VRTX » Topics » Item 8.01. Other Events.

This excerpt taken from the VRTX 8-K filed Oct 6, 2009.

Item 8.01.  Other Events.

 

On September 30, 2009, we entered into two financing transactions that resulted in aggregate payments to us of $155.0 million.  These financing transactions related to future milestone payments pursuant to our collaboration with Janssen Pharmaceutica, N.V., or Janssen.   In the first transaction, we received $122.2 million in cash for the issuance of the 2012 Notes, which are secured by $155.0 million in future telaprevir milestone payments that we are eligible to receive from Janssen for the filing, approval and launch of telaprevir in the European Union. The 2012 Notes have a face value of $155.0 million, were issued at a discount and do not carry an explicit interest rate. The 2012 Notes mature on October 31, 2012, subject to earlier mandatory redemption to the extent milestone events are achieved prior to October 31, 2012.  In the second transaction, we received $32.8 million in cash for the sale of rights to $95.0 million of potential future milestone payments that we are eligible to receive from Janssen for the launch of telaprevir in the European Union.

 

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SIGNATURES

 

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.

 

 

VERTEX PHARMACEUTICALS INCORPORATED

 

 

(Registrant)

 

 

 

 

 

Date: October 6, 2009

/s/ Kenneth S. Boger

 

Kenneth S. Boger
Senior Vice President and General Counsel

 

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This excerpt taken from the VRTX 8-K filed Mar 9, 2009.

Item 8.01.  Other Events.

 

On March 3, 2009, we entered into a share purchase agreement to acquire privately-held ViroChem, which is described above under Item 1.01 of this Current Report on Form 8-K.   ViroChem has two HCV polymerase inhibitors, VCH-222 and VCH-759, which are currently in Phase 1 clinical development.  We expect to begin clinical evaluation of novel combination regimens of our HCV protease inhibitor telaprevir, currently in Phase 3 clinical development, with VCH-222 and/or VCH-759 in the second half of 2009.

 

VCH-222 is a polymerase inhibitor that recently completed a Phase 1 viral kinetic clinical trial in HCV patients. In this clinical trial involving five treatment-naive genotype 1a and 1b HCV infected patients, VCH-222 dosed as 750 mg twice daily resulted in a median 3.7 log10 decrease in HCV RNA - equivalent to a 5,000-fold reduction in virus in the blood - at the end of three days of dosing. The results were consistent from patient to patient, and across HCV genotype 1 subtypes.  In clinical evaluations of VCH-222 to date, no serious adverse events have been observed. VCH-222 has completed 28-day non-clinical toxicology studies in two species.

 

VCH-759 is a polymerase inhibitor that has completed Phase 1b clinical development. In a Phase 1b trial reported at a medical conference in 2007, VCH-759 dosed as 800 mg three times daily showed a mean maximal 2.5 log10 reduction in HCV RNA and a median 1.7 log10 reduction in HCV RNA at the end of 10 days. In clinical evaluations of VCH-759 to date, no serious adverse events have been observed. VCH-759 has completed 28-day non-clinical toxicology studies.

 

This current report contains forward-looking statements, including the statements regarding our (i) expectation that the acquisition of ViroChem will be completed as soon as practicable; and (ii) plan to begin evaluation of novel combination regimens the second half of 2009.  While we believe the forward-looking statements contained in this current report are accurate, there are a number of factors that could cause actual events or results to differ materially from those indicated by such forward-looking statements. Those risks and uncertainties include, among other things, that the transaction contemplated by this current report might not be completed, that we may not obtain the benefits we expect to obtain from this transaction for a variety of reasons including the possibilities that we may not be able to successfully develop combination therapies involving telaprevir and the drug candidates that we are acquiring in this transaction and that early clinical trials and in vitro data regarding VCH-222 and VCH-759 may not be predictive of results that may be obtained from large clinical trials involving VCH-222 and/or VCH-759, and the other risks listed under Risk Factors in our annual report and quarterly reports filed with the Securities and Exchange Commission and available through our website at www.vrtx.com. We disclaim any obligation to update the information contained in this press release as new information becomes available.

