The Big Red Biotech Blog

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.

Bydureon Review Date Set

In the continuing saga that is Bydureon approval (or not) by the FDA, we at least now have a formal date for the next decision.  The three partners in crime Amylin Pharmaceuticals, Alkermes and Eli Lilly said today that the FDA has set a deadline of Jan. 28 to complete its review of the updated application for exenatide once-weekly (Bydureon). The companies are seeking FDA clearance to start marketing the new product as the first once-weekly injectable medicine for diabetes patients in the U.S. The drug was approved in the European Union in June.  See Xconomy.

Once approved - Amylin and Lilly can decide whether they will actually try selling the product together or keep on suing each other over Byetta/linagliptin spat.

Posted by Bruce Lehr Aug 12th 2011

Roche to Receive Early Approval for Melanoma Treatment

Reuters reports that Roche's experimental melanoma drug vemurafenib appears headed for an early approval by the FDA, well ahead of its scheduled November 11 date. The agency is apparently encouraged by some dramatic evidence that the drug significantly cut the risk of death versus chemotherapy.

Vemurafenib, which will be named Zelboraf on the market, is likely to join a roster of new cancer drugs to gain FDA approval. Others include Bristol-Myers Squibb's melanoma drug Yervoy and J&J's prostate cancer therapy Zytiga, and Dendreon's Provenge also for prostate cancer.  Peak sales of vemurafenib have been estimated at more than $700 million a year.  See Fierce Biotech.

The Pharma Strategy blog notes that Roche and BMS, the manufacturers of ipilimumab (Yervoy), have now met to discuss and finalize the much anticipated combination trial of Zelboraf and Yervoy.  It will be interesting to see if the combination will extend survival even further in patients with the BRAFV600E mutation.

Yervoy was launched recently with a $120K price tag for four infusions.  Sales are apparently were good in Q2.  It is given as a 3mg infusion every three weeks for 4 cycles, over a 3 month period.  It will be interesting to see what the Zelboraf monthly price will be, assuming it successfully garners approval.   Should the combination work out in the future, the cost of treating metastatic melanoma will likely become even more expensive despite only small incremental survival benefits. 

It will also be interesting to see how this expensive cocktail with relatively modest survival benefits will fare at this high cost - especially vis a vis Dendreon's Provenge.  The latter offers about a 4 months survival benefit at a cost of $93,000 per patient that is incurred in about 1month of treatment.  Dendreon has reported issues in getting physician's to prescribe the cost dense Provenge due to reimbursement concerns.  Will a Yervoy and Zelboraf cocktail surmount this hurdle?  If the cocktail does succeed, is that indicative of a better patient benefit or a better selling strategy to prescribers and third-party payers?

 

Posted by Bruce Lehr Aug 9th 2011.

FDA's Biosimilar Approval Path Looks Complex

Fierce Biotech reports that a leading group of FDA regulators have published in the NEJM the  "agency's thinking" on the proposed pathway to gain approval for a biosimilar.  It looks to be complex and customized to the product in question.  Anyone looking for a short, simple, straightforward and inexpensive abbreviated pathway need not apply.

The regulators say that there will be no "one size fits all" systematic assessment for biosimilars. Instead developers will need to integrate various types of evidence "since it seems possible to exceed a current state-of-the-art analytic characterization by evaluating more attributes and combinations of attributes at greater sensitivities with multiple complementary methods."  That sentence is a mouthful and certainly implies to me a high level of regulatory rigor.

The FDA warns it will need to create a new "paradigm" for its initial discussions with biosimilar developers, with a more extensive product review to detail the additional data needed for a biosimilar approval. Rules on interchangeability, which would allow doctors to switch a branded biologic for a biosimilar, are still in the works.  

Bottom line, the FDA is setting clinical demands that will raise effort and expenses to meet approval requirements. This will undoubtedly limit the field to larger players who will have the financial wherewithal and reosurces to compete.

 

 

Posted by Bruce Lehr Aug 4th 2011.

 

 

Comments on "improved" NDA Approvals in 2011

The Life Sci VC blog takes a closer look at the improved rate of 2011 approvals of NDAs by the FDA.  A couple weeks ago, many commentators -- and including FDA's Janet Woodcock -- ballyhooed the improvement in NDA approval rates and wondered aloud if this signalled big pharma R&D turning the corner toward more success in development of new drugs -- especially given some changes in R&D models over the past years.

