The biggest news this week was Merck’s MRK offer to buy small cancer biotech Peloton Therapeutics, which will add a late-stage kidney cancer candidate to its oncology pipeline. In other news, AbbVie’s ABBV late-stage study on a brain cancer candidate failed while Lilly’s LLY Crohn's disease candidate succeeded in a mid-stage study.
Recap of the Week’s Most Important Stories
Merck to Buy Small Cancer Biotech, Keytruda Breast Cancer Study Fails: Merck announced a definitive agreement to buy small private biotech, Peloton Therapeutics for $1.05 billion in cash to boost its oncology pipeline. The acquisition will add Peloton’s novel oral HIF-2α inhibitor, PT2977 to Merck’s oncology pipeline. PT2977 is currently being evaluated in multiple studies for renal cell carcinoma, the most common form of kidney cancer. In addition to the upfront payment, Merck will also be entitled to pay a further $1.15 billion of potential milestones payments. The transaction is expected to close in the third quarter of 2019.
Merck’s pivotal phase III KEYNOTE-119 study evaluating its blockbuster PD-L1 inhibitor, Keytruda in previously-treated metastatic triple-negative breast cancer did not meet its primary endpoints of overall survival (“OS”). Data from the study showed that Keytruda did not achieve superiority in OS compared to chemotherapy. Keytruda is presently not approved for any breast cancer indication.
AbbVie’s First-Line Brain Cancer Phase III Study Fails: AbbVie’s phase III study on Depatux-M, an investigational candidate, failed to show any survival benefit in patients with newly diagnosed glioblastoma, an aggressive form of brain cancer. At an interim analysis, the Independent Data Monitoring Committee recommended the study be stopped due to lack of survival benefit in patients receiving Depatux-M. Enrollment has been stopped in all ongoing Depatux-M studies.
Lilly’s Mirikizumab Meets Endpoints in Crohn's Disease Study: Lilly’s pipeline candidate, mirikizumab met the primary endpoint and key secondary endpoints in a phase II Crohn's disease study. Data from the phase II SERENITY study showed that treatment with mirikizumab led to significant reductions in clinical and endoscopic measures of disease activity at 12 weeks compared to placebo. Lilly plans to begin phase III studies on mirikizumab in Crohn's disease later this year. Mirikizumab is already being evaluated in phase III studies in other immune diseases, psoriasis and ulcerative colitis.
Lilly also announced that its lower priced version of Humalog, Insulin Lispro, is now available for order in pharmacies across the United States. The list price of Insulin Lispro, which contains an identical molecule as Humalog, is 50% lower than the current list price of Humalog U-100 (insulin lispro injection). Insulin Lispro will be available in vial (priced at $137.35) and pen (KwikPen - pack of five will cost $265.20) options.
FDA’s Priority Review Status to Invokana sNDA: The FDA granted priority review designation to J&J’s JNJ Invokana supplemental new drug application (sNDA) for the treatment of chronic kidney disease (“CKD”) in patients with type II diabetes when used in addition to standard of care. The sNDA filing was based on data from the phase III CREDENCE renal outcomes study. J&J had filed a sNDA in March. If the sNDA is approved, Invokana will be the first new therapy to be approved for reducing the risk of kidney failure and preventing renal or cardiovascular death in patients with CKD and type II diabetes in nearly 20 years.
Update from Novartis’s Analyst Day: Novartis NVS discussed its transformation strategy at its annual meet. Novartis plans to launch five blockbuster candidates in core therapeutic areas over the next two years — Mayzent, Zolgensma, Brolucizumab (RTH258), Ofatumumab (OMB157), and Fevipiprant (QAW039). Novartis also has multiple 2019 pipeline milestones, including six major readouts. The company also said that it has more than 10 biosimilar products in the pipeline
Novartis also presented data from two phase II studies on IND/GLY/MF (indacaterol acetate, glycopyrronium bromide and mometasone furoate), its investigational, once-daily, fixed dose inhaled combination asthma treatment. In one study, IND/GLY/MF was superior to the standard of care (long-acting beta-agonist/inhaled corticosteroid - LABA/ICS) in terms of lung function. In the other study, IND/GLY/MF was superior to placebo in lung function improvement irrespective of administration time of morning or evening
Glaxo’s Shingrix Gets Approval in China: Glaxo GSK gained approval for its successful vaccine, Shingrix in China for the prevention of shingles (herpes zoster) in adults aged 50 years or older. Shingrix is already marketed in the EU, United States, Canada, Japan and Australia and is the main driver of Glaxo Vaccine segment sales. Shingrix sales more than doubled to £357 million in the first quarter of 2019 driven by market expansion in new patient population.
The NYSE ARCA Pharmaceutical Index rose 1.04% 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:
Last week, all the stocks were in the green with Merck gaining the most (2.4%).
In the past six months, Merck has been the biggest gainer (7.4%) while Bristol-Myers BMY declined the most (10.3%).
(See the last pharma stock roundup here: FDA Okays Line Extensions of LLY, PFE, ABBV Cancer Drugs)
What's Next in the Pharma World?
Watch out for regular pipeline and regulatory updates next week.
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