Zacks Investment Research | Jun 14, 2019 08:42AM ET
This week Merck (NYSE:MRK) announced a definitive deal to buy private preclinical cancer biotech Tilos Therapeutics. In other news, Roche (OTC:RHHBY) won FDA approval for polatuzumab vedotin, to be marketed as Polivy, for diffuse large B-cell lymphoma (DLBCL) while Merck’s blockbuster PD-L1 inhibitor Keytruda won approval for first-line treatment of head and neck cancer.
Recap of the Week’s Most Important Stories
Merck to Buy Tilos Therapeutics, Gets FDA Nod for Keytruda for First-Line Head/Neck Cancer: Merck announced a definitive deal to additional data from two phase III studies — PRONTO-T1D and PRONTO-T2D — evaluatingits investigational ultra-rapid-acting lispro (URLi) for the treatment of type I and type II diabetes. Data from the study showed URLi provided similar A1C (an overall measure of glucose control) reductions compared to Humalog and also led to superior reduction in blood glucose spike post meals.
At ADA, Lilly also presented data from an outcomes study (REWIND) on Trulicity, which showed that the GLP-1 receptor agonist led to a 12% reductionin cardiovascular (CV) events like CV death, non-fatal myocardial infarction (heart attack) or non-fatal stroke in a broad range of type II diabetes patients. However, the 12% reduction fell short of investor expectations. In addition, Lilly also presented data from a study on tirzepatide, its dual GIP and GLP-1 receptor agonist and detailed results from CAROLINA outcomes study on DPP-4 inhibitorTradjenta.
Novo Nordisk presented data from the PIONEER 6 cardiovascular outcomes study evaluating oral semaglutide versus placebo in patients with type II diabetes and established cardiovascular disease. The data demonstrated that oral semaglutide does not increase the risk of major adverse cardiovascular events. Novo Nordisk also presented 26 and 52-week data from two phase IIIa studies evaluating oral semaglutide versus Lilly’s Jardiance (PIONEER 2 study) and its own GLP-1 receptor agonist Victoza (PIONEER 4 study) in type II diabetes. The data demonstrated that at 26 weeks, treatment with oral semaglutide led to superior reductions in blood sugar versus Jardiance and non-inferior blood sugar reductions versus Victoza.
Sanofi presented data from a phase III study evaluating Soliqua in type II diabetes patients whose disease was inadequately controlled by GLP-1 receptor agonist. The data showed that Soliqua significantly lowered blood sugar levels compared to GLP-1 receptor agonist treatments in such patients.
AstraZeneca’s (NYSE:AZN) Farxiga showed reduced progression of kidney disease or renal death in patients with type II diabetes per data from a pre-specified analysis of the phase III DECLARE-TIMI 58 outcomes study on the SGLT2 inhibitor. Farxiga showed a 47% reduction in the composite of kidney function decline, end-stage renal disease or renal death compared to placebo in the study. The DECLARE-TIMI 58 is evaluating Farxiga to reduce the risk of renal or cardiovascular death or to slow the progression of kidney disease in type II diabetes patients.
J&J (NYSE:JNJ) presented new data from the CREDENCE outcomes study on a SGLT2 inhibitor, Invokana.
The NYSE ARCA Pharmaceutical Index rose 1.6% in the last five trading sessions.
Here is how the seven major stocks performed in the last five trading sessions:
Last week, while J&J and Glaxo recorded the highest gain (3%), Lilly declined the most (4.2%).
In the past six months, Merck has been the biggest gainer (10.2%) while Bristol-Myers declined the most (7.1%).
(See the last pharma stock roundup here: ASCO Update, FDA Nod for LLY’s Emgality for Cluster Headache )
What's Next in the Pharma World?
Watch out for regular pipeline and regulatory updates next week.
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