Endo Pharmaceuticals - eigentlich kein Biotech aber ... - 500 Beiträge pro Seite
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ISIN: US29264F2056 · WKN: 940110
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Feedback
nachdem ich unverhofft auf diesen für mich bisher unbekannten US-Pharma-Konzern gestossen wurde und ich nach kurzer Recherche Endo durchaus interessant finde, fange ich mal eine neue Diskussion an.
Endo hat zudem von Bioniche den Wirkstoff/Medikament Urodocin einlizensiert und befindet sich in einer PIII, so dass es bei Biotech zumindest nicht vollkommen verkehrt ist.
Nachrichten zu Urodocin werden demnächst erwartet.
Es würde mich freuen, wenn sich noch jemand dafür interessiert.
Grüße Oberländler
Endo hat zudem von Bioniche den Wirkstoff/Medikament Urodocin einlizensiert und befindet sich in einer PIII, so dass es bei Biotech zumindest nicht vollkommen verkehrt ist.
Nachrichten zu Urodocin werden demnächst erwartet.
Es würde mich freuen, wenn sich noch jemand dafür interessiert.
Grüße Oberländler
Noch ein kleines bisschen Futter:
Additional Phase III clinical trial with Urocidin(TM) expected to commence in 2010
- analysis of data from first Phase III clinical trial nearing completion -
BELLEVILLE, ON, Aug. 19 /PRNewswire-FirstCall/ - Bioniche Life Sciences Inc. (TSX: BNC), a research-based, technology driven Canadian biopharmaceutical company, today provided an update on the clinical development program for its proprietary product for non-muscle-invasive bladder cancer - Urocidin(TM).
Bioniche and its development partner, Endo Pharmaceuticals Inc. (NASDAQ: ENDP), are in the process of finalizing a protocol for an additional clinical trial - expected to begin enrolling patients in 2010. Details of this new protocol, when finalized, will be made publicly available via the U.S. National Institutes of Health clinical trial registration service at http://www.clinicaltrials.gov.
"We're preparing to initiate a large study with Urocidin in the second half of this year that could become the pivotal study of this very interesting product to treat bladder cancer," said Dr. Ivan Gergel, Executive Vice President, Research and Development at Endo Pharmaceuticals Inc. "Urocidin is a novel treatment for refractory bladder cancer, which represents the type of innovative solutions we want to offer urologists and their patients."
Concurrently, 12-month data from the ongoing U.S. Food and Drug Administration (FDA) Phase III registration trial with Urocidin(TM) for non-muscle-invasive bladder cancer refractory to current therapy are undergoing thorough analysis. Endo expects to complete this process by the end of September, 2010.
In North America, bladder cancer is the fourth most common cancer in men and is in the top ten for women. In the United States, approximately 70,000 patients are newly diagnosed with bladder cancer each year and 500,000 living patients have been affected. The cancers of many of the previously-diagnosed patients remain unresolved, sometimes leading to cystectomy (bladder removal) or death. Approximately 70 percent of bladder cancer patients have the non-muscle-invasive form of bladder cancer and, on appropriate regulatory approvals, might be eligible for multiple treatments with Urocidin(TM).
Non-muscle-invasive bladder cancer is a form of bladder cancer localized in the surface layers of the bladder that has not yet spread into the deeper muscle layer. This form of bladder cancer is treated predominantly by urologists using surgical resection and intravesical infusion therapy. Urocidin(TM) is an intravesical infusion therapy, administered via trans-urethral catheter into the bladder.
Under the licensing agreement, Bioniche received an up-front payment of US$20 million in July, 2009, and has the potential to receive a total of US$110 million in payments associated with the achievement of certain clinical, regulatory and commercial milestones. Three milestones have been achieved by the Company since November, 2009, for total proceeds of US$14 million. Future milestones will be announced as they are achieved and, with its exclusive manufacturing supply contract, Bioniche will also receive a net-sales-based revenue stream upon product approval.
About Urocidin(TM)
Urocidin(TM) is a formulation of MCC, a sterile mycobacterial cell wall-DNA complex composition that has a dual mode of action: immune stimulation and direct anticancer activity. Urocidin(TM) is formulated for the treatment of bladder cancer, where it is administered by trans-urethral catheter directly into the bladder, coming into contact with immune system cells and bladder cancer cells. Industry Canada's Industrial Technologies Office (formerly Technology Partnerships Canada) has contributed to the development of Bioniche's mycobacterial cell wall technologies by means of a C$9.6 million loan to be repaid from sales.
Read more: http://www.nasdaq.com/aspx/company-news-story.aspx?storyid=2…
Additional Phase III clinical trial with Urocidin(TM) expected to commence in 2010
- analysis of data from first Phase III clinical trial nearing completion -
BELLEVILLE, ON, Aug. 19 /PRNewswire-FirstCall/ - Bioniche Life Sciences Inc. (TSX: BNC), a research-based, technology driven Canadian biopharmaceutical company, today provided an update on the clinical development program for its proprietary product for non-muscle-invasive bladder cancer - Urocidin(TM).
Bioniche and its development partner, Endo Pharmaceuticals Inc. (NASDAQ: ENDP), are in the process of finalizing a protocol for an additional clinical trial - expected to begin enrolling patients in 2010. Details of this new protocol, when finalized, will be made publicly available via the U.S. National Institutes of Health clinical trial registration service at http://www.clinicaltrials.gov.
"We're preparing to initiate a large study with Urocidin in the second half of this year that could become the pivotal study of this very interesting product to treat bladder cancer," said Dr. Ivan Gergel, Executive Vice President, Research and Development at Endo Pharmaceuticals Inc. "Urocidin is a novel treatment for refractory bladder cancer, which represents the type of innovative solutions we want to offer urologists and their patients."
Concurrently, 12-month data from the ongoing U.S. Food and Drug Administration (FDA) Phase III registration trial with Urocidin(TM) for non-muscle-invasive bladder cancer refractory to current therapy are undergoing thorough analysis. Endo expects to complete this process by the end of September, 2010.
In North America, bladder cancer is the fourth most common cancer in men and is in the top ten for women. In the United States, approximately 70,000 patients are newly diagnosed with bladder cancer each year and 500,000 living patients have been affected. The cancers of many of the previously-diagnosed patients remain unresolved, sometimes leading to cystectomy (bladder removal) or death. Approximately 70 percent of bladder cancer patients have the non-muscle-invasive form of bladder cancer and, on appropriate regulatory approvals, might be eligible for multiple treatments with Urocidin(TM).
Non-muscle-invasive bladder cancer is a form of bladder cancer localized in the surface layers of the bladder that has not yet spread into the deeper muscle layer. This form of bladder cancer is treated predominantly by urologists using surgical resection and intravesical infusion therapy. Urocidin(TM) is an intravesical infusion therapy, administered via trans-urethral catheter into the bladder.
Under the licensing agreement, Bioniche received an up-front payment of US$20 million in July, 2009, and has the potential to receive a total of US$110 million in payments associated with the achievement of certain clinical, regulatory and commercial milestones. Three milestones have been achieved by the Company since November, 2009, for total proceeds of US$14 million. Future milestones will be announced as they are achieved and, with its exclusive manufacturing supply contract, Bioniche will also receive a net-sales-based revenue stream upon product approval.
About Urocidin(TM)
Urocidin(TM) is a formulation of MCC, a sterile mycobacterial cell wall-DNA complex composition that has a dual mode of action: immune stimulation and direct anticancer activity. Urocidin(TM) is formulated for the treatment of bladder cancer, where it is administered by trans-urethral catheter directly into the bladder, coming into contact with immune system cells and bladder cancer cells. Industry Canada's Industrial Technologies Office (formerly Technology Partnerships Canada) has contributed to the development of Bioniche's mycobacterial cell wall technologies by means of a C$9.6 million loan to be repaid from sales.
Read more: http://www.nasdaq.com/aspx/company-news-story.aspx?storyid=2…
und:
Endo Pharmaceuticals Receives FDA Priority Review for New Formulation of Long-Acting Oxymorphone Designed to be Crush Resistant
CHADDS FORD, Pa., Sept. 22 /PRNewswire-FirstCall/ -- Endo Pharmaceuticals (Nasdaq: ENDP) announced that it recently received notification from the U.S. Food and Drug Administration (FDA) that Endo's new drug application (NDA) for its new oral formulation of long-acting oxymorphone, which is designed to be crush resistant, has been granted priority review status. The FDA has set the action date under the Prescription Drug User Fee Act (PDUFA) for Jan. 7, 2011.
This new oxymorphone formulation is a semi-synthetic opioid analgesic intended for the treatment of moderate to severe chronic pain in patients requiring continuous, around-the-clock opioid treatment for an extended period of time. It is a tablet formulation designed to resist crushing, breaking, powdering or pulverizing.
