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WHO Invites Applications from Drug Companies for Pre-Qualification of MDR TB Drugs
Mumbai: The World Health Organization recently invited drug companies to submit expression of interest to manufacture Bedaquiline and Delamanid-- the two new drugs for treating multi drug resistant Tuberculosis. Bedaquiline, sold under the brand name Serturu by Janseen (a subsidiary of Johnson & Johnson), and Delamanid, sold by Japanese drug maker Otsuka, are two of the new TB drugs approved by the US Food and Drug Administration and European Medicine Agency after 40 years. "The ultimate aim of this Express of Interest is to increase the range of selected products and sources available in relation to treatment for TB", the WHO said. "The recommended active ingredients, dosage forms and strengths listed in this document have been identified by WHO's Global TB Programme for effective treatment of people suffering from TB", the statement added. WHO said the expression of interest will be evaluated on the basis of product dossiers, which must include product data and information as specified in the guidelines for submission, manufacturing sites which must adhere to Good manufacturing practices and clinical sites.

 


 
Cabinet Approves Modicare with Budgetary Support of Rs 160 bn for 2 Years
New Delhi: The Cabinet has approved the Ayushman Bharat or National Health Protection Scheme (NHPS, also referred to as ModiCare), with budgetary support of Rs 160 billion for 2018-19 and 2019-20. Proposed to be portable across India, the scheme is intended to provide health care for at least 40 per cent of the population or 107.4 million households (500 million people). Each family will be entitled to health cover up to Rs 500,000 a year. The Cabinet also gave a nod to continuing the National Health Mission (NHM) till 2019-20, for a cost of Rs 852 billion. NHM provides free services to those below the poverty line and will complement the NHPS, said officials. NHPS will replace the Rashtriya Swasthya Bima Yojana (RSBY), where the annual health cover is up to Rs 30,000. To bring down costs, state governments will calculate package rates for treatment under the scheme. The cabinet approval includes setting up of nodal agencies by states or even a trust to run it. The health minister will head the scheme and take all decisions on policy. Coverage will be based on the Socio Economic Caste Census (SECC), which identifies poor in seven defined categories of deprivation. Some, such as Rajasthan and Gujarat, cover people other than those listed in these categories. The Karnataka government recently announced it would cover all state residents in its health insurance scheme, while West Bengal has decided not to implement NHPS. The Union health ministry and NITI Aayog had called state health secretaries to apprise them about NHPS. The Centre had earlier thought of an insurance scheme of Rs 100,000 but did not finalise it, as many states already had active schemes for more than that amount. Some states have provided insurance of around Rs 250,000 or even more in some cases. Transfer of funds will be through an escrow account directly, so that funds are transferred in an efficient and timely fashion, went an official statement. Transactions will be paperless and cashless. Private hospitals may also provide treatment under this scheme, once empanelled with the government, it added. A big challenge is to integrate the central and state schemes. There could be large overlaps and cost ramifications, since SECC data are not seeded with Aadhaar, the citizen identification. There could also be a possibility of exclusion of beneficiaries. So, states would be provided the flexibility to expand their existing schemes till the time SECC data was seeded with Aadhaar, say experts. Initially, the scheme was estimated to cost Rs 250 billion from both Centre and states for 2018-19 and 2019-20. This assumed Rs 650 per family from the Centre and Rs 432 from the states, including the administrative cost.

 


 
Zydus Cadila Gets USFDA Nod for Sedative Injection
New Delhi: Drug firm Zydus Cadila recently said it has received final approval from US health regulator to market Dexmedetomidine Hydrochloride injection used for sedation of intubated and mechanically ventilated patients. The approval from USFDA is to market Dexmedetomidine Hydrochloride injection 200 mcg (base)/ 2 ML and 100 mcg (base)/ ML single dose virals, Zydus Cadila said in a regulatory filing. The injection will be manufactured at the group's formulations manufacturing facility at Moraiya, Ahmedabad. The drug is indicated for sedation of intubated and mechanically ventilated patients during treatment in an intensive care setting and for sedation of non-intubated patients prior to and/or during surgical and other procedures, the company said.

