Hunt for next Sovaldi leads to $150M deal, Poxel raises €10M, AbbVie backs AM-Pharma round

Welcome to the latest edition of our weekly EuroBiotech Report. The search for a drug that can do to hepatitis B what Sovaldi does to hepatitis C led OnCure BioPharma to Sweden to strike a $150 million (€116 million) deal with NeuroVive Pharmaceutical (STO:NVP). NeuroVive handed over the global rights to its preclinical candidate in a backloaded deal with the U.S. biotech, which was founded by former Pharmasset staffers. France's Poxel and the Netherlands' AM-Pharma both raised cash to fund midstage trials. Poxel snagged €10 million to fund its Phase IIb Type 2 diabetes trial, while AM-Pharma turned to Gilde Healthcare, AbbVie ($ABBV) and others for €12.2 million to wrap up its midstage acute kidney injury study. Several European biotechs received less positive news. Clal Biotech (TLV:CBI) and Evotec (ETR:EVT) both suffered as a result of Hyperion Therapeutics' ($HPTX) allegations of clinical trial misconduct at Andromeda Biotech. And Servier found itself on the end of a telling off by a United Kingdom watchdog, which said the French pharma's failure to publish trial results had brought "discredit" upon the industry. And more. Nick Taylor (email | Twitter)

1. Sovaldi team's new venture strikes $150M HepB deal with NeuroVive
2. AM-Pharma raises €12.2M from AbbVie, Gilde for PhII AKI trial
3. Poxel plans Asian trials of Type 2 diabetes drug after raising €10M
4. Clal Biotech, Evotec hit by fallout from Andromeda trial allegations
5. U.K. industry watchdog chastises Servier for bringing 'discredit' upon pharma

And more >>

Sovaldi team's new venture strikes $150M HepB deal with NeuroVive

NeuroVive Pharmaceutical (STO:NVP) has struck a $150 million (€116 million) hepatitis B deal with OnCore BioPharma, a startup founded by people who worked on Sovaldi at Pharmasset. The deal gives OnCore the exclusive global rights to oral formulations of NeuroVive's hepatitis B candidate.

Lund, Sweden-based NeuroVive got into antiviral drug development last year as a byproduct of its acquisition of assets from British biotech Biotica, a deal primarily focused on mitochondrial medicine. As the antiviral assets were outside its area of focus, NeuroVive began searching for a partner for the lead asset, an oral cyclophilin inhibitor called NVP018. Preclinical data suggest NVP018 may directly inhibit certain stages of hepatitis B virus replication.

OnCore CSO Michael Sofia

The data were sufficient to attract OnCore, a Pennsylvania-based biotech founded to discover a Sovaldi for hepatitis B. "We perceive considerable potential in NVP018 and consider this agreement to be an important step towards developing a successful treatment for chronic hepatitis B," OnCore CSO Michael Sofia said in a statement. "Our objective is to cure chronic hepatitis B, building on our success in hepatitis C at Pharmasset."

If the drug makes it all the way to market, NeuroVive will receive upfront payments and milestones totalling $150 million, plus royalties on sales. In its initial release NeuroVive gave no details of the upfront-to-milestone mix, prompting Nasdaq OMX Stockholm to tell the company to provide more information. The second release said the upfront payment is "nonmaterial" compared to the milestones and also emphasized the drug is still a long way from commercialization. OnCore expects to start Phase I next year. - read the first release, the follow-up and OnCore's take

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AM-Pharma raises €12.2M from AbbVie, Gilde for PhII AKI trial

AM-Pharma has snagged €12.2 million ($15.8 million) from AbbVie ($ABBV), Gilde Healthcare and other investors to take its acute kidney injury (AKI) candidate to the cusp of Phase III trials. Bunnik, Netherlands-based AM-Pharma is currently running a 290-person Phase II dose-finding study.

AM-Pharma CEO Erik van den Berg

The four-arm trial of recAP--an injectable recombinant form of alkaline phosphatase (AP)--is designed to position AM-Pharma to start a Phase III study in an indication that is draining money from the healthcare system. Data suggest AKI costs the United Kingdom's National Health Service (NHS) up to £620 million a year, which is more than the organization spends on breast cancer. The NHS is trying to cut costs and improve care by detecting AKI earlier. AM-Pharma thinks it has a therapeutic solution.