About Endo
Endo Pharmaceuticals is a U.S.-based, specialty healthcare solutions company, focused on high-value branded products and specialty generics. Endo is redefining its position in the healthcare marketplace by anticipating and embracing the evolution of health decisions based on the need for high-quality and cost-effective care. We aim to be the premier partner to healthcare professionals and payment providers, delivering an innovative suite of complementary diagnostics, drugs, devices and clinical data to meet the needs of patients in areas such as pain, urology, oncology and endocrinology. For more information about Endo Pharmaceuticals, and its wholly owned subsidiary HealthTronics Inc., please visit www.endo.com.
Read more: http://www.nasdaq.com/aspx/company-news-story.aspx?storyid=2…
Endo Pharmaceuticals Receives FDA Priority Review for New Formulation of Long-Acting Oxymorphone Designed to be Crush Resistant
CHADDS FORD, Pa., Sept. 22 /PRNewswire-FirstCall/ -- Endo Pharmaceuticals (Nasdaq: ENDP) announced that it recently received notification from the U.S. Food and Drug Administration (FDA) that Endo's new drug application (NDA) for its new oral formulation of long-acting oxymorphone, which is designed to be crush resistant, has been granted priority review status. The FDA has set the action date under the Prescription Drug User Fee Act (PDUFA) for Jan. 7, 2011.
This new oxymorphone formulation is a semi-synthetic opioid analgesic intended for the treatment of moderate to severe chronic pain in patients requiring continuous, around-the-clock opioid treatment for an extended period of time. It is a tablet formulation designed to resist crushing, breaking, powdering or pulverizing.
About Endo
Endo Pharmaceuticals is a U.S.-based, specialty healthcare solutions company, focused on high-value branded products and specialty generics. Endo is redefining its position in the healthcare marketplace by anticipating and embracing the evolution of health decisions based on the need for high-quality and cost-effective care. We aim to be the premier partner to healthcare professionals and payment providers, delivering an innovative suite of complementary diagnostics, drugs, devices and clinical data to meet the needs of patients in areas such as pain, urology, oncology and endocrinology. For more information about Endo Pharmaceuticals, and its wholly owned subsidiary HealthTronics Inc., please visit www.endo.com.
Read more: http://www.nasdaq.com/aspx/company-news-story.aspx?storyid=2…
und noch einen:
Endo Pharmaceuticals Announces Agreement to Acquire Qualitest Pharmaceuticals for $1.2 Billion
CHADDS FORD, Pa., Sept. 28 /PRNewswire-FirstCall/ --
Diversifies Revenue Streams and Boosts Scale in Existing Generics Business, and Strengthens Core Pain Franchise
Transaction Expected to be Immediately Accretive to Adjusted Diluted Earnings per Share by $0.40 in First Full Year After Close
Company Reiterates Full-Year 2010 Financial Guidance
Endo Pharmaceuticals (Nasdaq: ENDP) announced today that it has entered into a definitive agreement to acquire Qualitest Pharmaceuticals, a leading, privately-held generics company in the U.S., for approximately $1.2 billion in cash. The combined company will deliver more comprehensive healthcare solutions across its diversified businesses in Branded Pharmaceuticals, Generics, Devices & Services in key therapeutic areas including pain and urology.
Qualitest, the sixth largest U.S. generics company as measured by prescriptions filled, is focused on cost competitive, high quality manufactured products with high barriers to entry. Qualitest has cGMP facilities in the U.S. including the ability to manufacture controlled substances, which make up approximately 40 percent of its product portfolio, and liquids, which are roughly 17 percent of its portfolio. The company brings a broad range of generics to Endo encompassing 175 product families. Thirty-two of Qualitest's products are listed among the top 250 generics by total prescription (TRx) volume. In addition, the combined company will have an extensive pipeline of abbreviated new drug applications (ANDAs) with 46 ANDAs under active FDA review in multiple therapeutic areas, including pain, urology, CNS, as well as oncology and hypertension and an additional 24 ANDAs under development in multiple therapeutic areas.
Endo believes Qualitest brings critical mass to Endo's current generics business, further diversifies its business lines and product offerings and enhances Endo's portfolio of pain management products. Combining the companies' generics portfolios will also significantly boost Endo's revenue and earnings growth. On a pro forma basis for fiscal 2010, the combined company would have had revenues of approximately $2.0 billion and more than 3,000 employees.
Commenting on today's transaction, David Holveck, President and Chief Executive Officer of Endo, said, "This is an exciting day for Endo. The acquisition of Qualitest accelerates our stated strategy of building a diversified healthcare company, better able to respond to the changing economics that drive the U.S. healthcare environment. We believe that this transaction will accelerate and diversify our revenues and earnings streams, while also providing our partners in the industry with a wider range of products and services at multiple value points. The transaction provides Endo with an enhanced competitive position and critical mass in the generics market and when combined with our growing Branded Pharmaceuticals and Devices & Services businesses, makes us a more comprehensive healthcare solutions provider. Together, we will be well positioned to strengthen our relationships with physicians and payment providers to deliver better outcomes for patients and to meet the demands of the evolving health care system in the U.S."
In addition, with more than 90 percent of all pain prescriptions now filled by generic drugs in the $15 billion U.S. pain market, the acquisition of Qualitest is a key step to Endo remaining at the forefront of providing pain solutions to its customers. Forty percent of Qualitest's revenues are derived from pain products, making the acquisition a natural extension of Endo's competitive position in pain and controlled substances. Endo believes that combining its technology platforms with Qualitest's already substantial business holds the potential for significant advantages in the new healthcare environment. The combined leadership team will bring vast experience in the generics space, including in product development, manufacturing and collaborative technical management.
Marvin Samson, Chairman and Chief Executive Officer of Qualitest, added, "Today's announcement brings together two highly successful businesses that I believe are an excellent fit. I am confident Qualitest's unique capabilities as a leading generics provider ideally complement Endo's diversified businesses. I am convinced that this combination will enable our management team and employees to accelerate the growth of our business and continue the important work we do here at Qualitest."
Qualitest brings a highly qualified and experienced management team to Endo, with a track record of success in building leading and growing generics businesses. Further, Endo believes Qualitest adds important new capabilities, with the combined company having exceptional breadth and depth in the development, manufacture, distribution and sale of generic pharmaceuticals. The current Chairman and CEO of Qualitest, Marvin Samson, along with Julie McHugh, Endo's Chief Operating Officer, will lead an integration team comprised of senior leaders from both organizations focused on accelerating the growth of the combined business. Endo intends to retain Qualitest's facilities located in Huntsville, Ala. and Charlotte, N.C., as well as its own facility in Westbury, N.Y.
Endo is acquiring Qualitest Pharmaceuticals from funds advised by Apax Partners, one of the world's leading private equity investment groups. Buddy Gumina, Partner and Co-Head of Global Healthcare at Apax, said, "We have been proud to work with the management team at Qualitest over the past three years as they have built one of the leading generics businesses in the U.S. by supplying high quality, cost effective pharmaceuticals. Qualitest, and now Endo, represents an important part of the solution to the challenges faced by the U.S. healthcare system."
Under the terms of the agreement, which have been unanimously approved by Endo's Board of Directors, Endo will acquire 100 percent of Qualitest for a total cash consideration of $1.2 billion. Endo intends to finance the purchase using $500 million in cash from its balance sheet, drawing down an existing $300 million revolving credit facility and has secured financing for up to $400 million.
Endo expects the transaction to be immediately accretive to adjusted earnings per share in the first full year after close. Upon deal closing, Endo anticipates that Qualitest would add approximately $400 million in annualized revenue and $0.40 in annualized adjusted diluted earnings per share. Endo also expects revenue growth of the combined generics business to be at least 15 percent over the next two years. Endo expects to realize a $30 million annualized cost synergy run-rate in 2013. The synergies will be associated with procurement, distribution, manufacturing and other general and administrative expenditures. The agreement contains customary representations, warranties, covenants, indemnities, conditions and termination provisions. The transaction is subject to regulatory review, including clearance by the relevant antitrust authorities and is expected to close late in the fourth quarter of 2010 or early in the first quarter of 2011.
Financial Guidance
Endo also reiterates its 2010 revenue guidance of between $1.63 billion and $1.68 billion dollars and full-year adjusted diluted earnings per share to be between $3.30 to $3.35 per share. The company also estimates reported (GAAP) diluted earnings per share to be between $1.88 to $1.96 per share. For an explanation of Endo's reasons for using non-GAAP measures, see Endo's Current Report on Form 8-K filed today with the Securities and Exchange Commission.