 


 
Sun Pharma Gets USFDA Nod for Plaque Psoriasis Drug
Mumbai: Sun PharmaBSE 1.09 % Wednesday received a US Food and Drug Administration approval for its novel psoriasis drug TildraKizumab, the first new drug approval for India’s largest drug maker. The drug, which will be sold under brand name Ilumya, is expected to treat adults with moderate-to-severe plaque psoriasis, an auto immune disease. Illumya was a molecule that Sun Pharma acquired from US drug maker Merck in its early stage of development to strengthen its potential in the speciality drug business. “With the approval of Ilumya and our long-standing commitment in dermatology, we are focused on making a difference for people living with moderate-to-severe plaque psoriasis,” said Abhay Gandhi, CEO, North America, at Sun Pharma. “We are committed to working with all relevant stakeholders to make Ilumya available to appropriate people with plaque psoriasis.” With the FDA approval, Sun pharma will take on Johnson and Johnson, Novartis and Eli Lilly, which have similar products in the psoriasis space. J&J’s Stelara, Novartis Cosentyx and Eli Lilly’s Ixekizumab are the three products already in the US market.

 


 
States Must Recall Drugs, Combination Medicines Sold Without DCGI Nod
Mumbai: In an effort to close the tap on new drugs and combination medicines entering the market without regulatory approval, the Drug Controller General of India is writing to State regulators to review and recall such medicines already in the market. The DCGI has also urged the Health Ministry to alert State health authorities to not give manufacturing approvals to new drugs and combination medicines that have not been approved by the Central regulator or the DCGI. The development follows raids last week by the Central Drugs Standards Control Organisation (CDSCO) on manufacturing plants in Haridwar and Roorkee (Uttarakhand) that were making drugs not approved by the Central authority, which is against the law. Over 70 of the 118 products there were found to be without the DCGI’s approval, though they had been licensed by the State licensing authority. Dr. Eswara Reddy, the recently appointed DCGI, told BusinessLine that it was unfortunate that some authorities, especially in smaller States, were giving manufacturing approvals to companies, despite knowing that a new drug or combination medicine needs to be cleared first by the DCGI. While the office of the DCGI has sent show-cause notices to Mascot Healthcare and Ambic Aayurchem whose plants were raided, Reddy said show-cause notices would also be sent to the companies marketing these medicines which included Wockhardt, Medley Pharmaceuticals, Galpha Laboratories, Nectar Biopharma, Bilogical E and Dr Morepen among others. The DCGI's office is writing to other State authorities to not just review and recall such medicines in their markets but to also communicate that with other State authorities, a CDSCO representative said.

 


 
CDSCO to Create Forum to Discuss "Various Issues" Pertaining to Drug Regulations
New Delhi: India's apex drug regulator has decided to constitute a forum for its chief to meet pharma associations regularly as part of efforts to improve ease of doing business for the country's pharmaceutical industry. Two representatives of each association will be invited every quarter for a discussion with the Drug Controller General of India "on various issues" pertaining to the Central Drugs Standard Control Organisation, according to an office order dated March 14. The associations that are to participate in the forum are the Indian Pharmaceutical Alliance, Indian Drugs Manufacturers Association, Bulk Drugs Manufacturers Association, Federation of Pharmaceutical Entrepreneurs, Confederation of Indian Pharmaceutical Industry and Laghu Bhartiya Udyog, according to the order. "Invitation to these meetings shall strictly be by name and only the nominated personnel shall be allowed to attend the meeting. Subject experts from the association may be allowed in the meeting with prior permission only," stated the order. The discussions are expected to include any issues relating to the industry and the country's drug regulations, said a senior health ministry official. The meetings will further help the CDSCO assess the impact of its regulations on the industry and is also expected to help promote innovation, according to the official.

