Apr 3, 2008 - Taro Pharmaceutical Industries Ltd. reported today that it has received tentative approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for Lamotrigine Tablets 25 mg, 100 mg, 150 mg, and 200 mg.
Lamotrigine is a prescription product used for the treatment of seizures and is bioequivalent to GlaxoSmithKline's Lamictal(R) Tablets. According to industry sources, Lamictal(R) Tablets had annual U.S. sales of approximately $2.6 billion.
The tentative ANDA approval for Taro's Lamotrigine Tablets is an FDA determination that Taro's ANDA submission for this product currently satisfies the substantive requirements for approval, subject to the expiration of all relevant patents or statutorily imposed exclusivities and restrictions (currently expected to occur during January 2009), or any new information that may come to the FDA's attention. Tentative approvals do not grant marketing rights; a company may only market a product upon receiving final approval for an ANDA submission.
Taro Pharmaceutical Industries Ltd. is a multinational, science-based pharmaceutical company, dedicated to meeting the needs of its customers through the discovery, development, manufacturing and marketing of the highest quality healthcare products.
Thursday, April 3, 2008
Wednesday, April 2, 2008
Eli Lilly begins phase 3 trial of 'LY450139' for Alzheimer's disease
Eli Lilly and Company has started a phase III clinical trial studying LY450139, an investigational gamma secretase inhibitor for the treatment of mild to moderate Alzheimer's disease. LY450139 is being tested to see if it can slow the progression associated with Alzheimer's disease by inhibiting gamma-secretase, an enzyme that can create a sticky protein called amyloid beta. Current Alzheimer's disease theory is that subtypes of amyloid beta clump together into plaques that eventually kill off brain cells. By blocking gamma secretase, there is less amyloid beta formed, potentially slowing brain-cell death.
Slowing the rate of disease progression could preserve independent functioning and quality of life for Alzheimer's patients in the milder stages of the disease, potentially delaying the onset of the severe stages of the disease. Currently available treatments for Alzheimer's disease have no documented effect on amyloid beta. They provide modest improvements in symptoms but do not slow the underlying disease process.
IDENTITY (Interrupting Alzheimer's Dementia by EvaluatiNg Treatment of AmyloId PaThologY) is a randomised, double-blind, placebo-controlled trial that would be conducted in the US and 21 additional countries. As part of IDENTITY, 1,500 patients will be studied for 21 months, and an open-label extension will be available to all participants completing the study. Patients who are taking currently available symptomatic treatments for Alzheimer's disease can continue treatment during their participation in IDENTITY. Because the IDENTITY study also incorporates a "randomised delayed start" design, even those subjects initially assigned to the placebo arm of the study will be started on active LY450139 treatment sometime before the end of the 21-month study period. Both the subjects and investigators will be blinded to the exact timing of this delayed start of study drug administration.
"Alzheimer's is a devastating disease that destroys brain cells, affecting everything from a patient's memory to their work and social life. Currently available medications treat the symptoms of Alzheimer's disease but have not been shown to change its underlying progression, creating an urgent unmet medical need. Today, we are proud to announce the start of the IDENTITY clinical trial and hold hope that LY450139 will represent an advance in the attempt to slow the progression of this fatal disease. We encourage patients or their caregivers to review the enrollment criteria for IDENTITY to see if they are eligible to participate," said Eric Siemers M.D., medical director, Alzheimer's disease research, Eli Lilly and Company.
Alzheimer's disease is a progressive neurodegenerative condition that is the most common cause of dementia in patients over 65 years of age. Estimates show that 6-8 per cent of people over age 65 are affected by Alzheimer's disease, totalling approximately 5 million people in the United States alone. Every 72 seconds, an American is developing Alzheimer's disease, and it is the seventh-leading cause of death in the United States. The direct and indirect health care costs associated with Alzheimer's disease in the US are estimated to be about $150 billion. In 2005, the total cost worldwide was estimated at $315.4 billion.
To more completely characterise the disease-modifying effects of LY450139, a number of optional biomarker sub-studies will be available to patients. These optional sub-studies will utilize new brain-scanning techniques to determine the amount of amyloid beta plaque in the brain, employ other, more established scanning techniques to examine brain structure and function, and evaluate a number of additional biochemical measures of Alzheimer's disease. By determining the effect of LY450139 on these objective biomarkers, a more complete understanding of the effect of LY450139 on underlying Alzheimer's disease pathology is possible.
