Q2 2018 Highlights
HeartFlow gets NHS England Innovation and Technology Payment
NHS England has chosen the HeartFlow® FFRct Analysis as part of the Innovation and Technology Payment (ITP) programme.
The HeartFlow Analysis was chosen as a new technology to be funded by ITP through a competitive process comprised of almost 300 applicants.
It is the only ITP recipient focused on coronary artery disease (CAD), which affects 2.3 million people in the UK.
The goal of the ITP is to create the conditions necessary for proven innovations to be adopted faster and more systematically throughout the NHS.
Through a competitive process, NHS England identified innovations where financial or procurement barriers were preventing widespread adoption, despite strong evidence that broader adoption would deliver efficiency and improve quality in healthcare.
NHS England will provide reimbursement for usage of these technologies through the ITP program to support their adoption throughout the NHS.
The ITP designation for the HeartFlow Analysis follows medical technology guidance issued by the National Institute for Health and Care Excellence (NICE) in February 2017, which recommended the HeartFlow Analysis as the most cost-effective option, following a coronary computed tomography angiogram (CTA) when additional information is needed by the clinician for patients with stable chest pain.
Additionally, NICE clinical guidelines recommend coronary CTA as the initial diagnostic test for most patients with stable chest pain.
NodThera secures $40 million Series A
NodThera, a Cambridge U.K. based biotech company focused on the discovery and development of next generation NLRP3 inflammasome inhibitors for the treatment of diseases driven by chronic inflammation has announced it has closed its Series A financing round for a total of £28 million ($40 million).
The Series A second closing was co-led by leading healthcare investors Sofinnova Partners and 5AM Ventures, with further participation from Epidarex Capital and F-Prime Capital Partners.
NodThera was created and seed funded by life science investor, Epidarex Capital in 2016 based on earlier research conducted at Selvita, a Polish drug discovery company which remains a shareholder in NodThera.
NodThera is developing small molecule inhibitors of the NLRP3 inflammasome, a multi-protein complex which initiates an innate immune response in the body. NodThera’s next generation approach could bring new treatment options to patients in areas where current standard of care is sub-optimal or non-existent across a wide range of therapeutic areas related to chronic inflammation.
The NodThera strategy is to develop its leading drug candidate through to proof-of-concept in humans in an inflammatory disease and to bring forward further drug candidates specifically addressing high unmet medical needs such as neurodegenerative diseases and certain cancers.
Henrijette Richter, PhD, Managing Partner of Sofinnova Partners and Scott Rocklage, PhD, Founding Partner of 5AM Ventures will both join the Board of Directors with Henrijette Richter additionally serving as Chair.
Amazon enters Online Pharmacy market and also eyes health tech sector
Amazon and PillPack have announced that they have entered into a definitive merger agreement under which Amazon will acquire PillPack.
No financials were disclosed but Amazon said it expects the deal to complete by H2 2018.
Earlier this year, CNBC reported that Walmart had been working on a deal to acquire PillPack for a price tag of “under $1 billion. PillPack was last valued at $361 million in 2016.
News of Amazon’s acquisition caused shares in rival healthcare firms to tumble, with CVS Health and Walgreens Boots Alliance stock falling by more than 8% on the back of the announcement.
PillPack, which was founded in 2013, is available in every US state except Hawaii, has raised about $120m from investors, and was named one of Forbes ‘Next Billion-Dollar Startups’ in September 2017.
Amazon declined to comment on whether it has plans at this stage for PillPack style international expansion outside the US.
In other news, Amazon is understood to have created a research division with a view to extending its reach into healthcare technology, cancer research and medical records.
According CNBC reports, the company’s Grand Challenge research group has been working with Fred Hutchinson Cancer Research Center to develop machine learning tools for oncology.
A Fred Hutch spokesperson told CNBC that it has several early-stage projects underway with tech pioneers, including Amazon, Microsoft and Tableau Software, and that hopes to preview them later in the year.
According to CNBC, Grand Challenge sits within the Amazon Web Services divison and team members are chosen through its annual “Think Big” competition, involving presentations of the next big ideas.
Amazon has already explored into the pharmacy and drug distribution spaces. Some industry analysts believe the company could dive in as early as next year.
Earlier this year, Amazon hired FDA’s former chief informatics officer, Taha Kass-Hout, M.D., who was the agency’s inaugural CIO who led the FDA’s DNA sequencing data programme – PrecisionFDA.
Virta Health Raises $45 Million to advance T2D Reversal
San Franciso based, Virta Health, the first company with a clinically-proven treatment to safely and sustainably reverse type 2 diabetes (T2D) and other chronic metabolic diseases, without the use of medications or surgery, has raised a $45 million Series B funding round, bringing its total equity funding to $75 million to date.
According to the most recent data from the Centers for Disease Control and Prevention and American Diabetes Association, 30 million people in the U.S. have diabetes, creating an estimated $327 billion economic burden with cardiovascular disease, a common comorbidity, even more prevalent, affecting more than 1 in 3 adults (about 92.1 million) U.S. adults, costing the nation over $316 billion.
Diabetes UK estimates that the U.K.s National Health Services spends £14bn, or ~10%, of its annual budget on the disease.
Last year, 14% of the global population was obese and 9% had type 2 diabetes, according to a new study, presented at the European Congress on Obesity in Vienna. The study predicts that by 2045, 22% will be obese and 12% will be suffering from type 2 diabetes, if obesity continues to climb,
Virta’s clinically-proven treatment, reverses type 2 diabetes and significantly improves several chronic comorbidities. Recently released 1-year peer-reviewed results from Virta’s ongoing clinical trial demonstrated that the Virta Treatment can quickly reverse and then sustain T2D reversal at one year while substantially improving obesity, blood pressure, cardiovascular disease risk and inflammation.
60 percent of patients receiving the Virta Treatment had T2D reversed and 94 percent of insulin users reduced or stopped usage altogether.