Gilde Healthcare--a €450 million fund that helped Ablynx (EBR:ABLX) and uniQure ($QURE) grow into public companies--led the latest round, giving AM-Pharma the money it needs to gather Phase II data. AM-Pharma will use the rest of the cash to advance its other clinical-stage candidate, an oral formulation of recAP for treating ulcerative colitis. An oral formulation of bovine AP came through a 21-person study in 2006, and AM-Pharma now has the means to move the drug towards Phase II. 

The fundraising comes almost exactly three years after AM-Pharma last went to the financing well. In the September 2011 Series D round AM-Pharma raised €29.2 million from investors including the venture capital wings of Abbott ($ABT) and Shire ($SHPG). A lot has changed for both companies in the intervening three years, but each still has a connection to the latest fundraising round. AbbVie was among the existing investors that contributed to the latest fundraising effort. - read the release

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Poxel plans Asian trials of Type 2 diabetes drug after raising €10M

Poxel has raised €10 million ($13 million) from new investors to advance its two Type 2 diabetes drugs through the clinic. The French biotech--which spun out of Merck Serono in 2009--will use some of the cash to start trials of its midstage candidate in Asia.

Poxel CEO Thomas Kuhn

French public investment bank Bpifrance put forward some of the cash--which was raised in an extension of the 2012 Series B round--with Kreos Capital contributing the rest through a debt facility. Poxel plans to spread the money across its pipeline. Some of the funds will go towards an ongoing Phase IIb trial of Poxel's lead candidate, oral Type 2 diabetes therapy Imeglimin. Another tranche is being set aside for starting trials of Imeglimin in Asia, with the rest going towards moving another drug into the clinic.

The Phase IIb data is the near-term focus, though. "With Imeglimin's Phase IIb final results expected in 2015, this further financing gives the company additional resources to accelerate the development of its innovative programs and to attract partners for the next development phase," Raphael Wisniewski, a partner at Edmond de Rothschild Investment Partners, which led the original Series B round, said in a statement.

Poxel committed to going through Phase II unpartnered when it completed the original Series B back in December 2012 but has been clear about its desire to find an ally for the final clinical hurdle. If positive, the publication of data from the 400-person Phase IIb trial will cause partnership talks to intensify. - read the release

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Clal Biotech, Evotec hit by fallout from Andromeda trial allegations

The fallout from an Israeli diabetes trial that allegedly involved an "unprecedented level of deceit" has hit Evotec (ETR:EVT), sending shares in the German biotech down as much as 22%. Evotec will take a charge of €8.7 million ($11.2 million) and may miss out on a €3.4 million milestone as a result of the collapse of the study.

Evotec CEO Werner Lanthaler

Hyperion Therapeutics ($HPTX) made the allegations, telling investors staff at the Israeli company it bought earlier this year--Andromeda Biotech--had colluded with a biostatistics company to manipulate data from a Phase III trial of DiaPep277. Evotec got involved with the drug--which has a long and convoluted history--in 2010 when it bought DeveloGen, a German biotech that had licensed the candidate to Teva ($TEVA) a few years earlier.

DiaPep277 is the most advanced candidate in Evotec's pipeline but is now unlikely to generate much cash for the company. The most immediate concern is a €3.4 million milestone payment Evotec is relying on to meet its goal of matching last year's earnings. "We are in talks about getting the payment and we are confident of getting it," a spokesperson for Evotec told Reuters. Hyperion is also evaluating whether it is worth mounting a legal case to recoup the $20 million it paid for Andromeda.

The data-manipulation allegations could prove to be the final chapter in the storied history of DiaPep277. Aventis paid a reported $15 million to license the drug from Peptor back in 2002, at which time the candidate was already on the cusp of Phase III. After that progress stalled and the drug changed hands a few times, eventually ending up with Hyperion. Clal Biotech (TLV:CBI) sold Andromeda to the U.S. biotech and this week wrote off NIS 506 million in the wake of the allegations.

