April 15, 2008 - Provectus Pharmaceuticals, Inc. (OTC BB: PVCT), a development-stage oncology and dermatology biopharmaceutical company, has received allowance of its patent application in the European Union covering its lead dermatology agent, PH-10, along with a number of related agents and their use. Provectus has also received allowance of another patent application in Canada covering applicator devices used with PH-10 and related agents. The pending patents cover topical products for treatment of skin diseases such as psoriasis and eczema, along with certain medical devices for application of PH-10 to internal surfaces of the body.
"Coming on the heels of our recent patents in the U.S. and India for PH-10, these pending patents from the European Patent Office (EPO) and the Canadian Intellectual Property Office are further milestones validating our efforts to obtain maximum right of ownership for products that may be sold in major markets worldwide," said Craig Dees, PhD, CEO of Provectus. "The EPO patent will also cover topical products based on PH-12, our novel photoactive analog of PH-10."
Tuesday, April 15, 2008
MonoSol Rx Granted US Patent for Thin Film Manufacturing Process
MonoSol Rx, a drug delivery company specializing in quick dissolving thin film pharmaceutical products, today announced that it has been granted U.S. patent No. 7,357,891 from the United States Patent and Trademark Office (USPTO). The patent, which is expected to issue on April 15, 2008, relates to the Company's proprietary mixing system technology and controlled film drying process.
"Granting of this patent is a significant milestone for MonoSol Rx as it validates and protects our thin film drug delivery technology. As we strive to expand the patent protection of our thin film technology, this milestone serves to fortify our leadership position in the delivery of prescription drugs using thin film" said A. Mark Schobel, president and chief executive officer of MonoSol Rx. "Our proprietary mixing and drying processes enable us to maintain precise content uniformity of the drug, incorporate taste-masked drug encapsulations, and allow the manufacture of sensitive drug targets that may otherwise not be possible. Each of these factors, combined with the convenience and dosing benefits of thin film, are key to the success of our technology, and help to differentiate MonoSol Rx from similar thin film offerings and other modes of drug delivery."
The patent relates to MonoSol Rx's Dual Integrated Mixing System. This patented mixing process is designed to provide a continuous batch coating of a drug contained in the film to ensure product uniformity while delivering consistent organoleptic performance throughout the film manufacturing process.
Also encompassed in the patent is MonoSol Rx's controlled film drying process. This controlled drying process is critical to maintaining content uniformity of a drug within the film thereby ensuring accurate and predictable dosing for patients.
Mr. Schobel also said, "This is an important acknowledgement of the innovative technology that MonoSol Rx has developed for thin film drug delivery. We are committed to pursuing and developing technology that provides significant advantages for MonoSol Rx and its development partners."
"Granting of this patent is a significant milestone for MonoSol Rx as it validates and protects our thin film drug delivery technology. As we strive to expand the patent protection of our thin film technology, this milestone serves to fortify our leadership position in the delivery of prescription drugs using thin film" said A. Mark Schobel, president and chief executive officer of MonoSol Rx. "Our proprietary mixing and drying processes enable us to maintain precise content uniformity of the drug, incorporate taste-masked drug encapsulations, and allow the manufacture of sensitive drug targets that may otherwise not be possible. Each of these factors, combined with the convenience and dosing benefits of thin film, are key to the success of our technology, and help to differentiate MonoSol Rx from similar thin film offerings and other modes of drug delivery."
The patent relates to MonoSol Rx's Dual Integrated Mixing System. This patented mixing process is designed to provide a continuous batch coating of a drug contained in the film to ensure product uniformity while delivering consistent organoleptic performance throughout the film manufacturing process.
Also encompassed in the patent is MonoSol Rx's controlled film drying process. This controlled drying process is critical to maintaining content uniformity of a drug within the film thereby ensuring accurate and predictable dosing for patients.
Mr. Schobel also said, "This is an important acknowledgement of the innovative technology that MonoSol Rx has developed for thin film drug delivery. We are committed to pursuing and developing technology that provides significant advantages for MonoSol Rx and its development partners."
AstraZeneca Settles US Nexium Patent Litigation with Ranbaxy
April 15, 2008--AstraZeneca today announced it has entered into a settlement agreement in its Nexium patent infringement litigation against Ranbaxy Laboratories Ltd. and its affiliates (“Ranbaxy”).
The agreement settles the patent infringement litigation filed by AstraZeneca following Ranbaxy’s submission to the United States Food & Drug Administration of an Abbreviated New Drug Application for a generic version of Nexium. Under the settlement agreement, Ranbaxy concedes that all six patents asserted by AstraZeneca in the patent litigation are valid and enforceable. Ranbaxy also accepts that four of the patents would be infringed by the unlicensed sale of Ranbaxy’s proposed generic product.
The settlement agreement will allow Ranbaxy to commence sales of a generic version of Nexium under a licence from AstraZeneca on 27 May 2014. This date marks the expiry of US Patent Numbers 5,877,192 and 6,875,872. AstraZeneca’s patents protecting Nexium have expiration dates that range from 2014 through 2019.
AstraZeneca and Ranbaxy have filed a Consent Judgment with the US District Court for the District of New Jersey reflecting the terms of the settlement agreement. With the Court now having entered the Consent Judgment, the settlement agreement is final, and the patent infringement litigation against Ranbaxy has been dismissed.
Merck & Co., Inc., through KBI Inc. and KBI-E and under the terms of Merck's restructured partnership with AstraZeneca announced in 1998, has also entered into the settlement agreement.
AstraZeneca’s Nexium patent infringement litigations against Teva/IVAX and Dr Reddy’s Laboratories remain ongoing.
