The Big Red Biotech Blog

FDA Oncology Chief Promises Use of Breakthrough Designation

Richard Pazdur, oncology chief at FDA, says he plans to push the breakthrough drug program hard.  He says the staff at FDA view this as a potentially game changing mechnism to get new therapies on the market and change lives -- provided the drugs show their stuff early in clinical programs.

Pazdur says he is prepared to make this a priority in his division and the FDA will partner with companies with breakthrough status to conference early and often to help shepard drugs through the agency. This could shave a couple years off a program's reaching the market. The agency will even work to adapt trials as information becomes available.

Industry observers are cautiously optimistic.  But, like everything FDA (or government for that matter), the proof is in the actual performance.  Right now, companies like Merck, Roche and BMS have oncology drugs with this designation. We'll see how they progress to the market or not. See Fierce Biotech.

Posted by Bruce Lehr June 3rd 2013.

 

Roche's T-DM1 Crosses Finish Line as Kadcyla

The second ADC in the past year has crossed the finish line to be approved by the FDA.  This time it is Roche's (Genentech) Kadcyla to be used in the treatment of HER2 positive breast cancers.  The drug has performed in clinicals -- despite missing out on accelerated approval -- as it was widely expeced to be approved this time around.

"Kadcyla is an antibody-drug conjugate representing a completely new way to treat HER2-positive metastatic breast cancer, and it helped people in the EMILIA study live nearly six months longer," said Hal Barron, Roche's chief medical officer and head of global product development

Unfortunately, it is priced at $9800 per month per patient and is expected to cost about $94,000 for a single course of treatment -- about double its predeccessor (non-ADC) Herceptin alone.  While I am excited to see ADCs make it to market --- and to be successful clinically.  I do worry about pricing models that have most new biological drugs -- particularly in oncology areas --- costing a minimum of 6 figures per patient course. 

It is the type of thing that does not seem sustainable in the current world fiscal and economic crisis.  See reports from Fierce Biotech and Xconomy for more on the medicine and FDA approval.

On a happier economic note, Genetech (no doubt boosted by successes like Kadcyla) announced that it will be adding 600 new staff in the US.  Just to put that into perspective, 600 staffers would easily handle the work of more than 30 average biotechs in pursuit of their first drug approval.  Genentech says it prefers to promote from within, making a number of these new hires replacements for upward bound employees. And they pay well, with many of these positions tied to starting salaries that range from $70,000 to $80,000 a year.  At least this company is hiring for more success as it experiences new successes. Huzzah!  See Fierce Biotech.

Posted by Bruce Lehr Feb 23rd 2013

 

PS - There is no truth to the rumor that Kadcyla battled Xalkori to a draw over Tokyo for control of that fine metropolis.    

Actual Companion Diagnostics Sighting!

Xconomy published today on Qiagen's recent application to the FDA for the approval of a diagnostic test that looks at a mutation in the EGF receptor.  The test is useful in the diagnosis of the speed of disease spread in non-small cell lung cancers (NSCLC) -- 10 to 15 percent of Caucasions and 40 percent of Asians carry the mutation.  The test was developed in conjunction with Boehringer Ingelheim's cancer therapy, afatinib that targets the mutation -- and they've asked the FDA to approve both products simultaneously.

This type of "companion diagnostic" has long been talked about, particularly with cancers, as being advantageous to define the target patient population that will respond to the drug. This helps recruitment for clinical trials and to better ensure the drug will actually be effective in the trial. The proto-type for this concept is Roche's combination Herceptin and the HER2 positive breast cancer from the late 90's. But not much else has really reached the market since then.

With Qiagen's/BI's application, we expect to see a new surge in companion diagnostics-therapeutic combination being developed and brought forth. In fact, co-development of the therapy and the diagnostic is the major difference in these programs now compared to what may have been done in the past where a test was typically developed sometime well after the therapy was available.  The result is that the tests didn't work particularly well and only 1% of drugs in the US actually have a companion diagnostic -- most in cancer area.

That's changing as the FDA has encouraged this approach.  Qiagen says it now has 15 programs in progress -- including with not only BI -- but with big companies like Pfizer and AZ. Last year, Roche had a companion diagnostic it developed with its Zelboraf treatment for melanoma. Pfizer's Xalkori has a companion diagnostic developed by Abbott. Other drug-companion diagnostic programs in progress include the following companies:

• Synadex Pharmaceuticals and Ventana Medical with entinostat & NSCLC's 
• Seattle Genetics/Takeda and Ventana Medical with Adcetris & hopefully various cancers
• Qiagen and Bayer with tests therapies and tests for solid tumors
• Qiagen also has a similar deal with Pfizer
• Astellas Pharma and Roche with Tarceva and lung cancers

The industry and FDA are looking for more of these to be successful -- and would expect clinical trials to flow more smoothly and result in more approved drug applications. It remains to be seen if this will translate into reality -- though the promise is clearly there.

