| 2008-02-13 | Alliances | In an effort to improve the success rate of investigational cancer drugs entering clinical trials, the Center for Applied Cancer Science (CACS) of the Dana-Farber Cancer Institute and Merck and Co., Inc., have established a collaboration to identify promising drug targets, and develop therapeutic candidates to reach those targets.
“Currently, there is a 95 percent failure rate in cancer drug development,” says Ronald DePinho, MD, of the CACS. “Drugs that pass safety testing in Phase I trials too often fail to show efficacy in later-stage trials, or prove effective in only a small subset of patients.”
The use of genomic information in identifying therapeutic targets and appropriate trial designs requires the integration of genomics with function, mechanism and, importantly, cancer biology, explains Dana-Farber’s Lynda Chin, MD, who will be the senior investigator in the CACS-Merck alliance. “By actively facilitating communication,” says Chin, “this new agreement represents an important advance toward true team science between Dana-Farber and one of world’s the leading pharmaceutical companies.”
Under the terms of the agreement, Merck will provide up-front and research support funding to the CACS as well as milestone and royalty payments upon market approval. The CACS will investigate drug targets using integrative and cross-species genomic analysis and stringent multi-level functional and clinicopathological validation testing. The CACS will work together with Merck to shepherd the drug assay development of lead compound discovery and then work together to test these drugs in CACS’s highly sophisticated model systems that closely replicate human disease.
The collaboration will also involve CACS faculty, under the direction of James DeCaprio, MD, and Kenneth Anderson, MD, working together with scientists from Merck Research Laboratories, to further evaluate tumor pathobiology and clinical outcomes to better pinpoint the tumor types most susceptible to the drug.
Dana-Farber established the CACS, which is supported by the Robert A. and Renée E. Belfer Foundation, in 2004. CACS is part of the Robert A. and Renée E. Belfer Institute for Innovative Cancer Science, which also houses the Arthur and Rochelle Belfer Center for Cancer Genomics.
The CACS consists of team scientists and core laboratory facilities for identifying genetic alterations in cancer, pinpointing those alterations most crucial to tumor formation and maintenance, validating those targets in a wide range of cell and tissue cultures assays and sophisticated animal models, and, in the case of monoclonal antibodies, developing them into useful therapies. The CACS retains the right to develop its antibodies independent of the Merck collaboration.
“Collaborations with external partners are an integral and essential part of our oncology research and development strategy,” says Stephen Friend MD., Ph.D., senior vice president and franchise head, Oncology, Merck Research Laboratories. “Through this collaboration with Dana- Farber, one of the world's premier cancer centers, we hope to establish an open and collaborative relationship through our common goal of advancing cancer treatment.”
Merck, established in 1891, is a global leader in the discovery, development, manufacture, and marketing of vaccines and medicines. Its products include treatments for conditions ranging from diabetes and osteoporosis, to HIV infection and asthma. |
| 2008-02-08 | Earnings/Dividends |
WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Merck & Co., Inc. announced today that, subject to final review of its first-quarter results, it anticipates its first-quarter earnings per share (EPS) will be $0.84, excluding restructuring charges related to site closures and position eliminations, and its reported EPS will be $0.78. Merck attributed these anticipated results to strong revenue performance across the Company's range of products. The Company also raised its anticipated 2007 full-year EPS range to $2.75 to $2.85, excluding restructuring charges related to site closures and position eliminations, and its full-year 2007 reported EPS range to $2.60 to $2.75.
This guidance does not reflect the establishment of any reserves for any potential liability relating to the VIOXX litigation.
As previously announced, Merck will report its actual first-quarter earnings on Thursday, April 19. The company will hold its first-quarter 2007 sales and earnings conference call with institutional investors and analysts beginning at 9 a.m. ET that day. During the call, Richard T. Clark, chief executive officer and president, and Judy C. Lewent, executive vice president and chief financial officer, will provide an overview of Merck’s financial performance for the quarter. The first-quarter sales and earnings press release and supplemental financial disclosures will be issued that day, prior to the start of the conference call.
About Merck
Merck & Co., Inc. is a global research-driven pharmaceutical company dedicated to putting patients first. Established in 1891, Merck discovers, develops, manufactures and markets vaccines and medicines in more than 20 therapeutic categories. The company devotes extensive efforts to increase access to medicines through far-reaching programs that not only donate Merck medicines but help deliver them to the people who need them. Merck also publishes unbiased health information as a not-for-profit service. For more information, visit www.merck.com.
Forward-Looking Statement
This press release contains “forward-looking statements” as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements are based on management's current expectations and involve risks and uncertainties, which may cause results to differ materially from those set forth in the statements. The forward-looking statements may include statements regarding product development, product potential or financial performance. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Merck’s business, particularly those mentioned in the risk factors and cautionary statements in Item 1A of Merck’s Form 10-K for the year ended Dec. 31, 2006, and in its periodic reports on Form 10-Q and Form 8-K, which the company incorporates by reference. |
| 2008-02-08 | Earnings/Dividends |
WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Merck & Co., Inc. will hold a third-quarter 2007 sales and earnings conference call with institutional investors and analysts beginning at 9 a.m. EDT on Monday, Oct. 22. During this call, Graeme Bell, executive director, investor relations, joined by Richard T. Clark, chairman, president and chief executive officer, and Peter N. Kellogg, executive vice president and chief financial officer, will provide an overview of Merck’s financial performance for the quarter.
Journalists are invited to listen only by calling (706) 758-9928 or (800) 399-7917. A replay of the call will be available starting at 11 a.m. EDT on Oct. 22 through 5 p.m. EDT on Oct. 29. To listen to the replay, dial (706) 645-9291 or (800) 642-1687 and enter ID # 1990767.
Investors, journalists and the general public may access a live audio webcast of the call on Merck’s Web site at http://www.merck.com/newsroom/webcast. Software needed to listen to the webcast is available on the corporate Web site and should be downloaded prior to the beginning of the webcast. A replay of the webcast will be available from 11 a.m. EDT on Oct. 22 through 5 p.m. EDT on Oct. 29. The third-quarter sales and earnings press release and supplemental financial disclosures will also be available in the newsroom.
About Merck
Merck & Co., Inc. is a global research-driven pharmaceutical company dedicated to putting patients first. Established in 1891, Merck discovers, develops, manufactures and markets vaccines and medicines to address unmet medical needs. The company devotes extensive efforts to increase access to medicines through far-reaching programs that not only donate Merck medicines but help deliver them to the people who need them. Merck also publishes unbiased health information as a not-for-profit service. For more information, visit www.merck.com. |
| 2008-02-08 | Earnings/Dividends |
WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Merck & Co., Inc. today updated its 2007 financial guidance and, for the first time, provided 2008 guidance. Merck's senior management will host a conference call to discuss the details of the Company's financial guidance at 8:30 a.m. EST.
“Since 2005, we have been changing every aspect of our business in order to position Merck for sustained revenue and earnings growth," said Richard T. Clark, chairman, president and chief executive officer. "These changes – combined with our current and recently launched products, anticipated new product introductions and cost-savings initiatives – will help position Merck to deliver compound annual double-digit earnings growth, excluding certain items, by 2010 from that 2005 base.
