GlaxoSmithKline reported that it entered into an agreement to purchase Sirtris Pharmaceuticals for $22.50 per share in a transaction valued at about $720 million. GlaxoSmithKline said the deal is expected to boost its metabolic, neurology, immunology and inflammation research efforts.
Sirtris' lead drug candidate, SRT501, is currently in Phase II testing for diabetes, with results anticipated later this year.
Tuesday, April 22, 2008
Thursday, April 17, 2008
Wyeth and ViroPharma halt development of thier HCV candidate
Wyeth and ViroPharma have decided to discontinue development of their hepatitis C drug HCV-796, after concerns about hepatotoxicity were raised during a Phase II trial last year.
CEO of ViroPharma Vincent Milano commented that "significant activities were undertaken to determine a clear path forward for HCV-796; however, the risk associated with potential hepatotoxicity ultimately posed too high of a hurdle to merit further development." ViroPharma also stated that the two companies do not plan to collaborate on future development of hepatitis C drugs
CEO of ViroPharma Vincent Milano commented that "significant activities were undertaken to determine a clear path forward for HCV-796; however, the risk associated with potential hepatotoxicity ultimately posed too high of a hurdle to merit further development." ViroPharma also stated that the two companies do not plan to collaborate on future development of hepatitis C drugs
Tuesday, April 15, 2008
Ranbaxy could earn additional USD 1.5 billion in next 6 years
AstraZeneca entered into an agreement to settle US patent infringement litigation with Ranbaxy over Nexium. Under deal terms, Ranbaxy will be allowed to sell a generic version of Nexium under licence from AstraZeneca starting on May 27, 2014. Ranbaxy will have a 180-day period of exclusivity as the only distributor for generic Nexium, and conceded – as part of the agreement – that "all six patents asserted by AstraZeneca in the patent litigation are valid and enforceable." No financial terms of the deal were disclosed.
In addition, the drugmakers entered into an agreement under which Ranbaxy will manufacture a portion of AstraZeneca's US supply of Nexium from May 2010, as well as the treatment's active ingredient from May 2009. Furthermore, the companies signed distribution deals that allow Ranbaxy to be the distributor for authorised generic versions of hypertension compound Plendil and proton pump inhibitor Prilosec in the US.
Ranbaxy CEO Malvinder Singh stated that the agreements with AstraZeneca could earn as much as $1.5 billion in revenue over the next six years
In addition, the drugmakers entered into an agreement under which Ranbaxy will manufacture a portion of AstraZeneca's US supply of Nexium from May 2010, as well as the treatment's active ingredient from May 2009. Furthermore, the companies signed distribution deals that allow Ranbaxy to be the distributor for authorised generic versions of hypertension compound Plendil and proton pump inhibitor Prilosec in the US.
Ranbaxy CEO Malvinder Singh stated that the agreements with AstraZeneca could earn as much as $1.5 billion in revenue over the next six years
Wednesday, February 13, 2008
Nektar to Cut 20 Percent of Work Force
SAN CARLOS, Calif. — Biopharmaceutical company Nektar Therapeutics said Tuesday it cut about 150 employees, or roughly 20 percent of its work force, as part of a restructuring plan and said its Chief Operating Officer Dr. Hoyoung Huh will step down.
Nektar said the restructuring plan is designed to complete the company's transition from providing drug delivery services to developing therapeutic drugs.
According to a filing with the Securities and Exchange Commission Tuesday, the job cuts include about 110 full-time staff and around 40 open positions. The company notified the affected employees Monday.
Nektar estimates a pretax restructuring charge in 2008 of about $7 million to $8 million, mostly related to one-time severance costs.
Separately, the company said Tuesday that Huh, who also was head of the company's PEGylation business, will serve on Nektar's board of directors.
In May, Nektar said it would cut 25 percent of its work force to reduce costs
Nektar said the restructuring plan is designed to complete the company's transition from providing drug delivery services to developing therapeutic drugs.
According to a filing with the Securities and Exchange Commission Tuesday, the job cuts include about 110 full-time staff and around 40 open positions. The company notified the affected employees Monday.