Lazard is acting as exclusive financial advisor to Endo and Skadden, Arps, Slate, Meagher & Flom LLP are acting as Endo's legal counsel. JPMorgan Chase Bank N.A. and RBC Capital Markets are providing financing commitments.
J.P. Morgan Securities LLC is acting as exclusive financial advisor to Qualitest Pharmaceuticals and Kirkland & Ellis LLP are acting as Qualitest Pharmaceuticals' legal counsel.
Read more: http://www.nasdaq.com/aspx/company-news-story.aspx?storyid=2…
Endo Pharmaceuticals Announces Agreement to Acquire Qualitest Pharmaceuticals for $1.2 Billion
CHADDS FORD, Pa., Sept. 28 /PRNewswire-FirstCall/ --
Diversifies Revenue Streams and Boosts Scale in Existing Generics Business, and Strengthens Core Pain Franchise
Transaction Expected to be Immediately Accretive to Adjusted Diluted Earnings per Share by $0.40 in First Full Year After Close
Company Reiterates Full-Year 2010 Financial Guidance
Endo Pharmaceuticals (Nasdaq: ENDP) announced today that it has entered into a definitive agreement to acquire Qualitest Pharmaceuticals, a leading, privately-held generics company in the U.S., for approximately $1.2 billion in cash. The combined company will deliver more comprehensive healthcare solutions across its diversified businesses in Branded Pharmaceuticals, Generics, Devices & Services in key therapeutic areas including pain and urology.
Qualitest, the sixth largest U.S. generics company as measured by prescriptions filled, is focused on cost competitive, high quality manufactured products with high barriers to entry. Qualitest has cGMP facilities in the U.S. including the ability to manufacture controlled substances, which make up approximately 40 percent of its product portfolio, and liquids, which are roughly 17 percent of its portfolio. The company brings a broad range of generics to Endo encompassing 175 product families. Thirty-two of Qualitest's products are listed among the top 250 generics by total prescription (TRx) volume. In addition, the combined company will have an extensive pipeline of abbreviated new drug applications (ANDAs) with 46 ANDAs under active FDA review in multiple therapeutic areas, including pain, urology, CNS, as well as oncology and hypertension and an additional 24 ANDAs under development in multiple therapeutic areas.
Endo believes Qualitest brings critical mass to Endo's current generics business, further diversifies its business lines and product offerings and enhances Endo's portfolio of pain management products. Combining the companies' generics portfolios will also significantly boost Endo's revenue and earnings growth. On a pro forma basis for fiscal 2010, the combined company would have had revenues of approximately $2.0 billion and more than 3,000 employees.
Commenting on today's transaction, David Holveck, President and Chief Executive Officer of Endo, said, "This is an exciting day for Endo. The acquisition of Qualitest accelerates our stated strategy of building a diversified healthcare company, better able to respond to the changing economics that drive the U.S. healthcare environment. We believe that this transaction will accelerate and diversify our revenues and earnings streams, while also providing our partners in the industry with a wider range of products and services at multiple value points. The transaction provides Endo with an enhanced competitive position and critical mass in the generics market and when combined with our growing Branded Pharmaceuticals and Devices & Services businesses, makes us a more comprehensive healthcare solutions provider. Together, we will be well positioned to strengthen our relationships with physicians and payment providers to deliver better outcomes for patients and to meet the demands of the evolving health care system in the U.S."
In addition, with more than 90 percent of all pain prescriptions now filled by generic drugs in the $15 billion U.S. pain market, the acquisition of Qualitest is a key step to Endo remaining at the forefront of providing pain solutions to its customers. Forty percent of Qualitest's revenues are derived from pain products, making the acquisition a natural extension of Endo's competitive position in pain and controlled substances. Endo believes that combining its technology platforms with Qualitest's already substantial business holds the potential for significant advantages in the new healthcare environment. The combined leadership team will bring vast experience in the generics space, including in product development, manufacturing and collaborative technical management.
Marvin Samson, Chairman and Chief Executive Officer of Qualitest, added, "Today's announcement brings together two highly successful businesses that I believe are an excellent fit. I am confident Qualitest's unique capabilities as a leading generics provider ideally complement Endo's diversified businesses. I am convinced that this combination will enable our management team and employees to accelerate the growth of our business and continue the important work we do here at Qualitest."
Qualitest brings a highly qualified and experienced management team to Endo, with a track record of success in building leading and growing generics businesses. Further, Endo believes Qualitest adds important new capabilities, with the combined company having exceptional breadth and depth in the development, manufacture, distribution and sale of generic pharmaceuticals. The current Chairman and CEO of Qualitest, Marvin Samson, along with Julie McHugh, Endo's Chief Operating Officer, will lead an integration team comprised of senior leaders from both organizations focused on accelerating the growth of the combined business. Endo intends to retain Qualitest's facilities located in Huntsville, Ala. and Charlotte, N.C., as well as its own facility in Westbury, N.Y.
Endo is acquiring Qualitest Pharmaceuticals from funds advised by Apax Partners, one of the world's leading private equity investment groups. Buddy Gumina, Partner and Co-Head of Global Healthcare at Apax, said, "We have been proud to work with the management team at Qualitest over the past three years as they have built one of the leading generics businesses in the U.S. by supplying high quality, cost effective pharmaceuticals. Qualitest, and now Endo, represents an important part of the solution to the challenges faced by the U.S. healthcare system."
Under the terms of the agreement, which have been unanimously approved by Endo's Board of Directors, Endo will acquire 100 percent of Qualitest for a total cash consideration of $1.2 billion. Endo intends to finance the purchase using $500 million in cash from its balance sheet, drawing down an existing $300 million revolving credit facility and has secured financing for up to $400 million.
Endo expects the transaction to be immediately accretive to adjusted earnings per share in the first full year after close. Upon deal closing, Endo anticipates that Qualitest would add approximately $400 million in annualized revenue and $0.40 in annualized adjusted diluted earnings per share. Endo also expects revenue growth of the combined generics business to be at least 15 percent over the next two years. Endo expects to realize a $30 million annualized cost synergy run-rate in 2013. The synergies will be associated with procurement, distribution, manufacturing and other general and administrative expenditures. The agreement contains customary representations, warranties, covenants, indemnities, conditions and termination provisions. The transaction is subject to regulatory review, including clearance by the relevant antitrust authorities and is expected to close late in the fourth quarter of 2010 or early in the first quarter of 2011.
Financial Guidance
Endo also reiterates its 2010 revenue guidance of between $1.63 billion and $1.68 billion dollars and full-year adjusted diluted earnings per share to be between $3.30 to $3.35 per share. The company also estimates reported (GAAP) diluted earnings per share to be between $1.88 to $1.96 per share. For an explanation of Endo's reasons for using non-GAAP measures, see Endo's Current Report on Form 8-K filed today with the Securities and Exchange Commission.
Lazard is acting as exclusive financial advisor to Endo and Skadden, Arps, Slate, Meagher & Flom LLP are acting as Endo's legal counsel. JPMorgan Chase Bank N.A. and RBC Capital Markets are providing financing commitments.
J.P. Morgan Securities LLC is acting as exclusive financial advisor to Qualitest Pharmaceuticals and Kirkland & Ellis LLP are acting as Qualitest Pharmaceuticals' legal counsel.
Read more: http://www.nasdaq.com/aspx/company-news-story.aspx?storyid=2…
Endo Pharmaceuticals Reports Strong Third Quarter 2010 Financial Results; Reaffirms 2010 Financial Guidance and Provides Financial Guidance for 2011
CHADDS FORD, Pa., Nov. 1, 2010 /PRNewswire-FirstCall/ --
Total quarterly revenues increase 23 percent versus prior year; branded drug sales up 8 percent.
Reported diluted EPS of $0.46, up 10 percent from prior year; adjusted diluted EPS of $0.86, reflecting growth of 37 percent from 2009.
Company reaffirms 2010 guidance for revenue of $1.63 to $1.68 billion and adjusted diluted EPS of $3.30 to $3.35. Increases 2010 GAAP EPS to $1.91 to $1.99.
Company issues 2011 guidance for revenue of $2.2 to $2.3 billion, GAAP EPS of $2.05 to $2.15 and adjusted diluted EPS of $4.15 to $4.25, reflecting diversified growth in core operations and the expected close of the acquisition of Qualitest Pharmaceuticals.
Endo Pharmaceuticals (Nasdaq: ENDP) today reported financial results for the third quarter 2010.