“I believe that this agreement is the right business decision and gives increased clarity and stability to allow us to continue investing substantially in our growing pipeline of new medicines for patients. We continue to have confidence in the strength of our patents and will vigorously defend our intellectual property,” said David Brennan, Chief Executive Officer of AstraZeneca.
The agreement settles the patent infringement litigation filed by AstraZeneca following Ranbaxy’s submission to the United States Food & Drug Administration of an Abbreviated New Drug Application for a generic version of Nexium. Under the settlement agreement, Ranbaxy concedes that all six patents asserted by AstraZeneca in the patent litigation are valid and enforceable. Ranbaxy also accepts that four of the patents would be infringed by the unlicensed sale of Ranbaxy’s proposed generic product.
The settlement agreement will allow Ranbaxy to commence sales of a generic version of Nexium under a licence from AstraZeneca on 27 May 2014. This date marks the expiry of US Patent Numbers 5,877,192 and 6,875,872. AstraZeneca’s patents protecting Nexium have expiration dates that range from 2014 through 2019.
AstraZeneca and Ranbaxy have filed a Consent Judgment with the US District Court for the District of New Jersey reflecting the terms of the settlement agreement. With the Court now having entered the Consent Judgment, the settlement agreement is final, and the patent infringement litigation against Ranbaxy has been dismissed.
Merck & Co., Inc., through KBI Inc. and KBI-E and under the terms of Merck's restructured partnership with AstraZeneca announced in 1998, has also entered into the settlement agreement.
AstraZeneca’s Nexium patent infringement litigations against Teva/IVAX and Dr Reddy’s Laboratories remain ongoing.
“I believe that this agreement is the right business decision and gives increased clarity and stability to allow us to continue investing substantially in our growing pipeline of new medicines for patients. We continue to have confidence in the strength of our patents and will vigorously defend our intellectual property,” said David Brennan, Chief Executive Officer of AstraZeneca.
Monday, April 14, 2008
Study shows once-yearly Aclasta better than risedronate
New data show that a once-yearly infusion of Aclasta (zoledronic acid 5 mg) was significantly better than risedronate at increasing bone mass in patients with osteoporosis caused by glucocorticoids, commonly known as steroids. These medications are widely used to treat inflammatory conditions but can cause bone loss and osteoporosis.
Up to 50 per cent of patients receiving long-term glucocorticoid therapy are at increased risk of fracture due to osteoporosis, and approximately nine million people worldwide are affected by glucocorticoid-induced osteoporosis (GIO).
Results of a clinical study in 833 men and women were presented at the European Congress on Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ECCEO) in Istanbul, Turkey.
"Recognizing and treating GIO is an important need, as glucocorticoid therapy is so widely used and presents an ongoing challenge for physicians," said Professor David M. Reid, head of the division of applied medicine at the University of Aberdeen, UK. "The significant efficacy of this once-yearly treatment, offering year-long bone protection, will provide a very valuable treatment option for healthcare professionals treating and managing osteoporosis induced by glucocorticoids".
The trial investigated both prevention (288 patients) and treatment (545 patients) of GIO. Results demonstrated that a single yearly infusion of Aclasta significantly increased bone mineral density (BMD) in the lumbar spine at 12 months compared to risedronate in both the treatment group.
Risedronate is one of the established treatments for GIO and, like Aclasta, is a member of the bisphosphonate class of drugs. Risedronate is taken in the form of a daily pill, whereas Aclasta is given as a once-yearly 15-minute infusion, promoting compliance with bisphosphonate treatment and providing annual protection against the consequences of osteoporosis.
Novartis is applying for an indication with the European Medicines Agency (EMEA) and the US Food and Drug Administration (FDA) for the treatment and prevention of GIO.
Up to 50 per cent of patients receiving long-term glucocorticoid therapy are at increased risk of fracture due to osteoporosis, and approximately nine million people worldwide are affected by glucocorticoid-induced osteoporosis (GIO).
Results of a clinical study in 833 men and women were presented at the European Congress on Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ECCEO) in Istanbul, Turkey.
"Recognizing and treating GIO is an important need, as glucocorticoid therapy is so widely used and presents an ongoing challenge for physicians," said Professor David M. Reid, head of the division of applied medicine at the University of Aberdeen, UK. "The significant efficacy of this once-yearly treatment, offering year-long bone protection, will provide a very valuable treatment option for healthcare professionals treating and managing osteoporosis induced by glucocorticoids".
The trial investigated both prevention (288 patients) and treatment (545 patients) of GIO. Results demonstrated that a single yearly infusion of Aclasta significantly increased bone mineral density (BMD) in the lumbar spine at 12 months compared to risedronate in both the treatment group.
Risedronate is one of the established treatments for GIO and, like Aclasta, is a member of the bisphosphonate class of drugs. Risedronate is taken in the form of a daily pill, whereas Aclasta is given as a once-yearly 15-minute infusion, promoting compliance with bisphosphonate treatment and providing annual protection against the consequences of osteoporosis.
Novartis is applying for an indication with the European Medicines Agency (EMEA) and the US Food and Drug Administration (FDA) for the treatment and prevention of GIO.
Novartis' lung cancer drug enters phase 3 stage
Novartis announced that ASA404, its novel cancer agent, has entered into a phase III lung cancer trial following positive outcomes of a phase II trial. The novel mechanism of action of ASA404 may represent a new approach to treating the most prevalent cause of cancer death.
ASA404 is a Tumour-Vascular Disrupting Agent (Tumour-VDA) that selectively causes the collapse of existing tumour blood supply leading to extensive tumour cell death. The action of ASA404 is distinct from that of angiogenesis inhibitors, which inhibit the formation of new tumour blood vessels.