LY450139 inhibits gamma secretase, an enzyme that cuts a protein, creating a shorter, sticky protein called amyloid beta. Alzheimer's disease theory suggests that some subtypes of amyloid beta clump together into plaques that eventually kill off brain cells. Clinical studies have examined the effect of LY450139 on amyloid beta in blood and cerebrospinal fluid. The most frequently occurring side effects experienced in earlier clinical studies with LY450139 include diarrhoea, upset stomach, and fatigue.
Slowing the rate of disease progression could preserve independent functioning and quality of life for Alzheimer's patients in the milder stages of the disease, potentially delaying the onset of the severe stages of the disease. Currently available treatments for Alzheimer's disease have no documented effect on amyloid beta. They provide modest improvements in symptoms but do not slow the underlying disease process.
IDENTITY (Interrupting Alzheimer's Dementia by EvaluatiNg Treatment of AmyloId PaThologY) is a randomised, double-blind, placebo-controlled trial that would be conducted in the US and 21 additional countries. As part of IDENTITY, 1,500 patients will be studied for 21 months, and an open-label extension will be available to all participants completing the study. Patients who are taking currently available symptomatic treatments for Alzheimer's disease can continue treatment during their participation in IDENTITY. Because the IDENTITY study also incorporates a "randomised delayed start" design, even those subjects initially assigned to the placebo arm of the study will be started on active LY450139 treatment sometime before the end of the 21-month study period. Both the subjects and investigators will be blinded to the exact timing of this delayed start of study drug administration.
"Alzheimer's is a devastating disease that destroys brain cells, affecting everything from a patient's memory to their work and social life. Currently available medications treat the symptoms of Alzheimer's disease but have not been shown to change its underlying progression, creating an urgent unmet medical need. Today, we are proud to announce the start of the IDENTITY clinical trial and hold hope that LY450139 will represent an advance in the attempt to slow the progression of this fatal disease. We encourage patients or their caregivers to review the enrollment criteria for IDENTITY to see if they are eligible to participate," said Eric Siemers M.D., medical director, Alzheimer's disease research, Eli Lilly and Company.
Alzheimer's disease is a progressive neurodegenerative condition that is the most common cause of dementia in patients over 65 years of age. Estimates show that 6-8 per cent of people over age 65 are affected by Alzheimer's disease, totalling approximately 5 million people in the United States alone. Every 72 seconds, an American is developing Alzheimer's disease, and it is the seventh-leading cause of death in the United States. The direct and indirect health care costs associated with Alzheimer's disease in the US are estimated to be about $150 billion. In 2005, the total cost worldwide was estimated at $315.4 billion.
To more completely characterise the disease-modifying effects of LY450139, a number of optional biomarker sub-studies will be available to patients. These optional sub-studies will utilize new brain-scanning techniques to determine the amount of amyloid beta plaque in the brain, employ other, more established scanning techniques to examine brain structure and function, and evaluate a number of additional biochemical measures of Alzheimer's disease. By determining the effect of LY450139 on these objective biomarkers, a more complete understanding of the effect of LY450139 on underlying Alzheimer's disease pathology is possible.
LY450139 inhibits gamma secretase, an enzyme that cuts a protein, creating a shorter, sticky protein called amyloid beta. Alzheimer's disease theory suggests that some subtypes of amyloid beta clump together into plaques that eventually kill off brain cells. Clinical studies have examined the effect of LY450139 on amyloid beta in blood and cerebrospinal fluid. The most frequently occurring side effects experienced in earlier clinical studies with LY450139 include diarrhoea, upset stomach, and fatigue.
European Regulatory Agency Accepts Cell Therapeutics, Inc.'s Marketing Authorization Application for Xyotax for Lung Cancer for Review
Cell Therapeutics, Inc. (CTI) today announced that the European Medicines Agency (EMEA) has accepted for review CTI's Marketing Authorization Application (MAA) for XYOTAX(TM) (paclitaxel poliglumex, CT-2103) for first-line treatment of patients with non-small cell lung cancer (NSCLC) with ECOG (Eastern Cooperative Oncology Group) performance status 2 (PS2). CTI submitted the MAA at the beginning of March. The validation of the MAA for XYOTAX initiates the marketing approval review process, which generally takes 15 to 18 months. The application is based on advice from the Scientific Advice Working Party, or SAWP, at the EMEA. The EMEA agreed that switching the primary endpoint from superiority to non-inferiority is feasible if the retrospective justification provided in the marketing application is adequate. The discussions with the SAWP focused on using the STELLAR 4 study as primary evidence of non-inferiority and the STELLAR 3 study as supportive of the MAA.
