Initial results from a phase I study were presented on Sunday at the European Society of Cardiology (ESC) meeting in London. (NASDAQ:ALNY) and Medicines Co. cut bad cholesterol levels among patients in a small trial by about as much as new treatments from Sanofi, Regeneron Pharmaceuticals Inc. and Amgen Inc., with far less frequent dosing. This was achieved with a dose of 300 mg and the study found that the drug could hold cholesterol levels low for at least 140 days. Alnylam stock, on the other hand, traded up 5.65% to $102.91 per share. The leaders get to grow the market, and once it’s mature, Alnylam, which stands to earn double digit royalties in its deal with Meanwell, and The Medicines Company, can jump in with a drug that “could be very disruptive”.
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So what: Although these results should be viewed as preliminary given that the study wasn’t large enough to truly assess efficacy, the two companies did note in their presentation that ALN-PCSsc’s cholesterol lowering ability appears comparable to Amgen’s and Sanofi/Regeneron’s PCSK9 inhibitors that recently won FDA approval. Repatha and Praluent, on the other hand, have to be administered to patients every two to four weeks. Like all drugs developed by Alnylam, ALN-PCSsc works by turning off the gene that produces PCSK9 through RNA interference.
Based on these promising results, analysts expect Medicines to reach sales of $1.6 billion this year, up from last year’s revenue of $724.4 million, The Wall Street Journal reports. The company believes that ALN-PCSsc has a profile of extremely competitive one compared to the anti-PCSK9 monoclonal antibodies, which were labeled for twice-monthly closing.
Patients taking the drug in a randomized trial saw bad cholesterol levels fall as much as 64 percent, on average, compared with about a 20 percent decline for those taking a placebo.
Cost is a major issue for PCSK9 drugs, with Repatha and Praluent priced at more than $14,000 a year, before discounts. Analyst Gbola Amusa advised investors to be “more selective in the biotech space”, saying that since Regeneron is now trading at 95% of its price target on the stock, it warranted a downgrade.
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Analysts at Leerink Swann raised their price target on shares of Alnylam Pharmaceuticals (NASDAQ:ALNY) from $145.00 to $151.00 in a report released on Monday, Market Beat Ratings reports. “However, as a counter to these strengths, we also find weaknesses including feeble growth in the company’s earnings per share, deteriorating net income and disappointing return on equity”. The 1-year stock price history is in the range of $63.48 – $140. The current trial will likely to close with the higher probability of success of 60% during peak sales o f $1.6 billion. The higher price target estimate for the stock has been calculated at $180 while the lower price target estimate is at $115. What’s most intriguing about this new drug is the potential that it might help solve the compliance problem.
