This week Allergan (AGN - Free Report) and Denmark’s Novo Nordisk (NVO - Free Report) announced second quarter results. The European Commission granted approval to AbbVie’s (ABBV - Free Report) chronic hepatitis C drug Maviret and Sanofi’s (SNY - Free Report) eczema medicine Dupixent for expanded patients groups. Pfizer (PFE - Free Report) , Roche (RHHBY - Free Report) AstraZeneca and Lilly (LLY - Free Report) provided pipeline/regulatory updates.
Recap of the Week’s Most Important Stories
Allergan & Novo Nordisk Report Q2 Results: Allergan beat estimates for both earnings and sales in the second quarter and raised its sales guidance for the year.
Earnings declined 0.9% year over year due to lower operating profits while sales rose 1.2%, excluding the impact of currency. Botox, Juvéderm fillers, Vraylar and Ozurdex drove sales growth, making up for loss of exclusivity on some brands and lower sales of Restasis and textured breast implants.
Novo Nordisk missed estimates for both earnings and sales in the second quarter. Sales in both the Diabetes and Obesity Care segment and Biopharmaceuticals segment increased 6% at constant exchange rate (CER). Novo Nordisk raised its sales growth expectations from a range of 2-5% at CER to a range of 4-6% at CER.
EU Approval for AbbVie’s Maviret and Sanofi’s Dupixent for New Patient Groups: The European Commission granted approval to AbbVie’s Maviret as a once-daily, 8-week regimen for treatment-naïve, chronic hepatitis C (HCV) patients with genotype (GT) 1, 2, 4, 5 and with compensated cirrhosis. The approval was based on data from a study, which showed 97.9% cure rate across this group of patients with no reported virologic failures. However, analysis of data from the same study evaluating Maviret as an 8-week, once-daily treatment option for GT3 chronic HCV patient population (with cirrhosis) is ongoing. At present, Maviret is approved as a once-daily, 8-week regimen for treatment-naïve HCV patients without cirrhosis.
The regulatory agency also approved Sanofi’s new drug, Dupixent for atopic dermatitis (AD), also called eczema, in the adolescent (aged 12-17 years) patient population. Dupixent was approved for this patient population by the FDA in March.
Meanwhile, the European Commission also granted approval to include positive cardiovascular outcomes and renal data from the DECLARE outcomes study on the label of AstraZeneca’s type II diabetes medicine, Forxiga. The DECLARE-TIMI 58 study evaluated the cardiovascular (CV) and renal effects of Forxiga (dapagliflozin) in adults with type II diabetes compared to placebo. A similar application is under review in the United States.
Bayer to Buy Remaining Stake in BlueRock Therapeutics: Bayer announced a deal to buy its remaining stake in Cambridge, MA-based private biotech BlueRock Therapeutics to strengthen its position in cell therapy. BlueRock makes engineered cell therapies focused on neurology, cardiology and immunology, using a proprietary induced pluripotent stem cell (iPSC) platform. Its lead program is a pre-clinical candidate in Parkinson’s disease, which is expected to enter clinical studies by the end of this year. Bayer presently holds 40.8% stake in BlueRock and has agreed to pay $240 million upfront and potential milestone payments of $360 million to buy the rest of BlueRock’s stake. This will bring the total value of 100% stake in BlueRock to $1 billion. BlueRock was established in 2016 as a joint venture between Bayer and Versant Ventures. The deal is expected to close in the third quarter of 2019.
Sanofi’s Dupixent Succeeds in Eczema Study in Children: Sanofi and partner Regeneron’s phase III study evaluating Dupixent in pediatric AD population met the primary and secondary endpoints. Top-line data from the study showed that Dupixent plus standard-of-care topical corticosteroids (TCS) significantly improved measures of overall disease severity, skin clearing, itching and health-related quality of life in children (aged 6 to 11 years) with severe AD compared to TCS alone. The companies expect to submit an application in the United States to get approval for use in children in the fourth quarter.
Dupixent is also marketed to treat moderate-to-severe asthma and was approved by the FDA for the third indication, chronic rhinosinusitis with nasal polyposis in adults in June.
AbbVie Files NDA for Elagolix in Uterine Fibroids: AbbVie and partner Neurocrine Biosciences announced the filing of a new drug application (NDA) looking for approval of elagolix for reducing heavy menstrual bleeding (HMD) in premenopausal women with uterine fibroids. The NDA was based on data from two pivotal phase III studies (ELARIS UF-I and ELARIS UF-II), which showed a statistically significant reduction in HMB with elagolix, in combination with add-back therapy, compared to placebo. Elagolix is already marketed as Orilissa for management of pain associated with endometriosis, a common gynecologic disorder, for which approval was received in July last year.
Pfizer’s Sickle Cell Disease Candidate Fails: Pfizer’s phase III study evaluating its investigational candidate, rivipansel in patients with sickle cell disease experiencing acute pain crises or VOC did not meet its primary or key secondary efficacy endpoints. The primary endpoint of the study was the time to readiness-for-discharge. Rivipansel was initially being developed under a worldwide licensing agreement with GlycoMimetics. After completion of the phase II study, Pfizer took charge of the development of rivipansel.
AstraZeneca’s Lynparza Phase III Study Meets Endpoint: AstraZeneca announced positive results from a phase III study evaluating its successful PARP inhibitor, Lynparza in men with metastatic castration-resistant prostate cancer (mCRPC) selected for BRCA1/2 or ATM gene mutations, a subpopulation of HRR gene mutations. The study met the primary endpoint of significantly increasing the time patients live without radiographic disease progression versus standard of care treatment
Roche’s Tecentriq Combo Improves PFS in Bladder Cancer Study: Roche announced interim data from a phase III study evaluating its PD-L1 inhibitor, Tecentriq plus platinum-based chemotherapy for the treatment of patients with previously untreated advanced bladder cancer. The IMvigor130 study reduced the risk of disease worsening or death in such patients compared with chemotherapy alone, thereby meeting the study’s co-primary endpoint, progression free survival (PFS). While encouraging overall survival results were observed as well, these data were not mature. Roche will submit the PFS data to the FDA and European Medicines Agency for approval.
Lilly’s Emgality Succeeds in Phase III Study in Difficult-to-Treat Migraine Patients: Lilly’s new migraine drug, Emgality, met the primary and all key secondary objectives in a phase III study, evaluating it in patients with chronic and episodic migraine who failed previous migraine preventive treatments. Treatment with Emgality led to reduction in monthly migraine headache days in such patients by 4.1 days, compared with 1 day for placebo, thereby meeting the study’s primary endpoint of superiority over placebo in reducing the number of monthly migraine headache days.
The NYSE ARCA Pharmaceutical Index rose 1% in the last five trading sessions.
Here is how the seven major stocks performed in the last five trading sessions.
Bristol-Myers recorded the highest increase (4.6%) while Pfizer declined the most (3.6%)
In the past six months, AstraZeneca has been the biggest gainer (20.4%) while Pfizer declined the most (11.5%).
(See the last pharma stock roundup here: PFE, MRK, LLY Q2 Earnings, Upjohn-MYL Merger)
What's Next in the Pharma World?
Watch out for regular pipeline and regulatory updates next week.
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