 


 
Merck Appoints Milind Thatte as MD
New Delhi: Drug firm Merck Ltd. recently said Milind Thatte has been appointed as managing director of the company effective from April 1, 2018. The company’s board today has appointed Milind Thatte, General Manager Healthcare, as an additional director and managing director of the company, in place of Anand Nambiar, Merck Ltd said in a BSE filing. Thatte’s appointment will become effective from April 1, 2018, it added. Currently, Thatte is responsible for the healthcare business of India and Frontier markets, Merck said. He heads the leadership team of healthcare sector and is the member of the country council of Merck India, it added. Shares of Merck Ltd were today trading 0.29 per cent higher at Rs.1,500.30 per scrip in the afternoon trade on the BSE.

 


 
Pharma Exports From Visakhapatnam Set to Become Hassle-Free
Hyderabad: Drug and pharmaceutical exports from Visakhapatnam sea port and airport will now become easy. To facilitate exports, a team of officials, including an assistant drug controller (ADC), drug inspector and an assistant drug inspector, has been appointed to function from this port city. According to Uday Bhaskar, Director–General, Pharmaceutical Exports Promotion Council (Pharmexcil), drug manufacturers and exporters were having difficulty till now in exporting by sea and air due to the non-availability of officials to complete the mandatory No Objection Certificate (NoC). “Though Visakhapatnam air and sea ports have been notified as eligible for export/import of drugs and pharmaceuticals two years ago, ADC/drug inspectors have not been appointed so far and the exporters had to come to Hyderabad for completing all formalities,’’ Uday Bhaskar said. Pharmexcil brought the issue to the notice of the Central Drug Standards Control Organisation (CDSCO) which facilitated the appointment of the official team, he said. This will be an advantage for drug exports as Visakhapatnam has a pharma city with presence of many global players such as Eisai Pharma and Indian multinational drug-makers. There have been plans to set up a second pharma city near Nakkappli in Visakhapatnam disrict as well. According to industry estimates, post-bifurcation of Andhra Pradesh in 2014, north Andhra region in the State is poised to emerge as a major destination for pharma firms due to its strategic location and airport, highway and sea connectivity. As Telangana has no sea port, few bulk drug manufacturers from Hyderabad, which is known as bulk drug capital of India, have also been exporting from Visakhapatnam. According to Pharmexcil data, pharma exports from India were at $16.4 billion during the financial year ended March 31, 2017.

 


 
‘Piramal Pharma Solutions Wins in Six Categories at the ‘CMO Leadership Awards 2018’
Mumbai: Piramal Pharma Solutions (PPS) is pleased to announce that it was recognized as a winner at the CMO Leadership Award 2018 in all six categories. The event was held on March 21st, 2018 in New York during the Drug, Chemical and Associated Technologies Association (DCAT) week. Piramal was recognized across all six categories - Capabilities, Compatibility, Expertise, Quality, Reliability, and Service. Vivek Sharma, Chief Executive Officer at Piramal Pharma Solutions said “We are delighted to be recognized again at the CMO Leadership Awards, this is the sixth consecutive year that we have won. To be one of the few service providers to be recognized in all six categories is humbling, and I would like to congratulate the entire PPS team for their efforts. I also want to thank our customers for their continued trust in us, as we seek to serve the needs of the end patients." Vivek Sharma added, “Piramal Pharma Solutions continues to make significant strides as we build around the pillars of Customer Centricity, Innovation, and Quality, with an emphasis on scientific excellence. We are focused on investing in our customers’ future needs, and be the ‘integrated partner of choice’ for pharma and biotech organizations, world-wide.” 7th edition of the CMO Leadership Awards, conducted by Life Science Leader magazine, provides industry veterans with accurate and reliable customer feedback to assist them in choosing a reputable partner for their development and manufacturing needs. The recipients are evaluated by the customers they have actually worked with, and include six critical categories of capabilities, compatibility, expertise, quality, reliability and service. An award in any of these categories adds to the distinction and reputation of CMOs throughout the global drug discovery, development, manufacturing and marketing industries. This year, more than 110 contract manufactures were assessed by 23 performance metrics in ISR’s annual Contract Manufacturing Quality Benchmarking survey. Piramal Pharma Solutions is the Contract Development and Manufacturing arm of Piramal Group with operations across North America, Europe and Asia. Piramal is a global leader in integrated solutions and offers a unique platform of services across the drug lifecycle – from drug discovery and development through commercial manufacturing of drug substance and drug product. With accreditations from regulatory bodies from North America, Europe and Japan, our development centers and manufacturing sites across the globe have a pool of over 700 scientists committed to research & development programs. Our capability as an integrated service provider & experience with various technologies enables us to serve innovator and generic companies worldwide.

