News and Comments

A Promising Strategic Agreement Between A Large and A Small Biotech Firms.

  Thursday, October 13, 2016

When plenty of news comes out of the biotech sector, we are left with no option but prioritizing. Connecting the dots also might serve some purpose, including smelling take-over possibilities that make sense or contribute to improvements of the treatments and of firms’ finances. Prioritizing comprises selecting as much as possible the most concrete subjects that are safe to explore.  More...

Biotech Firms with Guaranteed Growth Potential

  Thursday, July 07, 2016

Good news is not always great news that makes a difference. In the drug industry, clinical trial results that demonstrate a drug has fulfilled the requirements of the trials, including the primary and secondary endpoints does not always guarantee that the drug will be successful if and when it hits the market. Experience and follow up on certain firms enables us to see the real light at the end of the tunnel, not just celebrate reaching the end of it without knowing what to expect outside. This makes a big difference.  More...

A Judge is Offended About False Claims Against Gilead. Good News from Regeneron

  Monday, May 02, 2016



  Tuesday, August 06, 2013

Each and every time investors believed Regeneron (REGN) highest high value has been reached, like a magician, it pulled another chicken out of its long black hat and made it lay another golden egg. Regeneron’s new different egg is expected to boost its wealth, turning the current estimation upside down, i.e., from overvalued or fairly valued into undervalued.    More...


  Tuesday, May 15, 2012

The time has come for redefining the meaning of “creating shareholders value” in the biotech sector. Pinpointing the real value has become imperative. It is the road to a fair assessment of innovative biotech firms. It helps investors reap the fruits of the real value of excellent firms at the right time, rather than rush to sell extremely promising stocks while still undervalued. It makes investors think twice before throwing their shares of firms that are installing one by one the building blocks of their vision. Creating shareholders value is investing in the future. The cost of this investment shouldn’t be cause for downgrading the stocks because of overspending, which has become a normal pattern. We still see all development-stage biotech stock prices slashed following the announcement of their quarterly results. There is a big difference between spending on the future and spending because the money has been made available. Investors can know the difference. The first thing to look for is whether the firm has any program in development that is worth spending on, including buying firms having a technology that is badly required for the successful outcome of the firm’s program. This kind of investment should not be punished or treated as unnecessary spending. 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...

Monster Blockbuster Anti-Cholesterol Drugs In Biotechs’ Pipelines

  Wednesday, August 31, 2011

The new biological science is evolving at the speed of light. As a matter of fact, the bright penetrating light of the genomic revolution is effectively reaching the dark corners where the utmost reality remained hidden since millions of years. The new light enabled the insight to match the sight in divulging the buried secrets of body at the molecular level. With the most advanced tools ever created by human minds, scientists have reached a stage where they can spend much less effort in solving much more puzzles on the road towards solving the problems of diseases at their root-origin. The successful are those researchers who keep their eyes open and their minds prepared. More...


  Thursday, May 05, 2011

First, we congratulate our subscribers who did not follow the skeptics and believed in the rationality of science and kept their Vertex’ (VRTX) and Regeneron’s (REGN) shares despite years of negative campaigns against the two firms. Following the rally in VRTX, another rally started in REGN for rational reasons. Both firms are among our TOP TEN selection. More...

Regeneron: A Sound, Well-Executed Strategy

  Tuesday, February 22, 2011

When Regeneron (REGN) was a development stage firm, it spent a substantial time in developing and validating a solid scientific, technological and industrial infrastructure. At its inception, Regeneron’s vision was to provide a self-sufficient capability for discovering and developing far-reaching breakthrough products. Its strategy for its therapeutic discovery has been to establish a solid foundation that enables it to build its pipeline product through in house genomic technology for understand functional gene expression. Its drug design strategy focused on creating a novel approach, which would enable controlling signaling proteins, whose excesses cause cell deregulation. The strategy focused also on designing human monoclonal antibodies that are far-reaching, time consuming and impacting. Until the time these technologies were put in place and was validated, REGN served as a vehicle for daily trading. Both positive and negative players benefited from the yo-yoing of the stock. Stock investors and analysts are not impressed with breakthrough technologies created by development stage biotech firms until they are validated. Otherwise, they consider them untested, hence, not credible and not trustable for long-term investing.  More...