In the STELLAR 4 trial, single-agent XYOTAX resulted in comparable survival to gemcitabine or vinorelbine in first-line patients and, with the exception of neuropathy known to be associated with taxane therapy, demonstrated significant reduction in several clinically meaningful toxicities, such as severe neutropenia and infection, and in the requirement for transfusions and use of hematopoietic growth factor support. In addition to improved tolerability, XYOTAX offered more convenient administration compared to currently used treatments and a reduction in overall utilization of medical resources compared to gemcitabine or vinorelbine.
"CTI looks forward to working with the EMEA as it begins the review process for XYOTAX," said James A. Bianco, M.D., President and CEO of CTI. "This is an important step toward making XYOTAX available for lung cancer patients in Europe."
In the STELLAR 4 trial, single-agent XYOTAX resulted in comparable survival to gemcitabine or vinorelbine in first-line patients and, with the exception of neuropathy known to be associated with taxane therapy, demonstrated significant reduction in several clinically meaningful toxicities, such as severe neutropenia and infection, and in the requirement for transfusions and use of hematopoietic growth factor support. In addition to improved tolerability, XYOTAX offered more convenient administration compared to currently used treatments and a reduction in overall utilization of medical resources compared to gemcitabine or vinorelbine.
"CTI looks forward to working with the EMEA as it begins the review process for XYOTAX," said James A. Bianco, M.D., President and CEO of CTI. "This is an important step toward making XYOTAX available for lung cancer patients in Europe."
Tuesday, April 1, 2008
US federal court sides with GSK, strikes down USPTO rules
Dear All,
We have been tracking this case from long time and finally the decision is here http://pdfserver.amlaw.com/dc/USPTO.pdf
IP lawyers rejoiced Tuesday as a federal judge rejected new rules for streamlining the patent process that had applicants apoplectic.
Eastern Virginia U.S. District Judge James Cacheris voided the rules because, he wrote, the U.S. Patent and Trademark Office doesn't have the authority to make the changes.
"There's a lot of good cheer going around," said Hans Troesch, a veteran patent prosecutor with Fish & Richardson in Redwood City, Calif. "It's a great relief to the practitioners."
The patent office was seeking to unclog the backlog of patent applications by reducing the number of claims, listed in each one to help define a patent, and the number of continuations, which are used to amend patent claims and contest those that are rejected. Claims would have been limited to 25, and continuations to just three. Currently, there are no limits.
But patent lawyers criticized the new rules for unfairly limiting complex patents and for retroactively affecting pending applications.
The rules were scheduled to go into effect on Nov. 1, 2007, but Triantafyllos Tafas, founder of medical technology company Ikonisys, and drug maker GlaxoSmithKline filed lawsuits last fall against the PTO and its director, Jon Dudas, to block them. Cacheris granted a preliminary injunction on Oct. 31, and GlaxoSmithKline and Tafas filed for summary judgment on Dec. 20.
In granting summary judgment Tuesday, Cacheris wrote that the patent office can't make "substantive" changes to the rules, only "procedural" ones.
"[B]ecause the Final Rules are substantive in nature, the court finds that the Final Rules are void as 'otherwise not in accordance with law' and 'in excess of statutory jurisdiction [and] authority,'" Cacheris wrote, citing 5 U.S.C. §706(2).
The patent office, which had argued that the changes were only procedural, said in a prepared statement that it did not agree with the court and is considering an appeal.
"We are disappointed with this court's decision, which rejects our view that the USPTO has the authority to implement the proposed rules about claims and continuations," the statement reads. "The USPTO believes that these rules are consistent with existing statutes and will strengthen the U.S. patent system for all stakeholders."
US court reverses ruling for Forest in Caraco suit
A federal appeals court reversed on Tuesday a ruling favoring Forest Laboratories Inc. in a patent dispute with generic drugmaker Caraco Pharmaceutical Laboratories over the blockbuster antidepressant drug Lexapro.
The U.S. Court of Appeals for the Federal Circuit reversed and remanded the case back to the U.S. District Court for the Eastern District of Michigan, which had dismissed Caraco's request for a declaratory judgment of noninfringement for US6916941.
The appeals court said there was no record the lower court considered two cases establishing the legal precedents to be taken into account in such a patent dispute.
In September, the same appeals court upheld the validity of a Lexapro patent and affirmed a decision by a federal court in Delaware that blocked generic forms Lexapro made by Teva Pharmaceutical TEVA.O and Cipla Ltd.
Lexapro's first patent is expected to expire in 2012.
Forest had Lexapro sales of about $2.5 billion in the 12-month period ending Sept. 30, according to the research firm IMS Health.
