Global pharmaceutical and healthcare company Eli Lilly and Co. (LLY:NYSE) today announced that "the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation for donanemab, its investigational antibody therapy for Alzheimer's disease (AD)."
Eli Lilly explained that Breakthrough Therapy designation is awarded in order help accelerate the development and review process of promising drugs designed to treat serious medical conditions for which there are no other available alternatives or when clinical evidence suggests that a new medicine displays substantial and significant improvements in achieving primary clinical endpoints compared to drugs and therapies that were previously granted full FDA approval.
The company stated that "the FDA Breakthrough Therapy designation is based on clinical evidence for donanemab, an investigational antibody that targets a modified form of beta amyloid called N3pG." The firm advised that the approval was based upon the results compiled from its Phase 2 TRAILBLAZER-ALZ Trial, which was structured to evaluate the efficacy and safety of donanemab in patients with early, symptomatic AD.
Eli Lilly advised that based on data obtained from the TRAILBLAZER-ALZ trial, later this year it intends to prepare and submit a biologics license application (BLA) for donanemab under the FDA's accelerated approval pathway program.
The company stated that the Phase 2 TRAILBLAZER-ALZ trial is a randomized, multi-center study designed to measure donanemab's safety, tolerability and efficacy in patients diagnosed with early symptomatic AD. The study enrolled a total of 272 patient subjects who were studied over a period of 76 weeks for how they progressed according to the Integrated Alzheimer's Disease Rating Scale (iADRS). The firm added that "key secondary endpoints included changes between baseline and 76 weeks in the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog13), ADCS-iADL, MMSE, and Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) scores."
The company noted that that AD causes progressive decline in memory and cognition and is a fatal illness. The firm pointed out that "dementia due to Alzheimer's disease is the most common form of dementia, accounting for 60-80% of all cases." The disease effects over 50 million people globally and is forecast to triple to 152 million by 2050. The debilitating dementia causing disease takes its toll on both patients and caregivers and comes with an enormous societal and economic cost.
Eli Lilly is a global pharmaceutical and healthcare company headquartered in Indianapolis, Ind. The company has a large portfolio of medicines for use in treatment in the areas of bone muscle joint, cardiovascular, diabetes, endocrinology, immunology, neurodegeneration, neuroscience, oncology and pain. The firm employs approximately 34,000 people worldwide and is actively involved in all phases of drug development, manufacturing, marketing and distribution to around 120 countries. In addition to its human pharmaceutical products, the company is also engaged in the development of sale of animal pet and livestock feed and health products. The company operates in the U.S. and 14 other countries and has a market cap of over $208 billion.
Eli Lilly began the day with a market cap of around $208 billion with approximately 959 million shares outstanding. LLY shares opened more than 8% higher today at $234.92 (+$17.82, +8.21%) over yesterday's $217.10 closing price and reached a new 52-week high price this morning of $239.97. The stock has traded today between $230.42 and $239.37 per share and is currently trading at $234.25 (+$17.15, +7.90%).
[NLINSERT]Disclosure:
1) Stephen Hytha compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. He or members of his household own securities of the following companies mentioned in the article: None. He or members of his household are paid by the following companies mentioned in this article: None.
2) The following companies mentioned in this article are billboard sponsors of Streetwise Reports: None. Click here for important disclosures about sponsor fees.
3) Comments and opinions expressed are those of the specific experts and not of Streetwise Reports or its officers. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.
4) The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports' terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company mentioned on Streetwise Reports.
5) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the decision to publish an article until three business days after the publication of the article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases.
6) This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.
