June's top stories: China-Germany quality alliance, AstraZeneca cancer focus
The CCCMHPIE and German Good Manufacturing Practices third party auditor form alliance for drug quality, while Genmab and ADC Therapeutics collaborate to develop new antibody-drug conjugate (ADC) product for multiple cancer indications. Drugdevelopment-technology.com wraps up key headlines from June 2013.
The Chinese Chamber of Commerce for Import & Export of Medicines & Health Products (CCCMHPIE) has signed a strategic co-operation contract with blue inspection body, the German Good Manufacturing Practices (GMP) third party auditor, to maintain drug quality.
The alliance is designed to enable Chinese drug and active pharmaceutical ingredients (APIs) manufacturers to frame their quality management system (QMS) in compliance with the European GMP regulations.
Blue inspection body managing director Dr Stefan Kettelhoit said that the initiative is expected to strengthen the global pharmaceutical supply chain.
Cancer Research UK's commercial arm, Cancer Research Technology (CRT), has entered into two partnership agreements with the University of Manchester and British biopharmaceutical firm AstraZeneca to develop new cancer drugs.
Under the first agreement, Manchester scientists at Cancer Research UK's Paterson Institute for Cancer Research will develop new drugs that have the potential to target a vital protein involved in DNA damage response.
The second agreement involves the testing of a potential drug target against AstraZeneca's compound collection at its screening facility in Alderley Park to evaluate any promising molecule's potential to work as a new cancer drug.
Switzerland-based Novartis has announced encouraging results from a pivotal Phase III trial demonstrating the efficacy of Afinitor (everolimus) tablets in significantly delaying tumour growth in HER2-positive advanced breast cancer.
The study met the primary endpoint of progression-free survival (PFS) by demonstrating a 22% reduction in the risk of disease progression with the addition of everolimus, an mTOR inhibitor, to trastuzumab and vinorelbine in heavily pretreated patients.
Emory University School of Medicine department of haematology and medical oncology educational affairs professor and vice-chair and lead study author Ruth O'Regan said the data demonstrates everolimus's impact in heavily pretreated HER2 positive advanced breast cancer patients.
"Everolimus works differently than available treatment options for HER2 positive advanced breast cancer by inhibiting mTOR, and may offer an important new option for physicians and their patients," O'Regan said.
Denmark-based Genmab and Switzerland-based ADC Therapeutics have collaborated to jointly develop a new antibody-drug conjugate (ADC) product targeting multiple cancer indications.
The collaboration will focus on developing the ADC product by combining HuMax-TAC, Genmab's high-affinity fully human antibody targeting CD25, and ADC's PBD-based warhead and linker technology.
Genmab chief executive officer Dr Jan van de Winkel said: "We believe our unique HuMax-TAC antibody has optimal characteristics for creation of an ultra-potent antibody-drug conjugate when used in combination with ADC Therapeutics' novel PBD-based warhead and linker technology, which employs an emerging class of highly potent anticancer agents."
AstraZeneca and Bristol-Myers Squibb's (BMS) diabetes drug Onglyza (Saxagliptin) has failed to meet the primary efficacy objective of superiority in the Phase IV SAVOR-TIMI-53 cardiovascular outcomes trial.
Onglyza, which met the primary safety objective of non-inferiority, failed to demonstrate superiority in reducing cardiovascular deaths, non-fatal myocardial infarction or non-fatal ischemic stroke compared with placebo in type two diabetes patients.
Conducted at more than 700 sites globally, the randomised, double-blind, placebo-controlled SAVOR trial was led by the academic research organisations TIMI Study Group and Hadassah University Medical Center.
Kowa Pharmaceuticals America and Eli Lilly and Company have reported results of the pre-specified safety analysis from the INTREPID trial, a Phase IV study designed to evaluate Livalo (pitavastatin) 4mg against pravastatin 40mg in HIV-infected patients with dyslipidemia.
The new data showed that pitavastatin 4mg demonstrated neutral effects on fasting serum glucose (FSG) and levels of blood glucose and glycated haemoglobin (HbA1c) levels over 12 weeks.
Kowa Pharmaceuticals America medical affairs vice president Dr. Craig Sponseller said: "We are pleased with the results of this safety analysis that showed neutrality for the maximum dose of pitavastatin 4mg on parameters of glucose metabolism, which are consistent with our previous findings in non-HIV-infected adult populations with dyslipidemia."
Biotechnology company CytomX Therapeutics has signed a strategic agreement with Pfizer for the development and commercialisation of multiple Probody drug conjugates (PDCs) in the field of oncology.
The collaboration will result in a highly differentiated approach to developing safe and effective antibody drug conjugates (ADCs) using CytomX's novel Probody platform.
As per the agreement, Pfizer will make approximately $25m in upfront, research reimbursement and preclinical milestone payments and $610m in regulatory and sales milestones, in addition to tiered royalties on sales.
Pfizer oncology research unit senior vice president and chief scientific officer Robert Abraham said: "Pfizer's investment in CytomX's emerging Probody platform is an important component of our overall strategic focus to advancing the next generation of ADCs and reflects the disruptive potential of this approach."
Pharmaceutical companies have launched generic version of Pfizer's Viagra (sildenafil), prescribed to treat erectile dysfunction, in European markets immediately after its patent expired in the region.
Teva Pharmaceutical Industries introduced generic sildenafil in Germany, the UK, Italy, the Netherlands, Switzerland, Ireland, Austria, Belgium and Denmark, in addition to Spain and Canada where the drug is already available.
Actavis launched Sildenafil Actavis 25mg, 50mg and 100mg tablets in 11 Western-European markets, including Austria, Denmark, France, Germany, Ireland, Italy, the Netherlands, Spain, Sweden, Switzerland and the UK.
The patent for Viagra in the UK expired earlier in June, opening gates for generic versions, which are expected to cost as low as £1 each against nearly £9 for Viagra.
Antibody-drug conjugates combine the efficacy of cytotoxic drugs and the tumour-specific targeting of antibodies to maximise anti-cancer potency and minimise side effects.
Scientists in the US have found a new way of manipulating naïve T-cells to study their roles in fighting against cancer and HIV.