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US FDA names new deputy commissioner; China approves 1st homegrown IO drug


Essential IR Insights Newsletter Fall - 2023

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US FDA names new deputy commissioner; China approves 1st homegrown IO drug

Top news

* U.S. Food and Drug Administration Commissioner Scott Gottlieb said the agency appointed Amy Abernethy as principal deputy commissioner, a position she will fill early in 2019. Abernethy is the chief medical officer, chief scientific officer and senior vice president at New York City-based Flatiron Health Inc., where she specializes in real-world evidence, a stated "top strategic priority" at the FDA. Roche Holding AG completed its $1.9 billion acquisition of Flatiron in April.

* Shanghai Junshi Biosciences Co. Ltd. received approval from Chinese regulators to launch its cancer treatment for melanoma, making it the first Chinese drugmaker to get the green light for the immuno-oncology medicines that pharma giants Merck & Co. Inc. and Bristol-Myers Squibb Co. have turned into blockbusters with Keytruda and Opdivo.

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* Johnson & Johnson will repurchase $5 billion of its common stock days after losing $25 billion in market value following a Reuters report alleging the healthcare giant was aware that its baby powder products contained asbestos.

* Tennessee Republican Sen. Lamar Alexander said he plans to retire at the end of his current term and will not seek re-election in 2020, relinquishing a seat he has held since 2003. The 78-year-old lawmaker — a former Tennessee governor — leads the Senate Health, Education, Labor and Pensions Committee, where he helped shepherd major bipartisan bills affecting the healthcare and biopharmaceutical industries through Congress.

* More than 4,000 people lost Medicaid eligibility at the end of November due to Arkansas' work requirements program, bringing the total number of people who have lost coverage to nearly 17,000, according to new data from the state's Department of Human Services.

M&A and capital markets

* Versant Venture Management LLC, also known as Versant Ventures, raised a total of US$700 million across two funds. The biotechnology-focused investment firm's primary global fund, Versant Venture Capital VII L.P., garnered US$600 million, while its Canadian companion fund, Versant Voyageurs I, collected US$100 million.

* Hong Kong-based Aptorum Group Ltd. closed its previously announced IPO of 761,419 class A ordinary shares, priced at $15.80 apiece. The pharmaceutical company raised gross proceeds of about $12 million through the offering.

* Australia's Exopharm Ltd. raised A$7 million in its IPO. The Melbourne, Victoria-based developer of regenerative medicines sold 35 million of its shares at 20 cents apiece. The shares are expected to start trading Dec. 18 on the ASX.

* Singapore-based Biolidics Ltd. said it expects to raise about S$6.1 million in net proceeds as part of an IPO to list its shares on the Singapore Exchange. The cancer diagnostics company priced the offering of 27.5 million shares at 28 Singaporean cents per share.

* Rowville, Australia-based Sigma Healthcare Ltd., which focuses on wholesale and distribution of pharmaceutical products, established a receivables purchase agreement with Westpac Banking Corp., securing A$500 million over three years.

Drug and product pipeline

* FibroGen Inc. said China's National Medical Products Administration approved roxadustat to treat anemia associated with chronic kidney disease in patients on dialysis. San Francisco-based FibroGen is collaborating with AstraZeneca PLC to develop and market roxadustat in China.

* Imugene Ltd.'s gastric cancer vaccine HER-Vaxx was found to be safe and tolerable in an early-stage study, which the company said will support the drug's advancement to a phase 2 trial. HER-Vaxx is an add-on vaccine therapy for gastric cancer designed to trigger an immune response against cancer cells that overexpress a gene called HER-2.

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* Innovation Pharmaceuticals Inc. discontinued the development of its psoriasis drug Prurisol after the therapy failed to show adequate efficacy in a mid-stage trial. The phase 2b study is evaluating Prurisol in moderate-to-severe chronic plaque psoriasis, an autoimmune disease that causes raised, red, scaly patches to appear on the skin.

