Drug Yondelis in the US Market - Case Study Example

Table of Contents I. 2 II. Body 3 A. Identify the categories of stakeholders of a company of your choice: Zeltia. 3 i. Public investors of Zeltia 3 ii. Creditors 3 iii. Major shareholders and board of directors 4 iv. Joint venture partners 4 v. US general public 5 vi. Zeltia/PharmMar company employees (research team) 5 vii. US Food and Drug Administration 6 viii. US cancer experts 6 ix. US medical society and professionals 6 x. US consumers (cancer patients) 7 xi. US cancer advocacy groups 7 xii. Public investors of J&J 8 xiii. Media; market and financial analysts 8 xiv. US policy makers 9 B. Following that, place each category of stakeholders on one of the four quadrants of the power/interest matrix, justifying your decision. 9 i. Low power, low interest: Minimal effort 9 ii. Low power, high interest: Keep informed 10 iii. High power, low interest: Keep satisfied 11 iv. High power, high interest: Key players 12 III. Conclusion 13 IV. References 15 I. Abstract This paper aims to identify the relevant categories of stakeholders of a company usually depends on the planned change or activities that give rise to certain parties to protect some interests. For Zeltia, the stakeholders are identified in relation to a certain activity of the company—introduction of Yondelis ® in the US. The stakeholders are grouped into different quadrants of the power-interest matrix. For the low power-low interest quadrant, the US public and the information gatekeepers such as the media and analysts are included. For the low power-high interest, those who are more directly involved in treating the disease such as cancer experts, medical professionals, consumers and cancer advocacy groups are included. Public investors of Zeltia, as well as J&J, the companys co-venturer, as well as creditors of Zeltia, and US policy makers, with their economic and political powers are included in the high power-low interest quadrant. The key players, or stakeholders that fall under the high power-high interest quadrant include the US FDA, joint venture partners J&J and Janssen Cilag, Zeltias key research team as well as the major shareholders and board of directors. II. Body A. Identify the categories of stakeholders of a company of your choice: Zeltia. For Zeltia, the following are the categories of stakeholders, or groups with interest to the companys decision of introduction of Yondelis ® as a drug for ovarian cancer. These stakeholders are identified according to their interests and power as apparent in the recent articles that tackle the developments concerning this decision of the company. i. Public investors of Zeltia Zeltia is a publicly-listed company in the Stocks Exchange in Spain (Grupo Zeltia 2008). A publicly-held company has a fiduciary relationship with its investors, where under some laws it is required to disclose many of its activities which could impact the value of the company. Therefore, public investors, or investors who invest in Zeltias stocks through the stock market are a group of stakeholders for the company. The public investors at large determines the dynamics that affect the stock price of the company, hence, the companys market value (Carroll 2009). ii. Creditors As apparent in the companys annual report (Grupo Zeltia 2008, note 13), part of the companys financing includes debt. The companys debt has long-term as well as short-term debts, loans, short-term interest accrued, and financial leases. Another group of stakeholders for Zeltia include the creditors. These include the banks, the suppliers, and other financial institutions that provide loan to the company, or in any case where the financing qualifies as debt. They also have a stake in the result of the change: if the decision results in a failure, it can shake the companys financial prospects and projections, which can affect its credit rating. iii. Major shareholders and board of directors Aside from the public investors and creditors, the companys major shareholders such as the owner Jose Maria Fernandez Sousa-Faro, as well as others who have controlling stakes in the business. Apart from these shareholders, there is the board of directors who make the majority of the decisions for the company, especially in matters concerning policy and top management regulations. With this power, this group is another category of stakeholders of Zeltia. They will be concerned over the result that can impact the value of the company, which is a function of the expectations of the public investors in the stock market (WSJ.com 2009). iv. Joint venture partners Zeltia has agreed on a joint venture agreement in pushing Yondelis ® in the market for ovarian cancer. The companys joint venture partner is US-based company J&J, under its Ortho Biotech subsidiary (PRNewswire.co.uk 2008). Since the company is part of the joint venture, it has stakes on the results of the decision to expand the scope of Yondelis ® from treating soft-tissue sarcoma, to ovarian cancer. Whatever the results are, J&J has a share of both the risks and earnings of the venture. J&J is both responsible for helping Zeltia apply for approval for the US FDA, as well as the manufacture and marketing in the United States.Apart from Ortho Biotech, Zeltias agreed partner for distribution around the world is Jannsen Cilag (MedicalNewsToday.com 2009). Therefore, this company