Elan (ELN) was granted FDA approval of Tysabri for Multiple Sclerosis in November 2004. It was great news for the firm and its shareholders, as it was no secret that the drug was a breakthrough expected to become bestseller in a huge market. The celebration of the great achievement was of short duration. Three patients developed PML (progressive multifocal leukoencephalopathy), two of them died. It was Biogen Idec, Elan’s partner on Tysabri, not the FDA, which decided to withdraw the drug from the market. The FDA was aware that the reward from such a great drug outweighs the risk, which is a rare complication that would occur with any drug that compromises the immune system and there are many on the market. Bottom line, Tysabri was reinstated on the market on condition that the patients take part in a risk-minimization program with mandatory patient registration and regular follow-up. More...

The comeback of a prodigious biotech company with unique scientific capability and a revered history of breakthrough achievements is always welcome. Elan’s (ELN) stock price has doubled since November 2010 at the time many investors had given up on the firm and sold the stock of the firm they had long valued for its great science and scientists. As a matter of fact, Elan’s science has always been appreciated even during the firm’s crises in 2008, when its stock crashed. At the time, mismanagement and other circumstances have broken the back of the firm’s finances, paralyzing its scientists. It was heartbreaking watching the firm’s beautiful minds held hostage by a paucity of funds and huge uncalled for debt. Both the fans and foes deemed the damage to be insurmountable. Contrary to many investors’ expectations, instead of going to the drain, in November last year, the stock began to steadily climb up. When the stock doubled in the past six months, more investors’ and analysts’ began to pay attention. The stock’s unexpected outperformance created a fertile land for gossip. Analysts, writers and chatters suggested various explanations for the stock rally, the long-lasting speculation, though, was the firm’s acquisition by a deep-pocketed pharmaceutical company. More...

Biogen Idec (BIIB) announced positive results of a process aimed at Identifying high-risk patients for a life-threatening side effect of prolonged use of the multiple sclerosis drug Tysabri. This test is a necessity because it detects an antibody that points to the presence of the Polyomavirus JC (JC virus), which causes the life-threatening progressive multifocal leukoencephalopathy (PML). This side effect in one per thousand patients has deprived Elan from billions of dollars in expected sales of Tysabri.  More...

The tale, this time, is not about London and Paris and is not written by Charles Dickens in 1859. It is about two biotech firms, Xoma (XOMA) and Elan (ELN), written by the market in the 21st century. The similarity between the old and the new tales is the furry the constituents of the two cities and companies have against their rulers’ mismanagement.  More...

A few days before Elan (ELN) submitted a supplemental Biologics License Application (sBLA) to the United States FDA and a Type II Variation to the European Medicines Agency (EMA) regarding Tysabri’s label update, investors began to accumulate ELN. The change in label includes a test that can pinpoint patients who are susceptible to developing Progressive multifocal leukoencephalopathy (PML) while on Tysabri. Informed investors knew that the test could double or more Tysabri’s current one billion sales’ revenues.  More...