PIPELINE PREVIEWS

The National Psoriasis Foundation has published new guidelines for the management of plaque psoriasis—the most prevalent form of the most common autoimmune disease in the country. The consensus guidelines from the National Psoriasis Foundation Medical Board, adapted from the Canadian Guidelines for the Management of Plaque Psoriasis to reflect U.S. practice patterns, aim to clarify when to use oral and biologic medications for people whose psoriasis requires more than topical treatment.

A table summarizing the latest research and thinking on eight drugs provides data on when and how to best use them in a way that has not been done before. In fact, the new Guidelines differ in some instances from the FDA recommendations. One example is the recommendation that cyclosporine, an immunosuppressant drug taken orally, may be used as a short-term solution for up to 12 weeks, although FDA guidelines allow its use for up to 12 months.

The new guidelines also state that ustekinumab, commonly known as Stelara, is safe and effective as a first-line therapy. Previously, its use has been limited to second- and third-line treatment.

Ulthera, Inc.—a global, growth-stage medical device company pioneering aesthetic and medical applications using its therapeutic ultrasound platform technology—will expand its operations to include the manufacturing of various components of its patented technology. This expansion, as well as continued product development and operational growth, are anticipated to create more than 100 new, high-wage jobs and result in $1.68 million of capital investment by 2014.

Ulthera will lease a 35,000 square foot building in Mesa, Arizona, which will house its manufacturing facility and its new global headquarters. As a result of the expansion, Ulthera will receive funding from the Arizona Competes Fund, and will potentially qualify for reimbursement from the state's Job Training Program under the Arizona Competitiveness Package.

The Ulthera System has been cleared by the FDA for use as a non-invasive treatment of the face to lift the eyebrow to achieve a desired aesthetic effect. The System combines ultrasound imaging with focused ultrasound therapy. It has been available internationally since 2008 and in the US since September 2009. Ulthera has sold over 800 Ulthera Systems and reports that nearly 80,000 treatments using the System have been performed.

Genentech has announced that its Erivedge^TM (vismodegib) capsule has been approved by the FDA for the treatment of adults with basal cell carcinoma (BCC) that has metastasized, has come back after surgery or that their healthcare provider has advised cannot be treated with surgery or radiation. Erivedge is the first FDA-approved medicine for people with advanced forms of BCC. It is a capsule that is taken orally once a day.

Erivedge will be available in the United States through specialty pharmacies. Roche has also submitted a marketing authorization application (MAA) for Erivedge in the European Union (EU).

Erivedge is an oral medicine designed to selectively inhibit abnormal signaling in the Hedgehog pathway, which is an underlying molecular driver of BCC. Roche and Genentech are also evaluating Erivedge in a Phase II trial in people with operable forms of BCC.

The FDA approval of Erivedge is based on results from ERIVANCE BCC (SHH4476g), an international, single-arm, multicenter, two-cohort, open-label, Phase II study that enrolled 104 patients with advanced BCC, including locally advanced BCC (71) and metastatic BCC (33).

The study showed Erivedge shrank lesions (objective response rate, or ORR) in 43% (27/63) of patients with locally advanced BCC and 30% of patients (10/33) with metastatic BCC, as assessed by independent review, the primary endpoint of the study. The median duration of response was 7.6 months.

Patients with locally advanced BCC had lesions that recurred after surgery, were not candidates for surgery (inoperable, or for whom surgery would result in substantial deformity), recurred after radiotherapy or were not candidates for radiotherapy (radiotherapy was contraindicated or inappropriate). Study participants received 150 mg of Erivedge orally, once daily until disease progression or unacceptable toxicity.