About

Elan Corporation, plc (Elan) is a neuroscience-based biotechnology company. Its principal research and development, manufacturing and marketing facilities are located in Ireland and the United States. Elan’s operations are organized into two business units: Biopharmaceuticals and Elan Drug Technologies (EDT). Biopharmaceuticals engages in research, development and commercial activities primarily in neuroscience, autoimmune and severe chronic pain. EDT focuses on the specialty pharmaceutical industry, including specialized drug delivery and manufacturing.

Life Sciences Research, Inc. (LSR) announced Thursday that it has entered into a definitive merger agreement to be acquired by Lion Holdings, Inc., an entity controlled by LSR’s Chairman and Chief Executive Officer, Andrew Baker, for $8.50 per share in cash. Mr. Baker currently beneficially owns approximately 17.5% of the outstanding shares of LSR.

On our March 16, 2009 post, we specified that LSR was a special situations play with a high probability of realization. We also pointed out that this was not a long-term play, as its mediocre earnings power did not make it a long-term value candidate. We are now closing our position on LSR, for an absolute return of 20%.

Jim Cramer says a lot of contradictory things when it comes to predictions, but he doesn’t waver from at least one piece of critical advice: risk only what you can afford to lose on spec plays.

Thursday a biotech spec play called Insmed Inc. (INSM) is currently down 54% after the company said its drug Iplex failed to treat the most common form of muscular dystrophy in a midstage study. I bought into the story when the stock was $1.24 on advice from a hedge fund manager closely following the company. First, let me explain I never trade based on naked tips. But I will perform my own due diligence on a tip and decide if I want to get involved. In the case of INSM, I bought some shares for the following legitimate reasons:

Below is a summary of updates to the BioMedReports.com FDA Calendar, which includes a database of 250 entries as of 7/9/09. I originally created the calendar to track companies with pending new drug, biological agent, or medical device new product decisions at the FDA. With the launch of BioMedReports.com, the FDA Calendar has expanded to include the following categories: pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), pending complete response letter (CRL) re-submissions to the FDA, and pending late-stage clinical trial results.

Shares of Amgen (Nasdaq: AMGN) are soaring following the news that a Phase III trial of the company’s Denosumab drug for osteoporosis showed superior effects in treating adverse bone reactions in patients with advanced forms of breast cancer.

In the trial summary data released after Tuesday’s close, “Dmab” went head-to-head with the existing treatment option, Zometa from Novartis (NYSE: NVS), and showed a “statistically significant” (magic words in pharma-land) improvement in delaying or preventing bone factures, spinal cord compression, and other injuries related to bone weakness.

Analysts are busy jawboning yesterday morning about the side effect Amgen revealed cropped up in a large, late-stage study of its bone drug known as D-mab for breast cancer patients whose disease has spread to the bones. It's known as osteonecrosis of the jaw, or ONJ, for short. The jaw decay is a known side effect with another type of popular drugs for osteoporosis, like Novartis' (NVS) Zometa, which was the drug Amgen (AMGN) used in this head-to-head study with D-mab.

AMGN shares are up huge on the data showing D beat Z. Many analysts think the kind of dual-purpose drug could become a billion-dollar-plus blockbuster. The FDA is scheduled to first decide whether to approve it for osteoporosis in October.

Below is a summary of updates to the BioMedReports.com FDA Calendar, which includes a database of 246 entries as of 7/8/09. I originally created this calendar to track companies with pending new drug, biological agent, or medical device new product decisions at the FDA. With the launch of BioMedReports.com, the FDA Calendar has expanded to include the following categories: pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), pending complete response letter (CRL) re-submissions to the FDA, and pending late-stage clinical trial results.

Obesity contributes to rising health care costs because of other conditions that go along with it. For instance, obesity is a risk factor for various metabolic syndromes, which can lead to cardiovascular disease and diabetes.

Currently, based on Vanda's website, it is not recruiting any salesforce. Also, there is no news that the company is raising money from investors. Apparently, it is looking for partnership or to sell the company outright. This does not come as a surprise, as in Feb, 2007, when its share price was still in mid-30s, Vanda already hired JP Morgan to find a partner for its experimental drug or to sell the company.

Microsoft (MSFT): Although it was a small and largely insignificant dip by the tech giant on Tuesday, I added some shares of Microsoft (MSFT) as it dipped below $23. Microsoft is not the dominant giant in the tech sector that it once was and will always face constant competition from Google (GOOG) and Apple (AAPL), but with all that cash on hand the software giant will always be a player through innovation and / or acquisitions.