 


 
Fortis Sells Hospital Business to Manipal, TPG Capital
Mumbai: After months of intense negotiations, the board of Fortis Healthcare Ltd. late on Tuesday night announced the sale of its hospital assets to Manipal Health Enterprises Pvt. Ltd. and buyout firm TPG Capital. The Fortis Healthcare board has also approved the sale of its 20% stake in SRL Diagnostics to Manipal Hospitals. The resultant entity, Manipal Hospitals, will be a publicly traded company listed on NSE and BSE, Fortis Healthcare said in a statement. Fortis Healthcare will become an investment holding company with a 36.6% stake in SRL Diagnostics. As part of the proposed transaction, Manipal promoter Dr. Ranjan Pai and TPG Capital will invest Rs3,900 crore into Manipal Hospitals. The funds will be utilized by Manipal Hospitals to finance the acquisition of 50.9% stake in SRL—20.0% from Fortis Healthcare and 30.9% from investors Avigo Capital, Jacob Ballas and International Finance Corp. (IFC), for which discussions are currently underway. The investment will support the proposed acquisition of hospital assets owned by RHT Health Trust and the growth of the hospitals and the diagnostics businesses, the statement added. The proposal will be put to vote before shareholders in a special meeting scheduled to be held in the next 30 days. The deal catapults TPG-backed Manipal Health to pole position among India’s largest hospital chains, with a combined annual revenue of Rs5,400 crore. The combined entity will also become the largest hospital chain in terms of number of beds (around 11,000 against current leader Apollo Hospitals Enterprise Ltd’s 4,550). “As an organization, we are thrilled with this transaction as it enables us to take the next bold step into our future,” said Fortis Healthcare CEO Bhavdeep Singh on the Fortis-Manipal deal. “We believe Manipal has built a terrific franchise and team and the coming together of our two organizations will be transformational for the healthcare industry.” Pai of Manipal Health said, “The companies make a compelling strategic fit in terms of complementary geographies, clinical strengths as well as a shared commitment to providing outstanding patient care. We have an excellent opportunity to leverage this strength to expand coverage and service delivery, in response to the burgeoning demand for world class healthcare.” Earlier in the day, Fortis Healthcare said it had received an unsolicited non-binding offer from Manipal Health Enterprises. Fortis said that its board is evaluating the proposal received on 23 March 2018. The board of the company has received an unsolicited non-binding indication of interest from Manipal Health for possible transaction with the company, Fortis Healthcare said in a filing to the BSE. “The said proposal is still under evaluation by the management and no firm decision in this regard has been taken by the board,” it had added. Fortis Healthcare has been without a defined promoter ever since the shareholding of founders Malvinder and Shivinder Singh dropped to a minuscule 0.77% following the sale of their pledged shares by some lenders in February this year. Currently, 80% of Fortis’s shares are with institutional funds and the public while 20% of pledged promoters shares are held by lenders Yes Bank Ltd and Axis Bank Ltd. In August 2016, the board of Fortis Healthcare approved the demerger of the diagnostics business—which consists of both its own centres and the 56.4% stake in SRL, which has diagnostics centres across India—and proposed listing it separately through a reverse merger with Fortis Malar Hospitals Ltd, a listed unit of Fortis Healthcare. Mint had reported earlier that bulge bracket PE Funds, including TPG, KKR, Bain and Singapore-Malaysia based IHH Healthcare Bhd were in the fray to acquire a significant stake in Fortis Healthcare.

