Theranos investors cannot pursue class action: U.S. judge

A U.S. judge has ruled that investors who claimed that Theranos Inc defrauded them into investing indirectly in the company by touting revolutionary blood-testing technology that never existed cannot pursue their claims as a class action.

The ruling late on Thursday by U.S. Magistrate Judge Nathanael Cousins in San Jose, California, is a setback for investors who might otherwise recover more by suing Theranos, Chief Executive Elizabeth Holmes and former Chief Operating Officer Ramesh “Sunny” Balwani as a group.

The proposed class had included more than 200 people who invested in funds between July 29, 2013, and Oct. 5, 2016 for the purpose of buying shares in Theranos, once a star of Silicon Valley.

Cousins, however, said individual lawsuits were appropriate because some investors might be unable to show they relied on the blood-testing company’s alleged misrepresentations.

“It is easy to imagine, for example, that someone invested simply because a friend suggested it, or because all that percolated down the grapevine was vague insight that Theranos was a fast-growing company, or had promising (but unspecified) technology,” Cousins wrote in a 34-page order.

Reed Kathrein, a lawyer for the plaintiffs, said he may appeal or seek reconsideration.

“It is too early to say anything other than we are very disappointed,” ahead of the scheduled depositions of Holmes and Balwani and completion of discovery this month, Kathrein said in an email.

Indirect investors in private companies such as Theranos cannot sue under federal securities laws, which address the integrity of public markets. The Theranos investors sought to avoid this by suing under California state law.

Michael Mugmon, a lawyer for Theranos, said: “We are pleased by the court’s ruling, as it brings the company a step closer to resolving its outstanding legal issues.”

Lawyers for Holmes and Balwani did not immediately respond to requests for comment.

Once valued at $9 billion, Theranos’ fortunes darkened amid reports that its technology, which offered hope that one drop of blood could help Americans control their health, did not work.

On March 14, the U.S. Securities and Exchange Commission charged Theranos, Holmes and Balwani with running a “massive fraud” by exaggerating the technology while raising more than $700 million from investors.

Holmes settled by agreeing to cede majority control, pay a $500,000 fine, and not serve as an officer or director of public companies for 10 years. Balwani did not settle.

Theranos also faces a criminal probe into whether it misled investors, The Wall Street Journal said in April.

The case is Colman et al v Theranos Inc et al, U.S. District Court, Northern District of California, No. 16-06822.

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ASCO stand on Trump drug price proposals

A leading U.S. group of cancer doctors is wary of new Trump administration proposals for lowering drug prices, particularly if new negotiation tools are introduced that will mean the U.S. government no longer routinely pays for all cancer drugs in the Medicare health program for older people.

The rising cost of cancer care will be in focus during an annual meeting of the American Society of Clinical Oncology (ASCO) that begins Friday in Chicago. In recent years, potent new immunotherapies and treatments that target genetic mutations underlying cancer have successfully curbed the disease in some patients.

But they have come with ever-rising price tags, spurring new questions about how much individuals, corporations and the government in the United States, already the world’s most expensive health system, will pay for these breakthroughs.

President Donald Trump last month unveiled a “blueprint” to reduce drug prices by promoting the entry of cheaper rivals to existing drugs and giving private insurers more scope to negotiate prices.

In private health insurance plans, insurers have tools to negotiate prices on the drugs they cover for their members. In exchange for manufacturer discounts, insurers may lower the patient co-payment below competing treatments, or drop coverage of a rival drug altogether, to increase prescriptions.

The Trump proposal includes the possibility that the government would stop covering all approved drugs for certain illnesses, including cancer, in the Medicare program. It has requested feedback from the industry on this and other ideas.

“It is a balancing act, because we do think that there should be an ability to negotiate price, but we are always driven by our belief that patients should not be denied the most effective drugs for their condition,” ASCO’s chief executive officer, Dr. Clifford Hudis, told Reuters.

Another idea is to change Medicare’s reimbursement of doctors including a fee calculated as a percentage of a drug’s price. Critics say the payments encourages physicians to use the most expensive drugs. Hudis said ASCO is not opposed to changing the formula, but argues that oncology practices will still need to be reimbursed for handling specialized cancer medicines delivered by infusion or injection.

ASCO, the nation’s leading association of cancer physicians, said it will publicize its full response after submitting feedback to the Trump administration by a July 16 deadline.

EFFECTIVENESS VS PRICE

U.S. spending on cancer drugs reached almost $50 billion last year – nearly doubling since 2012 – and is projected to double again to $100 billion in five years, according to IQVIA, which collects drug sales data.

Expensive new cancer treatments like Merck & Co’s $162,000-per-year immunotherapy Keytruda and Gilead Sciences Inc’s $373,000 blood cancer therapy Yescarta, which have helped some patients survive previously untreatable disease, are contributing to the increase.

