June 15, 2016
By Mark Terry, BioSpace.com Breaking News Staff
UK-based Ziarco Pharma Ltd. is looking for a buyer, according to inside sources. The company is reportedly working with Rothschild & Co. on a deal, which could run more than $1 billion, although, according to Bloomberg, “with part of that coming from an upfront payment and the rest through royalties and after the company achieves certain targets, one of the people said.”
Because one of Ziarco’s investors is Pfizer Venture Investments, there is some speculation on whether Pfizer might be interested, although Allergan (AGN)’s focus on dermatology would probably make more sense, assuming Allergan were interested. Other investors include Amgen (AMG)’s Amgen Ventures, and Lundbeckfond Ventures, which is a shareholder in Danish companies H. Lundbeck A/S and ALK-Abello A/S.
Canadian company Valeant Pharmaceuticals (VRX) would have seemed like a good candidate, given its focus on dermatology and merger-and-acquisition activities, but with the company in disarray, facing numerous investigations and under the new leadership of former Perrigo boss Joe Papa, that seems unlikely.
Earlier this week, Ziarco reported positive Phase IIa results for ZPL-389 in moderate to severe atopic dermatitis. ZPL-389 is a once daily oral histamine H4 receptor antagonist.
“The effect of ZPL-389 on inflammation is significant and the effect does not seem to have plateaued after eight weeks of treatment,” said Thomas Werfel, the principal investigator of the study, with the Hannover Medical School in Germany, in a statement. “In addition, the various improvement in pruritus seen with ZPL-389 versus placebo are extremely encouraging. I am looking forward to seeing the outcome of the longer 12-week Phase IIb trial that is planned to start later this year. The impact of atopic dermatitis on patients’ lives is significantly debilitating and this drug could be transformational.”
Despite this, analysts are not completely on board. Writing yesterday, Seeking Alpha said, “Ziarco’s oral atopic dermatitis contender ZPL-3893787 failed to meet its primary endpoint in a proof-of-concept trial, so the company must hope that signs of efficacy will be enough to help it reel in a partner. The private UK group highlighted secondary endpoint success and said it would start a Phase IIb study in the second half of this year. The question is whether this is good enough to secure a partner for ZPL-389.”
Seeking Alpha notes that Ziarco and ZPL-389 would be entering the market opposite Sanofi (SNY)/Regeneron (REGN)’s interleukin inhibitor dupilumab, which is expected to be the first systemic drug to be approved for atopic dermatitis. Sanofi and Regeneron are planning to file for approval in the third quarter of this year.
Also, Johnson & Johnson (JNJ)’s toreforant is in Phase II for asthma and psoriasis.
As a potential buyer, Seeking Alpha notes that “Pfizer, which licensed ZPL-389 to Ziarco back in 2012, recently acquired Anacor Pharmaceuticals (ANAC) and its eczema cream crisaborole, which is under review by U.S. regulators—perhaps decreasing its appetite for further dermatology deals.”
Ziarco’s chairman, Mike Grey, told EP Vantage that “Dupilumab, as an injectable biologic, will be conserved for the most severe patients. The average body surface area affected in our Phase II study was 44 percent—if you can imagine having to apply a topical treatment to half your body twice a day, you can see that an oral drug would be very attractive to patients.”
“More data could help secure a partner,” writes Seeking Alpha, “but Ziarco is already seeing ‘a lot of interest from companies,’ says the chairman. ‘So while we’re preparing to start a Phase IIb study by the end of this year … we could be persuaded to think about an alternative course.’ But for now, bigger companies might be wary of Ziarco.”