 


 
Multisorb Hires Olivier Valentin as Business Development Leader – Healthcare Packaging EMEA
Buffalo, New York: Multisorb Technologies is pleased to announce the appointment of Mr. Olivier Valentin to the position of Business Development Leader for Healthcare Packaging supporting the valued customers throughout Europe, Africa and the Middle East. Valentin has been working in the European Pharma Packaging market for 20+ years. In addition to his years of business development experience, Valentin has earned a master’s degree in technical sales from Nancy University in France. Valentin, a seasoned business development professional is based in Lyon, France and will report directly to Frédéric Laurent, Commercial Director for EMEA. According to Frédéric, “His appointment reinforces our commitment to provide the European marketplace with world-class pharmaceutical and diagnostic stability solutions and superior technical support.” Multisorb Technologies has been the global leader in sorbent technology for over 50 years. By partnering with our customers to deliver the most effective solution, Multisorb has pioneered countless firsts in active packaging innovations.

 


 
Waters Corporation to Invest $215 Million in Precision Chemistry Manufacturing in Massachusetts
Following recent approval by its Board of Directors, Waters Corporation (NYSE: WAT) announced plans to significantly expand its precision chemistry operation in Taunton, Mass. The company anticipates investing approximately $215 million to build and equip a new state-of-the-art facility that will support rising global customer demand, as well as ongoing innovation in chemistry technology. The company's Taunton, Massachusetts site is responsible for bulk synthesis of chromatographic media which is critical to sample analysis for pharmaceutical, biopharmaceutical, materials, food, clinical and biomedical research applications. "Our portfolio of innovative precision chemistry products is critical to scientific advancements in the life, materials and food sciences," said Christopher J. O'Connell, Waters Corporation Chairman and CEO. The expansion of our Taunton facility will ensure Waters customers continue to benefit from the most innovative chromatography particle R&D and the highest quality production in the industry." The Taunton project is a noteworthy example of Waters’ capital allocation strategy, which prioritizes investing for long term growth and innovation. The return on this investment will be enhanced by the company's access to capital following U.S. tax reform, as well as the strong partnership of the Commonwealth of Massachusetts and the City of Taunton. The company plans to employ LEED certification standards as well as state-of-the-art manufacturing and process technology to construct a new center-of-excellence that meets output, cost, quality and sustainability objectives. Specific plans remain subject to refinement, however the company expects the new plant will be operational by 2022. Until then, the existing Taunton facility will fully meet operational and growth needs.

 


 
Sun Pharma’s Ilumya will Face Strong Competition in The US Market, Says GlobalData
Sun Pharma’s newly approved Ilunya will face strong competition from established IL-17 inhibitors, according to GlobalData, a leading data and analytics company. In March 2018 the FDA approved Sun Pharma’s Ilumya for the treatment of adults with moderate-to-severe plaque psoriasis (PsO), who are candidates for systemic therapy or phototherapy. Ilumya marks the second interleukin-23 (IL-23) inhibitor to gain FDA approval within the past year, following the approval of J&J’s Tremfya in July 2017. These recent approvals follow an influx of IL-17 inhibitors into the US PsO market between January 2015 and February 2017, including Novartis’ Cosentyx , EIi Lilly’s Taltz, and Valeant’s Siliq. The FDA approval of Ilumya was based on the results of the Phase III reSURFACE clinical development program, including two multicenter, double-blind, placebo-controlled trials (reSURFACE1 and reSURFACE2). In the reSURFACE1/reSURFACE2 studies, 64%/61% and 58%/55% of patients who received Ilumya (100mg) achieved a PASI75 score and PGA 0/1 at Week 12, respectively, compared with 6%/6% and 7%/4% of patients receiving placebo. In terms of safety, the drug comes with a warning for hypersensitivity, infections, and tuberculosis. The most common adverse events associated with use of Ilumya are upper respiratory tract infections, injection site reactions, and diarrhea. However, Tremfya and all three marketed IL-17 inhibitors are associated with similar warnings, and therefore GlobalData does not expect Ilumya’s safety profile to impact its performance in the US market. GlobalData anticipates that Sun Pharma will face an uphill battle marketing Ilumya in the US. J&J has an eight-month head start marketing Tremfya in the US, while IL-17 inhibitor Cosentyx reached blockbuster status in 2016, and Taltz and Siliq are not far behind. With nine biologics now approved for the treatment of PsO in the US – not to mention biosimilars – IL-23 inhibitors, especially Ilumya, face significant challenges to establish themselves in an already overcrowded market.