Posted by Bruce Lehr Jan 31st 2013.

 

India's Government Targets Cancer Drugs

India's government has been rattling sabres for some time with regard to high priced drugs and compulsory licenses.  Now they will go after three more cancer drugs and their makers to force licenses.  The drugs are Roche's Herceptin (breast cancer), BMS' Ixabepilone chemotherapeutic agent, and Dasatinib for leukemia. 

Last year, the government forced Bayer to give a compulsory license for its Nexaver (kidney and liver disease).  The drug's price dropped by a whopping 95% in country after the generic maker Natco Pharma took a license.

This is all about the price Western companies charge in India for cancer meds.  Herceptin is priced at $1400 per month, Ixabepilone is similarly priced and Dasatinib is priced at $300 per month.  These are out of the reach of India's common man.

One enthusiastic oncologist was quoted , "It's a very good move and will not just benefit Indians but possibly also bring down cancer drug prices in countries where the pharma market is not controlled by the US and western European countries."

Said another patient advocate from the group Knowledge Ecology International, "Companies like Roche have cut prices of Herceptin in the past but the price cust has been a joke."

So there continues to be a strong backlash against western style pricing in emerging markets like India. This will no doubt result in companies having to re-evalute their competitive strategies in these markets -- and certainly will affect the profits they can expect.  The so-called pharmerging markets are fighting back more frequently now and may not be the panacea once supposed for Big Pharma struggling to gain new profits to make up for those that have gone over the "patent cliff".  India, for sure, is not cooperating so far. See Pharmalot.

Posted by Bruce Lehr Jan 15th 2013.

T-DM1: Four More Months! Four More Months!

Roche reported today that the FDA has granted it (and partner ImmunoGen) a priority review for its breast cancer drug T-DM1.  The decision is due by Feb 26th.  When approved, T-DM1 will be the second approved ADC on the market. The EMA also accepted Roche's marketing application for the key European market.  Phase III results for T-DM1 have been strong and the drug is considered to be a potential blockbuster by many analysts.  Peak sales volumes of $5B or greater have been projected upon its approval. See Fierce Biotech.

We only have 4 months (maximum) to wait.

Posted by Bruce Lehr Nov 7th 2012.

ADCs Clear Another Hurdle as Adcetris Gains EU Approval

Backers of ADCs have more good news coming from Europe today as the EU approves Adcetris for use in the treatment of relapsesed Hodgkin's and ALCL.  Millennium (Takeda) licensed rights to sell the product outside the US from its inventor Seattle Genetics and will now pay the latter a $25 M milestone.  SeaGen will also receive tiered double digit royalties on the sales of the product.

Thus ADCs continue their role as one of the hottest new technologies in the treatment of cancers. SeaGen has already generated nearly $150 M in sales in the US since the drug's approval earlier this year.  Many companies now have ADC programs in their pipelines and there are 10's of drugs in clinical trials. This is only expected to expand with Adcetris' success so far and the expected approval soon of Roche's T-DM1 for breast cancer. See Xconomy.

ADCs Poised to Go Beyond Cancer Treatment

I meant to comment on the news last week that Merck will pay $15 M upfront with plenty (possible $288 M) in back end incentives to partner with Ambrx on its ADC technology. I'm big on the potential of ADC particularly with the success we're seeing this year with Seattle Genetics' Adcetris and with Genentech's T-DM1 soon to join the party.

Up till now, ADC programs have been geared to the treatment of various cancers. But with Ambrx's unique binding methods for linking antibodies to toxins that allow it to better control the ratio of bound toxins to antibodies, the Merck-Ambrx partnership will look to go after other diseases outside the cancer arena.  This could include autoimmune conditions and diseases like diabetes. I think it is exciting to see the technology extend to these other chronic disease areas. See Xconomy here and here.

Posted by Bruce Lehr Jun 22, 2012

Is Cancer Research Focused on Too Few Targets?