In a randomized phase II study, ASA404, in combination with chemotherapy, demonstrated a median overall survival advantage of more than five months in first-line treatment of advanced non-small cell lung cancer (NSCLC) compared with chemotherapy alone. A similar survival advantage was observed in a subsequent extension of the phase II study.
Non-small cell lung cancer, the potential lead indication for ASA404, accounts for about 85 per cent to 90 per cent of all lung cancers. Worldwide, lung cancer is the number one cause of death from cancer each year in both men and women, with 1.2 million new cases per year and 921,000 deaths.
"With the launch of ATTRACT-1, we look forward to exploring the unique mechanism of action of ASA404 in non-small cell lung cancer to potentially help the more than one million people who develop lung cancer each year," said Alessandro Riva, Executive vice president and global head of development of Novartis Oncology.
ASA404 is one of six novel oncology compounds Novartis is developing for potential registration over the next five years. The other investigational therapies which focus on a broad array of cancer targets include RAD001 (renal cell carcinoma and other cancers), SOM230 (Cushing's disease/refractory carcinoid tumours, acromegaly), LBH589 (cutaneous T-cell lymphoma and other cancers), EPO906 (ovarian cancer), and PKC412 (acute myelogenous leukaemia and aggressive systemic mastocytosis).
"Today, our broad and deep pipeline includes both small molecules and monoclonal antibodies that utilize a variety of mechanisms such as vascular-disruption, anti-angiogenesis, and kinase inhibition to treat cancer," said David Epstein, President and CEO of Novartis Oncology. "These exciting potential discoveries have the possibility to change medical treatment for patients suffering with many forms of cancer".
The trial will be a randomized, double-blind, placebo-controlled, multi-centre study of ASA404 in combination with paclitaxel and carboplatin as first-line treatment for locally advanced or metastatic (Stage IIIb/IV) NSCLC of squamous or nonsquamous histology.
ASA404 is a small-molecule tumour-VDA that selectively disrupts existing tumour blood vessels. Solid tumours rely on a network of blood vessels to survive and grow. ASA404 targets existing tumour blood vessels causing death of vessel endothelial cells and the collapse of tumoral blood vessels.
Novartis signed an exclusive licensing agreement with Antisoma plc for the worldwide rights to ASA404 in April 2007.
ASA404 is a Tumour-Vascular Disrupting Agent (Tumour-VDA) that selectively causes the collapse of existing tumour blood supply leading to extensive tumour cell death. The action of ASA404 is distinct from that of angiogenesis inhibitors, which inhibit the formation of new tumour blood vessels.
In a randomized phase II study, ASA404, in combination with chemotherapy, demonstrated a median overall survival advantage of more than five months in first-line treatment of advanced non-small cell lung cancer (NSCLC) compared with chemotherapy alone. A similar survival advantage was observed in a subsequent extension of the phase II study.
Non-small cell lung cancer, the potential lead indication for ASA404, accounts for about 85 per cent to 90 per cent of all lung cancers. Worldwide, lung cancer is the number one cause of death from cancer each year in both men and women, with 1.2 million new cases per year and 921,000 deaths.
"With the launch of ATTRACT-1, we look forward to exploring the unique mechanism of action of ASA404 in non-small cell lung cancer to potentially help the more than one million people who develop lung cancer each year," said Alessandro Riva, Executive vice president and global head of development of Novartis Oncology.
ASA404 is one of six novel oncology compounds Novartis is developing for potential registration over the next five years. The other investigational therapies which focus on a broad array of cancer targets include RAD001 (renal cell carcinoma and other cancers), SOM230 (Cushing's disease/refractory carcinoid tumours, acromegaly), LBH589 (cutaneous T-cell lymphoma and other cancers), EPO906 (ovarian cancer), and PKC412 (acute myelogenous leukaemia and aggressive systemic mastocytosis).
"Today, our broad and deep pipeline includes both small molecules and monoclonal antibodies that utilize a variety of mechanisms such as vascular-disruption, anti-angiogenesis, and kinase inhibition to treat cancer," said David Epstein, President and CEO of Novartis Oncology. "These exciting potential discoveries have the possibility to change medical treatment for patients suffering with many forms of cancer".
The trial will be a randomized, double-blind, placebo-controlled, multi-centre study of ASA404 in combination with paclitaxel and carboplatin as first-line treatment for locally advanced or metastatic (Stage IIIb/IV) NSCLC of squamous or nonsquamous histology.
ASA404 is a small-molecule tumour-VDA that selectively disrupts existing tumour blood vessels. Solid tumours rely on a network of blood vessels to survive and grow. ASA404 targets existing tumour blood vessels causing death of vessel endothelial cells and the collapse of tumoral blood vessels.
Novartis signed an exclusive licensing agreement with Antisoma plc for the worldwide rights to ASA404 in April 2007.
sNDA for Risperdal Consta Submitted to the FDA for the Treatment of Frequently Relapsing Bipolar Disorder
April 14, 2008--Alkermes, Inc. today announced that its partner, Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD), submitted a Supplemental New Drug Application (sNDA) for Risperdal Consta ((risperidone) Long-Acting Injection) to the U.S. Food and Drug Administration (FDA) seeking approval for adjunctive maintenance treatment to delay the occurrence of mood episodes in patients with frequently relapsing bipolar disorder (FRBD).
FRBD is defined as four or more manic or depressive episodes in the previous year that require a doctor's care. The condition may affect 10 to 20 percent of the 27 million people with bipolar disorder worldwide.(1,2)
The sNDA is based on results from a recent study comparing patients who received RISPERDAL CONSTA and standard treatment to those who received standard treatment combined with placebo. The study found that patients with FRBD had a significant delay in the time to an initial relapse when RISPERDAL CONSTA was combined with standard treatment. The study was presented at the 14th Biennial Winter Workshop on Schizophrenia and Bipolar Disorders in Montreux, Switzerland on February 3, 2008.
