Russian biotechnology company BIOCAD prepares to enters the European market

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The largest Russian biotechnology company BIOCAD plans to enter the European market with oncological and autoimmune medicines. So far, there are seven molecules in the European portfolio of BIOCAD. This are innovative and biosimilar products, which could be used in treatment of melanoma, breast, stomach, kidney and lung cancer, rheumatoid arthritis, psoriasis and multiple sclerosis.

“The presence of Russian innovative medicines on the European market depends on the speed of approval process in the EMA (European Medicines Agency) which correlate with readiness to provide sufficient documents from manufacturer. BIOCAD is the only pharmaceutical company in Russia, which is ready to provide dossiers for its medicines according to ICH CTD format in the shortest possible time, “says Dmitry Morozov, general director of BIOCAD biotechnological company. In addition, the advantage of BIOCAD is its own production plant, which the company builds in Finland, in the city of Turku.

Currently, the Russian pharmaceutical company BIOCAD has not only biosimilars and generics in its pipeline, but also original molecules for the treatment of oncological and autoimmune diseases. The company invests in clinical trials of all this products. The last preparations are underway for conducting European Phase III clinical trials of adalimumab biosimilar and the original anti-IL-17 molecule. The preliminary agreement for the distribution of adalimumab in the European Union countries is planed to be signed in Frankfurt at CphI exhibition.

“As for the EU countries, where the approval of biological product goes under centralized procedure through the European Medicines Agency, taking into account the need for local clinical trials, we expect to get marketing authorization for biological products in 2021,” says Dmitry Morozov. In addition, in 2021, the generics of oncology drugs – docetaxel, paclitaxel, pemetrexed and irinotecan – will also enter the European countries.

BIOCAD is interested in licensing innovative products from small companies on mutually favorable terms for the Russian market. During the visit to Frankfurt, Russian experts will discuss with their Swiss colleagues the prospects of collaboration on a drug against hard-to-treat chronic viral infections based on a molecule obtained in the laboratories of the Swiss company. In addition, the company plans to sign a preliminary agreement on the licensing of an immune-oncology molecule with a pharmaceutical company from Germany. This drug will be used in combination therapy of some cancers along with the original BIOCAD medicine.

Novartis announces the planned acquisition of Advanced Accelerator Applications to strengthen oncology portfolio

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Novartis has announced, that it has entered a memorandum of understanding with Advanced Accelerator Applications (AAA) under which Novartis intends to commence a tender offer for 100% of the share capital of AAA subject to certain conditions. Advanced Accelerator Applications is a radiopharmaceutical company that develops, produces and commercializes Molecular Nuclear Medicines including Lutathera® , a first-in-class RLT product for neuroendocrine tumors (NETs). Radiopharmaceuticals, such as Lutathera, are unique medicinal formulations containing radioisotopes which are used clinically for both diagnosis and therapy. The transaction would strengthen Novartis’ oncology presence with both near-term product launches as well as a new technology platform with potential applications across a number of oncology early development programs.

“Novartis has a strong legacy in the development and commercialization of medicines for neuroendocrine tumors where significant unmet need remains for patients,” said Bruno Strigini, CEO, Novartis Oncology. “With Lutathera we can build on this legacy by expanding the global reach of this novel, differentiated treatment approach and work to maximize Advanced Accelerator Applications broader RLT pipeline and an exciting technology platform.”

Lutathera was approved in Europe in September 2017 for the treatment of unresectable or metastatic, progressive, well differentiated (G1 and G2), somatostatin receptor positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs). Lutathera is under review in the U.S. with a Prescription Drug User Fee Act (PDUFA) date of January 26, 2018.

The efficacy and safety of Lutathera were established in the pivotal Phase III trial known as NETTER-1. The primary endpoint of the study was progression free survival with secondary endpoints including objective response rates, overall survival, safety and tolerability. The study met its primary endpoint with Lutathera achieving statistically significant and clinically meaningful 79% reduction in risk of disease progression or death compared to the control therapy (hazard ratio 0.21, 95% confidence interval: 0.13-0.33, p<0.0001). At the time of study publication in the New England Journal of Medicine (January 2017), median PFS in the control arm was 8.4 months and had not yet been reached in the Lutathera arm.

In addition to Lutathera, AAA brings a broad set of skills in developing, manufacturing and commercializing radiopharmaceuticals, including the companion diagnostics for Lutathera (NETSPOT® and SomaKit TOC(TM)). AAA had sales of EUR 109 million in 2016.

