In a busy week for the pharma sector, drug giants Merck (MRK - Free Report) and Eli Lilly (LLY - Free Report) reported fourth-quarter results along with Glaxo (GSK - Free Report) and Sanofi (SNY - Free Report) . The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) gave positive recommendations, granting marketing approval to several drugs this week. Meanwhile, Sanofi gained FDA approval for Cablivi to treat a rare blood disorder while Glaxo signed a global immuno-oncology collaboration with Germany’s Merck KGaA.
Recap of the Week’s Most Important Headlines
Inside Q4 Earnings: Merck’s fourth-quarter results were strong as the company beat estimates for earnings as well as sales. Importantly, its PD-1 inhibitor, Keytruda continued its robust performance, recording sales of $2.15 billion in the quarter, up around 14% sequentially and 66% year over year. Its 2019 guidance was also in line with expectations.
Lilly’s fourth-quarter results were mixed as it beat estimates for sales but missed the same for earnings. However, Lilly lowered its previously issued earnings and sales guidance for 2019 to account for the costs related to the pending acquisition of Loxo Oncology and the Lartruvo confirmatory study failure.
Glaxo beat estimates for earnings as well as sales. It expects earnings per share to decline 5-9% at constant exchange rates (CER) in 2019, which includes the impact of Advair generic launch and costs related to the acquisition of TESARO. It also assumes closure of the joint venture with Pfizer (PFE - Free Report) for Consumer Healthcare business and divestment of certain nutrition brands like Horlicks in India and Bangladesh.
Sanofi’s fourth-quarter 2018 results were mixed as it beat estimates for earnings and missed the same for sales. In 2018, Sanofi’s business earnings grew 5%, at the higher end of its guided range of 4%-5%. Sanofi expects business earnings to grow between 3% and 5% at CER in 2019.
CHMP Gives Positive Opinion to Several Drugs: Pfizer gained positive CHMP opinion, which recommended marketing approval for its new lung cancer medicine, Vizimpro (dacomitinib) that was approved in the United States last September. The CHMP also gave nod to AstraZeneca’s (AZN - Free Report) application looking for approval of its type II diabetes medicine, Forxiga for a new indication — as an oral adjunct treatment to insulin in adults with type-1 diabetes. Sanofi also gained a positive CHMP opinion to include data from the phase III cardiovascular outcome study (ODYSSEY OUTCOMES) on the label of its anti PCSK9 therapy, Praluent Injection. A similar application is awaiting FDA’s decision, which is expected in April.
Roche’s (RHHBY - Free Report) filing for label expansion of Hemlibra for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in patients with haemophilia A without factor VIII inhibitors was also given a positive opinion by the CHMP. Hemlibra is presently marketed for the treatment of haemophilia A patients with factor VIII prophylaxis. In the United States, a similar label expansion was approved in October last year.
The CHMP also gave nod to Merck’s label expansion filing looking for approval of Keytruda, in combination with chemotherapy, as a first-line treatment for metastatic squamous NSCLC – a difficult-to-treat lung cancer patient population - regardless of PD-L1 expression. The filing was based on data from the phase III KEYNOTE-407 study. In the United States, a similar label expansion was approved in early October last year.
The final decision by the European Union on these products is expected in the coming months.
Glaxo’s Immunotherapy Deal with Merck KGaA: Glaxo entered into a global immuno-oncology collaboration with Germany’s Merck KGaA to jointly develop and commercialize the latter’s bifunctional fusion protein immunotherapy M7824, which has the potential to treat multiple difficult-to-treat cancers. Eight studies are ongoing or expected to be initiated this year on M7824 including studies in non-small cell lung and biliary tract cancers. M7824 is designed to simultaneously target two immuno-suppressive pathways in the body, TGF-β and PD-L1, which are commonly used by cancer cells to evade the immune system.