Virta estimates that the medical and pharma cost savings alone total $9,600 on average per patient in the first two years.
Virta will use its Series B investment to further improve outcomes, scale the Virta Treatment and invest into growth to help millions of people suffering from reversible chronic diseases.
Key existing investors including Venrock, Obvious Ventures, Creandum, Caffeinated Capital, and Max Levchin’s SciFi VC participated in the round, along with new investors including Founders Fund and Playground Global.
Poseida Raises $30.5 Million in Series B Financing
Poseida Therapeutics Inc., a San Diego-based company translating best-in-class gene engineering technologies into lifesaving cell therapies, has announced the company raised $30.5 million in an oversubscribed Series B financing round, led by Longitude Capital.
Additional new investors included Vivo Capital and the Tavistock Group, joined by existing investor Malin Corporation plc. In conjunction with the financing, David Hirsch, M.D., Ph.D., managing director at Longitude Capital, has joined Poseida’s Board of Directors.
Proceeds from this financing will be used to further advance a pipeline of autologous and allogeneic CAR-T immunotherapies, as well as gene therapies, using Poseida’s suite of gene engineering technologies.
Quidel Corporation opens new European facility in Ireland
Quidel Corporation a provider of rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems, has officially opened its new Business Service Centre in Galway, Ireland. It is the company’s first expansion into international facilities.
The new premises will support Quidel’s growing international business, a portfolio that has experienced substantial growth due to the recent acquisition of Alere’s Triage® business.
The company expects to create 75 new in jobs in Finance, Human Resources, Customer, Service, Technical Support, Sales, IT and Legal.
The company, headquartered in San Diego, California, employs approximately 1,200 people in operations in North America, Europe, Latin America, Japan, and other parts of Asia.
Medidata Defines Announces Acquisition of SHYFT Analytics
Medidata, a software as a service solutions for clinical trials, has announced that it has entered into a definitive agreement to acquire SHYFT Analytics which will bring together leading platforms for clinical development, commercial and real-world data analytics.
Medidata will acquire SHYFT for a total consideration of $195 million, subject to customary closing adjustments, inclusive of Medidata’s 6% ownership in SHYFT’s business, and funded with existing cash on Medidata’s balance sheet.
The acquisition has been unanimously approved by the Boards of Directors of each company and the stockholders of SHYFT, and is expected to close in the second quarter of 2018, subject to customary closing conditions.
The combined platform will deliver market-leading applications, services, and proven data science capabilities, powered by the largest global pool of research data, companies’ own CRM data, 3rd party commercial data, and real-world data sources.
Finland’s Kaiku Health raises €4.4 million to accelerate digital therapeutics trials
Helsinki based, Kaiku Health, a provider of patient monitoring software for healthcare providers across Europe, has raised €4.4 million in a Series A round.
Kaiku Health – previously known as Netmedi – will use the funding to advance its international expansion and conduct several clinical trials validating its digital therapeutics offering.
The objective is that through the structured capture and analysis of patient-reported data, clinicians will be able to evaluate the effectiveness of therapies and to detect and treat concerns earlier.
The Kaiku platform is used in routine care by over 30 clinics in Switzerland, Germany, Italy, Sweden, and Finland and more than 64,000 patient engagements to date.
The investment was led by Debiopharm Innovation Fund SA and Tesi with participation from Finnish funds, Prodeko Ventures and existing investors Reaktor Ventures, Metsola Ventures and Athensmed.
Rapid Micro raises $60M to advance microbial detection
Massachusetts-based Rapid Micro Biosystems has raised $60 million to accelerate the growth of its microbial detection business.
Rapid Micro Biosystem’s Growth Direct™ – is the first growth-based system to fully automate traditional microbial testing – detects contamination more quickly at manufacturing sites, enabling manufacturers, shorten manufacturing cycles, reduce product losses and improve quality control.
The financing will enable Rapid Micro up to expand its commercial reach and build out operational capacity to support technology that automates the detection of microbes at production plants.
The funding was led by new investors Bain Capital Life Sciences and Xeraya Capital with Asahi Kasei Medical, also participating along with existing investors Longitude Capital, Quaker Partners, TVM Capital and Richard K. Mellon and Sons following their participation in Rapid Micro’s $25 million series C round in 2015.
Metacrine raises $65M for clinical testing
Metacrine has raised $65 million in a series C round to fund the clinical development of its early stage program in non-alcoholic steatohepatitis and gastrointestinal diseases.
The San Diego-based biotech’s program targets the Farnesoid X Receptor (FXR), linked to diseases such as primary biliary cholangitis and NASH.
Some predict the fatty liver disease will outpace alcoholism and hepatitis as causes of transplants within the next decade.
Metacrine’s financing round was led by Venrock Healthcare Partners and added new investors Franklin Templeton Investments, Deerfield Management, Arrowmark Partners, Invus, Lilly Asia Ventures, Vivo Capital and others.
Since its foundation in 2015, Metacrine has raised up $125 million in equity financing, including a $22 million series B round in December 2017.
Health Tech Murj in $8.5M Series B
Murj, Inc., the Santa Cruz based cardiac devices company has raised $8.5 million in a Series B financing to progress its digital solution for the adoption of implantable cardiac medical devices to help clinicians streamline and improve care for patients.
Murj has developed a cloud-based workflow intended to lighten clincian workload which pulls in data on patients and their devices to make for easier monitoring and processing.
The funding round was led by Longitude Capital, with participation from True Ventures and other existing investors.
Murj previously received $4.5 million in its series A round in April 2017.
CMR raises $100M Series B to commercialize surgical robot
Cambridge U.K. based CMR Surgical, has raised $100 million in a series B to commercialize its surgical robot.
The funding enables CMR to start promoting portable, modular Versius devices intended to make robotic surgery routine.