RISPERDAL CONSTA was approved for the treatment of schizophrenia in the U.S. in 2003. RISPERDAL CONSTA is marketed by Janssen, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., in the U.S. and is manufactured by Alkermes.
FRBD is defined as four or more manic or depressive episodes in the previous year that require a doctor's care. The condition may affect 10 to 20 percent of the 27 million people with bipolar disorder worldwide.(1,2)
The sNDA is based on results from a recent study comparing patients who received RISPERDAL CONSTA and standard treatment to those who received standard treatment combined with placebo. The study found that patients with FRBD had a significant delay in the time to an initial relapse when RISPERDAL CONSTA was combined with standard treatment. The study was presented at the 14th Biennial Winter Workshop on Schizophrenia and Bipolar Disorders in Montreux, Switzerland on February 3, 2008.
RISPERDAL CONSTA was approved for the treatment of schizophrenia in the U.S. in 2003. RISPERDAL CONSTA is marketed by Janssen, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., in the U.S. and is manufactured by Alkermes.
New Powerful Antihypertensive Micardisplus 80/25 (80mg Telmisartan/25mg Hydrochlorothiazide) Approved by EU Commission
14 April 2008 - Boehringer Ingelheim today announced that the European Commission has granted marketing authorisation of the new powerful strength of their fixed dose combination antihypertensive drug MicardisPlus® 80/25 in all 27 EU member states. It will be launched in Germany and Denmark in the coming weeks, followed soon by Ireland, the United Kingdom and the rest of EU, and when approved also in other countries around the world.
The product is licensed for the treatment of essential hypertension in patients whose blood pressure is not adequately controlled on MicardisPlus® 80/12.5 (80 mg telmisartan/12.5 mg hydrochlorothiazide) or patients who have been previously stabilized on telmisartan and hydrochlorothiazide separately at the same dosages. 1,2
The new strength will be marketed by Boehringer Ingelheim in all 27 countries of the European Union under the brand name MicardisPlus® 80/25. It’s co-marketing partners will market the new drug in selected countries under their own brands.
“The approval of MicardisPlus® 80/25 provides physicians with a powerful new drug for patients with difficult to treat essential hypertension“, said Dr Andreas Barner, Member of the Board of Boehringer Ingelheim and responsible for Research, Development and Medicine.
European approval of MicardisPlus® 80/25 follows the submission of efficacy and safety data from 12 clinical trials performed in patients with mild to moderate hypertension. The core clinical development programme consisted of two consecutive trials designed to demonstrate the superiority of the fixed dose combination 80 mg telmisartan/25 mg hydrochlorothiazide (T80/H25) versus 80 mg telmisartan/12.5 mg hydrochlorothiazide (T80/H12.5).2 971 patients, who were inadequately controlled for their blood pressure (BP) on existing antihypertensive treatment, were enrolled in the programme. Treatment with T80/H25 provided superior diastolic and systolic blood pressure lowering power after 8 weeks of treatment1 compared to T80/H12.5. In the consecutive follow up trial 639 patients (633 patients evaluated for efficacy) were treated with the T80/H25 for further 6 months. At the end of this treatment interval the proportion of patients achieving DBP control had increased from 52.4% to 71.4%.2
No clinically meaningful differences in the adverse event profiles of T80/H25 and T80/H12.5 were detected. No specific increased incidence was identified for all adverse events. No additional specific safety issues have been identified1,2. Other studies considered by the EMEA showed clearly superior clinical benefits for a T80/H25-based treatment compared with 160 mg valsartan /25 mg hydrochlorothiazide, the market leading ARB´s high strength combination.
The product is licensed for the treatment of essential hypertension in patients whose blood pressure is not adequately controlled on MicardisPlus® 80/12.5 (80 mg telmisartan/12.5 mg hydrochlorothiazide) or patients who have been previously stabilized on telmisartan and hydrochlorothiazide separately at the same dosages. 1,2
The new strength will be marketed by Boehringer Ingelheim in all 27 countries of the European Union under the brand name MicardisPlus® 80/25. It’s co-marketing partners will market the new drug in selected countries under their own brands.
“The approval of MicardisPlus® 80/25 provides physicians with a powerful new drug for patients with difficult to treat essential hypertension“, said Dr Andreas Barner, Member of the Board of Boehringer Ingelheim and responsible for Research, Development and Medicine.
European approval of MicardisPlus® 80/25 follows the submission of efficacy and safety data from 12 clinical trials performed in patients with mild to moderate hypertension. The core clinical development programme consisted of two consecutive trials designed to demonstrate the superiority of the fixed dose combination 80 mg telmisartan/25 mg hydrochlorothiazide (T80/H25) versus 80 mg telmisartan/12.5 mg hydrochlorothiazide (T80/H12.5).2 971 patients, who were inadequately controlled for their blood pressure (BP) on existing antihypertensive treatment, were enrolled in the programme. Treatment with T80/H25 provided superior diastolic and systolic blood pressure lowering power after 8 weeks of treatment1 compared to T80/H12.5. In the consecutive follow up trial 639 patients (633 patients evaluated for efficacy) were treated with the T80/H25 for further 6 months. At the end of this treatment interval the proportion of patients achieving DBP control had increased from 52.4% to 71.4%.2
No clinically meaningful differences in the adverse event profiles of T80/H25 and T80/H12.5 were detected. No specific increased incidence was identified for all adverse events. No additional specific safety issues have been identified1,2. Other studies considered by the EMEA showed clearly superior clinical benefits for a T80/H25-based treatment compared with 160 mg valsartan /25 mg hydrochlorothiazide, the market leading ARB´s high strength combination.