 

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SIGNATURES

 

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.

 

 

VERTEX PHARMACEUTICALS
INCORPORATED

 

(Registrant)

 

 

 

 

Date:  March 9, 2009

/s/ Kenneth S. Boger

 

Kenneth S. Boger

 

Senior Vice President and General Counsel

 

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This excerpt taken from the VRTX 8-K filed Mar 31, 2008.

Item 8.01.  Other Events

 

On March 31, 2008, an abstract entitled “A Study of Telaprevir (TVR) with Peginterferon alfa-2A (P) and Ribavirin (R) in Subjects with Well-documented prior P/R Null Response, Non-Response or relapse: Preliminary Results” for a poster to be presented at the 43rd Annual Meeting of the European Association for Study of the Liver, or EASL, was posted on the internet at http://www.easl.ch/liver-meeting/program/SessionIndex.asp by EASL.   A copy of the abstract is attached to this Current Report on Form 8-K as Exhibit 99.1 and is incorporated herein by reference.

 

This excerpt taken from the VRTX 8-K filed Nov 27, 2007.

Item 8.01.  Other Events

 

On November 20, 2007, we announced that Merck & Co., Inc. had suspended enrollment in clinical trials of MK-0457 (VX-680), the lead investigational Aurora kinase inhibitor in our pharmaceutical development collaboration with Merck, pending a full analysis of all efficacy and safety data for MK-0457. The decision was based on preliminary safety data, in which a clinical safety finding of QTc prolongation was observed in one patient. Patients currently enrolled in these trials may continue to be treated with MK-0457, with additional monitoring for QTc prolongation. In addition, the development of the Aurora kinase inhibitor MK-6592 (VX-667) was discontinued after the compound did not meet pharmacokinetic objectives in a Phase 1 clinical trial.  Merck plans to initiate in early 2008 a Phase 1 clinical trial of the Aurora kinase inhibitor VX-689 in patients with advanced and/or refractory solid tumors.

 

Safe Harbor Statement

 

This current report contains forward-looking statements, including the statement that Merck expects to initiate a Phase 1 clinical trial of VX-689 in early 2008. While we believe the forward-looking statements contained in this current report are accurate, there are a number of factors that could cause actual events or results to differ materially from those indicated by such forward-looking statements. Those risks and uncertainties include, among other things, the risk that planned clinical trials will not be commenced due to unanticipated scientific developments or business constraints, that unexpected and adverse outcomes in ongoing clinical and nonclinical studies will occur, and other risks listed under risk factors in our annual report on Form 10-K filed with the Securities and Exchange Commission on March 1, 2007. We disclaim any obligation to update the information contained in this current report.

 

 

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SIGNATURES

 

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.

 

 

VERTEX PHARMACEUTICALS INCORPORATED

 

(Registrant)

 

 

 

Date:  November 27, 2007

/s/ Ian F. Smith

 

Ian F. Smith

 

Executive Vice President and Chief Financial Officer

 

 

3


This excerpt taken from the VRTX 8-K filed Nov 2, 2007.

Item 8.01.  Other Events

 

On November 2, 2007, we issued a press release in which we updated information regarding our ongoing Phase 2 clinical trials of telaprevir.  A copy of that press release is attached to this Current Report on Form 8-K as Exhibit 99.1 and is incorporated herein by reference.

 

This excerpt taken from the VRTX 8-K filed Jul 3, 2007.

Item 8.01  Other Events

On June 29, 2007, we announced the appointments of Kurt C. Graves as our Executive Vice President, Chief Commercial Officer and Head, Strategic Development and Amit K. Sachdev as our Senior Vice President, Public Policy and Government Affairs.  We expect both Mr. Graves and Mr. Sachdev to join Vertex during July 2007.  A copy of the press release announcing the appointments is attached as Exhibit 99.1 to this Current Report on Form 8-K and incorporated herein by reference.

This excerpt taken from the VRTX 8-K filed Jun 12, 2007.

