Successful Investigational New Drug application (IND) Review for Intravenous CP-4126

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Clavis Pharma news.
Date Posted: 03 July 2009

Oslo, Norway, 3 July 2009 - Clavis Pharma ASA (OSE: CLAVIS) announces today that it has received clearance by the United States Food and Drug Administration (FDA) to include patients in the USA in its phase II clinical programme for Intravenous CP-4126. Intravenous CP-4126 is in development as a new, first-line treatment for pancreatic cancer and the phase II program has already been initiated in Europe. Clavis Pharma will now begin preparations at selected clinical sites for an expansion of the phase II programme into the USA. Intravenous CP-4126 is based on Clavis Pharma's proprietary Lipid Vector Technology (LVT) and aimed at improving the therapeutic profile of the current standard treatment for advanced pancreatic cancer, gemcitabine (Gemzar®). Currently it is estimated that pancreatic tumours in up to two-thirds of patients have a deficient cellular uptake of gemcitabine due to deficient expression of a necessary transport protein, hENT1 (human equilibrative nucleoside transporter 1) on the tumour cell membrane1. This is known to limit the efficacy of gemcitabine treatment in these patients. In contrast, cellular uptake of Intravenous CP-4126 is independent of hENT1, which offers a potential clinical advantage for the product in the treatment of pancreatic cancer. In the phase II programme, cancer tissue (biopsies) from each patient will be collected and analysed with regard to levels of hENT1. The relation between response to treatment and hENT1 levels will be studied. "Our phase II programme for Intravenous CP-4126 follows the successful completion of a phase I study in solid tumour cancer patients. This earlier trial, in line with preclinical data, suggests that CP-4126 may be of clinical benefit for patients that do not respond to gemcitabine as well as those that currently benefit from gemcitabine," says Geir Christian Melen, CEO of Clavis Pharma. "The acceptance of the IND is an important milestone for us that acknowledge our data on file for Intravenous CP-4126 and may enable us to accelerate our phase II programme through expansion in the USA."  
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Teva Announces Approval and Launch of Tri-Lo Sprintec Tablets

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TEVA news.
Date Posted: 01 July 2009

Jerusalem, Israel, July 1, 2009 - Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration has granted approval for the Company's Abbreviated New Drug Application (ANDA) to market a generic version of Ortho McNeil Janssen's oral contraceptive, Ortho Tri-Cyclen® Lo. Shipment of this product, for which Teva's trade name is Tri-Lo Sprintec, has commenced. As the first company to file an ANDA containing a paragraph IV certification for this product, Teva has been awarded a 180-day period of marketing exclusivity. Annual sales of Ortho Tri-Cyclen® Lo were approximately $400 million in the United States for the twelve months that ended March 31, 2009 based on IMS sales data. Teva is currently involved in patent litigation concerning this product in the U.S. District Court for the District of New Jersey. A trial date has not been set.
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SCHERING-PLOUGH ANNOUNCES PHASE II AND III DATA FOR CORIFOLLITROPIN ALFA

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Schering-Plough Corp news.
Date Posted: 01 July 2009

