Thursday, April 22, 2010

Drugs Deliver

The Ernst & Young's 2010 global pharmaceutical report described non-traditional companies that will induce pharmaceutical companies to broaden their focus in creating partnerships for innovation. This report led me to consider a company not mentioned in their review. “Dominos Delivers” is a phrase that encompassed a significant accomplishment in a competitive industry that served to promote a product that was consistent in quality and available to customers almost anywhere and at anytime. In the world of pizza, with thousands of competitors making essentially a generic product, Dominos Pizza emerged as a powerhouse that delivered quality and convenience. The generic drug industry faces a conundrum not unlike the pizza world which may provide fresh ideas for drug developers. Recent patent expirations for many efficacious drugs with established safety profiles along with an ever increasing plethora of efficient delivery and formulation technologies have set the stage for differentiated products that can satisfy the unmet needs of many patients. The key issue is differentiation via leveraging the relevant delivery technology coupled with effective presentation of scientific evidence that patients and practitioners will recognize and government regulators will approve. While drug delivery and formulation technologies hold great promise for the development of enhanced versions of generic drugs, sound strategies based upon a clear understanding of the needs to be met are a must. Analogous to the potential seen by Tom Monaghan fifty years ago when he founded Dominos, significant clinical and commercial achievements are on the horizon for companies that carefully analyze key therapeutic areas for unmet needs that may be resolved by combining existing drugs with the optimal delivery technology.

The utilization of drug delivery technology to improve a drug’s therapeutic profile is certainly not new. High profile companies such as Elan, Eurand and Skye Pharma have documented success in either greatly improving the efficacy and/or safety of drugs as well as implementing effective life cycle management (LCM) strategies based upon their technology. Several large pharmaceutical companies have drug delivery divisions for internal programs as well as provision of services to other companies. Going forward, these and other companies must not only continue to effectively leverage their delivery platforms in key therapeutic areas, they must do so in an increasingly competitive marketplace comprising upstart companies with state of the art technology platforms and a growing track record of success. According to a recent report from BCC Research, the market for drug delivery systems was estimated to be approximately $139 billion in 2009 and with a projection of more than $196 billion by 2014. Specific to the pain market, the launch of at least 20 new formulations of analgesics is anticipated to increase growth by 3% according to a report from Decision Resources. The drugs will be reformulations of conventional analgesics such as fentanyl, oxycodone, diclofenac and bupivacaine. Evidence for these projections can be seen from the recent US FDA approval of a reformulated version of Purdue Pharma’s OxyContin. The new version slowly releases oxycodone making the drug less prone to overdosing and abuse. In addition, the new formulation allows patients to take the drug less frequently. Another relevant application of drug delivery technology in the CNS arena involves Boehringer Ingelheim’s recently launched Mirapexin (pramipexole) in a new once-daily formulation to help patients deal with the debilitating symptoms of Parkinson's disease (PD). The new formulation is anticipated to benefit patients who are awakened in the middle of the night due to PD symptoms; clinical studies documented that the once a day prolonged release formulation was as effective as the three-times-a-day formulation at the same daily dose.

Considering the extensive R&D around the globe, including prolific activity in China and India, some may consider projected revenue from reformulated drugs to be on the conservative side. So what strategies may prove effective in maximizing the potential for enhancing the benefits of key drugs using drug delivery technology? Will the winners be companies with the most or the best tools or will they be the ones that utilize existing tools in the most efficient and prudent manner? Perhaps the greatest achievements will be made by companies that recognize the needs to be met and fill those needs with the best technology available. In my experience, the conventional process for identifying key unmet needs comprises a comprehensive therapeutic review of target disease indications. Such reviews can be conducted via contributions from market research, technical and competitive intelligence as well as information from medical liaison resources. The research should focus on not only existing therapies and their deficiencies, but also a thorough analysis of the disease indication pipeline. The analyses will reveal clues regarding the likelihood for approval, key safety issues as well as the potential efficacy of the drugs, all of which taken together can reveal unmet needs. This approach may work well for medium to larger size companies, but what about smaller firms with limited resources? Even if a thorough review is conducted within a key disease indication, what is the likelihood that the results can be exploited with a presumed limited technology range? Considering that smaller companies will most likely target larger firms as partners in their drug development efforts, I advocate a strategic review of potential partners as a starting point for setting the overall R&D strategy. Such a review will, by default, include a more thorough therapeutic review done by the target partners. The identification of potential deficiencies in existing and development-stage drugs of potential partners can be an effective, inexpensive and yet comprehensive means of setting an R&D strategy focused on the enhancement of the therapeutic profiles of known drugs. In fact, now is an ideal time to conduct such reviews since several companies have recently announced realignment of therapeutic focus due to completed M&A milestones and other justifications. Within the US and a few other countries, public companies must disclose their R&D investments and most do in a very transparent manner. For instance, at the beginning of the year, Pfizer announced that it will cut 100 drug development programs from its pipeline swollen by the merger with Wyeth. The remaining programs are focused on six key areas: oncology, pain, inflammation, Alzheimer's disease, psychoses and diabetes. Another pharma giant, Novartis, announced that it will focus on cardiovascular & metabolism, oncology, CNS and ophthalmics, respiratory, immunology and infectious disease. Relevant to drug delivery and its stated focus within respiratory, Novartis (Sandoz) recently announced the acquisition of Oriel Therapeutics, a company with a portfolio of generic drugs and technologies targeting asthma and COPD. Oriel will be integrated as a development unit within Sandoz including its FreePath drug delivery technology. The company stated that the Oriel technology has the potential to address several of the hurdles in regulatory approval of generic inhaled medicines in the US. Oriel also brings to Sandoz the Solis disposable dry powder inhaler based on the FreePath delivery technology. Sandoz believes the acquisition of Oriel will enable the company to better leverage its existing range of in-market products. At the very least, the acquisition should provide valuable insight to companies with comparable technology to better position their R&D programs for collaboration with Novartis or a competitor. This strategy makes sense considering the recent announcement by the Food and Drug Administration (FDA) that it will more stringently regulate the use of long-acting beta agonists (LABAs) as treatments for asthma. Also, the FDA has mandated additional studies be conducted by manufacturers of LABAs to validate the safety of the drugs when used in combination with inhaled corticosteroids. As an example, the utilization of nanotech / micron and related platforms to reduce dosage while maintaining efficacy of LABAs makes a lot of sense in light of this increase in regulatory scrutiny.

These are just a few examples of recent developments involving drug delivery / formulation that support the premise of establishing an effective strategy as the basis for utilizing technology platforms for enhanced therapeutic benefits. This strategy can be employed using existing technology or can form the basis of a licensing effort to acquire new platforms or even build an effort from scratch. The seminal item, to draw again on the pizza analogy, is the improvement of a known commodity, the drug, via optimized formulation and delivery. The analogy reminds me of the college student who was delivering pizza. When asked about the usual tip, the student stated that if he got a quarter, he would be fine. The customer, feeling somewhat insulted, handed him a five dollar tip and asked him about his major, to which the student replied, “applied psychology.” The drug industry can use a little applied psychology to look for opportunities in what seems to be not so obvious places.

Robert Morrison, Ph.D. is Director, The Invotex Group, a specialty consulting firm that provides a range of financial and technical services to companies and academic institutions. Dr. Morrison’s practice focuses on issues associated with clinical development and intellectual property of pharmaceuticals and medical diagnostic applications.


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