But so are less effective drugs without competitors whose prices are raised by manufacturers each year. Oncologists and other specialists benefit from price increases on drugs that are administered in their offices.

Without percentage-based fees, oncology practices would lose “their ability to make considerable sums off their relationship with the pharmaceutical industry,” said Dr. Peter Bach, director of Memorial Sloan Kettering’s Center for Health Policy Outcomes in New York. ASCO and other institutions have proposed their own methods for reducing healthcare costs, but stopped short of urging drugmakers to lower prices. ASCO has recommended ranking drugs on their comparative clinical value, including relative efficacy and side effects, but not price. The group has also suggested that the price of a cancer drug could vary depending on how effective it is for a specific indication, or how well an individual patient fares after the treatment.

The association does not support moving to a flat fee for treating cancer patients, including drugs, an approach that is being used in other specialties. That “could force providers to make suboptimal or lower-value choices,” the organization said. At ASCO’s annual meeting, which runs from June 1-5, cancer researchers will provide new data on survival rates with Keytruda, on the emerging class of CAR-T cell treatments for blood cancers and on genetically targeted therapies.

Some research will address the cost question, including a comparison of treatment costs and outcomes for colon cancer patients in the United States and Canada.

https://reut.rs/2LegmB5

Euro regulators recommend restrictions on Merck, Roche immunotherapies

The European Medicines Agency on Friday recommended restricting use of two immunotherapies, one from Roche and the other from Merck, in initial bladder cancer treatment, saying they may not work as well as chemotherapy in some patients.

“Early data from two clinical trials show reduced survival with (Merck’s) Keytruda and (Roche’s) Tecentriq when used as first-line treatments for urothelial cancer in patients with low levels of a protein called PD-L1,” the agency said. “The data indicate that Keytruda and Tecentriq may not work as well as chemotherapy medicines in this group of patients.”

https://reut.rs/2snWFzO

Roche gets Euro OK for breast cancer med-chemo combo therapy

Roche announced that the European Commission has approved Perjeta in combination with Herceptin and chemotherapy for post-surgery treatment of adult patients with HER2-positive early breast cancer at high risk of recurrence. High risk of recurrence is defined as lymph node-positive or hormone receptor-negative disease. The Perjeta-based regimen should be administered for a total of one year as part of a complete regimen for eBC and regardless of the timing of surgery. “Despite advances in the treatment of HER2-positive early breast cancer, many people still have a recurrence and progress to an incurable stage. In the early breast cancer setting, where the ultimate goal is cure, it is critical that we continue building on existing therapies,” said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. “Today’s approval is great news, as we believe the Perjeta-based regimen has the potential to make a significant impact on the lives of people with HER2-positive early breast cancer who are at high risk of recurrence. We are committed to working with EU member states to ensure the Perjeta-based regimen is available to eligible patients as soon as possible.”

https://bit.ly/2J1MNpH

Estrogen, T cell immune response linked to autoimmune inflammation

Women are more prone to the development of autoimmune diseases. The female hormone estrogen is likely to affect the immune system. A team of scientists from Turku Center for Biotechnology and University of Georgia reported new findings related to the involvement of estrogen hormone receptor in autoimmune diseases.

The incidence of autoimmune diseases such as MS, RA, and SLE is higher in women than in men. The estrogen hormone secreted in women may contribute to the pathogenesis of these diseases. A research team led by Docent Zhi Chen from Turku Center for Biotechnology of the University of Turku has collaborated with researchers from the University of Georgia, United States to address the long-standing issue of hormonal effect on autoimmune diseases.

Estrogen hormone shows its action on cells mostly through estrogen receptor alpha (ERα). Researchers from Turku generated mice with ERα protein specifically deleted in T cells.

“The eureka moment of our research is that in a mouse model of human inflammatory bowel disease, transfer of naive T helper cells from ERα deficient mice did not succumb to colitis, unlike transfer from their counterparts,” Docent Zhi Chen says.

“Furthermore, using cutting-edge technique RNA sequencing approach combined with in vitro and in vivo experiments, we discovered that ERα regulates multiple aspects of T cell function, including T cell activation, proliferation and survival,” Chen adds.

Regulatory T cells are group of T cells that help in preventing autoimmune diseases. The researchers found that ERα influences the function and differentiation of regulatory T cells.

More information: Imran Mohammad et al, Estrogen receptor α contributes to T cell–mediated autoimmune inflammation by promoting T cell activation and proliferation, Science Signaling (2018). DOI: 10.1126/scisignal.aap9415

https://bit.ly/2J1LY0d

Lipid molecules can be used for cancer growth

When the blood supply is low, cancer cells can use lipid molecules as fuel instead of blood glucose. This has been shown in animal tumour models by researchers at Karolinska Institutet, Sweden, in a study published in Cell Metabolism. The mechanism may explain why tumours often develop resistance to cancer drugs that inhibit the formation of blood vessels.

