The Zacks Analyst Blog Highlights: Famous Dave's of America, P.F. Chang's China Bistro, Buffalo Wild Wings, Onyx Pharmaceuticals and Celgene

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Oct 05, 2011, 09:30 ET

CHICAGO, Oct. 5, 2011 /PRNewswire/ -- Zacks.com announces the list of stocks featured in the Analyst Blog. Every day the Zacks Equity Research analysts discuss the latest news and events impacting stocks and the financial markets. Stocks recently featured in the blog include: Famous Dave's of America Inc. (Nasdaq: DAVE), P.F. Chang's China Bistro Inc. (Nasdaq: PFCB), Buffalo Wild Wings Inc. (Nasdaq: BWLD), Onyx Pharmaceuticals Inc. (Nasdaq: ONXX) and Celgene Corp. (Nasdaq: CELG).

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Here are highlights from Tuesday's Analyst Blog:

Famous Dave's Steps Outside U.S.

Famous Dave's of America Inc. (Nasdaq: DAVE) recently inked a multi-unit franchise deal with Famous Ribs of Canada Ltd, a subsidiary of Tribal Councils Investment Group of Manitoba Ltd. ("TCIG"). The terms of this very first international deal signed by Famous Dave's were not disclosed. The initial location is anticipated to come up in June 2012 in Winnipeg, Manitoba.

As a successful private investment holding company, TCIG enjoys local market knowledge and has a proven track record of owning and franchising businesses in wholesale, retail, construction, health services, financial services, transportation and real estate holdings.

This deal affirms management's intent to make Canada one of the prime international markets for Famous Dave's. The Canadian market offers great growth opportunities as Canadians are appreciative of high quality food such as authentic Bar-B-Que for which the company is particularly renowned.

Since this is Famous Dave's first international venture, we foresee ample business opportunities ahead for it. In the domestic market, the company presently owns and franchises 184 restaurants in 37 states.

Earlier, Famous Dave's management thought of considering international ventures many a times, but either the timing or the deal did not resonate with the company's business plan.

Some other U.S. restaurant chains like P.F. Chang's China Bistro Inc. (Nasdaq: PFCB) and Buffalo Wild Wings Inc. (Nasdaq: BWLD) are also expanding their footprints in Canada.

Famous Dave's has stepped into the international market through a licensing agreement as it reduces the company's capital intensity. Generally under a license agreement, a company is entitled to receive an initial territory fee, store opening fees and ongoing royalty revenues based on a percentage of international restaurant sales. Minnetonka, Minnesota-based Famous Dave's is counting on these sources of income to boost its profitability.

We believe that the company is trying to spread its presence beyond the U.S. more aggressively following cut-throat competition in the rather saturated domestic casual dining market.

Onyx Seeks Myeloma Drug Approval

Onyx Pharmaceuticals Inc. (Nasdaq: ONXX) recently announced that it has completed the submission of the rolling new drug application (NDA) to the US Food and Drug Administration (FDA) for its pipeline candidate, carfilzomib. The company is seeking approval of carfilzomib as a treatment for patients with relapsed and refractory multiple myeloma. Additionally, Onyx Pharma requested the regulatory body to review the application on a priority basis.

We note that Onyx Pharma had initiated the submission of the rolling NDA in January 2011, after the FDA granted a fast track designation to carfilzomib. The company's NDA submission is based on positive results on the candidate from a mid-stage trial (003-A1).

The trial demonstrated that patients experienced an overall response rate of 24.1%, while the clinical benefit rate was higher at 34.2%. The duration of response was 8.3 months, while the median overall survival was 15.5 months. The patients, who enrolled in the study, had already received a median of five prior lines of therapy and their disease was refractory to their last therapeutic regimen.

We note that the FDA granted orphan drug designation to carfilzomib for the treatment of multiple myeloma in 2008. Following the drug's approval, this status will provide Onyx Pharma with seven years of US marketing exclusivity.

Onyx Pharma is currently conducting a randomized international phase III trial (ASPIRE or 009) which will evaluate the combination of Celgene Corp.'s (Nasdaq: CELG) Revlimid and low dose dexamethasone with or without carfilzomib in relapsed multiple myeloma patients.

The study, which is being conducted under the FDA's special protocol assessment (SPA) program, is expected to complete enrollment in the first half of 2012. Data from the study is expected to be released in the first half of 2013.

Additionally, the company is conducting a phase III study (FOCUS) to support the European filing of carfilzomib as a treatment for relapsed and refractory myeloma. Top-line data from the study is expected in the first half of 2012.

Onyx Pharma has an agreement with a Japanese company, Ono Pharmaceutical Co. Ltd., for the development and commercialization of carfilzomib and ONX 0912, in Japan. ONX 0912, the follow-on version of carfilzomib, is currently in phase I testing. Onyx Pharma plans to initiate a mid-stage trial with ONX 0912 in the fourth quarter of 2011.

We believe that the approval of carfilzomib would be a major positive for Onyx Pharma, which currently has just one marketed product, Nexavar (cancer), in its portfolio.

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