CMR’s objective is is to design versatile and affordable robotic devices that become routine and commonplace in operating theatres but achieving that will require significant investment.
Zhejiang Silk Road Fund is a new investor joining A round funders Escala Capital Investments, LGT, Cambridge Innovation Capital and Watrium.
CMR’s business model is based around manged service rtaher than the more traditional routes of outright purchase. Instead of a multi-million dollar capital expenditure, CMR customers will offer hospitals a managed, comprising technology, training, instrumentation and support. CMR belives the model will make robotic surgery viable for a significantly wider healthcare market.
Martin Frost, CMR CEO, has previously said the company may need £100 million ($134 million) to execute its strategy. Although, both its business model and its devices remain yet unproven, with its $100 million series B round hot on the heels of its $46 million series A round last September, CMR would appear to now have the funding at least, to make it’s mission fly.
EIP Pharma gets $20.5M for Alzheimer drug
Massachusetts-based, EIP Pharma has closed a $20.5 million series B round to support its phase 2b program of its Alzheimer’s treatment, neflamapimod.
The funding will also help team expansion and support the exploration of other central nervous system disorders.
EIP Pharma licensed neflamapimod from Vertex in 2014. EIP is hoping to reverse synaptic dysfunction rather than just delay it. Three weeks of treatment reversed cognitive deficit in animals, while a pair of phase 2a trials that ran for six and 12 weeks led to improvement in episodic memory function, according to the company said.
EIP aims to finish enrolling its phase 2b study by the end of the year. The study will involve about 150 patients, half of whom will take neflamapimod capsules daily, while the other half will receive placebo. It will run for six months, with a primary endpoint of improving episodic memory. Its secondary endpoints include broader measures of cognition and function, as well as markers of neurodegeneration in the spinal fluid.
Q1 2018: EUROPE
PredictImmune secures $5.9M funding for Crohn’s biomarker
PredictImmune, a U.K.-based developer of diagnostics, secured $5.9 million (£4.3 million) in funding from the Wellcome Trust to be used for a multi-site clinical trial of its prognostic biomarker test for treatment guidance related to Crohn’s disease.
The company’s biomarker ‘PROFILE’ test is a simple whole blood test based on genetic markers that provides a first diagnosis of disease and a prediction of the course it may take, thereby identifying a patient’s likely to experience severe relapse.
Last year, PredictImmune raised $6.4 million (£4.7 million) in series A funding for the commercial development of laboratory services and diagnostic kits for routine use in clinical gastroenterology in Europe and the U.S.
MorphoSys exceeds IPO expectation with $208M for cancer R&D
German biotech MorphoSys has raised $208 million to develop its anti-CD19 antibody MOR208. Its IPO haul gives the company a $500 million fund to develop the drug it believes, provides safer, more durable efficacy without the cost or complexity of cell therapies.
MorphoSys anticipated a $150 million IPO delivery but it raised nearly 40% more than anticipated.
MorphoSys delivered its IPO without input from existing investors who held meaningful minority stakes in MorphoSys going into the IPO but opted against adding to their holdings.
MorphoSys believes it has a schance of winning FDA approval for MOR208 in relapsed or refractory diffuse large B cell lymphoma (DLBCL) on the strength of midphase data, setting it up to bring the antibody to market in the first half of 2020.
WuXi Biologics to Invest €325 million on Biomanufacturing facility in Ireland
Hong Kong-listed biologics tech, WuXi Biologics, is to invest €325 million and create 400 new jobs over five years in a new biologics drug substance manufacturing facility in Ireland.
A total of 48,000L fed-batch and 6,000L perfusion bioreactor capacity will be installed, representing the world’s largest facility using single-use bioreactors.
The 26-hectare campus is the company’s first site outside of China.
Mereo abandons IPO, blaming ‘challenging’ stock market conditions
London-based Mereo BioPharma has withrwan its plans to list its stock on Nasdaq.
The Novartis-backed biotech had set a target of $80 million (€66 million) to take its brittle bone disease drug into phase 3 but struggled to raise funds on its required terms.
Mereo blamed the setback on “challenging stock market conditions.”
In a statement, CEO Denise Scots-Knight, Ph.D., talked up the “positive feedback and strong levels of institutional interest” Mereo received, but this failed to translate into a successful offering.
The setback leaves Mereo without a cash jolt. As of the end last year, Mereo had $73 million in cash and short-term deposits and investments – sufficient to keep momentum but short of the sum needed to execute the R&D strategy sketched out in the IPO filing.
Almac to invest €34m in Irish campus
Irish pharma group, Almac, is to invest £30 million (€34 million) in a new campus in Ireland that will be ready for operation by January 2019.
The investment includes a new laboratory, a packaging facility for drugs, and a 79,000 sq ft EU Distribution Centre for clinical trial supply. The Irish campus is part of a global expansion that has seen Almac grow its operation capabilities and staff in the US, UK and Asia. It currently employs almost 5,000 people worldwide.
Vaccitech secures £20m Series A with GV, OSI and Sequoia China
Vaccitech, an Oxford University spinout company which is developing a universal flu vaccine and other vaccine-related products, has secured £20m ($27.1m) in Series A financing.
The round was co-led by new investors GV, Sequoia China, and existing backer Oxford Sciences Innovation, which manages a £600m fund aimed at Oxford University spinouts. Neptune Ventures joined in participation.
In total, Vaccitech has now raised £30m since inception in 2016.
Vaccitech is currently a clinical stage company, with six products that are based on inducing cellular immune responses using non-replicating viral vectors for treatment or prophylaxis against diseases at various stages.
Q1 2018: USA and Rest of World
BioCryst and Idera announce merger plans
BioCryst and Idera have announced plans to create a company focused on the development and commercialization of medicines to serve patients suffering from rare diseases.
Samsung BioLogics’ stock slides after regulators query accounting practices
Samsung BioLogics has seen its value slide, by almost $6 billion after South Korean securities regulators announced it had notified the company that it broke accounting rules to inflate its net profit before going public.
