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Saturday, December 15, 2018

BeiGene Announces Updated Phase 1A/1B Data on Tislelizumab Presented at ESMO


BeiGene, Ltd. BGNE, +1.85% (hkex:06160), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, announced that updated clinical data from an ongoing Phase 1A/1B trial of tislelizumab, an investigational anti-PD-1 antibody, were presented in an oral session and a poster at the European Society for Medical Oncology Immuno-Oncology (ESMO-IO) Congress, being held December 13-16 in Geneva, Switzerland.
“We continue to be pleased with the results of tislelizumab in solid tumors,” commented Amy Peterson, M.D., Chief Medical Officer, Immuno-Oncology, at BeiGene. “We believe that these updated results provide support for the continued development of tislelizumab in patients with bladder, esophageal, stomach, liver and non-small cell lung cancers, and we have registration-enabling studies ongoing or planned to start soon in each of these indications.”
Summary of ESMO-IO Presentations from the Ongoing Phase 1A/1B Trial
The multi-center, open-label Phase 1A/1B trial (NCT02407990) of tislelizumab as monotherapy in advanced solid tumors is being conducted in Australia, New Zealand, the United States, Taiwan and South Korea and consists of dose-escalation and dose-expansion phases in disease-specific cohorts.
Updated Results in Patients with Urothelial Carcinoma (UC)
Data presented at ESMO-IO included updated results from an analysis of tislelizumab in 17 patients with UC. At the time of the data cutoff on August 31, 2018, median treatment duration was 4.1 months (0.7-30.4 months), with two patients still on treatment.
Treatment-related adverse events (TRAEs) as assessed by the investigator occurred in 15 patients (88.2%). Of those, fatigue (n=5), infusion-related reactions (n=3), rash (n=3), nausea (n=2), pain in extremity (n=2), peripheral adema (n=2), and proteinuria (n=2) occurred in two or more patients. Three treatment-related Grade 3 or 4 AEs occurred in two patients, fatigue (n=1), and hyperglycemia and latent autoimmune diabetes (n=1). One patient discontinued treatment due to recurrent infusion-related reactions considered related to tislelizumab.
At the time of the data cutoff, all 17 patients were evaluable for response, defined as having a baseline tumor assessment with at least one post-baseline tumor response assessment, or progression or death. The confirmed response rate was 29.4 percent, with one complete response (CR) and four partial responses (PR). Three additional patients achieved stable disease (SD) as their best response. There was one CR, one PR and one SD among the eight patients with PD-L1 high tumors and two PRs and two SDs among the eight patients with PD-L1 low or negative tumors (one tumor was not-evaluable for PD-L1 expression). The median duration of response was 18.7 months (6.2-18.7 months).
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Friday, December 14, 2018

Astellas gains three cancer drugs with $405m Potenza buy


Astellas has taken an option to acquire US biotech Potenza Therapeutics after the companies spent more than three years working together on cancer immunotherapies.
The Japanese pharma said the acquisition marks the successful outcome of a collaboration that began in 2015 to build a portfolio of novel immuno-oncologytherapies.
Through the R&D collaboration Astellas and Massachusetts-based Potenza have discovered and developed three novel drugs that are responsive or resistant to the current generation of immunotherapies.
The drugs that will be added to Astellas’ portfolio include phase 1 drugs SP 8374/PTZ-201, an anti-TIGIT antibody immune checkpoint inhibitor and ASP 1948/PTZ-329, an anti-NRP1 antibody inhibiting T-regulatory cells.
It also includes ASP1951/PTZ-522, a novel format GITR agonistic antibody for T cell priming and costimulation, which has recently cleared for clinical development by the FDA.
The deal closed yesterday and Potenza has become a wholly-owned subsidiary of Astellas, establishing a fully owned clinical immune-oncology pipeline.
Astellas paid $164.6 million upfront to acquire Potenza, and shareholders will be eligible for additional payments totalling up to $240.1 million, depending on how clinical development progresses.
Astellas is reviewing the impact of the acquisition on its financial results for the fiscal year ending March 31, 2019.
Kenji Yasukawa, Astellas’ president and CEO said: “This transaction underscores Astellas’ commitment to innovation and scientific partnerships to advance our creation of value for patients.”
“In oncology, Astellas has focused on developing treatments for unmet medical needs with novel mechanisms of action and modalities. We believe the novel assets we have developed with Potenza have the potential to make an even more pronounced difference for patients in need.”
Dan Hicklin, president and CEO of Potenza, added: “I am pleased that these therapies will now have access to the resources of a large international company, with world-class R&D and the strategic and financial backing to support the development of these innovative potential new medicines for cancer patients in need.”
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Ipsen warns over medicine supplies amid Brexit uncertainty