 


 
Agendia Announces CE Mark for NGS-Based MammaPrint® BluePrint® Kit Enhancing Access to Personalized Treatment for Breast Cancer Patients in Europe
Irvine, CA, USA, Amsterdam, the Netherlands (B3C newswire): Agendia, Inc., a world leader in personalized medicine and molecular cancer diagnostics, today announces that its next-generation sequencing (NGS)-based MammaPrint® BluePrint® Breast Cancer Recurrence and Molecular Subtyping Kit is now CE marked, enabling the Company to commercialize the device in Europe. Dr. Marjolaine Baldo, Commercial Vice President, EMEA at Agendia said: “Obtaining the CE mark for the MammaPrint BluePrint Kit is a huge milestone. For the first time, prestigious cancer centers across Europe will be able to run MammaPrint and BluePrint in their own labs, using their existing NGS instruments. As a result, patients will have better access to these vital tests and the significant benefits that they bring in personalizing breast cancer management. “We are proud of the drive, dedication and expertise of our team, partners and co-validation centers who, in recognizing the need for a decentralized solution, have worked tirelessly to develop, validate and deliver this important device to the market. We look forward to collaborating with leading breast cancer centers to provide them with these tools, enabling them to offer breast cancer risk-of-recurrence testing in-house.” MammaPrint analyzes 70 genes most associated with breast cancer recurrence to provide a binary Low or High Risk of cancer recurrence result, while BluePrint analyzes 80-genes which classify a patient’s breast cancer into functional molecular subtypes. This new device, which combines both MammaPrint and BluePrint, can aid physicians in personalizing treatment management decisions for their patients by identifying women with early-stage breast cancer who are at a genomic Low or High Risk for distant metastasis within five years. The MammaPrint BluePrint Kit is an RNA-sequencing based version of Agendia’s existing MammaPrint and BluePrint tests, which are currently performed centrally at the Company’s CLIA-certified and CAP-accredited laboratories in Irvine, CA and Amsterdam, the Netherlands. The Kit was developed in partnership with Agilent Technologies using their SureSelect target enrichment system and with Bluebee, who provided the secure and convenient data processing solution for clinicians. Dr. William Audeh, Chief Medical Officer at Agendia, said: “The clinical utility of the MammaPrint test has been demonstrated by the landmark MINDACT trial. It showed, with the highest level of clinical evidence, that 46% of patients identified as high risk for recurrence according to clinical-pathological factors and who would therefore be typical candidates for adjuvant chemotherapy were reclassified as Low Risk by MammaPrint, indicating that they were unlikely to benefit from chemotherapy. “With breast cancer being the most common cancer in women, affecting one in eight in Europe and with almost 500,000 new cases a year, the quality-of-life and cost benefits of identifying women previously selected for chemotherapy that may not have significant benefit from it is considerable.”.

