Essay about Abgenix Case Analysis

Due to these incidents and many severe cases of drug side effects that had happened in the past including deaths, the current way drugs are developed and approved are unethical. Therefore, reform in FDA’s management as well as the guidelines is necessary to strengthen safety standards and eliminate problems regarding drug development and regulation.

is American industry at too much risk of lawsuits to remain competitive? Should companies trying to develop drugs be given immunity from lawsuits?

There are multiple health concerns worldwide and more and more drugs are needed every day. Many drugs however, are extremely expensive to develop, test, and produce. According to the Tufts Center for the Study of Drug Development (2002), it costs up to $802 million to bring a new drug to the market. In 2002, pharmaceutical companies spent $34 billion in research and development (Center-Watch, 2003). In addition to the costs, the overall time from the discovery to approve and market the drug can take up to 15 years.

Comparing these potential market size, we can easily observe that Oxyglobin is roughly two times as profitable as Hemopure. Accordingly, Biopure should take these data into account to evaluate whether or not to launch Oxyglobin immediately. On the other hand, this revenue expectation is not so realistic. In fact, it is almost impossible that the company will capture the whole potential markets because of its small production capacity. This latter represents the main obstacle to a potential success of Biopure in both animal and human

Pharmaceutical companies are provided with temporary monopoly rights on the production of new drugs which result in a higher cost on consumers. If competing companies were allowed to produce generic forms of those drugs, consumers will be able to afford those medications even in cases where those consumers have no insurance coverage. The company responsible for developing and inventing the original medication could be offered incentives to invent in the future by either obtaining tax breaks or NIH funding for future research. They could even be offered a percentage of the sales of the generic drugs. Economist Gary S. Becker advocates dropping many FDA requirements that, in his opinion, provide no additional safety measures but rather delay the development of new drugs.[12] Betamethasone, for example, has been part of the standard prenatal care in Europe since the late 1970’s while it got adopted in the U.S. after 1997. On many occasions, the FDA ignores all scientific evidence concerning certain drugs because the manufacturer did not follow their mandated bureaucratic standards.

The ALPES S.A. case deals with Charles River Laboratories (CRL) and their consideration of a joint venture proposal with an animal vaccine company in Mexico. The senior V.P. is preparing to present the proposal of a $2 million investment for the firm. The CEO, Jim Foster, is concerned with the associated risks that CRL would be undertaking if they accept this venture.  Key issues of concern are; the partnership with a relatively small, family run business; having operations in Mexico, which could pose difficulties; maintaining CRL’s focus on U.S. expansion; and the proposed partner’s lack of funds to invest, which will leave CRL  to  bear the entire cost of the venture.

The agreement states Pharmagen will receive up to $500 million funding for R&D costs as they are incurred solely for the research efforts of a potential new drug “X”

Extremely risky drug discovery and development, lengthening development times which increase development cost, return on investments, and generic competitors.

The high prices set by pharmaceutical companies for drugs allows the companies to continue researching, developing, and producing new drugs. As new diseases are discovered, new medications must be discovered in order to treat them.

1. Cost: The drug development is a lengthy and an expensive process. It will aid in the predevelopment process to identify future demand and to identify if it is a worthwhile venture. The future of a company could depend on the success or failure of a new drug in the market.

Step 1: How will you identify the “vital” cellular protein that the virus targets for degradation? (Hint: think proteomics). (3 pts.)

seeking approval for Antegren, a drug that Biogen Idec was developing in partnership with Elan to

NeoMed Technologies should’ve considered applying their initial product development to the technology of screening for drugs, drug delivery applications or detecting cancer. These areas would’ve possibly allowed for a quick to market product, without the additional approvals, quality standards applied in the medical equipment space, and FDA approvals needed. Bringing a simpler product to market first could’ve brought in revenue to fund the long-term product focus of a CAD screen system. The profits from a drug screening or drug delivery product could’ve assisted in funding their long-term product focus, they missed an opportunity to develop a quick revenue steam.

The strategic implications for Vertex attempting to fund and develop four drugs are as following:

One factor that must be considered is that the drug had not yet been approved by the FDA, but was in phase III trials. Historical data shows that 65% of drugs in this phase eventually get approved for sale to the market. It was felt that approval of the drug would occur late in 1998.