Chiesi Ventures in the new venture capital firm born from the strategic partnership between the Italian leading pharmaceutical company Chiesi Group and A.M. Pappas & Associates, a venture company fully dedicated to the life science business sector. Chiesi Ventures will focus its activities on the area of rare and orphan disorders through investments in early stage development opportunities in order to complement the strategy of Chiesi Group in the area. A. M. Pappas & Associates will provide expertise and network to access and assess deals and opportunities of investments to the newborn venture company, which will also support and accelerate the expansion of the Chiesi network in the US.
Cristiana Bernini
Hepatitis drug in developing nations
Gilead Sciences has licensed its hepatitis C drug sofosbuvir to seven India-based pharma companies, including Cipla and Ranbaxy, in order to give access to the generic version of the drug to people living in 91 developing nations. This corresponds to 54 percent of total global hepatitis-infected population. The other companies participating to the deal are Cadila Healthcare, Sequent Scientific, Strides Arcolab, Hetero Drugs and Mylan Laboratories. Companies will independently set the price for the medicine and will pay royalties to Gilead.
Chronic hepatitis C is affecting approx. 150 million people worldwide. Sofosbuvir is the up-to-date treatment for hepatitis C, showing a better efficiency and lower collateral effects than older therapies. The cost for a 12-week course treatment in the US is approx. $ 84,000.
New CEO for KDev Oncology
Swedish company Karolinska Development announced the appointment of Bruno Lucidi as Chief Executive Officer of the wholly owned subsidiary KDev Oncology and the portfolio companies Aprea and Akinion Pharmaceuticals. Lucidi was previously CEO of Idenix and Chairman of Pharmasset. He served also as European Head of Oncology for BMS and Global head of Oncology Strategy for J&J.
KDev Oncology assists the clinical portfolio companies in developing cancer drugs and attracting strategic partners and co-investors. Karolinska Development aims to create value by developing innovations from world-class science into differentiated products that can be partnered. Its innovative potential comes from an exclusive deal flow agreement with Karolinska Institutet Innovations AB, along with other cooperation agreements with leading universities. The current portfolio consists of 33 projects, of which 16 are in clinical development.
A slippery beginning for the Juncker Commission
One of the first proposals made from new European Commission President Jean-Claude Juncker might have a deep impact on the pharmaceutical business: within the global framework of the Commission’s plans to reallocate portfolios, pharmaceutical and health technology policy supervision should leave the control of the Health and Food Safety Commissioner to pass to the new Commissioner for Internal Market, Industry, Entrepreneurship and SMEs. Commission’s President Barroso established the opposite direction in 2009, which moved health business under the control of directorate general for Health and Consumers in order to better safeguard public interests.
The proposed change might affect the quarrel between pharma industry and the European Medicines Agency (EMA) to give free access to clinical trial data, in order for doctors to better evaluate safety and effectiveness of treatment options. The proposed reallocation now coming from the Commission immediately caused reactions from involved stakeholders.
“I trust the people in these units have the integrity to continue to put patient safety first,” said Richard Bergstrom, director general of the European Federation of Pharmaceutical Industries and Associations (EFPIA).
“This is a potential disaster. It is disappointing that President-elect Juncker believes these objectives fall a pale second place to appeasing big business. It sends a terrible message during times when criticism is being levelled at Europe: the College of Commissioners should work for the interest of citizens and not anonymous corporate masters,” said Peggy Maguire, President of the European Public Health Alliance (EPHA).
“Clearly, we’ve not been involved in the decision to move the portfolio but it doesn’t change our role, which is to provide independent science-based opinions and advice to the Commission and the member states,” said EMA’s spokesman Martin Harvey Allchurch.
Delamanid, a novel drug for multidrug-resistant tuberculosis
Otsuka Pharmaceutical Co., Ltd. (Otsuka) announced that the European Commission has granted a marketing authorization for Deltyba™ (delamanid) for use as part of an appropriate combination regimen for pulmonary multidrug-resistanttuberculosis (MDR-TB) in adult patients when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability. Deltyba is a bactericidal agent with a novel mode of action that interferes with the metabolism of the Mycobacteriumtuberculosis (MTB) cell walls. It also has high activity in vitro against various MTB strains, including those resistant to first-line anti-TB drugs, such as isoniazid and rifampicin.
Propandiol in infantile haemangioma
The European Commission granted a marketing authorisation valid throughout the European Union for Hemangiol on 23 April 2014. Hemangiol is a medicine that contains the active substance propranolol and It is used to treat children with proliferating infantile haemangioma (benign tumours of blood vessels. Hemangiol is used in infants with serious complications, such as painful ulcers, scarring and breathing difficulties, who require systemic therapy (treatment which can have an effect on the whole body).
New vaccine candidates against malaria enter clinical development
Under the coordination of the European Vaccine Initiative (EVI), sixteen projects are devoted to the acceleration of malaria vaccine development of which two novel vaccine candidates recently received ethical and regulatory approval to start clinical development. The two new vaccine candidates – called P27A and AMA1-DiCo- form part of EVI’s sustained commitment to support the development of new solutions and strategies to combat malaria.
Phase I/II trial on tkm-plk1 in patients with hepatocellular carcinoma
Tekmira Pharmaceuticals Corporation (TKMR) begins a Phase I/II open-label, multi-center clinical trial to determine the safety, tolerability and clinical benefit of TKM-PLK1 Phase I/II in patients with advanced hepatocellular carcinoma (HCC). The study will be conducted at sites in North America and Asia. Tekmira is also conducting a separate Phase I/II clinical trial evaluating TKM-PLK1 in patients with Gastrointestinal Neuroendocrine Tumors (GI-NET) or Adrenocortical Carcinoma (ACC). HCC is one of the most common cancers worldwide and the third most common cause of cancer-related death worldwide. HCC is overwhelmingly related to chronic liver disease, particularly hepatitis B and hepatitis C.
Monoclonal antibody in childhood brain tumor
Findings from the Phase I study on monoclonal antibody hu14.18K322A were published recently online and will appear in the Journal of Clinical Oncology. The experimental antibody is produced at St. Jude Children’s Research Hospital. Phase 1 studies focus on questions related to the safety and best dose of experimental therapies. The research involves patient volunteers whose cancer has returned or did not respond to standard treatment, which for neuroblastoma includes surgery, chemotherapy, radiation and bone marrow transplants.In this study 38 patients received one of nine different doses of hu14.18K322A.
Progress but many remaining challenges
Fifty years and 7 revisions later, the 2013 version of the Declaration of Helsinki includes emphasis in protecting research participants especially vulnerable patients
Caterina Lucchini
The 2014 marks the 50th anniversary of the Declaration of Helsinki (DoH). Consequently, the World Medical Association (WMA) has developed its eighth version of the Declaration. The DoH was initially enacted in 1964 and it contained 11 articles and 713 words. In this 50 years DoH has been revised six times and tripled in size with its 35 articles and 2045 words. The new formatting will also be welcomed by readers because the subsections improve the readability of the document. “The ethical principles contained within the Declaration of Helsinki are no less important today than they were at the time it was first adopted in 1964- stated Ramin W. Parsa-Parsi, MD, MPH, of the German Medical Association, Chair of the Workgroup on the revision of the. Declaration of Helsinki-. Then, as now, the unique character of the Declaration, as a collection of ethical principles for medical research involving human beings rather than a detailed rule book, provides researchers the world over with an invaluable ethical guidance tool”.
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