The opinion issued Tuesday can be found at:
http://www.cafc.uscourts.gov/opinions/07-1404.pdf
The U.S. Court of Appeals for the Federal Circuit reversed and remanded the case back to the U.S. District Court for the Eastern District of Michigan, which had dismissed Caraco's request for a declaratory judgment of noninfringement for US6916941.
The appeals court said there was no record the lower court considered two cases establishing the legal precedents to be taken into account in such a patent dispute.
In September, the same appeals court upheld the validity of a Lexapro patent and affirmed a decision by a federal court in Delaware that blocked generic forms Lexapro made by Teva Pharmaceutical TEVA.O and Cipla Ltd.
Lexapro's first patent is expected to expire in 2012.
Forest had Lexapro sales of about $2.5 billion in the 12-month period ending Sept. 30, according to the research firm IMS Health.
The opinion issued Tuesday can be found at:
http://www.cafc.uscourts.gov/opinions/07-1404.pdf
Labopharm Appeals FDA's Decision on Once-Daily Tramadol to Next Supervisory Level After Additional Analysis Supports Efficacy
Labopharm Inc. today announced that it has appealed the U.S. Food and Drug Administration's (FDA) decision on its once-daily tramadol formulation to the next supervisory level under the FDA's Formal Dispute Resolution process. Labopharm's continuation of the appeal process follows the completion of additional statistical analysis of existing data per the suggestion of Dr. John K. Jenkins, M.D., the FDA's Director for the Office of New Drugs, Center for Drug Evaluation and Research, as a means to potentially satisfy the FDA's requirements for regulatory approval. The Company believes that the additional analysis confirms the conclusions of efficacy of its once-daily tramadol formulation as demonstrated in previous analyses that were included in its New Drug Application (NDA) and additional submissions thereafter.
"We have maintained the position that our strong body of data warrants the approval of our once-daily tramadol formulation and believe that the additional analysis we conducted as proposed by the FDA confirms our position," said James R. Howard-Tripp, President and Chief Executive Officer, Labopharm Inc. "We believe that continuing the Formal Dispute Resolution process, as opposed to submitting a complete response, is the most appropriate path to resolving the outstanding matter and achieving our objective of commercialization in the United States."
As part of the appeal process, Labopharm has requested a meeting with Dr. Janet Woodcock, M.D., the FDA's Director, Center for Drug Evaluation and Research. The Agency usually grants such requests within 30 days and typically provides a written response to the appellant within 30 days of a meeting.
"We have maintained the position that our strong body of data warrants the approval of our once-daily tramadol formulation and believe that the additional analysis we conducted as proposed by the FDA confirms our position," said James R. Howard-Tripp, President and Chief Executive Officer, Labopharm Inc. "We believe that continuing the Formal Dispute Resolution process, as opposed to submitting a complete response, is the most appropriate path to resolving the outstanding matter and achieving our objective of commercialization in the United States."
As part of the appeal process, Labopharm has requested a meeting with Dr. Janet Woodcock, M.D., the FDA's Director, Center for Drug Evaluation and Research. The Agency usually grants such requests within 30 days and typically provides a written response to the appellant within 30 days of a meeting.
BioDelivery Sciences Receives $2.5 Million and Announces Marketing Partner Meda AB has Filed for European Approval of BEMA Fentanyl
Apr 1, 2008 - BioDelivery Sciences International, Inc. (Nasdaq: BDSI) announced that Meda AB, its commercialization partner for BEMA(TM) Fentanyl in North America and Europe, has submitted a dossier seeking approval to market BEMA(TM) Fentanyl for the treatment of breakthrough pain in opioid tolerant cancer patients to the German Federal Institute for Drugs and Medical Devices (BfArm). Meda has chosen to utilize the Decentralized Procedure to obtain marketing approval throughout the European Union with Germany serving as the reference member country.
BioDelivery Sciences received a $2.5 million milestone payment for completion of the clinical trial work supporting the dossier and expects to receive an additional milestone payment on approval, followed by revenues from a double digit royalty on net sales.
"This submission clearly reflects the priority Meda has placed on gaining approval for BEMA(TM) Fentanyl both in Europe and in the U.S.," said Dr. Mark A. Sirgo, President and Chief Executive Officer of BioDelivery Sciences. "It also reflects our opinion there is a clear market opportunity for BEMA(TM) Fentanyl and underscores our unwavering focus toward providing a new treatment option for cancer patients experiencing breakthrough pain."