Single-dose of investigational sustained follicle stimulant achieves similar efficacy to daily injections of follitropin beta given over a one week period in Phase III Study AMSTERDAM, THE NETHERLANDS, July 1, 2009 -- Schering-Plough Corp., (NYSE: SGP) today announced results from the Phase III ENGAGE clinical trial demonstrating that a single injection of corifollitropin alfa, first in the class of sustained follicle stimulants, achieved similar efficacy to recombinant follicle stimulating hormone (rFSH) given once daily for seven days. The ENGAGE data was presented along with data from the Phase III ENSURE trial and the Phase II REALIZE trial at the 25th annual meeting of the European Society of Human Reproduction and Embryology (ESHRE) in Amsterdam, The Netherlands."The burden of fertility treatment is a major challenge for women experiencing difficulty conceiving," said Thomas Koestler, executive vice president and president, Schering-Plough Research Institute. "Schering-Plough is committed to making fertility treatments easier, and these results demonstrate that corifollitropin alfa in combination with a GnRH antagonist may be an effective treatment that can reduce the number of injections and the length of treatment protocols."ENGAGE is the largest double-blind fertility agent trial ever performed. The ongoing pregnancy rate, the primary endpoint of the ENGAGE non-inferiority trial, obtained in the 150 mcg corifollitropin alfa treatment arm (38.9 percent per started cycle) was similar to that achieved in patients receiving a daily dose of 200 IU rFSH (follitropin beta) for seven days (38.1 percent per started cycle).1 ENGAGE also demonstrated that a single injection of 150 mcg corifollitropin alfa achieved similar oocyte and embryo quality compared to a daily dose of 200 IU rFSH given for one week.2 Further sub-analyses of the ENGAGE trial showed a single injection of 150 mcg corifollitropin alfa, compared to the daily rFSH treatment arm, achieved consistently high pregnancy outcomes regardless of fertilization procedure (in-vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI), number of embryos transferred (single or double), or day of embryo transfer (day three or five), confirming the robustness of the main efficacy outcome.1An additional sub-analysis of the ENGAGE data demonstrated that endogenous luteinizing hormone (LH) levels do not affect ongoing pregnancy rates in women undergoing controlled ovarian stimulation (COS) with a standardized rFSH / gonadotropin-releasing hormone (GnRH) antagonist protocol.3 An analysis compared data from the ENGAGE trial to data from the ENSURE trial. The ENSURE trial used a similar protocol to ENGAGE with identical patient inclusion criteria but different body weight categories. It showed that exposure and ovarian response were similar after a single-dose of 100 mcg corifollitropin alfa in patients weighing 60 kg or less, as compared to 150 mcg corifollitropin alfa in patients weighing more than 60 kg. 4 Additional data from the ENSURE trial show that in patients weighing 60 kg or less, a single dose of 100 mcg corifollitropin alfa resulted in significantly more oocytes and an equally short duration of treatment as those receiving 150 IU rFSH daily during the first week of stimulation.5Data was also presented from the Phase II REALIZE study, a 50 patient, open-label uncontrolled pilot study. In this study, a single dose of 100 mcg or 150 mcg corifollitropin alfa in a long GnRH agonist protocol was able to support multifollicular development during the first week of ovarian stimulation. 6 About ENGAGE ENGAGE was a non-inferiority trial designed to compare corifollitropin alfa 150 mcg to 200 IU rFSH (follitropin beta). A total of 1,506 patients (greater than 60 kg) at 34 IVF clinics in North America and Europe were randomized to receive either corifollitropin alfa 150 mcg or a daily dose of 200 IU rFSH, followed by rFSH (maximum 200 IU/day) from stimulation day eight onward, when required. Starting on stimulation day five, all patients received 0.25mg gonadotropin-releasing hormone (GnRH) antagonist until triggering of final oocyte maturation by human chorionic gonadotropin (hCG). The primary endpoint was the ongoing pregnancy rate assessed at ten weeks or more after embryo transfer. The number of oocytes retrieved was the co-primary endpoint. The incidence of ovarian hyperstimulation syndrome (OHSS) was similar between both groups, 7.0 percent in the corifollitropin alfa group (1.9 percent severe) and 6.3 percent in the follitropin beta group (1.3 percent severe).1 Key Findings The ongoing pregnancy rate in the 150 mcg corifollitropin alfa treatment arm (38.9 percent per started cycle) was similar to that achieved in patients receiving daily 200 IU rFSH (follitropin beta) (38.1 percent per started cycle).1 Corifollitropin alfa achieved similar efficacy regardless of fertilization procedure; number of emb...
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Trial of Novel H1N1 ‘Swine’ Flu candidate vaccine to take place in Adelaide

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CSL news.
Date Posted: 01 July 2009

CSL Limited, Australia’s leading biopharmaceutical company, will shortly be commencing a clinical trial of a candidate vaccine against Novel H1N1 ‘Swine’ Flu. The trial will be undertaken in partnership with Clinical Research Organisation CMAX and the Royal Adelaide Hospital in South Australia. Healthy adults aged between 18 and 64 years are being sought to participate, and must be available to meet four appointments in Adelaide over a 6 month period. The trial will involve participants receiving two injections of the vaccine, three weeks apart, and will compare a standard with an increased dosage of vaccine. Volunteers will need to submit to blood tests to check that they are generating an appropriate immune response to the virus. “We understand flu vaccines very well from our long experience with yearly seasonal strains, as well as research into novel flu vaccines.” Global Director of Clinical Development at CSL, Dr Russell Basser said today. “We appreciate that new influenza strains like the ‘swine flu’ can surprise us with properties that mean they might require higher dosing and two injections rather than one to provoke the desired level of immune response in humans.” “CSL will be addressing these questions in the trial to ensure we know the optimum way for the vaccine to be given to protect against this strain of flu.” It is anticipated that participants in the trial will commence being vaccinated in mid-July. This trial is being conducted with view to fulfilling a commitment to the Australian Department of Health and Ageing to supply up to 10 million people with a vaccine against Novel H1N1 ‘swine’ influenza.
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UCB brings Neupro® back to all patients in Europe

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UCB news.
Date Posted: 29 June 2009

