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J&J sells Lifescan for $2.1B; Merck's Keytruda gets FDA nod for cervical cancer

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J&J sells Lifescan for $2.1B; Merck's Keytruda gets FDA nod for cervical cancer

Top news

* Johnson & Johnson agreed to sell its LifeScan diabetes care business to Platinum Equity for $2.1 billion, the latest in a string of private equity acquisitions in the industry. The transaction will probably close by the end of the year, subject to antitrust clearances and other closing conditions, the New Brunswick, N.J.-based company said yesterday.

LifeScan, which manufactures and supplies blood glucose-monitoring equipment and insulin pumps for hospital and home use, generated $1.5 billion of net revenue in 2017.

* The U.S. FDA approved Merck & Co. Inc.'s Keytruda to treat cervical cancer patients whose disease has returned or has spread to other parts of the body on or after chemotherapy and whose disease contains the PD-L1 protein.

The approval is based on a study named Keynote-158, which included a group of 98 patients with recurrent or metastatic cervical cancer. Keytruda has now been approved for skin cancer, lung cancer, head and neck cancer, classical Hodgkin lymphoma, bladder cancer, cancers in the urinary system, and stomach cancer.

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* AbbVie Inc. said patients treated with its investigational rheumatoid arthritis drug upadacitinib showed additional improvements, based on new data from three phase 3 trials. The three studies, called Select-Next, Select-Beyond and Select-Monotherapy, evaluated the drug in adults with moderate to severe rheumatoid arthritis.

On the policy front

* A number of drugmakers have been in discussions with the U.S. Department of Health and Human Services about lowering their prices, Secretary Alex Azar told lawmakers on Capitol Hill. However, the U.S. health chief was unable to provide evidence those companies were ready to commit.

Azar also said biopharmaceutical companies that would like to "execute substantial, material reductions in their drug prices" are running into hurdles from pharmacy benefit managers — often called middlemen — and distributors. While Azar was condemning PBMs on one hand, he said "we need to unleash them" when it comes to Trump's plan to move some of the Medicare Part B drugs to Part D, where he said those middlemen could negotiate better deals.

* The $500 million in added funds that Congress allotted to the National Institutes of Health earlier this year to address the opioid crisis will be spent on pursuing extended-release and longer-acting formulations of drugs to treat addiction, vaccines to protect against fentanyl and heroin overdoses, and new nonaddictive therapies to manage pain.

The funds backing the Helping to End Addiction Long-term Initiative, unveiled April 4, will also be used to develop stronger and longer duration formulations of opioid overdose-reversal agents, like naloxone, whose effectiveness is short-lasting and requires multiple doses to reverse respiratory arrest in situations involving synthetic opioids, like fentanyl.

* U.S. Food and Drug Administration Commissioner Scott Gottlieb is proposing a new reimbursement scheme for antibiotic drugs that aims to do away with a per-use reimbursement approach, the agency chief said in a statement. Gottlieb said the current model puts new antibiotics — that may be effective against very rare and dangerous pathogens — at a disadvantage because they tend to be used sparingly.

The regulator is also promoting the wider use of generic drugs through public service radio announcements, both in English and in Spanish, FiercePharma reported, citing an email by a U.S. FDA spokesman.

M&A and capital markets

* Bioton SA shareholders approved the proposed acquisition of SciGen Ltd. by YiFan International Pharmaceutical Co. Ltd. Bioton is the holding company of SciGen, a Singapore-based developer of genetically engineered biopharmaceutical products.

* Sanofi priced an offering of $2 billion of notes — selling $1 billion of 3.375% fixed rate notes due June 19, 2023, and $1 billion of 3.625% fixed rate notes due June 19, 2028.

* Kezar Life Sciences Inc. is looking to sell 4,666,667 common shares at a price of between $14 and $16 per share in its IPO.

* New York's MeiraGTx Holdings PLC closed its IPO to raise gross proceeds of $75 million, selling 5 million ordinary shares at $15 per share.

