ContraVir expands hep B portfolio with Ciclofilin acquisition

NJ-based ContraVir has bought out the privately held early-stage biotech Ciclofilin Pharmaceuticals to get hold of its lead hep B product CPI-431-32.

The drug, which is currently in preclinical testing, is a cyclophilin inhibitor designed to treat chronic hepatitis B (HBV) by lowering the levels of the virus as well as potentially reducing the level of liver scarring from the disease, which can lead to liver failure and cancer.

ContraVir said in a statement that it will acquire all of the outstanding equity interests in Ciclofilin for the right to get hold of future milestone payments, which will consist of up to an aggregate $17 million cash and up to 10% of ContraVir's issued and outstanding common stock as of the closing date of the merger.

This will be paid when certain developmental and/or regulatory milestones related to CPI-431-32 are made--although the drug has not yet started human testing.

Once the merger has been formally signed and sealed, Ciclofilin's founder and CEO Robert Foster will join ContraVir in the role of CSO, and will continue leading the development of CPI-431-32 into IND-enabling studies.

The merger is set to expand and strengthen ContraVir's own portfolio of complementary antiviral candidates targeting HBV, which includes CMX157, a lipid conjugate of tenofovir, currently undergoing Phase Ib/II clinical trials. 

ContraVir will remain headquartered in Edison, NJ, and will acquire Ciclofilin's R&D facilities in Edmonton, Canada.

James Sapirstein, CEO of ContraVir, said: “Completing this strategic transaction will firmly position ContraVir as an important player in the hepatitis B space. Similar to our clinical stage candidate CMX157, we will add to our portfolio what we believe is a superior molecule that improves significantly upon the established efficacy and safety of the class of compounds from which it is derived, thereby enhancing its clinical utility as an antiviral. 

“Furthermore, the mechanism of action of CPI-431-32 is complementary to CMX157, each inhibiting distinct critical steps in the viral life cycle, adding robustness to our HBV portfolio. We look forward to completing the merger and to continuing the pre-clinical development of CPI-431-32 in preparation for potentially entering the clinic in 2017.”

Foster added: “CPI-431-32 is positioned to be the leading non-immunosuppressive cyclophilin inhibitor antiviral for the treatment of hepatitis B. My team and I are excited to join ContraVir to accelerate development of this asset, based on ContraVir's deep understanding of HBV and clear dedication to providing needed therapies for this complex, chronic infection. 

“Both CPI-431-32 and CMX157 have demonstrated best-in-class potential and have the benefit of positive clinical experience using related compounds, creating a very strong hepatitis B pipeline.”

There are already a number of Big Pharma companies in the hep B space, with Gilead ($GILD) already marketing Viread (tenofovir disoproxil fumarate)--which made just over $1 billion in sales last year--with older treatments in the form of Bristol-Myers Squibb's ($BMY) Baraclude (entecavir) and Roche's Pegasys (peginterferon alfa-2a).

Earlier this year, Gilead presented data showing its next-gen, once-daily hep B treatment tenofovir alafenamide (TAF) was as effective as Viread--but, crucially, was safer for patients.,

The French biotech upstart Enyo Pharma also raised $24 million in Series A financing in February to begin Phase I trials for its candidate EYP001, in combination with currently approved viral polymerase inhibitors--i.e., Gilead curative hep C drugs Harvoni and Sovaldi--which is expected to cure hep B after a 6-month treatment, according to the company.

Current medicines cannot cure but simply manage the disease. This means any new drug that could eradicate the condition and/or reduce liver scarring would likely be highly successful--and potentially reach the dizzying sales heights seen with Harvoni and Sovaldi.

On potential patient numbers, hep C has around half the prevalence of hep B, with WHO estimating that about 3% of the world's total 7.4 billion population has been infected, with more than 170 million chronic carriers who are at risk of developing liver cirrhosis and/or liver cancer, compared to the 350 million with chronic hep B.

While there is no hep C vaccine, there are immunization programs against hep B, such as Glaxo’s ($GSK) Engerix-B and a marketed program from Merck ($MRK), but this will not help those already infected, and the patient pool awaiting a cure remains huge.

- check out the release

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