3 Things to Watch With Seattle Genetics
November 3rd, 2012 12:47 amSeattle Genetics (Nasdaq: SGEN) is a biotech company focused on the development of monoclonal antibody-based treatments for cancer. The company's antibody-drug conjugate, or ADC, technology treats cancer by sending in an antibody and an attached drug, which bind with cancer cells and stops cell division from the inside. The company currently has one drug, Adcertis, available for sale.
The company has a small field of competitors in the ADC realm. Leading that pack is ImmunoGen (Nasdaq: IMGN) with a targeted antibody payload, or TAP, technology that works similarly to ADC technology, and has led to the company striking several large partnerships to license it. Pfizer (NYSE: PFE) is in the early stages of developing its own ADC technology, even as it works on other drugs created with Seattle Genetics' technology that could become competitors for Adcertis. Medarex, a subsidiary of Bristol-Myers Squibb (NYSE: BMY) , has ADC technology and is developing monoclonal antibody drugs that could compete with Adcertis.
Here are three ways Seattle Genetics is working to expand its revenues past the currently narrow definitions of its sole drug on the market.
Geographic expansionAdcetris is a treatment that's been approved by the Food and Drug Administration for resistant forms of Hodgkin lymphoma and systemic anaplastic large cell lymphoma. The drug was approved last summer, but revenues have failed to ramp up sharply due in part to the domestic limitation of the drug.
Geographic expansion could be just around the corner. A European Commission decision is expected any day now, following a July committee recommendation, which would make the treatment available in 27 countries. Canadian approval is following right behind. Health Canada accepted the New Drug Submissionfor Adcetris back in May, and a decision is expected in early 2013.
Adcetris is a partnership between Seattle Genetics and Millennium, an oncology subsidiary of Takeda. The partnership grants Seattle Genetics the drug rights in the U.S. and Canada, and requires Millennium to pay up to $230 million in milestone payments plus a double-digit percentage of net sales from its global markets.
Expanded useExpanding the approved indications for Adcetris would also boost its revenues. Seattle Genetics' pipeline is half full of trials for new indications. There are two phase 3 trials that deserve closer attention.
The AETHERA trialtests Adcetris versus a placebo in patients at risk for residual Hodgkin lymphoma after an autologous stem-cell transplant. The study has a primary endpoint of progression-free survival, and secondary endpoints include overall survivability and safety. Data is expected in late 2013 or early 2014.
The ALCANZA trialcompares Adcetris to methotrexate or bexarotene in patients with specific mature type of t-cell lymphoma. This trial is still enrolling, so its data will come in behind ATHERA, which finished enrollment in late September.
There are also Adcetris trials in earlier stages. The potential indications include front-line HL when used in conjunction with chemotherapy, front-line HL in elderly populations, and non-lymphoma malignancies.
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3 Things to Watch With Seattle Genetics