Merck Set to Join Forces with Project Data Sphere to Pioneer Global Big Data Alliance

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Merck has announced that it will enter into a strategic collaboration with Project Data Sphere LLC, an independent, not-for-profit initiative of the CEO Roundtable on Cancer’s Life Sciences Consortium, to jointly lead the Global Oncology Big Data Alliance (GOBDA). This was announced at the signing of a Memorandum of Understanding yesterday, to coincide with Merck KGaA, Darmstadt, Germany’s, Award Ceremony announcing the recipients of its 2017 Grant for Oncology Innovation, held during the annual European Society for Medical Oncology Congress (ESMO 2017) in Madrid, Spain.

“The ultimate goal of our alliance with Project Data Sphere is to unleash the power of big data to bring value to cancer patients,” said Belén Garijo, Member of the Executive Board of Merck KGaA, Darmstadt, Germany, and CEO Healthcare. “Merck KGaA, Darmstadt, Germany, is deeply committed to investing in initiatives that push the boundaries of cancer research, that we hope will accelerate the discovery, development and delivery of innovative treatments to all who need it.”

The GOBDA initiative has been formed to expand the open-access of de-identified patient data sets to further enhance analytical capabilities, by building on Project Data Sphere’s innovative digital platform. The current platform contains historical clinical trial data from almost 100,000 patients provided by multiple organizations, and access to this information has already led to new and potentially practice-changing findings. GOBDA will expand this platform to include rare tumor trial, experimental arm and real-world patient data. Leveraging these data with big data analytics will help to optimize clinical trials, build a registry of data and help to enable advancement in the understanding of cancer treatment globally, with the mission to address the significant unmet needs in this field. In addition, by unleashing analytical power and big data to study and learn how to better manage rare but serious immune-mediated adverse events, institutes and industry will be able to assist regulators to adapt these new learnings into treatment guidelines. As well as establishing models to help enable early adverse event identification and improved patient outcomes.

“Big data is changing the face of healthcare as we know it, and advances in our ability to collect data, share and analyze it has already led to ground-breaking work,” said Dr Martin J. Murphy, CEO of Project Data Sphere LLC. “The joint force of Merck KGaA, Darmstadt, Germany, and Project Data Sphere will aim to connect and empower a truly global oncology community with these big data and analytical capabilities. We are excited about the Global Oncology Big Data Alliance initiative and the continuing engagement of a diverse community focused on finding solutions for cancer patients.”

Investment in the initiative builds on Merck KGaA, Darmstadt, Germany’s, commitment to rewarding innovation and creative thinking that could further advance the field of medicine, and begins a new chapter for global oncology innovation. Since 2014, the company has awarded a total of €4 million to further research in oncology through the Grant for Oncology Innovation award, which has engaged over 1,000 investigators worldwide, generated 12 winning research proposals from leading academic institutions, and generated seven high impact manuscripts.

OncoQR ML’s Vaccine Platform closes the Final Gap in the Immunological Attack against Cancer

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OncoQR ML GmbH has announced that even a single therapeutic vaccine based on its proprietary S-TIR™ platform technology, is able to induce the killing of tumor target expressing cells by simultaneously activating all possible immunological pathways (humoral and cellular).

Scientific Breakthrough

By showing this, the Austrian Biotech is the first company* to succeed in controlling all the relevant immune checkpoints that prevent the immune system from attacking and defeating cancer.

Whereas current passive checkpoint specific immunotherapy lacks tumor cell specificity with the risk of massive autoimmune reactions, this new active therapy is totally tumor target specific.

Geert Mudde, PhD, inventor of the S-TIR™ technology and OncoQR’s Chief Scientific Officer, said, “We are proud and excited to have finally demonstrated the ability to activate and use the full potential of the patient’s own immune system to eradicate cancer. Previously, we had already shown all forms of antibody mediated tumor killing – now we have the definite proof that our S-TIR™ vaccines are able to simultaneously induce and activate tumor specific T Cell killing as well. With our approach, the tumor has no more chance to escape the immune system – it is attacked from all possible sides at the same time.”

