Map Pharmaceuticals, Inc. 8-k (events Or Changes Between Quarterly Reports) 2009-02-23
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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): February 23, 2009
MAP PHARMACEUTICALS, INC. (Exact Nam e of Re gistran t as S pe cifie d in its C h arte r)
Delaware
001-33719
20-0507047
(State or O the r Ju risdiction of In corporation )
(C om m ission File Nu m be r)
(IRS Em ploye r Ide n tification No.)
2400 Bayshore Parkway, Suite 200, Mountain View, CA
94043
(Addre ss of Principal Exe cu tive O ffice s)
(Zip C ode )
Registrant’s telephone number, including area code: (650) 386-3100
(Form e r Nam e or Form e r Addre ss, if C h an ge d S ince Last Re port.)
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): ®
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
®
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
®
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
®
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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Item 8.01.
Other Events.
In a press release issued on February 23, 2009, MAP Pharmaceuticals, Inc. (the “Company”) announced results of its initial Phase 3 clinical trial of Unit Dose Budesonide (“UDB”) for the potential treatment of children with asthma. The Company announced that the clinical trial did not meet its co-primary endpoints, asthma control as assessed by changes from baseline in nighttime and daytime composite symptom scores, in either of the doses evaluated when compared with placebo. A copy of the press release is attached hereto as Exhibit 99.1. Item 7.01.
Regulation FD Disclosure.
In a press release issued on February 23, 2009 and attached hereto as Exhibit 99.1, the Company announced results of its initial Phase 3 clinical trial of Unit Dose Budesonide (“UDB”) for the potential treatment of children with asthma. The Company will host a conference call at 5:30 p.m. Eastern time / 2:30 p.m. Pacific time on Monday, February 23, 2009, to update stockholders on the results of its initial Phase 3 clinical trial of Unit Dose Budesonide announced today. Callers may join the call via telephone at 888-631-5931 (domestic) or 913-312-4375 (international). Access to the live webcast will be available via the Investor Relations section of the Company’s Website at www.mappharma.com . A replay will also be available within 24 hours for at least seven days following the conference call. The information in this Item only, including Exhibit 99.1 attached hereto, is furnished pursuant to Item 7.01 of this Form 8-K. Consequently, it is not deemed “filed” for the purposes of Section 18 of the Securities and Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section. It may only be incorporated by reference in another filing under the Exchange Act or the Securities Act of 1933, as amended, if such subsequent filing specifically references this Form 8-K. Item 9.01. Financial Statements and Exhibits. (d) Exhibits Exh ibit No.
99.1
De scription
Press Release of MAP Pharmaceuticals, Inc., dated February 23, 2009
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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. Date: February 23, 2009 MAP PHARMACEUTICALS, INC. By: /s/ Charlene A. Friedman Name: Charlene A. Friedman Title: Vice President, General Counsel and Secretary
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INDEX TO EXHIBITS FILED WITH THE CURRENT REPORT ON FORM 8-K DATED FEBRUARY 23, 2009 Exh ibit
99.1
De scription
Press Release of MAP Pharmaceuticals, Inc., dated February 23, 2009 Exhibit 99.1 MAP Pharmaceuticals Announces Phase 3 Study of Unit Dose Budesonide in Children with Asthma Did Not Meet Primary Endpoints —Conference Call at 5:30 p.m. ET Today —
Mountain View, CA, February 23, 2009 – MAP Pharmaceuticals, Inc. (NASDAQ: MAPP) announced today that its initial Phase 3 clinical trial of Unit Dose Budesonide (UDB) for the potential treatment of children with asthma. The Company announced that the clinical trial did not meet its co-primary endpoints, asthma control as assessed by changes from baseline in nighttime and daytime composite symptom scores, in either of the doses evaluated, when compared with placebo. Median nebulization times were less than four minutes for both doses in the study. Initial review of the data has not identified any serious adverse events attributed to study drug. Patients continue to be treated in a 52week safety study to collect long-term safety data on the two doses under investigation. “Based on our initial review of these data, both the placebo and study groups experienced improvements in asthma symptoms, but the differences were not statistically significant. We observed a higher than expected response in the placebo group, starting as early as one week after randomization and continuing throughout the 12 week treatment period,” said Timothy S. Nelson, Chief Executive Officer of MAP Pharmaceuticals. “We and our partner, AstraZeneca, are conducting further analyses of these data to determine appropriate next steps going forward for the program. The Company remains dedicated to developing therapies for children suffering with asthma.” About the AstraZeneca Collaboration MAP Pharmaceuticals and AstraZeneca have a collaboration agreement to develop and commercialize UDB in the United States, and AstraZeneca has rights to develop and commercialize UDB outside of the United States. About the Study In this randomized, double-blind, placebo-controlled study, 360 steroid naïve children with asthma, 12-months to eight years of age, were randomized to receive 0.25mg UDB, 0.135mg UDB or placebo twice a day over a 12-week period. The co-primary endpoints evaluated asthma control as assessed by changes from baseline as compared to placebo in nighttime composite symptom scores, and daytime composite symptom scores, both comprised of cough, wheeze and shortness of breath. Conference Call Details MAP Pharmaceuticals management will host a conference call at 5:30 p.m. ET today to discuss these results. Page 1
