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AMGEN INVESTIGATIONAL DRUG ROMOSOZUMAB IS PROMISING FOR POSTMENOPAUSAL OSTEOPOROSIS

  Thursday, January 02, 2014

Osteoporosis is caused by a progressive decrease in bone mass and density which increases the risk of fracture. The reduced, bone mineral density (BMD) impacts the bone architecture and alters the amount and variety of proteins in the bones.  More...

YES AMGEN IS THE KING

  Wednesday, December 18, 2013

When Amgen (AMGN) develops a drug, the wise King do whatever it takes to squeeze every drop of its therapeutic capability before submitting the new drug application (NDA) to the FDA for approval. The firm is rich in its science, scientists, pipeline of investigational products and its approved products. All the problems the firm encountered that analysts believed would erode its fortune, such as limiting the use of its growth factors did not impact the firm’s growth, but unveiled the character and culture that made the king deserve its throne.   More...

BIOTECHNOLOGY: ON THE WAY TO MEETING HIGHLY AMBITIOUS EXPECTATIONS

  Wednesday, September 05, 2012

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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...

CYTOKINETICS’ NEW PLAN WITH AMGEN INCREASES THE DOSE OF OPTIMISM TOWARDS THE H.F. DRUG.

  Sunday, February 06, 2011

In the news, Cytokinetics (CYTK) announced that, in the first half of 2011, the company and Amgen (AMGN) have agreed to initiate a Phase IIb clinical trial of an intravenous formulation of omecamtiv mecarbil for patients with left ventricular systolic dysfunction hospitalized for acute heart failure. Amgen will conduct the trial in collaboration with Cytokinetics.  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...

Why Amgen’s Prolia is considered a breakthrough and a blockbuster?

  Thursday, June 03, 2010
In a surprising move, the FDA approved Amgen’s (AMGN) osteoporosis drug Prolia (denosumab) two months earlier than the scheduled date, after it had caused several months delay in the drug’s marketing. The question is, why scientists label Prolia a breakthrough and why most analysts expect it to become a blockbuster, generating billions of dollars in revenues?

Assessment of breakthrough drugs entails many intellectual practices that require knowledge of history that would confirm the absence of precedents in the same category and science that enables evaluating the drug’s structure and understanding the physiological and pathological pathways of the body system targeted for treatment. These are usually followed by a hypothetical assumption of efficacy based on the results collected from all the above studies. Confirmation of the degree of both safety and efficacy, however, comes only with the results of well-planned clinical trials. 

History confirms that being a fully human monoclonal antibody, Prolia becomes the first biological drug to be developed for osteoporosis. To understand Prolia’s action and effect, one has to know first that two kinds of cells control bone formation: The osteoclasts, which remove bone tissue mineralized matrix and break up the organic bone in a process known as bone resorption and the osteoblasts that are involved in bone formation. So, while osteoclasts resorb bone, osteoblasts make bone. These antagonistic actions enable the two cells to be in control of bone formation.

Amgen’s drug Prolia binds to and inhibits the action of the receptor activator of nuclear factor kappa B ligand, (RANKL), the principal mediator of osteoclastic bone resorption. This inhibition favors bone building by osteoblasts over bone resorption by the osteoclasts. In addition, it is known that aberrant activation of nuclear factor kappa B is observed in many cancers. The suppression of the same nuclear factor by Prolia would limit the proliferation of cancer cells, making the drug a potential therapeutic for cancer. Moreover, the same nuclear factor is also a key player in the inflammatory response. Prolia’s could also be a potential therapeutic candidate for inflammatory diseases, which are many and affect a large number of patients who are at the age of developing osteoporosis. As a matter of fact, results of clinical studies with Prolia, while confirming its efficacy and safety in treating postmenopausal osteoporosis have also demonstrated positive results in bone metastasis, rheumatoid arthritis, multiple myeloma and, giant cell tumor of bone. Confirming these results, which Amgen is in the process of doing through conducting more clinical trials, would be huge positive news for the patients, the company and for Amgen’s shareholders. 

Current good news for the sufferers of osteoporosis who are vulnerable to bone fractures is that the drug will be available within the next two weeks. Good news for investors is that the cost of the drug will be $825 per 60-milligram injection based on wholesale acquisition cost. Considering the fact that the drug will be administered only twice a year, the annual cost becomes less than that of conventional drugs. In case the drug will be used for cancer or debilitating inflammatory conditions, or other life-threatening conditions, the annual cost of the drug would become much higher, as the drug will have to be used more frequently.