Advagraf (extended release tacrolimus) Is Now Available in Canada For Kidney Transplant Patients
April 14, 2008- Advagraf(TM) (tacrolimus extended release capsules), marketed by Astellas Pharma Canada, Inc., has been approved by Health Canada for the prevention of organ rejection in patients receiving an allogeneic kidney transplant.(1) Patients who have received a kidney transplant now have access to a new once-a-day immunosuppressant therapy.
"Kidney transplantation is a life-altering experience which places a great deal of responsibility on a patient to take multiple medications at different times of the day to avoid compromising the kidney transplant," says Dr. Sita Gourishankar, a nephrologist in the University of Alberta's Department of Nephrology. "A once-daily anti-rejection therapy will be of considerable benefit and will help simplify the drug regimen required by post-transplant patients."
Extended release tacrolimus is a new formulation of Prograf(R), (tacrolimus twice daily), a leading immunosuppressant agent developed and marketed by Astellas.(2) Tacrolimus twice daily has been available in Canada since 1997. Both extended release tacrolimus and tacrolimus twice daily, which is indicated for prevention of kidney, liver and heart transplant rejection, are indicated for use concomitantly with corticosteroids and mycophenolate mofetil (MMF).(3)
"Because this is a once-a-day therapy, Advagraf helps streamline the number of medications patients need to take. This is an important step forward to improve long-term adherence to immunosuppressant therapy," says Barbara Reynolds, Director of New Product Development at Astellas Pharma Canada, Inc. "Astellas is very pleased to be able to offer the Canadian transplant community a new therapeutic option that not only helps prevent organ rejection, but that is more convenient for patients."
"Kidney transplantation is a life-altering experience which places a great deal of responsibility on a patient to take multiple medications at different times of the day to avoid compromising the kidney transplant," says Dr. Sita Gourishankar, a nephrologist in the University of Alberta's Department of Nephrology. "A once-daily anti-rejection therapy will be of considerable benefit and will help simplify the drug regimen required by post-transplant patients."
Extended release tacrolimus is a new formulation of Prograf(R), (tacrolimus twice daily), a leading immunosuppressant agent developed and marketed by Astellas.(2) Tacrolimus twice daily has been available in Canada since 1997. Both extended release tacrolimus and tacrolimus twice daily, which is indicated for prevention of kidney, liver and heart transplant rejection, are indicated for use concomitantly with corticosteroids and mycophenolate mofetil (MMF).(3)
"Because this is a once-a-day therapy, Advagraf helps streamline the number of medications patients need to take. This is an important step forward to improve long-term adherence to immunosuppressant therapy," says Barbara Reynolds, Director of New Product Development at Astellas Pharma Canada, Inc. "Astellas is very pleased to be able to offer the Canadian transplant community a new therapeutic option that not only helps prevent organ rejection, but that is more convenient for patients."
Jazz Pharmaceuticals' Luvox CR Is Now Available for Patients With Social Anxiety Disorder (SAD) and Obsessive Compulsive Disorder (OCD)
Jazz Pharmaceuticals, Inc. announced today that Once-A-Day Luvox(R) CR (fluvoxamine maleate) Extended-Release Capsules is now available at pharmacies throughout the United States. LUVOX CR was recently approved by the U.S. Food and Drug Administration (FDA) for the treatment of social anxiety disorder (SAD) and obsessive compulsive disorder (OCD) in adult patients. SAD and OCD are two difficult-to-treat, underdiagnosed and undertreated anxiety disorders.
Jazz Pharmaceuticals is dedicated to helping patients suffering from serious psychiatric and neurological disorders. Jazz Pharmaceuticals is supporting a number of programs and resources for SAD and OCD patients and for physicians. These efforts include education kits, disease education Web sites and diagnostic screening tools. The company is also introducing CT STEPS(TM), a novel, Internet-based cognitive behavioral therapy (CBT) program to help OCD patients.
Earlier this month, Jazz Pharmaceuticals' sales team began communicating with office-based psychiatrists and select primary care physicians about the unique attributes of LUVOX CR. These sales professionals will provide samples of LUVOX CR in 100 mg and 150 mg dose strengths that physicians may choose to distribute to their patients.
LUVOX CR incorporates Elan's proprietary SODAS(R) (Spheroidal Oral Drug Absorption System) technology, which is designed to minimize peak-to-trough fluctuations in plasma levels over a 24-hour period. In three Phase III trials, LUVOX CR was shown to provide tolerability in two common areas of concern to patients(1,2). In the trials, LUVOX CR demonstrated a weight-neutral profile with no significant weight gain or loss(3,4,5,6). In addition, patients taking LUVOX CR had a low incidence of sexual adverse events in the trials(4). Less than 1 percent of patients treated with LUVOX CR discontinued therapy due to any individual sexual adverse event(3-6).
"We are very excited about the introduction of LUVOX CR to the United States market. The availability of LUVOX CR provides physicians with a new and effective treatment option for the millions of adults in the United States suffering from SAD and OCD," said Samuel Saks, M.D., chief executive officer of Jazz Pharmaceuticals. "Through our educational efforts, we hope to provide physicians and their patients with important information about SAD and OCD. As part of our commitment to helping patients, their families and caregivers, we are working with advocacy organizations to increase awareness about these serious and underdiagnosed conditions."
Jazz Pharmaceuticals is dedicated to helping patients suffering from serious psychiatric and neurological disorders. Jazz Pharmaceuticals is supporting a number of programs and resources for SAD and OCD patients and for physicians. These efforts include education kits, disease education Web sites and diagnostic screening tools. The company is also introducing CT STEPS(TM), a novel, Internet-based cognitive behavioral therapy (CBT) program to help OCD patients.