Economical Aspects

Christof Langer, Chief Executive Officer of OncoQR ML, said: “These spectacular results confirm the viability and huge potential of our proprietary S-TIR™ platform. Besides constituting a significant milestone in the development of our immunotherapy platform technology, to our knowledge, no other anti-cancer drug has shown comparable results so far. The new data are not only spectacular from a scientific point of view: The S-TIR technology will also break the trend that new cancer therapies have to be unethically expensive. Our therapeutic vaccines are designed to have low cost of goods which is paired with a personalized low treatment frequency at low treatment dose. Drugs based on our technology can be used as monotherapy but can also be combined with existing therapies (like chemotherapy). Therefore, all in all, groundbreaking news for patients, and healthcare organizations, but of course also for us and our future partners.”

Lilly and Nektar Therapeutics announce alliance to develop a novel autoimmune therapy

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Eli Lilly and Company and Nektar Therapeutics have announced a strategic collaboration to co-develop NKTR-358, a novel immunological therapy discovered by Nektar. NKTR-358, which achieved first human dose in Phase 1 clinical development in March of 2017, has the potential to treat a number of autoimmune and other chronic inflammatory conditions.

NKTR-358 is a potential first-in-class resolution therapeutic that may address an underlying immune system imbalance in patients with many autoimmune conditions. It targets the interleukin (IL-2) receptor complex in the body in order to stimulate proliferation of powerful inhibitory immune cells known as regulatory T cells. By activating these cells, NKTR-358 may act to bring the immune system back into balance. This could lead to a profound clinical impact and healthy organ function in autoimmune conditions.

“We look forward to working with Nektar to study this novel approach to treating a number of autoimmune conditions,” said Thomas F. Bumol, Ph.D., Senior Vice President of Biotechnology and Immunology Research at Lilly. “NKTR-358 is an exciting addition to our immunology portfolio and reinforces Lilly’s commitment to sustain a flow of innovative medicines in our pipeline.”

Under the terms of the agreement, Nektar will receive an initial payment of $150 million and is eligible for up to $250 million in additional development and regulatory milestones. Lilly and Nektar will co-develop NKTR-358 with Nektar responsible for completing Phase 1 clinical development. The parties will share Phase 2 development costs 75 percent Lilly and 25 percent Nektar. Nektar will have the option to participate in Phase 3 development on an indication-by-indication basis. Nektar has the opportunity to receive double-digit royalties that increase commensurate with their Phase 3 investment and product sales. Lilly will be responsible for all costs of global commercialization. Nektar will have an option to co-promote in the U.S. under certain conditions.

“We are very pleased to enter into this collaboration with Lilly as they have strong expertise in immunology and a successful track record in bringing novel therapies to market,” said Howard W. Robin, Nektar’s President and Chief Executive Officer. “Importantly, this agreement enables the broad development of NKTR-358 in multiple autoimmune conditions in order to achieve its full potential as a first-in-class resolution therapeutic.”

Roche acquires mySugr to form a leading open platform for digital diabetes management

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Roche and mySugr have signed an agreement under which Roche acquired all shares of mySugr GmbH. Counting more than one million users globally, mySugr is one of the leading mobile diabetes platforms in the market and will become an integral part of Roche’s new patient-centered digital health services platform in diabetes care. The acquisition allows Roche to expand its leading position in the area of diabetes management.

“We are excited about this agreement, as we will be able to offer seamlessly accessible patient solutions within an open platform to better respond to the unmet needs of people with diabetes. Our aim is to support people with diabetes to spend more time in their ideal glucose target range and improve their quality of life,” said Roland Diggelmann, CEO Roche Diagnostics. “Having partnered with mySugr since 2014, we see an excellent cultural fit, as both our companies are passionate about taking diabetes management to the next level and making a difference in managing diabetes.”

 
“We started mySugr to solve our everyday problems and simplify diabetes therapy through smartphones,” said Frank Westermann, CEO and Co-Founder of mySugr. “The mySugr team has filled a gap for over a million loyal users so far, and with Roche’s diabetes expertise and global network, mySugr will become an indispensable companion for hassle-free life.”

As a focal point for Roche`s integrated diabetes management strategy, mySugr is foreseen to remain a separate legal entity with an open platform for all diabetes devices and services. Users will continue to have the ability to automatically upload blood glucose data from their preferred device into the mySugr logbook app as well as the facilitated data sharing with healthcare professionals and caregivers.

Sarepta Therapeutics Opens its Research and Manufacturing Center at Andover

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Sarepta Therapeutics, a U.S. commercial-stage biopharmaceutical company focused on the discovery and development of unique RNA-targeted therapeutics for the treatment of rare neuromuscular diseases, has announced the grand opening of its Research and Manufacturing Center in Andover, Massachusetts.