 


 
Dolomite Offers Dedicated Microfluidics Platform for Drug Encapsulation
St. Neots, UK: Dolomite Microfluidics is simplifying research into drug encapsulation by offering a complete automated system for polymer micro- and nanoparticle generation. The company’s Drug Encapsulation System provides scientists with a quick, simple and scalable way of encapsulating drug samples, without the need for extensive microfluidics knowhow. The Drug Encapsulation System has been developed specifically to meet the demands of the drug development sector. It draws on Dolomite’s extensive microfluidics expertise to create a straightforward and flexible solution that offers ‘plug and play’ encapsulation of drugs into biodegradable polymeric particles (e.g. PLGA). The exceptional process control offered by this system allows reliable and reproducible generation of polymer particles with a narrow size distribution, and enables the user to ‘tune’ particle size from 50 nm to 100 μm to suit their application. This approach ensures high product purity and uniform API distribution, with almost 100 % encapsulation efficiency, simplifying optimization and validation studies. Once these studies are complete, the process can be readily scaled up using Dolomite’s Telos® High Throughput Droplet System. Backed by the company’s in-depth knowledge of the drug development market, these technologies put microfluidics-based drug encapsulation within reach for virtually any laboratory. Mark Gilligan, CEO of Dolomite, commented: “For over 15 years, we have been developing microfluidic technologies to provide reproducible particle synthesis, efficient API distribution and easy scale-up – all critical considerations for drug delivery applications. With Dolomite technology, microencapsulation has never been easier.”

 


 
Pricing Adjustments for CAR-T Therapies Likely to Take Place in 2018, Forecasts GlobalData
London, U.K.: Despite the promising findings that the currently approved chimeric antigen receptor T-cell (CAR-T) immuno-oncology (IO) therapies – Kymriah and Yescarta – are beneficial, practical challenges associated with their pricing and reimbursement remain, says leading data and analytics company GlobalData. Currently, Novartis’s Kymriah and Gilead/Kite Pharma’s Yescarta are the only CAR-T cell therapies available in the US market. The labels for both drugs contain boxed warnings for severe adverse events—cytokine release syndrome as well as neurologic toxicities. Upon launch, Kymriah (August 2017) and Yescarta (October 2017) were priced at $475,000 and $373,000 per treatment, respectively, placing these among the highest-priced drugs on the oncology market. Fern Barkalow, PhD, Oncology Director at GlobalData says: “With both Kymriah and Yescarta currently being considered for approval by regulatory authorities in the cost-conscious European market, pricing is even more of a concern to stakeholders. In addition, approval by the FDA for additional indications, will increase the available population for treatment and could have some effect on the cost of these drugs.” The majority of studies examining CAR-T -pricing have indicated that the costs are not justified. A fairly comprehensive study reported in February 2018 on the Health Affairs Blog claims that Novartis could lower the price of Kymriah by two-thirds and still achieve a profit. On the other hand, the Institute for Clinical and Economic Review’s (ICER) weighed in just a week or so after release of the Health Affairs site study, with release of a report stating that the drugs were appropriately priced. Barkalow concludes: "In the short term, affordability for those who stand to benefit from CAR-T treatment is of major concern. In addition to the cost of the drug itself, further costs will most likely be incurred, including potential hospitalizations in the case of severe adverse events. “Given the constraints of toxicity issues, insufficient real-world data on cost-effectiveness and efficacy, the eventual development of both off-the-shelf and next-generation therapies, and pressure from payers to reduce prices, GlobalData believes that price adjustments in the initial wave of approved CAR-T drugs will be seen starting in the second half of 2018.”