Globes quotes anonymous sources as saying rumors of discrepancies between trial data from Israeli medical centers and published results have surfaced in the past. - read Reuters' article, Globescoverage and follow-up, plus FierceBiotech's take

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U.K. industry watchdog chastises Servier for bringing 'discredit' upon pharma

The United Kingdom's Prescription Medicines Code of Practice Authority (PMCPA) has chastised Servier for failing to comply with clinical trial data disclosure standards. PMCPA found Servier guilty of bringing "discredit upon" the pharma industry, the most serious charge it can level at a company.

Paris, France-based Servier was hit with the charge for failing to disclose clinical trial data within the timeframe set by the Association of the British Pharmaceutical Industry (APBI). The case relates to Valdoxan, an antidepressant that won approval in the European Union in 2009. An APBI-funded paper published in November 2013 first noted that Servier was behind on its disclosures of trial results, leading to a complaint from a member of the public and subsequent investigation by PMCPA.

While Servier reportedly "strongly refuted" it was guilty of breaching clause 2--which covers bringing "discredit" on the pharma industry--PMCPA saw things differently. "The panel … considered that failure to disclose meant that Servier had brought discredit upon, and reduced confidence in, the pharmaceutical industry," PMCPA wrote in its ruling. PMCPA reached the conclusion because Servier failed to publish the results even after the APBI paper, a project to which the company had contributed by providing the authors with details of its clinical trials.  

PMCPA also investigated trial disclosures by AstraZeneca ($AZN), Bristol-Myers Squibb ($BMY), Pfizer ($PFE) and other drugmakers, each of which was featured in the November 2013 APBI paper. At worst the companies were found to have belatedly disclosed results, meaning that none of them were charged with bringing "discredit" upon the industry. - read the rulings and Pharmalot's take

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Of Note:

AstraZeneca ($AZN), Boehringer Ingelheim and GlaxoSmithKline ($GSK) each presented data on drugs in their respiratory pipelines. Boehringer brought its COPD combo candidate a step closer to market with positive Phase III data, while AstraZeneca's hopes in the same indication were dented by the failure of its Phase IIa study. Finally, a Phase III trial of GlaxoSmithKline's asthma drug met its endpoints, only for an expert to question the real-world value of the treatment. AstraZeneca | Boehringer | GlaxoSmithKline

Bellevue Group bought Adamant Biomedical Investments for an undisclosed fee. Adamant is a Swiss healthcare investment group that manages CHF 831 million ($891 million). Reuters

Genmab (CPH:GEN) and Seattle Genetics ($SGEN) expanded their relationship, with the Danish biotech paying $11 million (€8.5 million) and committing to $200 million in milestones to access an antibody-drug conjugate technology. FierceBiotech

Protalix (TLV:PLX) became the latest biotech to experience an Ebola-driven jump in its stock price. The Israeli company's chief scientist sparked the surge by commenting on its ability to manufacture Ebola drugs, only for the CEO to downplay the statements and wipe out the share gains. Reuters

GlaxoSmithKline ($GSK) published positive preclinical data on the Ebola candidate it acquired in last year's $325 million buyout of Swiss biotech Okairos. Monkeys in the treatment arm survived exposure to Ebola and didn't develop symptoms, while those that received the placebo died within 6 days. FierceBiotech

Serodus completed a Phase IIa trial of its systolic hypertension candidate. The Norwegian biotech saw a drop in systolic blood pressure and no serious adverse events in the treatment arm in the short trial. Serodus bought the drug from Zealand Pharma (CPH:ZEAL) in 2010. Release

Israel's chief scientist awarded local company BiondVax Pharmaceuticals (TLV:BNDX) NIS 4.87 million ($1.34 million) to develop its universal flu vaccine. GEN

Alizé Pharma raised €5 million ($6.5 million) from Bpifrance and existing investors. The French biotech will put the cash towards two clinical trials, a Phase II study in hyperphagia related to Prader-Willi syndrome and a Phase Ib trial in Type 2 diabetes. Release

Bayer Pharma made a milestone payment to Sweden's BioInvent (STO:BINV) in relation to the enrollment of the first patient in a Phase I trial. The study is evaluating a candidate from BioInvent's antibody library. Release

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Read previous editions of the EuroBiotech Report here.

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