Masterpiece of nano-gold

The test

Russian technique...

Patent cliff, Life ycle management and formulation strategies

Very useful article: http://www.pharmtech.com/pharmtech/Formulation/Can-Pharma-Defy-Gravity-at-the-Patent-Cliff/ArticleStandard/Article/detail/828013

 

 

 

Generic-drug competition has become increasingly aggressive, especially in an environment where healthcare policies are placing stronger emphasis on pharmacoeconomics and demanding better treatment outcomes at a lower cost. A 2012 analysis by IMS Health estimated that patent expiries will reduce brand spending in developed markets by $127 billion through 2016 (1). With drug-development expenditures escalating at an alarming rate while R&D productivity continues to decline, branded drug-makers are under pressure to maximize the value of their products throughout their lifecycles.

 

Strategies:

 

Modified-release formulations

Switch-and-grow formulations

Expand-and-grow formulations

Combination Products

 

Skolkovo innovations. Yes, we can!

Eroom's Law works in 2013 too!

What is Erooms Law? More info is here.

 

Drug approvals this year are about quality more than quantity. It looks like the year could end with 34 drugs and biologics approved, down significantly from the record 43 last year. Fewer, yes, but this year will have turned out a new crop of blockbusters whose combined revenues 5 years out are forecast to reach $18.7 billion, besting last year's record of $16.4 billion in projected sales.

 

This will be the result of the industry moving away from me-too drugs and putting its efforts behind drugs for hard-to-treat and specialist diseases, according to a report released today by EP Vantage, the editorial group of EvalutePharma. A good example is Biogen Idec's ($BIIB) multiple sclerosis drug Tecfidera. The projected blockbuster has already blasted past analysts' forecasts in each of three quarters this year and is expected to reach sales of $2.9 billion in 2018, EP Vantage says.
 

 

The FDA has approved 27 drugs through Nov. 11. Those 27 alone are projected to have combined sales of $13.9 billion. The $18.7 billion total assumes the 7 still awaiting approval this year get FDA support. The setback earlier this year for Novo Nordisk's ($NVO) diabetes drug Tresiba is a good reminder that expected approvals don't always materialize. The number also assumes approval of Gilead Sciences' ($GILD) sofosbuvir, the highly anticipated drug which would be part of an interferon-free, all-oral hep C regimen. Based on analysts' 5-year sales projections, it would be the most valuable drug approved in 2013, with sales expected to hit nearly $3 billion in 2018, edging out Tecfidera. That means sofosbuvir would make up 16% of the total for the class of 2013.

Targeted failure of the week. Post No 124. EPZ-5676

          

Epizyme Inc. (NASDAQ:EPZM) fell $11.77 (37%) to $19.94 on Thursday after reporting data from 16 patients in the first four cohorts of an open-label Phase I trial of EPZ-5676 to treat adults with heavily pre-treated advanced hematological malignancies -- the first human data from the company. Epizyme said treatment effects "consistent with the genetically defined therapeutic mechanism of action" of EPZ-5676 were observed in four of eight acute leukemia patients with a rearrangement of the myeloid-lymphoid or mixed-lineage leukemia (MLL; HRX) gene. No treatment effects were observed in patients without MLL rearrangement. The maximum tolerated dose has not yet been reached.

 

Analysts said the data are too early and patient number too small to draw conclusions, but they expressed concern about EPZ-5676's lack of effect in the four of the eight patients with the MLL rearrangement. Analysts also said the "dose and regimen are far from optimized." One analyst also attributed the selloff to Epizyme being overvalued prior to the data release; the company raised $88.7 million through the sale of shares at $15 in an IPO in 1H13. Before Thursday's slide, Epizyme was valued at $901.2 million.

Desacralization of reality. The masterpiece of Dugin

http://www.evrazia.tv/content/fascinaciya-realnostyu-vremya-vverh-lekciya-4

 

Targeted failure of the week. Post No 123. Lemtrada

Sanofi (SAN)’s Lemtrada hasn’t proven to help against disability in the treatment of relapsing multiple sclerosis, said U.S. advisers who questioned whether the company’s studies were conducted well enough to assess the drug.

 

While the U.S. Food and Drug Administration advisory panel decided that potential safety risks don’t preclude approval of Lemtrada, its members voted 14-2 that the drug didn’t help improve a patient’s disability. The agency isn’t required to accept the recommendations of its advisers.

Lemtrada, approved in Europe earlier this year, was a key part of Paris-based Sanofi’s $20 billion acquisition of Genzyme Corp. in 2011. The drug if cleared in the U.S. would enter a crowded field in which relapsing MS patients now have 10 treatment options with varying degrees of efficacy, including Biogen Idec Inc. (BIIB)’s Tecfidera and Teva Pharmaceutical Industries Ltd. (TEVA)’s Copaxone.

 

“If the study is biased, then everything that flows from the study can’t be trusted,” Robert Clancy, a panel member and professor of neurology and pediatrics at the University of Pennsylvania School of Medicine, said at yesterday’s meeting. The panel voted 11-6, with one abstention, that the two large studies Sanofi submitted on the drug’s behalf weren’t adequate and well-controlled.

 

Alemtuzumab (marketed as Campath, MabCampath or Campath-1H and currently under further development as Lemtrada) is a monoclonal antibody used in the treatment of chronic lymphocytic leukemia (CLL), cutaneous T-cell lymphoma (CTCL) and T-cell lymphoma. It is also used in some conditioning regimens for bone marrow transplantation, kidney transplantation and Islet cell transplantation.

 

Alemtuzumab binds to CD52, a protein present on the surface of mature lymphocytes, but not on the stem cells from which these lymphocytes are derived. After treatment with alemtuzumab, these CD52-bearing lymphocytes are targeted for destruction.

Bad karma?