The near 20% drop in value was the company’s biggest intra-day share price fall since it went public in 2016.
The company denies it broke accounting rules which were supported by the country’s top three accounting firms and added that it may sue the regulator.
The company said the profit at the centre of the allegation was the result of following IFRS accounting standards and dates back to when its books for 2015 were collated.
Ultragenyx announces Public Offering pricing and E.U. Marketing Authorization
Ultragenyx Pharmaceutical Inc. the Novato, California biopharmaceutical company focused on the development of novel products for rare and ultra-rare diseases, announced the pricing of its underwritten public offering of 4,385,965 shares of its common stock at a price to the public of $57.00 per share, resulting in gross proceeds of $250 million before underwriting discounts.
In addition, Ultragenyx and Kyowa Kirin International PLC announced that Crysvita (burosumab) has received a positive European Commission decision granting a conditional marketing authorization to Kyowa Kirin for the treatment of X-linked hypophosphatemia (XLH) with radiographic evidence of bone disease in children 1 year of age and older and adolescents with growing skeletons.
Aimmune announces public offering of common stock
Aimmune Therapeutics announced that it had commenced an underwritten public offering of USD 150,000,000 of shares of its common stock.
The net proceeds from this offering will be applied to fund its ongoing clinical development of AR101, regulatory activities related to the potential filings with the FDA and the EMA and the potential commercialization of AR101.
Sanofi suffers further diabetes sales slide in U.S.
Following a 30% fall in diabetes product sales in the US in Q4 2017, after CVS Health and UnitedHealthcare axed top sellers, French pharma giant Sanofi has revealed that its Q1 2018 diabetes sales dropped another 27% due to the decline for diabetes drugs under Medicare Part D
During its first-quarter earnings announcement, Sanofi revealed that price cuts on Lantus also came into play as generic competition increased. All told, Lantus sales in the U.S. dropped 28.7% to €498 million ($602 million) during the quarter. That caused worldwide sales of the product to fall 13.5% to €1,108 million ($1.3 billion).
Though Sanofi still managed to beat its Q1 earnings expectation, it had to cut its operating expenses in order to do so.
Rapid Micro raises $60M to grow microbial detection business
Massachusetts-based Rapid Micro Biosystems has raised $60 million to accelerate the growth of its microbial detection business.
The financing sets Rapid Micro up to expand its commercial reach and build out operational capacity to support technology that automates the detection of microbes at drug production plants.
Major pharma and biotech companies have adopted the technology at some plants, but the overall penetration of automated testing is low, creating an opportunity for Rapid Micro and its backers.
Bain Capital co-led the $60 million financing with fellow new investor Xeraya Capital. Another new backer, Asahi Kasei Medical, also participated in the round. Existing investors Longitude Capital, Quaker Partners, TVM Capital and Richard K. Mellon and Sons returned, having helped Rapid Micro to a $25 million series C round in 2015.
Merck R&D and Qiagen announce major U.K. Investments
Merck is to invest up to £1 billion ($1.3 billion) to open a drug research facility in London.
The announcement was widely welcomed by the UK’s beleaguered Brexit Government and heralded as evidence that big industry is still intent in UK based investment, despite the current post-Brexit uncertainties.
Meanwhile, Germany’s Qiagen will expand its investment in its DNA-based diagnostics for personalised healthcare at its existing campus in Manchester, England.
The U.K. life sciences sector is one of the UK’s fastest developing industries, with a turnover in excess of £64bn and employing 233,000 throughout the U.K.
Fresenius Kabi to invest $100M, add 445 jobs in North Carolina
Following its $4.75 billion acquisition of generics maker Akorn and its $730 million purchase of Merck KgaA’s biosimilars portfolio, Fresenius Kabi says it will now spend more than $100 million and add 445 jobs over 5 years, at its syringe and drug-making site in Wilson, North Carolina.
The deal includes $7.2 million in state aid over a 12 year period.
The investment is in addition to the $250 million that the company is investing in a sterile injectables manufacturing site in Melrose Park, Illinois.
Regeneron Announces $100 M investment in Ireland
Regeneron Pharmaceuticals, Inc. one of the fastest-growing companies in the global biotechnology industry, today announced further expansion of its Industrial Operations and Product Supply (IOPS) bioprocessing campus in Ireland with an investment of $100 million and additional 300 jobs, bringing the total expected employment at the site to 800 and a total investment to $750 million.
Regeneron’s 400,000 square foot, state-of-the-art production facility in Limerick, SW Ireland is the largest scale bulk biologics production facility in Ireland and one of the largest biologic production operations in the world. The additional $100 million investment will support the construction of a number of manufacturing suites to increase drug substance production capacity and enable the company to meet demand for its life-transforming medicines for patients with serious diseases
Akari Therapeutics Announces Pricing of Public Offering
Akari Therapeutics (NASDAQ:AKTX), a biopharmaceutical company focused on the development and commercialization of innovative therapeutics to treat orphan autoimmune and inflammatory diseases has priced its previously announced underwritten public offering of 3,480,000 American Depositary Shares, or ADSs, at a public offering price of $5.00 per ADS.
Akari expects to receive gross proceeds of approximately $17.4 million, assuming no exercise of the underwriters’ option to purchase additional ADSs.
Clinigen strengthens global access with Japanese purchase
With an already a strong managed access presence in Europe, Clinigen is now one step closer to becoming the field’s global leader.
The company has bought International Medical Management Corporation (IMMC), Japan’s largest supplier of unlicensed medicines.
The news came one year after the CRO and pharma hybrid launched its Japanese business with the establishment of Clinigen K.K., and a month later, it decided to buy up compatriot Quantum Pharma for £150.3 million ($200 million).
Clinigen made a move in the Japanese market in 2015 via an acquisition of medicines and medical devices supplier Link Healthcare.