Total revenues during the third quarter of 2010 increased 23 percent to $444.1 million, compared with $361.0 million in the same quarter of 2009. Net income for the three months ended September 30, 2010 was $54.2 million, compared with $49.4 million in the comparable 2009 period. As detailed in the supplemental financial information below, adjusted net income for the three months ended September 30, 2010, was $100.8 million, compared with $74.3 million in the same period in 2009. Reported diluted earnings per share for the quarter ended September 30, 2010, were $0.46 compared with $0.42 in the third quarter of 2009. Adjusted diluted earnings per share for the same period were $0.86 compared with $0.63 reported in 2009.
($ in thousands, except per share amounts)
3rd quarter Nine months Ended September 30
2010 2009 Change 2010 2009 Change
Total Revenues
$444,103 $361,027 23% $1,205,039 $1,069,435 13%
Reported Net Income
54,206 49,422 10% 166,021 118,488 40%
Reported Diluted EPS
0.46 0.42 10% 1.42 1.01 41%
Adjusted Net Income
100,839 74,251 36% 282,720 239,141 18%
Adjusted Diluted EPS
$0.86 $0.63 37% $2.41 $2.04 18%
"Endo had another strong quarter, with record revenues and adjusted earnings," said Dave Holveck, president and CEO of Endo. "I'm excited that we achieved these results while completing important steps in our ongoing transformation of Endo into a leading provider of healthcare solutions."
2011 Financial Guidance
Endo estimates 2011 revenues to be between $2.2 billion and $2.3 billion, Reported (GAAP) diluted earnings per share to be between $2.05 and $2.15 and adjusted diluted earnings per share to be between $4.15 and $4.25. A detailed reconciliation of projected 2011 adjusted diluted earnings per share to 2011 reported diluted earnings per share is provided below, and is subject to certain assumptions as set forth below, which could have a significant impact on the actual reported diluted earnings per share in the future. The company's guidance for reported (GAAP) earnings per share does not include any estimates for potential future changes in the fair value of contingent consideration or for potential new business development transactions. Our guidance also assumes that the company's previously announced acquisition of Qualitest Pharmaceuticals will close by late fourth quarter 2010 or in early 2011.
Third quarter 2010 Financial Results and 2010 Financial Guidance
The third quarter benefitted from very good contributions from across our business. Branded drug sales rose 8 percent year-over-year, reflecting strong growth by key products in pain, urology and oncology and revenues from our generics business increased 20 percent. The third quarter also benefits from the performance of the devices and services of our HealthTronics urology business.
Endo also reiterates its 2010 revenue guidance of between $1.63 billion and $1.68 billion dollars and full-year adjusted diluted earnings per share to be between $3.30 to $3.35 per share. The company also estimates reported (GAAP) diluted earnings per share to be between $1.91 to $1.99 per share. For an explanation of Endo's reasons for using non-GAAP measures, see Endo's Current Report on Form 8-K filed today with the Securities and Exchange Commission. A reconciliation of GAAP to non-GAAP results is attached to this press release.
Selected Operating Highlights ...
Read more: http://www.nasdaq.com/aspx/company-news-story.aspx?storyid=2…
Grüße Oberländler
CHADDS FORD, Pa., Nov. 1, 2010 /PRNewswire-FirstCall/ --
Total quarterly revenues increase 23 percent versus prior year; branded drug sales up 8 percent.
Reported diluted EPS of $0.46, up 10 percent from prior year; adjusted diluted EPS of $0.86, reflecting growth of 37 percent from 2009.
Company reaffirms 2010 guidance for revenue of $1.63 to $1.68 billion and adjusted diluted EPS of $3.30 to $3.35. Increases 2010 GAAP EPS to $1.91 to $1.99.
Company issues 2011 guidance for revenue of $2.2 to $2.3 billion, GAAP EPS of $2.05 to $2.15 and adjusted diluted EPS of $4.15 to $4.25, reflecting diversified growth in core operations and the expected close of the acquisition of Qualitest Pharmaceuticals.
Endo Pharmaceuticals (Nasdaq: ENDP) today reported financial results for the third quarter 2010.
Total revenues during the third quarter of 2010 increased 23 percent to $444.1 million, compared with $361.0 million in the same quarter of 2009. Net income for the three months ended September 30, 2010 was $54.2 million, compared with $49.4 million in the comparable 2009 period. As detailed in the supplemental financial information below, adjusted net income for the three months ended September 30, 2010, was $100.8 million, compared with $74.3 million in the same period in 2009. Reported diluted earnings per share for the quarter ended September 30, 2010, were $0.46 compared with $0.42 in the third quarter of 2009. Adjusted diluted earnings per share for the same period were $0.86 compared with $0.63 reported in 2009.
($ in thousands, except per share amounts)
3rd quarter Nine months Ended September 30
2010 2009 Change 2010 2009 Change
Total Revenues
$444,103 $361,027 23% $1,205,039 $1,069,435 13%
Reported Net Income
54,206 49,422 10% 166,021 118,488 40%
Reported Diluted EPS
0.46 0.42 10% 1.42 1.01 41%
Adjusted Net Income
100,839 74,251 36% 282,720 239,141 18%
Adjusted Diluted EPS
$0.86 $0.63 37% $2.41 $2.04 18%
"Endo had another strong quarter, with record revenues and adjusted earnings," said Dave Holveck, president and CEO of Endo. "I'm excited that we achieved these results while completing important steps in our ongoing transformation of Endo into a leading provider of healthcare solutions."
2011 Financial Guidance
Endo estimates 2011 revenues to be between $2.2 billion and $2.3 billion, Reported (GAAP) diluted earnings per share to be between $2.05 and $2.15 and adjusted diluted earnings per share to be between $4.15 and $4.25. A detailed reconciliation of projected 2011 adjusted diluted earnings per share to 2011 reported diluted earnings per share is provided below, and is subject to certain assumptions as set forth below, which could have a significant impact on the actual reported diluted earnings per share in the future. The company's guidance for reported (GAAP) earnings per share does not include any estimates for potential future changes in the fair value of contingent consideration or for potential new business development transactions. Our guidance also assumes that the company's previously announced acquisition of Qualitest Pharmaceuticals will close by late fourth quarter 2010 or in early 2011.
Third quarter 2010 Financial Results and 2010 Financial Guidance
The third quarter benefitted from very good contributions from across our business. Branded drug sales rose 8 percent year-over-year, reflecting strong growth by key products in pain, urology and oncology and revenues from our generics business increased 20 percent. The third quarter also benefits from the performance of the devices and services of our HealthTronics urology business.
Endo also reiterates its 2010 revenue guidance of between $1.63 billion and $1.68 billion dollars and full-year adjusted diluted earnings per share to be between $3.30 to $3.35 per share. The company also estimates reported (GAAP) diluted earnings per share to be between $1.91 to $1.99 per share. For an explanation of Endo's reasons for using non-GAAP measures, see Endo's Current Report on Form 8-K filed today with the Securities and Exchange Commission. A reconciliation of GAAP to non-GAAP results is attached to this press release.
Selected Operating Highlights ...
Read more: http://www.nasdaq.com/aspx/company-news-story.aspx?storyid=2…
Grüße Oberländler
Trading Spotlight
Ist wohl nur mein "privater" Endo-News-Sammler geworden. 
Schade.
Zum Jahresausklang noch eine nette kleine Meldung:
Endo Pharmaceuticals Receives FDA Approval for FORTESTA™ (Testosterone) Gel as a Class III Product for Topical Use for Men with Low Testosterone...
CHADDS FORD, Pa., Dec. 29, 2010 /PRNewswire-FirstCall/ -- Endo Pharmaceuticals (Nasdaq: ENDP) today announced that the U.S. Food and Drug Administration (FDA) has approved FORTESTA Gel for the treatment of low testosterone, or 'Low T,' also known as hypogonadism. Symptoms associated with Low T include erectile dysfunction and decreased sexual desire, fatigue and loss of energy, mood depression, regression of secondary sexual characteristics and osteoporosis. Low T is a condition that has an estimated prevalence in nearly 14 million men in the United States, yet only about 1.3 million, (9 percent) are currently being treated. Endo Pharmaceuticals expects to introduce FORTESTA™ Gel in the United States in early 2011.
...
Read more: http://www.nasdaq.com/aspx/company-news-story.aspx?storyid=2…
Auf grüne Kurse 2011.
Oberländler
Schade.Zum Jahresausklang noch eine nette kleine Meldung:
Endo Pharmaceuticals Receives FDA Approval for FORTESTA™ (Testosterone) Gel as a Class III Product for Topical Use for Men with Low Testosterone...
