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Bristol-Myers blood cancer drug's potential; Novartis' Kymriah remains effective


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Essential IR Insights Newsletter - February 2023

Bristol-Myers blood cancer drug's potential; Novartis' Kymriah remains effective

Top news

* Bristol-Myers Squibb Co. said a combination of its drug Empliciti met its main goal in a phase 2 study for treating certain patients with multiple myeloma, a type of blood cancer. Under the Eloquent-3 trial, adding Empliciti to Celgene Corp.'s Pomalyst and low-dose dexamethasone significantly extended the lives of multiple myeloma patients while keeping their disease at bay compared to patients who were treated with Pomalyst and dexamethasone alone.

* Novartis AG said its chimeric antigen receptor T cell therapy Kymriah continued to deliver durable responses in patients with diffuse large B cell lymphoma, or DLBCL, a type of blood cancer. A 14-month follow up of the Swiss pharmaceutical giant's Juliet study showed that 40% of the 93 evaluable DLBCL patients had no detectable cancer remaining after treatment, a measure known as complete response.

* According to EvaluatePharma, global sales of orphan drugs, or those intended to treat rare diseases, are expected to rise 11% to $262 billion by 2026, the Financial Times reported.

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* In a series of tweets, the U.K. Home Office said Home Secretary Sajid Javid used "an exceptional power" to allow Billy Caldwell, a 12-year-old severely epileptic boy, to use cannabis oil as treatment. Caldwell suffered seizures after the medicinal cannabis oil, which was flew in from Canada, was confiscated at the Heathrow Airport, Sky News noted.

On the policy front

* Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases at the National Institutes of Health, said he expects a highly deadly form of the flu, not some other devastating disease, to cause the next big infectious disease outbreak in the U.S. Fauci warned that if Congress and the American public were waiting for a universal flu vaccine to protect them from all strains of the virus, including the H7N9 avian flu, that is going to be "years and years and years away."

* While the NIH stands to gain big in the House proposed fiscal 2019 federal budget — possibly garnering an additional $1.25 billion, for a total of $38.3 billion — the CDC would again see its funding cut, this time by as much as $663 million below the fiscal 2018 enacted level. The House's proposed total of $7.6 billion for the CDC, however, is still $2 billion more than what President Donald Trump requested for the agency.

* U.K. Prime Minister Theresa May pledged to boost annual funding for the National Health Service by £20 billion starting 2023/2024, after the country leaves the EU, Reuters reported. In an interview with London-based LBC Radio, May said the extra funding would come from money that will no longer be contributed to the EU.

* Portugal's parliament on Friday overwhelmingly passed a bill to legalize cannabis-based medicines, with all parties voting in favor of the legislation except for the center-right CDS-PP, which abstained, Reuters reported. Portuguese President Marcelo Rebelo de Sousa will now have to sign the bill into law.

* Zambian Health Minister Chitalu Chilufya said a cholera outbreak in the country has been contained, recording no cases after 14 consecutive days, Reuters reported. The infectious disease, which is caused by bacteria from contaminated food or drinking water, has killed 114 people and affected more than 5,000 people in Zambia over eight months.

M&A and capital markets

* China Biologic Products Holdings Inc. received an offer from CITIC Capital Holdings Ltd. unit CCRE Holdings Ltd. under which CCRE will acquire all of the outstanding share capital of China Biologic that CCRE does not already own for $110 per share. CCRE intends to finance the acquisition, which is subject to conditions, with a combination of debt and equity.

* AMAG Pharmaceuticals Inc., a U.S. developer of women's health treatments, is selling its Cord Blood Registry business to GI Partners LLC, a private equity firm, for $530 million in cash.

Drug and product pipeline

* The China National Drug Administration approved Bristol-Myers' Opdivo to treat certain patients with non-small cell lung cancer. The biopharma company said Opdivo is the first and only PD-1 inhibitor and immuno-oncology agent approved in China.

* Meanwhile, a combination of Affimed NV's cancer drug AFM13 and Merck & Co. Inc.'s Keytruda showed a reduction in the disease of certain patients with Hodgkin's lymphoma, a type of blood cancer. Affimed said data from the ongoing phase 1b trial showed that about 89%, or 16 out of 18 patients, treated with the highest dose showed a reduction in their cancer.

* Epizyme Inc.'s experimental drug tazemetostat reduced the extent of a type of blood cancer in patients in a mid-stage trial. The ongoing phase 2 study evaluated tazemetostat as a standalone therapy for patients with follicular lymphoma that had returned or did not respond to initial treatment.

* Two experimental MorphoSys AG therapies showed early effectiveness against two different blood cancers, the Munich-based drugmaker said in presentations during the European Hematology Association's annual meeting. MorphoSys was evaluating experimental medicine MOR202 — in combination with either Celgene's Revlimid and a low-dose steroid, or Celgene's Pomalyst and steroids — in a phase 1/2a trial in multiple myeloma, and MorphoSys's experimental MOR208 and Gilead Sciences Inc.'s Zydelig in a phase 2 study in chronic lymphocytic leukemia.

* The U.K. National Institute for Health and Care Excellence did not recommend Roche Holding AG's Perjeta in combination with Herceptin and chemotherapy for use under the National Health Service to treat certain breast cancer patients.

* Additionally, NICE did not recommend Ultragenyx Pharmaceutical Inc.'s Crysvita for use under the National Health Service to treat X-linked hypophosphatemia, a rare hereditary skeletal disorder.

* Teva Pharmaceutical Industries Ltd. will end human testing of fremanezumab as a treatment for chronic cluster headache after an analysis determined that the study was unlikely to meet its main goal. Testing of the drug as a therapy for episodic cluster headaches will continue, the Israeli drugmaker said.

* hVIVO PLC said the phase 2b study of FLU-v in managing influenza met its main and secondary goals of stimulating immune responses. FLU-v reduced flu infection rates and severe symptoms, the London-based specialty biopharma company said.

* Solid Biosciences Inc. said the U.S. Food and Drug Administration lifted the clinical hold on the phase 1/2 study of SGT-001, the company's investigational microdystrophin gene therapy for treating Duchenne muscular dystrophy, a rare genetic disease. The trial, known as Ignite DMD, was put on clinical hold after a patient was hospitalized.

Operational activity

* Indivior PLC secured a temporary restraining order from a district court in New Jersey that stops Dr. Reddy's Laboratories Ltd. from selling a generic version of Suboxone film, Indivior's opioid addiction treatment. The action comes a day after the U.S. Food and Drug Administration's approvals of the first generic versions of Indivior's Suboxone film.

Moody's placed the ratings of Indivior's units RBP Global Holdings Ltd. and Indivior Finance Sarl, including the B3 corporate family rating and the Caa1-PD probability of default rating, under review for downgrade to account for the possible impact of generic Suboxone entering the market.

Our features

'Arms race' against opioids brings potent antidotes, search for new pain meds: As the United States' opioid crisis barrels on, pharmaceutical companies search for new pain options and more powerful ways to fight overdoses.

Other features

* Chinese biotech companies are luring in top talent from multinational drugmakers, including Johnson & Johnson and Pfizer Inc., as these local startups — which focus on developing innovative medicines — offer higher salaries and equity, the Financial Times wrote.

The day ahead

Early morning futures indicators pointed to a lower opening for the U.S. market.

In Asia, the Hang Seng was down 0.43% to 30,309.49. The Nikkei 225 fell 0.75% to 22,680.33.

In Europe, as of midday, the FTSE 100 was down 0.32% to 7,609.25, and the Euronext 100 was down 0.99% to 1,058.92.

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