Biotime, Inc. Announces Closing of Public Offering
BioTime, Inc. (NYSE American and TASE: BTX), a late stage clinical biotechnology company focused on developing and commercializing products addressing degenerative diseases has announced the closing of its previously announced public offering of 9,615,385 shares of common stock, including 1,442,308 shares sold pursuant to the underwriters’ exercise in full of their option to purchase additional shares.
The offering price to the public was $2.60 per share, and gross proceeds from the offering were approximately $28.8 million.
BioTime intends to use the net proceeds from this offering for general corporate purposes, including to fund clinical trials, research and development activities and for general working capital.
Elsalys Biotech acquires worldwide rights of LEUKOTAC
France based Elsalys Biotech, a new player in immuno-oncology, has acquired from Jazz Pharma, the development and commercialization rights of LEUKOTAC® (inolimomab), a monoclonal antibody that has recently demonstrated its clinical superiority in the treatment of Steroid-Resistant acute Graft-versus-Host Disease (steroid-resistant aGvHD), an orphan disease with very poor prognosis.
Immune Design Prices $80.0 Million Public Offering of Common Stock
Immune Design Corp. (Nasdaq:IMDZ) has announced the pricing of an underwritten public offering of 19,500,000 shares of its common stock at a price to the public of $4.10 per share. All of the shares of common stock are being offered by Immune Design. Proceeds to Immune Design from this offering are expected to be approximately $80.0 million, before deducting underwriting discounts and commissions and estimated offering expenses.
Immune Design plans to use the net proceeds of the offering to fund its Phase 3 clinical trial for CMB305 in synovial sarcoma patients, continue to develop CA21, its next-generation prime-boost product candidate, and file an IND for its initial development, as well as for working capital and general corporate purposes.
NorthSea Therapeutics Secures €25 Million Funding for Clinical Development of NASH Drug
NorthSea Therapeutics, a newly established Dutch biotech company, has completed a €25m Series A funding for the development of icosabutate, as a novel, oral approach for the treatment of non-alcoholic steatohepatitis (‘NASH’).
The fundraising was led by Forbion and BVG, with the participation of Novo Seeds and New Science Ventures.
NASH is the leading cause of liver disease, affecting a total of 15-30 million patients in the US, Western Europe and Japan.
According to Allergan, NASH is now the leading cause of liver cirrhosos and cancer and nothing currently exists to effectively treat it. Earlier this year, French Biopharma Genfit estimated the untapped NASH market to be worth €37Bn per annum.
BaseHealth Raises $8.5 Million in Series C Funding
BaseHealth, the creator of the first predictive, evidence-based, and data-driven population health management solution, has announced that it has received an overall investment of $8.5 million, including $2.5 million from lead investor HBM Healthcare Investments (SIX HBMN), a listed healthcare investment company with net assets over $1 billion.
Strongbridge Biopharma plc Closes Public Offering of Ordinary Shares
Strongbridge Biopharma plc (NASDAQ:SBBP) has announced the closing of its previously announced underwritten public offering of 4,000,000 ordinary shares. The total net proceeds of the offering are approximately $23.4 million. The Company intends to use the net proceeds from the offering for investment in expanded commercial infrastructure for Keveyis, continued development of Recorlev and veldoreotide, commercialization expenditures, and for other general corporate purposes
Pfizer weighing-up Sale of Consumer Health Business
Pfizer says it weighing up its consumer health business, with a “range of options” being considered including a spinoff, a sale, and business as usual.
The division generated sales of $3.4 billion in 2016 and its porfolio includes OTC households brands such as Centrum, Advil, Chapstick and AnbesolA divestment would not be alien to Pfizer who sold its baby food business to Nestlé in 2012 and its animal health unit to Zoetis in 2013. The question is whether a buyer can be enticed, especially with Merck KGaA suggesting it is is considering its options with its consumer portfolio, including a full or partial sale or strategic partnerships
J&J investing $350M in EU biologics facility
Johnson & Johnson is making a significant investment in its biologics capacity with the announcement of a $350 million expansion project in Ireland.
The expansion will see its Janssen drug unit investing more than €300 million to expand its County Cork facility by 205,590 square feet. The project will get underway this month and is expected to take two years to complete. The company says it will create 200 new on-site jobs once up and running.
As well as a new manufacturing facility, the project will also expand existing warehouse capacity, laboratory and administration structures and expansion of its wastewater treatment.
According to Kyran Johnson, Janssen’s GM of supply chain in Ireland, the new operations will increase API capacity for drugs that treat multiple myeloma, rheumatoid arthritis and Crohn’s Disease
Takeda expanding E.U. presence while AstraZeneca ponders U.K. exit
Takeda is to make another investment in its E.U. production operations
It is understood they will invest up to €100 million in a new manufacturing plant at its site in Dublin, Ireland Dublin, Ireland
In a statement, the company said, “As part of the company’s future growth strategy, Takeda is seeking advance planning permission to facilitate the potential expansion of its Grange Castle site. By having planning permission already in place, Takeda Ireland Limited will be better positioned to win more investment in the future. At this time, we are not disclosing further details on the expansion or investment”.
While Takeda’s plans are seen as a sign of faith in a post-Brexit EU, other companies have been hesitant to progress E.U. based projects until the political picture is clearer.
Leif Johansson, chairman of Anglo-English AstraZeneca, has already flagged that the company may have to pull some manufacturing and research operations out of the UK, if there is not a workable Brexit solution for the UK from the European Union.
“If something doesn’t happen to take away the current uncertainty it will become a big and important matter for us. Moving manufacturing takes several years.” Johansson said in an interview with a Swedish newspaper
Avara Pharma aquires third plant in 3 months
Contract manufactuer, Avara Pharmaceutical Services has completed its third acquisition in the last three months.
Following its acquisition a Pfizer sterile injectables facility in August, and a GSK consumer plant in September it has this month purchased, a solid dose facility with packaging and distribution operations in Reims, France from AstraZeneca.