Just when we were all pumped about the news coming out of ASCO this week, leave it to the Life Sci VC blog to throw us a curve by pointing out how concentrated the pharma industry's efforts are with regard to cancer targets being investigated.  And, Bruce's argument is supported by facts and data. I hate that. I try to never let the facts get in the way of a good story.

The blog post notes that of the 990 cancer programs, greater than 20% are aimed at 8 targets, each of which has more than 24 programs in clinical development. VEGF itself has 70!  The data is presented in a bar chart in the post. By Bruce's estimates, $5 B+ has been spent in the past few years on these programs.  He points out that they ALL can't be winners.  This appears to be an egregious waste of resources at the expense of more novel but unproven targets.

This illustrates one of the problems we've been seeing with the lack of productivity of Big Pharma R&D as embodied by failed programs and low ROIs.  There's a lot of me-too thinking that undoubtedly arises out of a desire to reduce risk and increase success -- but the calvary charge of projects concentrated on a few targets virtually guarantees a lot of commercial failures.  Only so many people can fit in the pool before it overflows.

It is an interesting post and I think you should read it for yourself.  He concludes the pieces by saying,

"We need to stop being target lemmings, or our group-think and risk avoidance will run our industry off a cliff."  Now that's something to ponder (and correct if you agree) before it's too late.

Posted by Bruce Lehr June 7th 2012.

 

Reports on ASCO Consolidated

Today you can read summaries of the going's on at ASCO as reported in Pharmalot, Fierce Biotech and Xconomy.  Clearly the cancer treatment world is heating up and there were a number of exciting clinical trials reported on at this year's meetings.  The concensus seems to be the companies following made the biggest splashes (with patients, analysts and investors) with their clinical results.

Who Got The Most Buzz At The Noisy ASCO Fair? // Pharmalot.

In the order mentioned in the Pharmalot post:

• J&J reported on Zytiga for treatment of prostate cancer for patients who have not received chemo
• Roche reported results on its latest stage antibody-drug conjugate, T-DM1, for the treatment of breast cancer. Roche says it has 8 ADCs in the clinic and 25 in its pipeline targeted at cancers
• BMS reported on its drug, BMS-936558, which targets PD-1 in a variety of cancer cells. BMS hopes to establish this as a blockbuster for a number of cancers. PD-1 encourages the patient's immune system to fight the cancer
• Bayer reported on regorafenib for the treatment of stomach cancer. It is also being directed toward colorectal cancers and gastrointestinal stromal tumors

Other notable results were reported by Dendreon (prostate), Ariad Pharmaceuticals (CML), Onyx Pharmaceuticals (colorectal cancer), Aveo (kidney cancer), and GSK (melanoma). 

These drugs have the potential to change the standard of care and the "empowered antibodies" being pushed by Roche utilizing technologies from Seattle Genetics or Immunogen look to usher in the world of ADCs with so-called "smart bombs".  All and all an exciting conference with exciting results.

Posted by Bruce Lehr June 6th 2012.

 

 

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.

 

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.

Roche Makes It Personal

Personalized medicine, which targets individualized treatment and care based on personal and genetic variations, is hot. Several Big Pharma players continue to invest in this emerging field as evidenced by Roche’s $5.7-billion bid last week for Illumina, a provider of gene-sequencing tools and related analytics.  Look out for whole genome sequencing - some folks idea of the Holy Grail in enabling personalized medicine.

PharmTech Talk » Roche Makes Bid to Advance Position in Personalized Medicine.

Roche, perhaps, more than any other pharmaceutical company, is banking heavily on the combination of diagnostics and drug development to drive pharmaceutical innovation.  Roche is uniquely positioned in that regard as it is ONE of the leading diagnostics and pharmaceutical companies. Roche has 6 personalized NMEs and companion diagnostics in its commercial or late-stage pipeline.  These include Zelboraf/BRAF companion for metastatic melanoma, and Tarceva/cobas EGR companion for non-small cell lung cancer.

Drug-companion diagnostics are a hot area in cancer treatment, and surely are ushering in a new era of personalized medicine.

Posted by Bruce Lehr Jan 30th 2012.

 

Genentech and Curis Gain FDA Approval for Drug to Treat Skin Cancer

Another biological oncology drug received approval from the FDA today.  This time it was Genentech and Curis' drug vismodegib (marketed as Erivedge) for the treatment of basal cell carcinoma, a common skin cancer.  They won the approval well ahead of the agency's decision deadline. And top regulators signaled that they would look kindly on other developers who take the same approach to targeted therapeutics.

