The Big Red Biotech Blog

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.

CureTech's Plus Results Equal Teva's Investment

CureTech, in reporting positive results for its CT-011, anti-PD-1, therapy against relapsed lymphoma, spurred Teva to increase its investment in the company by another $19 M.  Teva will also commit up to another $50 M on top of that to fund late stage R&D.  Thus, Teva now owns 75% of the company and has the option to purchase the final 25%.

"The investment is part of Teva's strategy to expand our branded activities into specialty therapeutic areas, such as oncology," said Dr. Aharon Schwartz, head ot Teva's Innovative Ventures.  See Fierce Biotech.

Teva marches on in diversifying its portfolio of small molecule generics, to biosimilars and now increasingly to innovator drugs, particularly in the cancer area at present.  I still maintain that within the next 5 years many companies will have similar mixed portfolios and the distinction between "innovator" and "generic or biosimilar" producer will become increasingly blurred if not mostly meaningless.

 

Posted by Bruce Lehr Sep 13th 2011.

Termeer Spends some of his Sanofi Cash on Personalized Medicine

The grass is not growing around Henri Termeer's ankles.  The former CEO of Genzyme donated $10 M to Mass General Hospital to found a new center called the Henri and Belinda Termeer Center for Targeted Therapies.  The new center will work to advance new drugs that target tumors defined by a specific genetic profile shared by niche patient populations.  See Fierce Biotech and Xconomy. 

Said Termeer, "I hope this will help Massachuesetts be recognized globally as the knowledge center in targeted medicines.  This is a global effort, but Massachuesetts has the responsibility to lead, to use the talents and capabilities it has built over many years."

So in one grand gesture, Termeer has backed an important growth area in cancer treatment.  Targeted therapies coupled with companion diagnostic tests are clearly a major trend that the pharma companies are workign on and which is also supported philosophically by the regulatory bodies. And, Termeer has founded the new effort in his home ground territory in Massachuesetts which no doubt will lose some jobs due to Sanofi purchase of Genzyme but now will gain some momentum to build in another key area of medicine. 

Posted by Bruce Lehr Sep 13th 2011.

Dendreon Restructures - BIG TIME!

Dendreon announced its restructuring plan today to reduce its burn rate given the slower than expected uptake of the newly approved Provenge for the treatment of prostate cancer.   The plan calls for the company to lay off 500 persons or about 25% of the total work force.  Among the casualties is the Dendreon COO, Hans Bishop. 

Dendreon reassured investors that it still has $600 M in cash and equivalents on hand, and that its run rate would be reduced from $390-$400 M to about $300 M annually.  Dendreon says it can hit cash flow break even with sales of $500 M a year.  Currently, Dendreon has sold $77.6 M in all of 2011 with sales of $22 M in August.  Some analysts question Dendreon, with its reimbursement problems for a $93,000 drug, can hit sales higher than $450 M before 2021.  Dendreon pulled its sales estimate for $350-$400 M in 2011 at its last quarterly conference call and was punished by investors to the tune of losing $3.5 B from its market valuation.

"While the last month has been difficult for our employees, these cost reductions are necessary to ensure the long-term growth of our compnay," said Dendreon CEO Mitch Gold. See Xconomy.

 

Posted by Bruce Lehr Sep 8th 2011.

Jennerex Goes i.v. With Cancer Fighting Virus

Jennerex Biotherapeutics is reporting a breakthrough that will allow it to deliver its anti-cancer oncolytic viruses via an intravenous route of injection -- as contrasted with the need to directly inject the viruses into a tumor. In a Nature article this week, Jennerex reports it oncolytic viruses injected i.v. were able to migrate from the bloodstream to the tumor site. Eureka!

"The idea has been around for decades, but nobody has been able to show you could deliver [an oncolytic virus] through an IV. If you can achieve IV delivery, it opens up the possibility of treating 10-fold mor tumors," says David Kim, Jennerex CEO.  See Xconomy.

There are no approved products using oncolytic viruses or this iv delivery concept but let's give them hand for the latest success. Hopefully, this will work and provide another possible way to go after tumors.

Posted by Bruce Lehr Aug 30th 2011.

Niche Cancer Drugs Making Inroads

Fierce Biotech reminds us today that new cancer drugs aimed at defined patient niches and paired with a companion diagnostic are starting to see regulatory success in the market.  Yesterday, Pfizer's crizotinib received approval for the treatment of non-small cell lung cancer in ALK+ patients.  It will be marketed under the trade name Xalkori (former consort of Xena Warrior Princess).  It's priced at $115,000 per year and analysts are pegging it to hit $540 million in annual revenues by 2015. 

Similarly, Roche's Zelboraf (vemurafenib) and its companion diagnostic (and $56,000 6-months price tag) were approved earlier this month for the treatment of certain melanoma patients.  It in fact received accelerated approval as the agency appears to be motivated to get these type of targeted therapies on the market. The FDA has now approved 25 drugs so far this year (as compared to 21 all of 2010) and is rolling toward a big year.