Regeneron: Arcalyst is the missing link in the treatment of gout

  Friday, June 11, 2010
Regeneron’s (REGN) Phase 3 study in gout patients initiating allopurinol therapy to lower their uric acid levels showed that the company’s drug Arcalyst (rilonacept), known as IL-1 Trap, prevented gout attacks, as measured by the primary endpoint of the number of gout flares per patient over the 16 week treatment period.

Is this s good, or bad news?

Judging from investors’ reaction to the news, one would believe the clinical trial results are a failure. However, judging based on understanding the disease, its causes, complications, symptoms and what current conventional treatments are accomplishing, or lacking would prove that Arcalyst might be the missing link in the treatment of gout. The drug neutralizes a major mediator of the severe attacks of inflammatory symptom flare up the patients suffer from after taking the uric acid lowering drugs, which is the fundamental treatment of gout. That’s what makes the bulk of patients who abandon the treatments that deal with the cause of disease, i.e., elevated uric acid. of the cause of disease. No conventional drug taken at a safe dose has been effective in preventing the flare up of the symptoms, which take their toll on patients and probably lead to worsening of the disease. It is easier for gossipers to perpetrate skepticism towards Regeneron’s drug Arcalyst if the listeners do not understand what gout is and what treatments are required for its successful management. The fact is that, gout requires more than two classes of drugs to stop the main cause of this disease, control its disabling symptoms, and prevent the attacks, thus, the consequent complications if the disease is not well treated.  

Gout occurs in patients who have elevated levels of uric acid. The uric acid is deposited in the joints and other body tissues. In the joints uric acid causes joint inflammation, joint pain, stiffness swelling, redness and heat. Deposited in soft tissues, uric acid causes the same it does the joints. Generally, patients experience flare up of symptoms that no drug is yet capable of preventing. The current management of gout aims first at lowering uric acid by either decreasing its formation or increasing its elimination from the body with uric acid-lowering drugs. Drugs exist that can tackle one or the other of the two actions. For example, the drug Allopurinol, decreases uric acid formation and  Probenecid helps the body eliminate excess uric acid through the kidneys and into the urine. The problem is that controlling the level of uric acid does not stop all the symptoms right away but the pain and suffering might increase and persist for long. The reason is that the breakup of uric acid crystals boosts inflammatory mediators, especially interleukin-1 (IL-1), which causes the flare. IL-1 is targeted for inhibition by Regeneron’s drug Arcalyst. The flare the patients experience after the treatment makes it difficult for them to adhere to uric acid-lowering therapies and discontinue the treatment within the first few months of therapy. That’s why Arcalyst is badly needed.

Currently, physicians are using the anti-inflammatory drug colchicine to calm down inflammation. In many cases, however, the dose required for the control of severe inflammatory symptoms is high and must be taken for a long time, which makes its side effects prohibiting. Patients would suffer severe diarrhea, abdominal cramps, nausea, and vomiting. Non-steroid anti-inflammatory drugs are used also, but in many cases they do not control the severe inflammatory symptoms during the flare, unless very high doses are given for a long time. Long-term use of high dose can provoke grave side effects, including peptic ulcer, kidney failure and liver failure. Steroids are resorted to, yet, again, their long-term high dose use could result in detrimental side effects, which go from immune system suppression, to osteoporosis, bone fracture, endocrine system deregulation, difficulty of wound healing, diabetes and the list goes on and on.

So, the most important results from Arcalyst phase 3 study is the one, which confirms that the concomitant use of the drug with uric acid-lowering therapy for the first several months may help avoid gout flares. The use of Arcalyst is expected to improve patients’ adherence to uric acid lowering drugs, sustain their wellbeing and improve the outcome of their disease. Is this bad news? More...

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