The drug will be used to treat BCC patients who's cancers have spread after surgeries or other treatments. The median progression-free survival rate was 9.5 months. Erivedge is the first drug that targets the hedgehog signaling pathway that has been approved.  More are on the way. See Xconomy.

This is Curis' first approved drug. The company is now due a $10 M milestonepayment from Genentech upon the approval. Curis also stands to earn royalties on sales.  Curis investors spared no time in starting to cash in by selling their shares in brisk trading today.

Posted by Bruce Lehr Jan 30th 2012. 

Sigma-Aldrich differentiates to HPAPIs for future

The market for production of small molecule APIs is becoming much more competitive - especially as these become more genericized and manufacturing moves to lower cost (for now) Asian suppliers.

Sigma-Aldrich looks to HPAPIs as generic sector heats up.

As a result, SAFC is moving its focus away from these more generic APIs and is focusing its efforts on the product of high potency APIs (HPAPIs).  SAFC has several new facilities that are geared toward this type of higher value more difficult manufacturing -- which separates its right away from some of the lower cost, less specialized manufacturers.  This capability allows SAFC to cater to drug developers working in cancer therapeutics with both HPAPIs and antibody drug conjugates.

Sigma-Aldrich CEO Rakesh Sachdev commented on this approach at the recent JP Morgan Healthcae Conference, "A greater percentage of [custom pharma] will become highly specialized offerings."  Sigma's focus will be "on very unique products" and this is driving our expansion in the high potency area to give ourselves a competitive advantage.

Posted by Bruce Lehr Jan 18th 2012.

 

Why is CEO of Onyx smiling?

There is news today that Bayer's new colorectal cancer drug, regorafenib (aka "son of Nexavar') will be submitted to the FDA for approval in 2012. Not only is this a potential blockbuster for Bayer, but this is likely to inspire some smiles at Onyx too. The biotech landed a $160 million payday and won a 20% royalty stake in the drug last fall after prevailing in a bitter dispute over the rights to regorafenib, which bears a close resemblance to the jointly-owned Nexavar. Onyx had accused Bayer researchers of secretly developing analogs of Nexavar before the two partners finally managed to reach an agreement on ownership.

Winning in court and then in the clinic is likely to inspire smiles -- especially for a $160 M plus payday -- and if the analysts are right about the drugs' billion dollar potential the 20% royalty will be worth A LOT.

As Onyx CEO Tony Coles put it, “we are in position to go from one product for two tumors (Nexavar) to potentially three products with strong data or [an FDA clearance] for seven different cancers by the end of this year,” Coles says. The other drug besides Nexavar and regorafenib is known as carfilzomib, which is being reviewed by the FDA as a new treatment for multiple myeloma.

“When you see that kind of momentum in the business in such a short period of time, it’s unrivaled,” Coles says. “We think the future is very bright.”

Say Cheese Tony.

See Fierce Biotech and Xconomy articles.

Posted by Bruce Lehr Jan 18th 2012.

 

Dendreon Under-promises and Over-delivers in Q4

Temperence sometimes has its rewards. Dendreon suffered through a poor sales year in 2011 of its own making that hammered the company's stock.  But in Q4, Dendreon achieved Provenge sales ($82 M) that were considerably higher than its guidance. As such, their stock price is being rewarded today -- despite a considerable shortfall of $228 M in revenue for 2011 versus its beginning of year forecast of $350-$400 M.

But by giving the market an expectation of $66 M or so in Q4 Provenge revenue but achieving $82 M instead, its price ramped up $1.98 per share to $9.58 or more than 26 percent.  Better to be under-promisers and over-deliverers than the converse when it comes to speaking with the Market -- as the Market has once again affirmed. 

Of course, that doesn't help the 500 workers laid off in September, but it may remind Dendreon CEO Mitch Gold of a valuable lesson.  See Xconomy.

 

Posted by Bruce Lehr Jan 5th 2012.

ImmunoGen and Lilly Cut ADC Deal

From Fierce Biotech, ImmunoGen and Eli Lilly announced a deal for the latter to gain an exclusive license to a defined number of treatments utilizing the formers antibody drug conjugate technology.  ImmunoGen will receive $20 M in upfront payments, can earn up to $200 M in milestones and also can earn royalties when the drugs reach commercialization.

Lilly plans to exploit the ADC technology with its pipeline of oncology drugs to "develop agents with clear clinical benefit in specific patients populations."

Posted by Bruce Lehr Dec 20th 2011.

