Two case reports published this month call attention to the evolving safety profile of Novartis’ (NVS) Gilenya for multiple sclerosis (MS).

Gallego-Pinazo and colleagues describe a case of branch retinal vein occlusion occurring in a 47-year-old woman who had been treated with Gilenya for six years (J Neuroophthalmol, Sep 2011; 31(3):292-3).

Conzett and colleagues present a case report of melanoma ex naevo occurring in a 41-year-old woman after 57 months of treatment with Gilenya (Arch Dermatol, Aug 2011; 147:991–992).

Neither of these case reports shows a causal relationship between Gilenya and the adversity.

Still, the association of Gilenya with melanoma is not new. The TRANSFROM study showed an association with cutaneous malignancies including malignant melanoma with Gilenya. In the FREEDOMS I trial, that association was not apparent. The recently completed FREEDOMS II trial will be the tiebreaker. Data are expected by the end of…

The FDA granted accelerated approval of Adcetris (brentuximab vedotin), the Seattle Genetics (SGEN) anti-CD30 antibody-drug conjugate, as salvage therapy for Hodgkin lymphoma and systemic anaplastic large cell lymphoma (ALCL).  Although this is a milestone for Seattle Genetics and the antibody-drug conjugate field, the revenue potential from these two indications is modest.

Seattle Genetics announced aggressive pricing of Adcetris ($4,500 per 50mg vial or $13,500 per average dose), in line with our estimates. 

Despite the high price and a Hodgkin lymphoma label that also includes transplant-ineligible refractory patients, the initial Adcetris indications address very small markets.

After fine tuning our model, our U.S. 2018 revenue estimate increases to $146 million from $131 million (Figure 1).

This limited potential may one day be offset by expanded use in earlier stage Hodgkin lymphoma or in CD30-positive non-Hodgkin lymphoma (phase II trial announced…

Transdermal Delivery of Sumatriptan Good for Nauseated Migraineurs

inThought anticipates FDA approval for NuPathe’s (PATH) Zelrix next week by its August 29 PDUFA date. Zelrix is a transdermal form of sumatriptan, the most commonly used oral drug for acute treatment of migraines. 

The transdermal form of sumatriptan is likely to be well received by migraine patients and their physicians.

• 50% of migraineurs experience nausea that can limit the use and absorption of oral medications. 
• Other sumatriptan formulations, including nasal sprays and subcutaneous injections, have not been successful. Zelrix appears to avoid their specific limitations.
• Zelrix bypasses the GI tract without pain or discomfort, minimizing triptan adversities.

inThought models $51 million of U.S. revenue from Zelrix its first year on the market, with sales increasing to $143 million by 2018.…

The FDA has approved Roche (RHHBY) and Daiichi Sankyo’s BRAF inhibitor Zelboraf (vermurafenib) for the treatment of unresectable or metastatic melanoma with a BRAF^V600E mutation. The companion BRAF mutation test was also approved to screen for the ~50% of patients with the V600E mutation.

The approval was widely expected, but came over two months ahead of the FDA’s October 28 PDUFA date, showing that the FDA responds well to active drugs aimed at molecularly defined patient populations. By similar logic, a timely approval of Pfizer’s (PFE) crizotinib for lung cancer is likely.

Zelboraf now joins Bristol’s (BMY) Yervoy, approved in March, as a therapeutic option for advanced melanoma. Zelboraf should see rapid uptake for BRAF mutated melanomas, although the development of resistance, typically within 6 months, will limit the drug’s potential. inThought forecasts 2018 worldwide Zelboraf sales of $314 million.…

Two promising drugs for multiple sclerosis (MS) have presented data in the last few weeks. Actelion’s (Swiss: ATLN) ponesimod is an orally available S1P receptor inhibitor similar to Novartis’s (NVS) recently approved Gilenya (fingolimod). Biogen Idec (BIIB) and Abbott’s (ABT) daclizumab is an anti-IL2 receptor antibody currently approved as Zenapax for kidney transplant rejection.

Data from a phase IIb dose-finding study of ponesimod in patients with relapsing-remitting MS support advancement to phase III trials. We assign an inThought Approvability Index (IAI) score of 53%(B) pending further analysis of the phase II study and details of the phase III protocol.

inThought estimates U.S. approval of ponesimod in May 2016, with 2018 worldwide sale of $589 million if approved.…

Data from Qnexa’s (Vivus; VVUS) phase III program released at the American Association of Diabetes Educators (AADE) yesterday do not change our cautious outlook for the drug.

• Patients treated with full dose Qnexa during the 56-week EQUIP and CONQUER trials showed statistically significant improvements in quality of life versus placebo, as measured by two surveys.
• More color will come from the FORTRESS study, a retrospective observational study of fetal outcomes of offspring of women exposed to topiramate, in the fourth quarter.
• Qnexa’s inThought Approvability Index (IAI) remains 49%(F). We estimate approval in August 2012 and forecast 2018 worldwide sales of $861 million if approved.

Also in obesity drug news, Amylin (AMLN) and Takeda have discontinued development of pramlintide/metreleptin. The decision is largely attributed to the requirement for unwieldy injections multiple times per day. 

Finally, results from the…