Item 8.01.  Other Events

On June 12, 2007, we issued a press release in which we updated information regarding the clinical development of our drug candidates.  A copy of that press release is attached to this Current Report on Form 8-K as Exhibit 99.1 and is incorporated herein by reference.

This excerpt taken from the VRTX 8-K filed Mar 7, 2007.

Item 8.01.   Other Events.

On March 5, 2007, we announced that holders of all of our 5.75% Convertible Senior Subordinated Notes due in February 2011, or 2011 Notes, had converted their 2011 Notes into shares of our common stock.  As of February 2, 2007, the date the 2011 Notes were called for redemption, the aggregate outstanding principal amount of the 2011 Notes was approximately $59.6 million.  In accordance with the terms of the indentures governing the 2011 Notes, the $59.6 million in outstanding principal amount of 2011 Notes was converted into shares of our common stock at a conversion rate of $14.94 per share.  As a result of the conversions of all of the outstanding 2011 Notes, we issued 3,992,473 shares of our common stock.

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SIGNATURES

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.

VERTEX PHARMACEUTICALS INCORPORATED

 

(Registrant)                  

 

 

Date:  March 6, 2007

/s/ Kenneth S. Boger

 

Kenneth S. Boger

 

Senior Vice President and General Counsel

 

3



This excerpt taken from the VRTX 8-K filed Dec 18, 2006.

Item 8.01. Other Events.

On December 15, 2006, Vertex Pharmaceuticals Incorporated (the “Company”) received formal notification from GlaxoSmithKline (“GSK”) that GSK will discontinue clinical development of the investigational HIV protease inhibitor brecanavir (VX-385).  Brecanavir had been previously selected by GSK for clinical development and commercialization under the research and development collaboration between the Company and GSK begun in 1993 (the “HIV Protease Collaboration”), and had advanced to Phase 2 clinical trials.  The HIV Protease Collaboration also covers two previously approved and marketed HIV drugs, Agenerase and Lexiva.   GSK has informed the Company that GSK is halting brecanavir development because GSK believes it will be difficult to develop an appropriate formulation of brecanavir.  The decision to halt the brecanavir development program does not alter the companies’ relationship with respect to the marketing of Lexiva under the HIV Protease Collaboration.  Lexiva and Agenerase are trademarks of GSK.

2




 

SIGNATURES

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.

 

VERTEX PHARMACEUTICALS
INCORPORATED

 

 

   (Registrant)

 

 

 

Date:  December 15, 2006

 

/s/ Kenneth S. Boger

 

 

Kenneth S. Boger

 

 

Senior Vice President and General Counsel

 

3



This excerpt taken from the VRTX 8-K filed Sep 21, 2006.

Item 8.01.  Other Events.

On September 20, 2006, Vertex Pharmaceuticals Incorporated issued a press release that announced the completion of its public offering of 9,100,000 shares of common stock.  A copy of that press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

This excerpt taken from the VRTX 8-K filed Aug 8, 2006.

Item 8.01.  Other Events.

See Item 3.02.  The Company expects to incur a non-cash charge of approximately $5.0 million as a result of the exchanges.  This charge is related to the incremental shares to be issued in the transaction over the number that would have been issued upon conversion of the notes under their original terms, and will be reported in the Company’s third quarter 2006 financial results.

2




 

SIGNATURES

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.

 

 

VERTEX PHARMACEUTICALS

 

 

INCORPORATED

 

 

(Registrant)

 

 

 

 

 

 

Date:  August 8, 2006

 

/s/ Ian F. Smith

 

 

Ian F. Smith

 

 

Executive Vice President and Chief Financial Officer

 

 

 

3



This excerpt taken from the VRTX 8-K filed May 15, 2006.

Item 8.01. Other Events.

The Company’s 2006 Annual Meeting of Stockholders was held on May 11, 2006. At the Annual Meeting of Stockholders, the Company’s stockholders approved the Plan and re-elected Mr. Eric K. Brandt, Mr. Bruce I. Sachs and Dr. Eve E. Slater to serve on the Board of Directors until the Annual Meeting of Stockholders to be held in 2009.