has also a stake on the results of the decision. If this introduction is successful, Jannsen Cilag will also count on reaping a huge part of the earnings. v. US general public As Yondelis ® will be introduced to the US market, the US general public also has some stakes on the decision of the company. The acceptance of the drug in the US by the general public will pose a concern for the company. This can be handled by J&J, the joint venture partner in the US. Consumers are part of the US general public, which makes the US general public also a category of stakeholder for the company. vi. Zeltia/PharmMar company employees (research team) PharmMar is Zeltias arm that takes charge of developing Yondelis ® . The employees who were part of the team and helped developed the drug has a stake on the decision of the company. Aside from the credits, because they have the know-how, they are also one group of the stakeholders. If the drug does not push through a certain market due to technical issues, this group is concerned. vii. US Food and Drug Administration As Zeltia chooses to push Yondelis ® to the US market, there are regulatory entity that protect the interests of the general consumers as regards approval of certain drugs that can enter the drug market. This entity is the US FDA or the US Food and Drug Administration. Zeltia will not be able to enter the US drug market unless it gets approval from the US FDA (Berkrot 2009). Therefore, this is also one category of stakeholders for the decision. They have interest and power over the planned change of pushing the drug to the US drug market for ovarian cancer. viii. US cancer experts As Zeltia introduces the drug to the US drug market for ovarian cancer, another group that has a stake on the decision includes cancer experts in the country. These include academicians and researchers who have long studied cancer and have a say over the effects of a certain drug from a third-party perspective. Because these cancer experts have an interest and certain power over the decision of the introduction of Yondelis ® , they are a different category of stakeholders for the company. ix. US medical society and professionals Distinct from the US cancer experts are the US medical society, professionals and medical practitioners as another category of stakeholders. Instead of studying about cancer, these practitioners benefit from the opinions of cancer experts when they treat their patients. Therefore, because they are concerned with how the drug will be used on the patients, they have an interest in the decision (MedicalNewsToday.com 2008). They are distinct from the cancer experts, in a way that only according to their diagnosis and prescription of certain patients can the drug Yondelis ® be used (Chustecka 2009). x. US consumers (cancer patients) The people with the most concern over this decision will be the consumers, or in the case of Yondelis ® , the cancer patients in the country. If the drug proves to be successful, these people have more alternative that can better help treat their illnesses. As the drug is made for these people, in this case people with ovarian cancer, these people can look forward to another form of help in curing cancer (Pharma Watch 2009). Therefore, the US consumers would have much interest in the introduction of the drug in their country. xi. US cancer advocacy groups There are also consumer advocacy groups in the country that help support victims as well as their families in the US (Berkrot 2009). These cancer advocacy groups that aim to not only support, but also inform will also be interested in the decision of the company to introduce Yondelis ® in the country (MedicalNewsToday.com). Because they look for information that will be of help to the consumers and their family, they will have some interest over the decision of the company. xii. Public investors of J&J Because the introduction of Yondelis ® to the US is a joint venture effort between J&J and Zeltia, public investors of J&J will have an interest in the decision (Reuters.com 2009). If the drug proves to be successful in the country, it will have an effect on J&Js value which is the concern of these public investors. Therefore, they are also another category of stakeholder in Zeltias decision. xiii. Media; market and financial analysts In relation to the US general public—both the consumers and the public investors, the media as well as other information gatekeepers such as the market analysts and financial analysts will have an interest over the decision of the Zeltia (Reuters.com 2009). Keeping the interest of the public at large, they will be on-guard looking for accurate information that will affect the public. xiv. US policy makers The introduction of the drug Yondelis ® concerns the public and the society at large. With this, the policy makers in the US will have an interest on Zeltias decision (Reuters.com 2009). The power of these policy makers when it comes to matter such as public health regulations will have to be considered by the company as regards its decision. B. Following that, place each category of stakeholders on one of the four quadrants of the power/interest matrix, justifying your decision. i. Low power, low interest: Minimal effort Among these stakeholders, those who qualify to the first quadrant, low power-low interest-minimal effort group include the US general public, as