The 60,000 square foot state-of-the-art facility significantly enhances Sarepta’s research and manufacturing capabilities as it expands its global commercial footprint and rapidly advances its Duchenne muscular dystrophy (DMD) pipeline, which comprises a robust exon skipping platform, and next generation approaches such as gene therapy and utrophin upregulation programs. The current focus of the manufacturing facility will be to advance Sarepta’s development pipeline and research programs. By the end of the year, Sarepta could have up to seven investigational DMD treatments in the clinic.

Ultimately, Sarepta’s goal is to help as many individuals with DMD as possible. To support this objective, Sarepta plans to expand its headcount in Andover by 100 percent over the next 12 to 18 months, adding to the approximately 50 employees currently based in Andover.

“Since first moving to Massachusetts in 2013, Sarepta has benefited enormously from the Commonwealth’s talented and highly-educated workforce,” said Edward Kaye of Sarepta. “This expansion underscores our ongoing commitment to patients with Duchenne and investment in the vibrant Massachusetts economy. We are grateful to Governor Baker, the Massachusetts Life Sciences Center, MassBio, the Town of Andover, and other state and local officials who support our mission to serve the greater DMD community.”

System pharmacology modelers throw light on drug discovery in Alzheimer’s

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InSysBio scientific group led by Tatiana Karelina developed a quantitative system pharmacology model of Alzheimer’s disease. First part published in CPT PSP shows how to design initial phases of clinical trials of new drugs and to interpret the data obtained.

Alzheimer’s is a chronic neurodegenerative disease which leads to the senile cognitive impairment and memory loss. Every third person older than 70 years suffers from it. Such changes are caused by functional disorders and subsequent death of neurons. However triggers of processes resulting in brain cell death are still remain unknown. That’s why there is no effective therapy for Alzheimer’s disease.

At the moment, the most common hypothesis is a theory of the toxic effect of the beta-amyloid protein, which accumulates in the brain with age, aggregating into insoluble amyloid plaques. The presence of these plaques in the brain is the main marker of Alzheimer’s disease (unfortunately, often found postmortem). Soluble (not aggregated into plaques) forms of the protein are considered to be toxic too.

All modern therapies act in one of the three ways: they can block production of soluble beta-amyloid, destruct protein before transformation into insoluble form, or to stimulate the plaque degradation. “Clinical trials for Alzheimer’s therapies have got one significant feature – their short duration. They last for no more than 5 years, whereas the disease can progress for decades. And early Phase I-II tests last for only few weeks. With such experiment design one can affect only on the processes of distribution and degradation of the soluble beta-amyloid forms. Therefore we developed this part of our model to analyze and predict the dynamics of the new generation of drugs, for instance the inhibitors of amyloid production”, says Tatiana Karelina, the head of the neurodegenerative disease modeling group, InSysBio LLC.

The first difficulty encountered by drug developers is the interpretation of the results obtained in animal tests. In general, most studies of the distribution of amyloid are carried out on mice: scientists inject a labeled protein into the mouse brain and observe the distribution of the radioactive label. Alternatively, the dynamics of amyloid in the presence of drugs is studied. Based on the data obtained, researchers can calculate the “therapeutic window” for the medication – a range of doses from the minimum effective to the maximum non-toxic. Then doses for human or monkey are calculated by using mass or volume scaling (for the body, the parameters change as many times as its mass or volume is greater than the mass or volume of the mouse).

The project team collected the data from the literature and derived a system of equations that fully described the existing results. Firstly the model was calibrated (i.e. the missing parameters were estimated) for the mouse, and then for the human and monkey. It turned out that one cannot use the scaling method to transfer results from rodents to primates (as it’s often done). The deduced mathematical equations have shown that not only the rate of production of beta amyloid (as activity of corresponding genes) differs, but moreover the blood-brain barrier is different in rodents and higher primates. At the same time, there was no significant difference between the human and the monkey, and the standard scaling can be used to translate predictions between them.

The next big question in Alzheimer’s clinical trials is how to understand if the drug affects specific target on the short term. It is impossible to observe the processes that occur in the human brain directly. Usually a cerebrospinal fluid probe is taken for analysis of the change in the concentration of beta-amyloid. Actually, these data strongly differ from the values of amyloid concentration in the brain, since the cerebrospinal fluid is strongly influenced by the processes taking place in the blood plasma, and amyloid demonstrates another dynamicsy.

“If there is such a big structural model calibrated on the big amount of data one can easily match the results of cerebrospinal fluid sample analysis with the real processes in the patient brain. This will greatly accelerate the development of new drugs and improve the accuracy of the therapy selection”, explains Tatiana Karelina.