European Commission lifts the treatment restrictions for Neupro® Neupro® can be prescribed for all patients in accordance with the approved indications Neupro® available again to all patients with Parkinson's disease Neupro® newly available to adult patients with moderate to severe Restless Legs Syndrome Brussels (Belgium), 29 June 2009 - press release, regulated information - UCB announced today that Neupro® (rotigotine transdermal patch) can now be prescribed to all patients with idiopathic Parkinson's disease in Europe and is newly available for the symptomatic treatment of moderate to severe idiopathic Restless Legs Syndrome (RLS) in adults. This follows the decision of the European Commission to lift treatment restrictions on Neupro® in line with the recommendation of the European Medicines Agency (EMEA), issued on 29 May 2009. "We are delighted that all patients with Parkinson's disease in Europe can once again benefit from continuous drug delivery and the improvement in symptoms that is offered with Neupro® and that, for the first time, people with RLS in Europe will also experience the advantages of this important treatment," said Troy Cox, Senior Vice President CNS Operations, UCB. Since June 2008, Neupro® supply in Europe has been limited to patients already established on the drug while a new cold-chain storage and distribution system was developed to meet the need for refrigeration of the product from manufacturer to patient. Following full implementation of this system, refrigerated stocks of Neupro® are available in all doses so Neupro® can be prescribed by European physicians for all patients with idiopathic Parkinson's disease. Neupro® in Parkinson's disease Parkinson's disease affects over six million people worldwide and approximately three million patients in the seven major markets (U.S., Japan, Germany, UK, France, Italy and Spain). Formulated as a once-a-day transdermal patch, Neupro® continuous drug delivery provides stable drug levels in the bloodstream. Neupro® provides statistically significant and clinically relevant improvements in movement and ability to carry out everyday activities in people with early-stage Parkinson's disease and significantly reduces off time and increases on time in people with later stage Parkinson's disease. Neupro® is generally well-tolerated. Adverse drug reactions reported in more than 10% of Parkinson's patients treated with Neupro® are nausea, dizziness, somnolence and application site reactions. Neupro® in RLS In August 2008, the European Commission approved Neupro® for the symptomatic treatment of idiopathic moderate to severe RLS in adults. The UK and Germany are the first European countries to launch Neupro® (1 mg/24 h, 2 mg/24 h and 3 mg/24 h) in this new indication. RLS affects between 3 and 10% of the population to some extent. In a clinical trial of 458 patients with moderate to severe RLS, Neupro® (1 mg/24 h, 2 mg/24 h and 3 mg/24 h dose) proved more efficacious than placebo in relieving bedtime, night and daytime symptoms in patients over a six month treatment period. Neupro® was shown to reduce symptoms by >=50% in over half of patients (54.2%) compared to symptom reduction in approximately one third (29.9%) of patients on placebo. In addition more patients receiving Neupro® (3 mg/24 h) achieved clinical remission (47.3% vs. 22.8% placebo) and symptom freedom (31.3% vs. 12.3% placebo). "We look forward to having Neupro® available as a new treatment option for RLS patients. The results of this rotigotine trial demonstrated efficacy, increased opportunity for symptom freedom in moderate to severely affected RLS patients and improvements to patients' quality of life" said Dr Claudia Trenkwalder from the Paracelsus-Elena Hospital, Kassel, Germany and lead investigator of the study.
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WYETH PHARMACEUTICALS AND CATALYST BIOSCIENCES ANNOUNCE AGREEMENT TO DEVELOP AND COMMERCIALIZE FACTOR VIIa PRODUCTS

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WYETH PHARMACEUTICALS news.
Date Posted: 01 July 2009

Multi-Product Collaboration Valued Potentially at More Than $500 Million Collegeville, PA and South San Francisco, CA, June 30, 2009 - Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE) and Catalyst Biosciences, Inc. today announced that the two companies have formed an exclusive worldwide collaboration for the discovery, development and commercialization of Factor VIIa products to treat hemophilia and other bleeding conditions. Total payments under the collaboration, including an upfront payment of $21 million, research funding and milestone payments, could exceed $500 million, exclusive of royalty payments. Through the collaboration, Wyeth will support the discovery, research and preclinical development by Catalyst of Factor VIIa products, including CB 813, Catalyst’s investigational candidate drug for the treatment and prophylaxis of acute bleeding in patients with hemophilia. The term of the exclusive research portion of the collaboration is two years, and may be extended by Wyeth for up to three additional years. During the research term of the agreement, Catalyst will receive support for up to twelve full-time employees. Wyeth will be responsible for the development, manufacturing and worldwide commercialization of products resulting from the collaboration. In addition, during the research term, Wyeth would have the right of first negotiation for any additional clotting factors discovered by Catalyst to treat hemophilia and other bleeding conditions. Catalyst anticipates it would earn payments of up to $40 million or more over the next two years, including the upfront payment, committed research funding and preclinical and clinical milestone payments. In addition, Catalyst will be eligible to receive escalating clinical development and commercialization milestones, plus tiered double-digit royalties on sales of products resulting from the collaboration. “This collaboration serves as an excellent fit with our recombinant Factor VIII and Factor IX hemophilia products and provides us with an opportunity to expand Wyeth’s hemophilia franchise,” says Mikael Dolsten, M.D., Ph.D., President, Wyeth Research. “We have been impressed by the caliber of Catalyst’s therapeutic protein engineering skills used in the Factor VIIa program and the lead candidate CB 813. We look forward to a highly productive collaboration.” “We are thrilled to join forces with Wyeth, a biopharmaceutical company at the forefront of both hemophilia treatment and the development and commercialization of biologic therapies,” says Nassim Usman, Ph.D., Chief Executive Officer of Catalyst Biosciences. “This collaboration highlights the value Catalyst has created in our Factor VIIa portfolio of products. Revenues generated from research collaborations such as this one allow us to continually expand and support existing discovery efforts around bleeding disorder product candidates and the engineering of new Alterase therapeutic products.”
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SIMPONI™ (Golimumab) Receives Positive Opinion from Chmp for Once-Monthly Subcutaneous Treatment of Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis

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Johnson & Johnson news.
Date Posted: 29 June 2009

Positive Opinion Recommends Approval of New Anti-TNF Therapy in Three Rheumatic Diseases with Novel SmartJect™ Autoinjector Horsham, PA and Kenilworth, NJ (June 25, 2009) – Centocor Ortho Biotech Inc. and Schering-Plough Corporation (NYSE: SGP) announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) adopted a positive opinion recommending the approval of SIMPONI™ (golimumab) as a once-monthly, subcutaneous therapy for the treatment of moderate-to-severe, active rheumatoid arthritis (RA), active and progressive psoriatic arthritis (PsA) and severe, active ankylosing spondylitis (AS). Upon Commission approval in the European Union, SIMPONI given as a 50 mg subcutaneous injection once a month will be indicated for: In combination with methotrexate, the treatment of moderate-to-severe, active RA in adult patients when the response to disease-modifying anti-rheumatic drug (DMARD) therapy, including methotrexate, has been inadequate. SIMPONI has also been shown to improve physical function in this patient population. Alone or in combination with methotrexate, the treatment of active and progressive PsA in adult patients when the response to previous DMARD therapy has been inadequate. SIMPONI has also been shown to improve physical function in this patient population. The treatment of severe, active AS in adult patients who have responded inadequately to conventional therapy. “With today’s decision, SIMPONI moves one step closer to becoming the first once-monthly subcutaneous anti-TNF therapy for the treatment of rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis in the European Union,” said Jerome A. Boscia, M.D., Senior Vice President, Clinical R&D, Centocor Research & Development, Inc. “We are optimistic that SIMPONI will be a welcome addition as a new anti-TNF treatment option for rheumatologists, and adults living with these inflammatory conditions who are seeking an effective and convenient therapy.” Upon receipt of the corresponding Commission Decision, SIMPONI will be the first and only once-monthly subcutaneous anti-tumor necrosis factor (TNF) alpha therapy approved in Europe for the simultaneous treatment of RA, PsA, and AS. SIMPONI will be available in two device forms, either through the SmartJect™, a novel autoinjector designed to meet the needs of arthritis patients, or as a prefilled syringe. The CHMP recommendation serves as the basis for a European Commission approval decision. A Commission approval of this application will result in Marketing Authorization with unified labeling that will be valid in all European Union Member States. In April 2009, SIMPONI™ (golimumab) was approved by the U.S. Food and Drug Administration (FDA) and Health Canada for the treatment of moderately to severely active RA, active PsA and active AS. “This positive opinion is an important step toward an approval as SIMPONI has the potential to benefit a broad range of patients in Europe by offering once-monthly subcutaneous treatment administered through an autoinjector device designed specifically with arthritis patients in mind,” said Thomas P. Koestler, Ph.D., executive vice president and president, Schering-Plough Research Institute. “Schering-Plough continues to pride itself on being a leading provider of rheumatic disease therapies within the European rheumatology community.” The efficacy and safety of SIMPONI have been studied in a comprehensive Phase 3 development program that included more than 2,000 patients living with moderately to severely active RA, active PsA and active AS. In Phase 3 rheumatoid arthritis trials, SIMPONI was shown to be effective regardless of prior treatment experience, which included patients inadequately responding to methotrexate and patients previously treated with anti-TNF agents. Centocor Ortho Biotech Inc. developed and discovered golimumab and has exclusive marketing rights to the product in the United States. Following regulatory approvals, Schering-Plough will assume exclusive marketing rights outside the United States except in Japan, Indonesia and Taiwan, where golimumab will be co-marketed by Mitsubishi Tanabe Pharma Corporation and Janssen Pharmaceutical Kabushiki Kaisha; Hong Kong, where golimumab will be exclusively marketed by Janssen-Cilag; and China, where golimumab will be exclusively marketed by Xian-Janssen.
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