"The 2007 and 2008 guidance that we are providing today helps position the Company to meet its long-term performance targets. In 2007, we have made strides to remove a significant amount of uncertainty related to legal concerns through the U.S. VIOXX product liability settlement agreement announced on Nov. 9, 2007, as well as the anticipated resolution of other litigation. In 2008 the Company expects continued growth in newer franchises, including the on-going global launches of GARDASIL, JANUVIA, JANUMET and ISENTRESS as well as other potential new product introductions. Many of the investments that we are making today to grow our pipeline and to re-engineer our business are enabling us to deliver sustained revenue and earnings growth beyond 2010 and we look forward to discussing our progress at our Annual Business Briefing for investors on Dec. 11," Mr. Clark added.
2007 Guidance
The Company reaffirms its full-year 2007 non-GAAP (generally accepted accounting principles) earnings per share (EPS) guidance range of $3.08 to $3.14, excluding certain items and anticipates a 2007 GAAP EPS range of $1.45 to $1.51. The Company has included in its full-year 2007 GAAP guidance: The previously disclosed pretax charge of $4.85 billion for the U.S. VIOXX product liability litigation settlement. As previously disclosed, the Company has established a reserve solely for future legal defense costs related to the VIOXX litigation which was $720 million as of Sept. 30, 2007. The Company continues to evaluate that reserve. A previously disclosed pretax charge of approximately $700 million associated with its global restructuring program. A pretax charge of $670 million in connection with the anticipated resolution of investigations, the first of which was disclosed beginning in 2002, of civil claims by federal and state authorities relating to certain past marketing and selling activities, including nominal pricing programs and samples. The resolution of these matters is still subject to execution of definitive agreements. An anticipated fourth-quarter, pretax gain of approximately $450 million relating to insurance proceeds which the Company was awarded (or agreed to receive pursuant to negotiated settlements) in the previously disclosed arbitration with the Company's upper level excess product liability insurance carriers relating to coverage for costs incurred in the VIOXX product liability litigation.
A reconciliation of 2007 EPS as reported in accordance with GAAP to non-GAAP EPS, which adjusts for certain items, is provided in the table that follows. Full-Year 2007 GAAP EPS $1.45 to $1.51 EPS impact of items* $1.63
Non-GAAP EPS, which adjusts for items listed below1 $3.08 to $3.14
1 Merck is providing information on earnings per share in 2007 and 2008, adjusted for certain items, because of the nature of these items and the impact they have on the analysis of underlying business performance and trends. Management believes that providing this information enhances investors' understanding of the Company's performance. This information should be considered in addition to, but not in lieu of, earnings per sha |
| 2008-02-08 | Earnings/Dividends | Merck Co., Inc. today announced full year and fourth quarter 2006 results that reflected solid sales growth and strong results from the MerckSchering Plough partnership. Total sales were $22.6 billion for the full year of 2006, an increase of 3% from the full year of 2005. Net income for 2006 was $4,433.8 million, compared to $4,631.3 million last year. A reconciliation of earnings per share (EPS) as reported in accordance with generally accepted accounting principles (GAAP) to EPS, adjusted for certain significant items is provided in the table below.
“The impressive sales performance of our newer and in line products coupled with the rapid uptake of new, first in class vaccines and medicines like GARDASIL and JANUVIA, speaks to the strength of our underlying business and product portfolio,” said Richard T. Clark, chief executive officer and president. "These results clearly set the stage for our performance in 2007 as well as continued progress toward our long term financial targets."
Worldwide sales were $6.0 billion for the quarter, an increase of 5% from the fourth quarter of 2005. Net income for the fourth quarter of 2006 was $473.9 million, compared to $1,119.7 million in the fourth quarter of 2005. Results for the fourth quarter of 2006 included $75 million added to the VIOXX legal defense reserve and a $48 million charge to establish a legal defense reserve for litigation that alleges FOSAMAX causes osteonecrosis of the jaw. For the fourth quarter of 2005, results included the addition of $295 million to the VIOXX legal defense reserve as well as the restructuring charges and the AJCA charge noted in the chart above.
“During the fourth quarter, we made investments to support the future success of our strategic research and marketing initiatives," Mr. Clark continued. "The $1.1 billion acquisition of Sirna is a notable example of this type of investment as RNA interference has the potential to transform the drug discovery and development process."
Materials and production costs were $1.7 billion for the quarter and $6.0 billion for the year. The quarter and the year include $164.3 million and $736.4 million, respectively, for costs associated with the global restructuring program, primarily related to accelerated depreciation and asset impairment costs. The gross margin for the fourth quarter was 72.4%, which reflects a 2.7 percentage point unfavorable impact relating to the restructuring costs as noted above. For the full year of 2006, the gross margin was 73.5%, which reflects a 3.3 percentage point unfavorable impact relating to restructuring costs.
Marketing and administrative expenses increased 10% in the fourth quarter of 2006 and 14% for the full year. Included in marketing and administrative expenses for the full year are an additional $598 million reserve added in the third quarter and a $75 million reserve added in the fourth quarter each solely for future legal defense costs for VIOXX litigation. Also included is the $48 million charge for the FOSAMAX litigation in which 104 cases had been filed against Merck as of Dec. 31. Excluding these costs in 2006, as well as the addition of $295 million for the VIOXX legal defense reserve in 2005, marketing and administrative expenses increased 21% for the fourth quarter and 9% for the year. The results largely reflect the increase in the level of activity to support the launches of three new vaccines and JANUVIA in the United States.
Research and development expenses were $1.7 billion for the quarter and $4.8 billion for the year, an increase from the comparable period in 2005 of 55% and 24%, respectively. The fourth quarter and full year amounts include a $466 million acquired research charge for Sirna. In addition, costs relating to the global restructuring program of $57 million were included for the full year of 2006 and $19 million for the full year of 2005. Excluding the Sirna and restructuring charges, research and development expe |
| 2008-02-08 | Earnings/Dividends | The Board of Directors of Merck Co., Inc., meeting today, declared a quarterly dividend of $0.38 per share on the Company’s common stock for the second quarter of 2007.
The $0.38 per share dividend is payable on April 2, 2007 to stockholders of record at the close of business on March 9, 2007.
About Merck
Merck Co., Inc. is a global research driven pharmaceutical company dedicated to putting patients first. Established in 1891, Merck discovers, develops, manufactures and markets vaccines and medicines to address unmet medical needs. The Company devotes extensive efforts to increase access to medicines through far reaching programs that not only donate Merck medicines but help deliver them to the people who need them. Merck also publishes unbiased health information as a not for profit service. For more information, visit "http://www.merck.com" target=_blank www.merck.com. ! END STORY BODY /DIV! END STORY /DIV! end main story table DIV releaseBottom! START CONTACT INFO DIV contacts style="FLOAT: left; MARGIN: 10px 0px 0px; WIDTH: 35%" |
| 2008-02-08 | Earnings/Dividends |
WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Merck & Co., Inc. today announced third-quarter 2007 earnings per share of $0.75, excluding restructuring charges, and third-quarter reported EPS of $0.70. Worldwide sales were $6.1 billion for the quarter, an increase of 12 percent from the third quarter of 2006. Net income for the third quarter of 2007 was $1,525.5 million compared with $940.6 million in the third quarter of 2006. Net income and EPS for the third quarter of 2007 include the impact of an acquired research charge of $325 million or $0.15 per share related to the purchase of NovaCardia, Inc. and a net gain of approximately $100 million resulting from the settlement during the quarter of certain patent disputes. Net income and EPS for the third quarter of 2007 and 2006 also include the impact of reserving an additional $70 million and $598 million, respectively, solely for future VIOXX legal defense costs.
