News and Comments

ARIAD (ARIA): Announcement

  Tuesday, August 02, 2011

At this stage, we are more interested in Ariad’s (ARIA) product pipeline than in the financial results of an era where the firm will soon move from a development-stage to a revenue-generating biotech company. Our logic could be the same as that, which led Harvey J. Berger, M.D., chairman and chief executive officer of the firm to begin his financial results’ announcement by writing about the outstanding progress the firm has made towards advancing its pipeline of cancer-drug candidates. The man wrote about the firm’s expectations about the near-term drivers of shareholder value. He wrote about interim data that will be presented later this year on ponatinib trial. More important and impacting is that Merck, the firm’s partner on ridaforolimus has already filed for regulatory approval of the cancer drug with the European Medicines Agency in the European Union, and the firm’s expectation that Merck will submit a new drug application in the U.S. shortly. Another drug, AP26113, will also begin clinical development this quarter. More...

Gilead Sciences: Providing a shop full of options for individual HIV victims’ needs.

  Tuesday, August 02, 2011

Gilead Sciences (GILD): Fingers of traders on the sell button as of a routine practice has produced an initial decline in GILD price after refreshing financial results. The firm has exceeded analysts’ exaggerated expectations. Nobody was stunned about the stock’s initial decline, as everybody has become accustomed to the rule of thumb – sell on good news and obviously on bad news, i.e., sell, sell, sell; that’s all. The initial selling was initiated before and even after the announcement of Gilead’s second quarter financial results. More...

Sangamo: Aiming High

  Tuesday, July 26, 2011

In early March 2011, we gave a brief history of HIV treatments. The article has also referred to recent studies demonstrating that early treatment with highly active antiretroviral therapy (HAART) further improves survival of asymptomatic patients with higher CD4+ T cell counts. Instead of fading away as many studies do, these studies were accompanied with parallel studies demonstrating that the prophylactic use of HAART succeeded in shielding exposed individuals from contracting HIV. These studies, no doubt, were favorable to Gilead Sciences (GILD), as demonstrated in the stock’s recent performance. What makes this news important is the fact that sustained treatment with these drugs for to avert the reactivation of the virus and the progression of AIDS subjects the patients to dangerous adverse effects and the drugs to the risk of viral resistance. More...

The Sky’s The Limit For Micromet’s BiTE Technology’s Capability

  Tuesday, July 19, 2011

Micromet (MITI) added another important collaborator, Amgen (AMGN), to a long list of large and small drug developing companies that are attracted to Micromet’s BiTE technology. Amgen/Micromet agreement looks fair for both. It fits Amgen’s strategy of focusing on adding next-generation products to its pipeline and helps Micromet’s financial requirements during the development of its promising proprietary cancer programs. Amgen wanted to select from among three BiTE-based drugs against three undisclosed solid tumor targets. The giant biotech will pay upfront, milestone, and other payments in a deal that could be worth over $900 million for the two selected drugs, or half of this amount if it selects only one drug, in addition to double-digit royalties in the event of approvals and sales. More...

ELAN: Reasons For The Stock's Outperformance

  Tuesday, June 28, 2011

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...

Ariad’s ALK inhibitor could be a huge step forward in lung cancer treatment.

  Tuesday, June 28, 2011

One year ago, an anaplastic lymphoma kinase (ALK) inhibitor called crizotinib developed by Pfizer (PF) for non-small-cell lung cancer demonstrated it shrank the tumors in most of the 82 patients after two months of treatment. Knowing in fact that it was too mature to fall for the drug, oncologists, nevertheless, couldn’t stop themselves from wowing crizotinib at the 2010 cancer conference meeting of the American Society of Clinical Oncology. The patients had advanced cancers, including some who had brain metastasis and had been treated with an average of three other drugs to no avail. Pfizer’s ALK inhibitor crizotinib showed no serious side effects. Larger trials were required, however, to confirm the drug’s safety, replicate its efficacy, see whether it would improve survival and whether cancer resistance would emerge in some patients as it usually does following initial drugs’ efficacy More...

IMMUNOGEN: The TAP Technology

  Wednesday, June 15, 2011

Something to think about the fact that using ImmunoGen’s (IMGN) TAP technology makes targeted cancer drugs beat their own efficacy. This reality seems to be increasingly considered by cancer drug developers. Using ImmunoGen’s technology enables approved, or investigational targeted cancer drugs developed by pharmaceutical companies to gain extra-efficacy as first line treatments, in addition to overcoming cancer resistance in case of recurrences. The oncology drug developers would love to see their same products bring better safety and efficacy, cover more patients and succeed if recurrences occur. More...

VERTEX: First Drugs ever to target the root-cause of cystic fibrosis are promising.

  Monday, June 13, 2011

Like many other chronic progressive intractable diseases, Cystic Fibrosis (CF) pathology is about misfolding of the transmembrane conductance regulator (CFTR) protein as a result of CFTR gene mutations. The malfunctioning CFTR protein loses its trafficking capability and fails to reach the cell membrane, resulting in the accumulation of thick, sticky mucus that plugs the airways and chokes the pancreas. The symptoms are chronic coughing, difficulty breathing, malabsorption of food and nutrients from the intestine, inability to gain weight, diarrhea, or bulky, foul-smelling, greasy stools, or constipation. The disease is debilitating and affects about 100,000 babies, children and adults worldwide. The presence of salty skin confirms the diagnosis of the disease. More...

VERTEX: What About Now?

  Wednesday, May 25, 2011

Yesterday, the FDA approved Incivek (telaprevir), Vertex’ (VRTX) HCV protease inhibitor, which demonstrated in clinical trials it cures more treatment naïve patients and more patients who did not benefit from conventional treatments in much less time than Merck’s Victrelis (boceprevir). Less than a month ago, the FDA Antiviral Drugs Advisory Committee voted 18-0 to recommend approval Incivek for HCV patients with genotype 1 chronic hepatitis. The recommendation was based on clinical trial data demonstrating that combining Incivek with pegylated interferon/ribavirin produced a higher cure rate in less time than standard therapy alone. This improvement is most notable for hard-to-treat patients including those with HCV genotype 1, people with liver cirrhosis, and those who did not respond to a prior course of conventional. Merck's drug Victrelis (boceprevir) also an HCV protease inhibitor, was given a positive recommendation and was eventually approved. More...

SEQUENOM Announces the Date of Launch of the Non-Invasive Down Syndrome

  Saturday, May 07, 2011

When Sequenom (SQNM) was welcoming analysts and shareholders who are “interested in discussing the results for the first quarter of 2011,” the firm’s CEO was quite aware that most attendees were, in fact, much more interested in the progress of the firm’s plans for the non-invasive prenatal tests, especially the Down Syndrome test. Shareholders, he knew, are interested in reading the future of Sequenom Center for Molecular Medicine (CMM). As a matter of fact, that’s what investors in development-stage biotech firms and small firms generating poor revenues firms on the road to realizing their dreams should look for i.e., the firm’s technologies and programs. In the case of Sequenom, its success in bringing non-invasive predictive prenatal tests to the market, especially, the promised Down Syndrome test, is a game changer that could either make this firm or break it. Meeting or exceeding expectations and promises of controlling expenses even if they lead to 25% reduction in losses, would be of minimal or no impact at all when the fate of the test is officially declared. More...

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