Tumour growth and spread rely on angiogenesis, a process of growing new blood vessels that supply the cancer cells with nutrients and hormones, including glucose (sugar). Treatment with antiangiogenic drugs reduces the number of blood vessels in the tumour as well as the blood glucose supply. Many such drugs have been developed and are now used in human patients for treating various cancer types. However, the clinical benefits of antiangiogenic drugs in cancer patients are generally low and the cancers treated often develop a resistance to drugs, especially cancer types that grow close to fat tissues such as breast cancer, pancreatic cancer, liver cancer and prostate cancers.

In collaboration with Japanese and Chinese scientists, a research group at Karolinska Institutet in Sweden has discovered a new mechanism by which cancers can evade antiangiogenic treatment and become resistant.

The reduction of tumour blood vessels results in low oxygenation in tumour tissues—a process called hypoxia. In the current study, the researchers show that hypoxia acts as a trigger to tell fat cells surrounding or within tumour tissues to break down the stored excessive lipid energy molecules. These lipid energy molecules can when the blood supply is low be used for cancer tissue expansion.

“Based on this mechanism, we propose that a combination therapy consisting of antiangiogenic drugs and drugs blocking lipid energy pathways would be more effective for treating cancers. In animal tumour models, we have validated this very important concept, showing that combination therapy is superior to monotherapy,” says Yihai Cao, Professor at the Department of Microbiology, Tumor and Cell Biology at Karolinska Institutet, who led the study.

Professor Cao’s group now plans to work with drug companies and clinical oncologists to explore whether such a new combination therapy would improve the quality of life and lifespan in human cancer patients.

More information: “Cancer lipid metabolism confers antiangiogenic drug resistance”Cell Metabolism (2018).

https://bit.ly/2IZH2c6

With black box, low dose, Lilly-Incyte rheumatoid arthritis med in uphill fight

Eli Lilly and partner Incyte have finally secured FDA approval for their rheumatoid arthritis drug Olumiant (baricitinib), but it’s not the unalloyed win the companies had hoped for. Only the lower dose was approved, and that version comes with a black-box safety warning. Now, launching into an already competitive field, Olumiant will debut at a less-effective dose and with safety concerns, too.

The FDA’s decision came as an unwelcome surprise to Lilly execs, who maintained that the higher dose should hit the market, too—even after an FDA advisory panel backed the lower dose and shunned the higher one. At the time, analysts pressed Eli Lilly management to say how Lilly would respond if the FDA only approved the smaller dose.

On a conference call, Christi Shaw, president of Lilly Bio-Medicines, maintained that the panel discussion showed the need for both baricitinib doses, highlighting the fact that the higher dose proved more effective in trials—a statement that illustrates what Olumiant will be up against as it launches.

 “I think you saw yesterday the reinforcement by everyone with the 4 milligram dose is really needed for patients from an efficacy standpoint,” Shaw said, adding, “Our goal is to actually have both doses available and we continue to study both the 2 and the 4 milligrams and other studies that are ongoing,” she said.

CEO David Ricks said he was hopeful, too. Lilly is “confident in the benefit-risk profile of both baricitinib 2-mg and 4-mg for the treatment of patients with RA, supported by the clinical data generated to-date, and by the experience in more than 40 countries in which both doses are approved and available,” he said. The drugmaker would continue to work with the FDA on the “important application,” he added.

Analysts had expressed worries that a limited approval could hobble the Olumiant launch. Bernstein’s Tim Anderson previously wrote that “bears may argue that without the 4 mg dose, the perception and commercial profile of baricitinib is wounded.”

Lilly will soon have a chance to find out. A once-daily tablet, Olumiant comes with a label warning of serious infections, malignancy and thrombosis risks. The JAK inhibitor is approved to treat adults with moderate to severe rheumatoid arthritis who’ve failed to respond to at least one anti-TNF drug, according to the label posted on the FDA’s website.

The approval follows a rough history at the FDA. Last year, Olumiant was among a group of Lilly meds analysts predicted would grow to blockbuster sales, but it hit two FDA delays. The agency first put off its decision by three months, and then, in April 2017, it opted to send it back for more work. In a complete response letter, the agency asked Lilly for additional clinical data to determine the best dose.

Olumiant will face off against Pfizer’s Xeljanz in the market, with potential rivals from GlaxoSmithKline and Johnson & Johnson, Sanofi and Regeneron, and Gilead Sciences and Galapagos in the pipeline. Analysts previously predicted the drug can pull in $1.8 billion in sales by 2022, but that was before the CRL and safety concerns.

https://bit.ly/2Lgtypk