"Breakthrough pain is a common condition in cancer patients, so it is important to continue developing improved therapies in this area," stated Anders Lonner, Chief Executive Officer of Meda AB. "We are pleased with BioDelivery Sciences' progress and are eager to introduce BEMA(TM) Fentanyl for breakthrough cancer pain to the European market where current treatment modalities continue to prove suboptimal."
As previously disclosed, the U.S. Food and Drug Administration (FDA) accepted for filing BioDelivery Sciences' New Drug Application (NDA) for BEMA(TM) Fentanyl. BioDelivery Sciences is expecting a response from FDA on the BEMA(TM) Fentanyl NDA by August 31, 2008. In September 2007, BioDelivery Sciences announced a licensing agreement with Meda AB for the distribution rights in the U.S., Canada, and Mexico for BEMA(TM) Fentanyl. In August 2006, Meda AB secured from BioDelivery Sciences the rights to distribute BEMA(TM) Fentanyl in Europe.
Breakthrough cancer pain is characterized by the episodes of severe pain that "break through" the base opioid medications used to control persistent pain. The worldwide market for breakthrough cancer pain is expected to reach $2.5 billion by 2016 according to Datamonitor. In addition, a recent European Pain in Cancer (EPIC) survey revealed that 63 percent of cancer patients report they are affected by breakthrough pain. The study disclosed that only one-third of these patients take additional medications to treat their breakthrough pain, and merely 35 percent of patients taking additional medications report the medicine is effective.
About BEMA(TM) Fentanyl
BDSI's lead product under development is BEMA(TM) Fentanyl, a potential treatment for "breakthrough" pain (i.e., episodes of severe pain which "break through" the medication used to control the persistent pain). BEMA(TM) Fentanyl consists of a small, dissolvable, polymer disc, formulated with the opioid narcotic fentanyl for application to the buccal (inner lining of cheek) membranes. Fentanyl belongs to the group of medicines called narcotic analgesics, which are used to relieve pain. The BEMA(TM) delivery technology is particularly well suited for the delivery of products where rapid onset of activity and convenient administration are important. BDSI believes there is a clear need and growing market for additional narcotic agents in alternative dosage forms to provide rapid and convenient pain relief.
BioDelivery Sciences received a $2.5 million milestone payment for completion of the clinical trial work supporting the dossier and expects to receive an additional milestone payment on approval, followed by revenues from a double digit royalty on net sales.
"This submission clearly reflects the priority Meda has placed on gaining approval for BEMA(TM) Fentanyl both in Europe and in the U.S.," said Dr. Mark A. Sirgo, President and Chief Executive Officer of BioDelivery Sciences. "It also reflects our opinion there is a clear market opportunity for BEMA(TM) Fentanyl and underscores our unwavering focus toward providing a new treatment option for cancer patients experiencing breakthrough pain."
"Breakthrough pain is a common condition in cancer patients, so it is important to continue developing improved therapies in this area," stated Anders Lonner, Chief Executive Officer of Meda AB. "We are pleased with BioDelivery Sciences' progress and are eager to introduce BEMA(TM) Fentanyl for breakthrough cancer pain to the European market where current treatment modalities continue to prove suboptimal."
As previously disclosed, the U.S. Food and Drug Administration (FDA) accepted for filing BioDelivery Sciences' New Drug Application (NDA) for BEMA(TM) Fentanyl. BioDelivery Sciences is expecting a response from FDA on the BEMA(TM) Fentanyl NDA by August 31, 2008. In September 2007, BioDelivery Sciences announced a licensing agreement with Meda AB for the distribution rights in the U.S., Canada, and Mexico for BEMA(TM) Fentanyl. In August 2006, Meda AB secured from BioDelivery Sciences the rights to distribute BEMA(TM) Fentanyl in Europe.
Breakthrough cancer pain is characterized by the episodes of severe pain that "break through" the base opioid medications used to control persistent pain. The worldwide market for breakthrough cancer pain is expected to reach $2.5 billion by 2016 according to Datamonitor. In addition, a recent European Pain in Cancer (EPIC) survey revealed that 63 percent of cancer patients report they are affected by breakthrough pain. The study disclosed that only one-third of these patients take additional medications to treat their breakthrough pain, and merely 35 percent of patients taking additional medications report the medicine is effective.
About BEMA(TM) Fentanyl
BDSI's lead product under development is BEMA(TM) Fentanyl, a potential treatment for "breakthrough" pain (i.e., episodes of severe pain which "break through" the medication used to control the persistent pain). BEMA(TM) Fentanyl consists of a small, dissolvable, polymer disc, formulated with the opioid narcotic fentanyl for application to the buccal (inner lining of cheek) membranes. Fentanyl belongs to the group of medicines called narcotic analgesics, which are used to relieve pain. The BEMA(TM) delivery technology is particularly well suited for the delivery of products where rapid onset of activity and convenient administration are important. BDSI believes there is a clear need and growing market for additional narcotic agents in alternative dosage forms to provide rapid and convenient pain relief.
