The Zacks Analyst Blog Highlights: Anthera Pharmaceuticals, Amgen, Eli Lilly, Actelion and InterMune
CHICAGO, July 21, 2014 /PRNewswire/ -- Zacks.com announces the list of stocks featured in the Analyst Blog. Every day the Zacks Equity Research analysts discuss the latest news and events impacting stocks and the financial markets. Stocks recently featured in the blog include the Anthera Pharmaceuticals, Inc. (Nasdaq:ANTH-Free Report), Amgen, Inc. (Nasdaq:AMGN-Free Report), Eli Lilly and Company (NYSE:LLY-Free Report), Actelion Ltd. (OTC:ALIOF-Free Report) and InterMune, Inc. (Nasdaq:ITMN-Free Report).
Today, Zacks is promoting its ''Buy'' stock recommendations. Get #1Stock of the Day pick for free.
Here are highlights from Friday's Analyst Blog:
Anthera Acquires Sollpura from Eli Lilly
Anthera Pharmaceuticals, Inc. (Nasdaq:ANTH-Free Report) is a biopharmaceutical company focussed on developing and commercializing therapeutics for the treatment of autoimmune diseases. The company's primary candidate, blisibimod, was acquired from Amgen, Inc. (Nasdaq:AMGN-Free Report).
Anthera is currently developing blisibimod for the treatment of systemic lupus erythematosus in a phase III program. The company is running the first of two pivotal studies and has submitted the final protocol to the FDA for the second study. On the basis of results from both these studies Anthera is expected to file for blisibimod in the U.S. for the treatment for patients suffering from active lupus. Blisibimod is also being developed for the treatment of multiple myeloma in a preclinical study.
Earlier in the week, the company announced that it has acquired another mid-stage development candidate, Sollpura, from Eli Lilly and Company (NYSE:LLY-Free Report). The candidate is being developed for the treatment of patients suffering from low digestive enzyme levels or exocrine pancreatic insufficiency (EPI), due to cystic fibrosis or other potential diseases.
Anthera mentioned in its press release that it also intends to form a subsidiary, Alkira Therapeutics, to sublicense all rights, obligations and intellectual property for the development and commercialization of Sollpura. Anthera is expected to provide adequate funding to Alkira so that it can advance Sollpura into phase III development.
The phase III pivotal registration study, which was agreed by the FDA last year, is expected to start in mid-2015. As per the terms of the agreement, Alkira will be responsible for making all contingent milestone payments upon product approval and on certain annual sales achievements. Alkira will also pay royalties on any product sales after achieving certain sales thresholds of cumulative net sales of Sollpura.
The company currently has no approved products. Hence, the successful development of these candidates is crucial for the company.
Anthera currently carries a Zacks Rank #1 (Strong Buy). Some other stocks worth considering include Actelion Ltd. (OTC:ALIOF-Free Report) carrying a similar bullish rank.
Intermune (ITMN) Gets Breakthrough Designation for Esbriet
InterMune, Inc. (Nasdaq:ITMN-Free Report) received breakthrough therapy designation for its primary product, Esbriet (pirfenidone), from the FDA. InterMune is looking to get Esbriet approved in the U.S. for the treatment of adults suffering from idiopathic pulmonary fibrosis (IPF).
Breakthrough therapy designation is a status provided to candidates that show superiority over existing therapies for the treatment of serious or life threatening diseases or conditions. The designation helps to speed up the development and review process for experimental drugs targeting serious and life-threatening diseases. A candidate with breakthrough therapy designation could benefit from the FDA's existing fast track development program features as well as more intensive FDA guidance on efficient development of the candidate.
In May 2014, InterMune resubmitted its New Drug Application (NDA) for Esbriet based on encouraging top-line results from the phase III ASCEND study which was announced in February this year. The ASCEND study is evaluating Esbriet in patients suffering from IPF in the U.S. Results from the study showed that treatment with Esbriet significantly reduced IPF disease progression at week 52, thus meeting its primary objective.
Esbriet also demonstrated significant treatment effects in the six-minute walk test distance change and progression-free survival. Moreover, the drug demonstrated favorable safety and tolerability profiles.
Esbriet is already approved and available in several EU countries including Germany, France, Italy and the UK among others. The drug is also approved in countries like Canada, Japan, China, India, Argentina and Mexico. The company recorded Esbriet sales of $30.3 million in the first quarter of 2014. Esbriet sales in 2014 are expected in the range of $130 million to $140 million.
Though Esbriet is the only approved medicine for IPF, several companies are developing their candidates to tap the IPF market. The nearest threat for InterMune is from Boehringer Ingelheim's IPF candidate nintedanib, which was filed in the U.S. in Jul 2014. Nintedanib was also granted a breakthrough therapy designation by the FDA earlier in the month. Nintedanib is under review in the EU as well.
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