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Sanofi proposes to switch Cialis OTC

BY Michael Johnsen

PARIS — Sanofi and Eli Lilly and Co. on Wednesday announced an agreement to pursue regulatory approval of nonprescription Cialis (tadalafil). Cialis is currently available by prescription only worldwide for the treatment of men with erectile dysfunction.

"This agreement provides us with an opportunity to work with Lilly, a leader in men’s health, to transform how this important medicine is offered to millions of men throughout the world," stated Vincent Warnery, SVP global consumer healthcare division, Sanofi. "The opportunity to forge an industry-leading partnership that adds to Sanofi Consumer Healthcare’s leading portfolio and successful track record of over-the-counter switches reinforces consumer health care as a major growth platform for Sanofi." 

"Millions of men worldwide trust Cialis to treat ED. We are pleased to work with Sanofi to pursue a path that could allow more men who suffer from ED to obtain convenient access to a safe and reliable product without a prescription," added David Ricks, SVP Lilly, and president Lilly Bio-Medicines. "Switching a medicine to over-the-counter is a highly regulated process that is data-driven and scientifically rigorous. Together with Sanofi, we look forward to working closely with regulatory authorities to define the proper actions and necessary precautions to help patients use over-the-counter Cialis appropriately."

Under the terms of the agreement, Sanofi acquires the exclusive rights to apply for approval of Cialis OTC in the United States, Europe, Canada and Australia. Sanofi also holds exclusive rights to market Cialis OTC following Sanofi’s receipt of all necessary regulatory approvals. If approved, Sanofi anticipates providing Cialis OTC after expiration of certain patents. 

Terms of the licensing agreement were not disclosed.

Cialis was first approved by the European Medicines Agency in 2002, then by the U.S. Food and Drug Administration in 2003, for the treatment of erectile dysfunction. Ultimately, Cialis has received approval in more than 120 countries for indications that vary by country. Cialis reached $2.2 billion in worldwide sales in 2013 and has recorded total global sales of more than $14 billion since launch. 

To date, more than 45 million men worldwide have been treated with Cialis, the companies stated.

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CVS Caremark launches Specialty Connect program in all pharmacy locations

BY Antoinette Alexander

WOONSOCKET, R.I. — Looking to reinvent the specialty patient experience, CVS Caremark has announced that its Specialty Connect prescription services program is now available at all CVS/pharmacy locations.

The program leverages CVS Caremark’s retail and specialty pharmacy resources to offer patients greater choice and flexibility in how they access their specialty medications, while providing centralized clinical support.

Specialty medications treat complex conditions, including hepatitis C, multiple sclerosis, psoriasis, oncology and rheumatoid arthritis, and often require special handling, storage and administration. Historically, patients faced three key challenges when filling a new prescription for a specialty medication: submitting the prescription, having easy access to centralized expert clinical and benefits support, and navigating the logistics involved in receiving the drug. For example, as many as one-quarter of patients who tried to fill a specialty prescription at a traditional retail pharmacy faced barriers. These complications often resulted in delayed or abandoned treatment and added to the confusion that patients already face when managing a new or chronic condition.

With Specialty Connect patients have a new option to bring their specialty prescriptions to any CVS/pharmacy location, as a complement to existing specialty pharmacy processes. After initiating their prescriptions, patients receive insurance guidance and clinical support by phone from a team of specialty pharmacy experts, trained in each therapeutic area, who are available 24 hours a day, 365 days a year. The program also is designed to make it easy for patients to get their specialty drugs, whether they choose between in-store pickup at any of the 7,600 CVS/pharmacy stores nationwide or receive their medications via mail service delivery.

"Specialty Connect helps specialty patients with these critical therapies by helping to eliminate common challenges they had often faced and by offering them flexibility and choice," stated Alan Lotvin, EVP of specialty pharmacy for CVS Caremark. "The program makes it easier and more convenient for patients to submit and receive their specialty prescriptions either through CVS/pharmacy or by mail. What’s more, it increases medication adherence, improves outcomes and lowers overall health care costs for specialty patients and payors."

According to the company, Specialty Connect has demonstrated high levels of patient satisfaction as well as improved adherence for specialty pharmacy patients. In fact, pilot program results demonstrated a 13-percentage point increase (from 66% to 79%) in patients who were optimally adherent to their medication. Early program results also show that the program is improving upon the patient experience and reducing traditional barriers to getting started on medication, with 97% of patients successfully starting on therapy after only their first interaction at a CVS/pharmacy store. In addition, more than half of patients, many of whom were existing mail service pharmacy customers, chose to pick up their specialty medications at CVS/pharmacy.

CVS Caremark was awarded the 2014 Rx Benefit Innovation Award by the Pharmacy Benefit Management Institute for the Specialty Connect program.

 

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Taro posts 13.2% annual gain to $759.3 million

BY Michael Johnsen

HAWTHORNE, N.Y. — Taro Pharmaceutical Industries posted a net sales increase of 13.2% to $759.3 million for its fiscal year ended March 31. Research and development expenses increased 19.2% to $55.4 million or 7.3% of net sales.

The Company recently received approval from the Food and Drug Administration for an abbreviated new drug application for phenytoin chewable tablets USP, 50 mg. During the quarter, the company filed three aNDAs with the FDA. 

With this, aNDAs representing 27 products await FDA approval, of which one is tentatively approved.

 

 

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