Net income was $4,906.3 million, and worldwide sales were $18 billion for the first nine months of 2007. Total sales increased 8 percent for the same period.
A reconciliation of EPS as reported in accordance with generally accepted accounting principles (GAAP) to EPS, adjusted for certain significant items, is provided in the table that follows. Quarter Ended Sept. 30 Nine Months Ended Sept. 30 2007 2006 2007 2006 EPS, as reported $ 0.70 $ 0.43 $ 2.24 $ 1.81 Costs related to the global restructuring program 0.05 0.08 0.16 0.21
EPS, adjusted for significant items listed above1 $ 0.75 $ 0.51 $ 2.40 $ 2.02
"Our third-quarter results reflect the continued progress Merck is making to deliver on our strategy," said Richard T. Clark, chairman, president and chief executive officer. "Merck again delivered strong results, including 12 percent sales growth and double-digit earnings-per-share growth, fueled by the performance of SINGULAIR, JANUVIA, GARDASIL, VARIVAX, VYTORIN and ZETIA."
In addition, Mr. Clark said, "We were very pleased to gain FDA approval of our groundbreaking HIV treatment, ISENTRESS. The approval of this novel HIV integrase inhibitor further underscores the Company's ongoing commitment to developing truly innovative new medicines to meet unmet medical needs."
Materials and production costs were $1.5 billion for the quarter, a decrease of 2 percent from the third quarter of 2006. The third-quarter 2007 and third-quarter 2006 costs include $129 million and $200 million, respectively, for costs associated with the global restructuring program. The gross margin was 75.0 percent for the third quarter of 2007 and 71.5 percent for the third quarter of 2006, reflecting 2.1 and 3.7 percentage point unfavorable impacts, respectively, relating to the restructuring costs noted above.
Marketing and administrative expenses were $2.0 billion for the third quarter of 2007. Included in marketing and administrative expenses is an additional $70 million reserve solely for future VIOXX legal defense costs. Excluding this cost and the additional $598 million reserve for VIOXX legal defense costs recorded in the third quarter of 2006, marketing and administrative expenses increased 6 percent from the third quarter of 2006. The increase largely reflects the necessary support for new and anticipated product launches.
Research and development expenses were $1.4 billion for the quarter, an increase of 52 percent from the third quarter of 2006. The amount for the third quarter of 2007 includes a $325 million acquired research charge associated with the purchase of San Diego-based NovaCardia, Inc., which included that company's investigational Phase III compound for acute heart failure, rolofylline (MK-7418). Excluding the NovaCardia acquired research charge, research and development expenses increased 18 percent from the third q |
| 2008-02-08 | Earnings/Dividends |
WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--The Board of Directors of Merck & Co., Inc., meeting today, declared a quarterly dividend of $0.38 per share on the Company’s common stock for the first quarter of 2008.
The $0.38 per share dividend is payable on Jan. 2, 2008 to stockholders of record at the close of business on Dec. 7, 2007.
About Merck
Merck & Co., Inc. is a global research-driven pharmaceutical company dedicated to putting patients first. Established in 1891, Merck discovers, develops, manufactures and markets vaccines and medicines to address unmet medical needs. The Company devotes extensive efforts to increase access to medicines through far-reaching programs that not only donate Merck medicines but help deliver them to the people who need them. Merck also publishes unbiased health information as a not-for-profit service. For more information, visit www.merck.com.
|
| 2008-02-08 | Earnings/Dividends |
WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Merck & Co., Inc. today announced second-quarter 2007 results that reflected an increase in earnings per share of 12% fueled by strong performance across a broad range of the Company's products. Worldwide sales were $6.1 billion for the quarter, an increase of 6% from the second quarter of 2006. Net income for the second quarter of 2007 was $1,676.4 million, compared to $1,499.3 million in the second quarter of 2006. Net income and EPS for the second quarter of 2007 include the impact of reserving an additional $210 million solely for future VIOXX legal defense costs. Net income and EPS for the second quarter of 2006 include the impact of a $296 million acquired research charge related to the GlycoFi, Inc. acquisition. Net income was $3,380.7 million and worldwide sales were $11.9 billion for the first six months of 2007. Total sales increased 6% for the same period. A reconciliation of EPS as reported in accordance with generally accepted accounting principles (GAAP) to EPS, adjusted for certain significant items, is provided in the table below. Quarter Ended June 30 Six Months Ended June 30 2007 2006 2007 2006 EPS, as reported $ 0.77 $ 0.69 $ 1.55 $ 1.38 Costs related to the global restructuring program 0.05 0.04 0.11 0.13
EPS, adjusted for significant items listed above1 $ 0.82 $ 0.73 $ 1.66 $ 1.51
“A broad range of our newer and established products delivered strong growth again during the second quarter," said Richard T. Clark, chairman, president and chief executive officer. "Our overall performance has positioned us well to achieve our business targets, meet the challenges that lie ahead, and continue to invest in drug discovery."
Materials and production costs were $1.6 billion for the quarter, an increase of 7% from the second quarter of 2006. The second-quarter 2007 and second-quarter 2006 costs include $119 million and $168 million, respectively, for costs associated with the global restructuring program. The gross margin was 74.6% for the second quarter of 2007 and 75.0% for the second quarter of 2006, which reflect 1.9 and 2.9 percentage point unfavorable impacts, respectively, relating to the restructuring costs noted above.
Marketing and administrative expenses were $2.1 billion for the second quarter of 2007. Included in marketing and administrative expenses is an additional $210 million reserve solely for future legal defense costs for VIOXX litigation. Excluding this cost, marketing and administrative expenses increased 8% from the second quarter of 2006. The increase largely reflects the necessary support for the new product launches currently under way.
Research and development expenses were $1.0 billion for the quarter, a decrease of 12% from the second quarter of 2006. The amount for the second quarter of 2006 included $296 million for acquired research from the GlycoFi acquisition.
Restructuring costs, primarily representing separation costs associated with the Company’s global restructuring program, were $56 million for the second quarter of 2007. Total costs associated with the Company's global restructuring program included in materials and production, research and development and restructuring costs were $172 million and $161 million for the second quarter of 2007 and 2006, respectively, primarily related to separations, accelerated depreciation and asset impairment costs.
Financial Guidance
Merck raises full-year 2007 guidance and now anticipates EPS range of $3.00 to $3.10, excluding the restructuring charges related to site closures and position eliminations. Merck anticipates reported full-year 2007 EPS of $2.80 to $2.95. Please see pages 8 - 9 of this news release for the full details of Merck’s full-year 2007 financial guidance.
The Company remains on track to deliver double-digit c |
| 2008-02-08 | Earnings/Dividends |
WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Merck & Co., Inc. today announced first-quarter 2007 results that reflected strong performance across a range of the Company's products and those of the Merck/Schering-Plough partnership, as well as gains from certain asset and product divestitures. Worldwide sales were $5.8 billion for the quarter, an increase of 7% from the first quarter of 2006. Net income for the first quarter of 2007 was $1,704.3 million, compared to $1,520.0 million in the first quarter of 2006. A reconciliation of earnings per share (EPS) as reported in accordance with generally accepted accounting principles (GAAP) to EPS, adjusted for certain significant items, is provided in the table below. Quarter Ended March 31 2007 2006 EPS, as reported $ 0.78 $ 0.69 Costs related to the global restructuring program 0.06 0.09 EPS, adjusted for significant items listed above1 $ 0.84 $ 0.78
“Many of our key products, both established and newly-launched, posted impressive growth and reinforced the underlying strength of our core business,” said Richard T. Clark, chief executive officer and president. "Our performance in the first quarter is further evidence that the path we have charted to return Merck to a leadership position in our industry is the right one. We still have much to do to realize our longer-term goals, but we are executing on our plan with confidence."