Earlier this month, Jazz Pharmaceuticals' sales team began communicating with office-based psychiatrists and select primary care physicians about the unique attributes of LUVOX CR. These sales professionals will provide samples of LUVOX CR in 100 mg and 150 mg dose strengths that physicians may choose to distribute to their patients.
LUVOX CR incorporates Elan's proprietary SODAS(R) (Spheroidal Oral Drug Absorption System) technology, which is designed to minimize peak-to-trough fluctuations in plasma levels over a 24-hour period. In three Phase III trials, LUVOX CR was shown to provide tolerability in two common areas of concern to patients(1,2). In the trials, LUVOX CR demonstrated a weight-neutral profile with no significant weight gain or loss(3,4,5,6). In addition, patients taking LUVOX CR had a low incidence of sexual adverse events in the trials(4). Less than 1 percent of patients treated with LUVOX CR discontinued therapy due to any individual sexual adverse event(3-6).
"We are very excited about the introduction of LUVOX CR to the United States market. The availability of LUVOX CR provides physicians with a new and effective treatment option for the millions of adults in the United States suffering from SAD and OCD," said Samuel Saks, M.D., chief executive officer of Jazz Pharmaceuticals. "Through our educational efforts, we hope to provide physicians and their patients with important information about SAD and OCD. As part of our commitment to helping patients, their families and caregivers, we are working with advocacy organizations to increase awareness about these serious and underdiagnosed conditions."
Patents Issued
April 14, 2008 - Pharmalink AB, a specialty pharma company, announces today that the U.S. Patent and Trademark Office has approved U.S. Patent No. 7,351,427, relating to the pharmaceutical composition, method of preparation and method of treatment by use of busulfan, which is the active agent in Pharmalink's Busulipo(tm). Busulfan is a well-established chemotherapy agent used for myeloablation (severe suppression of bone marrow activity) as a preconditioning regimen to bone marrow stem cell transplantation, for example, in the treatment of leukaemia. The patent application was filed in the U.S. in 2003 and will expire in 2020 (term adjusted).
April 14, 2008- Starpharma Holdings Ltd has filed a patent application for the use of SPL7013, the active ingredient in VivaGel, to inhibit hyaluronidase activity in the treatment or prevention of a number of diseases.
April 14, 2008 /PRNewswire-FirstCall/ -- Progen Pharmaceuticals Limited announced today that it had presented new data on its patented PG500 series of compounds at the annual American Association for Cancer Research (AACR) meeting being held in San Diego. The meeting brings together approximately 17,000 participants from around the world to discuss new and significant advances in the knowledge surrounding the causes, diagnosis, treatment and prevention of cancer.
Genta Incorporated today announced that the Company has received notice that its patent application covering novel pharmaceutical gallium compositions and complexes has been allowed by the U.S. Patent Office.
April 14, 2008- Starpharma Holdings Ltd has filed a patent application for the use of SPL7013, the active ingredient in VivaGel, to inhibit hyaluronidase activity in the treatment or prevention of a number of diseases.
April 14, 2008 /PRNewswire-FirstCall/ -- Progen Pharmaceuticals Limited announced today that it had presented new data on its patented PG500 series of compounds at the annual American Association for Cancer Research (AACR) meeting being held in San Diego. The meeting brings together approximately 17,000 participants from around the world to discuss new and significant advances in the knowledge surrounding the causes, diagnosis, treatment and prevention of cancer.
Genta Incorporated today announced that the Company has received notice that its patent application covering novel pharmaceutical gallium compositions and complexes has been allowed by the U.S. Patent Office.
Teva Announces Brussels Court Decision To Revoke MSD's European Patent On Fosamax
April 11, 2008 - Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that on April 8, 2008, the Court of First Instance in Brussels, Belgium, decided to revoke the Belgium part of Merck Sharp & Dohme's ("MSD") European Patent No. 1,175,904, due to lack of inventive step. This patent relates to Fosamax® Once Weekly (Alendronate 70mg Once Weekly). This favorable decision follows a similar judgment rendered by the Hague District Court in the Netherlands regarding the same patent two months ago.
The decision may be appealed.
Teva's Alendronate products are subject to multiple European litigations between MSD, Teva and other parties, relating to both Alendronate 10mg and Alendronate 70mg. This patent is currently being litigated by Teva in France, Italy, Sweden and Spain as well as in the European Patent Office.
Teva is already marketing Alendronate 10mg and 70mg in various European countries and may market Alendronate 70 mg in Belgium starting April 15, 2008.
The decision may be appealed.
Teva's Alendronate products are subject to multiple European litigations between MSD, Teva and other parties, relating to both Alendronate 10mg and Alendronate 70mg. This patent is currently being litigated by Teva in France, Italy, Sweden and Spain as well as in the European Patent Office.
Teva is already marketing Alendronate 10mg and 70mg in various European countries and may market Alendronate 70 mg in Belgium starting April 15, 2008.
Sunday, April 13, 2008
Lundbeck Wins Appellate Ruling On Cipralex Patent
A British appellate court has overturned a ruling that found claims in H. Lundbeck A/S’ patent for its antidepressant drug Cipralex insufficient, scoring a win for the Danish pharmaceutical company in an ongoing patent challenge brought by three generics makers.
The details of the case can be read here.
The details of the case can be read here.
Nektar terminates negotiations for Inhaled Insulin after adverse reports
As a latest setback to the already faltering industry efforts to develop inhalable insulin, Nektar Therapeutics said it has ceased all negotiations with potential partners for its inhaled insulin programmes as a result of new data analysis from ongoing clinical trials conducted by Pfizer Inc. Nektar would also cease all spending associated with its inhaled insulin programmes and would not incur any additional charges related to this event.
