BEDMINSTER, NJ (
chief executive Joe Zakrzewski wasted shareholders' time with a tightly scripted conference call Tuesday in which he said little to erase concerns about the company's efforts to secure patent protection for its lipid-lowering drug AMR101.
Zakrzewski did further damage by raising the possibility that Amarin could choose to sell AMR101 on its own. Amarin is still in "active" discussions with potential partners and/or acquirers, he added, but the inclusion of the "self commercialization" option in his canned remarks was unsettling. The expectation (or hope) is for a speedy Amarin takeout as the best way to maximize the blockbuster value of AMR101.
Of course, potential buyers of Amarin aren't going to commit unless they're confident in AMR101's patent portfolio, which would protect the drug from generic competiton and increase the drug's value.
by repeated rejection notices for one key AMR101 patent (the so-called '889 patent) posted on the web site of the U.S. Patent and Trademark Office.
Amarin shares were up 5 cents to $7.66 Tuesday but the stock is down 60% from its three-year high of $19.50 reached in June.
On Tuesday's call, Zakrzewksi said USPTO rejections of patent claims were "not uncommon" and that the company was still "working to bring a favorable conclusion" to the patent process.
Amarin has 16 patents covering various AMR101 claims pending in front of the USPTO, some of which could grant protection throught 2030, the company says.
Yet Zakrzewksi failed to discuss Amarin's overall intellectual property strategy and refused to answer questions about AMR101 patents. Investors have become almost singularly focused on the acceptance of the '889 patent, but if that's a mistake -- if investors shouldn't be so worried about the '889 patent -- then Amarin could easily say something in its defense. Instead, Zakrzewski says nothing -- a monumental missed opportunity to assuage investor concerns that have killed Amarin's stock price.
The few analysts on the call deemed worthy of asking questions didn't help either by basically laying down and refusing to challenge Zakrzewski "no patent talk" policy.
I tried to ask a question on the call but was ignored.
Also left entirely untouched Tuesday was the issue of whether the U.S. Food and Drug Administration will deem AMR101 a "New Chemical Entity" or NCE, which would give the drug a minimum of eight years of exclusivity. Failure to receive an NCE status would give AMR101 only three and half years of exclusivity.
Monness Crespi Hardt analyst Avik Roy believes the NCE status of AMR101 is much more important than the patents because patents will be challenged in court by generic competitors even if they're granted.
"We continue to believe that investors are overestimating the importance of these patents, relative to the risk that AMR101 fails to gain New Chemical Entity exclusivity from the FDA when the drug is approved in 3q12," he wrote in a note to clients this week.
Amarin includes a discussion of AMR101's NCE status as a material risk factor in its regulatory filings:
"We believe that the AMR101 compound is a new chemical entity in the United States and may be eligible for market exclusivity under the Food Drug and Cosmetic Act… However, there is no assurance that our compounds will be considered to be new chemical entities for these purposes or be entitled to the period of marketing exclusivity. If we are not able to gain or exploit the period of marketing exclusivity, we may face significant competitive threats to our commercialization of these compounds from other manufacturers, including the manufacturers of generic alternatives."
At issue is whether AMR101 is chemically distinct from
Lovaza, which is already approved and on the market. Both drugs contain the lipid-lowering omega-3 fatty acids EPA and DHA derived from fish oil, although AMR101 is made up of more EPA and less DHA than Lovaza.
FDA threatened Amarin with the possibility that AMR101 would not be granted NCE status, forcing the company to reach out for help from its local congressman U.S. Rep. Joe Courtney, according to a Sept. 14, 2010 story
, a local newspaper in New London, Conn.
It's not clear what resulted from the lobbying efforts by Courtney or whether the FDA still has reservation about AMR101's status as a new drug. The company knows this issue has been raised but again, missed an opportunity Tuesday to address it head on.
Investors may not know about FDA's decision on AMR101's NCE status until the agency issues an approval decision on the drug, likely in the third quarter of next year.
AMR101 has the potential to be a blockbuster drug, generated billions in revenue, based on the data from two successful phase III studies. But Amarin's stock is getting no credit for this accomplishment because of legitimate concerns that poor patent protection or the lack of market exclusivity will invite generic competitors to the party well before AMR101 can generate meaningful profits.
Unfortunately, Amarin executives demonstrated once again Tuesday that a cavalier attitude about communicating with shareholders is doing more harm than good.
--Written by Adam Feuerstein in Boston.
>To contact the writer of this article, click here:
>To follow the writer on Twitter, go to
>To submit a news tip, send an email to:
and become a fan on
Adam Feuerstein writes regularly for TheStreet. In keeping with company editorial policy, he doesn't own or short individual stocks, although he owns stock in TheStreet. He also doesn't invest in hedge funds or other private investment partnerships. Feuerstein appreciates your feedback;
to send him an email.