Guest Post: 41 New Drugs Approved in '14 -- A Random Spike or a Growing Trend of Drug Innovation?

By Cambria Alpha-Cobb* and Anthony D. Sabatelli** --

If innovation drives progress, then 2014 was the year of progress!  During the past year the U.S. Food and Drug Administration approved 41 new drugs.  That is 14 more than 2013 and the highest number in 18 years!  What spurred this increase?  And what challenges do these new drugs face in the 2015 market?

The FDA publishes the drug approval data based on New Molecular Entities (NMEs) [1].  These drugs can be both the traditional small molecule drugs in addition to newer high-molecular weight biologics.  For information on NMEs and how they are classified, see "The Scorecard- Fewer New Drug Approvals in 2013: What's in store for 2014?" [2] a previous blog post by Dr. Anthony Sabatelli.  Using data published annually from the FDA, we plotted the number of approved NMEs since the 1940s [1][3], below.  After a dramatic peak in 1996, our plot shows a steady decline in approvals, followed by very little turnaround throughout the first decade of the 21st century and then a slow recovery in the past few years.  Not only does this 2014 spike continue a slow upward trend, but also the new generation of drugs it embodies is believed to represent key advances in new drug development, suggesting a more broad-based recovery [4].

One of the main changes to the drug pipeline has been the expansion of treatment options. Many of the breakthrough discoveries from the past year are diverging from the traditional small molecules into whole new technologies and therapies. Nearly 4 out of 10 of the approved NMEs in 2014 were for biologics, a dramatic increase from 1 in 10 biologic NMEs approved in 2005 [5]. The 2014 NMEs spanned 10 therapeutic areas, up from 8 last year, with infectious diseases dominating with 12 approvals [4]. Next in line were approvals for cancer treatments (8) and rare disease drugs (5), emphasizing the industry's focus on specialized products [6].

Chart of New Molecular Entities approved: Annual approved NMEs based on data from [1] and [3].

While this innovation is helping restore our faith in the drug industry, these drugs are arriving into a market where high prices are coming under attack, and more competition will only increase these attacks.  Fierce Pharma identified six therapeutic areas, including some rare diseases and cancer treatment, where increased competition could lead to heavy price competition [7].  This competition raises questions about future commercial prospects and could suggest reduced future development efforts due to these new pricing pressures [8].

As John Carroll, editor of Fierce Biotech, states, "Approvals aren't enough to determine whether a pipeline strategy is successful or not." [8]  However 2014 was the best year since 1996, and the innovative technologies provide encouragement that this spike might be part of a long-lived trend.  Competition in pricing may hinder the sales of some of these new drugs, however the future is promising as firms venture from their comfort zones and embrace these breakthrough discoveries [8].

* Dr. Cambria Alpha-Cobb is a Technology Specialist at Dilworth IP
** Dr. Sabatelli is a Partner with Dilworth IP

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[1]http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugInnovation/ucm20025676.htm
[2]http://www.dilworthip.com/scorecard-fewer-new-drug-approvals-2013-whats-store-2014/
[3]http://www.fda.gov/AboutFDA/WhatWeDo/History/ProductRegulation/SummaryofNDAApprovalsReceipts1938tothepresent/default.htm
[4]http://www.forbes.com/sites/bernardmunos/2015/01/02/the-fda-approvals-of-2014/
[5]http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/DrugandBiologicApprovalReports/NDAandBLAApprovalReports/ucm373420.htm
[6]http://in.reuters.com/article/2015/01/01/pharmaceuticals-approvals-idINL6N0UE2C120150101
[7]http://www.fiercepharma.com/story/limited-attention-span-focus-these-market-shake-ups-2015/2014-12-24
[8]http://www.fiercebiotech.com/special-reports/biopharma-posts-chart-topping-41-new-drug-approvals-2014/2015-01-02?utm_medium=nl&utm_source=internal

Comments

[Skeptical]

I am curious as to how many of these drug innovations are susceptible to challenges under the Court's (ever-expanding) 101 atomic bomb power of rejection, how many of these breakthrough discoveries can be (or will be) simply evaluated as being discoveries of "laws of nature" or mere abstract results of "laws of nature" from "old" methods...

If the advances in development are not claimed, are those same advances now at risk of becoming a roadblock to the fruits of that labor? After all, it appears to be a natural extension of the Court's logic that any new advance from old tools is not patent eligible (mind you, not eligible instead of not novel or not non-obvious); and the Court notably has not provided ANY stopping point for the use of its (quite evidently eviscerating) logic.

Some have called for a restraint in comments (such as the learned Paul Cole), but some (such as myself) have noted that our courts have not engaged that same restraint, and that in truth, the Supreme Court did not provide limits because it does not want to limit its own reach into patent matters.

It would be almost irresponsible not to note that a very extensive risk exists that many or perhaps even all of these drug innovations can be (in the future) deemed by the Court to be innovation undeserving of patent protection. Congratulations to the owners of these innovations that have already obtained patent coverage. Please do not be fooled into thinking that such coverage will be enforceable in this modern day version of "the only valid claim is one that has not yet appeared before us."

[Ronald A. Rader]

Presuming "new drugs" included biopharmaceuticals, you fell into the trap laid every year by CDER with this article! Most every other even expert-level news source also are also victims. Your article is so far off, wrong, in reporting 2014 ‘new’ FDA approvals (only 41), you should consider a major correction, redoing this article.

You obviously used the annual list of ‘new’ NDA and BLA approvals promulgated by FDA (or rather, CDER), the same list cited in an earlier Dec. speech by the Commissioner, etc. But essentially every year, this reporting totally ignores the biologics/BLAs approved by CBER! It only includes relevant/NME CDER approvals, both drugs and biologics. This list is in no way comprehensive concerning ‘new’ FDA 2014 approvals. See my running list of biopharmaceutical approvals at http://www.biopharma.com/approvals.html.

New products and most also clearly containing new molecular entities/NMEs approved with full BLAs by CBER in 2014 that you (and CDER/FDA) omit include:
1) recombinant human papiillovirus (HPV) vaccine, Gardasil 9, from Merck
2) meningococcal group B vaccine, Trumemba, from Pfizer
3) recombinant porcine (pig) Factor VIII, Obizur, from Baxter*
4) recombinant glucagon-like peptide-1 (GLP-1), Trulicity, from Lilly
5) a new combination — Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase - HYQVIA (Gammagard plus Hylenex)
6) recombinant complement C1 esterase inhibitor, Rhucin, expressed by transgenic rabbits (can’t get more novel than this), from Salix Pharmaceuticals, Ltd. (and Pharming Group NV)
7) recombinant Factor VIII, Eloctate, from Biogen-Idec
8) recombinant Factor IX-Fc fusion protein, Alprolix, from Biogen-Idec
9) hyaluronic acid, cross-linked, Monovisc, from Anika Therapeutics

Counting these, FDA likely had a truly record-setting year for 'new' API and product approvals.