UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, DC  20549

 


 

FORM 8-K

 


 

Current Report Pursuant

to Section 13 or 15(d) of the

Securities Exchange Act of 1934

 

Date of Report (Date of earliest event Reported):  July 14, 2008

 


 

THERAVANCE, INC.

(Exact Name of Registrant as Specified in its Charter)

 

Delaware

(State or Other Jurisdiction of
Incorporation)

 

000-30319

(Commission File Number)

 

94-3265960

(I.R.S. Employer Identification Number)

 

901 Gateway Boulevard
South San Francisco, California 94080
(650) 808-6000

(Addresses, including zip code, and telephone numbers, including area code, of principal executive offices)

 


 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

 

o            Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

o            Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

o            Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

o            Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

 



 

Item 7.01 Regulation FD Disclosure.

 

The information contained in this Item 7.01 and in the accompanying exhibits shall not be deemed filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or incorporated by reference in any filing under the Exchange Act or the Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such filing.

 

On July 14, 2008, Theravance, Inc. (the “Company”) issued press releases announcing results from a Phase 2 clinical study in its bifunctional muscarinic antagonist-beta2 agonist (MABA) program and a Phase 1 clinical study in its long-acting muscarinic antagonist (LAMA) program.  Copies of the press releases are attached hereto as Exhibits 99.1 and 99.2 and are incorporated herein by reference.  Members of the Company’s management will discuss these results and present a slide presentation on a conference call today at 5:00 p.m. Eastern Daylight Time. The slide presentation is available on the Company’s website on the bottom left corner under “Latest Presentation”, and is attached hereto as Exhibit 99.3 and incorporated herein by reference.

 

2



 

ITEM 9.01 Financial Statements and Exhibits.

 

 

(d)

Exhibits

 

 

 

 

Exhibit

 

Description

 

 

 

 

 

Exhibit 99.1

 

Press release dated July 14, 2008

 

Exhibit 99.2

 

Press release dated July 14, 2008

 

Exhibit 99.3

 

Slide presentation

 

3



 

SIGNATURE

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

 

 

 

THERAVANCE, INC.

 

 

 

 

Date: July 14, 2008

 

By:

/s/ Rick E Winningham

 

 

 

 

 

 

 

Rick E Winningham

 

 

 

Chief Executive Officer

 

4



 

EXHIBIT INDEX

 

Exhibit  No.

 

Exhibit

99.1

 

Press release dated July 14, 2008

99.2

 

Press release dated July 14, 2008

99.3

 

Slide presentation

 

5


 

Exhibit 99.1

 

Theravance Announces Positive Phase 2 Clinical Results in the

MABA Respiratory Program for the Treatment of COPD

 

Theravance Earns $10 million Proof-of-Concept Milestone Under

Strategic Alliance Agreement with GSK

 

SOUTH SAN FRANCISCO, CA/July 14, 2008 – Theravance, Inc. (NASDAQ: THRX) announced today the positive results from a Phase 2 study of the lead investigational compound GSK961081 (‘081) in the inhaled bifunctional muscarinic antagonist-beta2 agonist (MABA) program. The MABA program was licensed to GlaxoSmithKline (GSK) in 2005 under the terms of the companies’ Strategic Alliance Agreement as a potential treatment for patients with chronic obstructive pulmonary disease (COPD). The successful achievement of proof-of-concept in the MABA Phase 2 clinical study triggers a milestone payment of $10 million from GSK.

 

“We are very encouraged by the results of this study,” said Rick Winningham, Chief Executive Officer of Theravance.  “‘081 is the first compound studied in COPD patients that combines the activity of both a beta2 agonist and a muscarinic antagonist in a single small molecule. We believe that this compound may provide a new monotherapy treatment option for the increasing number of patients living with COPD, or potentially as combination therapy with an anti-inflammatory medication.”

