MorphoSys Presents Data on Lymphoma Combo

MorphoSys AG(FSE: MOR; Prime Standard Segment; MDAX & TecDAX; Nasdaq: MOR) today presented data from the primary analysis (cut-off date November 30, 2018) of the ongoing single-arm phase 2 clinical trial known as L-MIND in an oral presentation at the 15^thInternational Conference on Malignant Lymphoma (ICML) in Lugano, Switzerland.

The L-MIND study enrolled patients with relapsed or refractory diffuse large B cell lymphoma (r/r DLBCL), who are ineligible for high-dose chemotherapy (HDC) and autologous stem cell transplantation (ASCT). The primary analysis data reported today included 80 patients enrolled into the trial who had received tafasitamab and lenalidomide and had been followed-up as per protocol for at least one year. Efficacy results in this update are based on response rates assessed by an independent review committee for all 80 patients. Patients enrolled had a median age of 72 years and had received a median of two prior treatment lines.

The primary endpoint, defined as best objective response rate (ORR) compared to published data on the respective monotherapies, has been met. The ORR was 60% (48 out of 80 patients), and the complete response (CR) rate was 43% (34 out of 80 patients). 82% of the CRs were PET (positron emission tomography)-confirmed. The median progression-free survival (mPFS) was 12.1 months with a median follow-up of 17.3 months. Responses were durable with a median duration of response (mDoR) of 21.7 months. Median overall survival (mOS) was not reached (NR) (95% CI 18.3 months – NR) with a median follow-up time of 19.6 months. The 12-month OS rate was 73.3%.

Efficacy parameters, such as response rates, showed comparable results in most patient subgroups of interest, including rituximab refractory versus non-refractory and primary refractory versus non-primary refractory, amongst others.

https://www.marketscreener.com/MORPHOSYS-AG-436425/news/MorphoSys-Presents-Primary-Analysis-Data-from-L-MIND-Study-of-Tafasitamab-MOR208-in-combination-28798902/

Okla. unveils $17.5 billion abatement plan during state opioid trial

The state of Oklahoma unveiled on Friday a 30-year plan to abate Oklahoma's opioid epidemic that would carry a price tag of more than $17.5 billion.
The detailed abatement plan was slowly revealed during Day 19 of testimony in a trial in Cleveland County District Court, where Oklahoma Attorney General Mike Hunter has accused Johnson & Johnson and its subsidiaries of creating a public nuisance that helped cause the opioid crisis.
The state has accused the opioid manufacturer of false and deceptive marketing that downplayed the risks of opioid painkillers while overstating their benefits.
From 2000-2017, more than 6,100 people died in Oklahoma from prescription opioid use, officials say.
https://www.marketscreener.com/JOHNSON-JOHNSON-4832/news/Johnson-Johnson-State-unveils-17-5-billion-abatement-plan-during-state-opioid-trial-28798906/

Okla. agrees on how $85M Teva opioid case payment will be handled

An agreement has been reached between state lawmakers and Oklahoma’s attorney general in a dispute over how proceeds from a pending $85 million settlement with opioid maker Teva Pharmaceuticals USA Inc. will be handled, Cleveland County District Judge Thad Balkman said Friday.

The agreement, which is awaiting final signatures, calls for the $85 million to be deposited initially in an account controlled by the Whitten-Burrage law firm to allow attorneys who have been assisting the state in opioid litigation to take out their legal fees, Balkman said. Then, within 24 hours, the balance of the proceeds must be transferred into the Opioid Lawsuit Settlement Fund, which is being created within the state treasury.

The agreement calls for the money to be used only for the abatement of the nuisance created by the opioid crisis, pursuant to future appropriations, Balkman said.