Analysts Pick at Logic of Amgen and Watson Biosimilars Deal

Here's some follow up on the announced Amgen and Watson biosimilars deal yesterday where the analysts weigh in on their impressions of the deal.

Amgen, Watson & Biosimilars: What The Wags Say // Pharmalot.

Said Bernstein Research analyst Ronny Gal, “we tend to think there is not enough money in biosimilars to justify the host of branded companies marching into the field (Pfizer, Merck, Lilly, Biogen and now Amgen), especially as their entry provides a self-fulfilling prophecy for product commoditization.”

Moreover, Amgen may find itself in a tortured position trying to explain to physicians why they should choose certain brand-name meds over future biosimilar rivals, while at the same time taking the opposite tack to co-promote any biosimilar that is developed and marketed as part of the collaboration with Watson. He uses an example of a Roche and Genentech drug, since these are the key targets for the deal, to illustrate his point.

“This feels a lot like branded company participation in generics in the ’80’s, which ended with mass exit from the field. It will require some serious mental gymnastics to explain to an oncologist why Avastin can be replicated while Aranesp cannot. Further, the argument will be used against Amgen well before its biosimilar products come to market.”

Valid points to raise with regard to the marketng challenges in this deal.  One also neds to remember that some of the traditional powers in generics, e.g. Teva, Sandoz, Hospira, will also be trying to sell into this space.  That's pretty heady competition in a market segment with acknowledged lower profit margins.  It's hard to see that some big competitors won't be chased from the field of battle.

Posted by Bruce Lehr Dec 20th 2011.

Amgen and Watson to Team on Cancer Biosimilars

As reported in Xconomy, Amgen and Watson have announced a pact to produce and sell cancer biosimilars together.  The companies didn't say which drugs they would be targetting other than to say they wouldn't be going after Amgen's drugs. 

Who does that leave? Roche's (Genetech's) Avastin? Herceptin? Rituxan?

“This collaboration reflects the shared belief that the development and commercialization of biosimilar products will not follow a pure brand or generic model, and will require significant expertise, infrastructure, and investment to ensure safe, reliably supplied therapies for patients,” Amgen and Watson said in their joint statement.  The products that this team introduces will be sold under a joint label.

Let the Games begin. Teva, Samsung/Biogen, Merck, Pfizer, Sandoz can't be too far in the distance.....

Posted by Bruce Lehr Dec 19th 2011.

 

A Proposal To Expand Accelerated Approval

Looks like BIO has been reading my previous post.

From Pharmalot, a post describing BIO's lobbying efforts with the Senate and FDA to expand the use of accelerated review in the FDA for drugs to diseases that do not have any approved cures. This would be applied not only to drugs for Orphan conditions but likely to cancers or AIDs drugs as well.

Under accelerated approval, a drugmaker can conduct shorter trials based on the measured effect of the drug rather than on an actual clinical outcome.  Sen. Kay Hagan (NC-Dem) would also ask that Phase II data could be used for drugs where data can't be "ethically, feasibly or practicably generated."

A Proposal To Expand Accelerated Approval // Pharmalot.

Presumably, this lobbying effort is being done in part as a consequence of criticism that the FDA's approval process has become too unpredictable in these type of clinical areas.  The FDA responded that the agency has approved 85 rare-disease treatments since 2006, and that 75 percent were based on limited clinical trials.

That observation would tend to undermine industry's claims and make them sound as if they are sounding a "false alarm".  Notwithstanding, I would still tend to favor expedited approval on drugs meeting the criteria above if there is also strong post-approval surveilance.  Based on analysis of that data, all parties involved should be willing and prepared to pull drugs from the market that do not live up to their pre-approval performance predictions when exposed to larger patient groups.

 

 

 

 Posted by Bruce Lehr Nov 16th 2011.

 

 

Onyx Submits NDA for Carfilzomib

Onyx Pharmaceuticals submitted its new drug application for its multiple myeloma drug, carfilzomib, to the FDA today, and asked for expedited regulatory review. If approved, this would be Onyx's second cancer drug following in the footsteps of Nexavar (sorafenib) for kidney and lung cancers.

The new drug was acquired from Proteolix and will compete with Millenium's (Takeda) own myeloma drug of the same proteosome inhibitor class. The NDA was based on data from a Phase IIb trial and two Phase III trials remain in progress. About 25% of patients in the phase IIb trial responded to the treatment with tumors shrinking by at least half. This may be good enough for this condition.

