Stock Alert for Allos Therapeutics Inc. (ALTH)
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    Top Biopharm Alert – Allos Therapeutics Rebounds on Potential Expansion of Folotyn Reach

    Allos Therapeutics Inc. (NASDAQ: ALTH) soared 6.45% to $3.30 during the afterhours session yesterday, gaining nearly 5% in today’s early trading as the company’s results for Q4 2010 run above the analyst expectations. In addition, Allos announced that the Food and Drug Administration (FDA) agreed on phase III clinical trial of its lead drug Folotyn in patients with previously undiagnosed peripheral T-cell lymphoma (PTCL).

    The company has lost 28% since the beginning of 2011 after the announcement that it was laying off 13% or 25 jobs in order to focus the resources on the promotion and commercialization of lymphoma drug Folotyn.

    Allos is a biopharmaceutical company committed to the development and commercialization of innovative anti-cancer therapeutics. The company is focused on the development and commercialization of Folotyn (pralatrexate injection), which was approved by the FDA in September 2009 for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma. In fact, Folotyn is currently the only drug approved for PTCL, but it is for patients whose disease had stopped responding to chemotherapy.

    Following the commercial launch of Folotyn in January 2010, the company started to report meaningful revenue and significant sequential growth that outperformed the analyst estimates.  For Q4 2010, revenue increased 27% sequentially over Q3 2010 to $11.7 million and topped 35.2 million for full year 2010.

    Net loss for Q4 2010 and full year 2010 were $18.1 million and $77.4 million, or $0.17 and $0.74 per share, respectively. Analysts, polled by Thompson Reuters were expecting Allos to lose $0.18 on revenue of 11.2 million in Q4 2010.

    As of December 31, 2010, the biopharmaceutical company had cash and investments totaling $98.6 million, and virtually no debt.

    Allos retains exclusive worldwide rights to Folotyn for all possible indications and is currently developing it in other hematologic malignancies and solid tumors. Recently, the company obtained the FDA agreement to initiate phase III trial of lymphoma drug in previously untreated patients with PTCL, as part of the first line treatment. This clinical trial will seek to establish the safety and efficacy of sequential Folotyn versus observation in patients with PTCL who have achieved a response following initial treatment with CHOP (cyclophosphamide, doxorubicin, vincristine and prednisone) or CHOP-based chemotherapy. The study, which could commence this year, has the potential to significantly expand the drug’s marketing reach.

    Besides, the biopharmaceutical company plans to pursue regulatory approval to market Folotyn in the European Union for relapsed or refractory PTCL. The company’s Marketing Authorization Application was already accepted for review by the European Medicines Agency in December 2010. According to the company, the current annual incidence of PTCL is approximately 5,900 patients in the U.S. and approximately 6,000 to 7,000 patients in the top five European markets.

    According to Thompson Reuters, analysts expect Allos to narrow its losses in 2011 to $0.48 a share on revenue of $63.2 million. The solid initial adoption of Folotyn in the U.S. during the first full year of commercialization, as well as the pending expansion of the drug in the EU could suggest a stronger growth of Allos’ revenue in 2011. Moreover, the completion of the announced strategic partnership to accelerate the drug distribution outside the U.S. could further add to the company’s valuation.

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