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Pharmaceutical Evaluation of New Drug Investment

Market Barriers to the Development of Pharmacotherapies for the Treatment of Cocaine Abuse and Addiction: Final Report. Pharmaceutical Evaluation of New Drug Investment Opportunities

As discussed above, a pharmaceutical company's decision to develop and market a drug is predicated on a number of factors related to the probability of economic success of a given product. Each of the several companies that were interviewed for this study indicated that the evaluation of a candidate drug project hinged on an overall assessment of
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Industry Evaluation of New Drug Investment

Market Barriers to the Development of Pharmacotherapies for the Treatment of Cocaine Abuse and Addiction: Final Report. Industry Evaluation of New Drug Investment Opportunities

In order to provide context for the market environment and background for understanding the market barriers from industry's perspective, this section summarizes pharmaceutical and venture capital firms' approaches to the evaluation of new drug investments.
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Market Barriers to the Development of COCAINE

Market Barriers to the Development of Pharmacotherapies for the Treatment of Cocaine Abuse and Addiction: Final Report. Market Barriers to the Development of COCAINE Pharmacotherapies

The purpose of this section is to characterize private industry's views on market barriers to anti-addiction pharmacotherapy development. The 1995 IOM report, Development of Medications for the Treatment of Opiate and Cocaine Addictions , identified numerous market obstacles that appear to hamper private sector investment in anti-addiction medica
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Case Study 4: Nicorette

Market Barriers to the Development of Pharmacotherapies for the Treatment of Cocaine Abuse and Addiction: Final Report. Case Study 4: Nicorette

Introduction Drug Overview
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Case Study 3: Clozapine

Market Barriers to the Development of Pharmacotherapies for the Treatment of Cocaine Abuse and Addiction: Final Report. Case Study 3: Clozapine

Introduction Drug Overview
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Case Study 2: Naltrexone

Market Barriers to the Development of Pharmacotherapies for the Treatment of Cocaine Abuse and Addiction: Final Report. Case Study 2: Naltrexone

Introduction Drug Overview
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Case Study 1: LAAM

Market Barriers to the Development of Pharmacotherapies for the Treatment of Cocaine Abuse and Addiction: Final Report. Case Study 1: LAAM

Introduction Drug Overview
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Marketing Mandated Coverage

Market Barriers to the Development of Pharmacotherapies for the Treatment of Cocaine Abuse and Addiction: Final Report. Marketing Mandated Coverage

The federal government exercised a coverage mandate in the case of clozapine. Once Sandoz separated its expensive Clozaril Patient Monitoring System (CPMS) from sales of clozapine, the Health Care Financing Administration(now known as Centers for Medicare and Medicaid Services(CMS)) (HCFA(now known as CMS)) required all state Medicaid agencies to
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NDA Phase

Market Barriers to the Development of Pharmacotherapies for the Treatment of Cocaine Abuse and Addiction: Final Report. NDA Phase

A) Fast-track approval
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Existing Government Strategies to Lower Market

Market Barriers to the Development of Pharmacotherapies for the Treatment of Cocaine Abuse and Addiction: Final Report. Existing Government Strategies to Lower Market Barriers

The government was involved in aspects of development and marketing for each of the four case study drugs. These phases, adapted from the 1995 IOM report, include discovery, clinical studies, NDA phase, and marketing. Figure 23: Overview of Past Government Strategies to Lower Market Barriers   Strategy
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Summary of Case Study Results

Market Barriers to the Development of Pharmacotherapies for the Treatment of Cocaine Abuse and Addiction: Final Report. Summary of Case Study Results

The four case studies have several elements in common, particularly with regard to the target patient population. For example, three of the four drugs involve treatment for substance abuse including LAAM and naltrexone for heroin addiction, naltrexone for alcoholism, and Nicorette for smoking.
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Case Studies: LAAM, Naltrexone, Clozapine, and

Market Barriers to the Development of Pharmacotherapies for the Treatment of Cocaine Abuse and Addiction: Final Report. Case Studies: LAAM, Naltrexone, Clozapine, and Nicorette