With this type of encouragement, Big Pharma can be expected to deliver more targeted therapies (with high prices) to help replace its cadre of expiring broad population blockbusters (e.g. Lipitor) as the drug strategy begins to shift.  I personally hope to see more of these targeted drugs make it to market sooner rather than later.  See Fierce Biotech 1 and Fierce Biotech 2.

Posted by Bruce Lehr Aug 30th 2011.

All Dendreon All The Time

I'm just going to group a series of Dendreon tidbits on several topics into a single post.  It's All Dendreon All the Time around here.

First, Dendreon reports that its last facility in the US, in Atlanta, has now received FDA approval for the manufacture of Provenge.  This completes Dendreon's network of three US facilities -- the other two beng in New Jersey and Los Angeles. The scale up into all three facilities had been touted as being critical to the company's growth plan with Provenge.  However, recent events have shown that issues surrounding physician acceptance and reimbursement are equally important to establishing the product's sales trajectory.  In its last earnings announcment, Dendreon retracted its sales forecast of $350 - $400 million in 2011. See Xconomy.

Picking up on the physician reluctance to prescribe issue further, the Pharmalot blog continues with a report detailing physician anxiety with the product.  Several factors were cited as inhibiting use of Provenge:

• 68% of oncologists and urologists (N=101) the survival benefit was too low at 4.1 months and needed to be at least 7 months.  30% wanted at least 1 year.
• 68% also reported that they thought they would have problems with reimbursement - at $93,000 a pop even 1 patient not receiving reimbursement was viewed as trouble
• Provider education gaps and the novel nature of the treatment itself were also a barrier and was cited by 41% of the docs
• 68% also cited the co-pay for their patients as a major concern

The triple whammy going here is that docs don't know how to use yet, would like to see better survival benefit and worry about being reimbursed for an expensive treatment.

Finally, firmly in Dendreon's court, we have a report from Seeking Alpha decrying the misinformation out there surrounding Provenge.  The report, written by Saul Kerpelman,  says Provenge produced the "largest median survival advantage EVER" in hormone unresponsive prostate cancer patients.  The post further explains median survival benefit and its meaning. 

Provenge's 4.1 months median survival benefit means that 50% of the men in the clinical trial who received Provenge lived 4.1 months longer than 50% of the men in the non-treatment group.  So half the men in the non-treatment group died 4 months earlier than half the men in the Provenge group.  But, Provenge also reduced risk of death by 22.5% and increased 3 year survival by almost 40%.  So many men went on to survive much longer on Provenge. Provenge had 38% more men make it to three years.  So the statement that Provenge "extends life on average 4 months" is wrong.  And it is equally wrong to say that $93,000 buys you only 4 months. Provenge may give you many more years of life and with fewside effects compared to standard treatments.

Kerpelman says Dendreon needs to hire new PR to challenge erroneous and misleading media reports AND do a lot more on the physician and patient education side. Medicare already fully reimburses for Provenge and just issued a Q code (to speed reimbursement) in July. Better education as to benefit will fix the slow adoption rate.

Posted by Bruce Lehr Aug 30th 2011.

 

 

 

 

More Insurer Trouble for Provenge in Near Term

A new survey of insurers conducted by Reimbursement Intelligence indicates that Dendreon's Provenge is likely to face flat uptake over at least the next 6 months.  Cited reasons for this stem frm both physician and insurer perceptions about the new higher priced cancer drug.

Most Insurers Say Provenge Use Will Remain Flat // Pharmalot.

Physicians responding to the survey indicated low prescribing rates due to:

• Limited clinical value 
• The drug's high cost
• Lack of qualifying patients
• Smaller number of centers willing to administer Provenge
• Stricter utilization policies
• Complicated treatment regimen

Insurers for the most part indicated a willingness to reimburse for the drug provided it was being utilized on label. Although, some industry observers indicate that 3rd party payers may be using more stringent criteria to determine reimbursement than Medicare requires.     

This survey would seem to validate that Provenge is going to have a tougher time breaking into the market than perhaps first expected -- until it can establish a clinical record.  Of course, slower uptake will increase the time to establish a record. Based on this, it seems rationale that Dendreon backed off its bullish forecast but of curse raises the question as to why it was so bullish in the first place.  Regardless, it's clear Dendreon management has its work cut out for it.

 

Posted by Bruce Lehr Aug 25th 2011.

 

Hodgkin’s Lymphoma, Cancers And Drug Pricing

There is a lot of commentary out there in the blogosphere today on Seattle Genetics' just days-ago, FDA- approved, new drug Adcetris and its pricing.  Adcetris (brentuximab vedotin) is approved to treat Hodgkin's lymphoma and anaplastic large cell lymphoma (ALCL).  The drug targets CD30 in those patients cells that exhibit this marker. The overexpression of the marker can be determined readily by a simple diagnostic test to indicate whether the patient is a good candidate or not for the treatment.