 

GSK961081 is being investigated as an inhaled multivalent bifunctional bronchodilator that is a single small molecule functioning both as a muscarinic antagonist and a beta2 receptor agonist. This compound was discovered by Theravance through the application of multivalent design in a discovery program dedicated to finding new medicines for respiratory diseases such as COPD and asthma.  ‘081 is under development by GSK and Theravance as a potential treatment for patients with COPD.

 

In the recently completed Phase 2 study, both doses of ‘081 (400 mcg and 1,200 mcg) administered once daily demonstrated 24-hour bronchodilation on day 14 that was statistically greater than placebo and comparable to a combination therapy active control of salmeterol (50 mcg) dosed twice daily plus tiotropium (18 mcg) dosed once daily. At 24 hours on day 14 of treatment, 400 and 1,200 mcg doses of ‘081 produced placebo-adjusted, dose-dependent mean changes in FEV1 (forced expiratory volume in one second) of 115 mL (p=0.013) and 168 mL (p<0.001), respectively, while the active control of salmeterol plus tiotropium showed a change of 103 mL (p=0.009). This study was not powered to compare the results of salmeterol plus tiotropium control. Both the time to peak effect and the maximum bronchodilation of ‘081 at both doses were numerically better than salmeterol plus tiotropium control.

 

GSK961081 was generally well tolerated throughout the 14-day study. Adverse events occurred at a similar rate in the treatment and control groups, except for a low incidence of dry mouth (N=1/32) and tremor (N=2/32) in the high-dose ‘081 treatment group and a low incidence of abnormal taste at both doses. Adverse events were generally mild or moderate, with the most common adverse events being headache and dizziness, which were seen with similar frequency in the placebo and active control arms. There were no serious adverse events reported in the study.

 

Study Design

 

The Phase 2 clinical study was a randomized, crossover, incomplete block, double-blind, double-dummy, placebo- and active-controlled study designed to evaluate the safety and efficacy of ‘081 (400 mcg and 1,200 mcg) administered once daily for 14 days in a dry powder inhaler. A total of 50 patients with COPD of moderate severity were randomized to receive ‘081 dosed once daily, the combination of salmeterol dosed twice daily plus tiotropium dosed once daily, or placebo. The primary endpoint of this study was mean change in FEV1 for ‘081 or salmeterol plus tiotropium-treated patients compared to placebo.

 



 

Conference Call and Webcast Information

 

The company has scheduled a conference call to discuss this announcement today at 5:00 p.m. Eastern Daylight Time. To participate in the live call by telephone, please dial 877-545-1489 from the U.S., or 719-325-4907 for international callers. Those interested in listening to the conference call live via the internet may do so by visiting the company’s web site at www.theravance.com. To listen to the live call, please go to the web site 15 minutes prior to its start to register, download, and install any necessary audio software.

 

A replay of the conference call will be available on the company’s web site for 30 days through August 13, 2008. An audio replay will also be available through 11:59 p.m. Eastern Daylight Time on July 28, 2008 by dialing 888-203-1112 from the U.S., or 719-457-0820 for international callers, and entering confirmation code 5994317.

 

About Theravance

 

Theravance is a biopharmaceutical company with a pipeline of internally discovered product candidates. Theravance is focused on the discovery, development and commercialization of small molecule medicines across a number of therapeutic areas including respiratory disease, bacterial infections and gastrointestinal motility dysfunction. The company’s key programs include:  telavancin for the treatment of serious Gram-positive bacterial infections with Astellas Pharma Inc., the Horizon program with GlaxoSmithKline plc, and the Gastrointestinal Motility Dysfunction program. By leveraging its proprietary insight of multivalency toward drug discovery focused primarily on validated targets, Theravance is pursuing a next generation strategy designed to discover superior medicines in areas of significant unmet medical need.  For more information, please visit the company’s web site at www.theravance.com.

 

THERAVANCE®, the Theravance logo, and MEDICINES THAT MAKE A DIFFERENCE® are registered trademarks of Theravance, Inc.