Wyeth and Progenics Announce RELISTOR Receives Canadian Marketing Approval
Apr 1, 2008 - Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), and Progenics Pharmaceuticals, Inc. (Nasdaq: PGNX), today announced that Wyeth has received marketing approval from Health Canada, the Canadian Regulatory Agency, for RELISTOR(TM) (methylnaltrexone bromide injection) for subcutaneous use. RELISTOR is indicated for the treatment of opioid-induced constipation (OIC) in patients with advanced illness receiving palliative care. Health Canada's decision regarding RELISTOR marks the first regulatory approval of this novel medication anywhere in the world.
"Health Canada granted a priority review for RELISTOR, which underscores the important need that exists for an innovative medicine that addresses a serious health condition for which there had been limited medical advancement," says Joseph S. Camardo, M.D., senior vice president, Global Medical Affairs, Wyeth Pharmaceuticals. "Wyeth and Progenics are pleased to bring RELISTOR to patients as an example of our commitment to discover, develop and deliver important new medicines that work in novel ways to benefit patients who need them."
RELISTOR is the first approved therapy in a new class of drugs designed to relieve one of the significant side effects of opioids on the gastrointestinal tract without interfering with their ability to provide pain relief. When patient response to laxatives has been insufficient, RELISTOR should be used as an adjunct therapy to induce a prompt bowel movement. Wyeth expects that this product will be launched and available to patients in Canada within approximately 60 days.
"Progenics is proud to share this achievement with the Wyeth team, who have been instrumental in advancing this important new product to market," said Paul J. Maddon, M.D., Ph.D., Founder, Chief Executive Officer and Chief Science Officer, Progenics Pharmaceuticals, Inc. "We now await a decision from the U.S. Food and Drug Administration by the end of April on RELISTOR. In addition, we and Wyeth continue to work with the European and Australian regulatory authorities to expand the availability of RELISTOR."
"Health Canada granted a priority review for RELISTOR, which underscores the important need that exists for an innovative medicine that addresses a serious health condition for which there had been limited medical advancement," says Joseph S. Camardo, M.D., senior vice president, Global Medical Affairs, Wyeth Pharmaceuticals. "Wyeth and Progenics are pleased to bring RELISTOR to patients as an example of our commitment to discover, develop and deliver important new medicines that work in novel ways to benefit patients who need them."
RELISTOR is the first approved therapy in a new class of drugs designed to relieve one of the significant side effects of opioids on the gastrointestinal tract without interfering with their ability to provide pain relief. When patient response to laxatives has been insufficient, RELISTOR should be used as an adjunct therapy to induce a prompt bowel movement. Wyeth expects that this product will be launched and available to patients in Canada within approximately 60 days.
"Progenics is proud to share this achievement with the Wyeth team, who have been instrumental in advancing this important new product to market," said Paul J. Maddon, M.D., Ph.D., Founder, Chief Executive Officer and Chief Science Officer, Progenics Pharmaceuticals, Inc. "We now await a decision from the U.S. Food and Drug Administration by the end of April on RELISTOR. In addition, we and Wyeth continue to work with the European and Australian regulatory authorities to expand the availability of RELISTOR."
DiaKine Therapeutics to Be Awarded Patent for Restoring Insulin Producing Cell Function in Diabetics
Apr 1, 2008 - DiaKine Therapeutics, Inc. today announced that the U.S. Patent and Trademark Office indicated its intent to grant a patent for the use of Lisofylline (LSF) to restore insulin-producing beta cell mass and function in people with diabetes. The patent application, entitled Pharmaceutical compositions and methods for restoring beta-cell mass and function, also covers the use of LSF in combination with a growth factor.
"We have clearly demonstrated in previous pre-clinical studies that our immune modulating drugs, alone or in combination with other specific small molecules or peptides, may be used as a means to prevent, treat or possibly arrest diabetes," said Dr. Jerry Nadler, DiaKine's Chief Scientific Officer and co-inventor. "The patent application should help us move our work forward as we seek to put an end to this devastating disease."
"This is the second key patent office action we have received in recent months and further strengthens our portfolio of intellectual property," said Keith Ignotz, President, and CEO of DiaKine. "These patents boost our claims to precisely limit the body's mistaken and destructive inflammatory actions that lead to diseases such as diabetes."