France’s Ipsen has become the latest pharma company to warn about the impact of Brexit on the pharma industry and patients’ access to medicines.
As Theresa May attempts to drum up support for her Brexit deal, the French pharma said it was taking steps to minimise disruption to supplies of its drugs.
But Harout Semerjian, Ipsen’s chief commercial officer, said the “uncertain” political climate caused by Brexit is a headwind affecting the European market, and beyond.
Companies such as AstraZeneca have this year been increasing stockpiles of drugs in case of disruption caused by a ‘no deal’ Brexit.
Ipsen said it is taking similar steps, as it begins launching its cancer drug Cabometyx (cabozantinib) in second line liver cancer across Europe after recent approval by the European Commission.
The company is also building Cabometyx’s presence as a treatment for kidney cancer, in certain untreated patients and as a second line therapy.
In an interview with pharmaphorum, Semerjian said: “The current European political climate is also quite uncertain, as we still do not know the exact terms on which the UK will leave the EU – and the terms of the future relationship with the EU.
“However, leaving the EU and the single market will potentially impact the entire pharmaceutical industry; and could, in the absence of preparation, have serious implications for patients’ access to medicines and medical technologies.
“For us, the most important thing is to do all we can to ensure there is no disruption to patient supply of our medicines and we are currently preparing accordingly.”
Pharma companies have urged UK politicians to accept the deal that May has struck with European negotiators.
There are concerns that stricter border checks could lead to delays getting medicines across the channel between the UK and Europe, as well as uncertainties about how the political changes will affect drug regulation.
Nathalie Moll, director general of the European Federation of Pharmaceutical Industries and Associations (EFPIA), said in a blog last month that the deal on the table is “infinitely better” than the UK leaving without a deal.
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WuXi AppTec eyes acquisitions after $1bn Hong Kong IPO


Chinese biotech WuXi AppTec has completed its listing on Hong Kong’s HKEX, raising $967m just months after making its debut on the Shanghai exchange.
The company – which provides contract research, development and manufacturing services to pharma, medical device and biotech firms – said the new proceeds would be used to expand its global presence, which could include acquiring smaller outsourcing companies. It has driven the value of the company up above the $10 billion mark.
The fundraising comes shortly after WuXi AppTec opened a new facility in San Diego focusing on small-molecule drug development – providing services such as screening, discovery biology, pharmacology and process R&D, as well as small-scale manufacturing for early-stage clinical trials – and a new medical device testing facility in Suzhou.
WuXi AppTec’s chief executive Dr Ge Li said the capital unlocked by the HKEX listing would help the company “continue to enhance the capability and capacity of our platform”, with investments planned for new capacity in both China and the US, as well as on new technologies and “fostering” healthcare start-ups.
“We will continue to enhance the capability and capacity of our platform to enable our collaborative partners worldwide,” said Li, adding: “We aspire to foster a networked healthcare ecosystem, where scientists and entrepreneurs are empowered to participate.”
Shares in the company surged after it listed in Shanghai in May and raised $353 million, but didn’t do so well in Hong Kong, ending the day fractionally up on their opening price.
The latest IPO is yet more evidence that the HKEX is a hot location as a financing and exit route for biotechs and their venture capital backers, thanks to rules introduced earlier this year that allowed pre-revenue companies to list there for the first time.
WuXi AppTec is already a revenue generator and profitable, but it joins the likes of Ascletis, BeiGene, Hua Medicine, Zai Labs and Innovent among the wave of Chinese biotechs who have chosen Hong Kong for their listings this year, with some estimates suggesting dozens more are cueing up their own debuts.
Last year, WuXi group company WuXi Biologics – which focuses on drug development – raised $511 million on the HKEX and is also on an expansion push. Earlier this year it said it planned to invest $60 million in a manufacturing unit in Massachusetts.
A recent report from McKinsey suggests that within three years HKEX could become one of the preferred financing channels for biopharma companies, and some analysts suggest it could start to attract western as well as Asian companies.
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Does Diabetes Damage Brain Health?