Bruce Booth took a bit more somber (and realistic) approach to the data.  He noted two facts that should be considered before one declares unconditional victory in revamping the big pharma R&D machine.  Firstly, Booth notes that the majority of new NDAs were not sponsored by the originating organization and only 7 of 18 came from big pharma.  Thus, most did not originate the sponsors R&D group but rather in its BD group.  The jury must remain out on the value of any new R&D structures or models that have been implemented in the past five years as this data really doesn't speak to those changes.

Secondly, Booth noted that most of the newly improved drugs have been in development a long long long time -- since the 1990's -- and again appear to be from legacy R&D efforts rather than from any new fangled permutation that has arisen since then.  So again, any new changes in R&D will have to await their day in court to assess whether they are more effective than "the old ways". 

Finally, Booth concludes, it is great to celebrate the increased rate of NDA approvals but it is too early to attribute it to changes in R&D models.  One can also conclude that business development activity is very important in the mix of bringing new drugs to market.  And, one cannot forget that the time to market is a very long and complex journey making it damn difficult to assess the effectiveness of   changes to the R&D model in the short-term.

Posted by Bruce Lehr July 29th 2011.  

And Then There Were Two - Adcetris Gets OK for ALCL

Seattle Genetics' Adcetris (brentuximab vedotin) recieved its second thumbs up from a second FDA advisory panel today -- this time for the treatment of anaplastic large cell lymphoma (ALCL).  Once again, the panel voted 10-0 to recommend the drug's approval. 

About 2,000 new cases of anaplastic large cell lymphoma are diagnosed each year, half get effectively treated with chemo, but once it recurs, patients are only expected to live a little more than three months. The data for the Seattle Genetics drug in this group of patients was striking. The drug completely or partially shrank tumors in 86 percent of the patients studied in a mid-stage trial (50 of 58). Most of the patients (57 percent) went into complete remissions.

The FDA has a deadline of August 30 to complete its review of the Seattle Genetics application to start marketing the drug for patients with Hodgkin’s and anaplastic large cell lymphoma. If approved, the new drug will be Seattle Genetics’ first marketed product after 14 years in business, and it would the first commercially successful version of an “empowered antibody” -- a completely new type of molecule in the fight against cancer. See Xconomy.

 

Posted by Bruce Lehr July 14th 2011.

 

 

BMS' Yervoy Gains EU Approval

BMS' Yervoy (ipilimumab) is now approved in Europe to be used in the treatment of advanced melanoma. The drug was approved in March for use in the US and is the first treatment to extend lives of patients with melanoma.  BMS gained the drug when it acquired its partner Medarex and its pipeline. 

Since, Yervoy's approval in March, BMS has worked a collaboration deal with Roche to test Yervoy as a combination therapy.  BMS says it will look to do more of these type of deals in the future as combination therapies are expected to gain in popularity as a treatment strategy. See Fierce Biotech.

 

Posted by Bruce Lehr July 14th 2011.  

 

Seattle Genetics' Adcetris Gains FDA Panel Endorsement

Seattle Genetics, as expected, got the endorsement of an FDA advisory panel to approve Adcetris (brentuximab vedotin) for the treatment of Hodgkin's lymphoma.  If the drug is now approved by the FDA for sale (decision Aug 30th), it will be the first approved antibody drug conjugate (ADC) on the market.  Another FDA expert panel will be discussing this afternoon whether or not Adcetris should also be recommended for the treatment of anaplastic large cell lymphoma (ALCL). 

"Brentuximab works and it works well. People with Hodgkin's lymphoma will have another option for treating a terrible disease," said Michael Sekeres, an oncologist at the Cleveland Clinic. See Xconomy. 

Seattle Genetics will not only be gaining its first approved drug but as an ADC the first one of that class.  This is the second drug this year from the Seattle biotech pool, besides Dendreon's Provenge, that represents a novel treatment type for a cancer.  Fierce Biotech notes in an article today that Dendreon and Seattle Genetics would both appear to be high on Big Pharma's short list of acquisitions.  Cancer therapies are expected to grow twice as fast as the rest of the pharmaceutical market (according to IMS Health) and many novel oncology drugs have been approved so far in 2011 (see next post on Yervoy).  Indeed, look for more acquisitions in the oncology space to happen.

