(Not So) Wayback Machine

Readers of a certain age (“old”) will note my reference to a machine imagined by one of the most creative minds in animation, that of Jay Ward.  For those of more tender years, there is Wikipedia.  Since this is a good week to spend time with friends and loved ones which I hope you are doing as I am, I pulled out my version of the Way Back Machine to check up on the subjects of a few of my posts from the past year.  Here are my updates in reverse chronological order.

Epirus Biopharmaceuticals is a VC-backed company based in Boston with an explicit business plan for developing biosimilars (generic versions of successful biological therapeutics) made by proprietary manufacturing technology for the non-US/EU/Japan, rest-of-world markets (“Soup to Nuts” in July 2013).  The company had noted that is was in discussions for a deal on its lead product, a biosimilar for the anti-inflammatory drug, Remicade, and I posited that their model, that requires packaging products and services from technology suppliers, may make deal-making hard.  It was nice to see last month that Epirus closed its first big deal with Orygen Biotecnologica, a new Brazilian joint venture, to seek approval and then to manufacture the drug for Brazil to be followed by other Epirus products.  Orygen will build a new facility utilizing Epirus’s system and will pay the company, if all goes well, up to $275 million in milestone, royalty, and service fees (Epirus press release).  Orygen is a unique joint venture with partners being three Brazilian pharmas (Biolab Farmaceutica, Eurofarma, and Cristália) and encouragement from the government to build biologics manufacturing capacity in Brazil (Orygen BIO 2013 profile).

Back in June, I posted on Emory University’s new spin-out company called Drug Innovation Ventures at Emory (DRIVE) that was “to provide global solutions to address worldwide drug development and commercialization needs” (“Model or Muddle?”).  At the time I wrote my post, details were few and my concerns were several:  the source of molecules/lead candidates for DRIVE’s development program, whether it had the substantial funding needed for development, who will be liable for resulting products’ performance (the company or Emory), how involved Emory will be in the management, and whether the company could attract experienced management.  Recently, I noted that DRIVE has a better website although still lacking pertinent info (DRIVE) and that it had appointed Abel De La Rosa as CSO (DRIVE press release).  I noted previously Dr. De La Rosa’s experience is more in business and not science, and I am still muddled.

The Global Health Innovative Technology Fund (GHIT) was launched in May of this year by the Japanese government, the Gates Foundation, and several big Japanese pharmas, and I wondered about its impact on its stated goal of developing treatments, diagnostics, and vaccines for neglected infectious disease (“GHIT Ready”).  I posited that the program seemed to favor large companies and institutions, had too much bureaucracy, and may not award any one project sufficient funds to make a difference.  Earlier this month, GHIT announced its first awards that by design needed to be collaborations between a Japanese and a non-Japanese organization or company (FierceBiotechResearch article).  A total of $5.7 million was awarded to six groups, the largest (more than $3 million) going to two projects of the Takeda/Medicines for Malaria Venture team to fund pre- and clinical study of two new anti-malarial compounds.  It was nice to see awards also went to teams with smaller partners (three biotechs in US and Japan) and that about $500K will go to a project between Eisai, a Japanese drug company, and the Broad Institute, a research affiliate of MIT and Harvard.  The Broad has a substantial capability for identifying lead compounds unlike most academic institutions (Broad Therapeutics Platform) and is currently running about 50 screens including more than ten on global disease targets (Probe Pipeline).  I did not see in the GHIT announcement that projects will be funded for multiple years, but they should be.

About a year ago I reported on a new company in our local biotech community, Vaxxas, a start-up that is developing a nano-needle patch for vaccine delivery based on technology from an Australian researcher (“Vax Patch”).  Unfortunately, I found no news of note, and Merck remains the company’s only strategic partner.  My (free) advice is for Vaxxas to maintain its PR buzz with regular bits of news and to up its partnering effort.

Also last year (January), I reported on the take-over of the “non-profit pharmaceutical company” One World Health (OWH) by PATH, the Gates-backed global health product development program (PDP) (“Too Big to Flail”).  My rap against One World, and to a certain extent PATH, is that it had a large and expensive administration, spent too much on fund-raising, and had no clear path to commerce for its few products in development and no accountability to its backers (including me due to its tax-exempt status).  While OWH has a new website (OHW website) and a “A New Model of Drug Development” (really the standard PDP model in which commercialization [real use] is left to imagined company licensees), I did not see my concerns addressed.  On the plus side, I noted the recent announcement of practical project to develop an injectible form of an anti-viral drug for HIV prophylaxis with a potential commercial partner, Janssen (the pharma division of Johnson and Johnson) (OWH press release 1) and that it hired Ullrich Schwertschlag as CMO, an experienced drug developer and former colleague of mine at Wyeth (OWH press release 2).

Happy Thanksgiving, y’all.

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