EU IPOs: Up on '13, down on U.S., CRUK, MedImmune to run lab, Clal sues Hyperion

Welcome to the latest edition of our weekly EuroBiotech Report. Data suggest 2014 will go down as a bumper year for biotech IPOs and follow-on offerings on European markets, but the sums are still dwarfed by the amounts raised in the U.S. Discussion of why this is and whether it will change was on the agenda again this week, with the oft-cited idea that Europeans are wary of the risks of biotech investing featuring prominently. Molecular Partners, OSE Pharma and Probiodrug hope to provide evidence against the idea by pulling off successful IPOs on European markets in the coming months. DBV Technologies (EPA:DBV) has already shown it is possible. Shares in the French biotech are up 240% since its 2012 IPO in Paris, with fresh midstage data on its peanut allergy immunotherapy driving the latest surge. The lure of the U.S. is strong, though, and DBV is planning a Nasdaq listing. MedImmune and Cancer Research UK struck a deal to set up a joint oncology laboratory in Cambridge, England. Clal Biotech (TASE:CBI) upped the stakes in its spat with Hyperion Therapeutics ($HPTX) by filing a $200 million (€156 million) lawsuit. And more. Nick Taylor (email | Twitter)

1. EU IPOs in 2014: Way up on last year but still miles behind the U.S.
2. MedImmune, CRUK to set up joint oncology lab in Cambridge
3. Clal files $200M suit against Hyperion over "rash and ill-considered" decisions
4. Midstage peanut allergy data drive jump in DBV shares
5. Trio of European biotechs mull local IPOs to top off bumper year in EU

And more >>

EU IPOs in 2014: Way up on last year but still miles behind the U.S.

There are two ways to look at the health of European biotech IPOs and follow-on offerings in 2014. One take is that companies have already raised twice as much as they did last year. The other is that Europe is further behind the U.S. than at almost any time in the past decade.

OrbiMed's Geoffrey Hsu

Dealogic data show biotechs have raised $1.4 billion (€1.1 billion) through 28 public financings on European markets this year, the Financial Times reports. The figures are a big improvement on 2013 when the amount raised fell well short of $1 billion. Allergy vaccine developer Circassia (LON:CIR) is partly responsible for the gains--its £200 million London float is the biggest biotech IPO anywhere this year--but Horizon Discovery (LON:HZD), arGEN-X (EBR:ARGX) and others also raised significant sums.

In isolation the data are encouraging for European biotechs, but they compare unfavorably to the U.S. Biotechs have raised almost $4 billion through 43 financings on markets across the Atlantic. While Europe has regained some ground compared to 2013, it is still further away from the amount raised in the U.S. than at any other time over the past 10 years. As recently as 2007 and 2008 biotechs raised more on European markets than in the U.S., but a chasm has formed since 2011.

"When I go to London and explain the biotech growth story they view the sector as very risky. There have been some failures that still color perceptions even though the sector has changed a lot in the past decade," OrbiMed partner Geoffrey Hsu said. This is a well-established take on investors in Europe that some within the region think is somewhat outdated. Executives at Midatech and Nucana--British biotechs that are mulling IPOs--talked up the improved outlook in London. - read the FT feature (sub. req.)

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MedImmune, CRUK to set up joint oncology lab in Cambridge

Cancer Research UK (CRUK) has continued to deepen its ties to drug developers by agreeing to set up a joint laboratory with AstraZeneca's ($AZN) biologics subsidiary MedImmune. The agreement will see CRUK's commercial arm, Cancer Research Technology (CRT), work alongside MedImmune at a facility in Cambridge, England.

MedImmune VP Jane Osbourn

Scientists from CRUK and MedImmune will work together at the site--called the CRUK-MEDI Alliance Laboratory--for at least the next 5 years. CRUK is providing money to set up and run the facility, as well as contributing a team of scientists and a portfolio of drug targets. In return, MedImmune will manage the laboratory and provide access to technology, notably human antibody phage display libraries and established antibody-engineering tools.

MedImmune's VP of R&D, Jane Osbourn, thinks the arrangement benefits both parties. "CRUK will have access to MedImmune's capabilities and technology to help them develop preclinical candidates, while MedImmune will benefit from access to CRUK's principal investigators and scientists," Osbourn said in a statement. CRUK hopes to enter into more novel biologic drug development collaborations in the future.

