In a busy week for the pharma sector ahead of the festive season, the FDA granted approval to Merck’s (MRK - Free Report) vaccine for Ebola Zaire disease, Ervebo and Pfizer’s (PFE - Free Report) prostate cancer drug, Xtandi for an expanded patient population. The European Commission approved AbbVie’s (ABBV - Free Report) rheumatoid arthritis drug Rinvoq (upadacitinib) and Roche’s (RHHBY - Free Report) breast cancer drug Kadcyla for adjuvant treatment. Meanwhile, Lilly (LLY - Free Report) gave a better-than-expected financial outlook for the New Year while Roche finally closed its long pending acquisition of gene therapy maker, Spark Therapeutics.
Recap of the Week’s Most Important Stories:
FDA Approves Pfizer’s Xtandi for New Prostate Cancer Indication: The FDA granted approval to Pfizer’s supplemental new drug application (sNDA) looking for label expansion of Xtandi in men with metastatic castration-sensitive prostate cancer (mCSPC). Until now, Xtandi was approved to treat metastatic and non-metastatic castration-resistant prostate cancer. Xtandi is now approved for three indications in advanced prostate cancer – non-metastatic and metastatic CRPC and mCSPC. The sNDA was based on data from the phase III ARCHES study.
Meanwhile, the FDA accepted and granted priority review to Pfizer’s sNDA seeking approval of Braftovi Doublet (Braftovi plus Lilly’s Erbitux) for the treatment of BRAFV600E-mutant metastatic colorectal cancer after prior therapy. The sNDA was based on data from the BEACON CRC study. With the FDA granting priority review to the sNDA, the FDA’s decision is expected in April 2020. Braftovi plus Mektovi (an oral small molecule MEK inhibitor), which Pfizer acquired following its acquisition of Array BioPharma in 2019, is presently marketed as a treatment for BRAF-mutant melanoma, in 2018.
FDA Approves Merck’s Ebola Vaccine: The FDA granted approval to Merck’s investigational vaccine for Ebola virus disease (EVD), Ervebo. Ervebo is the first vaccine approved by the FDA for the prevention of EVD caused by Zaire Ebola virus in adults. The approval comes almost three months ahead of the scheduled PDUFA date of Mar 14, 2020. Ervebo was granted conditional marketing approval in Europe last month.
Meanwhile, the FDA’s Oncologic Drugs Advisory Committee (ODAC) voted in favor of approving new indications for Merck’s Keytruda and Lynparza (which it markets in partnership with AstraZeneca). The ODAC voted 9-4 in favor of approving Keytruda for the treatment of patients with high-risk, non-muscle invasive bladder cancer (NMIBC) and 7-5 for approving Lynparza as a first-line maintenance treatment in germline BRCA-mutated metastatic pancreatic cancer. The FDA’s decision on both regulatory filings is expected in a few weeks.
Lilly Gives Upbeat 2020 Guidance: Lilly announced a better-than-expected financial outlook for 2020 while re-affirming the previously issued 2019 sales and earnings projections. Lilly expects adjusted earnings in the range of $6.70-$6.80 per share in 2020. Revenues in 2020 are expected in the range of $23.6billion-$24.1 billion. The company said that if it achieves this sales range for 2020, it will be able to exceed its 7% revenue CAGR target for the 2015-2020 period. Importantly, in 2020, Lilly is likely to come up with important data readouts for several key pipeline medicines. Lilly also expects approvals for two new drugs in 2020 and up to three new launches.
Lilly also announced results from the EMPERIAL-Reduced and EMPERIAL-Preserved studies on Jardiance. The studies are evaluating Jardiance to improve exercise ability of patients, with and without diabetes, with chronic heart failure with reduced and preserved ejection fraction. The data from the studies showed no significant change from baseline to week 12 in exercise ability with Jardiance versus placebo. The change in exercise ability over 12 weeks was measured by the six-minute walk test, which was the primary endpoint of the studies.
EU Approvals for AbbVie’s Upadacitinib & Roche’s Kadcyla for Adjuvant Treatment: The European Commission granted approval to AbbVie’s oral JAK1-selective inhibitor, Rinvoq (upadacitinib). In EU, Rinvoq has been granted approval as monotherapy or in combination with methotrexate for the treatment of adults with moderate-to-severe rheumatoid arthritis (RA) in patients who experienced inadequate response or intolerance to one or more disease-modifying anti-rheumatic drugs (DMARDs). Rinvoq was approved by the FDA in August and the early uptake trends of the drug have been encouraging. Upadacitinib is also being evaluated in several multiple immune-mediated diseases and is expected to lower AbbVie’s dependence on its blockbuster immunology medicine, Humira.