Said Ted W. Love, R&D chief at Onyx, "While important strides have been made in treating patients with multiple myeloma in the last decade, this disease remains uniformly fatal, underscoring the need for new treatment options."  See Fierce Biotech and Xconomy.

 

Posted by Bruce Lehr Sep 28th 2011.

 

T-DM1 Generates More Positive Breast Cancer Data

Roche reported more positive data on T-DM1 in its latest breast cancer trial with 137 women. In this study, T-DM1 (aka trastuzumab emtansine) showed a 41% decrease in the progression of disease versus the standard of care -- Herceptin plus Taxotere.  T-DM1 kept patients' tumors from spreading an average of 5 months longer than the standard control. T-DM1 also had only about half the reported side effects and only 25% as many patients dropped out of treatment as the standard due to adverse events. Thus T-DM1 was better tolerated by patients.

This is more good news for Roche and its partner Immunogen in their quest to gain FDA approval for T-DM1, the latest antibody drug conjugate ("empowered antibody") to seek approval.  Thus the empowered T-DM1 appears to work better than its parent Herceptin plus standard chemotherapy.  Immunogen -- responsible for linking emtansine to Herceptin -- stands to gain as well from milestones and royalties when T-DM1 is finally approved.  Phase III results still await but the trend is positive. See Fierce Biotech and Xconomy.

 

Posted by Bruce Lehr Sep 26th 2011.

Market Reacts to RXi Split Up

As reported in Xconomy and Fierce Biotech this morning, RXi Pharmaceuticals plans to split in two parts -- Galena BioPharma that will focus on creating cancer vaccines and RXi Pharmaceuticals that will continue to try to develop RNAi based drugs. The move was spurred by investors who wanted to see the combined RXi offer its shareholders a quicker return.

Galena will focus on the continued development and commercialization of its lead product NeuVax (E75) for breast cancer, and its newly acquired Folate Binding Protein-E39 for ovarian and endometrial tumors.  The latter is headed toward Phase I trials by the end of 2011.

RXi for its part will continue its focus on RNAi drugs -- its lead candidate being RXi-109 for the treatment of scarring and fibrosis. It will also work on the therapeutic value of gene silencing more broadly -- and is still seeking partners. Investors were thrilled and showed it by driving RXi stock down 25%. 

 

 

 

 

Posted by Bruce Lehr Sep 26th 2011.

The Cost Of Treating Cancer Is ‘Unsustainable’

The crux of this one?  New cancer treatments cost too much, address too few patients and provide too little benefit (in terms of survival) to be sustainable in the future -- given the economic drag developing in the system.

The Cost Of Treating Cancer Is ‘Unsustainable’ // Pharmalot.

The Lancet Oncology says we need to wave a magic wand to create a radical shift in policy to stop tolerance of "unfairness in access to affordable cancer treatment" and to deliver "fair prices and real value from new technologies."

Oh! Is that all?

Posted by Bruce Lehr Sep 26th 2011.

 

 

 

Seattle Genetics and Oxford BioTherapeutics Team Up on Cancer

Seattle Genetics and Oxford BioTherapeutics (OBT) have formed a collaboration to discovery novel antibody-drug conjugates against cancer. OBT will create panels of mAbs against tumor-specific antigens identified using its Oxford Genome Anatomy Project (OGAP®) database. These will be screened using Seattle’s ADC technology.

The OGAP database is built on disease protein information generated by OBT in-house coupled with genetic and clinical data from 50 different human tissues, including 5,000 cancer membrane proteins. OBT claims the database integrates all clinical and experimental  expression data from about 1 million human protein peptide sequences, 15000  validated genes,  50 tissues/organs, 58 diseases, and about 8 million SNPs and haplotypes.

Under the deal's terms, the firms will have an equal number of alternating options to select programs from preclinical ADCs for exclusive, worldwide development and commercialization. Each firm will receive progress-dependent milestone payments and royalties on net sales of any resulting ADCs developed by its partner.

Seattle Genetics is focused on the development of antibody-based therapeutics against cancer.  Its ADC drug Adcetris was recently FDA approved for two indications:  Hodgkin lymphoma and systemic anaplastic large cell lymphoma (ALCL).  Seattle Genetics has three additional ADC candidates undergoing Phase I testing: SGN-75 is in development against renal cell carcinoma and non-Hodgkin lymphoma, ASG-5ME is being evaluated for the treatment of pancreatic cancer and prostate cancer, and ASG-22ME is in development against solid tumors. See GEN.

 

 

 

 

Posted by Bruce Lehr Sep 18th 2011.