At a meeting of the Company’s Board of Directors following the Annual Meeting of Stockholders, the Board of Directors addressed two corporate governance issues: the creation of a non-executive Chairmanship of the Board of Directors and the adoption of a policy regarding the election of directors.

In connection with the first of these corporate governance matters, Dr. Charles A. Sanders was appointed Chairman of the Board. Dr. Joshua Boger will continue to serve as the Company’s President and Chief Executive Officer.

In connection with the second of these corporate governance matters, the Board of Directors adopted a policy that will be incorporated into the Company’s Statement of Governance Principles. Under the new policy, any nominee for director in an uncontested election who receives a greater number of votes “withheld” from his or her election than votes “for” his or her election will tender his or her resignation to the Board of Directors. The Corporate Governance and Nominating Committee of the Board of Directors will recommend to the Board either that the Board accept or reject any such resignation or that the Board take some other action to address the underlying reasons for the outcome of the vote. The Company will make a public announcement of the Board of Directors’ response to any resignation tendered under the new policy.

This excerpt taken from the VRTX 8-K filed Mar 9, 2006.

Item 8.01.  Other Events.

 

On March 8, 2006, Vertex Pharmaceuticals Incorporated issued a press release that reported results from a Phase II clinical study with VX-702, an investigational oral p38 MAP kinase inhibitor, for the treatment of rheumatoid arthritis. A copy of that press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

 

This excerpt taken from the VRTX 8-K filed Feb 13, 2006.

Item 8.01.  Other Events.

 

The Company completed dosing in a 28-day, Phase II clinical study of VX-950, a hepatitis C protease inhibitor for the treatment of hepatitis C virus (“HCV”) infection.

 

Preliminary HCV RNA results in patients for weeks 1 through 4 are as follows:

 

              At the end of week 1 (day 8 of VX-950 dosing), plasma HCV RNA was below the limit of quantitation (30 IU/mL; Roche Taqman® assay) in six of the 12 patients; and undetectable (less than 10 IU/mL; Roche Taqman® assay) in two of 12 patients. 

 

              At the end of week 2, plasma HCV RNA was below the limit of quantitation (30 IU/mL) in 11 of 12 patients; and undetectable (less than 10 IU/mL) in three of 12 patients.

 

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              At the end of week 3, plasma HCV RNA was below the limit of quantitation (30 IU/mL) in 12 of the 12 patients; and undetectable (less than 10 IU/mL) in nine of 12 patients.

 

              At the end of VX-950 dosing (end of week 4; day 28), plasma HCV RNA was undetectable (less than 10 IU/mL) in all 12 patients.

 

              No patients showed evidence of viral breakthrough while on treatment.

 

The Company also completed three-month toxicology studies in animals that would support clinical studies of VX-950 of up to three months’ duration.  In connection with the announcement of the completion of these studies, the Company issued a press release titled “Vertex Successfully Completes Key Studies with VX-950 to Prepare for Next Steps in Clinical Program.”  That press release is attached to the Current Report as Exhibit 99.2 and is incorporated herein by reference.

 

In accordance with General Instruction B-2 of Form 8-K, the information set forth in Item 2.02, above, as well as Exhibits 99.1 and 99.2, shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liability of that section, and shall not be incorporated by reference into any registration statement or other document filed under the Securities Act of 1933, as amended or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.

 

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This excerpt taken from the VRTX 8-K filed Feb 7, 2006.

Item 8.01.  Other Events.

 

On February 7, 2006, Vertex Pharmaceuticals Incorporated (the “Company”) issued two press releases.  The first press release announced the successful completion of certain key studies of the Company’s hepatitis C protease inhibitor, VX-950.  The second press release reported the Company’s consolidated financial results for the year ended December 31, 2005.  A copy of first press release is attached as Exhibit 99.1 and is incorporated herein by reference.  A copy of the second press release is attached as Exhibit 99.2 and is incorporated herein by reference.

 

In accordance with General Instruction B-2 of Form 8-K, the information in this Current Report on Form 8-K, including Exhibit 99.1 and Exhibit 99.2, shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liability of that section, and shall not be incorporated by reference into any registration statement or other document filed under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.