Nektar estimates a pretax restructuring charge in 2008 of about $7 million to $8 million, mostly related to one-time severance costs.
Separately, the company said Tuesday that Huh, who also was head of the company's PEGylation business, will serve on Nektar's board of directors.
In May, Nektar said it would cut 25 percent of its work force to reduce costs
Wednesday, January 16, 2008
Pharma News Updates: Jan 15, 2008
Genentech's Avastin sales miss expectations in fourth quarter
Genentech reported Monday that its fourth-quarter net income rose 6 percent to $632 million over the year-ago period. Avastin's quarterly sales climbed 23 percent to $603 million, but fell short of analysts' expectations of $616 million.
Rituxan's fourth-quarter sales rose 6 percent to $596 million, while Herceptin's revenue climbed 2 percent to $327 million. Lucentis' quarterly sales were $197 million, a 9-percent decrease compared with the year-ago quarter. Commenting on the results, Robert W. Baird's Christopher Raymond, stated: "It's not much to write home about -- they were light on product revenues." The analyst noted that "Avastin was light, and it's a key number," adding that both Rituxan and Herceptin's quarterly sales were also lower than Wall Street estimates. Total revenue for the quarter was in line with analysts' forecasts at $2.97 billion, compared with $2.71 billion in the year-ago quarter.
The company also reported full-year results, stating that net income rose 31 percent to $2.8 billion on revenue of $11.7 billion. Avastin's full-year sales rose 32 percent to $2.3 billion while Rituxan recorded a 10-percent increase in revenue to $2.3 billion for 2007. Sales of Herceptin were up 4 percent to $1.3 billion for the year.
Additionally, the drugmaker specified that it decided not to continue development of its topical VEGF product, telbermin, for diabetic foot ulcers, following negative Phase II results. Looking forward, CEO Arthur Levinson stated that in 2008, the company "will continue to invest in the 20 new molecular entities in clinical development and look forward to new data from a number of potentially important line extensions, including Rituxan for multiple sclerosis and lupus and Avastin in combination with Tarceva for advanced non-small-cell lung cancer."
FDA approves Tysabri for use in Crohn's disease
The FDA granted expanded approval to Elan and Biogen’s Tysabri for the treatment of Crohn’s disease, Elan announced Monday. The company indicated that the drug should be made available for patients with the disease by the end of February.
The product is now indicated in the US for adults with moderately-to-severely active Crohn's disease with evidence of inflammation and who have had an inadequate response to conventional therapies and TNF-alpha inhibitors. The drug will have a specific risk management plan for patients with Crohn's, Elan noted.
Tysabri, which is approved to treat multiple sclerosis in the US and EU, received a negative opinion in the EU for Crohn's disease last year.
France backs cervical cancer vaccination with Gardasil
France's High Council for Public Health on Monday announced that girls 14 years of age should be vaccinated with cervical cancer vaccine Gardasil. The vaccine, which is sold in Europe by Sanofi Pasteur MSD, a joint venture between Merck & Co. and sanofi-aventis, protects against four strains of human papillomavirus.
The agency, which said the vaccine should protect against four HPV strains, also suggested that vaccination should be offered to women aged 15 to 23 years either before, or within a year, of their first sexual contact. Gardasil competes against GlaxoSmithKline's Cervarix, which protects against two strains of HPV.
Novo Nordisk discontinues development of inhaled insulin, AERx
Novo Nordisk will discontinue development of its AERx inhalable insulin product and plans to eliminate jobs as a result, the company reported Monday. The drugmaker said the move follows an analysis of future medical and commercial prospects for inhaled insulin.
Mads Krogsgaard Thomsen, Novo Nordisk's chief scientific officer, stated that Pfizer's recent move to end sales of its inhalable insulin product, Exubera, prompted Novo Nordisk's decision. Meanwhile, company spokesperson Lori Moore stated that a "significant number" of the 360 workers at the drugmaker's plant in Hayward, California will lose their jobs as a result of the decision.
