The safety and tolerability profile for Regeneron Pharmaceuticals, Inc.'s (NASDAQ:REGN) anti-PCSK9 antibody Alirocumab is in good stead against Amgen's AMG145, and supports upside potential of the Regeneron antibody in the multi-billion dollar market for cholesterol lowering drugs.
Alirocumab is a fully human monoclonal antibody that binds a protein called PCSK9. Alirocumab is being evaluated to manage low-density lipoprotein cholesterol (LDL-C), or "bad" cholesterol. Alirocumab is being evaluated to manage LDL cholesterol, including in people who do not get to their target LDL levels using statin medicines alone.
On the other hand, Amgen, Inc.'s (NASDAQ:AMGN) AMG 145 is an investigational human monoclonal antibody that inhibits PCSK9, a protein that reduces the liver's ability to remove LDL-C from the blood.
Elevated LDL-C is recognized as a significant risk factor for cardiovascular diseases. Despite the availability of various treatments to lower LDL-C, it is estimated that LDL-C is not well-controlled in two-thirds of treated, high-risk patients. There are a lot of generic drugs such as AstraZeneca's/Shionogi's Crestor and Merck's ezetimibe franchise—Zetia (ezetimibe), Vytorin (ezetimibe/simvastatin) and Liptruzet (ezetimibe/atorvastatin).
Review of published data across seven phase 2 studies and about 1255 treated patients reveals that Regeneron's anti-PCSK9 is set to become a well tolerated class of drug with low rates of adverse events (AEs) and serious adverse events (SAEs).
"With ~275 patients worth of phase 2 data for alirocumab and with ~980 patients worth of phase 2 data for AMG145, differences are notable in terms of more injection site reactions (ISR), low titer antibody measures and one-off immune reactions with alirocumab, while CK elevations and myalgias/myositis have been documented more often with AMG145," BMO Capital Markets analyst Jim Birchenough wrote in a note to clients.
Meanwhile, efficacy has been well established for both compounds with! comparable 66 percent reduction in LDL as add-on therapy to statins.
Last month, Amgen said its AMG 145 reduced bad cholesterol up to 59 percent in an efficacy analysis of pooled data from four 12-week Phase 2 studies evaluating AMG 145 in patient populations with high cholesterol.
Large phase 3 programs, including outcomes data are ongoing with initial data expected for both compounds in 2014. Sanofi expects to launch in 2015, with a global ramp in 2016 while Amgen seems to be a little less than 6 months behind Sanofi.
Following a detailed review of Alirocumab safety and tolerability, Regeneron's antibody is well positioned to withstand tough competition from Amgen's AMG145. Meanwhile, Pfizer, Roche and Novartis are also targeting this market.
Alirocumab news flow should accelerate into 2014. The results of two Phase III trials in statin intolerant patients are expected by the end of this year or early 2014. Several more trials will follow in 2014 and then a few more through 2018.
Decision Resources, one of the world's leading research firms for pharmaceutical and healthcare issues, finds that the dyslipidemia market will grow to just over $31 billion in 2022, at an annual rate of 2 percent from 2012. The launch of antidyslipidemic agents from two novel drug classes–PCSK9 and CETP inhibitors–will be the primary drivers of market growth, off-setting the voracious genericization that has and will continue to impact the market through 2022.
Although the number of patients who are not controlled on statins in the US is 11 million, Regeneron estimates another 1 million who are refractory to or intolerant of statins, which shows that even modest penetrations could lead to a multi-billion-dollar product. Given that the market could be $10 billion plus for these drugs, the opportunity, even with multiple players, appears large.
"With a statin market previously peaking at nearly $24B in sales and with ~1/3 of patients identified as statin inadequate responders we b! elieve th! at efficacy and favorable safety of anti-PCSK9 mAbs could support an $8B+ opportunity, shared equally between the two leading compounds," Birchenough said.
While rare immune reactions are noted with Alirocumab, the aggregate safety and efficacy support a $4 billion drug.
Regeneron is developing alirocumab in collaboration with Sanofi. In the US, Regeneron will share profits 50/50 with Sanofi. In the rest of the world (ROW), Sanofi will receive a higher share of profits starting at 65 percent and falling to 55 percent as profit increases. Regeneron will also share losses in the US at 50 percent and in the ROW at 45 percent.
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