AstraZeneca said about 130 employees will transfer to Avara but a small number will leave voluntarily.
Zogenix Announces Public Offering of 4.3 M Shares
Zogenix Inc., a pharmaceutical company developing therapies for the treatment of orphan and central nervous system (CNS) disorders, has announced its intention to offer and sell, subject to market and other conditions, 4,300,000 shares of its common stock in an underwritten public offering.
Zogenix also expects to grant to the underwriters a 30-day option to purchase up to an additional 645,000 shares of common stock.
All of the shares to be sold in the offering are to be sold by Zogenix.
Zogenix intends to use the net proceeds from the proposed offering to fund clinical research and development of ZX008, including the completion of Zogenix’s ongoing clinical trials and regulatory submissions for Dravet syndrome and to fund Phase 3 clinical development for Lennox-Gastaut syndrome, commercial infrastructure for ZX008 for Dravet syndrome and working capital and general corporate purposes.
CVC talks $4B Alvogen sale with Shanghai
The private equity owners of Alvogen— including CVC Capital Partners— are considering their options for the New Jersey based drugmaker, which could be valued at up to $4 billion, with a sale of Alvogen’s U.S. business to Shanghai Pharmaceuticals Holding Co. being a possibility.
CVC and its controlling shareholders—who gain their share in 2015 deal which then valued Alvogen at $2 billion—have held on-and-off talks with Shanghai, according to Bloomberg.
One potential scenario, could see Alvogen holding onto its operations in Asia and Europe, which include Alvogen Korea Co., a plant in Romania, and a packaging centre in Serbia. Shanghai, though, would pick up Alvogen’s biggest market, where it sells generics in areas such as oncology, cardiology and neurology and provides third-party services including contract manufacturing in clinical research.
For Shanghai, the buy would be a boost following its failed bid for German generics maker Stada, which is going through the sale process with Bain Capital and Cinven.
Amgen and Simcere target China in cancer biosimilar deal
In a co-development deal with Simcere, Amgen has signed an agreement with China for four undisclosed biosimilars in oncology and inflammation.
Amgen will be responsible for development, filing for approval from China’s FDA and manufacturing of the biosimilars, while Simcere will take care of distribution and commercialization in its home country.
The particular drugs covered and the financial terms were not disclosed.
Teva finishes women’s health sale with $2.38B deals
Teva concluded the sale of its women’s health divisions in deals worth $2.38 billion Proceeds will go towards to pay down of debt.
It has sold its Paragard product to CooperSurgical for $1.1 billion and sold its contraception, fertility, menopause and osteoporosis products to CVC Capital Partners Fund VI for $703.
These products generated $258 million in sales last year.
Simultaneously, they sold their emergency contraception brands to Foundation Consumer Healthcare for $675 million. These brands generated $140 million in sales last year.
All-in, the agreements represent women’s health divestitures totaling $2.48 billion.
Teva originally acquired its women’s health unit from Merck for €265 million in 2010.
It’s all part of an effort to refocus and pay down debt, after picking up Allergan’s generics offerings for $40.5 billion in 2015. It has just hired a new CEO – Kare Schultz from Lundbeck and has announced a major round of 7,000 job losses—in an attempt to improve its fortunes, not least in its share price which has dropped 64% in a year.
Novartis New York plant bought for $18M and resold for $30M
A vacant Novartis manufacturing facility in Suffern, New York, that initially sold for $18 million has been resold to a Manhattan-based developer for $30 million.
Novartis sold the 162-acre campus with its 585,000 sq ft building comprising office space, laboratories, manufacturing areas and warehouse space, to RS Old Mill in early September, whereupon RS Old Mill then flipped the property to Suffern Partners – an affiliate of Bridgewater Capital Partners. The new owner has not declared what it intends to do with the site but it is currently zoned only for light industrial use
In 2014, Novartis announced its plan to close about 20 sites as part of a restructuring of its pharma division. The decision to close Suffern was in line with the company losing exclusivity on its patent for the blood-pressure drug Diovan, which had also seen a decline in demand.
At its peak, the facility once employed more than 500 people.
Catalent acquires Cook Pharmica for $950M
Catalent has agreed to pay $950 million to buy Cook Pharmica and acquire its 875,000 square foot biologics manufacturing and development facility in Bloomington, Indiana.
New Jersey based Catalent says it will pay $750 million to the privately-held Cook Group on closing and the balance in $50 million tranches over the next four years.
It will also take on its 750 employees, including its executive team.
The Cook operation was founded in 2004 and has capabilities in sterile formulation and fill/finish across liquid and lyophilized vials, prefilled syringes, and cartridges.
The company generated revenues of $179 million last year.
Catalent has been building up its biologics and currently offers fill-finish services in Brussels, Belgium and Limoges, France, and conjugation technology in Emeryville, California. It has a biologics development and biomanufacturing facility in Madison in which it currently is investing about $35 million in single-use bioreactor capacity that it expects to be online in November.
Gates invests in U.K. Immunocore’s infectious disease R&D
The Bill & Melinda Gates Foundation is investing up to $40 million in Immunocore to spur research into the use of T cell receptor (TCR)-based therapeutics to treat tuberculosis and HIV.
Immunocore is primarily known for its work in cancer. That is what prompted AstraZeneca, Eli Lilly, GlaxoSmithKline and Roche’s Genentech to strike deals with Immunocore, and what underpinned its $320 million (€268 million) round in 2015. However, Immunocore’s early-stage teams are also working on autoimmune and infectious disease programs.
U.K.based Immunocore’s infectious disease work has attracted the attention of the Gates Foundation, prompting the world’s largest charitable foundation to invest up to $40 million in the company. Immunocore will use the money to advance programmes against tuberculosis and HIV.