The deal marks the first time CRT or MedImmune has committed to such a partnership, but both organizations have been moving in this direction for some time. CRT has formed or expanded alliances with Astellas Pharma, AstraZeneca and Teva ($TEVA) over the past 18 months. Similarly, MedImmune has formed a cancer imaging collaboration with the University of Cambridge, while its parent company AstraZeneca is working with the Medical Research Council to open an R&D site in the city. - read the release, PMLiVE's take and Pharmafile's coverage

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Clal files $200M suit against Hyperion over "rash and ill-considered" decisions

The four-way spat between Andromeda Biotech, Clal Biotechnology (TASE:CBI), Evotec (ETR:EVT) and Hyperion Therapeutics ($HPTX) is starting to get even uglier. Clal has fired the first legal shot, filing a $200 million (€156 million) suit against Hyperion and alleging the U.S. biotech made "commercially unreasonable, rash and ill-considered" decisions.

Tel Aviv, Israel-based Clal--which sold Andromeda to Hyperion--filed the suit in a Delaware court after reviewing documents relating to the clinical trial at the center of the controversy, Globes reports. Clal asked Hyperion to share files to substantiate claims of misconduct by Andromeda employees. As Clal sees it, the documents fall short of being a smoking gun. And even if Andromeda is guilty of misconduct, Clal has grievances with how Hyperion handled the situation.

With the events having caused Clal's share price to sink almost 50% over the past month, the company is seeking damages. "Hyperion's breach of the share purchase agreement and conduct have caused substantial damage to [Clal] (which was reflected by a sharp drop in its market capitalization), other stakeholders and the future of the drug," the Israeli biotech wrote in its lawsuit. News of the court actions comes one week after Evotec said it was willing to take legal steps against Andromeda. - read Globes article and its follow-up

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Midstage peanut allergy data drive jump in DBV shares

DBV Technologies (EPA:DBV) has posted encouraging data from a midstage clinical trial of its peanut allergy immunotherapy. More than half of the 6- to 11-year-old kids who received the highest dose of the patch-delivered drug for 12 months became desensitized to peanuts.

DBV CEO Dr. Pierre-Henri Benhamou

The result was sufficient for the trial to hit its primary endpoint, at least among kids who received the highest dose. A lower proportion of adolescents, adults and children who received smaller doses were desensitized by the end of the trial, although data suggest some teenagers reacted positively to the therapy. Investors focused on the encouraging aspects of the 221-person trial--which included strong adherence to the daily dosing regimen--sending shares in DBV up more than 20% in Paris.

Bagneux, France-based DBV now plans to advance the candidate--called Viaskin Peanut--into Phase III in the first quarter of 2016. By then DBV hopes to have raised $96 million (€75 million) through a Nasdaq listing of American Depositary Shares. The listing will give DBV--which floated in Paris in 2012--a way to raise money from U.S. investors. DBV has yet to release a full breakdown of how it will spend the $96 million, but taking Viaskin Peanut through to submission is at the top of its list of priorities.

Some of the cash will go toward adding U.S. clinical and commercial infrastructure, with the rest being allocated to development of early-stage products. Viaskin Milk is the most advanced of the other candidates. DBV thinks the Nasdaq listing will give it enough money to complete a Phase II trial of Viaskin Milk, with some left over for its eosinophilic esophagitis, pertussis booster vaccine and birch pollen allergy programs. - read the trial release and F-1

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Trio of European biotechs mull local IPOs to top off bumper year in EU

While the European biotech IPO market has remained a distant second to the U.S. in terms of volumes and value, there is still time for 2014 to become by far the region's biggest year in the past decade. The likelihood of such an outcome increased after Swiss biotech Molecular Partners, France's OSE Pharma and Germany's Probiodrug revealed plans to list on European exchanges by the end of 2014.

Molecular Partners CEO Dr. Christian Zahnd

With Dealogic data showing the value of biotech IPOs and follow-on offerings in Europe is above $1 billion (€776 million) for the first time since 2007, the listings of Molecular Partners--a 2014 Fierce 15 company--Probiodrug and OSE Pharma could push the region to new highs. Probiodrug and OSE Pharma have yet to disclose how much money they hope to receive, but Molecular Partners' plans are ambitious enough to add significantly to the amount raised in Europe this year.

