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Alberto Abaterusso
Alberto Abaterusso
Articles (1297) 

AbbVie Drug Receives Full Approval

The approval is backed by positive outcomes from the Murano trial

June 11, 2018 | About:

A drug that is used for the treatment of a type of cancer of the blood and bone marrow,  known as chronic lympotcytic leukemia, has received full approval from the U.S. Food and Drug Administration.

Venetoclax is used to treat those patients who show the presence of 17p deletion or are positive for TP53 mutation. The molecule, which is commercialized under Venclexta and Venclyxto in the U.S., has been co-developed by Roche Holding (RO) and AbbVie (NYSE:ABBV). The molecule is jointly commercialized by AbbVie and Genentech, a member in the U.S. of the Roche Group.

Genentech is entitled to commercialize Venetoclax in the U.S. while AbbVie holds rights for marketing the product outside the U.S.

The approval is based on the positive outcomes of the Murano study and is geared for patients who have received at least one prior treatment for the disease. The trial showed that, out of a total of 389 patients, the arm that received a Venetoclax/Rituximab combined therapy achieved a 92% overall response rate versus a 72% rate of the comparator arm. The comparator arm was administered with a treatment based on Bendamustine, which was combined with Rituximab.

Chronic lymphocytic leukaemia starts in the bone marrow before crowding out healthy blood cells. The origin of the disease in the bone marrow centers on a specific line of white cells that are called lymphocytes.

Since the lymphocytes don’t reach a complete maturation stage, these patients cannot easily fight off infections.

The onset of problems can take a long time and most patients can live for many years. Compared to acute leukemia, specialists consider chronic leukemia a tougher condition to treat.

Venclyxto inhibits a protein called B-cell lymphoma-2 (or BCL-2) that is responsible for a process that is called apoptosis. This process involves a programmed death of cells.

Since when previous therapies have failed, high percentages of this protein were found in chronic CLL patients, it is believed that inhibiting the BCL-2 may restore the signalling system that brings cells suicide. It therefore will improve the outcome for patients who are affected with chronic lymphocytic leukemia.

AbbVie is currently trading around $100.43 per share with a market capitalization of $159.37 billion, a price-book ratio of 44.85 times, a price-sales ratio of 5.43 times and a price-earnings ratio of 25.30 times.

Roche Holding AG ADR is currently trading around $26.39 per share with a market capitalization of $181.4 billion, a price-book ratio of 6.83 times, a price-sales (P/S) ratio of 3.26 times and a price-earnings ratio of 21.08 times.

AbbVie has outperformed Roche by 19%, so far this year.

(Disclosure: I have no positions in any stock mentioned in this article.)

About the author:

Alberto Abaterusso
If somebody asks what being a Value Investor means, Alberto Abaterusso would answer: “the Value Investor is not the possessor of a security that represents the company, but he is the owner of that company. As an owner of the company the Value Investor is actively involved in the dynamics of that company and his first aim is how to have sales progressively growing.”

Alberto Abaterusso would add: “probably the Value Investor is one of the least patient persons in the world concerning sales.”

Alberto Abaterusso is a freelance writer based in The Netherlands. He primarily writes about gold, silver and precious metals mining stocks. His articles have also been widely linked by popular sites, including MarketWatch, Financial Times, 24hGold, Investopedia, Financial.org, CNBS, MSN Money, Zachs, Reuters and others. Alberto holds an MBA from Università degli Studi di Bari (Italy), Aldo Moro.

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