well as the information gatekeepers such as the public media, market and financial analysts. In the most recent news as regards the decision of Grupo Zeltia to enter the US market and introduce the drug Yondelis ®, although the publics power and interest are low, the public are still concerned with the decision. The public, the people who do not qualify either as the patients or potential users of the drugs, the cancer experts, medical practitioners and the medical society as well as policy makers, cancer is still a social issue in which even those who are not affected are involved in some other way. As for the information gatekeepers, in relation to keeping the public informed either for the health or financial information for the public investors, these people have interest over the decision. However, but their interest is only limited to their job in providing accurate information to those who need it. ii. Low power, high interest: Keep informed The groups that fall under this quadrant include the cancer experts in the country, the medical practitioners, the consumers, as well as the advocacy groups. They have high interests as regards the decision, as Yondelis ® is one of the drugs that has been one of the most promising in curing recurrent ovarian cancer (PRNewswire.co.uk 2009). These groups of stakeholders have been counting on the drug, as these are the people who will be using the drug to help patients fight cancer. The high interest of these groups in the decision of Zeltia is grounded on the fact that Yondelis ® seem to provide hope to patients with recurrent ovarian cancer, who, due to unavailability of alternative treatments due to special cases of their illnesses, cannot be treated (MedicalNewsToday.com 2009). Yondelis ®, if approved will be a solution to a great problem that these groups have been long trying to address (Chustecka 2009). However, in the recent article that concerns the development of the Zeltias decision where the US FDA has rejected Yondelis ® due to discrepancy in the data presented as regards safety (Reuters.com 2009), the opinion of a cancer expert and lead investigator of the Phase 3 trial of Yondelis ® , Bradley Monk, MD, FACOG, FACS, associate professor and director of research in the Division of Gynecologic Oncology at the University of California Irvine Medical Center, seem not to be enough in order to affect the issue. Although these experts and the practitioners have high interests, their powers are low in order to affect the outcome. Even the consumers--the cancer patient who participated in the clinical trial and testified to the FDA how the drug has helped her (Berkrot 2009), does not have much power in order to influence the outcome. Because their interest is high these groups should be kept informed. iii. High power, low interest: Keep satisfied Among the stakeholders that are included in this quadrant are the public investors of Zeltia (WSJ.com 2009), the creditors of the company (Grupo Zeltia 2008), the public investors of J&J (Reuters.com 2009), and the US policy makers. These groups have high power in that the first three groups have economic power to influence the decision of Zeltia, and the fourth group, the US policy makers have the political power. They fall under this quadrant because, although they have high power, these groups have low interest over the decision. The power of the public investors of Zeltia and the public investors of J&J represent the market value of the company, and that if they are not kept satisfied as regards meeting their expectations such as increasing the value of their investments, their behaviours can affect the price of the company. But, for the specific decision of entering the US market in order to offer Yondelis ® as cure for recurrent ovarian cancers, their only concern is the success of the enterprise and its effect on their value. The US policy makers on the other their interest is low in that the drug should have minimum compliance in order to ensure public safety. Therefore, it is only vital that they are kept satisfied as regards their expectations. iv. High power, high interest: Key players The key players in the decision include the major shareholders and board of directors, the joint venture partner J&J as well as the distribution partner Janssen Cilag (MedicalNewsToday.com 2009), Grupo Zeltias/PharmaMars key research team, as well as the US FDA. Key to the policies of Zeltia is its major shareholders such as the Chairman and other members of the board of directors. Therefore, their expectation and say over the decision makes them key players. The joint venture partners such as J&J and Janssen Cilag have high powers as well as high interests, in the decisions in such that they share the risk of not being approved by the FDA, but also share in the return of the venture. If these co-venturers back out, the venture is less likely to be carried out—they have high power because of their resources and capability and role in the decision. As regards approval, the US FDA is a key player as well. Being the authority that regulates the drugs that can be sold in the US, the recent decision of the regulatory body to reject Yondelis ® due to some issues will prevent the company from marketing the product in the country. This proves its high power over the decision; its high interests comes from its responsibility to the country. To