Microsoft, in an attempt to challenge Google's dominance in the web-search arena, also recently launched an upgraded search engine at bing.com. Although I don't foresee Microsoft's new search engine unseating Google's dominance in the web-search arena, there is a chance that Bing, with some nifty 'scroll-over' previews and initial hype, could steal market share from Google. If that happens, more advertising dollars will roll into the MSFT coffers.

Below is a summary of updates to the BioMedReports.com FDA Calendar, which includes a database of 243 entries as of 7/7/09. The calendar was originally created by Mike Havrilla to track companies with pending new drug, biological agent, or medical device new product decisions at the FDA. With the launch of BioMedReports.com, the FDA Calendar has expanded to include the following categories: pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), pending complete response letter (CRL) re-submissions to the FDA, and pending late-stage clinical trial results.

Last month at the ASCO meeting, Curagen (CRGN) presented results for its lead drug, CR-011, in breast cancer and melanoma patients. CR011 had activity in both indications, however, most of the drug’s value should be ascribed to the breast cancer program, which represents a huge commercial opportunity and better chances of approval.

As I previously wrote, the significance of the breast cancer trial is not only in the clinical activity of CR-011, but more importantly, the ability to identify patients who are likely to respond to the drug. By defining the right target population, Curagen could substantially improve chances of approval, shorten development time and enjoy high market acceptance.

Amicus Therapeutics (FOLD) began registration for phase III trial of its investigational drug Amigal for the treatment of Fabry disease and expects to begin the dosing of subjects in the second half of this year. Along with the US FDA, the company has already decided on the primary endpoint of the pivotal trial which will be based on the change in the amount of kidney GL-3, the substrate that accumulates in the cells of Fabry patients.

The trial will consist of a six-month enrollment of approximately 60 subjects who are either new to enzyme replacement therapy (ERT) or have not received ERT for at least six months prior to the start of treatment with Amigal. The Amigal treatment arm dose and regimen will be 150 mg every other day.

Novo Nordisk (NOVO) wrote down $280 million for its investment in inhaled insulin in January of 2008, but this is dwarfed by Pfizer’s (PFE) write off in November of 2007 of $2.8 billion for its investment in Exubera, its entry into the inhaled insulin market. By March of 2008, Lilly (LLY) also gave up the ghost, and wrote down its efforts in the area.

Celsius Holdings (CSUH.ob): Shares of Celsius Holdings faced somewhat of a pullback during early trading on Monday after nearly doubling in price the previous week.

Interest in the stock remains high, as demonstrated by the large amount of trading activity at Monday's open (over 200,000 shares traded in the first five minutes of the trading day, over 500,000 in the first half hour.).

Below is a summary of updates to the BioMedReports.com FDA Calendar, which includes a database of 240 entries as of 7/6/09. The calendar was originally created by Mike Havrilla to track companies with pending new drug, biological agent, or medical device new product decisions at the FDA. With the launch of BioMedReports.com, the FDA Calendar has expanded to include the following categories: pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), pending complete response letter (CRL) re-submissions to the FDA, and pending late-stage clinical trial results.

1. No additional clinical studies have been requested;
2. The additional data requested do not involve new data analyses; and
3. The Company plans to formally respond to the FDA’s requests by 7/8/09.

Another week has gone by without word from the FDA regarding the approval of BioDelivery Sciences' (BDSI) Onsolis. It has been over two weeks now since the FDA informed the company of a minor delay; a delay in which they decided against issuing an official extension letter. Since the delay, many BDSI insiders have sold, prompting investors to speculate that the FDA will once again refuse approval of Onsolis.

The insider sales alone do not scare me, because if these insiders were selling based on their knowledge of a pending negative event it would be a blatant case of insider trading and they would be facing lawsuits and legalities after the fact.

Could a carrot-chomping Bugs Bunny become a drug pitchman? Well, maybe, if the small Israeli company Protalix BioTherapeutics (PLX) could pay Warner Brothers enough money for Bugs' services. PLX also needs to first win FDA approval of its drug for the rare, genetic Gaucher disease. And today that's looking like it could happen sooner rather than later.

Protalix announced this morning that the FDA has approached the company about possibly making the late-stage experimental drug available to certain patients under a special expanded access program before it's even formally approved. The agency is reacting to the recent setback suffered by biotech giant Genzyme (GENZ), which is having manufacturing issues at the plant that makes GENZ's very expensive, but widely used blockbuster Gaucher drug, Cerezyme. Apparently the agency is trying to avoid the impact of a potential shortage of treatments.

The FDA’s letter requested that Spectrum submits data files from the FIT study to support and verify a subset of the data that are currently under review for the proposed labeling. Many investors got disappointed, or pretended to be disappointed, and caused the stock to fall, rather than to be boosted on the good news.