Materials and production costs were $1.5 billion for the quarter, an increase of 14% from the first quarter of 2006. The first-quarter 2007 and first-quarter 2006 costs include $118 million and $205 million, respectively, for costs associated with the global restructuring program. The gross margin was 73.6% for the first quarter of 2007 and 75.2% for the first quarter of 2006, which reflect 2.0 and 3.8 percentage point unfavorable impacts, respectively, relating to the restructuring costs noted above. The gross margin in the current quarter was affected by changes in product mix.
Marketing and administrative expenses were $1.8 billion for the first quarter of 2007, an increase of 5% from the first quarter of 2006. The increases largely stem from the level of activity required to support the worldwide launches of GARDASIL and JANUVIA.
Research and development expenses were $1.0 billion for the quarter, an increase of 9% from the first quarter of 2006. The amounts for the first quarter of 2007 and the first quarter of 2006 included $2 million and $55 million, respectively, relating to the global restructuring program.
Amounts included in Restructuring costs were $65.8 million for the first quarter of 2007, primarily representing separation costs associated with the Company’s global restructuring program. Total costs associated with the Company's global restructuring program were $186 million and $304 million for the first quarter of 2007 and 2006, respectively, primarily related to separations and accelerated depreciation and asset impairment costs.
Financial Guidance
Merck anticipates second-quarter EPS of $0.67 to $0.71, excluding restructuring charges, and anticipates reported second-quarter EPS of $0.62 to $0.68. In the second quarter, the Company anticipates that revenue will be comparable to the amount reported in the first quarter of 2007. In addition, research and development expense, excluding restructuring charges, is anticipated to be higher than the amount reported in the comparable period of 2006.
Merck reaffirms full-year 2007 EPS of $2.75 to $2.85, excluding the restructuring charges related to site closures and position eliminations. Merck anticipates reported full-year 2007 EPS of $2.60 to $2.75. Please see pages 7 - 8 of this news release for the full details of Merck’s full-year 2007 financial guidance.
The Company remains on track to deliver double-digit compound annual EPS growth, excluding one-time items and restructuring charges, by |
| 2008-02-08 | Earnings/Dividends |
WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Merck & Co., Inc. will conduct a conference call with institutional investors and analysts beginning at 8:30 a.m. EST on Tuesday, Dec. 4. Continuing its past practice, during this call, Richard T. Clark, chairman, chief executive officer and president, and Peter N. Kellogg, executive vice president and chief financial officer, will provide an overview of the 2008 financial guidance.
Journalists are invited to listen only by calling (706) 758-9928 or (800) 399-7917. A replay of the call will be available starting at 10 a.m. EST on Dec. 4 through 5 p.m. EST on Dec. 11. To listen to the replay, dial (706) 645-9291 or (800) 642-1687 and enter ID # 21484042.
Investors, journalists and the general public may access a live audio Web cast of the call on Merck’s Web site at http://www.merck.com/newsroom/webcast. Software needed to listen to the Web cast is available on the corporate Web site and should be downloaded prior to the beginning of the Web cast. A replay of the Web cast will be available from 10 a.m. EST on Dec. 4 through 5 p.m. EST on Dec. 11. The financial guidance press release will also be available in the Newsroom.
About Merck
Merck & Co., Inc. is a global research-driven pharmaceutical company dedicated to putting patients first. Established in 1891, Merck discovers, develops, manufactures and markets vaccines and medicines to address unmet medical needs. The Company devotes extensive efforts to increase access to medicines through far-reaching programs that not only donate Merck medicines but help deliver them to the people who need them. Merck also publishes unbiased health information as a not-for-profit service. For more information, visit merck.com.
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| 2008-02-08 | Earnings/Dividends | WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Merck & Co., Inc. today announced financial results for the full-year and fourth-quarter 2007.
The Company reported full-year 2007 non-GAAP (generally accepted accounting principles) earnings per share (EPS) of $3.20, which excludes fourth-quarter charges related to the U.S. VIOXX Settlement Agreement and civil governmental investigations, restructuring charges and an insurance arbitration gain, and full-year GAAP EPS of $1.49. Merck also announced fourth-quarter non-GAAP EPS of $0.80, excluding the previously disclosed items noted above, and fourth-quarter GAAP EPS of $(0.75). Worldwide sales were $24.2 billion for full-year 2007, an increase of 7 percent over full-year 2006. For the fourth quarter of 2007, worldwide sales were $6.2 billion, an increase of 3 percent over the fourth quarter of 2006. Foreign exchange provided a favorable effect to global sales performance of 2 percent for the year and 4 percent for the quarter. Net income for full-year 2007 was $3,275.4 million compared with $4,433.8 million in the full year of 2006. The Company reported a net loss in the fourth quarter of $1,630.9 million, reflecting an aggregate reduction in net earnings of $3,392 million resulting from the charges and gain noted above. Merck reported $473.9 million in net income during the same quarter in 2006. A reconciliation of EPS as reported in accordance with GAAP to EPS, adjusted for certain previously disclosed items, is provided in the table that follows.
Fourth-Quarter 2007
Full-Year 2007 GAAP EPS
$
(0.75
)
$
1.49
EPS impact of items*
$
1.55
$
1.71
Non-GAAP EPS that adjusts for items listed below1
$
0.80
$
3.20
* Amount calculated as follows (In millions except per share amounts):
Fourth-Quarter 2007 Full-Year 2007 U.S. VIOXX Settlement Agreement charge
$4,850
$4,850
Costs related to the global restructuring program
274
810
Civil governmental investigations charge
671
671
Insurance arbitration gain
(455
)
(455
)
Net reduction before income taxes
5,340
5,876
Income tax benefits on above items
(1,948
)
(2,133
)
Reduction in net income
$3,392
$3,743
EPS impact of items
$ 1.55
$ 1.71
"Our performance in 2007 shows that the customer-focused, more efficient business model we began implementing more than two years ago is working," said Richard T. Clark, chairman, president and chief executive officer. "We have a strong portfolio of products, a robust pipeline of potential new therapies and a leadership team focused daily on improving operational performance. This positions us to build on our record of delivering essential breakthrough medicines and vaccines like JANUVIA, ISENTRESS and GARDASIL to the global marketplace."
Materials and production costs were $1.5 billion for the quarter and $6.1 billion for the year. These costs were $1.7 billion for the quarter and $6.0 billion for the year in 2006. The fourth-quarter 2007 and full-year 2007 costs include $118 million and $483 million, respectively, for costs associated with the global restructuring program. The costs for the fourth quarter and full year of 2006 include $164 million and $736 million, respectively, for costs associated with the global restructuring program. The gross margin was 75.3 percent for the fourth quarter of 2007 and 74.6 percent for the full year of 2007, reflecting 1.9 and 2.0 percentage point unfavorable impacts, respectively, relating to the restructuring costs noted above.
