Ex-Shire exec starts at Cortendo, Innate gets orphan nod, Ablynx trims in preclinical

Welcome to the latest edition of our weekly EuroBiotech Report. With AstraZeneca ($AZN) now back in play--if it chooses--talk of M&A involving European drugmakers has ratcheted up once again after a brief, post-Shire ($SHPG) lull. But Novo Nordisk ($NVO) has no plans to get involved as a buyer or seller, with the Danish company's CEO confident the company has enough in-house insulin innovation to continue growing quickly without a big buyout. Smaller deals are possible though. Sweden's Cortendo--which has a diabetes-focused subsidiary--got a new CEO this week, with former Shire executive Matthew Pauls starting at the company. Pauls has a full agenda. Cortendo is planning to go public in the fourth quarter and is trying to make up time in a Phase III trial. Ablynx (EBR:ABLX) is preparing for a Phase III trial of its lead candidate while trimming its preclinical pipeline. TiGenix (EBR:TIG) is further along with its late-stage study, the completion date for which has ebbed and flowed. Having put the date on which data is expected back from the second half of 2014 to the third quarter of 2015, the Belgian biotech has now inched its timeline forward. Innate Pharma reaffirmed its plans to advance its cutaneous T-cell lymphoma candidate into Phase I next year after the European Commission awarded the antibody orphan drug status. And more. -- Nick Taylor (email | Twitter)

1. Ex-Shire exec takes the reins at Cortendo ahead of planned Q4 IPO
2. Ablynx trims preclinical pipeline as it preps to take lead drug into PhIII
3. Innate Pharma bags orphan drug status for cancer therapy on route to clinic
4. Novo Nordisk puts faith in in-house innovation to drive growth
5. TiGenix narrows EU filing window after PhIII stem cell trial regains ground

And more >>

Ex-Shire exec takes the reins at Cortendo ahead of planned Q4 IPO

A former Shire ($SHPG) and Insmed ($INSM) executive took over as CEO of Cortendo on Monday, marking another step in the company's preparation for life on the Oslo Stock Exchange. The Gothenburg, Sweden-based biotech now expects to complete its IPO in the fourth quarter.

Cortendo CEO Matthew Pauls

Cortendo has spent all of 2014 preparing for the listing by adopting new accounting standards and reorganizing its board of directors, a process that led to former CEO Dr. H. Joseph Reiser taking over as chairman. The move created a vacancy for a CEO, which Cortendo filled on Monday when Matthew Pauls had his first day at the company. Pauls has previously worked as COO of Insmed and head of global commercial operations at Shire.

The IPO is high on Pauls' to-do list. Cortendo is now targeting a fourth-quarter IPO in Oslo, but the financial details of the plan have yet to emerge. The heavy involvement of international investors in Oslo has made it an attractive exchange for foreign companies, with Denmark's Serendex Pharmaceuticals among the overseas biotechs to list in the city. Cortendo hopes to tap into these financial resources as it advances its lead candidate through Phase III.

Enrollment in a Phase III trial of the Cushing's syndrome candidate, NormoCort, began earlier this month after study startup took longer than expected. Cortendo hopes to make up lost time by activating 45 trial sites, almost 20% more than was originally planned. A lot is resting on the trial. Cortendo is researching other drugs for Cushing's syndrome and has a diabetes-focused subsidiary, but neither program has advanced a candidate into the clinic yet. - read the release

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Ablynx trims preclinical pipeline as it preps to take lead drug into PhIII

Ablynx (EBR:ABLX) has trimmed its preclinical pipeline in recent months by opting out of a co-development project with Merck Serono and dropping an in-house severe allergic asthma candidate. The prioritization comes as the Ghent, Belgium-based biotech prepares to take its lead candidate into Phase III.

Preparations for a Phase III trial of the acquired TTP therapy, caplacizumab, are now underway, with Ablynx targeting a 2015 start. By then Ablynx could have brought a partner on board. Exploratory talks with potential partners have begun, but having raised €41.7 million ($55.0 million) earlier this year, Ablynx said it is in no rush to strike a deal.

"[We can] make decisions on partnering of assets based on medium to long-term business considerations rather than short-term financial need," Ablynx CEO Dr. Edwin Moses said in a statement. The Phase III trial is a key near-term priority, but Ablynx is also continuing to invest in its earlier-stage pipeline, with the company now claiming to have more than 30 active in-house and partnered R&D projects.

Ablynx has stepped away from some of these early-stage assets, notably by opting out of an oncology co-development deal with Merck Serono. Work on the preclinical candidate is continuing, but Merck Serono is now solely responsible for the project. Another project has stopped completely after Ablynx decided its severe allergic asthma candidate was too similar to the competition to warrant clinical trials. - read the release

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Innate Pharma bags orphan drug status for cancer therapy on route to clinic

The European Commission has granted Innate Pharma's cutaneous T-cell lymphoma (CTCL) candidate orphan drug status. And having secured the certification, the French biotech is preparing to move the cytotoxic antibody into Phase I trials.

Innate Pharma expects to start clinical trials of the drug--an anti-KIR3DL2 antibody known as IPH4102--in 2015. The drug targets the same family of killer cell immunoglobulin-like receptors--the KIR in KIR3DL2--as Innate Pharma's lead candidate, lirilumab, which Bristol-Myers Squibb ($BMY) licensed in 2011 for a $35 million upfront payment and up to $430 million in milestones. Bristol-Myers is trialing lirilumab in combination with its hot immune-oncology candidate nivolumab and its blockbuster Yervoy.