Scientists report that their model allows to predict how these new drugs must be administered. Total daily dose can be diminished but should be split for several parts during the day, providing optimal brain efficacy. InSysBio team is confident that the systems-pharmacological modeling can greatly improve the development of drugs from Alzheimer’s disease and are already negotiating the introduction of technology with their partners in the pharmaceutical industry.

Novartis Access and government of Pakistan sign memorandum of understanding

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Ministry of National Health Services, Regulations and Coordination has signed a Memorandum of Understanding with a multinational healthcare company Novartis to help the poor gain access to treatment of chronic diseases.

Under the MoU, Ministry and Novartis will partner in the delivery of a program called Novartis Access. This program will provide access to a basket of high-quality medicines in the public sector targeting four key non communicable diseases (NCDs)–cardiovascular diseases, diabetes, respiratory illnesses, and breast cancer. These diseases kill one-fifth of Pakistanis between the ages of 30 and 70 years every year.

Products within the Novartis Access portfolio are among the world’s most frequently prescribed medicines for the targeted chronic diseases.

In pilot phase, Novartis Access medicines will be available through selected empanelled hospitals of district Islamabad under the Prime Minister’s National Health Program. The government is committed to making these NOT for SALE drugs available free of charge to patients within the program. The aim is to extend the program to all districts of Prime Minister’s National Health Program over time and work has already started in this regard.

Speaking after witnessing the signing, Saira Afzal Tarar Minister for National Health Services Regulations and Coordination, said: “I am very pleased over the signing of this Memorandum of Understanding with Novartis. Pakistan is grievously affected by the growth of non communicable diseases, and having access to high-quality treatment at low cost is a critical part of our work to lessen the impact of chronic disease in Pakistan. It is part of the Prime Minister’s ambitious plans to make Pakistan a true welfare state.”

The MoU was signed on behalf of Ministry of National Health Services, Regulations and Coordination by Director Prime Minister’s National Health Program Dr. Faisal Rifaq and CEO Novartis Mr. Shahab Rizvi.

This is the beginning of the Novartis Access partnership, and the first treatment against chronic diseases are expected to reach Pakistan soon.

Boehringer Ingelheim Inaugurates World-Class Biopharmaceutical Manufacturing Facility in China

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Boehringer Ingelheim inaugurated its commercial production site for biopharmaceuticals in Zhang Jiang Hi-tech Park of Shanghai (China). The site, with the first-phase investment of more than €70 million, is the first and only biopharmaceutical facility established by a leading multinational active biopharmaceutical manufacturer in China utilizing mammalian cell culture technology. With its global network of biopharmaceutical production sites in Biberach ( Germany), Vienna (Austria), Fremont (USA) and now Shanghai, the contract manufacturing business Boehringer Ingelheim BioXcellence™ is well positioned to fulfil strongly increasing demands of the biopharmaceutical industry for innovative products – both in China and worldwide.

“Our Shanghai facility plays an important role in our globally leading biopharmaceutical contract manufacturing business and embodies our continuous and long-term commitment to China,” said Hubertus von Baumbach, Chairman of the Board of Managing Directors at Boehringer Ingelheim. “With this investment, we expect to have a significant impact on the development of China’s biopharmaceutical industry to ultimately supply innovative medicines to patients following high quality standards.”

Boehringer Ingelheim has made this strategic move with the long-term goal to become a leader for contract development and manufacturing of monoclonal antibodies and recombinant proteins in China. Since 2014, Boehringer Ingelheim China Biopharmaceuticals has been operating its Good Manufacturing Practice (GMP) clinical material supply at 100L and 500L scales. After its inauguration, the facility will operate for clinical and commercial supply on a 2000L single-use bioreactor scale. It is designed to flexibly add additional 2000L single-use bioreactors and fill/finish capabilities to meet increasing market demand.

“As a global leader in biopharmaceutical contract manufacturing, Boehringer Ingelheim has an extraordinarily long history in the field of biotechnology, having been in the industry for over 35 years,” said Dr Luo Jiali, General Manager of Boehringer Ingelheim Biopharmaceuticals (China) Co Ltd. “We offer tailor-made contract development and manufacturing services to the biopharmaceutical industry, providing the entire production technology chain from DNA to the finished product under one roof. With our strong know-how, global network, technology, and international quality standards we can support innovative Chinese and international companies to industrialize their research results.”