The state of Oklahoma has presented a proposed 30-year opioid epidemic abatement plan with a price tag of more than $17.5 billion.

https://www.marketscreener.com/TEVA-PHARMACEUTICAL-INDUS-56537293/news/Teva-Pharmaceutical-Industries-State-leaders-agree-on-how-85-million-opioid-case-payment-will-be-28798907/

Perrigo issues voluntary recall for formula sold at Walmart

Perrigo Company plc is issuing a voluntary nationwide recall of 35-ounce, 992-gram containers of Parent’s Choice Advantage Infant Formula Milk-Based Powder with Iron. This product, sold exclusively at Walmart, is being recalled because of the potential presence of metal foreign matter in a single lot of the product (C26EVFV). The total number of containers affected by this recall is 23,388.

No adverse events have been reported to date, and the recall is being initiated out of an abundance of caution stemming from a consumer report. No other products or retailers are affected by this recall.

Consumers who may have purchased the product should look for Lot Code C26EVFV with a “use by” date of February 26, 2021, which can be found on the bottom of the package. Any consumers who purchased the product should discontinue use and can visit any Walmart store for a refund.

Consumers with any health-related questions should contact their healthcare provider.

Consumers with questions about Parent’s Choice Advantage Infant Formula Milk-Based Powder with Iron can contact Perrigo Consumer Affairs at 866-629-6181.

This recall is being conducted in consultation with the U.S. Food and Drug Administration (FDA).

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/perrigo-issues-voluntary-recall-parents-choice-advantage-infant-formula-milk-based-powder-iron

Bayer’s regorafenib kicks off brain cancer platform trial

Bayer has become the first pharma company to take part in a new platform trial designed to find new treatments for brain cancer.

GBM AGILE (Glioblastoma Adaptive Global Innovative Learning Environment) is an international trial testing several therapies for patients with newly diagnosed and recurrent glioblastoma.

Using a master protocol, several therapies or combinations of therapies from pharma companies can be tested simultaneously, with potential treatments added or dropped from the phase 2/3 trial over time.

The idea is to adopt a more efficient approach to testing new therapies for glioblastoma, and Bayer is starting proceedings by opening enrolment for US patients in an arm evaluating its cancer drug regorafenib.

Sponsored by the non-profit charitable organisation the Global Coalition for Adaptive Research (GCAR), by the end of the year GBM AGILE will open in over 40 academic medical centres and community-based institutions across the US.

There are plans to expand across Europe, China, Canada, and Australia through 2020.

GCAR aims to expand and replicate what is learned using this model for GBM to benefit patients with other rare and deadly diseases.

A similar approach has already been used in breast cancer, where the I-SPY trials have used a platform design to test several different breast cancer drugs against the same control group.

This represents a more efficient and ethical approach that reduces the number of patients required, and limits exposure to the potentially less effective standard therapy.

Glioblastoma treatment options are limited and patient outcomes have remained largely unchanged over several decades and 95% of patients die within five years of diagnosis, with more than half dying within the first 15 months after diagnosis.

Regorafenib showed promise compared to standard of care in the randomised multi-institutional investigator-sponsored Phase 2 trial REGOMA, published in The Lancet Oncology in December, 2018.

Regorafenib is already approved under the brand name Stivarga in more than 90 countries, including the US, countries of the European Union, China and Japan for metastatic colorectal cancer, metastatic gastrointestinal stromal tumors and hepatocellular carcinoma.

The drug is an oral multi-kinase inhibitor that potently blocks multiple protein kinases involved in tumor angiogenesis (VEGFR1, -2, -3, TIE2), oncogenesis (KIT, RET, RAF-1, BRAF), metastasis (VEGFR3, PDGFR, FGFR) and tumour immunity (CSF1R).

Bayer’s regorafenib kicks off brain cancer platform trial

J&J’s Spravato for depression ‘should be much cheaper’: ICER

Johnson & Johnson has priced its new Spravato nasal spray for treatment-resistant depression (TRD) too high to offer value for money, says a US cost-effectiveness body.

The Institute for Clinical and Economic Review (ICER) has published its final report on Spravato (esketamine) and says the drug would need to be between 25% and 52% cheaper to meet its value threshold.

