Although companies like Teva (Read more: Teva Tops on Q4 Earnings, Maintains 2017 Guidance) and Shire reported fourth quarter results this week, focus remained primarily on Merck’s MRK announcement regarding its Alzheimer’s disease candidate.
Recap of the Week’s Most Important Stories
Merck’s Pipeline Setback in Alzheimer’s: Merck suffered a pipeline setback with its investigational Alzheimer’s disease treatment, verubecestat, being halted in a phase II/III study. The EPOCH study was stopped after an interim analysis by an external Data Monitoring Committee (eDMC) indicated that the study might fail.
While the EPOCH study has been stopped due to lack of efficacy, another study, APECS, will continue as the eDMC noted that the safety signals observed in the other study were not enough to stop APECS.
Verubecestat is a BACE1 inhibitor. While the EPOCH study was being conducted for mild-to-moderate Alzheimer’s disease, the APECS study is for people with prodromal Alzheimer’s disease. Results from the APECS study are expected in Feb 2019 (Read more: Merck Halts Late Stage Alzheimer Study; Shares Slip).
Meanwhile, Merck presented positive data from a pivotal study on its investigational NNRTI for HIV, doravirine. Doravirine met the primary endpoint of the head-to-head study versus once-daily ritonavir-boosted darunavir (Trade name: Prezista) in treatment naïve adults with HIV. Moreover, the doravirine arm showed statistically significant lower levels of fasting low density lipoprotein cholesterol (LDL-C).
Pfizer Reports Data on Xeljanz from Head-to-Head Study: Pfizer’s JAK inhibitor, Xeljanz, failed to show non-inferiority as a monotherapy to Humira plus MTX or Xeljanz plus MTX in a head-to-head study for the treatment of moderate to severe rheumatoid arthritis (RA). Xeljanz plus MTX, however, met the primary endpoint in showing non-inferiority versus Humira plus MTX.
AstraZeneca to Get $130M Milestone Payment for Siliq Approval: Valeant VRX gained FDA approval for Siliq for the treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy and have failed to respond or have lost response to other systemic therapies. With this approval, Valeant will make a $130 million milestone payment to partner AstraZeneca AZN.
Meanwhile, AstraZeneca said that its cancer drug Lynparza showed a statistically-significant improvement in progression-free survival compared to chemotherapy for the treatment of patients with HER2-negative metastatic breast cancer harboring germline BRCA1 or BRCA2 mutations.
Allergan to Buy ZELTIQ for $2.47B: Allergan AGN continues with its acquisition spree with the company now agreeing to shell out $2.47 billion for ZELTIQ Aesthetics, Inc. The acquisition, which is expected to be immediately accretive, is expected to close in the second half of the year. With this acquisition, Allergan is looking to strengthen its global medical aesthetics portfolio with the addition of ZELTIQ's flagship CoolSculpting System, a part of the $4 billion body contouring market. ZELTIQ’s 2016 net revenues were approximately $354 million with growth potential of 17–20% in 2017 (Read more: Allergan To Acquire ZELTIQ in $2.47 Billion Deal, ZELTIQ Shares Pop 13%).
J&J Gets Binding Offer for Codman Neurosurgery Biz: Integra LifeSciences has made a binding offer to acquire the Johnson & Johnson JNJ Codman Neurosurgery business for $1.045 billion in cash. The Codman Neurosurgery business comprises a portfolio of devices focused on advanced hydrocephalus, neuro-critical care and operative neurosurgery.
EU Nod for Lilly’s Olumiant: Lilly LLY and partner Incyte gained EU approval for their RA treatment, Olumiant. Olumiant can be used for the treatment of moderate-to-severe active RA in adult patients who have responded inadequately to, or who are intolerant to, one or more disease-modifying antirheumatic drugs (DMARDs). This makes Olumiant the first JAK inhibitor approved to treat RA in the EU which may be used as monotherapy or in combination with methotrexate. The EU approval triggers a $65 million milestone payment from Lilly to Incyte (Read more: Lilly's Olumiant Gets Marketing Authorization in Europe).
Olumiant is currently under review in the U.S. with the FDA extending the review period by three months in January. Lilly is a Zacks Rank #3 (Hold) stock. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here. So far in 2017, Lilly has outperformed the Zacks categorized Large Cap Pharmaceuticals industry with shares gaining 8.8% compared to the industry gain of 3.5%.
Large Cap Pharmaceuticals Industry 5YR % Return
The NYSE ARCA Pharmaceutical Index rose 2.7% over the last five trading sessions with all major pharma stocks recording gains. Bristol-Myers BMY was up 5.4% during this period while AstraZeneca lost 1.8%. Over the last six months, Merck was up 3.5% while AstraZeneca was down 14.3% during this period (See the last pharma stock roundup here: Allergan, GSK Top 4Q Earnings, Praluent Breather for Sanofi).
What's Next in the Pharma World?
Watch out for the usual pipeline and regulatory updates.
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