Will The Beacon Light Up Nektar?

(RTTNews) - Breast cancer is the most common cancer among women in the United States, other than skin cancer. The American Cancer Society estimates that there will be about 231,840 new cases of invasive breast cancer and 62,290 new cases of non-invasive breast cancer in 2015. Thanks to increased awareness and improved treatment, the death rates from breast cancer are said to have been on the decline since about 1989.

Awaiting topline data from a pivotal breast cancer study is Nektar Therapeutics (NKTR).

The clinical trial in focus, dubbed BEACON, is a phase III, head to head study comparing Nektar's investigational drug NKTR-102 to Treatment of Physician's Choice in patients with recurrent or metastatic breast cancer previously treated with cytotoxic chemotherapy regimens.

Unlike anticancer agents that target microtubules, which is the most common mechanism, NKTR-102 works by inhibiting topoisomerase I, an enzyme involved in unwinding of the DNA. Since the DNA cannot replicate normally without topoisomerases, the inhibition of topoisomerases can stop the proliferation of malignant cells. NKTR-102 is also designed to address potential cross-resistance and overlapping side effects of existing therapies.

The BEACON Study completed enrollment of 864 patients in August 2013, and topline data are expected next month.

Beyond breast cancer, NKTR-102 is also being explored in the indications of glioma, small cell and non-small cell lung cancers.

An investigator-sponsored phase II study of NKTR-102 in patients with Avastin-refractory high-grade glioma was successfully completed last May, with 55% of patients achieving six-week progression-free survival and 15% of patients achieving partial response.

Another investigator-sponsored phase II study of NKTR-102 in non-small cell lung cancer is also underway.

Nektar has a deep and diverse pipeline - with 6 clinical stage drug candidates and 8 preclinical programs.

Let's take a look at Nektar's other anticipated milestones for this year...

MOVANTIK, licensed to AstraZeneca plc (AZN), was approved by the FDA last September for the treatment of opioid-induced constipation in adult patients with chronic non-cancer pain. The drug is expected to be launched in the U.S. in Q1/Q2 of this year.

Two months after getting the go-ahead in the U.S., the drug was approved in the European Union under the brand name MOVENTIG. The drug is scheduled to be launched in the EU next quarter. (Q2-2015).

Nektar will receive $100 million from AstraZeneca when MOVANTIK is launched commercially in the United States and $40 million upon the European commercial launch of MOVENTIG.

The company is slated report phase I data for NKTR-171, a new sodium channel blocker being developed as an oral therapy for the treatment of peripheral neuropathic pain, in Q3-2015. The phase I study is assessing the pharmacokinetics and safety of NKTR-171 in healthy subjects.

Nektar's advanced polymer conjugate technology is used in two separate development collaborations with Baxter International Inc. in haemophilia.

The lead program is BAX 855 (Longer-acting ADVATE), a PEGylated recombinant FVIII molecule, which utilizes Nektar's proprietary PEGylation technology and Baxter's proprietary plasma and albumin free platform.

Baxter submitted a biologics license application to the FDA seeking approval of BAX 855, for hemophilia A last December. The regulatory agency's decision on BAX 855 is expected in Q4 2015. If all goes well as planned, BAX 855 may be launched the same quarter.

The company is scheduled to report its financial results for the fourth quarter and year-ended December 31, 2014 on Tuesday, February 24, 2015.

The last time we profiled Nektar was on June 7, 2013, and it was trading around $9.10 then. The stock rallied in the succeeding months and touched a high of $17.53 on December 2, 2014, representing a gain of 93%.

NKTR is now down 22% from its 52-week high of $17.53 and trades around $13.65. Will Nektar's fortunes move up on the BEACON study results? Stay tuned...