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Issue: March 25, 2016
March 25, 2016
3 min read
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Eye care market plays substantial role in Valeant’s plans for 2016

Walgreens and Valeant executives look at international collaborations beyond branded access agreement.

Issue: March 25, 2016
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The eye care market is expected to comprise 10% of Valeant Pharmaceuticals International’s business in 2016, Howard Schiller, the company’s then interim CEO, reported at the 2016 J.P. Morgan Healthcare Conference, with overall U.S. revenues expected to total $12.5 billion to $12.7 billion.

“In U.S. ophthalmology, since we bought B+L, we’ve taken our contact lens market share from 6% to almost 10%. In a tough cataract surgery market, we gained share against tough competition. Once we get the glaucoma approval later this year, we’ll have another engine for growth,” Schiller said, referring to the FDA review of Vesneo (latanoprostene bunod), a once-daily IOP-lowering single-agent eye drop for patients with open-angle glaucoma or ocular hypertension.

Ophthalmology pipeline

Latanoprostene bunod is one of Valeant’s “late-stage assets that we’re incredibly excited about,” Ari Kellen, executive vice president and company group chairman, said in the company’s presentation.

“We expect to be in label discussions later this year with the FDA. We continue to work on managed care coverage, and we have a PDUFA date on July 21,” Kellen said. “What’s interesting about this is, if approved, it will be the first novel therapy for open-angle glaucoma in over 2 decades.”

The drug, a combination of latanoprost and nitric oxide, increases aqueous outflow through both the trabecular meshwork and the uveoscleral pathway, Kellen said, with the nitric oxide playing an additional role in many functions around the body, including in the healthy eye.

“Studies have shown that patients with glaucoma have lower levels of nitric oxide than patients with normal eyes, so this is an important breakthrough,” he said.

Additionally, with regard to the U.S. devices pipeline, many products are being developed internally. “We’re working very hard, especially in the areas of unmet needs across a range of corneal and retinal diseases, to bring important programs to market,” Kellen said.

Valeant-Walgreens access program

For ophthalmics already on the market, Valeant and Walgreens Boots Alliance were scheduled to roll out a “branded access program” in January as part of a 20-year fee-for-service agreement between the companies, starting with dermatology products and later adding ophthalmology products, among others.

The goal of the brand for generic program “is to make branded Valeant drug available at generic prices and we expect that to be operational in mid-2016. The initial target is roughly 30 or so drugs,” Kellen said.

The agreement will cover ophthalmic products including Besivance (besifloxacin ophthalmic suspension 0.6%), Lotemax (loteprednol etabonate ophthalmic suspension 0.5%), Alrex (loteprednol etabonate ophthalmic suspension 0.2%), Prolensa (bromfenac ophthalmic solution 0.07%), Bepreve (bepotastine besilate ophthalmic solution 1.5%) and Zylet (loteprednol etabonate 0.5% and tobramycin 0.3% ophthalmic solution), according to an earlier company press release.

In a separate company presentation featuring executives of Walgreens Boots Alliance, Alex Gourlay, executive vice president and president of Walgreens, said of the fee-for-service agreement with Valeant, “Execution here will be critical ... to make sure that we do reduce the cost.”

Global opportunities

Both companies appear to be looking at future international collaborations.

“While we are resolutely focused on implementing the U.S. brands, and we will do that, we are already beginning discussions separately about international collaboration opportunities,” Kellen said in the presentation.

During the Walgreens Boots Alliance presentation, Gourlay said opportunities based on the 20-year deal in America could bear fruit for both companies and for consumers and payers.

“[Valeant is] a global company and we are becoming more global, and we have many opportunities across the globe to work together,” Gourlay said.

Officials from Valeant and from Walgreens declined to comment on the 20-year agreement. – by Matt Hasson and Patricia Nale, ELS

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