address these issues, the key research team of the company, its key employees as regards the development of Yondelis ® are also key players to the decision. Their power is high in that they possess the technological know-how about the development, and their interest in the decision is high as they are also partially responsible for the outcome of the tests that are used in approval. III. Conclusion The introduction of the drug Yondelis ® in the US market has helped identified the various stakeholders that have interest and power over the decision. The US public and the information keepers such as the media and analysts fall under the first quadrant as their interest and power are low over the decision to introduce the product. For the low power-high interest quadrant, those who are more engaged to the treatment of the disease such as cancer experts, medical practitioners, consumers or cancer patients, and advocacy groups are included. Their interests are high in that they are the ones who have been looking for the solution to the illness, but their power is low. Public investors of the two companies—Zeltia and J&J, as well as other creditors, and US policy makers, who have the economic and political power to influence the decision have low interest on the decision—their interest is that their expectations of the company and the outcome of the decision should just be met and satisfied. As for the key players, these include the major shareholders such as the founder and chairman himself, as well as other major shareholders, the board of directors, the joint venture partners J&J and Janssen Cilag, the US FDA as well as the key research team. These people who are key players have power over the policies, which eventually determine the outcomes of the decision. IV. References Berkrot, Bill. (2009 July 15). “U.S. Panel votes to reject J&J, Zeltia cancer drug (Reuters).” OvarianCancer.org. Retrieved on August 21, 2009 from http://www.ovariancancer.org/index.cfm?fuseaction=Feature.showFeature&CategoryID=1&FeatureID=647 Carroll, John. (2009 July 13). “Zeltia shares slide as regulators question Yondelis.” FierceBiotech.com. Retrieved on August 21, 2009 from http://www.fiercebiotech.com/story/zeltia-shares-slide-regulators-question-yondelis/2009-07-13 Chustecka, Zosia. (2009 July 23). “Trabectedin for ovarian cancer rejected by FDA committee.” Medscape.com. Retrieved on August 21, 2009 from http://www.medscape.com/viewarticle/706350 EMEA. (2009 May 25). “Summary of Product Characteristics: Yondelis, INN-Trabectedin.” European Medicines Agency. Retrieved on August 21, 2009 from http://www.emea.europa.eu/humandocs/PDFs/EPAR/yondelis/emea-combined-h773en.pdf Grupo Zeltia. (2008). “Annual Report 2008, Management Report” Zeltia.com. Retrieved on August 21, 2009 from http://www.zeltia.com/media/docs/ngpvscct.pdf Grupo Zeltia. (2009 February 6). “Yondelis(R) has been authorized for commercialization in Switzerland.” Zeltia.com. Retrieved on August 21, 2009 from http://www.zeltia.com/media/docs/cnlbxqrr.pdf Medical News Today. (2008 September 16). “Study of Yondelis(R) in ovarian cancer shows significant prolongation in progression free survival.” MedicalNewsToday.com. Retrieved on August 21, 2009 from http://www.medicalnewstoday.com/articles/121619.php Pharma Watch. (2009 January). “Ovarian Cancer Update.” Pharma Watch. Volume 8 Issue 1, p. 15-16. Retrieved on August 21, 2009 from http://web.ebscohost.com/ehost/detail?vid=1&hid=3&sid=d888d013-17e0-4943-84cb-058b3dd13872%40sessionmgr11&bdata=JnNpdGU9ZWhvc3QtbGl2ZQ%3d%3d#db=buh&AN=36067352#db=buh&AN=36067352#db=buh&AN=36067352#db=buh&AN=36067352#db=buh&AN=36067352#db=buh&AN=36067352#db=buh&AN=36067352 Pharma Watch. (2009 January). “Zeltia: files for approval of Yondelis for ovarian cancer in the US.” Pharma Watch. Volume 8 Issue 1, p. 11. Retrieved on August 21, 2009 from http://web.ebscohost.com/ehost/detail?vid=1&hid=3&sid=d888d013-17e0-4943-84cb-058b3dd13872%40sessionmgr11&bdata=JnNpdGU9ZWhvc3QtbGl2ZQ%3d%3d#db=buh&AN=36067352#db=buh&AN=36067352#db=buh&AN=36067352#db=buh&AN=36067352#db=buh&AN=36067352#db=buh&AN=36067352#db=buh&AN=36067352 PRNewsWire. (2009 April 4). “Phase III Trial of Yondelis(R) (Trabectedin) initiated in ovarian cancer patients.” PRNewswire.co.uk. Retrieved on August 21, 2009 from http://www.prnewswire.co.uk/cgi/news/release?id=143191 Thomson Reuters. (2009 July 13). “Update 2-US FDA staff question J&J, Zeltia cancer drug data.” Reuter.com. Retrieved on August 21, 2009 from http://www.reuters.com/article/marketsNews/idUSN1315155120090713?pageNumber=1&virtualBrandChannel=0 Thomson Reuters. (2009 July 10). “Update 2-Zeltias Yondelis gets first OK for ovarian cancer.” Reuters.com. Retrieved on August 21, 2009 from http://www.reuters.com/article/euRegulatoryNews/idUSLA37300320090710 Thomson Reuters. (2009 July 10). “Zeltias Yondelis gets approval in Philippines.” Reuters.com. Retrieved on August 21, 2009 from http://www.reuters.com/article/companyNews/idUSMDT00654120090710 Wall Street Journal. (2009 July 16). “Update: Zeltia -46% after FDA panel rejects Yondelis treatment.” WSJ.com. Retrieved on August 21, 2009 from http://online.wsj.com/article/BT-CO-20090716-706813.html#articleTabs_comments%26articleTabs%3Darticle Yondelis.com. (2009). “Yondelis(R) (Trabectedin).” Yondelis.com. Retrieved on August 21, 2009 from http://www.yondelis.com/mapa_europa.html Read More