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13 Amgen.

It is hard to say the word biotechnology without thinking of Amgen, the iconic California company which started up in 1980 and, using roller bottle technology, commercialized the first recombinant product, Epogen, for anemia treatment, nine years later.

The company recently hired a new CFO, David Meline, formerly with 3M, and has been strengthening its cancer drug pipeline, acquiring Onyx Pharma last October, investing $9.7 billion, to help it in this area.

Most recently, Amgen has had some significant breakthroughs in cancer immunotherapy. Some of them were discussed at the 50th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago. An example is talimogene laherparepvec, a treatment for metastatic melanoma that has been found to be potentially useful both as a single treatment and as part of a combination therapy.

In early Phase lb combination studies with ipilimumab, talimogene led to tumor shrinkage or removal in 56% of patients administered the drug.

"We are entering an era where new melanoma therapies are advancing clinical care for patients in ways not previously seen," said Sean E. Harper, M.D., Amgen's executive vice president of Research and Development. "Talimogene laherparepvec has demonstrated the ability to produce durable and complete responses in patients with metastatic melanoma, which provides a strong basis for a filing later this year and potential approval as a novel treatment."

Among patients who saw an overall response in Phase III studies, 40% showed complete response (i.e. no evidence of disease) after treatment, and, the company reported, among those who responded positively to the drug, there was a 65% probability of those responses lasting for at least a year. In Phase III trials of the drug, used alone, those who responded showed a 4.4-month improvement in overall survival.

"Novel investigational therapies are creating exciting momentum in melanoma research and our challenge is to better understand how to most appropriately develop these therapies," said Igor Puzanov, M.D., associate professor of Medicine at Vanderbilt-Ingram Cancer Center and lead author on the Phase lb combination study. "These latest findings support the potential of talimogene laherparepvec as a single agent and provide a strong rationale for further investigation as a combination therapy in a broad range of appropriate patients."

At ASCO, Amgen also presented results from Phase II tests that reinforced the improved overall survival benefit of panitumumab (Vectibix) when used in combination with FOLFOX, an oxaliplatin-based chemotherapy regimen, compared to bevacizumab (Avastin) plus FOLFOX as first-line treatment in patients with wild-type RAS metastatic colorectal cancer (mCRC).

Patients who received panitumumab plus FOLFOX and were then treated with aVEGF inhibitor-based treatment (including bevacizumab) had a median OS improvement of 41.3 months. By comparison, those who were given bevacizumab plus FOLFOX and were then treated with an anti-EGFR inhibitor-based treatment (including panitumumab/cetuximab), had a median OS improvement of 29.0 months.

Recently, FDA granted Breakthrough Therapy Designation to Amgen's investigational bispecific T cell engager (BiTE) antibody blinatumomab, for adults with Philadelphia-negative (Ph-) relapsed/refractory B-precursor acute lymphoblastic leukemia (ALL), a rapidly progressing cancer of the blood and bone marrow.

The Breakthrough Therapy Designation was based on the results of a Phase II trial of 189 adult patients with Ph-relapsed/ refractory B-precursor ALL treated with blinatumomab. Data from the Phase II trial were most recently presented at the 50th Annual Meeting of the American Society of Clinical Oncology (ASCO) and the 19th Congress of the European Hematology Association (EHA).

USING BIOMARKERS TO FIGHT LUNG CANCER

Amgen will collaborate with the National Cancer Institute (NCI), part of the National Institutes of Health, and other public and private sector partners on the Lung Master Protocol (Lung-MAP), a new clinical trial program that will use biomarker-driven research and genomic profiling to match squamous cell lung cancer patients to investigational treatments based on their individual cancer profiles. Lung-MAP is the first trial of its kind to study a large number of rare lung cancer subsets under one trial protocol.

Approximately 500 to 1,000 patients will be screened each year for more than 200 cancer-related genes, and the screenings will inform trial arm selection. Five investigational drugs have been selected for inclusion in the initial trial, including Amgen's rilotumumab.

13 AMGEN

Headquarters: Thousand Oaks, CA twitter.com/Amgen www.amgen.com
13 AMGEN

Headquarters: Thousand Oaks, CA
twitter.com/Amgen
www.amgen.com

HEADCOUNT:                   20,000
YEAR ESTABLISHED:              1980
PHARMA REVENUES:            $18,676                8%
NET INCOME:                  $5,081               17%
R&D BUDGET:                  $4,083               24%

DRUGS APPROVED

DRUG                        INDICATION

Xgeva                       giant cell bone tumor
  (Denosumab)

DRUGS IN PHASE MB AND BEYOND

DRUG                        INDICATION

Aranesp                     myelodysplastic syndromes
Bliatumomab                 acute lymphoblastic leukemia
Brodalumab                  psoriasis
Evolocumab                  dyslipidemia
Kyprolis                    multiple myeloma
Orikua                      male osteoporosis (EU only),
                            glucortlcoid-induced osteoporosis
Rilotumumab                 gastric cancer
Romosozumab                 post-menopausal osteoporosis
Sensipar/                   post renal transplant
  Mimpara
Talimogene                  melanoma
  Laher-parepvec
Trebananib                  ovarian cancer
Vectibix                    metastatic colorectal cancer (US only)
Velcalcetide                secondary hyperparathyroidism in patients
                            with CKD receiving dialysis
XGEVA                       delay or prevention of bone metastases in
                            breast cancer

EARLY RESEARCH PROJECTS

DRUG                        INDICATION

AMG 139                     inflammatory diseases
AMG 181                     inflammatory bowel diseases
AMB 334                     migraine
AMG 110                     various cancers
AMG 157                     asthma
AMG 172                     various cancers
AMG 208                     various cancers
AMG 232                     various cancers
AMG 282                     asthma

DRUGS COMING OFF PATENT

DRUG                        INDICATION

Neupogen (Enbrel)           psoriasis

TOP SELLING DRUGS

DRUG                        INDICATION         2013 SALES    (%)

Neupogen                    neutropenia          $5,790        3%
Enbrel                      psoriasis            $4,551        7%
Aranesp                     anemia               $1,911       -6%
Epogen                      liver disease        $1,953        1%
Xgeva                       bone cancer          $1,019       36%
Prolia                      osteoporosis           $744       58%
Sensipar/ Mimpara           kidney disease       $1,089       15%
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Title Annotation:TOP 25 PHARMA
Publication:Contract Pharma
Geographic Code:1U9CA
Date:Jul 1, 2014
Words:918
Previous Article:12 AbbVie.
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