Novo Nordisk said it will take a charge of 1.3 billion Danish kroner ($260 million) in the fourth quarter related to AERx.
Genentech reported Monday that its fourth-quarter net income rose 6 percent to $632 million over the year-ago period. Avastin's quarterly sales climbed 23 percent to $603 million, but fell short of analysts' expectations of $616 million.
Rituxan's fourth-quarter sales rose 6 percent to $596 million, while Herceptin's revenue climbed 2 percent to $327 million. Lucentis' quarterly sales were $197 million, a 9-percent decrease compared with the year-ago quarter. Commenting on the results, Robert W. Baird's Christopher Raymond, stated: "It's not much to write home about -- they were light on product revenues." The analyst noted that "Avastin was light, and it's a key number," adding that both Rituxan and Herceptin's quarterly sales were also lower than Wall Street estimates. Total revenue for the quarter was in line with analysts' forecasts at $2.97 billion, compared with $2.71 billion in the year-ago quarter.
The company also reported full-year results, stating that net income rose 31 percent to $2.8 billion on revenue of $11.7 billion. Avastin's full-year sales rose 32 percent to $2.3 billion while Rituxan recorded a 10-percent increase in revenue to $2.3 billion for 2007. Sales of Herceptin were up 4 percent to $1.3 billion for the year.
Additionally, the drugmaker specified that it decided not to continue development of its topical VEGF product, telbermin, for diabetic foot ulcers, following negative Phase II results. Looking forward, CEO Arthur Levinson stated that in 2008, the company "will continue to invest in the 20 new molecular entities in clinical development and look forward to new data from a number of potentially important line extensions, including Rituxan for multiple sclerosis and lupus and Avastin in combination with Tarceva for advanced non-small-cell lung cancer."
FDA approves Tysabri for use in Crohn's disease
The FDA granted expanded approval to Elan and Biogen’s Tysabri for the treatment of Crohn’s disease, Elan announced Monday. The company indicated that the drug should be made available for patients with the disease by the end of February.
The product is now indicated in the US for adults with moderately-to-severely active Crohn's disease with evidence of inflammation and who have had an inadequate response to conventional therapies and TNF-alpha inhibitors. The drug will have a specific risk management plan for patients with Crohn's, Elan noted.
Tysabri, which is approved to treat multiple sclerosis in the US and EU, received a negative opinion in the EU for Crohn's disease last year.
France backs cervical cancer vaccination with Gardasil
France's High Council for Public Health on Monday announced that girls 14 years of age should be vaccinated with cervical cancer vaccine Gardasil. The vaccine, which is sold in Europe by Sanofi Pasteur MSD, a joint venture between Merck & Co. and sanofi-aventis, protects against four strains of human papillomavirus.
The agency, which said the vaccine should protect against four HPV strains, also suggested that vaccination should be offered to women aged 15 to 23 years either before, or within a year, of their first sexual contact. Gardasil competes against GlaxoSmithKline's Cervarix, which protects against two strains of HPV.
Novo Nordisk discontinues development of inhaled insulin, AERx
Novo Nordisk will discontinue development of its AERx inhalable insulin product and plans to eliminate jobs as a result, the company reported Monday. The drugmaker said the move follows an analysis of future medical and commercial prospects for inhaled insulin.
Mads Krogsgaard Thomsen, Novo Nordisk's chief scientific officer, stated that Pfizer's recent move to end sales of its inhalable insulin product, Exubera, prompted Novo Nordisk's decision. Meanwhile, company spokesperson Lori Moore stated that a "significant number" of the 360 workers at the drugmaker's plant in Hayward, California will lose their jobs as a result of the decision.
Novo Nordisk said it will take a charge of 1.3 billion Danish kroner ($260 million) in the fourth quarter related to AERx.
Pharma News Update: January 16, 2008
Fortune scolds Merck for "risky" programs
Fortune writer John Simons is taking Merck to task for two development programs he finds particularly risky. "The riskiest of Merck's current projects is taranabant," writes Simons, "a treatment that until recently was hailed as an elegant solution for attacking excess weight. Rather than working in the gut, taranabant manipulates the brain to suppress appetite. More specifically, the drug acts on the same receptors in the brain that cause marijuana-smokers to experience hunger. Taranabant, in essence, causes a patient to experience the reverse-munchies."