Marketing and administrative expenses were $1.7 billion for the fourth quarter and $7.6 billion for the full year of 2007. In 2006, these costs were $2.3 billion for the fourth quarter and $8.2 billion for the full year. Included in the full-year marketing and administrative expenses in 2007 is $280 million in reserves for future legal defense costs |
| 2008-02-08 | Earnings/Dividends | Merck Co., Inc. today announced that EPS for the third quarter of 2006 were $0.51, including the impact of reserving an additional $598 million in the third quarter solely for future VIOXX legal defense costs and excluding a net $0.08 charge for site closures and position eliminations primarily associated with the global restructuring announced in November 2005. Reported EPS, including the impact of the net restructuring charge, were $0.43 for the third quarter of 2006 compared to $0.65 for the third quarter of 2005. Net income was $940.6 million, compared to $1,420.9 million in the third quarter of last year. Worldwide sales were $5.4 billion for the quarter, comparable to the third quarter of 2005. Excluding the impact of the restructuring charges, EPS for the first nine months of 2006 were $2.02. Reported EPS were $1.81, including the impact of the $0.21 net restructuring charges taken during the year. Net income was $3,959.9 million and worldwide sales were $16.6 billion for the first nine months of 2006. Total sales increased 2% for the first nine months. “The third quarter results reflect the recognition of the medical value of GARDASIL, our vaccine for cervical cancer. This week's approval of our firstinclass diabetes drug, JANUVIA, marks the fifth product approval this year for Merck,” said Richard T. Clark, chief executive officer and president. “Given the results of the quarter, we remain on track to meet the goals we set for ourselves with our new business strategy.” Materials and production costs increased 25% for the third quarter of 2006, including $199.6 million recorded in the third quarter for costs associated with the global restructuring program, primarily related to accelerated depreciation and asset impairment costs. Excluding these costs, materials and production increased 9% for the quarter. The gross margin was 71.5% which reflects a 3.7 percentage point unfavorable impact relating to the restructuring costs as noted above. For the first nine months of 2006, the gross margin was 73.9% which reflects a 3.4 percentage point unfavorable impact relating to restructuring costs. Marketing and administrative expenses were $2,370.6 million, an increase of 43% in the third quarter of 2006. Included in marketing and administrative expenses is an additional $598 million reserve solely for future legal defense costs for VIOXX litigation recorded in the third quarter. Excluding this cost, marketing and administrative expenses increased 7% for the quarter. The results reflect the increase in the level of activity to support the three recentlyapproved vaccines and the imminent launch of JANUVIA in the United States. Research and development expenses were $945.4 million for the quarter, comparable to the third quarter of 2005. Restructuring costs were $49.6 million for the quarter, representing separation and other related costs associated with the Company’s restructuring program announced in November 2005. In the third quarter of 2006, the Company eliminated approximately 500 positions, bringing the total to approximately 3,900 since the inception of the program. Merck remains on track to eliminate 7,000 positions by the end of 2008. FullYear 2006 EPS Guidance Merck anticipates fullyear 2006 EPS of $2.48 to $2.52, excluding the restructuring charges related to site closures and position eliminations. Merck anticipates reported fullyear 2006 EPS of $2.18 to $2.25. Please see pages 10 11 of this news release for details of Merck’s fullyear 2006 financial guidance. ThirdQuarter Performance Highlights Worldwide sales were strong for SINGULAIR, a onceaday oral medicine indicated for the chronic treatment of asthma and the relief of symptoms of allergic rhinitis, reaching $868 million for the third quarter, representing growth of 25% over the third quarter of 2005. Sales for the first nine months were $2.6 billion, a 21% increase over the comparable 2005 period. SINGULAIR continues to be the number one prescribed product in |
| 2008-02-08 | Contract/Agreements | Merck Co., Inc. announced that it has entered into a definitive agreement to settle its previously disclosed tax disputes with the Internal Revenue Service (IRS). This settlement resolves all of the issues that were in dispute. The agreement essentially brings to a close the IRS's examination of the Company for the period 1993 2001. Under the agreement, the final net cash cost to Merck is expected to be approximately $2.3 billion which covers federal tax, net interest after federal tax deductions and penalties. The impact for years subsequent to 2001 of the previously disclosed tax disputes is included in the settlement although those years remain open in all other respects.
Merck has previously reserved for these items and this settlement is not expected to have any material impact on the Company's annual earnings for 2007.
The Company concluded that given the theoretical amount in disagreement, it was in the Company's best interests to reach this settlement so as to remove the uncertainty and cost of potential litigation. Merck acknowledges that this agreement was reached as a result of the cooperation and reasonableness of the IRS and the Company.
About Merck
Merck Co., Inc. is a global research driven pharmaceutical company dedicated to putting patients first. Established in 1891, Merck discovers, develops, manufactures and markets vaccines and medicines to address unmet medical needs. The Company devotes extensive efforts to increase access to medicines through far reaching programs that not only donate Merck medicines but help deliver them to the people who need them. Merck also publishes unbiased health information as a not for profit service. For more information, visit "http://www.merck.com" target=_blank www.merck.com.
Forward Looking Statement
This press release contains "forward looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements are based on management’s current expectations and involve risks and uncertainties, which may cause results to differ materially from those set forth in the statements. The forward looking statements may include statements regarding product development, product potential or financial performance. No forward looking statement can be guaranteed, and actual results may differ materially from those projected. Merck undertakes no obligation to publicly update any forward looking statement, whether as a result of new information, future events, or otherwise. Forward looking statements in this press release should be evaluated together with the many uncertainties that affect Merck's business, particularly those mentioned in the cautionary statements in Item 1 of Merck's Form 10 K for the year ended Dec. 31, 2005, and in its periodic reports on Form 10 Q and Form 8 K, which the Company incorporates by reference. ! END STORY BODY /DIV! END STORY /DIV! end main story table DIV releaseBottom! START CONTACT INFO DIV contacts style="FLOAT: left; MARGIN: 10px 0px 0px; WIDTH: 35%" |
| 2008-02-08 | Contract/Agreements |
WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Merck & Co., Inc. today announced that it has entered into an agreement with the law firms that comprise the executive committee of the Plaintiffs’ Steering Committee of the federal multidistrict VIOXX litigation as well as representatives of plaintiffs' counsel in state coordinated proceedings to resolve state and federal myocardial infarction (MI) and ischemic stroke claims already filed against the Company in the United States. The agreement, which also applies to tolled claims, was signed by the parties this morning after they met with three of the four judges overseeing the coordination of more than 95 percent of the current claims in the VIOXX litigation.
If certain conditions under the agreement are met, the Company will pay a fixed amount of $4.85 billion into a settlement fund for qualifying claims that enter into the resolution process. This is not a class-action settlement. Claims will be evaluated on an individual basis.
"This is a good and responsible agreement that will allow the Company to concentrate even more fully on its mission of discovering, developing and delivering novel medicines and vaccines," said Richard T. Clark, chairman, president and chief executive officer of Merck. "The agreement is structured to provide a significant degree of certainty toward resolving the majority of the outstanding VIOXX product liability claims in the United States for a fixed amount."
