Learn how to ensure that your health plan – NOT your PBM – benefits from your employees’ generic drug use. This video will explain a) how numerous PBMs are retaining a large portion of the financial benefits resulting from generic drug use; b) how most PBMs manipulate their contracts with clients to do so; and c) what your health plan must do to ensure it obtains 100% of generic drug savings. Save your corporation or union or govt health plan large sums of money by following the basic steps outlined in this video. Our consulting firm has saved our clients millions of dollars in the past year alone using the strategies described. Presenter: Linda Cahn, Esq., President of Pharmacy Benefit Consultants
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Do you use generic drugs? Are they safe? Can they save you money? Tim Colligan, Director of Pharmacy at Optima Health, shares his insights into the value of using generic drugs.

The truth behind Generic Drugs.

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Welcome to Generic Biotech Drugs. A generic biotech drug is a drug which is produced and distributed without patent protection. The generic biotech drug may still have a patent on the formulation but not on the active ingredient. A generic must contain the same active ingredients as the original formulation.

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By extension, therefore, generics are considered (by the FDA) identical in dose, strength, route of administration, safety, efficacy, and intended use. The FDA’s use of the word identical is very much a legal interpretation, and is not literal. In most cases, generic products are available once the patent protections afforded to the original developer have expired.

When generic products become available, the market competition often leads to substantially lower prices for both the original brand name product and the generic forms. The time it takes a generic drug to appear on the market varies. In the US, drug patents give twenty years of protection, but they are applied for before clinical trials begin, so the effective life of a drug patent tends to be between seven and twelve years.

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July has been a good month for biotech investors. Share prices in the biotech sector as measured by the NYSE Biotechnology Index are up 24% compared to the 6.6% gain for the S&P 500. Earlier in the month, Amgen (AMGN) reported better-than-expected results from a trial of its experimental bone-protecting drug denosumab in patients with advanced breast cancer. Amgen’s shares vaulted 16% on the news.

In the week just ended, the momentum in biotech shares has continued further. While a host of favorable clinical trial results was the bigger driver, a large buyout announcement added the icing to the cake.

Clinical Trial Results

Bringing back memories of the dotcom era, shares of Human Genome Sciences (HGSI) rose nearly 300% to .50 a share after the company reported favorable results for its experimental lupus drug Benlysta. Targacept (TRGT) shares more than doubled to .25 a share after its depression drug candidate met its goals in a mid-stage trial. Onyx Pharmaceutical (ONXX) reported encouraging results for its breast cancer treatment Nexavar to push its shares higher by 21%. Shares of Celgene (CELG) jumped nearly 16% after the company announced significant improvement in progression-free survival of patients taking Revlimid as a first-line treatment for multiple myeloma.

Buyout

Continuing the trend of major pharma-biotech mergers, as in Roche (RHHBY.PK)-Genentech, and Eli Lilly (LLY)-ImClone, Bristol-Myers Squibb (BMY) announced it is buying Medarax (MEDX) for a share. The Medarex takeover implies a net price tag of over billion. Medarax shares jumped nearly 90% on the announcement.

Is it too Late to Board the Biotech Bandwagon?

Given strong gains in biotech shares in recent weeks, it is logical to ask if it is too late to get on the biotech bandwagon. I believe the answer, generally speaking, is no. Notwithstanding uncertainties surrounding health care reform, the fundamentals for biotech companies are reasonably favorable. Yet, one needs to take appropriate care in getting the timing right and in choosing proper investment vehicles.

Fundamentals

Several factors favor the long-term growth of biotech companies. These include an aging population, rising incidence of cancer and other degenerative diseases, and growing recognition that biotech products offer the best solutions for management of these diseases.

Several biotech drugs like Roche’s Avastin and Amgen’s Enbrel have the potential of becoming major blockbuster drugs by 2014. Biotech companies are seeking to expand uses of their approved drugs to treat more diseases. And, unlike drugs made by major pharmaceutical companies, biotech drugs

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Valuation of a start-up life science company that offers little more than the promise of success in the future can be very difficult. Stellar results in the basic research laboratory rarely directly result in a cure of disease.  Considering biotech, the drug development process requires many years to determine whether all the effort will translate into monetary returns for a company. Although valuation of the start-up may appear to be more guesswork than proven algorithm, the investment community has a generally accepted approach to valuing biotech companies that are years away from product approval. The generally accepted approach to valuation relies on discounted cash flow (DCF) analysis, which I will explain below.

Valuation of Portfolio
Biotech companies are often valued as a collection of one or more experimental drugs, each drug representing a potential market opportunity. The idea is to treat each promising drug independently within a portfolio. Using DCF analysis of all the promising drugs in the portfolio, one can determine the value of a company.

That is, using DCF one determines the forecasted free cash flow of each drug to establish each drug’s present value. Then the net present value of each drug, along with any cash assets, are added to determine the net value of the company.

Start-up biotech companies often have several drugs in their developmental pipeline. Not all drugs should be included in the valuation. In general, only those drugs in phase I, II, or III are included for valuation. A drug candidate that is in the discovery or non-clinical stage is not a good bet, with less than a 1% chance of reaching the market. Therefore drugs in the non-clinical stage are usually assigned zero value by professional investors.

Sales Revenue Forecasting
The most difficult and most important estimate needed in valuation is that of the sales forecast. Here a determination of expected peak sales is estimated based on the assumption that the drug candidate successfully progresses through clinical trials to FDA approval. The forecast of sales is typically for the first 10 years of the drug’s life.

