Biotech Analysis Central Pharma News: Novartis's Gene Therapy Catch, AstraZeneca's NASH Move, Clovis's Expanded Rubraca Market
Summary
- Novartis acquires AveXis for $8.7 billion.
- AstraZeneca fronts $30 million upfront for NASH licensing deal with Ionis Pharmaceuticals.
- Clovis Oncology obtains FDA approval for expanded use of Rubraca.
Welcome to Biotech Analysis Central Daily News, a daily news report and analysis about what has happened lately in the biotech industry.
Novartis Acquires AveXis For $8.7 Billion
News: Recently, Novartis (NVS) announced that it would acquire AveXis (AVXS) for $8.7 billion. This total amount registers at $217 per share, which was a 72% premium to AveXis's 30-day volume weight average stock price. The biggest reason for the deal was because of AveXis's knowledge in gene therapy. In addition, AveXis's main clinical candidate, AVXS-101, treats spinal muscular atrophy (SMA), which is a rare disease that affects the motor nerve cells in the spinal cord. It causes the loss of walking, eating, breathing, and other imperative functions.
Analysis: This was a good move by Novartis. That's because this acquisition will help the company build upon its neuroscience division. It is highly committed to advancing gene therapies to help treat a wide range of rare diseases. This wasn't the first rodeo for the company in stepping its foot in the gene therapy space. Back in January of this year, Novartis made a licence agreement with Spark Therapeutics (ONCE) to license its gene therapy treatment, Luxturna, for all markets outside of the United States. Novartis expects the acquisition of AveXis to go through my mid-2018. If all goes well, Novartis believes that it can file a BLA filing for AVXS-101 by the second half of 2018. That would put approval for the drug in 2019.
AstraZeneca Looks To Get Its Foot Into The NASH Space
News: AstraZeneca (AZN) has recently licensed a NASH drug from Ionis Pharmaceuticals (IONS) for $30 million. This deal was made possible because of a pact that was developed between both companies for developing a drug candidate targeting the cardiovascular, metabolic, and renal disease arena. If it all works out for the clinical candidate, known as IONIS-AZ6-2.5-LRx, Ionis would be eligible for up to $300 million in milestone payments. In addition, Ionis could obtain low-teen tiered royalties for sales made from the drug.
Analysis: AstraZeneca, like many other pharmaceutical companies, is quickly shifting around looking to see if it can make a huge effort to achieve successful studies in NASH. This space is starting to get very crowded, but that didn't deter AstraZeneca from trying to get the ball rolling to see if it can obtain some impressive data. That's because the NASH fibrosis market is expected to reach $25.6 billion by 2026. Another big pharmaceutical company that is looking to become a major leader in the NASH space is Gilead Sciences (GILD). Gilead has several programs underway in NASH, hoping that it can eventually become the leader in this space as well. However, thus far, there are two biotech companies which are the most advanced in terms of finishing phase 3 studies. These biotechs are Intercept Pharmaceuticals (ICPT) and Genfit (OTCPK:GNFTF). They are both currently running phase 3 trials, with results expected sometime between 2020 and 2021.
Clovis Oncology Expands Sales Potential For Rubraca
News: Recently, Clovis Oncology (CLVS) announced that it had obtained expanded approval for another indication for its ovarian cancer drug, Rubraca. That means Rubraca is now approved to treat women with recurrent ovarian cancer who had a partial or complete response to platinum-based chemotherapy regardless of what BRCA mutation is present. The FDA approval was given thanks to phase 3 results in which Clovis's Rubraca was able to beat placebo in reducing the risk of disease progression.
Analysis: This bodes really well for Clovis, because it will help to enhance sales of its ovarian cancer drug, Rubraca. Just how much will it really help? Evercore ISI's Steve Breazzano states that this new indication could boost Rubraca sales to $133 million this year. What I really like the most about Rubraca for this indication is that it treats patients regardless of whether or not they have a BRCA mutation. The problem is that Clovis is starting at a disadvantage for this indication. That's because there are two other pharmaceutical companies which have already received FDA approval to treat recurrent ovarian cancer. These two pharmaceutical companies are AstraZeneca and Tesaro (TSRO), respectively. The biggest problem is that many analysts are noting that Clovis Oncology will have a huge uphill battle to climb to catch up to both of those pharma companies. Clovis is expected to have a minority position for this indication, and future sales will likely depend upon how well its sales force performs. The company is attempting to build up its sales force to about 155 representatives in total. Time will tell if this will end up paying off in the long run.
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