Eli Lilly: Developing Cymbalta

Eli Lilly and gild is a pharmaceutic corporation that was established in 1876 by Colonel Eli Lilly, who had served in the union army during the civilian War. One of the crossways the company developed includes the antidepressant drug drug drug drug drug fluoxetine hydrocholoride, which has been a legendary point of intersection for the company and has generated billions of dollars since its lance. As fluoxetine hydrocholorides patent expiration date approached, thereby every(prenominal)owing the sale of generic versions in the U. S. , the company decided to pursue a intersection point to replace fluoxetine hydrocholoride, named Cymbalta.John Kaiser, the foodstuffing theater director at Eli Lilly and member of a cross-functional R&D team, new anti-depressant team (NAT), has been taxed to crest this effort. Kaiser prepared a presentation around the voltage successor, Cymbalta, and convened a meeting with the NAT members to handle its future potential. The goal of the me eting was to wholesome analyze and discuss the pros and cons about Cymbaltas reading and strategic opportunities based on the un resembling options of use. This paper will constitute the strategic issues and problems the NAT faced in maturation the new crossway.The paper will whence analyze and evaluate the industry and market behavior by using a SWOT analysis. Finally, this paper will offer up a limit of recommendations based on the surrounding circumstances and options available to the Eli Lilly team. appellative of the strategic issues and problems Eli Lilly and companys NAT members began the work of searching for a favored heir to Prozac by looking into the strategic choices, possibilities, and successful launch of a electrical switch shortly after the expiration of Prozacs patent.Cymbalta was considered as a possible successor to Prozac be face it seemed a) to be as good as or break away than existing antidepressants, b) to show no signs of gum elastic precauti ons or toxicity issues, c) to meet former unmet enduring needs, and d) to show promising signs of knowledge as a produce to similarly treat distract, especially if it did not cause special side effects. However, when Lilly developed Cymbalta butt in the early 1990s, for the major depressive perturbation (MDD) market, the product failed to show satisfactory levels of qualification for treating MDD in phase 2 runnels in 1993.Additionally, Lilly had so little experience in the therapeutic area. Moreover, there were variances in the opinions of Neurologists and Psychiatrists tie in to the symptoms of infliction, such(prenominal) as chronic cover bruise or recurring trouble tied to opinion. Those variances could peril the decision make process from the top management. Also, since there were no clear guidelines from the Food and Drug memorial tablet (FDA), for the development of pain indications associated to depressive disorder, the likelihood of FDA panegyric was very slim.Kaiser and the team in any case encountered some(prenominal) constraints. The team had to decide how to prioritize the clinical trials for Cymbalta within the range of $25 to $50 million and a snip sick of 15 to 18 months to design, enroll patients for trial, and then(prenominal) analyze and document results for the clinical trial. from each one study was a major task for the NAT members and the team had the opportunity to submit altogether one objective to the FDA for marketing compliment.On the another(prenominal) hand, since Cymbalta had been tested with twice free-and-easy social diseases of 20 mg, 30 mg, and 40 mg, NAT members also 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 deflect (MDD). The new option would provide to a greater extent expedient dosing for patients and would also put the product on par with the major competitors. compendium and Evaluation The U. S. pharmaceutical industry is labyrinthian and dynamic.Its an industry that is characterized by hi-tech research and development (R&D) expenditures and extensive ordination of its products, especially in comparison with other manufacturing sectors. The U. S. Food and Drug Administration (FDA) administrate policies that produce faster review and approval times for drugs. The agency carefully evaluates the guard of any new drug and its dexterity. much(prenominal) policies result in extended periods during which companies set up exclusively market their pharmaceutical products. agelong periods of market exclusivity for pharmaceuticals then increase gross gross revenue enhancement revenues, and increased sales revenues in expel lead to greater wampum and potentially more funding for R&D. interposition of depression is one area that the U. S. pharmaceutical industry has heavily indueed 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 beat back in the antidepressant market with its Prozac drug. Antidepressant product development companies invest heavily in Research and exploitation (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 trade in that product resulting in enormous profits for the company. Thus, drug companies continuously attempt to label their product from competitors and bundle in such a way that is more spare to segment of the market where they can dupe advanceder profits. SWOT Analysis Strengths emf successor to a highly successful brand Prozac from a well-established company in the pharmaceutical industry. Part of the selective serotonin reuptake inhibitors (SSRI) group of drugs, which is ordinary and had fewer side effects than tricyclic antidepressant drug anti-depressant (TCA) and monoamine oxidase inhibitors (MAOI). Potential to treat both depression and chronic pain, such as cephalalgia and backache caused by depression. Weaknesses Product that is not different from competitors brands. Twice-a-day dosing regimen of 20-40 mg.Threats Serious market aspiration from competitors brands such as Paxils and Zoloft with said(prenominal) efficaciousness. No clear concession amongst physicians as to the nature of link between depression and pain. Attempting to compare Cymbalta to existing SSRI on pain talent fail to once and for all separate from competitors, thus giving concern drugs an implicit endorsement for treating pain. Opportunities Potential development of 60 mg once-a-day dosage with high efficacy. The possibility of engage patients with fibromyalgia (severe muscle pain and chronic fatigue) and Diabetic peripheral neuropathic pain or DPNP (a painful and debilitating complication of diabetes).According to the National Studies of Health, over 40 millio n Americans were unable to find moderation from their pain, including patients with fibromyalgia and DPNP. Pros and Cons of Plausible Alternatives If developed successfully, Cymbalta could be a unique product that has the ability to importantly reduce and improve depression and pain. Patients with fibromyalgia and DPNP could greatly benefit from Cymbalta. The pain relief whitethorn also be great for patients who become 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 stupefy on patients. They also shit to rate 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(prenominal) obstacles could result in loss of the antidepressant market to competitors. Recommendations Depression and chronic pain diseases, such as fibromyalgia and DPNP, have a profound 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 come 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 past years, by building on the successful foundations Prozac has already established. It is important to develop an updated product that will undoubtedly outperform its competitors. Cymbalta might be a successful stand- in 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(prenominal) record sales than even Prozac.