The conditions in the agreement, which is open only to those cases filed or tolled on or before Nov. 8, 2007, include: To qualify, claimants will have to pass three gates: an injury gate requiring objective, medical proof of MI or ischemic stroke (as defined in the agreement), a duration gate based on documented receipt of at least 30 VIOXX pills, and a proximity gate requiring receipt of pills in sufficient number and proximity to the event to support a presumption of ingestion of VIOXX within 14 days before the claimed injury; Individual cases will be examined by administrators of the resolution process to determine qualification based on objective, documented facts provided by claimants, including records sufficient for a scientific evaluation of independent risk factors; The agreement provides that Merck does not admit causation or fault; Neither stroke claims that are hemorrhagic in nature nor transient ischemic attacks will qualify; Law firms on the federal and state Plaintiffs’ Steering Committees and firms that have tried cases in the coordinated proceedings must recommend enrollment in the program to 100 percent of their clients who allege either MI or ischemic stroke; The parties agree to seek court orders from the four coordination judges requiring plaintiffs’ attorneys to promptly register all of their VIOXX claims, whether filed or tolled, and to identify the alleged injury – in order to establish the universe of all existing claims in the United States; Participation conditions: payment obligations under the agreement will be triggered only if, by March 1, 2008 (subject to extension by Merck), plaintiffs enroll in the settlement process: (a) 85 percent or more of all currently pending and tolled MI claims, (b) 85 percent or more of all currently pending and tolled ischemic stroke claims; (c) 85 percent or more of all eligible claims involving a death; and (d) 85 percent or more of all eligible claims alleging more than 12 months of use; and This agreement applies only to U.S. legal residents and those who allege that their MI or ischemic stroke occurred in the United States.
Under the agreement, separate funds will be created by the Company in the amount of $4 billion for MI claims and $850 million for ischemic stroke claims. Once triggered, Merck’s total payment for both funds of $4.85 billion is a fixed amount to be allocated among qualifying claimants based on their individual evaluation. While at this time the exact number of claimants covered by t |
| 2008-02-08 | Earnings/Dividends |
WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--The Board of Directors of Merck & Co., Inc., meeting today, declared a quarterly dividend of $0.38 per share on the Company’s common stock for the third quarter of 2007.
The $0.38 per share dividend is payable on July 2, 2007 to stockholders of record at the close of business on June 8, 2007.
About Merck
Merck & Co., Inc. is a global research-driven pharmaceutical company dedicated to putting patients first. Established in 1891, Merck discovers, develops, manufactures and markets vaccines and medicines to address unmet medical needs. The Company devotes extensive efforts to increase access to medicines through far-reaching programs that not only donate Merck medicines but help deliver them to the people who need them. Merck also publishes unbiased health information as a not-for-profit service. For more information, visit www.merck.com. |
| 2008-02-08 | Earnings/Dividends | Merck Co., Inc. today announced that it reaffirms its full year 2006 earning per share (EPS) guidance and anticipates full year 2007 EPS of $2.51 to $2.59 excluding restructuring charges related to site closures and position eliminations. On a reported basis, the Company anticipates 2007 EPS in the range of $2.36 to $2.49. The 2006 and 2007 guidance does not reflect the establishment of any reserves for any potential liability relating to the VIOXX litigation and does not include the impact of any potential acquired research expense relating to the anticipated Sirna Therapeutics acquisition.
In 2007 the Company expects continued growth in newer franchises, including the on going launches of ROTATEQ, ZOSTAVAX, GARDASIL and JANUVIA, as well as potential new launches.
“Merck continues to focus on results. We will achieve these results by continuing to improve the way we discover, develop, manufacture and market our medicines and vaccines. Our mission is to deliver to patients the innovative medicines they need to live healthier lives. We look forward to discussing our progress at our Annual Business Briefing for investors on December 12,” said Richard T. Clark, chief executive officer and president.
“Building off the 2005 base, we remain focused on executing so that we can deliver sustained revenue and earnings growth over the long term," Mr. Clark added. "As we implement fundamental changes to our business model, our current products, anticipated new product introductions and cost savings initiatives will help position us to deliver compound annual double digit earnings growth, excluding charges and one time items, by 2010. Beyond 2010, we expect to deliver sustained revenue and earnings growth fueled by our growing pipeline.”
Commenting on the Company’s longer term financial prospects, Judy C. Lewent, Merck's executive vice president and chief financial officer, stated, “As we disclosed last year, Merck’s new and in line pharmaceutical products and vaccines are expected to drive revenue at a compound annual growth rate of 4 6% from 2005 through 2010, including 50% of the revenues from the joint ventures from which Merck derives equity income. We also expect that we can fully support our expanding pipeline with mid single digit compound annual growth in research funding over the same period. By sustaining our cost management initiatives, Merck expects to fully capitalize on the promise of our expanding product portfolio while maintaining marketing and administrative expense flat in 2010 relative to the 2006 base.”
"We expect bottom line earnings growth to begin in 2007, excluding restructuring charges and the impact of any potential acquired research expense relating to the anticipated Sirna Therapeutics acquisition," Ms. Lewent continued. "As earnings growth strengthens by the end of the period, on a compound annual basis, earnings per share growth is expected to reach double digits, excluding restructuring costs, net tax charges, any one time gains associated with the AstraZeneca partnership and the establishment of any reserves for any potential liability relating to the VIOXX litigation."
This anticipated performance, together with Merck's ongoing inventory and capital management programs which contribute to ensuring strong cash flow, supports the Company’s commitment to maintaining its dividend at current levels and is also expected to provide opportunities for share repurchases.
2006 Guidance
Merck anticipates full year 2006 EPS of $2.48 to $2.52, excluding the restructuring charges related to site closures and position eliminations. Merck anticipates reported full year 2006 EPS of $2.18 to $2.25. This 2006 guidance does not reflect the establishment of any reserves for any potential liability relating to the VIOXX litigation and does not include the impact of any potential acquired research expense relating to the anticipated Sirna Therapeutics acquisition.
2007 Guidance
M |
| 2008-02-06 | Alliances | Watson Pharmaceuticals, Inc. , a leading specialty pharmaceutical company, announced today that the company expects to initiate shipments of alendronate sodium in the 35 and 70 mg once weekly dosage strengths when Fosamax(R) loses market exclusivity, which is anticipated to occur at the close of business on February 6, 2008. Alendronate sodium is the generic version of Merck's Fosamax(R) tablets, indicated for the treatment of osteoporosis in postmenopausal women. Alendronate sodium is also indicated to increase bone mass in men with osteoporosis.
Under the terms of a supply agreement, Merck will manufacture and supply the alendronate sodium tablets to Watson, which will market, sell and distribute the product in the United States. Merck will receive a share of the profits from Watson's sales of the generic product in the U.S. market. Further details on the agreement have not been disclosed. |
| 2008-01-31 | Merger/Acquisition | Iroko Pharmaceuticals announces the acquisition of all non-US commercial rights to Aggrastat (tirofiban HCl) from Merck & Co., Inc.
Outside of the US market, Aggrastat in combination with heparin is indicated for patients with unstable angina or non-Q wave myocardial infarction to prevent cardiac ischemic events, and is also indicated for patients with coronary ischemic syndromes undergoing coronary angioplasty or atherectomy to prevent cardiac ischemic complications related to abrupt closure of the treated coronary artery. Aggrastat is indicated for the treatment of acute coronary syndrome, including patients who are to be managed medically and those undergoing percutaneous transluminal coronary angioplasty (PTCA).
Financial terms of the transaction were not disclosed.
We are excited to acquire this important medicine from Merck, stated John Vavricka, President and Chief Executive Officer of Iroko Pharmaceuticals. This acquisition plays to our strengths in focused sales and marketing efforts and building close working relationships with key opinion leaders. We look forward to ensuring the best positioning of Aggrastat in the marketplace for the benefit of patients.