Drug and product pipeline

* VTv Therapeutics Inc. is not giving up on its drug azeliragon even after the experimental Alzheimer's therapy failed to meet its goals in the second part of a late-stage study. The company will be discussing ways to advance azeliragon toward a regulatory approval with the U.S. FDA based on data collected so far, it said in a news release.

* Idera Pharmaceuticals Inc. said IMO-8400 failed to deliver statistically significant improvement over placebo in a phase 2 trial in patients with dermatomyositis — a rare inflammatory disease characterized by skin rashes, muscle weakness and muscle inflammation.

* French regulator ANSM has forbidden the use of Sanofi's epilepsy drug valproate during pregnancy, Reuters reported, citing a statement from the agency. ANSM, the national agency for the safety of medicines and health products, said valproate should not be prescribed to women of child-bearing age, barring exceptional circumstances.

* Pluristem Therapeutics Inc. said a mid-stage trial of its cell therapy PLX-PAD improved mobility in patients with intermittent claudication, a condition that causes aches or pain in the legs due to poor circulation of blood in the arteries of the legs. The disease can progress to critical limb ischemia, which occurs when severely obstructed arteries cause reduced blood flow to the limbs.

* Galmed Pharmaceuticals Ltd. said a certain dose of its Aramchol drug met the main goal of reducing liver fat in certain patients nonalcoholic steatohepatitis in a midstage trial. NASH, the most severe form of nonalcoholic fatty liver disease, is characterized by the abnormal accumulation of fat in the liver and in some cases could progress to more serious diseases such as scarring or cancer.

* Jorge Insuasty, Sanofi's global head of development, said the French company believes it can regain a leading position in the cancer drug market in the coming years, Reuters reported.

* Over a third of U.S. adults, or 37.2%, are taking medicines that can cause depression, according to a study published in the The Journal of the American Medical Association.

Operational activity

* Massachusetts Attorney General Maura Healey filed a lawsuit against Purdue Pharma LP and certain of its executives and directors for misleading prescribers and consumers regarding the addiction and health risks of their opioids, including OxyContin. The lawsuit alleges that Purdue Pharma misguided doctors and patients by disguising the risks of addiction and death related to prolonged use of the drug.

* PDL BioPharma Inc. reached a settlement agreement with Anchen Pharmaceuticals, Inc., which is looking to market a copycat version of the company's hypertension drug Tekturna. PDL BioPharma agreed to drop patent litigation against the company and grant the Irvine, Calif.-based drugmaker a license to manufacture and sell a generic version of Tekturna in the U.S. starting March 1, 2019.

* The U.S. FDA lifted supply restrictions from Sun Pharmaceutical Industries Ltd.'s Halol plant in Gujarat, India, following an inspection. Sun Pharma, India's largest drugmaker, can now resume shipments of therapies made at the facility.

* Roche Holding AG CEO Severin Schwan is not considering cutting costs by merging its Roche pharma research and development unit and its subsidiary Genentech's research and development unit, FierceBiotech reported.

* GlaxoSmithKline PLC said Luc Debruyne is leaving his role as president of the company's vaccines division at the end of 2018. The U.K.-based drugmaker appointed Roger Connor, who is the president of its global manufacturing and supply unit, to replace Debruyne by Sept. 1.

Other features

* Bloomberg News has a profile on Mark Murcko, the previous chief technology officer of Vertex Pharmaceuticals Inc. who helped the company bring five treatments to market — including drugs for hepatitis C and HIV.

* The number of children going unvaccinated are rising in states that allow parents to skip vaccinations for their kids due to personal beliefs, Reuters writes in a feature, citing a U.S. study.

* Celgene Corp. admitted its "self-inflicted" error over a botched plan to gain U.S. FDA approval for its multiple sclerosis drug, Financial Times writes in a feature.

The day ahead

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

In Asia, the Hang Seng lost 1.22% to 30,725.15, while the Nikkei 225 rose 0.38% to 22,966.38.

In Europe, around midday, the FTSE 100 gained 0.45% to 7,738.39, and the Euronext 100 increased 0.43% to 1,066.63.

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