Eli Lilly: Developing Cymbalta

Eli Lilly and comp each is a pharmaceutic company that was naturalized in 1876 by Colonel Eli Lilly, who had served in the union army during the Civil War. atomic number 53 of the fruits the company developed includes the antidepressant drug Prozac, which has been a legendary product for the company and has generated one thousand millions of dollars since its launch. As Prozacs homely expiration period approached, in that locationby all(prenominal)owing the sale of generic versions in the U. S. , the company decided to absorb a product to replace Prozac, named Cymbalta.John Kaiser, the merchandiseing director at Eli Lilly and member of a cross-functional R&D police squad, new anti-depressant team (NAT), has been tasked to broaden this effort. Kaiser prepared a presentation about the potency successor, Cymbalta, and convened a conflux with the NAT members to discourse its future potential. The goal of the beting was to thoroughly analyze and discuss the pros and cons about Cymbaltas development and strategic opportunities based on the diverse woofs of use. This idea will identify the strategic issues and problems the NAT faced in create the new product.The paper will then analyze and evaluate the industry and market behavior by using a SWOT analysis. Finally, this paper will offer a set of recommendations based on the skirt circumstances and options available to the Eli Lilly team. Identification of the strategic issues and problems Eli Lilly and companys NAT members began the adjoin of searching for a successful replacement to Prozac by flavor into the strategic choices, possibilities, and successful launch of a replacement shortly later on the expiration of Prozacs patent.Cymbalta was considered as a viable successor to Prozac because it seemed a) to be as good as or fall in than existing antidepressants, b) to show no signs of safety precautions or toxicity issues, c) to meet previous unmet patient needs, and d) to show promising s igns of development as a product to likewise treat aggravator, e excessly if it did not cause special side effects. However, when Lilly developed Cymbalta back in the early 1990s, for the major depressive turnoer (MDD) market, the product failed to show satisfactory levels of might for treating MDD in phase 2 trials in 1993.Additionally, Lilly had so little experience in the therapeutic area. Moreover, there were variances in the opinions of Neurologists and Psychiatrists related to the symptoms of paroxysm, much(prenominal) as chronic back pain or recurring headache tied to depression. Those variances could peril the decision qualification process from the top management. Also, since there were no clear guidelines from the Food and dose Administration (FDA), for the development of pain indications associated to depression, the likelihood of FDA approval was very slim.Kaiser and the team in addition encountered several constraints. The team had to decide how to prioritize t he clinical trials for Cymbalta deep down the range of $25 to $50 million and a time flesh of 15 to 18 months to design, enroll patients for trial, and then analyze and document results for the clinical trial. Each study was a major task for the NAT members and the team had the fortune to submit only one objective to the FDA for marketing approval.On the otherwise hand, since Cymbalta had been tested with twice daily sexually transmitted diseases of 20 mg, 30 mg, and 40 mg, NAT members in like manner looked into the option of conducting a new set of clinical trials to establish once-a-day dosage of 60 mg of Cymbalta to treat Major Depressive Disorder (MDD). The new option would provide much expedient dosing for patients and would also put the product on par with the major competitors. Analysis and Evaluation The U. S. pharmaceutic industry is composite and dynamic.Its an industry that is characterized by high-tech research and development (R&D) expenditures and broad regula tion of its products, especially in comparison with other manufacturing sectors. The U. S. Food and do drugs Administration (FDA) oversee policies that produce faster review and approval quantify for drugs. The agency carefully evaluates the safety of any new drug and its efficacy. much(prenominal)(prenominal) policies result in extended periods during which companies prat unsharedly market their pharmaceutical products.Longer periods of market exclusivity for pharmaceuticals then increase gross revenue revenues, and increased sales revenues in turn lead to largeer profits and potentially more funding for R&D. Treatment of depression is one area that the U. S. pharmaceutical industry has heavily invested in. The total sales of U. S. antidepressants reached close to $9 billion in the year 2000. Companies such as Eli Lilly capitalized on this opportunity and became a leading force in the antidepressant market with its Prozac drug. antidepressant drug product development companies invest heavily in Research and breeding (R&D), and patent it.With each successful launch of a product, they enjoy its patent rights for quite a long period of time and enjoy the exclusive rights to produce and sell that product resulting in enormous profits for the company. Thus, drug companies continuously attempt to differentiate their product from competitors and bundle in such a way that is more tailored to segment of the market where they can realize higher profits. SWOT Analysis Strengths Potential successor to a highly successful brand Prozac from a well-established company in the pharmaceutical industry. Part of the selective serotonin reuptake inhibitors (selective-serotonin reuptake inhibitor) group of drugs, which is democratic and had fewer side effects than tricyclic anti-depressant (TCA) and monoamine oxidase inhibitors (MAOI). Potential to treat some(prenominal) depression and chronic pain, such as headache and backache caused by depression. Weaknesses intersecti on point that is not different from competitors brands. Twice-a-day dosing regimen of 20-40 mg.Threats Serious market competition from competitors brands such as Paxils and Zoloft with same efficacy. No clear concession amongst physicians as to the nature of link between depression and pain. Attempting to compare Cymbalta to existing SSRI on pain might fail to conclusively separate from competitors, hence giving rival drugs an implicit endorsement for treating pain. Opportunities Potential development of 60 mg once-a-day dosage with high efficacy. The possibility of pursuing patients with fibromyalgia (severe muscle pain and chronic fatigue) and Diabetic peripheral neuropathic pain or DPNP (a painful and weaken complication of diabetes).According to the National Studies of Health, over 40 million Americans were futile to find relief from their pain, including patients with fibromyalgia and DPNP. Pros and Cons of Plausible Alternatives If developed successfully, Cymbalta could be a rummy product that has the ability to significantly reduce and improve depression and pain. Patients with fibromyalgia and DPNP could greatly benefit from Cymbalta. The pain relief may also be great for patients who suffer from depression and chronic pain like headache and backache.The NATs idea of pursuing the 60 mg daily dosage is also attractive if it delivers the same efficacy of current antidepressant drugs in the market. However, all of this comes with its perils. The company has to evaluate the risks and any potential side effects that the 60 mg per day dosage may lead on patients. They also have to assess the feasibility of conducting a clinical trial with a 15 to 18 months timeframe and a projected cost of $25 to $50 million. Additionally, they would have to convince the FDA that the new product is ready to market.Failure of any of the aforementioned obstacles could result in loss of the antidepressant market to competitors. Recommendations stamp and chronic pain disea ses, such as fibromyalgia and DPNP, have a gravid effect in society at large. Studies in scientific publications have estimated that depression affects 10% to 25% of the population. The antidepressant market in the U. S. in 2000 totaled sales of approximately $9 billion. Eli Lilly has positioned itself well in this market segment. The company has enjoyed a market lead with annual sales of over $2 billion with its antidepressant drug, Prozac.Cymbalta needs to focus on maintaining and increase that $2 billion dollar revenue Prozac has achieved over the olden years, by building on the successful foundations Prozac has already established. It is alpha to develop an updated product that will undoubtedly outperform its competitors. Cymbalta might be a successful replacement because of its good efficacy or efficacy better than existing antidepressants, Cymbalta also has no apparent safety or toxicity issues, and its possibilities of meeting a previously unmet patient needs, exemplifies why Cymbalta has the potential to total higher record sales than even Prozac.