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Anthera Could Be The Next Billion Dollar Biotech

Anthera Pharmaceuticals

Written by Ophir Gottlieb, 10-11-2015

Anthera Pharmaceuticals (ANTH) is focused on developing and commercializing drugs for serious and life-threatening diseases including systemic lupus erythematosus and exocrine pancreatic insufficiency due to cystic fibrosis. The company has no revenue and no products to market but it it does have a pipeline of two late-stage candidates – Sollpura and Blisibimod (Source: ZACKS).

This is a biotech to recognize right now, in its early stages. It has a market cap of under $250 million with drugs that very well could propel it to over a billion dollar valuation.

Blisibimod (Lupos Treatment)
Interestingly, Blisibimod was initially developed by Amgen and was subsequently acquired by Anthera Pharmaceuticals (Source: Anthera Press Release).

As of yet the causes of Lupus are still unknown, but a growing body of evidence suggests that inhibiting B-cell activation can improve disease symptoms and that's what ANTH is after with Blisibimod. This drug is in the most advanced clinical program for ANTH, and if there's a "hold your breath and wait" candidate, this is it. Anthera expects the full data from its Blisibimod trial in Lupus to be available in the second half of 2016 (Source: The Motley Fool).

There is a significant risk in any drug that is yet to receive FDA approval but at the same time, there is a substantial need for new lupus treatment options. Benzinga reported on Citi analyst Yigal Nochomovitz:

"The Phase 3 trial for Blisibimod for systemic lupus erythematosus is enrolling more severe patients who benefited in prior SLE trials. “This suggests 1) enhanced prospects for Ph3 success and 2) higher penetration of the target market vs. Benlysta"
(Source: Benzinga).

Blisibimod is currently being tested in a Phase 3 study, CHABLIS-SC1, for Systemic Lupus Erythematosus, and a Phase 2 study, BRIGHT-SC, for IgA nephropathy.

On July 14th, 2014, ANTH acquired Sollpura (liprotamase), a novel investigational Pancreatic Enzyme Replacement Therapy ("PERT") from Eli Lilly (Source: Anthera Press Release).

Here's how the company positions Sollupra:

Sollpura is potentially the first soluble, stable and non-porcine derived enzyme product intended for the treatment of patients with low digestive enzyme levels, or Exocrine Pancreatic Insufficiency (EPI), due to cystic fibrosis, and potentially other diseases.

EPI is estimated to afflict more than 150,000 patients in the United States alone, with more than $600 million spent on enzyme replacement therapy annually.

(Source: Anthera Press Release).

The PERT market is dominated by Creon, but the novel approach ANTH is taking with Sollpura has caught the eye of the investing world. Sollupura, in English, makes it significantly easier to digest the medication. Citibank reports that "the company should be able to witness significant adoption of Sollpura, given its differentiating features of 'pill burden reduction for adults' and 'powder formulation for paediatrics' (Source: Benzinga).

Conclusion: Let's Talk Dollars
In that same report published by Benzinga, Citibank estimated the size of the market for Sollupura to be between $240 million - $330 million depending on market share. Those revenue numbers are larger than ANTH's entire market cap. FDA approval targeted for 2018 and adoption are huge risks, but let us also not forget that the big gun here is not Sollpura, but rather Blisibimod, which is being tested for two different treatments.

Other Facts
On September 14th, 2015, Anthera was notified that its Blisibimod partner in Japan had terminated its agreement because "Progress of blisibimod in Japan, particularly for IgA nephropathy, has been disappointing. (Source: GlobeNewswire. Note, the disappointment was not based on results for Lupus but rather the Phase II trial for the alternative treatment.

Anthera reacted rather positively to the news, stating that the firm was "excited" to regain worldwide control of Blisibimod development. For now, ANTH is a micro-cap biotech with two very promising treatments in various stages of FDA trials. Blisibimods Lupus results coming out from Phase III trials should be delivered sporadically until the end-all be-all results next year. Sollpura will be a multi-year undertaking, but it too shows great promise.

While Anthera is hardly the type of a company one would consider a "core equity holding," it is a promising pharma, with real drugs in the pipeline each making significant progress and showing quite promising data. While the company is funding operations by selling stock and there is a risk that all fails, for now, a $240 million market cap pharma shows at least the promise of a multi-billion dollar firm in the future.