Psychiatric side effects could derail that program, says Fortune. The there's the cholesterol medicine, anacetripib, which bears far too close a resemblance for Simons to Pfizer's infamous torcetrapib. Towards the end of the piece there's at least one analyst willing to agree that Merck is taking big risks, but stands to gain enormous rewards. Sounds like the kind of bet the Big Pharma developers should make more often if they want to find a way to a brighter, richer future. The last thing biopharma needs now is an even more cautious approach to drug development
AstraZeneca launches head-to-head trial comparing Crestor and Lipitor
AstraZeneca on Tuesday announced the launch of a clinical trial to compare Crestor with Pfizer’s Lipitor for the treatment of atherosclerosis in patients with coronary artery disease.
The SATURN study will compare the 40-milligram dose of Crestor with the 80-milligram dose of Lipitor in about 1300 high-risk patients and is designed to measure the ability of the statins to decrease progression or induce regression of atherosclerosis, following two years of treatment.
The trial is expected to be completed in 2011, AstraZeneca noted
Forest's third-quarter profit up 21 percent on drug sales
Forest reported Tuesday that its profit in the third quarter rose 21 percent to $301.8 million over the prior-year quarter, on strong sales of Lexapro and Namenda. The drugmaker also raised its earnings forecast for its fiscal year ending March 31.
In the quarter, sales of Lexapro grew 11 percent to $603.5 million, while sales of Namenda jumped 26 percent to $218.7 million. Overall, third-quarter revenue was $998.2 million, a 12-percent increase over the same quarter in 2006, and higher than analysts' expectations of $947 million.
Regarding its pipeline, the drugmaker anticipates launching its recently approved hypertension drug, Bystolic, this month
HRT increases risk of lobular breast cancer, study
Study results suggest that combination hormone replacement therapy may raise the risk of lobular breast cancer after just three years. The findings are published in the January edition of Cancer Epidemiology, Biomarkers and Prevention.
"Previous research indicated that five or more years of combined hormone-therapy use was necessary to increase overall breast-cancer risk," noted lead researcher Christopher Li. However, Li added that "our study...suggests that a significantly shorter exposure may confer an increased risk."
In the trial, the researchers examined the histories of 1044 postmenopausal women with breast cancer and 469 postmenopausal women without the disease. The results showed that those who took combined HRT for as few as three years were about three times more likely to develop lobular breast tumours compared with those who did not take combined HRT.
Experts have indicated that the incidence of lobular cancer is increasing, and Li noted that "our research suggests that the use of postmenopausal HRT, specifically combined preparations, may be contributing to this
European regulators approve GlaxoSmithKline's Avamys
The European Commission granted marketing authorisation to GlaxoSmithKline’s allergic rhinitis drug, Avamys, the drugmaker announced Tuesday. The treatment is the first intranasal corticosteroid to show "consistently significant improvements" in both nose and eye allergy symptoms, the drugmaker noted.
In the EU, the once-daily nasal spray is indicated for use in adults, adolescents and children aged six to 11 years. The drug was approved by the FDA in April 2007 and is marketed as Veramyst in the US
Fortune writer John Simons is taking Merck to task for two development programs he finds particularly risky. "The riskiest of Merck's current projects is taranabant," writes Simons, "a treatment that until recently was hailed as an elegant solution for attacking excess weight. Rather than working in the gut, taranabant manipulates the brain to suppress appetite. More specifically, the drug acts on the same receptors in the brain that cause marijuana-smokers to experience hunger. Taranabant, in essence, causes a patient to experience the reverse-munchies."
