Key news this week include priority review for Roche’s (RHHBY - Free Report) experimental hemophilia A drug and EU approval for Novartis’ (NVS - Free Report) advanced breast cancer drug. Meanwhile, deals involving companies like AstraZeneca plc (AZN - Free Report) and Eli Lilly and Company (LLY - Free Report) were also announced this week.
Recap of the Week’s Most Important Stories
Priority Review for Roche Hemophilia A Drug: Roche’s investigational hemophilia A treatment, emicizumab, got priority review from the FDA with the agency expected to give a decision by Feb 23, 2018. Roche is looking to get emicizumab prophylaxis (preventative) approved as a once-weekly subcutaneous treatment for adults, adolescents and children with hemophilia A with factor VIII inhibitors.
According to information provided by the company, about one in three people with hemophilia A develop inhibitors to standard factor VIII replacement therapies. As a result, treatment options are limited and there is an increased risk of life-threatening as well as repeated bleeds (Also read: Roche Hemophilia A Drug Granted Priority Review).
Lilly Inks Multi-Year Deal with Topas: Lilly has entered into a multi-year research and option agreement focused on immune tolerance with Germany-based biotechnology company Topas Therapeutics. The initial focus will be on external antigens thought to induce inflammation and/or autoimmune disease. Pre-clinical proof-of-principle studies will be conducted by Topas, which will receive R&D funding from Lilly. Lilly has an option to in-license and develop all candidates produced under the collaboration. The deal signifies Lilly’s focus on immunology. Immune tolerance has been attracting the interest of quite a few large players with Celgene signing an exclusive global research collaboration with Anokion, a privately held company developing novel tolerance-inducing therapeutics for autoimmune diseases, earlier this year.
AstraZeneca in mRNA-Focused Deal with Ethris: AstraZeneca entered into a strategic deal with Germany-based Ethris for the development of mRNA therapies for respiratory diseases. The five-year strategic research deal will be focused on the use of Ethris’ proprietary SNIM RNA technology for new stabilized non-immunogenic mRNA therapies for respiratory diseases.
AstraZeneca will make an upfront payment of €25 million upfront and provide research funding as well. Other payments include research and development milestone payments and sales related royalties upon commercialization. AstraZeneca has the option to take exclusive worldwide licenses for each target under the collaboration. This is not the first time that AstraZeneca has signed an mRNA-focused deal. The company is collaborating with Moderna Therapeutics for mRNA therapeutic candidates for the treatment of a range of cancers, cardiovascular, metabolic and renal diseases as well.
Meanwhile, AstraZeneca also announced results from a new sub-analysis of data from the phase III PEGASUS-TIMI 54 study showing a 29% risk reduction in cardiovascular (CV) death from treatment with Brilinta compared to placebo in patients taking low-dose aspirin but still at high risk of an atherothrombotic event, a major cause of acute coronary syndrome and CV death. AstraZeneca is a Zacks Rank #3 (Hold) stock. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Cardiome Down on Brinavess Regulatory Update: Cardiome Pharma’s (CRME - Free Report) shares were down on news that the FDA has informed the company that its data package for the resubmission of the regulatory application for its antiarrhythmic drug, Brinavess, would not be sufficient.
The company was looking to resubmit the new drug application (NDA) for Brinavess based on the original file and six years of accumulated safety data from Brinavess sales across thirty-three countries, as well as interim results from more than 1,100 patients enrolled in the SPECTRUM study, a prospective post-authorization EU safety study, and pre-clinical data from subsequent studies completed by the company at the FDA’s request.
EU Nod for Novartis’ Advanced Breast Cancer Drug: Novartis’ CDK4/6 inhibitor, Kisqali, gained approval in the EU for use in combination with an aromatase inhibitor for the first-line treatment of postmenopausal women with HR+/HER2- locally advanced or metastatic breast cancer. Approval was largely expected considering the positive Committee for Medicinal Products for Human Use (CHMP) opinion earlier this year in June. According to information provided by the company, about 250,000 women are diagnosed with advanced breast cancer each year across the world and up to one-third of patients with early-stage breast cancer will eventually develop advanced disease. Kisqali was approved in the U.S. in Mar 2017 and Novartis is working on launching a full commercial campaign and gaining formulary coverage.
Shares of Novartis have gained 14.7% year to date, outperforming the industry’s 10.4% rally
Large Cap Pharmaceuticals Industry 5YR % Return
The NYSE ARCA Pharmaceutical Index gained 0.7% over the last five trading sessions. Among major stocks, Bristol-Myers Squibb (BMY - Free Report) was up 2.5% while J&J lost 0.1%. Over the last six months, J&J was up 10.7% while Merck & Co. (MRK - Free Report) declined 3.8% (See the last pharma stock roundup here: Multiple Sclerosis Drug Prices in Focus, Mixed Data on BMY's Opdivo).
What's Next in the Pharma World?
Watch out for the usual pipeline and regulatory updates.
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