The regulatory agency also approved Roche’s antibody-drug conjugate, Kadcyla for the adjuvant treatment of people with HER2-positive early breast cancer with residual invasive disease after neoadjuvant treatment. Until now, Kadcyla was approved in the EU as monotherapy in second-line setting for treating metastatic breast cancer in patients who have received treatment with Herceptin or/and taxane. Kadcyla was approved by the FDA for adjuvant treatment in May.
Roche Closes Spark Therapeutics Buyout: This week the Federal Trade Commission (FTC) and U.K. Competition and Markets Authority finally granted clearance to Roche’s pending $4.3 billion acquisition of Spark Therapeutics. Roche will not be required to sell any assets. With all necessary regulatory approvals received, the transaction has now been closed.
Roche announced its intention to buy Spark Therapeutics in February to boost its hemophilia A portfolio, which already includes its hemophilia drug, Hemlibra. However, closing of the transaction was delayed due to ongoing reviews by FTC and the U.K. Competition and Markets Authority of the pending deal. The regulatory authorities believed that the deal, if successful, may hurt competition in the hemophilia A market with Hemlibra and Spark’s gene therapy candidate, SPK-8011, both coming under the same roof
Novartis’ Asthma Candidate Disappoints in Phase III: Novartis (NVS - Free Report) announced disappointing top-line results from the two pivotal phase III studies evaluating its investigational oral, once-daily, DP2 receptor antagonist fevipiprant in patients with uncontrolled asthma. The pooled analyses from LUSTER 1 and 2 studies failed to show reduction in rate of moderate -to-severe exacerbation compared to placebo over a 52-week treatment period for either of the doses (150mg / 450 mg). Novartis said that the totality of the data thus does not support further development of fevipiprant in asthma.
Glaxo’s Benlysta Lupus Nephritis Study Meets Endpoints: Glaxo (GSK - Free Report) announced positive headline results from a phase III study - BLISS-LN - of Benlysta inpatients with lupus nephritis (LN). The study met its primary endpoint and all major secondary endpoints. The data showed that a statistically significant greater number of active LN patients treated with belimumab plus standard therapy achieved Primary Efficacy Renal Response (PERR) over two years compared to placebo plus standard therapy. Based on the positive phase III data, Glaxo plans to file regulatory applications seeking approval for Benlysta in LN in the first half of 2020.
CHMP Nod to Several Drugs: The CHMP recommended approval of label expansion for Lilly’s Cyramza in combination with Roche’s Tarceva in first-line metastatic non-small cell lung cancer (“NSCLC”) with EGFR mutation. The regulatory body also gave a nod to Pfizer’s Vyndaqel (61 mg) for wild-type or hereditary transthyretin amyloidosis in adult patients with cardiomyopathy (ATTR-CM), a rare and fatal illness associated with progressive heart failure. While Cyramza is under review in the United States for a similar indication, Vyndaqel was approved by the FDA for ATTR-CM in May.
Meanwhile, Merck’s new antibacterial injection, Recarbrio, a fixed combination of relebactam with imipenem/cilastatin was also given a positive CHMP opinion to treat infections due to aerobic Gram-negative organisms in adults with limited treatment options. Recarbrio was approved by the FDA in July for similar indication. Novartis’ wet age-related macular degeneration (AMD) drug, Beovu was also granted a positive opinion by CHMP. Beovu was approved by the FDA in October.
We note that the European Commission generally considers the CHMP recommendation while approving a drug but isn’t bound by it.
The NYSE ARCA Pharmaceutical Index was up 1.9% in the last five trading sessions.
Here is how the seven major stocks performed in the last five trading sessions.
Last week, all the stocks were in the green except Bristol-Myers, which declined 1.7%. AstraZeneca recorded the maximum gain (7.5%).
In the past six months, Bristol-Myers has risen the most (27.4%) while Pfizer (PFE - Free Report) lost the maximum (10.8%).
(See the last pharma stock roundup here: MRK, SNY to Buy Cancer Firms, LLY Starts New Lung Cancer Study)
What's Next in the Pharma World?
Watch out for regular pipeline and regulatory updates next week.
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