An increase in the number of new cases of lung cancer was observed in inhaled insulin patients as compared to the control group, according to a Pfizer report. All new incidences of lung cancer were in patients that are former smokers.
"The concern over this new data analysis from ongoing clinical trials has resulted in the termination of all negotiations with potential partners," said, Howard W. Robin, president and CEO, Nektar. "Fortunately, over the past year Nektar has significantly transformed its business, moving away from inhaled insulin. We have made great progress expanding our research efforts and have built a deep pipeline of novel partnered and proprietary drugs in various stages of development."
The Exubera label was updated by Pfizer to include the new warnings. In clinical trials of Exubera, there have been 6 newly diagnosed cases of primary lung malignancies among Exubera-treated patients, and 1 newly diagnosed case among comparator treated patients. There has also been 1 post-marketing report of a primary lung malignancy in an Exubera-treated patient. In controlled clinical trials of Exubera, the incidence of new primary lung cancer per 100 patient-years of study drug exposure was 0.13 (5 cases over 3900 patient-years) for Exubera-treated patients and 0.02 (1 case over 4100 patient-years) for comparator-treated patients. There were too few cases to determine whether the emergence of these events is related to Exubera. All patients who were diagnosed with lung cancer had a prior history of cigarette smoking, according to a press release issued by Nektar.
An increase in the number of new cases of lung cancer was observed in inhaled insulin patients as compared to the control group, according to a Pfizer report. All new incidences of lung cancer were in patients that are former smokers.
"The concern over this new data analysis from ongoing clinical trials has resulted in the termination of all negotiations with potential partners," said, Howard W. Robin, president and CEO, Nektar. "Fortunately, over the past year Nektar has significantly transformed its business, moving away from inhaled insulin. We have made great progress expanding our research efforts and have built a deep pipeline of novel partnered and proprietary drugs in various stages of development."
The Exubera label was updated by Pfizer to include the new warnings. In clinical trials of Exubera, there have been 6 newly diagnosed cases of primary lung malignancies among Exubera-treated patients, and 1 newly diagnosed case among comparator treated patients. There has also been 1 post-marketing report of a primary lung malignancy in an Exubera-treated patient. In controlled clinical trials of Exubera, the incidence of new primary lung cancer per 100 patient-years of study drug exposure was 0.13 (5 cases over 3900 patient-years) for Exubera-treated patients and 0.02 (1 case over 4100 patient-years) for comparator-treated patients. There were too few cases to determine whether the emergence of these events is related to Exubera. All patients who were diagnosed with lung cancer had a prior history of cigarette smoking, according to a press release issued by Nektar.
La Roche moves Delhi HC against Cipla
Swiss pharma major Roche has filed an appeal before the Delhi High Court challenging the order of the single bench that refused to restrain Cipla from manufacturing and selling anti-cancer drug Tarceva, alleged to be a copy of La Roche's patent.
The Swiss pharma company, through its counsel Abhishek Manu Singhvi, raised the matter before a bench comprising Justice Manmohan Sarin and Justice Manmohan and asked for an urgent hearing of the case. But the court posted it for hearing on April 22.
Earlier on March 19, Cipla had won the first round of the battle to continue marketing of the disputed anti-cancer drug Tarceva (Erlotinib) in the country after the Delhi High Court rejected an injunction plea by Swiss drug major Roche who holds the Indian patent right to the drug.
Roche received patent for Tarceva in India last year, but has been subsequently facing post-grant patent opposition from Cipla and NGOs. Two months ago, Cipla decided to market copycat versions of the drug. On January 19 this year, Roche Scientific filed infringement lawsuit in the Delhi HC. This is the first test case after the new patent regime came into force in 2005.
Contending that the interim order should be quashed, Singhvi said the single bench allowed the infringement of its patent rights stating that it was in public interest. He contended that there was no correlation between patent law and public interest as patent is an absolute monopoly.
The Swiss pharma company, through its counsel Abhishek Manu Singhvi, raised the matter before a bench comprising Justice Manmohan Sarin and Justice Manmohan and asked for an urgent hearing of the case. But the court posted it for hearing on April 22.
Earlier on March 19, Cipla had won the first round of the battle to continue marketing of the disputed anti-cancer drug Tarceva (Erlotinib) in the country after the Delhi High Court rejected an injunction plea by Swiss drug major Roche who holds the Indian patent right to the drug.
Roche received patent for Tarceva in India last year, but has been subsequently facing post-grant patent opposition from Cipla and NGOs. Two months ago, Cipla decided to market copycat versions of the drug. On January 19 this year, Roche Scientific filed infringement lawsuit in the Delhi HC. This is the first test case after the new patent regime came into force in 2005.
Contending that the interim order should be quashed, Singhvi said the single bench allowed the infringement of its patent rights stating that it was in public interest. He contended that there was no correlation between patent law and public interest as patent is an absolute monopoly.
Takeda to acquire Millennium Pharmaceuticals for $8.8 bn
Takeda Pharmaceutical Company Limited and Millennium Pharmaceuticals, Inc. have entered into a definitive agreement pursuant to which Takeda will acquire Millennium for approximately $8.8 billion through a cash tender offer of $25.00 per share. The transaction was unanimously approved by the boards of directors of both companies.
Upon completion of the acquisition, Millennium will become a wholly-owned subsidiary of Takeda, and will continue operations in Cambridge, Massachusetts, as a standalone business unit. Millennium will be known as Millennium Pharmaceuticals, Inc., a Takeda Company.
