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Essential IR Insights Newsletter - February 2023

Roche Q3 sales grow 7%; Changsheng slapped with hefty fine over vaccine blunder

Top news

* Roche Holding AG said third-quarter sales grew 7% year over year to about CHF13.97 billion for the quarter from CHF13.09 billion. The Swiss drugmaker confirmed its full-year 2018 earnings outlook driven by strong growth in China and a resilient performance from some of its older cancer medicines which have lost patent exclusivity.

* China's National Medical Products Administration imposed a fine of 9.11 billion Chinese yuan on Changchun Changsheng Life Sciences Ltd. for manufacturing substandard vaccines, FiercePharma reported, citing an official release. The health regulator charged the Changsheng Bio-Technology Co. Ltd. unit with eight violations of drug regulations as part of a probe, which found that the company fabricated records and flouted manufacturing rules while making its human rabies vaccines.

* The price hike for two dosages of heart medicine valsartan turned out to be the steepest in the U.S. in September, after China's Zhejiang Huahai Pharmaceutical Co., Ltd. recalled the drug following the detection of potentially cancerous impurities, Reuters reported. Prices for 160-milligram and 80-milligram valsartan tablets — used to treat high blood pressure and heart failure — rose more than twice last month from August rates, according to the National Average Drug Acquisition Cost survey by the Centers for Medicare & Medicaid Services.

* Minnesota Attorney General Lori Swanson is accusing Eli Lilly and Co., Novo Nordisk A/S and Sanofi of fraudulently raising the list prices for insulin while offering rebates to pharmacy benefit managers, which would then cover their products on behalf of health plans, Reuters wrote. Swanson filed a lawsuit in federal court in Trenton, N.J., accusing the drugmakers of misleading diabetes patients by inaccurately approximating the real cost of insulin, which is used to control blood sugar.

On the policy front

* The U.S. Food and Drug Administration and the U.S. Department of Homeland Security are strengthening their coordination to address cybersecurity threats in medical devices.

M&A and capital markets

* Pediapharm Inc. completed its previously announced acquisitions of Medexus Inc. and Medac Pharma Inc.

* SI-BONE Inc. priced its IPO of 7,200,000 common shares at $15 each, the high end of a previously announced range of between $13 and $15. The Santa Clara, Calif.-based medical device company expects to raise proceeds of up to $108 million.

* Equillium Inc. closed an IPO to list its common shares on the Nasdaq Global Market under the symbol EQ. The La Jolla, Calif.-based biotechnology company had said it expected gross proceeds of about $65.4 million from the flotation.

Drug and product pipeline

* The U.S. FDA approved Pfizer Inc.'s Talzenna, or talazoparib, for treating breast cancer with inherited BRCA-mutation, which does not express a large amount of a protein called HER2 and has advanced locally or spread to other organs.

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* Eiger BioPharmaceuticals Inc.'s experimental drug ubenimex failed to show an improvement in lower leg lymphedema — a chronic condition where excess fluid collects in tissues causing swelling — in a phase 2 trial.

* Eisai Co. Ltd. and Purdue Pharma LP said topline results from a late-stage study showed their experimental sleep-wake regulation treatment lemborexant helped insomnia patients fall asleep and stay asleep.

* Kala Pharmaceuticals Inc. is seeking FDA approval for its medicine KPI-121 0.25%, which could become the first approved therapy for treating symptoms of dry eye disease.

* The Drug Controller General of India asked Allergan PLC's Indian unit to recall its Ozurdex intravitreal implant after the company acknowledged that a silicone particle was found in the product during a routine manufacturing inspection, The Press Trust of India reported. Ozurdex is used to treat macular edema, or the buildup of fluid in the retina that causes swelling and distorted vision.

Operational activity

* Biogen Inc. and Samsung Bioepis Co. Ltd. launched Imraldi, a biosimilar of the world's best-selling drug Humira, in Europe. AbbVie Inc. is facing tougher competition for Humira, including from Amgen and Mylan NV, as the drug's European patent expired Oct. 16, Reuters noted.

* South Korea-based Samsung Biologics Co.Ltd. shares slumped Oct. 17 — the company's lowest since August — following local press reports that the country's financial regulator would slap the Samsung Group unit with disciplinary action for allegedly violating accounting standards, the Financial Times wrote.

* Johnson & Johnson signed a collaboration agreement with MeiraGTx Holdings plc to develop regulatable gene therapies, or technology that applies an on and off switch to deliver medicine according to the patient's needs. Financial terms of the agreement were not disclosed.

* Moody's downgraded Akorn Inc.'s corporate family rating to B3 from B1 and revised the rating outlook to developing from ratings under review. The rating agency said the downgrade reflects Lake Forest, Ill.-based Akorn's deteriorating stand-alone credit profile and the decreasing likelihood that it will be acquired by Germany's Fresenius SE & Co. KGaA.

Our features

Johnson & Johnson Q3 sales beat estimates at $20.3B despite pricing pressure: The company's earnings showed a stronger-than-expected third quarter, but the future still holds some risks amid increasing competition.

Other features

* A report by the Centers for Disease Control and Prevention showed that the number of Americans with acute flaccid myelitis — a rare debilitating neurological condition that causes weakness or paralysis in the legs and arms — has risen in the past two months, The Wall Street Journal highlighted.

* Reuters featured the rise of microcephaly — a birth defect characterized by a small head and serious developmental problems — in Africa amid an emerging Zika outbreak, a trend that has worried health officials as a link between the African strain of Zika and microcephaly has not been established.

The day ahead

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

In Asia, the Nikkei 225 was up 1.29% 22,841.12.

In Europe, as of midday, the FTSE 100 was up 0.20% to 7,073.55, and Euronext 100 had climbed 0.19% to 1,006.33.

Click here to read about today's financial markets, setting out the factors driving stocks, bonds and currencies around the world ahead of the New York open.

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