Helapharm has recently discovered a new peptide that shows signs of a viable anti-obesity treatment. Helapharm has enough funding to get them through the next six months, but will not have enough money to fund the majority of the project. The pre-clinical development phase, clinical validation phase, and drug launch phase are three major phases that need additional funds for the successful launch of this novel drug. Helapharm has created this project plan outlining key milestones, timeline, costs, and financial projections to be presented at a meeting with an interested venture capital firm. With sufficient funding and resources, Helapharm could launch a successful obesity treatment with far superior results than any of the current treatments available.
Over the last 30 years in the United States, obesity has become an epidemic with over 78 million United States (US) obese adults and about 12.5 million U.S obese children and adolescents in 2009 to 2010 (Ogden, 2012). According to the Center for Disease Control, obesity related costs are a huge burden on the US economy since obesity can lead to diseases such as diabetes, heart disease and cancer. Obesity costs the United States about $150 billion a year, or almost 10% of the national medical budget (NCCDDPH, 2011). Not only are there health issues to be resolved, there is a huge untapped market for weight loss drugs (LaRosa, 2012). Currently the market for weight loss drugs, food, and programs is worth $12 billion a year but that number could increase another $2.4 billion by tapping into some areas of weight loss niches (LaRosa, 2012). With a huge market opportunity and the obesity numbers rising, there is a growing need for treatments to counter the epidemic.
Helapharm, a small startup company, is in the process of developing a novel peptide from the saliva of a Gila Monster to treat obesity. Although the peptide has shown anti-obesity traits in its early development stage, there is still a long road until the peptide can become a commercialized product. With major milestones ahead of the company, it is important that the company receive adequate funding to make this drug become a reality. Like all novel drugs, there is a larger risk of failure, however, if successful, the investment will be well worth it. Helapharm’s project goals, milestones, schedule, critical factors and recommendations are discussed in the following sections.
3. Project Goals
With additional funds and resources, Helapharm expects to reach the following overall goals for this project: develop the novel peptide into a sub-cutaneous injection of 10 g a day, attain a patent for this novel drug, and attain Food and Drug Administration (FDA) approval for launching the product in the U.S market. In a project of this cost and duration, it will be valuable to break down the overall project goals into goals for each major phase of the project. During the peptide discovery, the goal is to fInd a drug candidate. The major goal for the pre-clinical testing is to perform extensive tests to ensure the peptide is safe enough for human testing. Helapharm needs to obtain FDA approval for the Investigational New Drug (IND) application, so that the drug can be tested on humans. The clinical trials need to show that the drug is safe and effective in humans. Following proven safety and efficacy of the drug, FDA review and approval of the drug is an important goal Helapharm needs to achieve. The company needs to successfully manufacture the biologic and meet the supply and demand of the new drug. Finally, monitoring the drug as it is used in the larger population to catch any unexpected serious side effects. If Helapharm reaches these project goals, it will be able to gain a profit margin within two years of product launch and saturate the rapidly growing anti-obesity drug market.
4. Key Project Milestones
To successfully reach the project goals stated above and launch the novel…