 

This press release contains and the conference call will contain certain “forward-looking” statements as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding, among other things, statements relating to goals, plans, objectives and future events. Theravance intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 21E of the Exchange Act and the Private Securities Litigation Reform Act of 1995. Examples of such statements include statements relating to the goals and expected timing of clinical studies and data from studies, statements regarding the potential benefits and mechanisms of action of drug candidates, statements concerning the timing of seeking regulatory approval of our product candidates, statements regarding the enabling capabilities of Theravance’s approach to drug discovery and its proprietary insights, statements concerning expectations for product candidates through development and commercialization and projections of revenue and other financial items. These statements are based on the current estimates and assumptions of the management of Theravance as of the date of this press release and conference call and are subject to risks, uncertainties, changes in circumstances, assumptions and other factors that may cause the actual results of Theravance to be materially different from those reflected in its forward-looking statements. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, among others, risks related to delays or difficulties in commencing or completing clinical studies, the potential that results of clinical or preclinical studies indicate product candidates are unsafe or ineffective, our dependence on third parties in the conduct of our clinical studies and risks of collaborating with third parties to develop and commercialize products. These and other risks are described in greater detail under the heading “Risk Factors”

 



 

contained in Item 1A of Theravance’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on May 8, 2008 and the risks discussed in our other periodic filings with the SEC. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Theravance assumes no obligation to update its forward-looking statements.

 

Contact Information:

 

Michael W. Aguiar

Senior Vice President and Chief Financial Officer

650-808-4100

investor.relations@theravance.com

 


Exhibit 99.2

 

Theravance Announces Clinical Results in the LAMA Respiratory Program

for the Treatment of COPD

 

GSK Intends to Return LAMA Program to Theravance

 

SOUTH SAN FRANCISCO, CA/July 14, 2008 – Theravance, Inc. (NASDAQ: THRX) today announced the results from a Phase 1 study designed to assess the safety, tolerability and pharmacokinetics of an investigational inhaled long-acting muscarinic antagonist (LAMA), GSK1160724/TD-4208 (TD-4208), for the treatment of chronic obstructive pulmonary disease (COPD). In this study, TD-4208 was generally well tolerated at all doses tested. In addition, TD-4208 showed the potential for 24-hour bronchodilation in COPD patients.

 

Originally discovered by Theravance, TD-4208 was licensed to GlaxoSmithKline (GSK) in 2004 under the terms of the companies’ Strategic Alliance Agreement. Recently, GSK informed Theravance that it intends to return the LAMA program to Theravance because the current formulation of TD-4208 is incompatible with GSK’s proprietary inhaler device. Both parties are currently discussing the transfer of information and materials back to Theravance.

 

“We are encouraged by these Phase 1 results which showed that TD-4208 dosed once daily was generally well tolerated,” said Rick Winningham, Chief Executive Officer of Theravance. “There is a large underserved COPD patient population that needs better long-acting treatment options. Upon the return of the LAMA program to Theravance, we intend to explore partnerships for the further development of this compound.”

 

Theravance and GSK will continue to progress development of other collaborative respiratory programs, including Horizon and the bifunctional muscarinic antagonist/beta2 agonist (MABA) program.

 

Study Design and Results

 

The Phase 1 clinical study was a single-dose randomized, crossover, incomplete block, double-blind, placebo- and active-controlled study designed to evaluate the safety, tolerability and pharmacokinetics of multiple doses of TD-4208. A total of 20 healthy volunteers were randomized to receive TD-4208 dosed once daily, tiotropium dosed once daily, or placebo. The primary endpoint of this study was overall safety and tolerability of TD-4208.

 

In the study, TD-4208 was generally well tolerated with a similar incidence of adverse events to placebo and there was no significant increase in heart rate or evidence of dry mouth. Abnormal taste was reported at the higher doses. All adverse events were mild or moderate with no serious adverse events reported in the study. Additionally, TD-4208 demonstrated evidence of bronchodilation in volunteers sensitive to muscarinic antagonists.