CHADDS FORD, Pa., Dec. 29, 2010 /PRNewswire-FirstCall/ -- Endo Pharmaceuticals (Nasdaq: ENDP) today announced that the U.S. Food and Drug Administration (FDA) has approved FORTESTA Gel for the treatment of low testosterone, or 'Low T,' also known as hypogonadism. Symptoms associated with Low T include erectile dysfunction and decreased sexual desire, fatigue and loss of energy, mood depression, regression of secondary sexual characteristics and osteoporosis. Low T is a condition that has an estimated prevalence in nearly 14 million men in the United States, yet only about 1.3 million, (9 percent) are currently being treated. Endo Pharmaceuticals expects to introduce FORTESTA™ Gel in the United States in early 2011.
...
Read more: http://www.nasdaq.com/aspx/company-news-story.aspx?storyid=2…
Auf grüne Kurse 2011.
Oberländler
Endo Pharmaceuticals Provides Regulatory Update on New Formulation of OPANA® ER Designed to be Crush-Resistant
CHADDS FORD, Pa., Jan. 7, 2011 /PRNewswire/ -- Endo Pharmaceuticals (Nasdaq: ENDP) today announced that it received a complete response letter from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for its new formulation of OPANA® ER designed to be crush resistant. The complete response letter did not require that additional clinical studies be conducted for approval of the NDA.
"As a result of ongoing discussions with FDA, we have begun to address the issue from the complete response letter and will work closely with the agency to finalize our response," said Dr. Ivan Gergel, M.D., executive vice president, R&D, Endo Pharmaceuticals. "We are confident that we can address the issue set forth, currently anticipate responding to the FDA by mid 2011 and would expect a six month review cycle once our response is filed. We remain focused on bringing this new formulation of OPANA ER to market for the relief of moderate to severe pain in patients requiring continuous, around-the-clock opioid treatment for an extended period of time."
Read more: http://www.nasdaq.com/aspx/company-news-story.asp…
Oberlaendler
Könnte noch interessant werden:
Endo Chief Says He Has $500 Million to Buy Cancer and Urology Products
By Sasha Damouni - Jan 12, 2011 10:06 PM GMT+0100
Endo Pharmaceuticals Holdings Inc. has a $500 million budget for acquisitions and is seeking health information technology and diagnostic tools for cancer and urology, Chief Executive Officer David Holveck said.
“Everything in the treatment of patients starts with diagnostics,” Holveck said today in an interview at the J.P. Morgan Healthcare Conference in San Francisco. “A lot of the earlier diagnostics didn’t have access to what we know today as molecular diagnostics that are much more specific.”
The Chadds Ford, Pennsylvania-based maker of tamper-proof pain pills has announced completion of six deals in the past five years, with an average size of $352.8 million and a typical premium of 49 percent, according to data compiled by Bloomberg.
Endo’s shares rose their highest value in three years on Sept. 28 after the company agreed to buy U.S. generic-drugmaker Qualitest Pharmaceuticals for about $1.2 billion from private- equity firm Apax Partners LLP. In May, the company said it would Acquire HealthTronics Inc., a provider of urologic lab services and devices, for $223 million.
Endo fell 5 cents, or less than a percent, to $34.10 at 4 p.m. New York time in Nasdaq Stock Market composite trading. The shares gained 73 percent in the past 12 months.
To contact the reporter on this story: Sasha Damouni in New York at sdamouni2@bloomberg.net
To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.
http://www.bloomberg.com/news/2011-01-12/endo-chief-has-500-…
Oberlaendler
Endo Chief Says He Has $500 Million to Buy Cancer and Urology Products
By Sasha Damouni - Jan 12, 2011 10:06 PM GMT+0100
Endo Pharmaceuticals Holdings Inc. has a $500 million budget for acquisitions and is seeking health information technology and diagnostic tools for cancer and urology, Chief Executive Officer David Holveck said.
“Everything in the treatment of patients starts with diagnostics,” Holveck said today in an interview at the J.P. Morgan Healthcare Conference in San Francisco. “A lot of the earlier diagnostics didn’t have access to what we know today as molecular diagnostics that are much more specific.”
The Chadds Ford, Pennsylvania-based maker of tamper-proof pain pills has announced completion of six deals in the past five years, with an average size of $352.8 million and a typical premium of 49 percent, according to data compiled by Bloomberg.
Endo’s shares rose their highest value in three years on Sept. 28 after the company agreed to buy U.S. generic-drugmaker Qualitest Pharmaceuticals for about $1.2 billion from private- equity firm Apax Partners LLP. In May, the company said it would Acquire HealthTronics Inc., a provider of urologic lab services and devices, for $223 million.
Endo fell 5 cents, or less than a percent, to $34.10 at 4 p.m. New York time in Nasdaq Stock Market composite trading. The shares gained 73 percent in the past 12 months.
To contact the reporter on this story: Sasha Damouni in New York at sdamouni2@bloomberg.net
To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.
http://www.bloomberg.com/news/2011-01-12/endo-chief-has-500-…
Oberlaendler
Hmmm......
Endo and Orion ink oncology R&D deal
January 28, 2011 — 10:25am ET | By Maureen Martino
Endo Pharmaceuticals and Finland's Orion Corporation have agreed to co-develop a pipeline of oncology drugs. The two companies will collaborate on eight discovery-stage candidates--four from Endo and four from Orion--and share all development costs. Financial details of the deal were not disclosed.
Orion will have marketing rights in Europe, including Russia, while Endo will retain marketing rights for North America. The companies will pay royalties to each other and decide how to handle rest of world territories after each oncology candidate completes Phase II trials. As its first move, Endo has licensed a novel androgen-receptor antagonist for advanced prostate cancer from Orion. Both companies will develop the drug, which is slated for Phase I trials in the near future.
"This alliance marks another milestone in the transformation of Endo's R&D platform," said Endo R&D executive Ivan Gergel. "This type of collaboration fits well into our new, efficient and effective virtual R&D model." Added Dr. Reijo Salonen, senior vice president of Orion R&D: "The agreement is...perfectly in line with Orion's R&D strategy to focus on risk-sharing partnerships." At the 2011 JP Morgan conference Endo CEO David Holveck noted that his company is looking to acquire new assets in the cancer and urology diagnostics space.
http://www.fiercebiotech.com/story/endo-and-orion-ink-oncolo…
Oberlaendler
Endo and Orion ink oncology R&D deal
January 28, 2011 — 10:25am ET | By Maureen Martino
Endo Pharmaceuticals and Finland's Orion Corporation have agreed to co-develop a pipeline of oncology drugs. The two companies will collaborate on eight discovery-stage candidates--four from Endo and four from Orion--and share all development costs. Financial details of the deal were not disclosed.
Orion will have marketing rights in Europe, including Russia, while Endo will retain marketing rights for North America. The companies will pay royalties to each other and decide how to handle rest of world territories after each oncology candidate completes Phase II trials. As its first move, Endo has licensed a novel androgen-receptor antagonist for advanced prostate cancer from Orion. Both companies will develop the drug, which is slated for Phase I trials in the near future.
"This alliance marks another milestone in the transformation of Endo's R&D platform," said Endo R&D executive Ivan Gergel. "This type of collaboration fits well into our new, efficient and effective virtual R&D model." Added Dr. Reijo Salonen, senior vice president of Orion R&D: "The agreement is...perfectly in line with Orion's R&D strategy to focus on risk-sharing partnerships." At the 2011 JP Morgan conference Endo CEO David Holveck noted that his company is looking to acquire new assets in the cancer and urology diagnostics space.
http://www.fiercebiotech.com/story/endo-and-orion-ink-oncolo…
Oberlaendler
ACHTUNG!
Aussteigen bevor in USA der Handel los geht!
2/5/2011 6:36:31 PM * Qualitest Pharma Issues Voluntary, Nationwide Recall Of Hydrocodone Bitartrate And Acetaminophen Tablets (ENDP)
Aussteigen bevor in USA der Handel los geht!
2/5/2011 6:36:31 PM * Qualitest Pharma Issues Voluntary, Nationwide Recall Of Hydrocodone Bitartrate And Acetaminophen Tablets (ENDP)
Antwort auf Beitrag Nr.: 40.993.578 von dottore am 07.02.11 11:47:21Hallo dottore,
danke für den Hinweis, vielleicht sollte man die Meldung aber genauer lesen:
HUNTSVILLE, Ala., Feb. 5, 2011 /PRNewswire/ -- Qualitest Pharmaceuticals today issued a voluntary nationwide recall of Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10mg / 500mg, NDC 0603-3888-20, 60 count, Lot Numbers T150G10B, T120J10E and T023M10A, and Phenobarbital Tablets, USP 32.4 mg, NDC 0603-5166-32, 1000 count, Lot Numbers T150G10B, T120J10E and T023M10A. An individual bottle of Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10mg / 500mg, NDC 0603-3888-20, 60 count was found incorrectly labeled with a Phenobarbital Tablets, USP 32.4 mg, NDC 0603-5166-32, 1000 count label, printed with Lot Number T150G10B. Lots T120J10E and T023M10A used the same stock inventory of labels as Lot T150G10B and are potentially impacted.