The patent application covers pharmaceutical compositions and methods for restoring beta-cell mass and function. The pharmaceutical compositions have a biological response modifier and a beta-cell growth factor in a mixture with a pharmaceutically acceptable carrier, adjuvant or vehicle. The invention provides for the use of compounds or agents that can block cytokine signaling or formation and thereby prevent autoimmune damage to regenerated/emerging new insulin producing cells. Without using an agent to block the autoimmune process, beta-cell differentiation and/or growth promoting agents will not be clinically effective because simultaneous regeneration of beta-cells and prevention of autoimmune reactions would not be realized.
"We have clearly demonstrated in previous pre-clinical studies that our immune modulating drugs, alone or in combination with other specific small molecules or peptides, may be used as a means to prevent, treat or possibly arrest diabetes," said Dr. Jerry Nadler, DiaKine's Chief Scientific Officer and co-inventor. "The patent application should help us move our work forward as we seek to put an end to this devastating disease."
"This is the second key patent office action we have received in recent months and further strengthens our portfolio of intellectual property," said Keith Ignotz, President, and CEO of DiaKine. "These patents boost our claims to precisely limit the body's mistaken and destructive inflammatory actions that lead to diseases such as diabetes."
The patent application covers pharmaceutical compositions and methods for restoring beta-cell mass and function. The pharmaceutical compositions have a biological response modifier and a beta-cell growth factor in a mixture with a pharmaceutically acceptable carrier, adjuvant or vehicle. The invention provides for the use of compounds or agents that can block cytokine signaling or formation and thereby prevent autoimmune damage to regenerated/emerging new insulin producing cells. Without using an agent to block the autoimmune process, beta-cell differentiation and/or growth promoting agents will not be clinically effective because simultaneous regeneration of beta-cells and prevention of autoimmune reactions would not be realized.
Oncolin Therapeutics Obtains an Exclusive Worldwide Right to Option Patents Covering the Composition and Use of Genistein Analogs for Cancer Treatment
Apr 1, 2008 - Oncolin Therapeutics, Inc., (OTCBB:OCOL) announces that it has obtained an exclusive worldwide right to option patents covering the composition and use of Genistein analogs for cancer treatment. The technology was discovered and patented by the Pharmaceutical Research Institute of Warsaw Poland and involves compounds that appear to be novel antimicrotubule agents.
Given the widespread success of antimicrotubule therapies in curative and palliative cancer treatment, the microtubule is perhaps the single best cancer target identified to date and continues to be recognized as a strategic target against which to direct new development efforts.
The approved drugs from this mechanistic class include the Vinca alkaloids such as vincristine, the taxanes with paclitaxel and docetaxel and the epothilones with its first drug recently approved by Bristol Myers. Each of these different types of compound classes appear to interact at different parts of the microtubule and have different spectrums of activity and show effectiveness against resistant disease.
"We are happy to have obtained this exclusive agreement on what may be another unique antimicrotubule class of compounds. We will work closely with both the Pharmaceutical Research Institute of Warsaw Poland and the University of Texas MD Anderson Cancer Center to further evaluate the compounds' anticancer activity in order to advance a lead compound into clinical development," said Dr. Donald Picker, President and COO of the company.
Given the widespread success of antimicrotubule therapies in curative and palliative cancer treatment, the microtubule is perhaps the single best cancer target identified to date and continues to be recognized as a strategic target against which to direct new development efforts.
The approved drugs from this mechanistic class include the Vinca alkaloids such as vincristine, the taxanes with paclitaxel and docetaxel and the epothilones with its first drug recently approved by Bristol Myers. Each of these different types of compound classes appear to interact at different parts of the microtubule and have different spectrums of activity and show effectiveness against resistant disease.
"We are happy to have obtained this exclusive agreement on what may be another unique antimicrotubule class of compounds. We will work closely with both the Pharmaceutical Research Institute of Warsaw Poland and the University of Texas MD Anderson Cancer Center to further evaluate the compounds' anticancer activity in order to advance a lead compound into clinical development," said Dr. Donald Picker, President and COO of the company.
Bayer Appeals Invalidity Ruling on Its Yasmin Patent Appeal Will Be Heard by the Federal Circuit
In continuation to the earlier published....
March 31, 2008 - Today, Bayer filed a Notice of Appeal in the United States District Court for the District of New Jersey.
Bayer is appealing from a March 3, 2008 opinion and order in which District Judge Peter G. Sheridan held that certain patent claims of Bayer Schering's U.S. Patent No. 6,787,531 for the company’s oral contraceptive Yasmin (drospirenone 3 mg and ethinyl estradiol 0.03mg) were invalid because they would have been obvious to the person of ordinary skill in the art.