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You may join the call via telephone at 888-631-5931 (domestic) or 913-312-4375 (international). Access to the live webcast will be available via the Investor Relations section of the Company’s Website at www.mappharma.com. A replay will also be available within 24 hours for at least seven days following the conference call. About MAP Pharmaceuticals MAP Pharmaceuticals is dedicated to developing and commercializing new therapies for children and adults suffering from chronic conditions that are not adequately treated by currently available medicines. The company has two product candidates in Phase 3 clinical development. Unit Dose Budesonide is being developed in collaboration with AstraZeneca for the potential treatment of asthma in children, and MAP0004 is being developed for the potential treatment of migraine. In addition, MAP Pharmaceuticals generates new pipeline opportunities by applying its proprietary drug particle and inhalation technologies to enhance the therapeutic benefits of proven drugs, while minimizing risk, by capitalizing on their known safety, efficacy and commercialization history. Additional information about MAP Pharmaceuticals can be found at http://www.mappharma.com. About AstraZeneca AstraZeneca is a major international healthcare business engaged in the research, development, manufacturing and marketing of meaningful prescription medicines and supplier for healthcare services. AstraZeneca is one of the world’s leading pharmaceutical companies with healthcare sales of US$ 31.6 billion and is a leader in gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infectious disease medicines. For more information about AstraZeneca, please visit: www.astrazeneca.com Forward-Looking Statements [Legal to update once main text is agreed upon] In addition to statements of historical facts or statements of current conditions, this press release contains forward-looking statements, including with respect to the clinical development of UDB and the collaboration between MAP Pharmaceuticals and AstraZeneca. Actual results may differ materially from current expectations based on risks and uncertainties affecting the company’s business, including, without limitation, the conduct and timing of clinical trials, risks and uncertainties relating to the failure to achieve favorable outcomes or to have UDB approved for commercial use by the U.S. Food and Drug Administration; and the risk that AstraZeneca may not continue its collaboration with MAP Pharmaceuticals. The reader is cautioned not to unduly rely on the forward-looking statements contained in this press release. MAP Pharmaceuticals expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law. Additional information on potential factors that could affect MAP Pharmaceuticals’ results and other risks and uncertainties are detailed in its Quarterly Report on Form 10-Q, filed with the SEC on November 13, 2008, and available at http://edgar.sec.gov. Contacts Christopher Y. Chai CFO, MAP Pharmaceuticals 650-386-3107 Page 2
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Nicole Foderaro Invigorate 415-215-5643 [email protected] Page 3
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): February 23, 2009
MAP PHARMACEUTICALS, INC. (Exact Nam e of Re gistran t as S pe cifie d in its C h arte r)
Delaware
001-33719
20-0507047
(State or O the r Ju risdiction of In corporation )
(C om m ission File Nu m be r)
(IRS Em ploye r Ide n tification No.)
2400 Bayshore Parkway, Suite 200, Mountain View, CA
94043
(Addre ss of Principal Exe cu tive O ffice s)
(Zip C ode )
Registrant’s telephone number, including area code: (650) 386-3100
(Form e r Nam e or Form e r Addre ss, if C h an ge d S ince Last Re port.)
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): ®
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
®
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
®
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
®
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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Item 8.01.
Other Events.
In a press release issued on February 23, 2009, MAP Pharmaceuticals, Inc. (the “Company”) announced results of its initial Phase 3 clinical trial of Unit Dose Budesonide (“UDB”) for the potential treatment of children with asthma. The Company announced that the clinical trial did not meet its co-primary endpoints, asthma control as assessed by changes from baseline in nighttime and daytime composite symptom scores, in either of the doses evaluated when compared with placebo. A copy of the press release is attached hereto as Exhibit 99.1. Item 7.01.
Regulation FD Disclosure.
In a press release issued on February 23, 2009 and attached hereto as Exhibit 99.1, the Company announced results of its initial Phase 3 clinical trial of Unit Dose Budesonide (“UDB”) for the potential treatment of children with asthma. The Company will host a conference call at 5:30 p.m. Eastern time / 2:30 p.m. Pacific time on Monday, February 23, 2009, to update stockholders on the results of its initial Phase 3 clinical trial of Unit Dose Budesonide announced today. Callers may join the call via telephone at 888-631-5931 (domestic) or 913-312-4375 (international). Access to the live webcast will be available via the Investor Relations section of the Company’s Website at www.mappharma.com . A replay will also be available within 24 hours for at least seven days following the conference call. The information in this Item only, including Exhibit 99.1 attached hereto, is furnished pursuant to Item 7.01 of this Form 8-K. Consequently, it is not deemed “filed” for the purposes of Section 18 of the Securities and Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section. It may only be incorporated by reference in another filing under the Exchange Act or the Securities Act of 1933, as amended, if such subsequent filing specifically references this Form 8-K. Item 9.01. Financial Statements and Exhibits. (d) Exhibits Exh ibit No.
