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GSK, Sanofi, Gilead report results; AstraZeneca heart drug cuts death risk

Top news

* GlaxoSmithKline plc posted adjusted fourth-quarter 2017 EPS of 27.2 pence compared to 25.5 pence in the year-ago period. It expects adjusted EPS to grow by 4% to 7% at constant exchange rates in 2018, if no substitutable competitor to Advair is released in the U.S. If an Advair generic is introduced by mid-year, it expects adjusted EPS to be flat to down 3% compared to 2017, at constant exchange rates.

* Sanofi booked fourth-quarter 2017 business net income of €1.33 billion, or €1.06 per share, down 10.8% year over year on a constant exchange rate basis. The French drugmaker expects its full-year 2018 business EPS to grow between 2% and 5%, taking into account expected contributions from recent acquisitions, including its €3.9 billion takeover of Ablynx NV.

Sanofi CEO Olivier Brandicourt predicted a 9% drop in sales of diabetes medicines in 2018 after the disease area suffered a near-20% fall in the fourth quarter of 2017 due to continued pressure on pricing in the U.S. market.

* Gilead Sciences Inc. said its fourth-quarter 2017 non-GAAP net income was $2.34 billion, or $1.78 per share, down from $3.59 billion, or $2.70 per share, in the year-ago period. For full year 2018, the drugmaker forecast product sales of $20 billion to $21 billion.

Meanwhile, the company's fourth-quarter sales slipped by more than $1.5 billion year over year. The losses, however, were partially offset by its overall HIV and hepatitis B franchise, which made $3.7 billion in the quarter.

* AstraZeneca PLC said prolonged use of its heart drug Brilinta, combined with aspirin, reduced the risk of major adverse heart events, including cardiovascular death, heart attack or stroke, in certain heart attack survivors.

On the policy front

* U.S. Food and Drug Administration Commissioner Scott Gottlieb said the U.S. addiction epidemic is migrating to substances his agency would not have suspected five or 10 years ago to be agents people would use to get high, such as the anti-diarrhea drug Imodium and the botanical substance kratom.

Separately, Gottlieb is optimistic the FDA will reach an accord with Congress on allowing critically ill patients who have tried all other options to have broader access to experimental drugs that have not yet gone through U.S. approval. The FDA commissioner has been upfront about his opposition to the so-called right-to-try legislation that passed the Senate last summer and is pending in the House of Representatives.

* Nearly two-thirds of the bills introduced in U.S. state legislatures this year to rein in drug prices target pharmacy benefit managers, including Express Scripts Holding Co., CVS Health Corp. unit CVS CareMark and UnitedHealth Group Inc.'s OptumRx. The benefit managers have been criticized for a variety of practices, including allegations that they pocket too much of the rebates offered by drug companies instead of passing them on to consumers.

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* Alabama Attorney General Steve Marshall filed a lawsuit against Purdue Pharma LP claiming that the drugmaker deceptively marketed and sold its opioid drugs and jeopardized the state's public health.

Drug and product pipeline

* Bavarian Nordic A/S said the phase 3 trial of its nonreplicating smallpox vaccine Imvamune met its main goals, showing the drug's effectiveness compared to U.S.-licensed vaccine Acam2000.

* Lupin Ltd. and Yoshindo Inc. said YLB113, an investigational biosimilar to Pfizer Inc. and Amgen Inc.'s Enbrel, was found in a phase 3 study to be equally effective and safe for treating rheumatoid arthritis compared to the original product.

* Celgene Corp. said a combination of cancer medicines Pomalyst and Imnovid with bortezomib and low-dose dexamethasone improved the survival of blood cancer patients who did not respond to prior therapy.

* Array BioPharma Inc. said a combination its investigational drugs encorafenib and binimetinib was better at keeping patients with a certain type of skin cancer alive when compared to Genentech Inc.'s Zelboraf.

* Sage Therapeutics Inc.'s Sage-217 received U.S. FDA breakthrough therapy designation for treating major depressive disorder.

* GlaxoSmithKline plc's vaccine Bexsero received its second U.S. FDA breakthrough therapy designation. The latest designation was granted to Bexsero for preventing invasive meningococcal disease, a bacterial infection, in children aged two to 10 years.

* Zogenix Inc.'s investigational drug, ZX008, also received FDA breakthrough therapy designation to treat a rare form of epilepsy.

Operational activity

* H. Lundbeck A/S said fourth-quarter 2017 core profit came in at 756 million Danish kroner, or 3.81 kroner per share, compared to a profit of 693 million kroner, or 3.50 kroner per share, in the corresponding quarter of 2016.

* Allergan plc's migraine pill ubrogepant has shown positive late-stage data for alleviating pain during migraine episodes, but the drugmaker said it is unlikely that sales will take off before late 2019.

Our features

GSK's chief strategy officer discusses M&A, pharma focus, US tax reform: GlaxoSmithKline chief strategy officer David Redfern told S&P Global Market Intelligence that the company will not make moves that would jeopardize its pharma R&D.

Other features

* Novo Nordisk A/S believes it can transform the diabetes market, which is dominated by injectable drugs, with oral semaglutide, Reuters said in a feature.

The day ahead

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

In Asia, the Hang Seng fell 0.89%% to 30,323.20, while the Nikkei 225 climbed 0.16% to 21,645.37.

In Europe, around midday, the FTSE 100 rose 0.69% to 7,190.61 and the Euronext 100 climbed 0.65% to 1,003.85.

The Daily Dose is updated as of 6:30 a.m. ET. Some external links may require a subscription.