Amgen (NASDAQ: AMGN) has claimed  gaining regulatory approval for its biosimilar of Humira, AbbVie's (NYSE: ABBV) mega blockbuster anti-inflammatory drug. The Big Biotech reports now that its clone of Humira--dubbed ABP 501--hit its marks on equivalency for efficacy and safety for treating plaque psoriasis. 

Amgen didn't spell out the actual data, but it declared victory in the first of two planned Phase III studies comparing its follow-on drug with Humira (adalimumab), which made $10.7 billion last year for use against a range of diseases like psoriasis, rheumatoid arthritis, Crohn's disease, ulcerative colitis and more. Humira currently accounts for 60% of AbbVie's revenue and loses patent protection in the U.S. in 2016 and in Europe in 2018.

The primary endpoint of the Phase III was the Psoriasis Area and Severity Index, or PASI, percent improvement from baseline to week 16 of treatment. 

Amgen was in the first wave of developers to stake out a plan to manufacture biosimilars, and Humira is a prime target in the field. Most analysts expect these biosimilars will carve 20% to 30% off the price of the branded biologic, a hefty discount but nothing close to the huge price cuts associated with traditional generics.

Amgen is also likely to face a host of newly approved biologics with a better efficacy and safety profile for psoriasis, including one of its own experimental therapies. Novartis (NVS), Celgene (CELG) and a partnership of AstraZeneca (AZN) and Amgen for brodalumab have all been hard at work. And Amgen is not alone in developing biosimilars to Humira. Sandoz started its Phase III program for its knockoff at the end of last year. And Coherus, which is targeting niche markets, also has one in the pipeline.

"Results from Amgen's biosimilar Phase III plaque psoriasis study met the primary endpoint for efficacy and showed comparable safety and immunogenicity to adalimumab, which further demonstrates the company's commitment to provide patients with access to high-quality medicines," said Dr. Sean Harper, the head of R&D at Amgen. "We look forward to continuing to leverage our experience and expertise in biotechnology to bring biosimilars to patients."

Conatus Pharmaceuticals Inc. (NASDAQ: CNAT) announced its late-breaking abstract was accepted for a poster presentation at The Liver Meeting(R), the annual meeting of the American Association for the Study of Liver Diseases (AASLD) in Boston, November 7-11, 2014. The poster, entitled "Rapid and statistically significant reduction of markers of apoptosis and cell death in subjects with mild, moderate and severe hepatic impairment treated with a single dose of the pan-caspase inhibitor, emricasan," will be presented on Monday, November 10, 2014. The abstract is available at www.aasld.org/.

In the abstract, Conatus disclosed that its lead drug candidate, the orally active pan-caspase protease inhibitor emricasan, reduced key biomarkers in a recently completed, single-dose, pharmacokinetic (PK)/pharmacodynamic (PD) Phase 1 clinical trial in subjects with mild, moderate or severe hepatic impairment (defined using the Child-Pugh criteria). Emricasan was administered to 28 subjects with hepatic impairment and 8 matched control subjects, and serial blood samples were collected over a 48 hour period. Levels of three key biomarkers of apoptosis (caspase-cleaved cytokeratin 18), cell death (full-length cytokeratin 18), and caspase enzymatic activity (caspase 3/7) were elevated at study baseline correlating to disease severity, and demonstrated rapid and statistically significant reductions after a single 50 mg oral dose of emricasan in all hepatic impairment subjects.

"We are encouraged by emricasan's ability to reduce key disease-elevated biomarkers of caspase activity, apoptosis and cell death rapidly after even a single dose," said Conatus President and Chief Executive Officer, Steven J. Mento, Ph.D. "Our ongoing Phase 2 trials in patients across a broad spectrum of liver disease are designed to assess whether reductions of these potential drivers of liver disease progression result in corresponding clinical benefit."

The company is conducting three clinical trials investigating the PK and PD activity of emricasan in patients with impaired organ function to support dose selection and prioritization for advancement in its overall clinical development program: the Phase 1 clinical trial in patients with various degrees of hepatic impairment described above; a Phase 1 clinical trial in patients with severe renal impairment; and a Phase 2b clinical trial in patients with acute-on-chronic liver failure (ACLF) who may have simultaneous impairment of both liver and kidney function as well as other organ involvement. Preliminary PK data from the Phase 1 hepatic impairment trial and Phase 1 severe renal impairment trial were sufficient to identify the appropriate patients for inclusion in a recently initiated Phase 2 clinical trial in patients with liver cirrhosis. Since patients with variable degrees of liver and kidney function are expected to be assessed in future clinical trials, final PK data from all three of the above clinical trials will be evaluated in the aggregate after completion of the ACLF trial, and are expected to inform on optimal dosing of emricasan in future studies in potential target patient populations.