 



 

About TD-4208 and the LAMA Program

 

TD-4208 is an inhaled, long-acting muscarinic antagonist (LAMA) discovered by Theravance through the application of multivalent drug design in a drug discovery program dedicated to finding new medicines for respiratory diseases such as COPD and asthma. Inhaled muscarinic antagonists are frequently used as bronchodilators for COPD and work by inhibiting muscarinic receptors in the airways, which leads to improved lung function. Theravance’s intent was to discover LAMA compounds that are highly lung-selective and have a prolonged effect. Higher lung selectivity should result in improved tolerability.  The goal of the LAMA program is to develop an effective once-daily medicine that offers improved efficacy and tolerability relative to the market leaders.

 

Conference Call and Webcast Information

 

The company has scheduled a conference call to discuss this announcement today at 5:00 p.m. Eastern Daylight Time. To participate in the live call by telephone, please dial 877-545-1489 from the U.S., or 719-325-4907 for international callers. Those interested in listening to the conference call live via the internet may do so by visiting the company’s web site at www.theravance.com. To listen to the live call, please go to the web site 15 minutes prior to its start to register, download, and install any necessary audio software.

 

A replay of the conference call will be available on the company’s web site for 30 days through August 13, 2008. An audio replay will also be available through 11:59 p.m. Eastern Daylight Time on July 28, 2008 by dialing 888-203-1112 from the U.S., or 719-457-0820 for international callers, and entering confirmation code 5994317.

 

About Theravance

 

Theravance is a biopharmaceutical company with a pipeline of internally discovered product candidates. Theravance is focused on the discovery, development and commercialization of small molecule medicines across a number of therapeutic areas including respiratory disease, bacterial infections and gastrointestinal motility dysfunction. The company’s key programs include:  telavancin for the treatment of serious Gram-positive bacterial infections with Astellas Pharma Inc., the Horizon program with GlaxoSmithKline plc, and the Gastrointestinal Motility Dysfunction program. By leveraging its proprietary insight of multivalency toward drug discovery focused primarily on validated targets, Theravance is pursuing a next generation strategy designed to discover superior medicines in areas of significant unmet medical need.  For more information, please visit the company’s web site at www.theravance.com.

 

THERAVANCE®, the Theravance logo, and MEDICINES THAT MAKE A DIFFERENCE® are registered trademarks of Theravance, Inc.

 

This press release contains and the conference call will contain certain “forward-looking” statements as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding, among other things, statements relating to goals, plans, objectives and future events. Theravance intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 21E of the Exchange Act and the Private Securities Litigation Reform Act of 1995. Examples of such statements include statements relating to the goals and expected timing of clinical studies and data from studies, statements regarding the potential benefits and mechanisms of action of drug candidates, statements concerning the timing of seeking regulatory approval of our product candidates, statements regarding the enabling capabilities of Theravance’s approach to drug discovery and its proprietary insights, statements concerning expectations for product candidates through development and commercialization and projections of revenue and other financial items. These statements are based on the current estimates and assumptions of the

 



 

management of Theravance as of the date of this press release and conference call and are subject to risks, uncertainties, changes in circumstances, assumptions and other factors that may cause the actual results of Theravance to be materially different from those reflected in its forward-looking statements. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, among others, risks related to delays or difficulties in commencing or completing clinical studies, the potential that results of clinical or preclinical studies indicate product candidates are unsafe or ineffective, our dependence on third parties in the conduct of our clinical studies and risks of collaborating with third parties to develop and commercialize products. These and other risks are described in greater detail under the heading “Risk Factors” contained in Item 1A of Theravance’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on May 8, 2008 and the risks discussed in our other periodic filings with the SEC. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Theravance assumes no obligation to update its forward-looking statements.

