INSM, Insmed Incorporated:Previous Insmed Posts:VFC's Follow-on Biologics Pick, INSMINSM: Signs of LifeInsmed UpdateVFC's Bear Market Picks, AGEN, MVL, INSM, CSUH.OBI've previously discussed Insmed as a great long term pick because of this small biopharmaceutical company's cancer treatment and follow-on biologics pipeline; not to mention it's ownership of the already FDA approved IPLEX, which is currently in experimental trials for the treatment of various conditions.
A couple of years ago, Insmed lost a patent case (
read about it here) which sent it's share price tumbling to below a dollar and it hasn't recovered since. In fact, the latest economic turmoil sent the stock price to near thirty cents, a price where smart investors were loading up for the future (in VFC's opinion).
VFC's Brief Review:What are Follow-On Biologics?
Follow-on biologics are versions of approved biologics that are developed after the original product has been created with the intention of marketing them after the patent on the innovator product has expired, thus bringing competition to monopolistic markets. In other words, when the patents on current drugs expire, other companies can step in with their own, possibly cheaper, products to create competition in the drug market.IPLEX- Almost two years ago, Insmed lost a patent-violation court case where it was argued that Insmed’s drug Iplex violated Tercica’s patent for it’s similar drug, Increlex. Both drugs were administered as insulin-like growth factor for short-statured patients, but Insmed’s drug, Iplex, is the superior drug. Iplex only needs to be injected once a day while Tercica’s drug, Increlex, is a twice a day shot. Insmed is also currently conducting various-phased trials for Iplex treatments for other indications, such as ALS, HIV and MMD. Eventually, Iplex itself has the potential for blockbuster status, although some of that money will be dished out to Tercica thanks to the patent infringement case.Today, Insmed released great news regarding IPLEX. In a joint release, Genentech, Ipsen/Tercica and Insmed announced that in an amendment to the previously-mentioned court agreement, Insmed will be permitted to supply IPLEX in connection with named-patient ALS programs worldwide on a royalty-free basis. This amendment is in response to the expressed desire of ALS patients to receive IPLEX for the treatment of their indication.
Although IPLEX is not yet approved for the treatment of ALS, it's been used in that capacity in Italy for a while now, and the results from Italy could be used to show efficacy for future approval.
According to today's
Press Release, Ipsen/Tercica may jump on board the IPLEX bandwagon and partner with Insmed for future commercial development and marketing of IPLEX to treat ALS.
In addition, Insmed, a leading developer of follow-on biologics, could be a benefector of the new Democratic Administration, as new follow-on biologics legislation should be on the agenda of the next Congress. Congressional attention to follow-on biologics has taken a backseat to the current economic crisis, but once the issue is re-visited, Insmed will be ahead of the game with four follow-on candidates in the pipeline.
Representatives from Insmed will be presenting at a couple of upcoming Health conferences, so it is possible that the Press Releases are just beginning, and in response, the share price could approach, if not surpass, the dollar mark in short time.
RISK:- IPLEX, although already approved to treat Short Stature, fails to demonstrate results in other indications.
- Insmed fails to bring any of their follow-on biologic candidates to market.
- Insmed fails to bring any other pipeline drugs to market.
- Insmed fails to get the share price above a dollar and faces delistment from the NASDAQ.
REWARD:- IPLEX begins to bring in cost-recovery revenue from it's ALS named-patient programs.
- IPLEX ultimately receives approval to treat ALS or another indication.
- Follow-on biologics partner is announced.
- Follow-on drugs are approved.
- Other drugs in the pipeline gain approval.
TIMEFRAME:I've been slowly accumulating INSM for about two years, and the lower the stock price dropped, the more shares I bought. As long as the stock price is below a buck, I'll still be buying as much as I can and I'm ready to wait a few years for the IPLEX story to development and for the follow-on candidates to reach approval stage.

SIRI, Sirius XM Radio:Shares of SIRI remail beaten down in the twenty cent range, and although revenues increased this past quarter, the 3Q results looked terrible thanks to a $4.8 billion dollar, merger related markdown.
Growth has slowed, in large part due to the failing auto industry, and until the economy picks up, sirius growth of the past cannot be expected.
Investor confidence in Sirius XM will remain downbeat until financial terms of the huge debt bill coming in 2009 are announced.
All looks bad for SIRI, doesn't it?
I believe that this company is going through it's absolute worst time right now, but once things begin to turn around, the patient investor will be rewarded. SIRI has crushed many a hopeful investor over the past year, and the FCC and DOJ have a lot to answer for that by taking 18 months to approve the merger.
Many investors have taken the loss and sold their SIRI shares, which I think is a mistake at this point. Granted, the immediate benefits of the merger went out the window with the slump in the auto industry (and consequently, the slump in SIRI XM growth), but once the Politicians quit telling the country that we are in a Great Depression and people start feeling positive again, money will flow back into the economy, jobs will be created, people will again be buying cars and subscriptions, and SIRI XM will have announced terms of their debt refinancing.
Our economy is not finished, and neither is SIRI XM.
Unless you're a trader looking for a quick buck, It's worth holding, and even adding shares of SIRI, to wait and see what this company brings in the next year.
RISK:- SIRI XM cannot refinance their immediate debt at resonable terms.
- SatRad loses steam and as a result SIRI XM loses subs.
- The company never turns a profit.
REWARD:- Re-finacing of debt is announced.
- Economy picks up, auto industry recovers and subscriber growth returns.
- Those investors buying now are rewarded down the road when the economy is turned around and debt issues are settled.
TIMEFRAME:At least a year, but in a few years from now investors should be happy (in VFC's opinion). I've got to give Sirius (
as I did with Celsius) a pass for at least this quarter and next as far as subscription growth goes, due to the weak economy. People simply are not spending money, especially on luxury items such as SatRad. Once the debt issue becomes clear, that should boost investor confidence and as that confidence returns, the short sellers should cover. If the economy remains in a slump, and if debt terms are not announced soon, a reverse split could be a possibility.
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