* Mylan NV has received the U.S. Food and Drug Administration's approval to launch the first generic of Allergan PLC's inflammatory bowel disease therapy Canasa Rectal Suppository. The drug is approved in the U.S. to treat mildly to moderately active ulcerative proctitis, which causes inflammation of the lining of the rectum.

* Teva Pharmaceutical Industries Ltd.'s medicine Ajovy was effective in a late-stage study in reducing headache days for migraine patients who had received prior therapy. The Israeli pharmaceutical giant evaluated Ajovy against placebo in 838 patients with chronic and episodic migraine in a phase 3b trial called Focus.

* Eiger BioPharmaceuticals Inc. said the U.S. Food and Drug Administration has granted breakthrough therapy designation to its Hepatitis delta virus medicine lonafarnib. Hepatitis delta virus causes an infection in patients who are already harboring the Hepatitis B virus and can lead to more severe liver disease.

* Evofem Biosciences Inc. plans to seek a U.S. approval for its contraceptive vaginal gel Amphora after the medicine, in a late-stage study, met its main goal of preventing pregnancy. Evofem evaluated Amphora in about 1,400 women aged 18 to 35 years in a phase 3 trial called Ampower over seven cycles of use.

* In a mid-stage study, Mereo BioPharma Group PLC's medicine BGS-649 was found to be safe and helped restore hormone levels in men with an infertility disorder. The London-based biopharmaceutical company evaluated BGS-649 in an extended phase 2b trial to treat men with hypogonadotropic hypogonadism with a body mass index over 30.

* Los Angeles-based Puma Biotechnology Inc. said its medicine Nerlynx helped breast cancer patients live longer without the disease worsening but did not improve overall survival as desired in a late-stage study.

* Amgen Inc. is seeking U.S. approval of a biosimilar competitor to Johnson & Johnson's Remicade treatment for autoimmune disorders including rheumatoid arthritis and psoriasis.

* Alkermes PLC, a Dublin-based biotechnology company, and its partner, Biogen Inc., have submitted a new drug application to the U.S. Food and Drug Administration seeking approval to market its multiple sclerosis treatment BIIB098.

Operational activity

* Elanco Animal Health Inc. forecast 2019 adjusted EPS of $1.02 to $1.12 and revenue in the range of $3.10 billion to $3.16 billion. The Greenfield, Ind.-based company, which makes medicines for animals, expects GAAP EPS of 36 cents to 48 cents in 2019.

* Pfizer Inc. will pay Kineta Immuno-Oncology LLC $15 million up front for access to the Seattle company's screening platform to develop cancer treatments. In addition to the up-front payment, Pfizer has agreed to pay Kineta up to $505 million when certain research, development and sales goals are met.

Our features

Oxeia CEO describes hunger hormone's potential as concussion treatment: Oxeia Biopharmaceuticals Inc. CEO Michael Wyand sheds light on the unmet medical need of those suffering concussions, and what Oxeia is doing to try and mitigate the long-term effects.

Other features

* Patients undergoing chemotherapy were at a higher risk of getting hospitalized due to serious kidney injury, Reuters reported citing a Canadian study which involved roughly 163,000 people.

* Stat wrote a feature on He Jiankui, the Chinese researcher who said in November that his experiment helped make the world's first babies whose genes were modified using the CRISPR technology.

* Abbott Laboratories' urine test to detect tuberculosis among HIV patients is being underutilized even after being recommended by the World Health Organization, The New York Times reported.

* Vanuatu, an archipelago of volcanic islands in the South Pacific region, has partnered with several global organizations to use drones for delivering vaccines for children in the country's remote islands, The New York Times wrote.

The day ahead

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

In Asia, the Hang Seng fell 1.05% to 25,814.25, and the Nikkei 225 dropped 1.82% to 21,115.45.

In Europe as of midday, the FTSE was down 0.39% to 6,746.86, and the Euronext 100 fell 0.30% to 929.32.

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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