 

This excerpt taken from the VRTX 8-K filed Dec 2, 2005.

Item 8.01.  Other Events.

 

The Company expects to incur a non-cash charge of approximately $9.8 million as a result of the November 28, 2005 exchange agreements, and approximately $0.9 million as a result of the November 30, 2005 exchange agreement, for an aggregate non-cash charge of approximately $10.7 million.  This charge is related to the incremental shares to be issued in the transactions over the number that would have been issued upon conversion of the notes under their original terms, and will be reported in the Company’s year-end 2005 financial results.

 

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SIGNATURES

 

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.

 

 

 

VERTEX PHARMACEUTICALS
INCORPORATED

 

(Registrant)

 

 

 

 

Date: December 2, 2005

/s/ Kenneth S. Boger

 

 

Kenneth S. Boger

 

Senior Vice President and General Counsel

 

3


This excerpt taken from the VRTX 8-K filed Sep 12, 2005.

Item 8.01.  Other Events.

 

The Company issued a press release on September 9, 2005 titled “Vertex Pharmaceuticals Announces Agreements to Exchange $40.5 Million of its Convertible Senior Subordinated Notes Due 2007 for Common Stock”.  In that press release, the Company disclosed that it expects to incur a non-cash charge of approximately $36.0 million in connection with the Exchanges.  This charge is related to the incremental shares issued in the Exchanges over the number that would have been issued upon conversion of the 2007 Notes under their original terms, and will be reported in the Company’s third quarter 2005 financial results.  The press release is filed as Exhibit 99.1 of this Current Report and is incorporated by reference herein.

 

This excerpt taken from the VRTX 8-K filed Jun 17, 2005.

Item 8.01.  Other Events.

 

On June 17, 2005, Vertex Pharmaceuticals Incorporated and Merck & Co., Inc. issued a joint press release that announced the initiation of an additional Phase I study with VX-680, a small molecule inhibitor of Aurora kinases.  A copy of that press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

 

This excerpt taken from the VRTX 8-K filed Jun 15, 2005.

Item 8.01.  Other Events.

 

On June 15, 2005, Vertex Pharmaceuticals Incorporated issued a press release that announced that the underwriters in the company’s public offering exercised their over-allotment option to purchase 1,762,500 shares of common stock.  A copy of that press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

 

This excerpt taken from the VRTX 8-K filed Jun 13, 2005.

Item 8.01.  Other Events.

 

On June 13, 2005, Vertex Pharmaceuticals Incorporated issued a press release that announced the completion of its public offering of 11,750,000 shares of common stock.  A copy of that press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

 

This excerpt taken from the VRTX 8-K filed Jun 10, 2005.

Item 8.01.  Other Events.

 

On June 10, 2005, Vertex Pharmaceuticals Incorporated issued a press release that announced the initiation of dosing in a Phase II clinical study with VX-702, an investigational oral p38 MAP kinase inhibitor, for the treatment of rheumatoid arthritis.  A copy of that press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

 

This excerpt taken from the VRTX 8-K filed Jun 8, 2005.

Item 8.01.  Other Events.

 

                The Company issued a press release on June 7, 2005 entitled “Vertex Pharmaceuticals Announces Pricing of Common Stock Offering” announcing the pricing of the public offering.  The press release is attached hereto as Exhibit 99.1 and is incorporated by reference herein.

 

This excerpt taken from the VRTX 8-K filed May 20, 2005.

Item 8.01.  Other Events.

 

On May 10, 2005, Vertex Pharmaceuticals Incorporated (the “Company”) issued a press release that announced interim results indicating that the Company’s investigational oral hepatitis C virus (“HCV”) protease inhibitor, VX-950, was well-tolerated and demonstrated potent antiviral activity in a Phase Ib clinical trial.  A copy of that press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

 

On May 17, 2005, the Company issued a press release that described the results of the Phase Ib clinical trial in further detail.  A copy of that press release is attached hereto as Exhibit 99.2 and is incorporated herein by reference.

 

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