Diabetes has been tied to a number of complications such as kidney disease, but new research has found that older people with type 2 diabetes can also have more difficulties with thinking and memory.
During a five-year study, participants with diabetes showed a decline in verbal memory and fluency. Using MRI scans, researchers saw that the participants’ brains were smaller at the start of the study — but the rates of decline in brain size did not differ over the years the patients were followed. The investigators didn’t find a connection between brain size and the thinking and memory troubles.
“Although memory and executive function [thinking and planning skills] declined at a greater rate in people with type 2 diabetes, this was not explained by a decline in brain volume,” said study author Michele Callisaya, a research fellow at the University of Tasmania.
Callisaya said the researchers were surprised by this finding. They expected that decreased brain volume would have been more common in people who were having memory and thinking issues. But she added that it’s possible over a longer time, a relationship between these factors might become evident.
And, she added, “The overall message is that type 2 diabetes affects brain function.”
Past research has found that having diabetes might double a person’s risk of dementia, the researchers said. Although previous studies have shown the connection between the two conditions, none has proven a cause-and-effect relationship. That’s what prompted Callisaya and her colleagues to look at whether or not a loss of brain volume might be behind the connection.
They recruited more than 700 people between 55 and 90 years old for the study. At three different points during the five years, the participants underwent testing to measure their thinking, planning and memory skills. They also had an MRI scan each time.
About half of the participants had type 2 diabetes (348 people) and their average age was 68. The group without diabetes had an average age of 73.
The researchers found that people with diabetes had lower scores on verbal memory and verbal fluency tests.
Verbal memory is the ability to recall words, and verbal fluency is a measure of thinking and planning skills. People who have problems in these areas might forget people’s names or have trouble finding things more frequently, Callisaya said. People who have trouble in verbal fluency might have difficulties with planning, initiating and organizing things, she added.
The MRI scans showed that people with diabetes had smaller brain volume at the start of the study than people without the blood sugar disorder. But Callisaya’s team saw no evidence that brain size was directly related to the declines in thinking and memory.
Dr. Gisele Wolf-Klein, director of geriatric education at Northwell Health in Great Neck, N.Y., reviewed the findings and said, “While there is no doubt that diabetes is a risk factor for the development of cognitive changes, the relationship with brain atrophy remains uncertain.”
Dr. Joel Zonszein, director of the clinical diabetes center at Montefiore Medical Center in New York City, agreed the study didn’t show any correlation between brain size, diabetes and thinking and memory troubles.
Zonszein said the differences in the two study groups may have played a significant role in the study’s findings. He said the people in the diabetes group were heavier, and had higher cholesterol and blood pressure than people in the other group.
“The take-home message to me is that good early control of all of these risk factors — blood sugar, cholesterol, weight and blood pressure — is important, along with getting good, regular exercise. People who have these risk factors have a higher risk for cognitive decline,” he said.
Wolf-Klein said that, while it hasn’t been proven that good blood sugar management can reduce the risk of brain health issues, “physical activity and a wholesome diet have been associated with a lesser risk of dementia in the general population, as well as a decreased incidence of diabetes.”
Callisaya agreed. “What’s good for the heart is also good for the brain,” she said. In addition to a healthy diet and regular activity, she also recommends to stay social and to keep challenging your brain.
The study was published Dec. 13 in the journal Diabetologia.
More information
The American Diabetes Association has more about managing type 2 diabetes.
SOURCES: Michele Callisaya, Ph.D., research fellow, University of Tasmania, and adjunct senior lecturer, Monash University, Melbourne, Australia; Gisele Wolf-Klein, M.D., director, geriatric education, Northwell Health, Great Neck, N.Y.; Joel Zonszein, M.D., director, clinical diabetes center, Montefiore Medical Center, New York City; Dec. 13, 2018, Diabetologia
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CVS defends settlement that allowed Aetna merger as judge assesses


CVS Health Corp defended on Friday an agreement with the U.S. Justice Department which allowed it to purchase health insurer Aetna for $69 billion, a settlement that a federal judge is still assessing.

The Justice Department approved the merger of CVS, a U.S. pharmacy chain and benefits manager, and Aetna in October on condition that Aetna sell its Medicare prescription drug plan business to WellCare Health Plans Inc. That sale was completed in November.
Now, the Justice Department and companies have found themselves in the unusual position of defending their antitrust settlement to a skeptical federal judge. Most judges approve consent decrees aimed at resolving competition concerns with no fanfare, and deals normally close before the judge rules.
But Judge Richard Leon of the U.S. District Court for the District of Columbia wrote in an order that he was “less convinced” than the government that the agreement would resolve antitrust concerns. He also has seemed annoyed that CVS closed its purchase of Aetna in October before his ruling.
In its brief, filed on Friday, CVS said that the deal had been extensively reviewed and urged the judge to allow the companies to continue integrating while he examines the settlement reached with the government.
CVS also noted that Aetna would be run separately from CVS, including decisions pricing and product offerings, during the court process.
In its filing, the government urged the judge to allow the companies to press on with integration, saying he did not have the power to stop the merger, only to reject the settlement.
“The United States remains mindful of the court’s responsibility to independently determine whether the proposed settlement is in the public interest and looks forward to discussing why the settlement meets that standard,” the government said.
While CVS and Aetna operate in largely separate business segments, the deal attracted opposition from groups including the American Medical Association and independent pharmacists, represented by the Pharmacists Society of the State of New York and Pharmacists United for Truth and Transparency.
The two pharmacist groups asked Leon to allow them to argue against the deal.
“We are asking the court to stop the consolidation so that the concerns of patients, providers and consumers can be heard,” said Debbi Barber, president of New York pharmacists.
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Time for National Standards in Addiction Treatment