 

Contact Information:

 

Michael W. Aguiar

Senior Vice President and Chief Financial Officer

650-808-4100

investor.relations@theravance.com

 


Exhibit 99.3

 

 

GRAPHIC

Theravance, Theravance’s logo and Medicines That Make a Difference are registered trademarks of Theravance, Inc. © 2008 Theravance, Inc. ® ® MABA Program Conference Call July 14, 2008

 


GRAPHIC

2 Safe Harbor This presentation contains certain “forward-looking” statements as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding, among other things, statements relating to goals, plans, objectives and future events. Theravance intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 21E of the Exchange Act and the Private Securities Litigation Reform Act of 1995. The words “may”, “will”, “should”, “could”, “would”, “plan”, “anticipate”, “believe”, “estimate”, “intend”, “goal,” “project”, “potential”, “expect”, “consistent”, “supportive”, “targeting” and “promising” and similar expressions are intended to identify such forward-looking statements. Examples of such statements include statements relating to the goals and expected timing of clinical studies and data from studies, statements regarding the potential benefits and mechanisms of action of drug candidates, statements concerning the timing of seeking regulatory approval of our product candidates, statements regarding the enabling capabilities of Theravance’s approach to drug discovery and its proprietary insights, statements concerning expectations for product candidates through development and commercialization and projections of revenue and other financial items. These statements are based on the current estimates and assumptions of the management of Theravance as of the date of this presentation and are subject to risks, uncertainties, changes in circumstances, assumptions and other factors that may cause the actual results of Theravance to be materially different from those reflected in its forward-looking statements. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, among others, risks related to delays or difficulties in commencing or completing clinical studies, the potential that results of clinical or preclinical studies indicate product candidates are unsafe or ineffective, our dependence on third parties in the conduct of our clinical studies, and risks of collaborating with third parties to develop and commercialize products. These and other risks are described in greater detail under the heading “Risk Factors” contained in Item 1A of Theravance’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on May 8, 2008 and the risks discussed in our other periodic filings with the SEC. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Theravance assumes no obligation to update its forward-looking statements.

 


GRAPHIC

3 M3 Ki (nM) ß2 Ki (nM) 83 >1,000 Muscarinic, ß2 Receptors: Dual Pharmacology 9 >10,000 824 25 0.2 1 >10,000 29 Inhaled compound for COPD with two validated mechanisms

 


GRAPHIC

4 Phase 2 Study Goal and Design Goal: To demonstrate an increase in FEV1 on day 14 with GSK961081 QD compared to placebo, benchmarked to the combination of tiotropium QD plus salmeterol BID Design Multi-center, randomized, double-blind, double-dummy, placebo- and active-controlled, incomplete block crossover design 14-day treatment period - GSK961081: 400 and 1200 mcg QD in DPI - Salmeterol (50 mcg) BID + Tiotropium (18 mcg) QD - Placebo 50 patients with COPD selected for responsiveness to both ipratropium and salbutamol at screening

 


GRAPHIC

5 0 50 100 150 200 400 mcg QD 1200 mcg QD Salmeterol BID plus Tiotropium QD Placebo-adjusted Mean ^ in FEV1 ‘081 Phase 2 14-Day DPI Dose-Ranging Study 24-hour Bronchodilation on Day 14 ‘081 QD bronchodilation comparable to salmeterol BID + tiotropium QD (mL) 115 mL (24–205) 168 mL (80–255) 103 mL (26-180) *P-value vs. placebo P=0.013* P<0.001* P=0.009*

 


GRAPHIC

6 0.0 2.0 4.0 6.0 8.0 10.0 400 mcg QD 1200 mcg QD Salmeterol BID plus Tiotropium QD ‘081 Phase 2 14-Day DPI Dose-Ranging Study Heart Rate Change on Day 14 Change in heart rate comparable to or lower than salmeterol BID + tiotropium QD Weighted Mean ^. from Baseline (0-4 hours) Placebo-Corrected Heart Rate (b.p.m.)

 


GRAPHIC

Theravance, Theravance’s logo and Medicines That Make a Difference are registered trademarks of Theravance, Inc. © 2008 Theravance, Inc. ® ®