Psychiatric side effects could derail that program, says Fortune. The there's the cholesterol medicine, anacetripib, which bears far too close a resemblance for Simons to Pfizer's infamous torcetrapib. Towards the end of the piece there's at least one analyst willing to agree that Merck is taking big risks, but stands to gain enormous rewards. Sounds like the kind of bet the Big Pharma developers should make more often if they want to find a way to a brighter, richer future. The last thing biopharma needs now is an even more cautious approach to drug development
AstraZeneca launches head-to-head trial comparing Crestor and Lipitor
AstraZeneca on Tuesday announced the launch of a clinical trial to compare Crestor with Pfizer’s Lipitor for the treatment of atherosclerosis in patients with coronary artery disease.
The SATURN study will compare the 40-milligram dose of Crestor with the 80-milligram dose of Lipitor in about 1300 high-risk patients and is designed to measure the ability of the statins to decrease progression or induce regression of atherosclerosis, following two years of treatment.
The trial is expected to be completed in 2011, AstraZeneca noted
Forest's third-quarter profit up 21 percent on drug sales
Forest reported Tuesday that its profit in the third quarter rose 21 percent to $301.8 million over the prior-year quarter, on strong sales of Lexapro and Namenda. The drugmaker also raised its earnings forecast for its fiscal year ending March 31.
In the quarter, sales of Lexapro grew 11 percent to $603.5 million, while sales of Namenda jumped 26 percent to $218.7 million. Overall, third-quarter revenue was $998.2 million, a 12-percent increase over the same quarter in 2006, and higher than analysts' expectations of $947 million.
Regarding its pipeline, the drugmaker anticipates launching its recently approved hypertension drug, Bystolic, this month
HRT increases risk of lobular breast cancer, study
Study results suggest that combination hormone replacement therapy may raise the risk of lobular breast cancer after just three years. The findings are published in the January edition of Cancer Epidemiology, Biomarkers and Prevention.
"Previous research indicated that five or more years of combined hormone-therapy use was necessary to increase overall breast-cancer risk," noted lead researcher Christopher Li. However, Li added that "our study...suggests that a significantly shorter exposure may confer an increased risk."
In the trial, the researchers examined the histories of 1044 postmenopausal women with breast cancer and 469 postmenopausal women without the disease. The results showed that those who took combined HRT for as few as three years were about three times more likely to develop lobular breast tumours compared with those who did not take combined HRT.
Experts have indicated that the incidence of lobular cancer is increasing, and Li noted that "our research suggests that the use of postmenopausal HRT, specifically combined preparations, may be contributing to this
European regulators approve GlaxoSmithKline's Avamys
The European Commission granted marketing authorisation to GlaxoSmithKline’s allergic rhinitis drug, Avamys, the drugmaker announced Tuesday. The treatment is the first intranasal corticosteroid to show "consistently significant improvements" in both nose and eye allergy symptoms, the drugmaker noted.
In the EU, the once-daily nasal spray is indicated for use in adults, adolescents and children aged six to 11 years. The drug was approved by the FDA in April 2007 and is marketed as Veramyst in the US
Tuesday, January 8, 2008
UK Government seeks 10% drugs price cut – FT report
Suggestions that the UK government is looking to push for a 10% cut in the prices of prescription medicines on the National Health Service have raised eyebrows within the pharmaceutical industry. The Financial Times has this morning reported that Alan Johnson, the UK’s health minister, told the newspaper he plans to generate substantial savings in the £11 billion annual drugs budget during talks with industry representatives concerning the Pharmaceutical Price Regulation Scheme.This 10% figure will come as a shock to drugmakers especially as they signed a five-year deal in 2004 offering price cuts of around 7% in return for increased allowances to encourage R&D of innovative products.The Department of Health surprised drugmakers in August by saying that renegotiation of the PPRS was needed, a move which came after the UK’s Office of Fair Trading published its controversial report on the PPRS, which concluded that the NHS could save up to £500 million a year. The August statement prompted a cautious response from the Association of the British Pharmaceutical Industry which said it recognised the Government’s need to gain best value for money from all aspects of NHS services, but pointed out that the system already benefits “from one of the most cost-effective medicines policies in Europe, with high levels of generics prescribed”.The ABPI told PharmaTimes World News that it is weighing up the comments of Mr Johnson and may make a statement later today.
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