Allos THx | Significant Milestone Achieved!!!

Now, some 48-hours later, it may be considered old news that Allos Therapeutics (NASDAQ: ALTH) received from FDA accelerated approval for Folotyn™ (pralatrexate) for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). Folotyn™ is the first and only drug approved by FDA for PTCL and represents a new treatment option for patients with relapsed or refractory PTCL. Allos anticipates entering the market with Folotyn™ in the US in October. The sound of champagne corks popping can be heard echoing up and down the Front Range as the Colorado life science ecosystem celebrates this significant and important milestone and simultaneously breaths a collective sigh of relief.

Let’s then take a bit of a closer look at Allos, their approved product, market and pipeline, shall we? (As always…if there is any erroneous data or statements identified and requiring correction please leave a comment below or email arubenstein@rnaventures.com and we will update with or without (your choice) attribution).

Hematological malignancies account for approximately 15% of all cancers and are categorized into four groups, 1. Multiple Myeloma, 2. Myelodysplastic Syndromes, 3. Leukemia – which includes acute myeloid, acute lymphoblastic, chronic myeloid, and chronic lymphocytic leukemia, and 4. Lymphoma – which is divided into Hodgkin’s and non-Hodgkin lymphoma. NHL is further grouped into:

• Cutaneous T-cell lymphoma
• Follicular lymphoma
• Mantle cell lymphoma
• Diffuse large B-cell lymphoma, and
• Peripheral T-cell lymphoma
  

According to the American Cancer Society, non-Hodgkin lymphoma incidence has grown 3.8% from 2005 to 2009. The US PTCL market is growing at an estimated incidence rate of 5% due, in part, to increased PTCL awareness; the addressable market is approximately 80-90% of estimated first-line patients treated (according to Allos), or more specifically of ~6,800 patients forecasted in 2013, ~6,200 are treatable. It has been reported that single agent treatments prescribed off label for PTCL average approximately $76,000 per patient per therapeutic and therefore one may calc the total addressable market at ~$516M to $471M per year – NOTE: this is not a market forecast for Folotyn™.

Allos maintains exclusive worldwide commercial rights to Folotyn™ for all indications and their exists the potential for co-promotion or out-licensing to reach EX-US markets. The composition of matter patent protection is in place till 2017 in the US and EU with the potential for an additional 5-year extension under Hatch-Waxman. Additional potential hematological malignancy indications for Folotyn™ that are under clinical investigation include B-cell non-Hodgkin’s lymphoma, non-Hodgkin’s lymphoma and cutaneous T-cell lymphoma, and in solid tumor indications for bladder cancer and non-small cell lung cancer.

Folotyn™, a next generation chemotherapy, is a rationally designed, for improved cancer cell uptake and retention, anti-folate. The mechanism of action of Folotyn™ is a folate analog that inhibits folate metabolism by binding to and inhibiting the enzyme DHFR. Folotyn™ has high affinity for the RFC-1 protein and is an efficient substrate for polyglutamation by the enzyme FPGS. Polyglutamated Folotyn™ has a prolonged intracellular half-life, which allows for prolonged action in malignant cells. The relative increase in cellular uptake by RFC-1 and differences in polyglutamate formation may account for the enhanced activity of Folotyn™.


Some additional players in the hematological malignancy market include Biogen Idec (NASDAQ: BIIB) who markets with Roche (VTX: ROG.VX) Rituxan® for non-Hodgkin’s lymphoma; Novartis (NYSE: NVS) who markets Gleevec® for chronic myeloid leukemia, and; Wyeth (Pfizer) (NYSE: WYE) who markets Mylotarq® for acute myeloid leukemia.

It will be fascinating to observe Allos evolve from a development-stage company to a commercial-stage entity. Needless to say this is an incredible achievement – bringing a new treatment option to market for patients with relapsed or refractory PTCL.

FDA Allos pic courtesy of http://topnews.us