 


 
Orchard Therapeutics Strengthens Executive Leadership Team with Appointment of Chief Commercial Officer and General Counsel
London, UK, (B3C newswire): Orchard Therapeutics, a clinical-stage biotechnology company dedicated to transforming the lives of patients with rare disorders through innovative gene therapies, today announced two key additions to its executive leadership team, appointing Jason Meyenburg as chief commercial officer and John Ilett as general counsel & company secretary. Mark Rothera, Orchard’s CEO, stated: “I am delighted to welcome Jason and John to Orchard’s executive leadership team. We are making great strides toward building a leading, global, fully-integrated company bringing transformative gene therapies to patients. Both Jason and John’s skills and experience will be essential in delivering Orchard’s vision, especially as we prepare for potential commercialization of our lead program as early as 2019.” Chief commercial officer Jason Meyenburg brings extensive global commercialization experience to Orchard including the launch of multiple therapies for ultra-rare life-threatening diseases, new market entry strategies, market access and organizational development. He joins the company to lead the global commercialization of gene therapies for primary immune deficiencies and inherited metabolic disorders. Orchard anticipates submitting a biological license application for its lead program OTL-101 for ADA-SCID (adenosine deaminase severe combined immunodeficiency) in 2018. Until recently, Meyenburg served as chief commercial officer at Sucampo Pharmaceuticals, Inc. and Vtesse. Mr. Meyenburg also led commercial operations at Alexion in the U.S. and Latin America in the hematology, nephrology and metabolic business units, and held commercial leadership roles expanding access to the company's products in Europe, the Middle-East, Africa and Japan. Mr. Meyenburg holds a Bachelor of Science in Biochemistry from the University of Maryland and a Master of Business Administration from Duke University's Fuqua School of Business. Mr. Meyenburg commented: "I am thrilled to be joining a stellar leadership team at Orchard to advance the commercialization of gene therapies for patients with rare and life-limiting diseases around the world.” General counsel and company secretary John Ilett brings broad expertise in corporate, commercial and IP law. He has extensive experience in legal, compliance and corporate secretarial roles in international biopharmaceutical and life sciences companies. He also brings commercial and biotech intellectual property experience. He joins Orchard to lead the company’s legal function. Prior to joining Orchard, Mr. Ilett was a non-executive director at Oxular Limited and group general counsel & company secretary at Consort Medical plc. He held senior legal affairs roles at several companies operating in the rare disease space including Synageva, BioMarin and Oxford GlycoSciences. Mr. Ilett is a qualified solicitor. He received his Bachelor of Law degree in Business Law from City of London, his postgraduate diploma in EC Competition Law from King's College, London and a postgraduate diploma in Intellectual Property Law from Queen Mary University of London. Mr. Ilett commented: “This is an exciting time to be joining Orchard with its advanced pipeline in gene therapy. Through my prior roles, I have developed a deep passion for the orphan disease sector and look forward to contributing toward the development of life transforming gene therapies.”

 


 
Senomyx Expands Cool Program Collaboration with Firmenich
SAN DIEGO, (PRNewswire): Senomyx, Inc. (NASDAQ: SNMX),a leading company using proprietary taste science technologies to discover, develop, and commercialize novel flavor ingredients and natural high intensity sweeteners, and Firmenich, the world's largest privately-owned company in the fragrance and flavor business, announced today the expansion of their Cool Program collaborative agreement. With this amendment to our Cool Collaboration Agreement, Firmenich continues its long-standing tradition of investing in innovation. Under terms of the amended agreement, Firmenich will be granted an exclusive license to CoolmyxTM CL19 and related cooling ingredients in all product categories. This amendment also includes a license expansion for product categories covering applications in the flavor, oral care and consumer product markets. "During the second quarter, Senomyx engaged an advisor to pursue strategic options related to certain flavor ingredient assets," stated John Poyhonen, President and Chief Executive Officer of Senomyx. "We have been gratified by the significant third-party interest in this family of cooling ingredients, and we believe that Firmenich's exclusive license of Coolmyx CL19 is an outstanding opportunity for both companies. Signing this amended agreement is consistent with our goal of securing non-dilutive funding to support our corporate priorities." Under the terms of the amended agreement, Senomyx will receive an upfront payment of $10 million for the exclusive license and pre-payment of Cool Program royalty obligations covering the period from 2018 through 2020. Under the terms of the amended agreement, Firmenich's royalty payment obligations will resume in 2021 and will continue through the length of the agreement.

 

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