Fosun offers revised $1.1B bid for stake in India’s Gland Pharma
China’s Fosun has issued a revised bid for a stake in India’s Gland Pharma, after its $1.26 billion deal for an 86% stake was vetoed by India’s cabinet.
Fosun has now temepred its offer to $1.1 billion for 74% which is sufficient to circumvent the Indian government’s intervention.
Fosun didn’t cite the regulatory blockade as its primary reason for revising its offer. In a statement to the Shanghai Stock Exchange said that, “given that Gland Pharma’s operation is in good condition, the founder shareholders intend to maintain a higher stake without impacting on Fosun obtaining a controlling share”
However, it did also mention that the transaction does not require approval from the India Foreign Investment Promotion Board and India’s Cabinet Committee on Economic Affairs (CCEA).
In an effort to boost the country’s pharma sector, the Indian government in June loosened up its rules for foreign investment, allowing an automatic permit route for investments in existing biopharma businesses of up to 74%. Only foreign investment in a pharma company above that threshold requires government approval.
Gland Pharma specializes in generic injectables. At $1.1 billion, it would make the transaction the largest made by a Chinese pharma abroad.
Alexion plans hundreds of layoffs and a HQ move
Alexion’s new management team is rolling out an overhaul that includes cutting 20% of its workforce – 625 people – and moving its headquarters to Boston’s biopharma hub over the next 12 months
Previously based in New Haven, Connecticut, the biotech will close multiple manufacturing facilities and regional and country offices, outlined in a September announcement. Cuts will also hit the R&D organization, which already restructured once this year which created 200 job losses.
All-in, the company expects to save about $250 million in annual expenses by 2019. The company says the restructuring will cost $340 to $440 million.
CEO Ludwig Hanston said the corporate overhaul is intended to help Alexion grow its rare disease business, focus R&D efforts, pursue business development opportunities and reorganize its infrastructure.
The company plans to begin closing its Rhode Island site this year because it does not have a “multiproduct”. The site currently makes lead drug Soliris. It is expected to close by mid-2018. The site has 250 employees but has a history of manufacturing lapses. It was issued an FDA Form 483 last August.
Going forward, the company plans to reduce production in the U.S. and move it to Ireland when its new $100M facility comes on stream there.
In moving its HQ to Boston, Alexion is joining many biopharma peers such as Takeda, Amgen, Biogen, Novartis, Pfizer and Sanofi and Merck KgaA who have also centralised in specific scientific hubs with larger talent pools.
China’s 3SBio JV to buy Canadian Therapure Biopharma CDMO for $290M
China’s 3SBio, in a joint venture with CPE Funds is looking to acquire Canadian Therapure Biopharma’s contract development and manufacturing business for $290 million subject to shareholder approval.
3Sbio say he purchase is part of their plans to enter the growing North American biopharma sector and build its global biologics business.
If completed, 3SBio would gain than 340 biologics professionals in North America, with a skill base in operations, management, market development, R&D and manufacturing.
The US biologics market has been expanding at at a notable pace of late.
In July, CMC Biologics which was acquired earlier in the year by Japanese conglomerate AGC Asahi Glass, said it would hire up to 150 more employees at its operation in the Seattle area, as it makes the location the centre of its expanding biologics-based CDMO business
Other Japanese companies also have made the move into biologics. Fujifilm, with a view of expanding beyond its declining film business, entered biologics manufacturing in 2011 when it reportedly paid about $490 million to buy biologics plants in North Carolina and in Middleborough UK and created Fujifilm Diosynth Biotechnologies.
BioMarin Expands Facility to Manufacture Medicine for Rare Genetic Diseases
BioMarin Pharmaceutical Inc has recently extended its site footprint to 20 acres in Cork, Ireland, as the company continues to experience a rise in the global demand for its therapies to treat rare genetic diseases that mostly affect children.
Since 2011, the company has grown to 2,400 employees globally. BioMarin focuses on developing first-in-class and best-in-class therapeutics that have the potential to improve clinical outcomes of patients with rare genetic diseases. The company currently has six approved products that are the only drugs available on the market today for patients who suffer from diseases, so rare, difficult to diagnose and progressively debilitating where the entire afflicted population may number as few as 1,000 worldwide.
BioMarin was certified by the European Medicines Agency (EMA), in Q1 2017 and its site in Cork, Ireland was subsequently licensed for commercial supply by the US FDA in May this year for a range of activities including bulk production, Quality Control testing, Quality Assurance release, final product secondary packaging and distribution.
The Top 10 generic drugmakers in 2016
Teva, topped the 2016 FiercePharma Top 15 Reveue List, just as it did in 2014 and its ongoing poll topping position looks probable for some time, following its $33.4 billion in cash and 100.3 million in shares of Teva stock valued at $5.4 bn in August 2016
Behind Teva came Mylan, on the back of a big deal of its own last year also in its $7.2 billion purchase of Meda which boosted its OTC portfolio and privided it with entry into new emerging markets.
In third spot was Novartis, whose Sandoz unit delivered $9 billion in off-brand sales for the year, according to commercial intelligence firm Evaluate.
From there, the industry saw a drop with Pfizer in fourth place with $4.6 billion and Allergan in fifth with near similar revenues
Despite likely legislative challenges ahead in the U.S., Evaluate predicts that generics will grow to $115 billion in 2022, up from $80 billion in 2016.
The Top 15 Generics manufacturers by revenue in 2016 were;
6. Sun Pharma
8. Endo Int
Vesalius Biocapital to invest in later-stage European life sciences
Specialist life sciences venture capital investor, Vesalius Biocapital has announced the first close of its third fund, Vesalius Biocapital III securing over Euro 65 million of commitments. Until the final closing in 2018, Vesalius Biocapital III will accept new investors on a “rolling closing” basis. Starting immediately, the fund plans to invest in later-stage European life sciences companies across drug development, medtech, diagnostics and digital health, providing capital to support their development.
