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companies to watch - 2013 Roundup Snapshot analyses of selected companies developing new life sciences products and technologies By Wayne Koberstein, executive editor ach month, Companies to Watch spotlights one company that has received scant press coverage but, nonetheless, contains an especially interesting story. At the end of this past year, we thought it would be useful to check in on our 2013 Companies to Watch with a "roundup of updates" on how all of the companies have fared since our coverage. We contacted each company, asking for responses to three questions: • What have been the most important developments for your company since it was featured in the ___ 2013 edition of Life Science Leader's Companies to Watch? • How would you summarize, in a single quotable sentence, the present status of the company in light of those developments? • What developments or milestones do you anticipate in 2014? We received full responses from 11 of the 12 Companies to Watch featured in 2013. Their input varied from highly cautious and formal to genuinely "excited." Together with our own brief summaries of the companies' progress, we offer their assessments and updates here, in our 2013 Companies to Watch Roundup. (Company statements appear in quotes.) E January — Acetylon Careful target selection — meant to help surround and overcome tumor cells' defenses by cutting off one of two pathways they use to degrade waste proteins — was the theme of our CtW analysis of Acetylon early last winter. Since then, the tune has changed to following up on promising clinical data — and with a new strategic partner. President and CEO Walter Ogier summarizes the company's current status: "Acetylon is capitalizing on its recent agreement with Celgene and the positive activity we've seen in clinical and preclinical studies to date by significantly expanding our clinical program for selective HDAC6 inhibitor, ricolinostat, with advancement of our ongoing trials plus new combinations in multiple myeloma and a new indication, lymphoma." DEVELOPMENTS TO DATE • July: Acetylon entered into an exclusive strategic collaboration with Celgene, structured with $100 million payment up front, a minimum $500 million future cash purchase price if or when Celgene exercises its option to acquire, plus up to $1.1 billion in regulatory and sales milestones. • December: Reported that its selective HDAC6 inhibitor, ricolinostat (ACY-1215), showed "striking" signs of therapeutic activity in its Phase 1b trial in combination with Revlimid (lenalidomide) and dexamethasone for the treatment of relapsed or refractory multiple myeloma. In the interim data, 69 percent of patients reported partial or better response. Positive results on ricolinostat also came from interim data in a Phase 1b trial in combination with Velcade and dexamethasone, as a single agent in lymphoma, and in separate combinations treating either multiple myeloma or lymphoma: with each of three proteasome inhibitors; with two PI3K inhibitors; and with a Bruton's tyrosine kinase inhibitor. 32 LifeScienceLeader.com February 2014 COMING IN 2014 • initiation of two additional clinical trials of ricolinostat for the treatment of multiple myeloma in combination with standard-of-care drugs • initiation of a clinical trial of ricolinostat for the treatment of lymphoma • completion of the Phase 1b portion of the currently ongoing trials in combination with Revlimid and Velcade and initiation of Phase 2 clinical development February — Auspex Gone dark. Not officially, but for all practical purposes, this developer of deuterium-based compounds has ceased shedding light on itself for journalists. Repeated attempts to contact the company about this report went unanswered. The long-time PR person for the company was let go a few weeks after a major management turnover. In October, Pratik Shah replaced former CEO Larry Fritz, who left at mid-year. At the same time, the company replaced the COO and CFO, and it added a "chief development officer." The company has issued no press releases or public statements since that time. The following comes from limited public disclosures: DEVELOPMENTS TO DATE • March: Square 1 Bank granted a terms loan, or "credit facility," to Auspex to help fund Phase 3 clinical trials for its lead compound SD-809. • July: initiation of Phase 3 Trial of SD-809 for treating chorea associated with Huntington's disease, with opportunities in two additional indications, tardive dyskinesia and Tourette's syndrome • October: major management turnover; replaced most of the management team including the CEO, and added new officers March — Centyrex A company inside a company. Much of J&J;'s pharma group consists of small units enveloped or overlapped with other parts of the organization. Centyrex has been an exception. It's an entrepreneurial business more or less making it on its own as any other bio start-up. But having developed its novel molecular-scaffold Centyrin platform to the point of creating original products, it is becoming more integrated into the Janssen R&D; Biotechnology Center of Excellence (BCE). Summarizing the company's progress, CEO Robert Hayes says, "Centyrex has delivered on its goals to develop a therapeutic platform that complements the strengths Janssen R&D; has in monoclonal antibodies." The company remains vague about the therapeutic areas and entities it is pursuing, as reflected in its responses for the CtW Roundup below. DEVELOPMENTS TO DATE • "making good progress on therapeutic targets in the oncology space" • "Janssen R&D; made the decision to continue support