Bayer had sued generic manufacturer Barr Laboratories for patent infringement in connection with Barr's application to the FDA for approval to market a generic version of Bayer's oral contraceptive Yasmin.
Bayer's appeal will be heard by the Federal Circuit, which is the federal court of appeals for patent cases.
March 31, 2008 - Today, Bayer filed a Notice of Appeal in the United States District Court for the District of New Jersey.
Bayer is appealing from a March 3, 2008 opinion and order in which District Judge Peter G. Sheridan held that certain patent claims of Bayer Schering's U.S. Patent No. 6,787,531 for the company’s oral contraceptive Yasmin (drospirenone 3 mg and ethinyl estradiol 0.03mg) were invalid because they would have been obvious to the person of ordinary skill in the art.
Bayer had sued generic manufacturer Barr Laboratories for patent infringement in connection with Barr's application to the FDA for approval to market a generic version of Bayer's oral contraceptive Yasmin.
Bayer's appeal will be heard by the Federal Circuit, which is the federal court of appeals for patent cases.
Breckenridge Pharmaceutical Enters Agreement With Helm AG to Develop Additional ANDA Project
Breckenridge announced today that it has entered into another separate agreement with Helm AG to develop and manufacture a generic ANDA product. Under terms of this new agreement, Breckenridge will submit an ANDA to the U.S. Food and Drug Administration (FDA) for the product which will be developed by Helm AG. The product currently shows U.S. sales of approximately $279 million, and is patent protected until 2011.
The two companies previously announced plans to develop and manufacture a generic tablet ANDA product in December 2007. The product was recently filed with the U.S. Food and Drug Administration (FDA).
The two companies previously announced plans to develop and manufacture a generic tablet ANDA product in December 2007. The product was recently filed with the U.S. Food and Drug Administration (FDA).
Update on Generic Prevacid Litigation
March 31, 2008 - Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. District Court for the District of Delaware has issued a decision in its litigation over the Company's Abbreviated New Drug Application (ANDA) to market its generic version of TAP Pharmaceutical Products Inc.'s Prevacid(R) (Lansoprazole) Delayed Release Capsules, 15 mg and 30 mg., holding that U.S. Patent No. 4,628,098 is valid and enforceable. Teva plans to appeal this decision.
As soon as I will get the details of the case I will post that.
As soon as I will get the details of the case I will post that.
Court Upholds Ortho-McNeil's Topamax Patent
A federal appeals court on Monday upheld a ruling that prevents generic drug maker Mylan (MYL.N: Quote, Profile, Research) from pursuing efforts to market a version of the epilepsy drug Topamax until Ortho-McNeil Pharmaceutical Inc's patent expires.
The U.S. Court of Appeals for the Federal Circuit found that a District Court in New Jersey district was correct in siding with Ortho-McNeil, a unit of Johnson & Johnson (JNJ.N: Quote, Profile, Research).
Ortho-McNeil said on its web site that the Topamax patent expires in September.
Under the Hatch-Waxman Act to encourage generic versions of drugs to be marketed quickly after a patent expires, Mylan had filed an application with the Food and Drug Administration saying it intended to bring out a version of Topamax. As part of that application, Mylan said Ortho-McNeil's patent was invalid.
But Ortho-McNeil disagreed, and filed a lawsuit saying its patent rights had been infringed.
http://www.cafc.uscourts.gov/opinions/07-1223.pdf
The U.S. Court of Appeals for the Federal Circuit found that a District Court in New Jersey district was correct in siding with Ortho-McNeil, a unit of Johnson & Johnson (JNJ.N: Quote, Profile, Research).
Ortho-McNeil said on its web site that the Topamax patent expires in September.
Under the Hatch-Waxman Act to encourage generic versions of drugs to be marketed quickly after a patent expires, Mylan had filed an application with the Food and Drug Administration saying it intended to bring out a version of Topamax. As part of that application, Mylan said Ortho-McNeil's patent was invalid.
But Ortho-McNeil disagreed, and filed a lawsuit saying its patent rights had been infringed.
http://www.cafc.uscourts.gov/opinions/07-1223.pdf
Bayer Appeals Yasmin Contraceptive Patent Invalidity
Bayer Schering Pharma AG has appealed a judge's recent finding that the patent at issue in the lawsuit against Barr Laboratories Inc. over the $488 million U.S. market for the contraceptive Yasmin is invalid due to obviousness.
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