Focus on efficient R&D pays dividends for physicians, patients

July 15, 2014

Despite the challenges of higher costs of developing drugs, increased regulatory requirements, and limitations on reimbursement for health care, the key to success in the pharmaceutical industry has been-and still is-innovation.

 

Editor’s Note: A lot of information has surfaced over the past several months in Valeant Pharmaceuticals’ $53 billion bid for Allergan. Though the war of words between the two companies has been thoroughly outlined and covered in the financial media, there is one argument that is the most significant to physicians-most importantly, ophthalmologists-and it’s research and development (R&D).

Both companies have different approaches to R&D. Scott M. Whitcup, MD, executive vice president of R&D for Allergan, and Calvin Roberts, MD, chief medical officer of Bausch + Lomb, outline their respective company’s position in developing and bringing new products to market. Valeant acquired B+L in 2013.

This forum was made available to both companies so readers would have a better understanding of the R&D issue and where each company stands in the ophthalmic market and what it means to physicians.

Dr. Whitcup

Despite the challenges of higher costs of developing drugs, increased regulatory requirements, and limitations on reimbursement for health care, the key to success in the pharmaceutical industry has been-and still is-innovation.

Research and development (R&D) organizations should be science-based and innovation-focused to provide true value to patients and physicians. For more than 60 years, Allergan has been committed to discovering and developing innovative pharmaceuticals, biologics, and medical devices.

Through thoughtful investment internally and collaboration with both academic centers and outside companies, the company has built an effective, efficient R&D model that has resulted in a long track record of developing and progressing new treatments through approvals at an industry-leading pace. Since 2010, the company has received 12 FDA approvals. This success is a direct result of hiring outstanding researchers who focus on science and innovation.

We believe our commitment to internal R&D development fosters a culture of innovation and expertise, an essential element to success. We focus our efforts in the specialty areas where we can develop scientific expertise and concentrate the vast majority of our pipeline on locally administered treatments, where side effects can be limited, and the benefits to patients can be optimized. This selective focus maximizes the potential of our pipeline.

In addition, we foster an entrepreneurial approach to R&D, where we follow the science and develop new indications or novel ways to deliver existing therapies.

An example of this approach is the development of bimatoprost, which was a new chemical entity we developed and received regulatory approval for as a topical eye drop (Lumigan) for the treatment of elevated IOP in people with open-angle glaucoma or ocular hypertension. Because poor patient compliance with eye drops leads to suboptimal therapeutic outcomes, we are now developing bimatoprost in a biodegradable sustained-release implant for glaucoma to ensure more optimal control of IOP.

 

Pipeline from product

OnabotulinumtoxinA (Botox) is perhaps the best-known example of developing a pipeline out of a product. In-licensed as a therapy for two small ophthalmic indications of strabismus and blepharospasm, the product has now been approved globally for 27 novel indications, including chronic migraine, upper limb spasticity, and overactive bladder. Currently, the drug is in a number of clinical development programs, including depression and osteoarthritis pain.

READ MORE: Bausch + Lomb's view

Having spent a decade at the National Institutes of Health, I also believe that research productivity can be enhanced when basic scientists work closely with clinicians to solve therapeutic dilemmas. Our greatest research successes come from investing in basic science and clinical research, with a laser focus on developing therapies that address unmet medical needs. Understanding disease pathogenesis allows for identification of novel targets for inventive repurposing of known drugs for new uses.

Cyclosporine ophthalmic emulsion 0.05% (Restasis) exemplifies the progressive thinking of our R&D team and how a focus on innovation has developed a new therapeutic market. In this instance, we took a drug used for suppression of organ transplant rejection to develop a therapeutic dry eye agent. This was only possible because our scientists understood that inflammation was a core contributor to the disease and were able to develop and utilize a complex emulsion to deliver the drug effectively to the eye.

 

Today, nearly a decade since first approved, the agent remains the first-and-only therapeutic product indicated for the treatment of chronic dry eye. Our deep-rooted ophthalmic scientific knowledge has allowed us to create and succeed in markets where other pharmaceutical companies have not been as successful.

Economist Theodore Levitt said, “Creativity is thinking about new things, innovation is doing new things.”

Pharmaceutical companies are uniquely positioned to ensure that scientific creativity leads to novel and innovative therapy. Efficient R&D and an innovative pipeline remain the cornerstones of success in the pharmaceutical industry.

It is no surprise then that Allergan’s R&D investment has a direct impact on stockholder value. As a public company, consistently generating innovative products creates stockholder value, and this is what enables us to continue to invest in R&D. Our stockholders and our patients and physicians should expect nothing less.

 

Scott M. Whitcup, MD, is executive vice president, research and development, chief scientific officer, Allergan Inc. The products mentioned are trademarks or copyrights of Allergan. For more information, visit www.allergan.com