Millennium is a leading biopharma company. In the US, markets Velcade (bortezomib) for injection - a novel, market-leading oncology product approved in more than 85 countries. Millennium has an innovation-driven discovery and development organisation, which is advancing a pipeline of novel product candidates in oncology and inflammation. This includes a potential therapy for inflammatory bowel disease (IBD), which is expected to enter phase III clinical trials in late 2008/early 2009. Millennium reported total revenues of approximately $528 million for 2007.
The acquisition of Millennium accelerates Takeda's vision of becoming a global leader in oncology with critical mass in the areas of oncology discovery, development, regulatory affairs and commercialisation. Millennium and Takeda have complementary research, development and commercialisation capabilities, which have the potential to create a powerful new drug development engine and accelerate the potential of an emerging drug pipeline.
"Millennium greatly strengthens Takeda's global oncology portfolio, led by the flagship product Velcade, and further enhances its pipeline with clinically differentiated, high-quality product candidates," said Yasuchika Hasegawa, president, Takeda Pharmaceutical Company Limited. "Takeda is committed to becoming a global leader in oncology by delivering novel therapies that improve the standards of care for patients. Millennium has strong discovery, development and commercial capabilities led by a well-established management team. We are pleased that Dr. Deborah Dunsire, president and chief executive officer, Millennium, and the current management team intend to continue to lead the company. Our strong desire is to retain Millennium employees, who have created an entrepreneurial and innovative culture."
Takeda said it expects that the acquisition of Millennium would provide access to a fully-integrated oncology discovery, development and commercial platform with a seasoned management team and talented employee base, add Velcade, a growing and market-leading oncology product with near-term worldwide blockbuster potential and supply access to Millennium world-class drug discovery organisation, including expertise in the novel research area of protein homeostasis. Takeda also said that capitalize on Millennium proven drug development capabilities and regulatory expertise, which allowed the company to bring Velcade to market rapidly, leverage the Millennium experienced sales force, established relationships with oncology thought leaders and highly-regarded marketing capabilities to launch future products; and expand Takeda's global pipeline in GI, adding a novel anti-a4ß7 antibody and an oral CCR9 inhibitor for the treatment of IBD.
Takeda will finance the acquisition through cash on hand. There is no financing condition to the tender offer or second step merger, the company informed in a press statement.
The acquisition is structured as an all cash tender offer for all of the outstanding shares of Millennium common stock, followed by a merger in which remaining shares of Millennium would be converted into the right to receive the same US$25.00 cash per share price paid in the tender offer.
The transaction has been unanimously approved by the Boards of Directors of Millennium and Takeda. The transaction is subject to the tender of a majority of Millennium common stock on a fully diluted basis as well as other customary closing conditions, including expiration of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 and the antitrust laws of applicable foreign jurisdictions. The transaction is expected to close in the second-quarter of 2008.
Upon completion of the acquisition, Millennium will become a wholly-owned subsidiary of Takeda, and will continue operations in Cambridge, Massachusetts, as a standalone business unit. Millennium will be known as Millennium Pharmaceuticals, Inc., a Takeda Company.
Millennium is a leading biopharma company. In the US, markets Velcade (bortezomib) for injection - a novel, market-leading oncology product approved in more than 85 countries. Millennium has an innovation-driven discovery and development organisation, which is advancing a pipeline of novel product candidates in oncology and inflammation. This includes a potential therapy for inflammatory bowel disease (IBD), which is expected to enter phase III clinical trials in late 2008/early 2009. Millennium reported total revenues of approximately $528 million for 2007.
The acquisition of Millennium accelerates Takeda's vision of becoming a global leader in oncology with critical mass in the areas of oncology discovery, development, regulatory affairs and commercialisation. Millennium and Takeda have complementary research, development and commercialisation capabilities, which have the potential to create a powerful new drug development engine and accelerate the potential of an emerging drug pipeline.
"Millennium greatly strengthens Takeda's global oncology portfolio, led by the flagship product Velcade, and further enhances its pipeline with clinically differentiated, high-quality product candidates," said Yasuchika Hasegawa, president, Takeda Pharmaceutical Company Limited. "Takeda is committed to becoming a global leader in oncology by delivering novel therapies that improve the standards of care for patients. Millennium has strong discovery, development and commercial capabilities led by a well-established management team. We are pleased that Dr. Deborah Dunsire, president and chief executive officer, Millennium, and the current management team intend to continue to lead the company. Our strong desire is to retain Millennium employees, who have created an entrepreneurial and innovative culture."
Takeda said it expects that the acquisition of Millennium would provide access to a fully-integrated oncology discovery, development and commercial platform with a seasoned management team and talented employee base, add Velcade, a growing and market-leading oncology product with near-term worldwide blockbuster potential and supply access to Millennium world-class drug discovery organisation, including expertise in the novel research area of protein homeostasis. Takeda also said that capitalize on Millennium proven drug development capabilities and regulatory expertise, which allowed the company to bring Velcade to market rapidly, leverage the Millennium experienced sales force, established relationships with oncology thought leaders and highly-regarded marketing capabilities to launch future products; and expand Takeda's global pipeline in GI, adding a novel anti-a4ß7 antibody and an oral CCR9 inhibitor for the treatment of IBD.
Takeda will finance the acquisition through cash on hand. There is no financing condition to the tender offer or second step merger, the company informed in a press statement.
The acquisition is structured as an all cash tender offer for all of the outstanding shares of Millennium common stock, followed by a merger in which remaining shares of Millennium would be converted into the right to receive the same US$25.00 cash per share price paid in the tender offer.
The transaction has been unanimously approved by the Boards of Directors of Millennium and Takeda. The transaction is subject to the tender of a majority of Millennium common stock on a fully diluted basis as well as other customary closing conditions, including expiration of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 and the antitrust laws of applicable foreign jurisdictions. The transaction is expected to close in the second-quarter of 2008.
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