The Swiss biotech is aiming to raise CHF 125 million ($133 million) on its local exchange before a possible overallotment. If Molecular Partners achieves its goal, the IPO will be the second biggest biotech listing in Europe this year and one of the largest anywhere in the world. The IPO will be the first time Molecular Partners has raised capital since its 2009 Series B round. Since then cash from deals with Roche ($RHHBY), Johnson & Johnson ($JNJ) and Allergan ($AGN) have kept its coffers filled.

Molecular Partners plans to use the cash injection to develop its own candidates from its genetically engineered protein platform, while also bolstering its pipeline and technologies through acquisitions and licensing deals. The company has a handful of in-house programs, the most advanced of which is a Phase I solid tumor candidate.

Probiodrug and OSE Pharma are more advanced. OSE Pharma plans to list in Paris to raise cash for a Phase III trial of its immuno-oncology asset, while Probiodrug is heading to Amsterdam, the Netherlands, to finance its midstage Alzheimer's study. - read Reuters' take on Molecular Partners, Probiodrug and OSE Pharma, plus FierceBiotech's coverage

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Of Note:

Sanofi ($SNY) renewed its agreement with Genfit (EPA:GNFT). The renewal positions Genfit to receive bigger milestones from the collaboration, which the companies entered into in 2011 to discover and develop drugs to correct mitochondrial dysfunctions linked to Type 2 diabetes and other metabolic disorders. Release (PDF)

A pair of European biotechs received orphan drug designations. The European Medicines Agency granted the status to Sweden's OxThera's treatment for short bowel syndrome. Berlin-based Noxxon Pharma's glioblastoma therapy was given the orphan drug nod by FDA. OxThera | Noxxon Pharma

Shares in Galmed Pharmaceuticals ($GLMD) jumped more than 35% after the FDA awarded its nonalcoholic steatohepatitis (NASH) candidate fast-track status. The Israeli biotech is racing against Intercept Pharmaceuticals ($ICPT) and Genfit (EPA:GNFT) to develop a NASH treatment. Globes

Foamix Pharmaceuticals ($FOMX) became the latest Israeli biotech to experience a bumpy start to life on public markets. The dermatology drug developer initially hoped to raise $65 million (€51 million) by selling shares at $11 a pop but ended up bringing in $40 million. In contrast, Dutch biotech ProQR ($PRQR) raised $98 million, significantly more than it originally targeted. FierceBiotech

Nicox set its sights on achieving blockbuster sales of its glaucoma drug after posting positive Phase III data. The French company will co-promote the drug in the U.S. with partner Bausch + Lomb. Reuters | FierceBiotech

Medigene (ETR:MDG1) subsidiary Trianta secured public funding for its immunotherapy platform, TABs. The grant covers 40% of the cost of a project to investigate T-cell leukemia and autoimmune diseases. Release

Parisien biotech Nanobiotix opened an office in Boston, MA. The expansion is intended to put Nanobiotix closer to industrial and financial communities in the U.S. Patrick Tricoli joined from Sanofi ($SNY) to lead the expansion. Release

Zeltia (BME:ZEL) revealed plans to license its cancer drug PM1183 to a large pharmaceutical company. Negotiations are underway. PM1183 is set to enter a Phase III trial in patients with ovarian cancer. CincoDias (Spanish)

Adaptimmune pulled off a $104 million (€82 million) Series A round to finance development of its T-cell receptor technology. News of the round came days after Adaptimmune was named as one of 2014's Fierce 15. FierceBiotech | More

Sobi (STO:SOBI) added a preclinical hemophilia program to its collaboration with Biogen Idec ($BIIB). Biogen gained access to the program through the $39 million (€31 million) deal it struck with Amunix in April. Release

Zealand Pharma (CPH:ZEAL) removed ZP1480 from its pipeline after AbbVie ($ABBV) discontinued development of the drug. AbbVie made the decision after reviewing data from a Phase II trial. Reuters

BioCancell (TASE:BICL) reported data from a small trial of its bladder cancer drug. Around two-thirds of patients had no recurrence of malignant tumors in the three months after beginning treatment with a combination of BioCancell's BC-819 and Bacillus Calmette-Guérin. Globes

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