern Time. To participate in this call, dial 719-457-2679,

confirmation code 880744, shortly before 2:00 p.m. The audio webcast

can be accessed at: http://www.genaissance.com. A replay of the call

will be available starting at 5:00 p.m., Eastern Time, through

midnight on Monday, September 27th. The replay number is 719-457-

0820, confirmation code 880744.

About Merck KGaA

Merck is a global pharmaceutical and chemical company with sales of

EUR 7.2 billion in 2003, a history that began in 1668, and a future

shaped by 28,300 employees in 56 countries. Its success is

characterized by innovations from entrepreneurial employees. Merck's

operating activities come under the umbrella of Merck KGaA, in which

the Merck family holds a 74% interest and free shareholders own the

remaining 26%. The former U.S. subsidiary, Merck & Co., has been

completely independent of the Merck Group since 1917.

About Genaissance

Genaissance Pharmaceuticals, Inc. is developing innovative products

based on its proprietary pharmacogenomic technology and has a revenue-

generating business in DNA and pharmacogenomic products and services.

The Company's product development strategy is focused on in-licensing

drug candidates with promising clinical profiles and finding genetic

markers to identify a responsive patient population. This strategy

enables Genaissance to leverage existing clinical data and, thus,

reduce the costs and risks associated with traditional drug

development and increase the probability of clinical success and

commercialization. Genaissance intends to use this strategy to build

a late-stage, proprietary candidate drug pipeline. The Company's lead

product, vilazodone for depression, is in Phase II of development.

Genaissance also markets its proprietary FAMILION Test, designed

to detect mutations responsible for causing Familial Long QT and

Brugada Syndromes, two causes of sudden cardiac death. For more

information on Genaissance, visit our website at:

http://www.genaissance.com.

This press release contains forward-looking statements that involve a

number of risks and uncertainties. For this purpose, any forward-

looking statements contained in this press release that are not

statements of historical fact may be deemed forward-looking

statements, including, without limitation, statements about the

expected timing of clinical trials studying vilazodone, the potential

clinical benefits of vilazodone and the growth and development of

Genaissance's business and market opportunities. Important factors

that could cause actual results, events and performance to differ

materially from those referred to in such statements, include, but

are not limited to, whether vilazodone will advance in the clinical

trials process, including the timing of such clinical trials; whether

clinical trials will warrant continued product development; whether

and when, if at all, vilazodone will receive approval from the U.S.

Food and Drug Administration or equivalent regulatory agencies, and

for which indications; the extent to which genetic markers

(haplotypes) are predictive of clinical outcomes and drug efficacy

and safety; whether vilazodone will be successfully marketed; whether

Genaissance will be able to develop or acquire additional products;

the attraction of new business and strategic partners; the adoption

of our technologies by the pharmaceutical industry; competition from

pharmaceutical, biotechnology and diagnostics companies; the strength

of our intellectual property rights and those risks identified in our

Quarterly Report on Form 10-Q filed with the Securities and Exchange

Commission on August 16, 2004, and in other filings we make with the

Securities and Exchange Commission from time to time. The forward-

looking statements contained herein represent the judgment of

Genaissance as of the date of this release. Genaissance disclaims any

obligation to update any forward-looking statement.

(1) Robins LN, Regier DA (Eds). Psychiatric Disorders in

America, The

Epidemiologic Catchment Area Study, 1990; New York: The Free

Press.

(2) National Institute of Mental Health website

(http://www.nimh.nih.gov)

(3) IMS Healthcare website (http://www.ims-global.com)