Now in its tenth year, Vesalius Biocapital has raised over €150 million for its two previous funds. The firm has completed over 20 investments with lead or co-lead positions, and achieved numerous exits through trade sales and IPO.
VC aims to raise Euro 50 million for Italian Biotech Sector
AurorA-TT, a Milan based Technology Transfer Intermediation company has announced plans to raise Euro 50 million in the Italian Biotech sector. Established in 2017, AurorA_TT intends to focus on Technology Transfer to exploit research potentials of academic and research institutions in Italy by providing capital and support for translating breakthrough discoveries in to patient therapies
Roche and Novartis fund gene therapy start-up
European biotech start-up, Vivet Therapeutics has received a €37.5 million ($41 million) kick-start, for its gene therapies for a host of rare diseases.
Novartis Venture Fund and Columbus Venture Partners led the round, with Roche Venture Fund, HealthCap, Kurma Partners and Ysios Capital also taking part.
The funding will go towards early work on a group of rare and inherited metabolic diseases, including Wilson disease. It is estimated that around 10,000 patients in the U.S. and 15,000 patients in the EU are sufferers
Vivet Therapeutics was founded in Paris in 2016, with a wholly owned subsidiary in Spain, and founded by ex-execs from Anokion, Novartis, Gensight Biologics and Sanofi.
GSK looking at consumer dominance with $10.3B Novartis JV buyout
Next March, GlaxoSmithKline will have the option to buy out Novartis’ stake in their 2014 established consumer health JV.
According to London’s Sunday Times, it is preparing for an £8 billion ($10 billion) offer for Novartis’ partner’s 36.5% share. Industry rumours are hinting that Novartis could use the windfall to help fund a major takeover—possibly AstraZeneca – a notion dismissed as fantasy by many.
GSK declined to comment but it has said in the past that its aim was to keep the JV in tact, long-term.
However, buying out Novartis would give GSK control of the world’s biggest consumer health operation. GSK has “been consistent all along that this is a business they want to own, and will move forward when the time is right,” a source told the Times.
Merck Sharp & Dohme to invest $310 million in biologics facility in Ireland
Merck & Co. says it invest further in Ireland with a $310 million expansion at two sites which will also deliver 330 new jobs.
Merck, known as Merck Sharp & Dohme outside of North America, has announced that it will invest €280 million over the next three years at its biologics operation in Brinny, County Cork, and also at its vaccines and biologics facilities in Carlow. The company said it will add about 120 jobs at the Carlow plant which does some of the work on its hugely succesful immuno-oncology drug, Keytruda
In addition the company will add more than 200 jobs at its fermentation and sterile filling operation in Cork where it does work on a number of its lung cancer, rheumatoid arthritis Hepatitis C programmes
Novartis cuts 500 manufacturing jobs but adds 350 in ‘high tech’ posts
Swiss drugmaker Novartis will cut hundreds of jobs in areas like “traditional manufacturing” in and around its Basel headquarters over the next 18 months but it will be increasing it’s staff numbers hi-tech areas by adding 350 roles in development and innovative biologics manufacturing.
The company says it remains committed to its home-country amid media rumblings that some jobs were being transferred to India where they opened an administrative centre in 2015
Overall, Novartis delivered healthy financials in the first quarter of this year and exceeded revenue expectations at $11.54 billion.
Mylan investors to vote against Chairman’s $97M pay deal
Some Institutional investors are calling for Mylan’s Chairman Robert Coury’s to be ousted following his $97 million compensation award in 2016.
Coury was the highest paid pharma executive in 2016, according FiercePharma research. He reportedly received $97.6 million in compensation last year, including stock worth $50 million and a $20 million bonus. This has enraged some investors in light of the fact that during the period, Mylan was under fire over price hikes on its EpiPen product and under investigation by Congress and federal agencies.
However, with regards to his $20 million bonus, the Mylan board decided that Coury had exceeded expectations with his “strategic vision,” the company’s “short- and long-term value creation for shareholders,” and its $7.2 billion buyout of Meda.
The aggrieved investors however believe that Coury’s compensation in 2016, when vesting of prior awards was factored in, totaled more than $160 million.
AstraZeneca shareholders revolt over CEO £13m pay package
AstraZeneca has suffered a shareholder backlash over executive pay, as two-fifths opposed a £13m pay package for its CEO, Pascal Soriot.
40% of investors voted against the group’s 2016 remuneration report at its AGM in London, last month while support for its new pay policy got the backing of 96% of investors.
Mr. Soriot received a total pay package of £13.4m last year comprising salary, bonus, long-term incentive plan (LTIP) and a one-off compensation payment.
His annual salary of £1.2m was topped-up with an annual bonus of £1.2m, and though lower than the £2m he received in 2015, his package was boosted by a further £6.9m LTIP payment, plus a one-off payment of £3.6m in compensation for lost bonuses following his departure from his previous employer.
Going forward, AstraZeneca said it had made changes to its long-term incentive plans and that its remuneration committee would “continue the dialogue with shareholders, as appropriate, regarding any concerns following its AGM”.
UK: NHS funding squeeze could see drugs firms leave Britain
Some of the globe’s largest drugs companies could abandon Britain and delay new product launches and developments, unless an extra £20 billion is provided to the National Health Service (NHS) NHS, according to the Association of the British Pharmaceutical Industry (ABPI) who represents more than 100 manufacturers
The trade body says an increase in health spending from 9.9% to 11% per cent of GDP is required.
According to the Times newspaper, ABPI President, Lisa Anson, claims that a funding squeeze on the health service could lead to an exodus of drugs firms from Britain.
Ms Anson, who is also UK and Ireland President of AstraZeneca, also said the future of the UK’s £30 billion life sciences sector could be in jeopardy.
She added that without an increase in healthcare spending, firms will not be able to carry out clinical trials or develop new drugs against existing treatments and that the UK would become a “desert for healthcare innovation”.