We are very pleased to conclude another transaction with Merck by acquiring this patent-protected asset, stated Osagie Imasogie, Irokos Chairman and Senior Managing Partner of Phoenix IP Ventures. Aggrastat substantially builds on Irokos presence in the cardiovascular space and leverages our existing worldwide capabilities and infrastructure. This transaction is consistent with our strategy of growing Iroko through targeted asset acquisitions. We are pleased that, with the acquisition of Aggrastat, Irokos annual revenues will achieve a major milestone by exceeding $100 Million Dollars on a most recent year basis. |
| 2008-01-25 | Alliances | Arena Pharmaceuticals, Inc. announced today that Merck & Co., Inc. initiated a Phase 1 clinical trial of a second generation oral niacin receptor agonist under a collaboration between the companies to discover drugs for the treatment of atherosclerosis and other disorders. The initiation of this trial does not trigger a milestone payment.
"We are very pleased with the progress of this collaboration investigating the therapeutic potential of niacin receptor agonists to treat atherosclerosis and other disorders. We are looking forward to the Phase 1 results and the continued progress of the program," said Jack Lief, Arena's President and Chief Executive Officer.
Arena also announced that preclinical investigation of MK-0354, a first generation niacin receptor agonist being evaluated for indications other than atherosclerosis, was discontinued for compound specific reasons.
About Atherosclerosis
Atherosclerosis is characterized by the collection of fatty material deposits, such as cholesterol, along artery walls. This fatty material thickens, hardens, and may eventually block the arteries, adversely affecting blood flow and increasing the risk of heart attack and stroke over time. The American Heart Association estimates that atherosclerosis accounts for nearly 75% of all deaths from cardiovascular disease. HDL cholesterol, commonly known as the "good" cholesterol, can help clear the fatty deposits from the walls of blood vessels and transport cholesterol to the liver for processing and removal from the body. Drugs that can influence the levels of HDL cholesterol, or "good" cholesterol, may potentially provide clinical benefits to patients by reducing the risk of heart attack and stroke. The niacin receptor, a G protein-coupled receptor, or GPCR, is believed to have potential in regulating plasma lipid profiles, including HDL. |
| 2008-01-15 | Alliances | Compugen Ltd. (NASDAQ:CGEN - News) announced today a collaboration with Merck & Co., Inc., Whitehouse Station, New Jersey, targeted at predicting peptides likely to activate selected G-protein coupled receptors (GPCRs) and validating their agonistic activity. The agreement includes an option to Merck for exclusive worldwide licenses for such peptides – on a peptide by peptide basis – covering the development and commercialization of therapeutic products.
“We are very pleased that our first collaboration based on this capability is with Merck, one of the world’s leading research-based pharmaceutical companies,” stated Alex Kotzer, President and Chief Executive Officer of Compugen. |
| 2008-01-07 | Alliances | Allosteric modulation company Addex Pharmaceuticals (Swiss:ADXN.SW - News) announced today that it has entered an exclusive worldwide license agreement with Merck & Co., Inc. ("Merck") to develop ADX63365, an orally available drug candidate for the potential treatment of schizophrenia and other undisclosed indications. Allosteric modulators are an emerging new class of therapeutic agents. ADX63365, currently in preclinical development, is a positive allosteric modulator (PAM) that targets the metabotropic glutamate receptor 5 (mGluR5), which is believed to be important as a target for the treatment of schizophrenia and other conditions. The deal also includes mGluR5 PAM backup compounds discovered by Addex.
Under the terms of the agreement, Addex will receive $22 million upfront and is eligible for up to $455 million in research, development, regulatory and sales milestones for the first product developed for two indications and up to $225 million in additional development, regulatory and sales milestones for a second product developed in two indications. Addex is eligible to receive royalties on sales of any products resulting from this collaboration. In addition, Addex has an option to co-promote in certain European Union countries and will participate in the joint oversight committee for further development that will be led by Merck.
"We are thrilled to establish a second deal with Merck to develop this groundbreaking new approach for patients suffering from schizophrenia and other important diseases," Vincent Mutel, CEO of Addex, said. "This deal confirms that Addex can successfully leverage its technology to produce drug candidates that can have broad benefit for human health."
"Merck scientists were the first to identify the potential for targeting mGluR5 to treat schizophrenia," said Darryle D. Schoepp, Ph.D., senior vice president and franchise head, Neuroscience, at Merck Research Laboratories. "Through this second collaboration with Addex we have now gained access to a promising drug candidate targeting this receptor that potentially allows us to address an area of high medical importance where current therapies are clearly inadequate."
On 3 December 2007, Addex announced a separate collaboration with an affiliate of Merck, Merck Sharp & Dohme Research Ltd, to discover and develop PAMs targeting mGluR4 for the treatment of Parkinson's disease and other undisclosed indications.
"We now expect 2008 full year cash burn to be in the range of CHF 25-30 million," Tim Dyer, CFO of Addex said, giving initial guidance for 2008. |
| 2008-01-01 | Merger/Acquisition | PRWT Services, Inc., a minority owned business enterprise, today announced that it has, through its wholly owned subsidiary, Cherokee Pharmaceuticals LLC, acquired the Cherokee chemical manufacturing plant in Riverside, PA, from Merck & Co., Inc. of Whitehouse Station, NJ. Cherokee has also entered into a five year supply agreement with Merck for an estimated value of $100 200 million annually.
Willie F. Johnson, Chairman & CEO of PRWT, said: "The acquisition of the Cherokee plant is consistent with PRWT's vision of growing the company by expanding into new markets, services, and lines of business. By establishing a presence in the Life Sciences market, PRWT can now participate in an industry with tremendous growth potential and establish a strategic supplier relationship with Merck, one of the premier pharmaceutical companies in the world." Mr. Johnson also acknowledged PRWT's employees who have established a culture of excellence at PRWT that gave Merck the confidence to complete this historic deal.
The Cherokee plant is a state of the art API manufacturing facility of products/antibiotics for humans and animals. All 400 employees working at the plant will be offered jobs and are expected to transfer their employment from Merck to PRWT effective January 1, 2008. PRWT also intends to make considerable capital investments in the Cherokee plant to support the growth of the business and increase the number of jobs available in the local community.
Justin Noll, the Cherokee plant manager, stated, "We are genuinely excited about the sale of the plant and becoming part of PRWT. Not only will it be good for the employees, but also for the community at large. We are looking forward to being a stand alone company and a company which will have great potential for expansion."
The sale of the site is part of Merck's global restructuring of its manufacturing operations (announced November 2005) to create a global manufacturing network that is better aligned to Merck's current and anticipated future product demand.
"The sale of the Cherokee plant, along with the supplier relationship Merck has established with Cherokee Pharmaceuticals, is another important step in the realigning of our manufacturing operations," said Larry Naldi, Senior Vice President, Science & Technology, Merck Manufacturing Division. "The completion of this sale also enables Merck to continue to have a presence in the local community through its interactions with Cherokee." |
| 2007-12-19 | Alliances | Cognizant , a leading provider of global IT and business process outsourcing services, announced today a multi-year, multi-million dollar engagement with Merck & Co. , a global research-driven pharmaceutical company.
Cognizant will extend its existing relationship with Merck, dating back to 2005, to become a key technology partner and provide a full suite of services encompassing applications outsourcing, IT infrastructure management and business process outsourcing services.
