The Big Red Biotech Blog

Antibody-Drug Conjugates Continue to Gain Momentum

Antibody-drug conjugates (ADCs) are continuing to garner greater attention in the treatment of cancers and are being prominently discussed at the American Society of Clinical Oncology (ASCO) this year. Both Genentech's (and partner Immunogen) T-DM1 -- a souped of version of herceptin -- and Seattle Genetics' Adcetris will be prominently featured for the treatment of breast cancer and lymphoma respectively. Success of these companies is further paving the way for other therapies using the antibody linked to chemotoxin strategy. See Fierce Biotech.

Venture groups, like Celtic Therapeutics, have invested more than $50 M in the development of future ADCs. Says Celtics managing partner, Stephen Evans-Freke, "I don't think there is a mjor pharma or a midsized pharma with interest in cancer that doesn't have a program or isn't scrambling to put one together."

Xconomy's, Luke Timmerman, wrote another good story on ADCs coming of age this week -- and profiled a dozen or more companies actively pursuing programs.  This included not only the 3 companies mentioned above but companies like BMS, Sutro Biopharma, Ambrx, CytomX Therapeutics, Allozyne, Igencia, Spirogen, Centrose, Mersana Therapeutics, PolyTherics and more. See Xconomy.

For those with further interest in this area, the 3rd Annual ADC Meeting is being held in San Francisco from October 23-26th. Look here to see a draft agenda, Download ADC Agenda.

Posted by Bruce Lehr June 1st 2012.

 

Pharma Corporate VC Investment Increases Odds of Success

Burrill & Company’s June 2012 report indicates that that pharma corporate venture capital (CVC)-backed companies have a higher rate of overall success than those without their involvement.  The analysis includes 2907 therapeutics companies that raised VC dollars between 2000-2010 across 5100 rounds of financing.  Corporate VCs were investors in about 10% of companies, and this pool of 286 companies had what appears to be a markedly higher hit rate: a ~60% higher rate of licensing deals, M&As and IPOs. See Life Sci VC blog.

These new data from Burrill are entirely consistent with pharma corporate VC playing an important role in the ecosystem, and that they seem to get involved in good companies that possess better than average probabilities of success.  It is uncertain whether corporate VCs are just good company pickers because they look for things their Pharma  R&D organizations may want, or if they actually help shape a better outcome once they get involved either through the value-added “stamp” of Pharma validation or through active deal management contributions. 

I suspect they add value both by picking companies working in areas where they have keen interest and knowledge -- and by helping to shape and manage deals in areas where they have honed expertise. One thing for sure, it looks like having a CVC on your side heightens your odds of success.

Posted by Bruce Lehr June 1st 2012.

Quick Senate Passage Puts House Under Pressure to Act on FDA User Fee Legislation

The Senate passed the FDA Safety and Innovation Act (FDASIA) authorizing the collection of some $6.4 billion in user fees to fund FDA.  The pay day was enough to halt partisan bickering and bring Senate Democrats and Republicans together quickly. The legislation, approved just before Memorial Day, reauthorizes hefty user fees from drug and medical device companies, along with a host of new requirements that will govern FDA operations over the next five years.

PharmTech Talk » House Under Pressure to Act on FDA User Fee Legislation Following Speedy Senate Approval..

The House is now under pressure to pass their version of the Bill.  And, lo and behold, they did so today in overwhelming fashion. The bill includes a section to "fast-track" review of new drugs that potentially treat serious or life-threatening diseases that have no good alternatives.  The FDA will also be empowered to pull drugs from the market that have been fast-tracked but don't live up to after market review requirements. See Fierce Biotech.

The House and Senate versions now need to be reconciled, but the biopharma industry should be happy that their lobbying effort has paid off. The reconciled bill should be ready for a vote by October 1st. Then it will be up to the FDA to act.

Posted by Bruce Lehr May 31st 2012.

Where The Deals Are… Cancer Remains Hot

This is a nice summary by the Pharmalot blog (via Deloitte) indicating where biopharma dealmaking occurred last year relative to disease areas.  Not surprisingly, cancer was in the number one slot with 161 deals and represented nearly 25% of the total. More than half the deals were signed during the discovery or pre-clinical phases.

Where The Deals Are… Cancer Remains Hot // Pharmalot.

Median deal sizes (at least those disclosed) were higher in areas other than cancer -- autoimmune and inflammatory -- followed by endocrine and metabolic -- were one and two. Not surprisingly, upfront payments rose in alignment with phase in the pipeline.  Phase I earned median payments $8.4 million, phase II $19.5 million and phase III $25 million. Registration stage compounds were more than double that at $59 million.

The five largest deals (out of 714 total) had an announced aggregate value of $8.2 billion with upfront payments totaling $738 million. So now you know where the money went, will it keep going there in coming years?

Posted by Bruce Lehr May 31st 2012.

IBCs 8th Annual Cell Line Development and Engineering

I have several colleagues appearing at this IBC conference in San Francisco in early June.  Kevin Kayser, head of our cell engineering program, is a session chair for "Application of Genomic and Other Omics Tools, Novel Technologies and Next Generation Sequencing".  Kevin's group has just completed the development of SAFC's new CHOZN GS -/- platform cell line matched to chemically defined media and feeds.  The line has proven to offer very quick selection with resultant high titers which greatly speeds development of new clones. It has been designed to be used as a biopharmaceutical production system.  

 

IBCs 8th Annual Cell Line Development and Engineering

Another colleague, John Kolman, Senior Director, Research and Development from our new Bioreliance acquisition, will also be speaking during the session about deep sequencing methods. SAFC is also sponsoring the best poster award and will be announcing the winners of the "Cell line 2012 SAFC Young Investigator Poster Award."

Here's a quick shout-out to Kevin and John.

Posted by Bruce Lehr May 31st 2012.