- Altimmune surges on coronavirus drug development.
- AbbVie down on poor venetoclax data.
- Pfizer's Advil Dual Action gets approved.
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AbbVie Slides as Venetoclax Trial Yields Negative Results
AbbVie (ABBV) reported that its Phase VIALE-C trial failed to meet its primary endpoint. The trial tested venetoclax (VENCLEXTA®) in combination with low-dose cytarabine (LDAC) versus LDAC in combination with placebo. The endpoint of the trial was related to proving statistically significant improvement of overall survival (OS) for patients suffering from acute myeloid leukemia (AML) who are not eligible for intensive chemotherapy.
The data showed that the venetoclax combination brought 25% reduction in the risk of death compared to LDAC with placebo. The median overall survival of the venetoclax with LDAC arm stood at 7.2 months in comparison to 4.1 months in the LDAC arm. The secondary endpoints of the trial pertained to complete remission, complete remission or complete remission with incomplete blood count recovery (CR+Cri), complete remission or complete remission with partial hematologic recovery, and complete remission or complete remission with incomplete blood count by the time of start of cycle 2.
The safety profile for the combination remained unaltered from the profile shown in the Phase 1/2 studies. Neil Gallagher, M.D., Ph.D., chief medical officer and vice president of development, AbbVie said,
"The study results, while not statistically significant, are indicative of the clinical activity of venetoclax in combination with low-dose cytarabine."
While the trial failed to prove statistically significant improvement, it still showed clinical activity in patients. The data showed that there was complete remission in 27.3 percent, while LDAC with placebo group had complete remission in 7.4 percent patients.
VENCLEXTA was granted accelerated approval in the United States in combination with LDA, decitabine, and azacitidine. AbbVie is working towards preparing a robust portfolio of AML therapies. Its VIALE-A is in Phase 3 and is designed to test the combination of venetoclax with azacitidine compared to azacitidine along with placebo in newly-diagnosed patients who are not eligible for intensive chemotherapy.
Pfizer Gets FDA Nod for Advil Dual Action
Pfizer (PFE) announced that it has received the FDA approval for Advil Dual Action with acetaminophen as an over-the-counter (OTC) product for pain relief. The new drug application for Advil Dual Action was given the approval under the Pfizer name. GSK (GSK) has the distinction of being the largest consumer healthcare company in the world after its new joint venture with Pfizer Consumer Healthcare.
The newly approved formula is the first of its kind FDA approved OTC combination of acetaminophen and ibuprofen in the United States. The drug is expected to be available in the domestic market by the end of this year. Franck Riot, Head of R&D, GSK Consumer Healthcare said,
"Now Advil, the No. 1 selling OTC pain reliever, will offer US consumers the first-ever alternative option -- a single, fixed-dose combination pain reliever."
GSK had recently received the FDA approval of Voltaren Arthritis Pain gel.
The application for the approval was supported by the data from seven clinical studies, including three related to pivotal efficacy and safety studies in pain relief. The data demonstrated that the fixed-dose combination achieves superior efficacy compared to the individual monocomponents of ibuprofen (250mg) and acetaminophen (500mg) alone. These results were manifested by substantial improvements in acute pain symptoms across multiple pre-specified endpoints.
The collaboration between GSK and Pfizer was finalized in August 2019. The JV combined Pfizer's Advil, Centrum and Caltrate with GSK's Sensodyne, Voltaren, and Panadol, among other brands.
Altimmune Gets Coronavirus Boost
Altimmune (NASDAQ:ALT) stock jumped as it reported completion of first development milestone toward coronavirus vaccine. The company is currently working on developing a single dose intranasal vaccine for treating coronavirus infection. The drug uses the company's proprietary technology to provide protection against COVID 19. The company has already completed the design and synthesis of the drug. It is currently working towards testing it on animals and then manufacturing.
The company claims that its drug is able to provide superior results due to its intranasal vaccine technology. Apparently, the use of this technology helps in providing "systematic protection against respiratory infections." Vipin K. Garg, Ph.D., President and Chief Executive Officer of Altimmune added,
"With the spread of COVID-19 outside of China, including the first case of unknown origin in the United States, we have taken action to develop and make our vaccine technology available to help address this crisis."
The company has used the same platform for developing its influenza drug candidate NasoVAX as well.
The onslaught of coronavirus has taken its toll on medical sector and economy as a whole. Several firms, including the established ones, are in fray to develop treatment for this pandemic. The most prominent ones are Gilead Sciences (GILD), Sanofi (SNY), and Johnson & Johnson (JNJ), among others. There are a number of startups and small pharma companies in the race as well. The overall impact of the outbreak has been negative on the economy and on the stock market. However, many pharma stocks, especially of smaller firms, saw speculative rise in their prices on the back of coronavirus related news.
Moderna Inc. (MRNA) has gained over 40 percent this year so far, with coronavirus scare accounting for a bulk of it. The company is working on its experimental SARS CoV 2 vaccine mRNA 1273. In February, Moderna claimed that it shipped its vaccine to National Institute of Allergy and Infectious Diseases. Its clinical trial is expected to start in April. Novavax Inc. (NVAX) saw over 100 percent increase in its stock price this year so far. The company announced its plan to develop coronavirus drug in January. It is looking to start Phase 1 trial of its drug candidate in May or June this year. However, the company management has said that it may take minimum four years to develop the treatment.
Coronavirus is now responsible for over 2,800 deaths across the world. There have been over 87,000 confirmed cases in the world, and the number is increasing. The outbreak is not showing any signs of abetting with new cases being confirmed in different countries. It has severely hit stocks in leisure, hotel and cruise segments. Other sectors are also expected to be affected negatively on account of lower demand. It is likely that the governments around the world may announce stimulus packages to arrest the downfall of stock indices.
Altimmune has followed the trajectory of its peers as its stock gained over 35 percent this year so far. As the company progresses with its coronavirus drug and other vaccine candidates, the stock is expected to retain its positive trajectory. However, following the steep rise in the stock price, it is advisable to wait for some meaningful pullback to initiate a position in the stock. However, it is also likely that the company stock will have stiff competition from other companies such as Moderna and Inovio Pharmaceuticals (INO) which are also working in the same area.
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