To forecast sales, start by making assumptions about the drug’s market potential. Use information provided by market research reports to determine the size of the patient group that will use the drug for a given indication. Data are utilized only for those markets were patients will pay market price for the drugs, usually those markets in industrialized countries.

 
To determine a drug’s potential market penetration one must consider many factors. If the candidate is entering a competitive drug market, with limited advantage offered by the candidate drug in terms of

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Building Biotech Technology Transfer Opportunities: Sponsor and developer strategies for success

Drug developers have long been under pressure to introduce new products in an environment of escalating R&D costs, blockbuster patent expiration and resulting generic competition. Current weak economic conditions have exacerbated these challenges with sweeping R&D staff and budget reductions. In order to remain competitive, drug makers must now do more with less. Technology transfer, particularly of new biotechnologies that offer novel means to address unmet medical needs, offer a way to cost effectively address these challenges. They also provide technology developers with a mechanism to monetize their inventions.

However, while some drug makers and technology developers have optimized their biotech tech transfer methodologies and have developed sophisticated processes to select, monitor and manage a wide range of relationships, many other biotech tech transfer projects fail. A large proportion of these failures could be averted as many of the most common reasons for failure are preventable problems relating to due diligence failures, shortcomings in deal structure, management changes, cultural challenges, and inappropriate project organization and expectations. This report provides details on how to avoid these common pitfalls with case studies that illustrate best practices.

Key features of this report

• Discussion of the factors leading to current imperatives to increased biotech tech transfer.
• Detailed descriptions of both effective and ineffective biotech tech transfer approaches.
• In depth analysis of the types of different biotech tech transfer relationships, their advantages and disadvantages.
• More than 10 case studies that illustrate biotech tech transfer best practices.
• Comprehensive discussion of offshore biotech tech transfer, particularly focusing on India and China.

Scope of this report

• Understand the driving forces behind biotech tech transfer.
• Save time and money with the report’s succinct compilation and analysis of current biotech tech transfer trends.
• Learn how biotech tech transfer will evolve over the next several years and why.
• Assess your competitive position vis-à-vis other technology sponsors or technology developers and learn about biotech tech transfer best practices via detailed case studies.
• Understand the reasons behind biotech tech transfer success and failure.
• Develop strategies to optimize your biotech tech transfer methodologies and protocols.

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According to the Kaiser Family Foundation, retail prescription prices increased from an average of .67 in 1994 to .26 in 2006. That’s almost triple the annual inflation rate. For many people, an increase in prices means an increased use of generic medications. icyou’s Rebecca Fox helps answer questions about the differences between the options. For more health related videos, please visit www.icyou.com
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Dr. Krobot talks about the tests generic drugs must pass to be approved by the FDA. www.unmc.edu/askunmc

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Comediennes such as Gilda Radner and Madeline Kahn, Oscar-winning actresses like Loretta Young and Sandy Dennis, singers Laura Nyro and Dinah Shore, actor Pierce Brosnan’s wife Cassandra Harris, actress Jessica Tandy, former Connecticut governor Ella Grasso, and Martin Luther King’s wife Coretta Scott King all died of ovarian cancer. It’s not just celebrities, politicians or movie stars, who are stricken with ovarian cancer. One in every 55 U.S. women is at risk for ovarian cancer. The American Cancer Society estimates about 22,000 new cases of ovarian cancer will be diagnosed. More than 16,000 women will die because the symptoms are often subtle, and her doctor did not recognize the symptoms soon enough. It is the leading cause of death from gynecologic malignancies, and the fifth leading cause of cancer deaths among women.
 
Silent and undetected, this cancer often spreads beyond the ovary or ovaries into the abdominal cavity, or by the final stage, into other body organs such as the liver or lungs. Family doctors often fail to properly diagnose “The Silent Killer” until it is too late. Last August, University of California Davis researchers reported 40 percent of women told their doctors about their symptoms for as long as a year before they were correctly diagnosed. A British survey discovered 75 percent of family doctors believed symptoms are only present during the advanced stages of the cancer. By the time women are diagnosed for ovarian cancer, 40 to 50 percent of the patients are in the advanced stage, where there is little hope for survival.

Less than one-half the women diagnosed with ovarian cancer will live five years. About 10 to 14 percent live beyond five years after their diagnosis. Their choices have been limited, mainly reserved to variations of chemotherapy drugs or a new way to delivery the drug. The general public is often unaware of the side effects ovarian cancer patients suffer during chemotherapy. In mid March, the U.S. Food and Drug Administration criticized the safety profile of Eli Lilly’s Gemzar for ovarian cancer patients, saying the 2.8 months increased survival seen in studies of patients taking the drug wasn’t enough to offset the treatment’s increased toxicity which included anemia, neutropenia (a blood disorder) and thrombocytopenia (reduced platelets in the blood). Presently used first-line treatments for ovarian cancer patients include Cisplatin, with associated side effects such as nerve, kidney and/or ear damage, Carboplatin (side effects: nerve damage in the arms and/or legs, joint pain, and/or thrombocytopenia), Paclitaxel (neurotoxicity), or Melphalan, with side effects which include irreversible bone marrow failure, bone marrow suppression).
 
A woman stricken with ovarian cancer faces first surgery, then chemotherapy. Recent widespread press heralding a new development in treating ovarian cancer, intra-abdominal or intraperitoneal

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