The last week has been an eventful one for pharma stocks with Novartis NVS announcing that it is acquiring gene therapy company AveXis while Merck MRK and AbbVie ABBV announced successful study results. In other news, Pfizer’s PFE kidney cancer drug, Inlyta missed primary endpoint in a phase III study.
Recap of the Week’s Most Important Stories
Novartis to Buy AveXis for $8.7 Billion: The big news early in the week was Novartis’ $8.7 billion deal to buy AveXis whose lead product candidate AVXS-101 is a one-time gene replacement therapy for spinal muscular atrophy (SMA). A regulatory filing for AVXS-101 in the United States is expected in the second half of this year. AVXS-101 has the potential to generate millions of dollars for Novartis, if approved. The company agreed to pay $218 for each share of AveXis, representing a whooping premium of 88% to AveXis’ closing price on Friday.
With boards of both the companies having approved the deal, the buyout is anticipated to close in the second half of the year. (Read More: Novartis Inks $8.7 Billion Gene Therapy Deal to Buy AveXis)
Merck’s Keytruda Succeeds in Another Key Lung Cancer Study: A pivotal lung cancer study, KEYNOTE-042, on Merck’s blockbuster PD-1 inhibitor, Keytruda met the primary endpoint. The KEYNOTE-042 study evaluated patients with locally advanced or metastatic nonsquamous or squamous non-small cell lung cancer (NSCLC) whose tumors express PD-L1 protein levels of 1 percent or greater (TPS of ≥1 percent). In such patients, Keytruda showed a significant survival benefit compared with platinum-based chemotherapy.
Notably, Keytruda monotherapy is already marketed for the first-line treatment of patients with metastatic NSCLC whose tumors express PD-L1 protein levels of 50 percent or greater (TPS of ≥50 percent).
If the OS data from KEYNOTE-042 study are approved to be included in Keytruda’s label, the drug can be prescribed to treat an expanded lung cancer patient population, further reinforcing its position in the lung cancer market. (Read More: Merck’s Keytruda Offers Survival Benefit in Lung Cancer Study)
AbbVie’s 4th Late-Stage Upadacitinib Study Succeeds: AbbVie’s oral JAK-1 selective inhibitor, upadacitinib, met all primary as well as secondary endpoints in the 4th phase III study from its SELECT program. The phase III study, SELECT-COMPARE, evaluated the candidate for moderate to severe rheumatoid arthritis in patients who are on a stable background of methotrexate and elicited an inadequate response.
After 12 weeks of treatment, the ACR20 response — the first primary endpoint — was achieved in 71% of the patients receiving the 15 mg dose of upadacitinib versus 36% for placebo. The second primary endpoint of clinical remission was achieved by 29% of the patients in the upadacitinib arm versus only 6% in the placebo arm. (Read More: AbbVie's RA Candidate Meets Primary Endpoints in Phase III)
Meanwhile, the FDA has extended the review period for AbbVie’s pipeline candidate elagolix by three months. The FDA’s decision, previously expected in the second quarter, will now come in the third quarter. (Read More: FDA Prolongs Review Date for AbbVie Endometriosis Candidate)
Pfizer’s Inlyta Misses Primary Endpoint in Phase III Study: Pfizer’s kidney cancer drug Inlyta (axitinib) failed to demonstrate a clear improvement in the primary endpoint of extending disease-free survival (DFS) compared with placebo in the phase III ATLAS study. Accordingly, an independent Data Monitoring Committee recommended the study be stopped at a planned interim analysis. (Read More: Pfizer’s Kidney Cancer Drug Misses Endpoint in Phase III).
Pfizer also announced initiation of dosing in an early-stage study evaluating its mini-dystrophin gene therapy candidate, PF-06939926, for the treatment of boys with Duchenne muscular dystrophy (DMD), the most common type of muscular dystrophy. Early data from the study is expected in the first half of 2019.
Pacira’s Exparel Gets FDA Nod for Expanded Label: Pacira Pharmaceuticals, Inc.’s PCRX supplemental new drug application (sNDA) for label expansion of Exparel in the nerve block setting for patients undergoing upper extremity surgeries got the FDA nod. The FDA’s approval came as a surprise after an FDA Committee voted six to four against approval of the expanded indication in February. (Read More: FDA Okays Label Expansion of Pacira's Exparel's, Stock Up)
Exparel generated sales of $282.9 million in 2017, representing an increase of 6% from 2016. With the latest label expansion, sales are expected to go up.
Glaxo to Divest Rare Disease Gene Therapy Drugs to Private Biotech: Glaxo GSK is divesting its rare disease gene therapy portfolio to private biotech Orchard Therapeutics in exchange for a 19.9% stake in the company as well as a seat on its board. The divesture is part of the strategic review that Glaxo announced in July last year to divest some preclinical/clinical programs and allocate 80% of capital to priority programs in two current areas, Respiratory and HIV/infectious, and two potential areas, Oncology and Immuno-inflammation. (Read More: Glaxo to Sell Rare Disease Gene Therapies to Private Biotech)
The NYSE ARCA Pharmaceutical Index rose 0.7% in the last five trading sessions.
Large Cap Pharmaceuticals Industry 5YR % Return
Large Cap Pharmaceuticals Industry 5YR % Return
Here is how the seven major stocks performed in the last five trading sessions:
All stocks recorded a gain except Bristol-Myers BMY and J&J. Merck and AstraZeneca were the biggest gainers rising 4.0% and 2.8%, respectively while Bristol Myers declined 5.6%.
In the last six months, AstraZeneca has been the biggest gainer (7.8%), while Merck declined the most (8.9%).
(See the last pharma stock roundup here: Pharma Stock Roundup: LLY’s Cyramza Shines in Cancer Study, PFE & AZN in Focus)
What's Next in the Pharma World?
Watch out for J&J’s and Novartis’ first quarter 2018 earnings results and other pipeline and regulatory updates.
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Bristol-Myers Squibb Company (BMY) : Free Stock Analysis Report
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