It seems that many analysts estimate the product could generate for Amgen $3.3 billion in annual global sales in 2014. Some of those analysts believe that the sales will be around $700 Millions in the first year, and climb higher and higher slowly in the beginning until they reach between $3B-$4B in 2014. In case the drug will be approved for cancer and inflammatory diseases, the sales, some estimate, would reach over $7B-$8B a year.

That’s not bad. No? More...

AMGEN: Prolia’s (denosumab) Approval in Europe is Great News

  Tuesday, June 01, 2010
June 1, 2010 - Postmenopausal women at increased risk of bone fractures from osteoporosis, and men with prostate cancer who suffer bone loss associated with hormone ablation treatment will finally get Amgen’s (AMGN) drug Prolia (denosumab) in Europe. The good news for these patients and for Amgen (AMGN) has come as the European Medicines Agency’s (EMEA) Commission has granted approval for the use of Prolia in both conditions. Suddenly, Prolia has been approved in 27 European Union member states plus Norway, Iceland and Liechtenstein. The European approval of Prolia marks the first approval of the product worldwide and the first and only approval in Europe for the treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures.

If approval was expected as many Wall Street analysts are stating now, why then such expectations, which also leads to expectations for billions of dollars to be generated by the drug were not reflected on the stock price, which went south instead of flying north? In addition to the drug’s proven efficacy and fast action, as demonstrated in clinical trials, the drug is convenient to take through a subcutaneous injection given every six months. All six clinical studies have demonstrated Prolia's ability to increase bone mineral density at all skeletal sites measured.

The market for Prolia is expected to be huge. Despite widely available treatments, specialists have always been eager to have new options that can really prevent bone fractures. Prolia might be the answer, as its approach innovative. The drug has a new target, RANK Ligand and has proven to tremendously reduce the risk of fracture in both postmenopausal women and prostate cancer patients who receive hormone ablation treatment. The pivotal three-year FREEDOM (Fracture, REduction, Evaluation of Denosumab in osteoporosis) study in 7,808 women with postmenopausal osteoporosis demonstrated a 68 percent reduction in the relative risk of suffering a new vertebral fracture compared to those receiving placebo. It also demonstrated a 40 percent reduction in the relative risk of suffering a hip fracture and a 20 percent reduction in the relative risk of suffering a non-vertebral fracture at 36 months. 

The some success with Prolia was demonstrated on prostate cancer patients who received hormone treatment ablation.  Results from the pivotal HALT (Hormone Ablation Bone Loss Trial) study in 1,468 men undergoing androgen deprivation therapy (ADT) for non-metastatic prostate cancer showed a 62 percent reduction in the relative risk of suffering a new vertebral fracture with Prolia compared to placebo at 36 months, with significant reduction observed as early as month 12.  

The market for osteoporosis is huge and osteoporosis is a serious disease that can significantly impact the lives of millions of women. Despite widely available treatments, new options that could protect against fractures were lacking.  The European approval was most needed for the patients and for Amgen. The drug is expected to generate billions of dollars and to be approved for more indications, including delaying cancer metastasis in bone.  

Amgen has a collaboration agreement with GlaxoSmithKline for Prolia for the postmenopausal osteoporosis indication in Europe, Australia, New Zealand and Mexico. It will be responsible for commercializing the product for all indications where Amgen lacks marketing presence. The selection of Glaxo as a partner is excellent as per this firm’s strong marketing presence in these areas. The expected approval of Prolia in the U.S. next July 25, 2010 will be tremendous news that promises adding billions of dollars in revenues into Amgen’s coffers. Prohost believes that AMGN is undervalued and has stock in one of its portfolio that comprises top-tier biotech stocks. More...

AMGEN (AMGN): Practicing Predictive Medicine Will Have Tremendous Benefit on Patients Health And On Healthcare Cost

  Monday, April 19, 2010

Practicing personalized medicine, or predictive medicine is no more a dream. It is real and it is performed at the genetic level. The breakthrough capability is made possible through the effective use of next-generation sequencing technologies provided by genomic firms that have constantly upgraded their gene analysis techniques and programs. Currently, millions of DNA sequences can be read simultaneously in a single experiment. What we are witnessing here is a quantum leap beyond the methods used since the sequencing of the first human genomes, i.e., twenty years ago.

