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FDA Approves KALYDECO™ (ivacaftor) The First Medicine to Treat the Underlying Cause of Cystic Fibrosis

  Tuesday, January 31, 2012

The U.S. Food and Drug Administration (FDA) has approved KALYDECOTM (ivacaftor), the first medicine to treat the underlying cause of cystic fibrosis (CF), a rare, genetic disease. KALYDECO  is approved for people with CF ages 6 and older who have at least one copy of the G551D mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. More...

Xoma: New Plans That Can Bring Hope

  Monday, January 23, 2012

Thursday’s news brought to mind our old friend, Xoma (XOMA), which, unlike Raymond, not everybody loves it. Actually, many still love Xoma, but with reservation and resentment. Many time we questioned whether Xoma is addictive. For a couple of months, when we had nothing to write, good or bad, about Xoma, readers accused us of infidelity. It is important to mention that two decades ago, many investors highly treasured Xoma, viewing it as the personification of hope for breakthrough drugs the budding biotechnology industry was promising to get across to medical practice. In London, investors asked us if we know Xoma and the same came about in Paris, Milan, Rome, and Zurich. As a matter of fact, this firm was esteemed everywhere for its technologies, scientists, and pipeline products. More...

Elan: Between Speculation and Reality, Where the Firm is headed now?

  Thursday, January 19, 2012

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...

Circumstances That Encourage Picking Specific Biotech Stocks

  Tuesday, January 10, 2012

Picking biotech stocks for short-term and long-term investment could be a good practice if investors know what to pick. In most cases, picking biotech stocks that have no near-term catalysts could be disappointing, leading investors to wait and wait, then get bored, and sell their shares at a great loss. To pick firms in early- or mid-phase development the firms should have very advanced technologies and product pipelines with strong evidence of promise that they are the envy of rich pharmaceutical firms. The large-pocketed drug developers usually desire what they need and buy what they desire. Most are currently in dire need of breakthrough products, as the patent lives of many of their bestsellers are expiring. Investors must be aware of the fact that stocks of development-stage firms’ are destined to fall after each and every quarterly financial results announcement, as they have no revenues or incomes. They also fall after shareholders get disappointed in the negative performances of their stocks, hence, trash them. Compensation can come early, however, in the event of takeovers, alliances that pay huge upfront payments, or the announcement of stunningly positive clinical trial results of products that deal with life-threatening diseases with large markets. Focused investors may be able to catch big fish in situations exemplified by the following three circumstances: More...

Like Dendreon (DNDN) Human Genome might have Bottomed

  Monday, January 09, 2012

As expected, Human Genome Sciences (HGSI) will report on progress with the commercialization of Benlysta® (belimumab) during a presentation at the 30th Annual JPMorgan Healthcare Conference in San Francisco. The drug is approved for the treatment of adult patients with active autoantibody-positive systemic lupus erythematosus (SLE) who are receiving standard therapy. More...

Dendreon: Going to the bottom of mysterious story

  Tuesday, January 03, 2012

We keep reading daily tails about Dendreon (DNDN), Human Genome (HGSI) and other firms granted FDA approvals for therapeutics, which had disappointing sales. Bullish and bearish analysts are filling the media with articles explaining the reasons for the sluggish sales of Dendreon’s drug Provenge and Human Genome’s drug Benlysta after investors have already lost their money. Predicting the drugs’ poor sales before they hit the market was no dilemma, as the barriers to successful launch were palpable. Both bullish and bearish analysts preferred not to reveal ongoing obstacles to satisfactory market penetration; the bullish were enjoying the rally and had no interest in halting it, and the short-selling analysts and their followers welcomed bubbling of stocks, so they would hit the jackpot if and when the bubbles burst. Investors’ disappointment wouldn’t have been as deep, resulting in a huge selloff of the stocks if they had done their due diligence towards developing realistic expectations. Instead, they interpreted analysts’ silence as a sign that the revenues being generated from the drugs’ sales would certainly meet the analysts’ and the firms’ projections. They didn’t. Why? That’s what investors needed to know. More...

BIOTECHNOLOGY PROMISES A HUGE GROWTH

  Wednesday, December 21, 2011

EXELIXIS’ (EXEL) advanced PI3K-delta research and development preclinical program attracted Merck, known as MSD outside of the United States and Canada. “PI3K-delta is therapeutic target that academic researchers and the drug industry are racing to develop therapeutic antagonists for both inflammatory diseases and cancer. To get to Exelixis program, Merck agreed to pay $12 million in upfront payment in addition to potential milestone payments for multiple indications of up to $239 million and royalties on net-sales of products that would emerge from the agreement. Merck will also pay Exelixis royalties on any compounds that would emerge from Exelixis’ PI3K-delta program or from certain compounds that arise from Merck’s internal discovery efforts targeting PI3K-delta during a certain period. More...

ONYX (ONXX): Deal or No Deal Time For Payoff

  Tuesday, November 29, 2011

When Onyx (ONXX) announced its intention to acquire the privately held company Proteolix in 2009, investors rushed to sell the stock. Investors are brainwashed into selling any biotech firm that would spend money, regardless of the reason for spending, including acquiring firms with promising breakthrough drugs in final phase trials. As a matter of fact, Onyx’ acquisition of Proteolix added to its products’ portfolio a new generation proteasome inhibitor, Carfilzomib, a drug designed for resistant multiple myeloma. Takeda’s breakthrough drug Velcade (bortezomib) and Celgene’s drug Revlimid (lenolidamide) considered top treatments for multiple myeloma could not prevent the cancer from offsetting their efficacy on a large percentage of patients. In contrast, clinical trials demonstrated that Carfilzomib has broken the cancer’s capability to recur and resist in a substantial percentage of late-stage cancer patients. The new drug is definitely more effective proteasome inhibitor than the current treatments, in addition to having a better safety profile, especially with regard to the intractable pain and numbness that patients experience with Velcade. More...

Incyte: Where do we go from here?

  Friday, November 18, 2011

The Food and Drug Administration has granted marketing approval ahead of time for Incyte’s drug Jakafi™ (ruxolitinib). The approval is for intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF and post-essential thrombocythemia MF - indications that represent 80 to 90 percent of MF patients.  The drug, Jakafi is an oral JAK1 and JAK2 inhibitor. It is the first in a new class of drugs, known as JAK inhibitors and the first and only product to be approved by the FDA for MF. The drug is also in Phase III trials for polycythemia vera, in Phase II for essential thrombocythemia, pancreatic cancer and solid hematologic tumors. More...

Regeneron & Amgen: More Breakthrough Drugs In The Horizon

  Wednesday, November 16, 2011

In controlling high cholesterol levels statins have reigned for a very long time, generating over $30 billion/year with products like Lipitor and crestor generating almost ten million/year each. Statins act by blocking HMG-CoA reductase, an enzyme required for the production of LDL, (the bad cholesterol) in the liver. Statins side effects could be severe. They can cause muscle damage. Some physicians believe they are overprescribed, as 30 million Americans currently take the cholesterol pills. More...


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