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Lubricants, Plan B boost sales

BY Michael Johnsen

Overall, the intimacy health category generated more than $870 million in sales, trending up in the low single-digits. Sales of condoms, the largest piece of the business, totaled $380.7 million across total U.S. multi-outlets for the 52 weeks ended April 20, and was down slightly by 1.8%. The growth is coming out of the personal lubricant ($213.4 million, up 2.9%) and emergency contraceptive ($253.2 million, up 12.3%) sectors.

(For the complete category review, including data, click here.)

Church & Dwight last year introduced the Trojan brand name to the personal lubricant space with Crazy Sexy Feel. Overall, C&D lubricants generated $18.5 million in sales, ranking the relative newcomer the third-largest personal lubricant brand manufacturer with a dollar share of 8.7%. And though overall sales of Johnson & Johnson lubricants were down 26.4% to $82 million, that lubricant franchise is about to get a fresh makeover as Reckitt Benckiser incorporates its newly bought KY brand into its Durex portfolio.

Niche marketer Lil’ Drug Store Products has carved out profitability in the personal lubricant space by targeting couples trying to conceive. Sales of its PreSeed lubricant were up 26.8% to $3.6 million. And the company is currently launching Replens Silky Smooth — targeting baby boomer women — to meet a demand for post-menopausal intimacy. “Research showed that 78% of Replens Moisturizer users also were using a lubricant, but many water-based lubricants tend to dry out and need to be reapplied during intimacy,” said Doug Marquardt, director of marketing for Replens. “To better enhance intimacy, Replens Silky Smooth was developed to last longer than most leading lubricants. Since Replens Silky Smooth is a premium silicone lubricant, it only needs to be applied once.”

Within the emergency contraceptive sector, the Food and Drug Administration recently ruled that generic equivalents to Teva Pharmaceutical’s Plan B emergency contraceptive can be sold alongside Plan B without any behind-the-counter merchandising restrictions or a requirement to verify the age of the purchaser. In the past year, Gavis Pharmaceuticals launched its My Way emergency contraceptive, and has thus far generated $8.1 million in sales. That has yet to make a dent into Plan B, however. Overall Plan B sales totaled $138 million, up 44.5%.

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Prescribers weigh-in on proposed label rule

BY DSN STAFF

A survey co-released by the Generic Pharmaceutical Association and the National Coalition on Healthcare reveals that 8-in-10 healthcare providers have serious concerns about a proposed Food and Drug Administration rule on generic drug labeling.

A random phone survey of 150 physicians, 150 physician assistants and 150 pharmacists conducted by Fairleigh Dickinson Universi-ty’s PublicMind on behalf of GPhA found strong reservations about many of the rule’s key provisions among all three groups.

The study comes as the FDA considers more than 100 responses to its controversial proposed rule, “Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products,” which would dramatically alter the current regulations to allow generic medicine manufacturers to change their safety labels without prior FDA review and without immediate access to the drug’s complete safety data

“Doctors, physician assistants and pharmacists are on the frontlines of health care in America, and large majorities said that provisions of the proposed rule would create confusion, take up essential time and impact their likelihood to prescribe generic drugs,” said Ralph Neas, president and CEO of the GPhA. “Most importantly, 81% of those surveyed believe FDA approval should be required prior to generic drug safety label changes.”

“The proposed rule raises significant concerns for practicing pharmacists, particularly in regard to patient confusion and effective risk counseling,” added Thomas Menighan, EVP and CEO of the American Pharmacists Association. “Pharmacists devote a great deal of time to counseling patients on appropriate medication use, and as the survey indicates, 67% of pharmacists asked are concerned that they will not have sufficient time to effectively address issues created by this proposed regulation.”

Other key findings of the study include:

  • 79% of physicians, pharmacists and physician assistants say they have heard “nothing” about the proposed rule;
  • 76% of prescribers and dispensers say their patients would be at least “somewhat confused” by the proposed changes, which would allow multiple safety labels for the same drug; 53% said it would be “very’ confusing even for themselves;
  • 71% anticipate the new rule would increase the amount of time they need to spend with patients reviewing patient history and the new labels;
  • 68% believe they would not have the time required to keep current with the labeling changes; and
  • 77% are at least “somewhat concerned” the proposed new rule could impact legal liabilities; even more pronounced among pharmacists (85%).

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Curating the life science data cloud

BY DSN STAFF

As lifetime earnings for pharmaceuticals decrease, commercialization expenses increase and payers tighten their belts on reimbursement, life science companies will be faced with shrinking margins over the next few years. In order to maintain basic operating margin levels and continue investing in research and development at current levels, life science manufacturers will be forced to reduce costs by more than $35 billion by 2017, according to results from a new survey of 70 life science organizations from the IMS Institute for Healthcare Informatics.

In order to produce cost savings and keep their businesses operationally efficient in the advent of change, IMS suggests in its new report, “Riding the Information Technology Wave in Life Sciences: Priorities, Pitfalls and Promise,” that the most reasonable approach is to adopt a strategy based on data integration and cloud-based technologies. To preserve operating margins, drug manufacturers need to incorporate new technologies and streamline the transfer and curation of data both internally and externally.

To offset rising expenditures, companies already have begun to reduce their marketing teams, outsource some of their in-house functions and adjust their drug development strategies to focus on specialty medications and therapies associated with smaller patient populations, noted the report. “We believe the large global pharmaceutical companies have more restructuring to undertake to remove costs from their business operations,” noted Murray Aitken, executive director of the IMS Institute for Healthcare Informatics. “Further efforts are needed to bring efficiencies to the commercial operations of life sciences companies.”

The authors of the report explained that the best use of the new, more efficiently packaged data housed on the cloud would be to inform future campaigns and improve multichannel marketing operations, track audience engagement and feedback through social media-based applications and patient mobile apps, and run commercial operations applications, such as those used by sales teams. Rather than spend money to produce and store company data, manufacturers could run these company functions through cloud-based applications. In addition, according to IMS, “companies typically experience a minimum of 20% to 30% on operating costs and lower total cost of ownership when moving their infrastructure to the cloud.”

Although pharmaceutical manufacturers have historically been resistant to the uptake of social and mobile applications, the report stated there is a new willingness to shift to the cloud, as cloud companies are improving compliance and becoming more sensitive to HIPAA-related issues. Plus, 74% of respondents reported a high or greater level of need to derive insights and value from data, particularly from specialty patient populations.

The report predicted that cloud-based technologies would contribute to better coordination across departments and would save time that would normally be wasted on data reconciliation; however, there could be some potential risks associated with the use of this technology, including security breaches, the intellectual property issues surrounding ownership of the data and/or the loss of control of the data, the report suggested. In addition, while the report noted that there may be a large cost associated with switching data from a “legacy” system, it does not address the costs associated with training employees on the new technology.

While the report contended “healthcare-specific data models with standardized fields are needed to merge and share patient electronic medical records,” there also could be some instances where companies don’t want to share what they consider to be proprietary data. Some pharmaceutical manufacturers don’t necessarily want competing companies to know which fields they are capturing within their forms, and some clinicians could argue that there is no such thing as a “standard” field in data collection, especially as it relates to complex medications that fall into the specialty or oncology category.

However, IMS’ Aitken predicted the adoption of integrated systems will allow for the “democratization of analysis,” and will help manufacturers make assessments and conclusions about the success or relative failure of a drug launch and its marketing activities.

“The healthcare industry is beginning to speak the language of real-world evidence,” Aitken said. “We think this is a significant step forward in helping life science companies not only understand how their products are being used but, more importantly, how they should and can be used to lower costs, as well as achieve improved patient outcomes.”

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