Endo Pharmaceutical Holdings Inc.| ENDP As a result of this mix-up patients may unintentionally take Hydrocodone and acetaminophen tablets, instead of the intended dose of Phenobarbital. Unintentional administration of Hydrocodone can lead to serious adverse events including respiratory depression, CNS depression, coma and death, especially in opioid naive patients and patients on other CNS depressants. Unintentional administration of acetaminophen may result in liver toxicity in patients on other acetaminophen containing medications, patients with liver dysfunction, or people who consume more than 3 alcoholic beverages a day. Additionally, missing doses of Phenobarbital could result in loss of seizure control.
No injuries have been reported to date.
Consumers who have affected product should stop using the product and contact Qualitest at 1-800-444-4011 for reimbursement. The lot number can be found on the side of the bottle.
The recall includes the following products:
Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10mg / 500mg, NDC 0603-3888-20, 60 count, Lot Numbers T150G10B, T120J10E and T023M10A
Phenobarbital Tablets, USP 32.4 mg, NDC 0603-5166-32, 1000 count, Lot Numbers T150G10B, T120J10E and T023M10A
This voluntary recall is being made with the knowledge of the U.S. Food and Drug Administration
http://www.thestreet.com/story/10997673/qualitest-pharmaceut…
Oberländler
danke für den Hinweis, vielleicht sollte man die Meldung aber genauer lesen:
HUNTSVILLE, Ala., Feb. 5, 2011 /PRNewswire/ -- Qualitest Pharmaceuticals today issued a voluntary nationwide recall of Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10mg / 500mg, NDC 0603-3888-20, 60 count, Lot Numbers T150G10B, T120J10E and T023M10A, and Phenobarbital Tablets, USP 32.4 mg, NDC 0603-5166-32, 1000 count, Lot Numbers T150G10B, T120J10E and T023M10A. An individual bottle of Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10mg / 500mg, NDC 0603-3888-20, 60 count was found incorrectly labeled with a Phenobarbital Tablets, USP 32.4 mg, NDC 0603-5166-32, 1000 count label, printed with Lot Number T150G10B. Lots T120J10E and T023M10A used the same stock inventory of labels as Lot T150G10B and are potentially impacted.
Endo Pharmaceutical Holdings Inc.| ENDP As a result of this mix-up patients may unintentionally take Hydrocodone and acetaminophen tablets, instead of the intended dose of Phenobarbital. Unintentional administration of Hydrocodone can lead to serious adverse events including respiratory depression, CNS depression, coma and death, especially in opioid naive patients and patients on other CNS depressants. Unintentional administration of acetaminophen may result in liver toxicity in patients on other acetaminophen containing medications, patients with liver dysfunction, or people who consume more than 3 alcoholic beverages a day. Additionally, missing doses of Phenobarbital could result in loss of seizure control.
No injuries have been reported to date.
Consumers who have affected product should stop using the product and contact Qualitest at 1-800-444-4011 for reimbursement. The lot number can be found on the side of the bottle.
The recall includes the following products:
Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10mg / 500mg, NDC 0603-3888-20, 60 count, Lot Numbers T150G10B, T120J10E and T023M10A
Phenobarbital Tablets, USP 32.4 mg, NDC 0603-5166-32, 1000 count, Lot Numbers T150G10B, T120J10E and T023M10A
This voluntary recall is being made with the knowledge of the U.S. Food and Drug Administration
http://www.thestreet.com/story/10997673/qualitest-pharmaceut…
Oberländler
Moin,
Urocidin™ Phase III Clinical Trial Results to be Presented at EAU and AUA Conferences
-overall one-year disease-free survival rate of 25 percent in treatment-refractory non-muscle-invasive bladder cancer-
CHADDS FORD, Pa. and BELLEVILLE, Ontario, Feb. 17, 2011 /PRNewswire/ -- Endo Pharmaceuticals (Nasdaq: ENDP) and Bioniche Life Sciences Inc. (TSX and ASX: BNC) today announced plans for peer-reviewed presentation of interim efficacy and safety results from the first Phase III trial of the intravesical formulation of Mycobacterial cell wall-DNA complex (MCC), known as Urocidin™ or EN3348. The results to be presented have been generated from an ongoing Phase III registration trial with Urocidin™ in the treatment of non-muscle-invasive bladder cancer (NMIBC) that is refractory to current first-line therapy (Bacillus Calmette-Guerin, known as BCG).
The first abstract and poster summaries of such results will be made available during the Annual Congress of the European Association of Urology (EAU) March 18-22 in Vienna, Austria. The accepted abstract is now available to EAU members. Further disclosure of results from this trial will be made during a podium presentation at the annual American Urological Association (AUA) meeting May 14-19 in Washington, D.C.
Phase III Results
The EAU and AUA abstracts highlight results based on an interim analysis of the Phase III trial. The objective of the trial is to evaluate the efficacy and safety of Urocidin™ in patients with non-muscle-invasive bladder cancer (NMIBC) who are refractory to intravesical BCG therapy and at high risk of progression. A total of 129 patients were enrolled from 25 centers in the U.S. and Canada, with high grade papillary and/or carcinoma in situ (CIS) and having failed to respond to one or more courses of BCG. The overall one-year disease-free survival (DFS) rate was 25 percent. DFS is defined as lack of recurrence or progression to muscle-invasive disease, as confirmed by biopsy. The one-year DFS rates, when sub-divided by tumor type (e.g., CIS with or without papillary tumors or papillary tumors alone) at study entry is disclosed in the conference materials, as is the median DFS interval (in days) of the intent-to-treat population. In terms of safety, the results showed that intravesical administration of Urocidin™ was well tolerated, with most adverse events being mild to moderate in severity and few leading to discontinuation of treatment. The authors of the abstract concluded that the interim analysis of this prospective trial indicates that Urocidin™ may provide an alternative to cystectomy for patients with BCG-refractory NMIBC.
Ongoing Phase III Clinical Program with Urocidin™
Summary details of a second Phase III clinical trial protocol being conducted by Endo are publicly available via the U.S. National Institutes of Health (NIH) clinical trial registration service at http://www.clinicaltrials.gov.
About Bladder Cancer
In North America, bladder cancer is the fourth most common cancer in men and the fifth overall between both men and women. In the United States, approximately 70,000 patients are newly diagnosed with bladder cancer each year and 500,000 living patients have been affected. In Europe, more than 100,000 patients are newly diagnosed each year. Bladder cancer is frequently a recurrent disease, with some cases becoming refractory to available chemotherapeutic or immunotherapeutic agents and leading to cystectomy (bladder removal) or death. Approximately 70 percent of bladder cancer patients have the non-muscle-invasive form of bladder cancer. Collectively across the U.S., Europe and Japan, approximately 350,000 non-muscle-invasive bladder cancer patients are newly diagnosed or have a recurrence each year.
Non-muscle-invasive bladder cancer is a form of bladder cancer localized in the surface layers of the bladder that has not yet spread into the deeper muscle layer. This form of bladder cancer is treated predominantly by urologists using surgical resection and intravesical infusion therapy. Urocidin™ is an intravesical infusion therapy, administered via trans-urethral catheter into the bladder.
About Urocidin™
Urocidin™ is a formulation of MCC, a sterile mycobacterial cell wall-DNA complex composition that has a dual mode of action: immune stimulation and direct anticancer activity. Urocidin™ is formulated for the treatment of bladder cancer, where it is administered by trans-urethral catheter directly into the bladder. The agent is then able to directly interact with the cells of the immune system and bladder cancer cells. Industry Canada's Industrial Technologies Office (formerly Technology Partnerships Canada) has contributed to the development of Bioniche's mycobacterial cell wall technologies by means of a C$9.6 million loan to be repaid by Bioniche from sales.
About the Endo-Bioniche Partnership
Endo holds exclusive global rights to develop and market Bioniche's patented formulation of Mycobacterial Cell Wall-DNA Complex (MCC), Urocidin™, being developed for the intravesical treatment of non-muscle-invasive bladder cancer.Under the licensing agreement, Bioniche received an up-front payment of US$20 million in July 2009, and became eligible to receive an additional US$110 million in milestone payments. Milestones are announced as they are achieved and, with its exclusive manufacturing supply contract, Bioniche provides clinical trial material and will also receive a net-sales-based revenue stream upon product approval.
About Bioniche Life Sciences Inc.