The purpose of the case studies is to gain insight into the experiences of companies that are relevant to developing and marketing medications for drug abuse and addiction. Presented below are two in-depth case studies of LAAM (Roxanne), for heroin addiction, and naltrexone (DuPont Merck), for heroin (as Trexan) and alcohol (as ReVia) addiction. I
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Discussion

Market Barriers to the Development of Pharmacotherapies for the Treatment of Cocaine Abuse and Addiction: Final Report. Discussion

As illustrated in the "Big Pharm Cold Start" scenario, the prospects of developing a new medication for cocaine abuse and taking it through a full product development cycle do not appear favorable given a moderate wholesale price comparable to LAAM ($2.50 per patient per day) and what amounts to an optimistic target market of 125,000 patients (i.e
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Scenario 5: Second Indication

Market Barriers to the Development of Pharmacotherapies for the Treatment of Cocaine Abuse and Addiction: Final Report. Scenario 5: Second Indication

Company S has a smoking cessation medication, Product S, that was recently introduced to the market. In its first two years, Product S has been highly successful, with projected PAR exceeding $500 million. Company researchers also have found strong early evidence that Product S may be very effective as a medication for cocaine addiction, and are e
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Scenario 4: Vaccine

Market Barriers to the Development of Pharmacotherapies for the Treatment of Cocaine Abuse and Addiction: Final Report. Scenario 4: Vaccine

In Scenario 4, the government has conducted preclinical R&D on a highly promising Product V that is designed to work as a vaccine with an annual booster.
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Scenario 3: Guaranteed Handoff

Market Barriers to the Development of Pharmacotherapies for the Treatment of Cocaine Abuse and Addiction: Final Report. Scenario 3: Guaranteed Handoff

In Scenario 3, a government research agency has taken a highly promising compound, Product G, into Phase III clinical trials. The government approaches a large pharmaceutical firm, Company G, that has a strong CNS product line. The government offers to turn over the rights to Product G in exchange for assistance in completing Phase III trials, sec
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Scenario 2: Biotech Gets Help

Market Barriers to the Development of Pharmacotherapies for the Treatment of Cocaine Abuse and Addiction: Final Report. Scenario 2: Biotech Gets Help

In this scenario, a small biotechnology firm, Company B, takes on the full product development cycle with a new class of compounds based on a recent scientific breakthrough that is highly specific to cocaine receptor neuropharmacology. The company anticipates that a new Product B from this class of compounds will have excellent compliance in the u
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Scenario 1: Big Pharm Cold Start

Market Barriers to the Development of Pharmacotherapies for the Treatment of Cocaine Abuse and Addiction: Final Report. Scenario 1: Big Pharm Cold Start

In this scenario, a large pharmaceutical company takes on the full product development cycle, i.e., a "cold start" with preclinical discovery and research. The new Product A will require about $150 million in uncapitalized expenditures to develop and will be ready for launch following FDA approval in 13 years. The company anticipates securing a pa
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Scenarios of Company Decision Making

Market Barriers to the Development of Pharmacotherapies for the Treatment of Cocaine Abuse and Addiction: Final Report. Scenarios of Company Decision Making

This report presents several scenarios of pharmaceutical company decision making regarding undertaking projects to develop pharmacotherapies for substance abuse (e.g., cocaine) under various sets of market conditions. Using a quantitative model developed by The Lewin Group, the market conditions are translated into financial and other parameters t
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Affordable Levels of Development Cost

Market Barriers to the Development of Pharmacotherapies for the Treatment of Cocaine Abuse and Addiction: Final Report. Affordable Levels of Development Cost

The final approach taken to assessing the financial attractiveness to commercial firms is to estimate the affordable level of R&D cost, given the expected peak annual revenue to the company. The base conditions for the model have been used to develop the estimates in Figure 21 (below). In particular, this set of calculations assumes that a com

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Form Approved OMB# 0990-0379 Exp. Date 9/30/2020