New Routes to Market Success

With drug innovators increasingly facing competition from generic drug makers, finding new chemical entities (NCEs) may seem to be the only means to sustain profitability. But market opportunities may also rest in using new delivery systems for existing drugs.

"Markets are mature in developed countries, and there is a generics threat. With few NCEs, the value shifts to devices," explained Hervé Pacaud, director of business development for Valois Pharma, now part of Aptar Pharma. Pacaud spoke at Pharmapack 2010 earlier this year, presenting the talk, "Think Lateral: Development of an Innovative Side-Actuated Nasal Spray Device."

"It is difficult to bring a new molecule to market, so companies could instead focus on life-cycle management of their existing molecules and look for ways to extend their lives," he added.

Changing delivery of those existing formulations may be an option. "If you can manage similar drug performance and you can prove it, you don’t need to conduct extensive clinical trials," Pacaud explains. Discussing nasally inhalable drugs, he says that "in addition to bioequivalence studies, companies will need, among other things, to evaluate droplet size and distribution as well as spray patterns." Utilizing the same pump and actuator while changing other elements of the device could keep development time to a minimum.

At Pharmapack, Pacaud spoke of efforts to ease drug delivery for patients. He described his company’s work to capture patient feedback about delivery devices through Patient Acceptance Studies conducted in the United Kingdom and the United States. Patients were given six devices with lateral versus front actuation. They provided feedback that favored improvements in these device features:

• Gripping ease.
• Force to actuate.
• Confidence in dosing.
• Finger position away from nostrils.

These results pointed Valois toward development of a novel package with a short nozzle, a side trigger, and a see-through window. "We believe such a package offers ease of use, patient comfort, and product differentiation, because it is easy to customize."

Further research was conducted that involved presenting this novel device to patients and physicians in the United Kingdom to see how well it satisfied the above points and to assess different nozzle lengths. The novel device achieved the good grip, eased actuation force, and definitive stroke necessary to foster confidence in dosing. Interestingly, however, the second group preferred longer nozzles.

Testing is to be performed in the United States to confirm the United Kingdom results, Pacaud told the audience.

In the meantime, Pacaud notes general market interest in moving away from top-actuating products.

He is also hopeful that the work of another Pharmapack presenter could encourage innovation. Michael Spallek, director of Boehringer Ingelheim’s Global Skill Center in Packaging Development, told attendees about the Polymer Forum. The consortium seeks to "improve and standardize the approach to marketing and supplying polymer materials," he explained. Fourteen companies currently make up the consortium, including Boehringer Ingelheim and other manufacturers listed on the site.

Pacaud says the forum "could set a few rules between pharmaceutical companies and polymer companies that would help us save a lot of evaluation time."

Valois and sister company Pfeiffer are realigning their pharmaceutical operations under the new market-focused brand, Aptar Pharma. For many years, Pfeiffer and Valois have been members of Aptargroup, a family of companies offering consumer dispensing and drug-delivery systems. Aptargroup recently announced a strategic realignment of its businesses under three market-focused business segments: Aptar Beauty + Home, Aptar Food + Beverage, and Aptar Pharma.

The Aptar Pharma organization will be implemented progressively during 2010 and will be fully operational starting in 2011, reported the press release. Aptar Pharma will have two divisions: Consumer Health Care, focused on drug-delivery solutions adapted to over-the-counter medications; and Prescription, focused on drug-delivery solutions specific to prescription drugs.

Aptar Pharma R&D and Marketing staff will work closer together in a global market-focused team of 200 people dedicated to satisfying customer needs. Approximately 6% of Aptar Pharma’s annual turnover is dedicated to research, development, and industrialization of novel products.

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