Bioniche Life Sciences Inc. is a research-based, technology-driven Canadian biopharmaceutical company focused on the discovery, development, manufacturing, and marketing of proprietary products for human and animal health markets worldwide. The fully-integrated company employs over 200 skilled personnel and has three operating divisions: Human Health, Animal Health, and Food Safety. For more information, please visit www.Bioniche.com.
About Endo Pharmaceuticals Inc.
Endo Pharmaceuticals is a U.S.-based, specialty healthcare solutions company, focused on high-value branded products and specialty generics. Endo is redefining its position in the healthcare marketplace by anticipating and embracing the evolution of health decisions based on the need for high-quality and cost-effective care. We aim to be the premier partner to healthcare professionals and payment providers, delivering an innovative suite of complementary diagnostics, drugs, devices and clinical data to meet the needs of patients in areas such as pain, urology, oncology and endocrinology. For more information about Endo Pharmaceuticals, and its wholly owned subsidiaries HealthTronics, Inc. and Qualitest Pharmaceuticals, please visit www.endo.com.
Read more: http://www.nasdaq.com/aspx/company-news-story.aspx?storyid=2…
Oberländler
Urocidin™ Phase III Clinical Trial Results to be Presented at EAU and AUA Conferences
-overall one-year disease-free survival rate of 25 percent in treatment-refractory non-muscle-invasive bladder cancer-
CHADDS FORD, Pa. and BELLEVILLE, Ontario, Feb. 17, 2011 /PRNewswire/ -- Endo Pharmaceuticals (Nasdaq: ENDP) and Bioniche Life Sciences Inc. (TSX and ASX: BNC) today announced plans for peer-reviewed presentation of interim efficacy and safety results from the first Phase III trial of the intravesical formulation of Mycobacterial cell wall-DNA complex (MCC), known as Urocidin™ or EN3348. The results to be presented have been generated from an ongoing Phase III registration trial with Urocidin™ in the treatment of non-muscle-invasive bladder cancer (NMIBC) that is refractory to current first-line therapy (Bacillus Calmette-Guerin, known as BCG).
The first abstract and poster summaries of such results will be made available during the Annual Congress of the European Association of Urology (EAU) March 18-22 in Vienna, Austria. The accepted abstract is now available to EAU members. Further disclosure of results from this trial will be made during a podium presentation at the annual American Urological Association (AUA) meeting May 14-19 in Washington, D.C.
Phase III Results
The EAU and AUA abstracts highlight results based on an interim analysis of the Phase III trial. The objective of the trial is to evaluate the efficacy and safety of Urocidin™ in patients with non-muscle-invasive bladder cancer (NMIBC) who are refractory to intravesical BCG therapy and at high risk of progression. A total of 129 patients were enrolled from 25 centers in the U.S. and Canada, with high grade papillary and/or carcinoma in situ (CIS) and having failed to respond to one or more courses of BCG. The overall one-year disease-free survival (DFS) rate was 25 percent. DFS is defined as lack of recurrence or progression to muscle-invasive disease, as confirmed by biopsy. The one-year DFS rates, when sub-divided by tumor type (e.g., CIS with or without papillary tumors or papillary tumors alone) at study entry is disclosed in the conference materials, as is the median DFS interval (in days) of the intent-to-treat population. In terms of safety, the results showed that intravesical administration of Urocidin™ was well tolerated, with most adverse events being mild to moderate in severity and few leading to discontinuation of treatment. The authors of the abstract concluded that the interim analysis of this prospective trial indicates that Urocidin™ may provide an alternative to cystectomy for patients with BCG-refractory NMIBC.
Ongoing Phase III Clinical Program with Urocidin™
Summary details of a second Phase III clinical trial protocol being conducted by Endo are publicly available via the U.S. National Institutes of Health (NIH) clinical trial registration service at http://www.clinicaltrials.gov.
About Bladder Cancer
In North America, bladder cancer is the fourth most common cancer in men and the fifth overall between both men and women. In the United States, approximately 70,000 patients are newly diagnosed with bladder cancer each year and 500,000 living patients have been affected. In Europe, more than 100,000 patients are newly diagnosed each year. Bladder cancer is frequently a recurrent disease, with some cases becoming refractory to available chemotherapeutic or immunotherapeutic agents and leading to cystectomy (bladder removal) or death. Approximately 70 percent of bladder cancer patients have the non-muscle-invasive form of bladder cancer. Collectively across the U.S., Europe and Japan, approximately 350,000 non-muscle-invasive bladder cancer patients are newly diagnosed or have a recurrence each year.
Non-muscle-invasive bladder cancer is a form of bladder cancer localized in the surface layers of the bladder that has not yet spread into the deeper muscle layer. This form of bladder cancer is treated predominantly by urologists using surgical resection and intravesical infusion therapy. Urocidin™ is an intravesical infusion therapy, administered via trans-urethral catheter into the bladder.
About Urocidin™
Urocidin™ is a formulation of MCC, a sterile mycobacterial cell wall-DNA complex composition that has a dual mode of action: immune stimulation and direct anticancer activity. Urocidin™ is formulated for the treatment of bladder cancer, where it is administered by trans-urethral catheter directly into the bladder. The agent is then able to directly interact with the cells of the immune system and bladder cancer cells. Industry Canada's Industrial Technologies Office (formerly Technology Partnerships Canada) has contributed to the development of Bioniche's mycobacterial cell wall technologies by means of a C$9.6 million loan to be repaid by Bioniche from sales.
About the Endo-Bioniche Partnership
Endo holds exclusive global rights to develop and market Bioniche's patented formulation of Mycobacterial Cell Wall-DNA Complex (MCC), Urocidin™, being developed for the intravesical treatment of non-muscle-invasive bladder cancer.Under the licensing agreement, Bioniche received an up-front payment of US$20 million in July 2009, and became eligible to receive an additional US$110 million in milestone payments. Milestones are announced as they are achieved and, with its exclusive manufacturing supply contract, Bioniche provides clinical trial material and will also receive a net-sales-based revenue stream upon product approval.
About Bioniche Life Sciences Inc.
Bioniche Life Sciences Inc. is a research-based, technology-driven Canadian biopharmaceutical company focused on the discovery, development, manufacturing, and marketing of proprietary products for human and animal health markets worldwide. The fully-integrated company employs over 200 skilled personnel and has three operating divisions: Human Health, Animal Health, and Food Safety. For more information, please visit www.Bioniche.com.
About Endo Pharmaceuticals Inc.
Endo Pharmaceuticals is a U.S.-based, specialty healthcare solutions company, focused on high-value branded products and specialty generics. Endo is redefining its position in the healthcare marketplace by anticipating and embracing the evolution of health decisions based on the need for high-quality and cost-effective care. We aim to be the premier partner to healthcare professionals and payment providers, delivering an innovative suite of complementary diagnostics, drugs, devices and clinical data to meet the needs of patients in areas such as pain, urology, oncology and endocrinology. For more information about Endo Pharmaceuticals, and its wholly owned subsidiaries HealthTronics, Inc. and Qualitest Pharmaceuticals, please visit www.endo.com.
Read more: http://www.nasdaq.com/aspx/company-news-story.aspx?storyid=2…
Oberländler
Nachtrag:
Endo Pharmaceuticals Raises 2011 Financial Guidance and Reports Strong Fourth Quarter 2010 Financial Results
CHADDS FORD, Pa., Feb. 28, 2011 /PRNewswire/ --
Company increases 2011 financial guidance of revenues to a range of $2.35B to $2.45B
Company increases 2011 financial guidance of adjusted diluted EPS to a range of $4.20 to $4.30 and now expects Reported or GAAP diluted EPS to be in a range of $2.43 to $2.53
Total quarterly revenues increase 31 percent versus prior year; Total annual revenues increase 17 percent versus prior year;
Reported quarterly diluted EPS of $0.77, down 38 percent from prior year; adjusted diluted EPS of $1.06 reflecting growth of 31 percent from 2009
Reported annual diluted EPS of $2.20, down 3 percent from prior year; adjusted diluted EPS of $3.48, reflecting growth of 23 percent from 2009
Endo Pharmaceuticals (Nasdaq: ENDP) today reported financial results for the fourth quarter 2010.
Total revenues during the fourth quarter of 2010 increased 31 percent to $511 million, compared with $391 million in the same quarter of 2009. Net income for the three months ended December 31, 2010 was $93 million, compared with $14 8 million in the comparable 2009 period. As detailed in the supplemental financial information below, adjusted net income for the three months ended December 31, 2010, was $128 million, compared with $95 million in the same period in 2009. Reported diluted earnings per share for the quarter ended December 31, 2010 were $0.77 compared with $1.25 in the fourth quarter of 2009. Adjusted diluted earnings per share for the same period were $1.06 compared with $0.81 reported in 2009.