99.1
De scription
Press Release of MAP Pharmaceuticals, Inc., dated February 23, 2009
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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. Date: February 23, 2009 MAP PHARMACEUTICALS, INC. By: /s/ Charlene A. Friedman Name: Charlene A. Friedman Title: Vice President, General Counsel and Secretary
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INDEX TO EXHIBITS FILED WITH THE CURRENT REPORT ON FORM 8-K DATED FEBRUARY 23, 2009 Exh ibit
99.1
De scription
Press Release of MAP Pharmaceuticals, Inc., dated February 23, 2009 Exhibit 99.1 MAP Pharmaceuticals Announces Phase 3 Study of Unit Dose Budesonide in Children with Asthma Did Not Meet Primary Endpoints —Conference Call at 5:30 p.m. ET Today —
Mountain View, CA, February 23, 2009 – MAP Pharmaceuticals, Inc. (NASDAQ: MAPP) announced today that its initial Phase 3 clinical trial of Unit Dose Budesonide (UDB) for the potential treatment of children with asthma. The Company announced that the clinical trial did not meet its co-primary endpoints, asthma control as assessed by changes from baseline in nighttime and daytime composite symptom scores, in either of the doses evaluated, when compared with placebo. Median nebulization times were less than four minutes for both doses in the study. Initial review of the data has not identified any serious adverse events attributed to study drug. Patients continue to be treated in a 52week safety study to collect long-term safety data on the two doses under investigation. “Based on our initial review of these data, both the placebo and study groups experienced improvements in asthma symptoms, but the differences were not statistically significant. We observed a higher than expected response in the placebo group, starting as early as one week after randomization and continuing throughout the 12 week treatment period,” said Timothy S. Nelson, Chief Executive Officer of MAP Pharmaceuticals. “We and our partner, AstraZeneca, are conducting further analyses of these data to determine appropriate next steps going forward for the program. The Company remains dedicated to developing therapies for children suffering with asthma.” About the AstraZeneca Collaboration MAP Pharmaceuticals and AstraZeneca have a collaboration agreement to develop and commercialize UDB in the United States, and AstraZeneca has rights to develop and commercialize UDB outside of the United States. About the Study In this randomized, double-blind, placebo-controlled study, 360 steroid naïve children with asthma, 12-months to eight years of age, were randomized to receive 0.25mg UDB, 0.135mg UDB or placebo twice a day over a 12-week period. The co-primary endpoints evaluated asthma control as assessed by changes from baseline as compared to placebo in nighttime composite symptom scores, and daytime composite symptom scores, both comprised of cough, wheeze and shortness of breath. Conference Call Details MAP Pharmaceuticals management will host a conference call at 5:30 p.m. ET today to discuss these results. Page 1
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You may join the call via telephone at 888-631-5931 (domestic) or 913-312-4375 (international). Access to the live webcast will be available via the Investor Relations section of the Company’s Website at www.mappharma.com. A replay will also be available within 24 hours for at least seven days following the conference call. About MAP Pharmaceuticals MAP Pharmaceuticals is dedicated to developing and commercializing new therapies for children and adults suffering from chronic conditions that are not adequately treated by currently available medicines. The company has two product candidates in Phase 3 clinical development. Unit Dose Budesonide is being developed in collaboration with AstraZeneca for the potential treatment of asthma in children, and MAP0004 is being developed for the potential treatment of migraine. In addition, MAP Pharmaceuticals generates new pipeline opportunities by applying its proprietary drug particle and inhalation technologies to enhance the therapeutic benefits of proven drugs, while minimizing risk, by capitalizing on their known safety, efficacy and commercialization history. Additional information about MAP Pharmaceuticals can be found at http://www.mappharma.com. About AstraZeneca AstraZeneca is a major international healthcare business engaged in the research, development, manufacturing and marketing of meaningful prescription medicines and supplier for healthcare services. AstraZeneca is one of the world’s leading pharmaceutical companies with healthcare sales of US$ 31.6 billion and is a leader in gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infectious disease medicines. For more information about AstraZeneca, please visit: www.astrazeneca.com Forward-Looking Statements [Legal to update once main text is agreed upon] In addition to statements of historical facts or statements of current conditions, this press release contains forward-looking statements, including with respect to the clinical development of UDB and the collaboration between MAP Pharmaceuticals and AstraZeneca. Actual results may differ materially from current expectations based on risks and uncertainties affecting the company’s business, including, without limitation, the conduct and timing of clinical trials, risks and uncertainties relating to the failure to achieve favorable outcomes or to have UDB approved for commercial use by the U.S. Food and Drug Administration; and the risk that AstraZeneca may not continue its collaboration with MAP Pharmaceuticals. The reader is cautioned not to unduly rely on the forward-looking statements contained in this press release. MAP Pharmaceuticals expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law. Additional information on potential factors that could affect MAP Pharmaceuticals’ results and other risks and uncertainties are detailed in its Quarterly Report on Form 10-Q, filed with the SEC on November 13, 2008, and available at http://edgar.sec.gov. Contacts Christopher Y. Chai CFO, MAP Pharmaceuticals 650-386-3107 Page 2
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Nicole Foderaro Invigorate 415-215-5643 [email protected] Page 3