The spray – which was approved by the FDA in March – has a wholesale acquisition cost of $295 per 28 mg device and costs around $32,400 for a year’s treatment, says ICER. To deliver fair value that price would have to come down to between $17,700 and $25,200 per year.

The watchdog reviewed the clinical evidence for the drug and agreed that it is an effective add-on therapy for people who can’t derive enough benefit from standard oral antidepressant therapy, an assessment that will be welcomed by J&J given two of the five large trials used to support the drug’s filing failed to reach their efficacy endpoints.

However, it said there wasn’t enough evidence to show it was better than ketamine, the generic drug from which it is derived, as well as other approaches to TRD such as “transcranial magnetic stimulation, electroconvulsive therapy, or augmentation with olanzapine.”

There also isn’t enough long-term data with Spravato yet to show that its benefits are long-lasting, says ICER, although it acknowledges that the drug is intended as a fast-acting rescue medication for people at real risk of suicide or self-harm.

“Treatment-resistant forms of major depression are common and have large negative effects on patient quality of life, so new therapies are badly needed,” said David Rind, ICER’s chief medical officer.

“It is hard to understand how a price exceeding usual cost-effectiveness thresholds is appropriate for a treatment that could be very widely used,” he continued, “particularly when that price is an order of magnitude higher than that of intravenous generic ketamine.”

Spravato is the first ketamine-based medicine approved to treat depression, and also the first of a new class of glutamate NMDA receptor-targeting drugs that have ended a decades-long drought at the FDA for new-mechanism antidepressants.

ICER’s final report follows a draft version published last month that arrived at much the same conclusions. J&J’s Janssen unit – which markets Spravato – said at the time it disagreed with the conclusions, which it claimed were “based on inaccurate assumptions…on the established positive benefit risk profile of Spravato.”

It has since published its own analysis suggesting that use of the drug on top of oral antidepressants costs at least $20,000 less per patient in those achieving remission than patients taking standard therapy plus placebo.

The large number of people with TRD has driven very high sales expectations for Spravato, with some analysts suggesting sales could reach around $2.3 billion within five years of launch.

There are some factors that could however limit its take-up. Firstly, it needs to be administered at certified treatment centres, and it also has a boxed warning on the risk of sedation and difficulty with attention, judgment and thinking, abuse and misuse, and suicidal thoughts.

Esketamine is also being reviewed by the EMA, which is looking to make a decision later this year or early 2020.

J&J’s Spravato for depression ‘should be much cheaper’

Novo Nordisk hemophilia A med approved in EU

Novo Nordisk today announced that the European Commission has granted marketing authorisation for Esperoct for the treatment of adolescents (12 years of age) and adults with haemophilia A. The authorisation covers all 28 European Union member states.

Esperoct is the brand name for turoctocog alfa pegol, N8-GP. Esperoct is indicated for prophylaxis and on-demand treatment of bleeding as well as for surgical procedures in adolescents and adults with haemophilia A (congenital factor VIII deficiency). The efficacy and safety evaluation was based on the results from the largest pre-registration clinical programme conducted in haemophilia A, with inclusion of 270 previously treated people (PTPs) with severe haemophilia A and more than 5 years of clinical exposure. The marketing authorisation follows the positive opinion from the Committee for Medicinal Products for Human Use (CHMP), under the European Medicines Agency(EMA), provided 26 April 2019.

We are excited about the approval of Esperoct in the EU, and we consider it an important expansion of the treatment options for patients with haemophilia A, said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk. We are confident that Esperoct will provide people with haemophilia A a simple and less burdensome, predictable dosing regimen for prophylaxis as well as treatment of bleeding episodes, resulting in improved quality of life.”

Novo Nordisk expects to launch Esperoct in the first European countries during the second half of 2019.

https://www.marketscreener.com/NOVO-NORDISK-AS-1412980/news/Novo-Nordisk-Esperoct-turoctocog-alfa-pegol-N8-GP-approved-in-the-EU-28798673/