In clinicals, 73% of patients of these selected Hodgkin's patients had significant tumor shrinkage and 86% of the similar selected ALCL patients showed tumor shrinkage. And, about 1/3 of the Hodgkin's patients and 1/2 of the ALCL patients went into remission.

Hodgin’s Lymphoma And A High-Priced Drug // Pharmalot.

Given that, and given this is the first new treatment for Hodgkin's since 1977, and the first treatment ever for ALCL, will the price of $13,500 per dose or on average $108,000 per course hold up?  Most commentators seemed to think this drug actually justifies its price given the serious disease it is treating, and the patient benefit that it is providing -- especially for patients in the prime of life (30-45 age range). But the volume of commentary underlines the scrutiny new cancer treatments and their pricing receive now.  It also underscores the need to show a good cost vs patient benefit profile to separate the Dendreon Provenge from the Seattle Genetics Adcetris. 

Seattle Genetics' CEO said it best, "We want to make sure we price this drug so that we can maximize the impact on patients, and maximize the effect for the company as well. What we are excited about doing is making sure we can treat as many patients as possible, and also do well for our shareholders."

That's the balance that needs to be struck in modern biotech.  And the challenge that all future medicine developers will face. See Xconomy 1, Xconomy 2, and The Pharma Strategy blog.

Posted by Bruce Lehr Aug 22nd 2011.

 

 

Roche Gets Early Approval Too for Zelboraf

Earlier this week, Roche also got early approval for its cancer drug Zelboraf (vemurafenib) for the treatment of BRAF V600E melanoma -- a full two months ahead of its PDUFA date. The approval marked a key milestone in personalizing treatment of metastatic melanoma.  This is good news for melanoma patients.  In fact, it is the second major new drug approved against melanomas this year -- the other being BMS' Yervoy (ipilumumab). 

Zelboraf is a small molecule tyrosine kinase inhibitor that targets BRAF --  specifically the V600E mutation.  This mutation is seen in approximately half of patients with metastatic melanoma.  The companion diagnostic (also from Roche) will enable oncologists to test patients upfront and determine who should receive the therapy since the clinical results have only been demonstrated in those with the mutation.  That's cool.  We can identify a clear population in which the drug will work.

As mentioned in the previous post on Adcetris, pricing is a hot topic of interest.  Roche plans to sell the drug for $56,400 per treatment course. Yervoy (mentioned above) sells for approximately $120,000 per course.  Wow these are expensive but do result in progression free survival in range of 5-6 months.  All in all it is an advance in the treatment of melanoma patients.  And it also represents a continuation of the increase in the number of approvals that we are seeing from the FDA. See the Pharma Strategy blog for more.

 

 

Posted by Bruce Lehr Aug 19th 2011.

FDA Clears Seattle Genetics' Adcetris for Sale in US

Cue the Trumpets!  Seattle Genetics gained FDA approval to market its antibody drug conjugate (ADC) brentuximab vedotin for the treatment of Hodgkin's lymphoma and anaplastic large cell lymphoma (ALCL).  Yeah!

This is the first ADC to gain approval on the US market and it will be sold under the name Adcetris.  The approval came about two weeks ahead of the official review date of August 30th.  This is great news for Seattle Genetics as it is the Company's first approved drug after being in business for 14 years and spending nearly $546 M in R&D to reach this point.

The industry has been watching the progress of so-called "empowered antibodies" -- antibodies linked to powerful toxins to target specific cancers -- and a big success here for Seattle Genetics will only embolden other companies in the field. Seattle Genetics also has several more candidates of its own in various stages of the clinical pipeline. 

The company didn’t discuss one of the key facts investors will want to know immediately about the new product—its price. Most analysts expect that the drug will end up costing more than $100,000 per patient, as it is given to patients in a series of intravenous infusions once every three weeks. Seattle Genetics said it plans to discuss more of its commercial plans on a conference call with investors at 8:30 am ET/5:30 am PT on Aug. 22.  See Xconomy. 

 

Posted by Bruce Lehr Aug 19th 2011.

BI Licenses ProBioGen’s GlymaxX Platform for Fucose-Free Antibody Production

Boehringer Ingelheim (BI) obtained a nonexclusive license to ProBioGen's GlymaxX technology for the production of afucosylated antibodies. Fucose-deficient antibodies show enhanced antibody dependent cell-mediated cytoxicity (ADCC) -- typically making them more potent against tumor cells. 

GEN | News Highlights:BI Licenses ProBioGen’s GlymaxX Platform for Fucose-Free Antibody Production.

The GlymaxX platform enables the production of new and pre-existing producer cell clones and can be engineered in less than 10 weeks.  The technology competes against BioWa's (Kyowa Hakko's) Potelligent system for the production of afucosylated antibodies.  Presumably both technologies will be competing in oncology applications.

Posted by Bruce Lehr Aug 12th 2011.