"Over the past two years, Merck has leveraged Cognizant's extensive pharmaceutical expertise to streamline operational efficiencies and to consolidate our IT portfolio," said Rich Branton, vice president Global Technology Solutions, Merck & Co. "We selected Cognizant as our ongoing strategic partner for the full suite of IT services as a result of our previous engagements and Cognizant's deep domain experience and leadership position in our space."
"With Cognizant's expertise in the Healthcare and Life Sciences industry, we are proud to be chosen by Merck as a trusted IT partner to deliver services globally for them," said Francisco D'Souza, president and CEO of Cognizant. "Our ability to integrate applications, infrastructure and business processes, coupled with our global delivery model, enables us to provide Merck with a strong platform for its global transformational initiatives." |
| 2007-12-19 | Alliances | Ambrx Inc. today announced that it has entered into a global, strategic collaboration with Merck & Co. Inc. to develop a novel therapeutic protein with biological properties similar to Fibroblast Growth Factor 21 (FGF-21) for the treatment of type 2 diabetes and related metabolic disorders such as obesity.
The collaboration utilizes Ambrx's proprietary protein technology, ReCODE(TM), to develop a chemically modified and optimized drug candidate designed to have improved therapeutic properties over the native FGF-21 protein.
"We are pleased to enter into this agreement with Merck, a world leader in the metabolic diseases field with a proven track record in the rapid development and launch of diabetes medicines," said Stephen W. Kaldor, Ph.D., Ambrx's president and chief executive officer. "We are excited about the potential of our initial FGF-21 protein drug candidates, as they promise unique pharmacological efficacy in the treatment of diabetes, a disease of large and rapidly increasing prevalence."
"Molecules capable of mimicking the biological properties of the natural protein FGF-21 represent promising candidates for the treatment of metabolic disorders such as type 2 diabetes and obesity," said Luciano Rossetti, M.D., senior vice president and franchise head, Diabetes/Obesity and Cardiovascular Franchises at Merck. "Ambrx has developed several novel preclinical protein therapeutic candidates designed to provide enhanced therapeutic properties that may complement our portfolio of products for people with metabolic disorders."
The transaction includes an initial upfront payment in addition to committed R&D payments. Ambrx will also be eligible to receive future milestone payments associated with research, development and commercialization of a drug candidate resulting from the collaboration along with royalties on net sales. Ambrx also has the right to exercise an "end of Phase II" profit sharing option. Additional terms of the agreement were not disclosed. It is expected that this collaboration, in conjunction with three others announced this year, will preclude the necessity for Ambrx to raise additional equity capital for a number of years. |
| 2007-12-14 | Alliances | Inovio Biomedical Corporation (AMEX:INO), a leader in enabling the development of DNA vaccines using electroporation-based DNA delivery, announced today it will receive a $2 million milestone payment from Merck & Co., Inc. resulting from the filing of a second Investigational New Drug application to the US Food & Drug Administration by Merck for a DNA-based vaccine using Inovio’s MedPulser® DNA Delivery System. The milestone relates to Inovio’s collaboration and license with Merck initiated in May 2004 for the development of certain DNA vaccines. Further development of the product may lead to additional milestone payments and royalties to Inovio. |
| 2007-12-14 | Alliances | Geron Corporation (Nasdaq:GERN - News) announced today that Merck & Co, Inc. has filed an Investigational New Drug application (“IND”) with the U.S. Food and Drug Administration (“FDA”) for a cancer vaccine candidate that targets telomerase. Merck is developing the vaccine under a July, 2005 Research, Development and Commercialization License Agreement with Geron, which provided Merck with exclusive worldwide rights to develop and commercialize non-dendritic cell based vaccines targeting telomerase. Geron has received a $4 million milestone payment from Merck on account of the IND filing, and is eligible to receive additional development milestones as well as royalties on worldwide product sales.
“We are pleased with the progress that Merck has made in advancing this program towards the clinic,” said Thomas B. Okarma, Ph.D., M.D., Geron’s president and chief executive officer. “We appreciate the collaborative nature of our relationship with Merck and look forward to working with them to realize the therapeutic potential of this cancer vaccine candidate.”
Geron’s Dendritic Cell-Based Cancer Vaccine
Separately, Geron is currently enrolling patients with acute myelogenous leukemia (AML) in a Phase I/II study of its own telomerase vaccine candidate, GRNVAC1, which delivers the telomerase antigen using autologous dendritic cells. In a prior study conducted at Duke University, the vaccine was shown to induce substantial T-cell anti-telomerase activity. The Geron study also incorporates a prime/boost vaccine dosing regimen designed to prolong the period of anti-telomerase immunity. Geron is also developing a second generation allogeneic telomerase vaccine based on dendritic cells made from human embryonic stem cells.
Telomerase and Cancer
Telomerase is an enzyme, active in most cancer cells, that maintains telomere length at the ends of chromosomes. This activity confers replicative immortality to the cells in the tumor, allowing the cancer to grow and metastasize over long periods of time. Because telomerase is inactive or only transiently expressed in normal human tissues, and is critical to the growth and progression of most cancer types, it is regarded as a universal and specific cancer target. |
| 2007-12-04 | Alliances | Addex Pharmaceuticals of Switzerland could see its coffers boosted by more than $170.5 million following the signing of a deal with Merck & Co to develop a new class of oral drugs to treat Parkinson’ disease.
The two firms are looking to develop positive allosteric modulators, which will target the metabotropic glutamate receptor 4. Current treatments for Parkinson's focus on dopamine replacement but most patients reach a stage where these drugs are no longer effective, coupled with debilitating side effects. It is now thought that bypassing the dopamine system may provide a more effective treatment strategy and selective activation of mGluR4 is one way to do this, whilst reducing the side effects.
Merck notes that its scientists provided the first evidence that mGluR4 activation has potential for the treatment of Parkinson's, “however, a remaining challenge has been to make drug-like molecules that activate mGluR4 in a specific fashion”.
Financially speaking, Addex will receive $3 million upfront and is eligible for up to $106.5 million in R&D and regulatory milestones for the first product developed for multiple indications. Additional milestones of up to $61 million would be payable if a second and third product is developed and the Geneva-based firm will receive undisclosed royalties on sales of any products resulting from the collaboration.
Both companies will collaborate on preclinical development, while Merck will be responsible for clinical studies. Addex has an option to co-promote in certain European Union countries and its chief executive, Vincent Mutel, said that the deal is “another important validation of our leadership in allosteric modulation”.
News of the Merck link-up pushed Addex shares up 12.3% to 41 Swiss francs, a welcome boost to the stock which was floated in May after an initial public offering brought in 137 million francs. The shares have fallen back since then and dipped again in October when Addex discontinued development of an experimental smoking cessation treatment which had failed a mid-stage trial. |
| 2007-12-04 | Alliances | ICx Technologies , a developer of advanced technology solutions for homeland security and force protection, announced today a research study with Merck & Co., Inc. and Fred Hutchinson Cancer Research Center of Seattle.
The purpose of the study is to test and refine a set of protocols for detecting and recovering circulating nucleic acids from blood -- a key early detector for cancer treatment - in order to support the development of an investigational cancer therapy. The study is being conducted by its La Jolla, Calif.-based Biosystems unit with participation by the Hutchinson Center.
"We have a history of aggressive research and development expertise and we're pleased to work with Merck," said ICx CEO Hans Kobler. "By applying the rapid and data-rich molecular diagnosis technology developed for security applications, ICx is hoping to aid the development of a diagnostic tool to assist in the evaluation of cancer therapies." |