The next-generation sequencing technologies enable the differential diagnosis of the same disease, for example colorectal cancer, based on the cancers’ genetic expressions, rather than on their morphologies. This capability enables the selection of effective treatments based on biomarkers analysis. The revolutionary practices will save patients from torture with ineffective drugs on a case by case basis, hence, save millions of dollars in unnecessary spending on experimentation with investigational and marketed drugs on thousands of patients.  

In the news, Amgen (AMGN) was the first to use the new technologies on colorectal cancer to enable using its drug Vectibix (panitumumab) only on colorectal cancers expected to respond to it. A new biomarker analysis of the pivotal Phase 3 "408" trial of Vectibix® plus best supportive care (BSC) compared to BSC alone used massively parallel, next-generation sequencing technology to investigate whether mutations in nine genes in colorectal cancer are predictive of response to Vectibix in metastatic colorectal cancer (mCRC). Highlighted results were presented at the opening press conference at the American Association for Cancer Research (AACR) 101st Annual Meeting 2010 in Washington, D.C.

Tumor samples from 288 patients, which had previously been analyzed for KRAS exon 2 mutations, were analyzed in this study for mutations in nine genes: KRAS (exon 3), NRAS, BRAF, PIK3CA, PTEN, AKT1, EGFR, beta-catenin (CINN1B) and TP53. All nine genes are either direct or indirect components of the EGFR signaling pathway. The study enabled scientists to learn that Vectibix improves progressive-free survival in patients with KRAS wild-type (WT) tumors and had no effect in patients with KRAS mutant tumors. Mutations in NRAS, another member of the RAS gene family, were associated with lack of response to Vectibix. Patients with both KRAS WT and NRAS WT tumors had improved progressive-free survival receiving Vectibix, compared with those receiving BSC. Further investigation in larger studies is required to determine the predictive value of BRAF mutations.

Commenting on the study, Marc Peeters, M.D., Ph.D., Department of Oncology, Antwerp University Hospital and the study's principal investigator said, "To our knowledge, this is the first time next-generation sequencing has been used to analyze tumor samples from a Phase 3 clinical trial and demonstrate how advancing technologies can be quickly applied to ongoing clinical research. The KRAS gene mutation is a well-established biomarker for a lack of response to anti-EGFR treatment and has played a pivotal role in the advancement of personalized medicine. We are excited to be taking another step forward in the advancement of additional biomarkers with the study results presented today. In addition to the excitement of this being among the first times this technology has been used in Phase 3 research, the superior sensitivity of next-generation sequencing revealed unexpected genotypic complexity in many patient tumors,”

It is known now that one hundred nine tumors have more than one mutant gene, and 20 had more than one mutation in a single gene. 

Results from studies performed over the last twenty-five years indicate that KRAS plays an important role in cell growth regulation. In mCRC, EGFR transmits signals through a set of intracellular proteins. Upon reaching the nucleus, these signals instruct the cancer cell to reproduce and metastasize, leading to cancer progression.  Anti-EGFR antibody therapies work by blocking the activation of EGFR, thereby inhibiting downstream events that lead to malignant signaling. However, it is hypothesized that in patients whose tumors harbor a mutated KRAS gene, the KRAS protein is always turned "on," regardless of whether the EGFR has been activated or therapeutically inhibited. KRAS mutations occur in approximately 40 – 50 percent of mCRC patients.

You know what this means? It means that we are giving treatments that inactivate EGFR to  patients who do not benefit from them. These patients amount to half of the cancer inflicted patients. Avoiding this practice promises less pain and torture for those patients and less money spent on futile treatments. In addition, other effective treatments could be pinpointed for those patients.

Again, we remind, the heroes’ behind this huge advancement in addition to Amgen, are the genomic firms. These firms are the backbone of the biotechnology and drug industries. Without them, no revolution in medical sciences can take place. Most of the genomic firms are scientifically sound and are evolving their technologies and kits and moving from research purposes to revolutionizing the medical practices from the diagnosis of diseases, to differential diagnosis of different types of the same diseases. Their sequencing and analysis capabilities  are making possible pinpointing effective therapeutics for each subtype of diseases.

We are no more knocking at the door. Trust us, we are already in.

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