IPH4102 is now set to join lirilumab in the clinic, with Innate Pharma planning to start Phase I trials next year. Innate Pharma hopes to use the drug's orphan drug status to fast-track it through the clinic. "This decision by the European Commission validates the IPH4102 approach in a disease with significant unmet need and supports our strategy for a rapid clinical development," Innate Pharma CEO Hervé Brailly said in a statement.

In preclinical tests the drug has targeted and destroyed cells expressing KIR3DL2, an inhibiting receptor found in certain forms of CTCLs, including transformed mycosis fungoides (TMF) and Sézary syndrome (SS). Both diseases are rare--TMF only affects a proportion of the 20,000 people in the U.S. who develop mycosis fungoides--and can be aggressive. Merck's ($MRK) Zolinza is approved for treatment of some cases of CTCL, the broad class of skin-related T-cell lymphomas that include TMF and SS. - read the release

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Novo Nordisk puts faith in in-house innovation to drive growth

With Novo Nordisk ($NVO) now commanding a larger market cap than the much bigger GlaxoSmithKline ($GSK), the Danish drugmaker will have to grow quickly in the coming years to justify its stock premium. But CEO Lars Sørensen won't be panicked into a big acquisition, with the executive confident there is plenty of growth left in the company's in-house insulin pipeline.

Lars Rebien Sørensen

Boosted by a diabetes epidemic and a lack of generic competition, Novo has consistently achieved double-digit growth in insulin sales over the past decade, a track record that contrasts with the stuttering performance of its Big Pharma rivals. The expectation that Novo can maintain its performance over the rest of the decade has seen its market cap rise significantly in recent years. And while competition from the likes of Eli Lilly ($LLY) is on the horizon, Novo has faith in its pipeline.

"We can still improve the insulins, perhaps another one or two generations," Sørensen told the Wall Street Journal. "I'm not going to run out of innovation." The bullish statement contrasts with the attitude of some of Novo's Big Pharma rivals, which as a group have become increasingly reliant on third parties for innovative drugs. Sørensen said Novo has no plans to make acquisitions that are too big to finance with its own cash flow.

Striking a big deal could make Novo less reliant on the fortunes of its diabetes business, but Sørensen sees such diversification as a distraction. "Major acquisitions and major mergers like the ones being proposed are hugely distractive and often destructive," he said. The Danish drugmaker's ownership structure--in which the Novo A/S foundation has a controlling stake--has also insulated it from the threat of being bought by a bigger rival. - read the WSJ article

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TiGenix narrows EU filing window after PhIII stem cell trial regains ground

A Phase III trial of TiGenix's (EBR:TIG) Crohn's disease candidate Cx601 has regained ground, with 95% of participants now enrolled. And the advancement of the stem cell study has allowed the Belgian biopharma to narrow the window in which it expects to file for approval in Europe.

TiGenix now plans to submit an application to the European Medicines Agency (EMA) in the first half of 2016, ahead of its most recent forecasts but still much later than originally planned. As recently as May 2013, TiGenix expected to deliver data in the second half of 2014, but its timeline slipped last year. In March, TiGenix reset the date on which it expects to have data to the third quarter of 2015, but it has now edged its forecast forward again.

TiGenix CEO Eduardo Bravo

"Our Phase III trial of Cx601 is on track to deliver results earlier than anticipated," TiGenix CEO Eduardo Bravo said in a statement. Bravo expects the trial to be fully enrolled later this year, putting it on course to deliver data before the third quarter of 2015. TiGenix enrolled the first patient back in July 2012, at which time it was in talks with companies about the rights to Cx601 in the U.S. and other markets. A deal has yet to materialize, though, prompting TiGenix to raise cash to do Phase III solo.

Having offloaded stock, sold its Dutch production plant and secured debt financing last year, TiGenix thinks it has enough cash to see it through to September 2015, by which time the Phase III data should be available or imminent. If the drug can build on its performance in Phase II and close the complex perianal fistulas that affect some people with Crohn's disease, TiGenix could get its second drug approved. That is only part of the challenge though. TiGenix's first commercial drug, ChondroCelect, brought in sales of €4.3 million ($5.9 million) last year. - read the release

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Of Note:

GlaxoSmithKline's ($GSK) HIV-focused venture ViiV Healthcare won FDA approval for its three-in-one antiviral treatment. Analysts think U.K.-based ViiV could rack up annual sales of $5 billion (€3.8 billion) for the pill, which combines previously approved HIV treatments from GSK, Pfizer ($PFE) and Japan's Shionogi. FierceBiotech

Compugen ($CGEN) named Ari Krashin as its CFO. The role became vacant after the Israel Securities Authority began investigating the husband of Israel-based Compugen's last permanent CFO for insider trading. Release

NeuroDerm raised $16 million (€12 million) from existing investors to advance its pipeline of Parkinson's candidates. The Israeli biopharma has reworked existing treatments into a form that can be delivered continuously via a wearable pump or patch, an innovation it thinks can limit peaks and troughs in drug concentration. FierceBiotech

Novartis ($NVS) CEO Joe Jimenez expects biosimilar sales to take off around 2017 when a host of major biologics start to lose patent protection. As it stands biosimilars generate $500 million (€380 million) a year for Novartis. Reuters

GlaxoSmithKline's ($GSK) Ebola vaccine candidate will begin clinical trials within weeks. Testing of the vaccine--which GSK acquired in its $325 million (€246 million) buyout of Okairos--will be compressed in an attempt to have it ready for use in Ebola-affected areas as soon as possible. FierceBiotech

Erytech Pharma got the green light to continue with a Phase IIb trial of its acute myeloid leukemia drug after a data and safety monitoring board completed its second safety assessment. A further analysis for safety and futility is planned for later this year. Release

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Read previous editions of the EuroBiotech Report here.

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