Most Americans can feel secure knowing the medical treatments they receive are safe, effective, and supported by scientific evidence and best practices. Unfortunately, the same cannot be said when it comes to fighting one of the deadliest epidemics our nation has ever faced: the crisis of opioid addiction.
As the rates of opioid use disorder (OUD) and associated deaths have skyrocketed over the past decade, America’s addiction treatment infrastructure has struggled to keep pace with an urgent and growing healthcare need. A chronic, treatable brain disease, substance use disorder (SUD) can be managed by combining appropriate medications with behavioral therapy and ongoing recovery support services.
While there are nationally recognized standards for evidence-based care, treatment programs are not required to follow them, and many lack the resources to do so – leaving patients and loved ones with little assurance that a particular program is equipped to deliver high-quality addiction treatment.
What has been missing is a way for healthcare consumers, insurers, and policymakers to verify that a treatment program provides standardized treatments and services backed by science and known best practices. Matching patients with the right treatment is incredibly important, since patients living with OUD and other addiction disorders are battling a chronic, progressive disease that has a high risk for death if untreated, or inadequately treated.
The recently enacted SUPPORT for Patients and Communities Act (HR 6) – a sweeping legislative package aimed at addressing the opioid crisis – included several important provisions to help promote the delivery of evidence-based care for the treatment of OUD.
But more needs to be done.
National Certification
Fortunately, the American Society of Addiction Medicine (ASAM) and CARF International (formerly the Commission on Accreditation of Rehabilitation Facilities) will soon pilot a national certification programthat evaluates whether a residential treatment program is aligned with nationally recognized standards for addiction treatment – standards known to those in the addiction medicine field as The ASAM Criteria.
A rigorous and continuously evolving compilation of best practices in addiction care, The ASAM Criteria help providers assess a patient’s condition across six dimensions of needs and then match those needs to the appropriate type and intensity of care.
This multidimensional assessment system considers critical recovery factors such as withdrawal potential, medical needs, emotional and behavioral conditions, readiness to change, potential for relapse, and an individual’s living situation and support systems. For each ASAM level of care, there are specific service characteristics, like staffing and treatment requirements, that are necessary to meet an individual patient’s needs.
Through the new certification program, CARF will assess individual treatment programs and certify those that have demonstrated the ability to deliver services consistent with ASAM’s guidelines for a specific level of care. To be clear, certification is not a grading system. Rather, certification designates that a given treatment program is capable of delivering services and treatments at one or more specific levels of care within a broad continuum of treatment needs.
Currently, more than 30 states require the use of The ASAM Criteria. In addition, more than 50 million Americans are covered by insurers that use the Criteria in payment decisions. With ASAM certification, care funders will have independent verification of a program’s fidelity to the Criteria. This will help them make payment and network decisions that promote the delivery of evidence-based care. Certified treatment programs will be able to demonstrate they are trained, capable, and committed to providing care directed toward optimal outcomes. Importantly, patients and loved ones will be able to make more informed decisions when selecting treatment.
Effective addiction care can – very literally – mean the difference between life and death for Americans with substance use disorders. Too often across our nation, many well-intentioned but inadequately trained providers provide suboptimal or incorrect care. Worse, a few unscrupulous proprietors of improperly staffed facilities prey upon the desperation of individuals and their families offering little in the way of effective treatment. Programs should offer their patients the resources and medical care needed to properly treat addiction.
With nearly 200 Americans dying every day from drug overdoses, the time for serious, standardized, and outcomes-based addiction care is now.
Americans trust their healthcare providers to make care decisions that offer the best chances of survival and long-term recovery. It’s time we move the field toward universal adoption of guidelines that will save lives. It’s also time for everyone who is suffering from addiction, directly or indirectly, to have the means to easily identify those programs that can deliver the specialized services they need and to have the best possible chance of meaningful remission and recovery.
Paul H. Earley, MD, DFASAM, has been an addiction medicine physician for 35 years, has authored two books and numerous articles on addiction and its treatment, and is the president-elect of the American Society of Addiction Medicine.
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