Read more: http://www.nasdaq.com/aspx/company-news-story.aspx?storyid=2…
Oberlaendler
Endo Pharmaceuticals Raises 2011 Financial Guidance and Reports Strong Fourth Quarter 2010 Financial Results
CHADDS FORD, Pa., Feb. 28, 2011 /PRNewswire/ --
Company increases 2011 financial guidance of revenues to a range of $2.35B to $2.45B
Company increases 2011 financial guidance of adjusted diluted EPS to a range of $4.20 to $4.30 and now expects Reported or GAAP diluted EPS to be in a range of $2.43 to $2.53
Total quarterly revenues increase 31 percent versus prior year; Total annual revenues increase 17 percent versus prior year;
Reported quarterly diluted EPS of $0.77, down 38 percent from prior year; adjusted diluted EPS of $1.06 reflecting growth of 31 percent from 2009
Reported annual diluted EPS of $2.20, down 3 percent from prior year; adjusted diluted EPS of $3.48, reflecting growth of 23 percent from 2009
Endo Pharmaceuticals (Nasdaq: ENDP) today reported financial results for the fourth quarter 2010.
Total revenues during the fourth quarter of 2010 increased 31 percent to $511 million, compared with $391 million in the same quarter of 2009. Net income for the three months ended December 31, 2010 was $93 million, compared with $14 8 million in the comparable 2009 period. As detailed in the supplemental financial information below, adjusted net income for the three months ended December 31, 2010, was $128 million, compared with $95 million in the same period in 2009. Reported diluted earnings per share for the quarter ended December 31, 2010 were $0.77 compared with $1.25 in the fourth quarter of 2009. Adjusted diluted earnings per share for the same period were $1.06 compared with $0.81 reported in 2009.
Read more: http://www.nasdaq.com/aspx/company-news-story.aspx?storyid=2…
Oberlaendler
Und:
ENDP
Endo Pharmaceuticals Holdings Inc.
NASDAQ-GS Qualitest Receives FDA Approval for Toresmide Tablets (Generic Demadex®) 5 mg, 10 mg, 20 mg, 100 mg, for the Treatment of Edema Associated with Congestive Heart Failure, Renal Disease, or Hepatic Disease
03/24/2011 8:30AM - PR Newswire
Endo to Present at the Barclays Capital 2011 GlobalHealthcare Conference
03/09/2011 9:00AM - PR Newswire
Qualitest Receives FDA Approval for Emoquette™ (.15 mg Desogestrel and .03 mg Ethinyl Estradiol), an Oral Contraceptive for Prevention of Pregnancy
03/04/2011 8:15AM - PR Newswire
Endo Pharmaceuticals Appoints Dr. David Nash to Board of Directors
03/03/2011 4:15PM - PR Newswire
Endo Pharmaceuticals Launches FORTESTA™ (Testosterone) Gel for Topical Use Class III for Adult Men in the U.S. With Low Testosterone
03/03/2011 8:30AM - PR Newswire
Read more: http://www.nasdaq.com/aspxcontent/newsHeadlines.aspx?symbol=…
So, Privatsammlung wieder aktuell.
Oberländler
ENDP
Endo Pharmaceuticals Holdings Inc.
NASDAQ-GS Qualitest Receives FDA Approval for Toresmide Tablets (Generic Demadex®) 5 mg, 10 mg, 20 mg, 100 mg, for the Treatment of Edema Associated with Congestive Heart Failure, Renal Disease, or Hepatic Disease
03/24/2011 8:30AM - PR Newswire
Endo to Present at the Barclays Capital 2011 GlobalHealthcare Conference
03/09/2011 9:00AM - PR Newswire
Qualitest Receives FDA Approval for Emoquette™ (.15 mg Desogestrel and .03 mg Ethinyl Estradiol), an Oral Contraceptive for Prevention of Pregnancy
03/04/2011 8:15AM - PR Newswire
Endo Pharmaceuticals Appoints Dr. David Nash to Board of Directors
03/03/2011 4:15PM - PR Newswire
Endo Pharmaceuticals Launches FORTESTA™ (Testosterone) Gel for Topical Use Class III for Adult Men in the U.S. With Low Testosterone
03/03/2011 8:30AM - PR Newswire
Read more: http://www.nasdaq.com/aspxcontent/newsHeadlines.aspx?symbol=…
So, Privatsammlung wieder aktuell.
Oberländler
Endo To Buy American Medical Systems For $2.9 Bln - Update
(RTTNews) - Generic drug maker Endo Pharmaceuticals Holdings Inc. (ENDP) Monday announced a definitive deal to acquire American Medical Systems Holdings Inc. (AMMD) for $30 per share or about $2.9 billion in cash. Boards of directors of both the companies have unanimously approved the merger agreement.
The purchase price of Endo includes the assumption and repayment of $312 million of American Medical's debt. Endo expects the acquisition to fulfill its strategy to build scale in devices and services business segment.
American Medical or AMS provides medical devices and therapies that help restore pelvic health. AMS' business consists of three segments: Men's Health, Women's Health and Benign Prostatic Hyperplasia Therapy, with about 73 percent of its sales in the U.S. and the remainder from Europe, Canada and the Asia Pacific and Latin America regions.
The transaction, which is subject to approval by AMS stockholders and clearance by relevant antitrust authorities, is expected to close late in the third quarter of 2011.
On a 2011 pro forma basis, the combined company, with about 4,000 employees, would have generated revenues of nearly $3 billion.
Endo expects the transaction to be immediately accretive in 2011 on an adjusted diluted earnings per share basis. The company also expects the combination will be immediately accretive to adjusted diluted earnings per share upon close and accretive by $0.60 in 2012, growing to around $0.80 in 2013.
On a reported basis, Endo anticipates the deal to be dilutive to 2011 earnings by $0.61, dilutive to 2012 earnings by $0.05 and accretive to 2013 earnings by $0.25, which will reflect purchase accounting and other transaction-related charges.
Further, Endo reaffirmed its stand alone 2011 revenue guidance of between $2.35 billion to $2.45 billion and full year adjusted earnings per share to be between $4.20 to $4.30 per share.
Analysts polled by Thomson Reuters expect the company to report earnings of $4.30 per share on revenues of $2.36 billion for the year. Analysts' estimates typically excludes special items.
In addition, Endo expects to achieve at least $50 million in cost synergies by 2013.
ENDP closed Friday's regular trading at $40.85 on the Nasdaq.
AMMD ended on Friday at $22.33.
Read more: http://www.nasdaq.com/aspx/company-news-story.aspx?storyid=2…
Grüße Oberländler
(RTTNews) - Generic drug maker Endo Pharmaceuticals Holdings Inc. (ENDP) Monday announced a definitive deal to acquire American Medical Systems Holdings Inc. (AMMD) for $30 per share or about $2.9 billion in cash. Boards of directors of both the companies have unanimously approved the merger agreement.
The purchase price of Endo includes the assumption and repayment of $312 million of American Medical's debt. Endo expects the acquisition to fulfill its strategy to build scale in devices and services business segment.
American Medical or AMS provides medical devices and therapies that help restore pelvic health. AMS' business consists of three segments: Men's Health, Women's Health and Benign Prostatic Hyperplasia Therapy, with about 73 percent of its sales in the U.S. and the remainder from Europe, Canada and the Asia Pacific and Latin America regions.
The transaction, which is subject to approval by AMS stockholders and clearance by relevant antitrust authorities, is expected to close late in the third quarter of 2011.
On a 2011 pro forma basis, the combined company, with about 4,000 employees, would have generated revenues of nearly $3 billion.
Endo expects the transaction to be immediately accretive in 2011 on an adjusted diluted earnings per share basis. The company also expects the combination will be immediately accretive to adjusted diluted earnings per share upon close and accretive by $0.60 in 2012, growing to around $0.80 in 2013.
On a reported basis, Endo anticipates the deal to be dilutive to 2011 earnings by $0.61, dilutive to 2012 earnings by $0.05 and accretive to 2013 earnings by $0.25, which will reflect purchase accounting and other transaction-related charges.
Further, Endo reaffirmed its stand alone 2011 revenue guidance of between $2.35 billion to $2.45 billion and full year adjusted earnings per share to be between $4.20 to $4.30 per share.
Analysts polled by Thomson Reuters expect the company to report earnings of $4.30 per share on revenues of $2.36 billion for the year. Analysts' estimates typically excludes special items.
In addition, Endo expects to achieve at least $50 million in cost synergies by 2013.
ENDP closed Friday's regular trading at $40.85 on the Nasdaq.
AMMD ended on Friday at $22.33.
Read more: http://www.nasdaq.com/aspx/company-news-story.aspx?storyid=2…
Grüße Oberländler
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