There is a lot happenig in the Healthcare sector this month. With the Supreme Court taking up hearing a challenge to the Affordable HealthCare Act, the cost of healthcare premiums could rise as much 779 percent if the Supreme Court erases ObamaCare subsidies in a majority of states this year, according to a new study. http://bit.ly/1MbGGaf
Within the pharmaceutical company space this quarter there have been some interesting events. Ligand and Amgen are both set to see their stocks do better from the positive news on Amgen’s Kyprolis (carfilzomib) study. Ligand, which saw a 5x surge in volume in response to the news, will receive milestone and royalty payments on sales of Captisol, which carfilzomib's IV formulation utilizes http://bit.ly/1B86wbt and Amgen’s Kyprolis recently beat out Takeda’s Velcade in a head-to-head study. http://bit.ly/1G2BnpA
As per an article in the Orange County Business Journal, on February 24, 2105, Allergan Inc.’s Chief Executive, David Pyott, is in line for a severance payment of $100 million as a result of Actavis PLC’s pending buy of the Irvine-based drug maker, according to a federal filing. We will find out March 10, if he stays or if Actavis’s Chief Executive Brent Saunders is expected to retain that post for the combined company. Stay tuned.
The Orphan Drug Act has come into focus this past week. When you add up all of the numbers since 1983, the FDA has approved 511 orphan drugs, granted 3,280 orphan drug designations, and received 4,738 orphan drug designation requests. Of the 511 approvals, some drugs have been approved for more than a single rare disease, and sometimes a single orphan drug designation has been the platform for multiple orphan drug approvals (and multiple periods of 7-year exclusivity). So what does it all mean? Well, clearly orphan drugs are trending up – way up! And there’s no indication of a slowdown any time soon. (The data also shows that the Orphan Drug Act has been an overwhelming success (for both patients and the drug and biotechnology industries). http://bit.ly/1CDlF6C
Meanwhile, a Federal Judge in Maine has overturned the law that allows residents to buy prescription drugs from foreign pharmacies as per an article in the WSJ.
And, the FDA is continuing to issue rules that implement the new compounding law passed by Congress in 2013, and this week the agency released a whole slew of documents—including the long-awaited draft Memorandum of Understanding (MOU) on the interstate distribution of compounded medications by traditional pharmacies. At issue is the so-called “5% rule” included in the law, which states that traditional compounding pharmacies can only send 5% of their sales out of state, which would be calculated on a monthly basis. Here is only one example of how why this rule is irrational: How can a pharmacy be sure that it has not or will not exceed this 5% until the end of the month, when it’s too late to do anything about it? “Good news!” says the FDA. “Now if your state signs our MOU, compounded drugs shipped out of state can make up a whopping 30% of your sales!” While 30% is certainly better than 5%, there shouldn’t be a limit on compounded sales at all, especially since FDA has offered no rationale for the 30% number or any other number. http://bit.ly/1ERnTyU
I will have more for you in a couple of weeks.
Editor's Note: Seth Yakatan is currently serving as Vice-President of Business Development for Invion, Ltd. (ASX:IVX). Seth has been professionally involved in the biotechnology industry for over 15 years through his work with Katan Associates.
Invion is a clinical-stage drug development company focused on the development of treatments for major market opportunities in inflammatory diseases including asthma, chronic bronchitis and lupus.
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