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Shares of Alnylam Pharmaceuticals [NASDAQ:ALNY] tumbled 5.65% to close at $102.91 a share on Monday after the company and its collaborating partner, The Medicines Company [NASDAQ:MDCO], presented the initial Phase I data at the European Society of Cardiology (ESC) Congress on its investigational drug ALN-PCSsc, a ribonucleic acid interference (RNAi) therapeutic targeting proprotein convertase subtilisin/kexin type 9 (PCSK9) for the treatment of hypercholesterolemia. Shares of The Medicines Company surged 21.88% to close at $41 a share on Monday.
In contrast to PCSK9 monoclonal antibodies (MAbs) inhibitors that inactivate PCSK9 proteins by binding to them, ALN-PCSsc acts by silencing genes to inhibit PCSK9 synthesis in the liver.
Based upon limited data from a trial consisting of 69 patients, Alnylam said a 300 mg dose of the drug helped lower the low-density lipoprotein cholesterol (LDL-C) level by a maximum of 67%, compared to 25% in placebo. Alnylam claimed that ALN-PCSsc can maintain its effectiveness of lowering LDL-C levels for over 140 days, and hence the drug is supportive of a once-quarterly and possibly bi-annual subcutaneous dose regimen.
In February 2013, The Medicines Company and Alnylam formed a strategic alliance to develop and commercialize the new class of PCSK9 drug, ALN-PCSsc. Under the deal, Alnylam will develop the program through preclinical and Phase I clinical trials and will be eligible to receive $25 million in upfront payments, in addition to milestone payments and royalties of as much as 20% on the product’s sales. The Medicines Company is responsible for Phase II and late-stage trials and commercialization.
Both companies said on Monday that The Medicines Company will launch the ORION development program with an initial Phase II study planned to begin by the end of 2015 and a Phase III study expected to begin by the end of 2017. ORION is expected to include a comparative study of ALN-PCSsc with other PCSK9 MAbs inhibitor drugs.
One of the investor concerns is that it could take up to five years for the ALN-PCSsc drug to reach the market. By then, Pfizer [NYSE:PFE] could already have its oral PCSK9 inhibitor drug in the market, and possibly an annual vaccine version as well. In January, Pfizer said they are developing a PCSK9 MAbs inhibitor oral pill and vaccine, bococizumab [RN 316], which now is in Phase III with top-line results expected next year.
ALN-PCSsc will be competing with Praluent (alirocumab) and Repatha (evolocumab), PCSK9 MAbs inhibitor drugs developed by Regeneron Pharmaceuticals [NASDAQ:REGN]/ Sanofi [NYSE:SNY] and Amgen [NASDAQ:AMGN], respectively. Praluent is administrated at a dose of 75 mg every week, where low LDL-C levels are likely to be of less concern, and then move up to 150 mg when necessary. Repatha is administered at a dose of 140 mg every 2 weeks, or 420 mg once a month.
Regeneron’s Praluent costs $14,600 for a one year treatment while Amgen’s drug costs $14,100 for the same duration of treatment. Investors could be at risk as it is not possible to estimate the treatment costs for a RNAi-based drug, such as ALN-PCSsc, when it reaches the market five years from now.
Technically, ALNY shares are traded in deep correction territory. There are supports at the $80.00 and $85.00 a share levels, if the stock continues to pull back. After the release of the Phase I data on the ALN-PCSsc drug, Piper Jaffray recommended an overweight rating on the stock and raised the price target to $184.00 a share from $180.00 a share. Leerink Swann also raised its price target to $151.00 a share from $145.00.
Disclosure: Long position in REGN. No positions in any other companies mentioned. |