For the deal, Glaxo made an upfront payment of 300 million euros to Merck KGaA, which is also entitled to potential development/commercial milestone payments, taking the potential deal value to up to 3.7 billion euros (($4.2 billion). The partnership is another step in Glaxo’s efforts to strengthen its oncology pipeline
Sanofi’s Cablivi Gets FDA Approval: The FDA granted approval to Sanofi’s Cablivi (caplacizumab) for the treatment of a rare blood disorder called acquired thrombotic thrombocytopenic purpura. Cablivi was added to Sanofi’s portfolio with the acquisition of Ablynx last year. In the EU, Cablivi was granted marketing authorization in September last year and was launched in the first market, Germany.
Sanofi also announced that a pivotal phase III study evaluating its pipeline candidate, isatuximab in combination with some standard of care medicines met the primary endpoint of prolonging progression free survival in patients with relapsed/refractory multiple myeloma. Sanofi plans to file regulatory applications for isatuximab later in 2019.
Lilly’s Olumiant Meets Endpoint in Eczema Study: Lilly and partner Incyte announced that its oral JAK inhibitor, Olumiant (baricitinib) met the primary endpoint in two late-stage studies evaluating it in a new indication— moderate-to-severe atopic dermatitis (AD), a type of eczema. Notably, the top-line results showed that after 16 weeks of treatment, a statistically significant proportion of patients treated with baricitinib monotherapy achieved the primary endpoint compared to those treated with placebo. The primary endpoint was defined by the Investigator's Global Assessment for AD (IGA) score of clear or almost clear.
Roche Submits sBLA for Kadcyla: Roche submitted a supplemental biologics license application to the FDA looking for label expansion of its breast cancer drug, Kadcyla for adjuvant (after surgery) treatment of patients with HER2-positive early breast cancer who have residual disease after neoadjuvant (before surgery) treatment. Kadcyla, an antibody-drug conjugate, is approved as monotherapy in second-line setting for treating metastatic breast cancer in patients who have received treatment with Herceptin or/and taxane since 2013 A potential approval will boost the prospects of the drug as it will expand the patient population.
FDA Accepts Merck’s NDAs for Two Anti-Bacterial Candidates: Merck announced that the FDA has accepted and granted priority review to its regulatory applications for two anti-bacterial candidates. This includes a new drug application for MK-7655A, a fixed combination of relebactam with imipenem/cilastatin and a supplemental NDA for label expansion of its antibacterial medicine, Zerbaxa. While Merck is looking to get MK-7655A approved for the treatment of complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI) caused by certain susceptible Gram-negative bacteria, the Zerbaxa sNDA has been filed to get FDA nod for nosocomial pneumonia. While FDA action on MK-7655A is expected on Jul 16, that on Zerbaxa sNDA is expected on Jun 3.
AstraZeneca’s Medicines Get FDA’s Priority Status: AstraZeneca’s monoclonal antibody, MEDI8897 was granted "Breakthrough Therapy" and "Prime" designations in the United States and Europe. MEDI8897 is a next-generation medicine being developed for the prevention of lower respiratory tract infection (LRTI) caused by respiratory syncytial virus (RSV) in infants. Meanwhile, AstraZeneca’s new respiratory biologic Fasenra was granted Orphan Drug Designation (ODD) by the FDA for a new indication — hypereosinophilic syndrome (HES). Fasenra is presently marketed as an add-on maintenance treatment for severe, eosinophilic asthma
The NYSE ARCA Pharmaceutical Index declined 0.1% in the last five trading sessions.
In the last five trading sessions, while Glaxo recorded the highest gain of 3.5%, Lilly declined the most (2%).
In the past six months, Merck has been the biggest gainer (16.4%) while Bristol-Myers declined the most (15.9%).
(See the last pharma stock roundup here: Q4 Earnings, Pipeline Updates at PFE, RHHBY)
What's Next in the Pharma World?
Watch out for pipeline and regulatory updates next week.
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