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HHS: Ebola outbreak a national security issue; BioMarin Q2 profit down 14.1% YOY

Top news

* The Ebola outbreak in the Democratic Republic of Congo is not only a public health emergency of international concern but also a national security concern, members of the U.S. Department of Health and Human Services said on the one-year anniversary of the crisis. As of Aug. 1, which marks one year since the first case, 1,813 deaths have been reported, and no evidence suggests that the outbreak is slowing down, the Centers for Disease Control and Prevention's Henry Walke said during a media briefing.

Meanwhile, Rwanda Health Minister Diane Gashumba said the border with Congo was fully open, after some Congolese traders had reported that it was closed, Reuters reported. The minister noted that there was a slowdown in traffic at the border due to intensified health screening after a third case was reported in Goma, a densely populated city in Congo that borders Rwanda.

* BioMarin Pharmaceutical Inc.'s second-quarter non-GAAP income amounted to $17.1 million, a decrease of 14.1% from $19.9 million in the prior-year period. The company forecasts non-GAAP income in the range of $130 million to $170 million for the full year, steady with the previous guidance.

* Scientists have developed an experimental blood test that can detect a protein called beta-amyloid, an indicator for Alzheimer's disease — although the test could still not be used in clinical studies for years.

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On the policy front

* The Centers for Medicare and Medicaid Services will increase Medicare payments in the fiscal year 2020 for hospice providers by $520 million, or 2.6%, according to a July 31 finalized rule. The agency also set the aggregate cap amount for providers. The finalized payment rate is slightly below the $540 million, or 2.7%, increase that CMS proposed in April.

* Thailand is about to begin the first official use of medical cannabis as it plans to distribute about 10,000 bottles of cannabis oil to hospital patients next week, Reuters reported. The Asian country legalized medical cannabis earlier this year.

M&A and capital markets

* Chinese pharmaceutical company I-Mab Biopharma has confidentially filed for a U.S. IPO, Bloomberg News reported, citing people with knowledge of the matter. I-Mab Biopharma is planning to raise up to $40 million in a private funding round, valuing the company at about $800 million, the report said.

* Elanco Animal Health Inc. acquired pig-vaccine maker Prevtec Microbia Inc. for C$78.5 million plus a contingent payment option. Prevtec, a Montreal-based privately held company, is eligible to receive up to C$21.5 million based on certain sales milestones.

Drug and product pipeline

* Ultragenyx Pharmaceutical Inc. filed an application with the U.S. Food and Drug Administration seeking approval for its medicine UX007 to treat long-chain fatty acid oxidation disorders — a group of rare genetic diseases that prevent the body from breaking down certain fats into energy.

* Eton Pharmaceuticals Inc. said the FDA accepted Aucta Pharmaceuticals' application seeking approval of the medicine ET-105 as an add-on therapy for seizures in epilepsy patients. Eton had acquired U.S. marketing rights for ET-105 — an oral liquid formulation of anti-epileptic drug lamotrigine — from Aucta in June.

Operational activity

* Celgene Corp. will pay Mylan NV about $62 million to settle claims that the drugmaker stifled generic competition for its cancer drugs Revlimid and Thalomid, FiercePharma reported. The move follows another agreement by Celgene to pay about $55 million to settle a class-action lawsuit in which the company allegedly refused to sell Revlimid and Thalomid samples and undertook exclusive agreements to influence supply flow.

* Medical cannabis company CannTrust Holdings Inc. is undertaking a strategic review that could potentially result in the full or partial sale of the company. CannTrust has formed a special committee to investigate Health Canada's compliance report, which said the company was involved in growing cannabis in five unlicensed rooms in its Pelham, Ontario-based greenhouse facility.

Meanwhile, the Ontario Securities Commission has started an investigation into CannTrust following Health Canada's findings, Reuters reported.

* Bausch Health Companies Inc. and its Salix Pharmaceuticals Ltd. unit agreed with Teva Pharmaceuticals USA Inc. to resolve litigation relating to the extended-release formulation of Apriso, used for treating inflammatory bowel disease ulcerative colitis in adults. Bausch will grant Teva a nonexclusive license to market a generic version of the drug in the U.S. starting Oct. 1, 2021, and it will not make any financial payments or other transfers.

* Akorn Inc. CEO Douglas Boothe said during the company's second-quarter earnings call that Akorn was taking steps to restore freedom to operate by addressing its capital structure and resolving litigation. Earlier in the week, Akorn agreed to pay about $74 million to settle a class-action lawsuit in relation to data integrity issues.

* Tokyo's Kyowa Kirin Co. Ltd. said it regained the non-oncology rights to tivozanib from AVEO Pharmaceuticals Inc. for an up-front payment of $25 million.

* Lonza Group Ltd. and Charles River Laboratories International Inc. are at odds over the future of a drug safety test that uses the blue blood of horseshoe crabs, Reuters reported. While Lonza is urging adopting a synthetic alternative called recombinant Factor C following pressure from wildlife protection groups, Charles River believes that moving too fast toward an alternative could jeopardize patient safety.

The day ahead

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

In Asia, the Hang Seng dipped 2.35% to 26,918.58, and the Nikkei 225 declined 2.11% to 21,087.16.

In Europe, around midday, the FTSE 100 was down 1.69% to 7,456.63, and the Euronext 100 was down 2.42% to 1,060.63.

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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