News and Comments

XOMA AND ELAN: THE TALE OF TWO COMPANIES

  Tuesday, January 11, 2011

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...

ELAN BETWEEN THE PML TEST AND ALZHEIMER'S DISEASE PILL

  Tuesday, December 28, 2010

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...

XOMA: Was the Rally really A surprise?

  Wednesday, December 22, 2010

Xoma (XOMA) soared yesterday on no news from the company. Early afternoon, Reuters put out a press release stating that the rally occurred on high expectations of the mid-stage results of XOMA 052 in the treatment of diabetes. To read the article, please click or copy and paste the link: http://classic.cnbc.com/id/40769319 More...

CYTOKINETICS (CYTK) And The Moment Of Truth

  Sunday, December 19, 2010

Rushing to wrong interpretations of the news and the triggering of computer programmed-selling of biotech stocks on good news devastate serious biotech sector shareholders. Also, routinely instigating sell offs of development-stage firms at each and every quarterly financial announcement of negative income, knowing in fact that these firms have yet to put products on the market, boxes these stocks. Now, we are witnessing another pattern of computer programmed selling, i.e. activation following announcements of clinical trial results, regardless of whether these results are positive or negative.  More...

ONYX’ drug Carfilzomib delayed the need for a stem cell transplant

  Wednesday, December 15, 2010

In October 8, 2010, we posted on our website a multiple-choice question, asking those who perpetrated pessimistic news about Onyx (ONXX), which led to a stock selloff to explain the reason for their pessimism towards this firm. The question was:  More...

Biotechnology Companies: A Model that’s Gaining Visibility

  Tuesday, December 07, 2010

The biotechnology company model founded on management skills rather than purely on scientific skills has begun to gain investors’ appreciation. The reason is that many firms built around skilled, experienced entrepreneurs have succeeded in bringing a large number of drugs to the market and in marketing them competently. These firms license or acquire drugs in mid-or late-phase trials. They sometimes acquire therapeutic molecules in early-stage development only if these molecules prove to have optimal affinity on validated proteins in pathways of diseases, and produce desired agonist or antagonist effects. In order to select the products that can be called breakthroughs, the most successful of the firms established and run by entrepreneurs with strong business acumen employ specialists in pharmaceutical sciences and in clinical trials. These scientists have experience in sensitive areas such as drug development, clinical trials, medicinal chemistry, and other important disciplines required for drug discovery, development and testing.   More...

Ariad’s (ARIA) ridaforolimus Brings Hope To Advanced Endometrial Cancer Patients.

  Monday, November 22, 2010

Endometrial cancer is the most common cancer of the female reproductive system. Advanced cases have virtually no effective treatments. Surgery, alone or in combination with radiation, chemotherapy, and/or hormonal therapy are good as initial therapy. In advanced stages, however, surgery has no role to play and chemotherapy has limited, if any, benefit.  More...

What Could Happen To HGSI’s SLE Drug On Tuesday?

  Monday, November 15, 2010

A few days before the independent FDA committee review of Human Genome Sciences’ (HGSI) systemic lupus erythematosus (SLE) drug Benlysta (belimumab), the FDA suggested that the drug has marginal efficacy and scary adverse effects. The agency expressed concerns about infection, neuropsychiatric complications, including the risk of suicide, and increased risk of death as a result of the use of the drug. The FDA message to the independent committee, which will convene on Tuesday, is to decide whether the reward is worth the high risk. The FDA has also observed that studies conducted outside the U.S. produced stronger data than the U.S.; these studies were not consistent with the U.S. results. The agency has also observed that the African-American lupus patients had benefited less from Benlysta than did non-African American patients.  More...

XOMA (XOMA): What would erase investors’ reservations?

  Thursday, November 11, 2010

According to data from its IL-1 beta inhibitor drug Xoma 052 in patients with uveitis, all seven patients with Behcet's uveitis enrolled in the XOMA 052 trial experienced rapid reduction of intraocular inflammation and improvement in visual acuity following a single treatment with the drug. A recent data presented at the 2010 American College of Rheumatology Scientific meeting demonstrate that all the five patients re-treated with XOMA 052 due to a recurring uveitis exacerbation have responded all over again to XOMA 052 and maintained their response for several months. Cytokine data showed reduced levels of IL-1 beta, IL-1 alpha and IL-6, as compared to baseline, with an increase in the levels of interferon gamma, which protects against infection.  More...

Cadence’s (CADX) Ofirmev: A safe adjunct new drug for pain?

  Friday, November 05, 2010

Cadence’s (CADX) Ofirmev US approval provides an important missing adjunct, or alternative to narcotic drugs for the relief of postoperative pain. The drug is an intravenous (IV) version of acetaminophen. Its antipyretic action makes it useful also for fever reduction in patients requiring emergency intervention. Preceding and following the Ofirmev approval, the Internet was bombarded with negative articles undermining Cadence and downplaying the value of Ofirmev, and, consequently, the value of its approval. We disagree with many of negative arguments.  In any case, sooner or later reality will surface, regardless of the right and wrong speculation  about tomorrow.  More...


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