 

Posted by Bruce Lehr July 14th 2011.

 

 

FDA's Woodcock says Drug Approvals at 20-year high

The FDA's Janet Woodcock, Director CDER, testified before Congress that the number of new chemical and molecular entity approvals had reached a 20-year high to date in 2011. Twenty drugs have been approved in 2011 so far as compared to 21 drug for all of 2010.

Woodcock further pointed out that the low number of approvals was more a function of attrition in the pharma pipelines than due to regulatory rulings by the FDA.  A recently issued report states that drugs moving to phase III dropped by 55% in 2010, with comparable decreases of 50% and 47% for phase II and phase I respectively.  Thus, the number of drugs reaching a submission for approval is down and therefore the number of approvals would be expected to follow.  See Fierce Biotech.

 

 

Posted by Bruce Lehr July 8th 2011.

J&J's Xarelto Passes FDA Scrutiny

J&J's Xarelto has been approved by the FDA for the treatment of venous thromboembolism (VTE) in a unique oral formulation that is taken once per day. The Company considers it one of its top 6 candidates in the pipeline and analysts believe it is poised to take a healthy share of what could be a $20 billion market.  The current market standard, warfarin, has been in practice for more than 50 years but has safety issues that could be improved upon by the newer competitors coming to market now.

J&J's approval -- though delayed for a couple years in the FDA -- still places it ahead of rival Pfizer's efforts with its own Factor Xa inhibitor, apixaban.  The head starts may be worth millions in the market place.  J&J is also pursuing additional applications for Xarelto -- the next being the prevention of strokes in patients suffering from atrial fibrillation. See Fierce Biotech.

 

 

Posted by Bruce Lehr July 5th 2011.

Cha-Ching! Seattle Genetics Gets $5M Milestone from Takeda for ADC

Seattle Genetics has begun to cash in on its antibody drug conjugate (ADC), brentuximab vedotin, for reaching a key milestone by filing an MAA with the European Medicines Agency (EMA).  The milestone triggers a $5 M payment from its licensing partner The Takeda Oncology Company.

Seattle Genetics retains marketing rights to brentuximab vedotin in the US and Canada while Takeda has the rights in the rest of the world. The partners are splitting development costs 50:50. The drug will be targeted to the treatment of Hodgkin's lymphoma and anaplastic large cell lymphoma (ALCL). Seattle Genetics application with the US FDA is pending for both applications as well.

The review date with the FDA is scheduled on Bastille Day (July 14th) and the action date is August 30, 2011. See PBR story.

 

Posted by Bruce Lehr June 28th 2011.

FDA Sets Review Date on SGN-35 ADC

Seattle Genetics has its review date with the FDA set for July 14th to get an Advisory Committee decision on its antibody drug conjugate (ADC) brentuximab vedotin (SGN-35).  BLA's for the drug's use in the treatment of Hodgkin's and anaplastic large cell lymphoma will both be reviewed in back to back sessions.

SGN-35 remains on pace to be the first ADC approved.  And if the committe recommendation is positive as widely expected, Seattle Genetics will be really have something to celebrate (besides Bastille Day) as it moves to storm the market.

 

Posted by Bruce Lehr June 16th 2011.

FDA Bests EMA on Speed to Cancer Drug Approvals

If you feel the need for speed, then you perhaps should pursue your new cancer drug approval through the FDA instead of the EMA to get on the market more quickly says a new study. Friends of Cancer Research in studying 23 new cancer drug submissions filed with both agencies found that ALL 23 made it through the FDA first. The FDA took only half the time too -- 350 days in EMA versus half that at FDA.

FDA Commissioner Margaret Hamburg said that the study "reflects FDA's commitment to foster access to effective therapies in a responsive and timely manner."  See Fierce Biotech.

 

 

Posted by Bruce Lehr June 16th 2011.

BMS Guides Kidney Drug through the FDA

BMS scores again this year with the announcement that the FDA has approved its new drug Nulojix (belatacept) for the prevention of kidney transplant rejections.  This comes on the heels of BMS' Yervoy (ipilumumab) receiving approval for the treatment of melanoma just a few months ago.

Nulojix is the first new kidney anti-rejection drug to be approved in more than 10 years.  It is a T-cell costimulation blocker to mitigate the bodies immune response.  It is designed to be used with other immunosuppressants like corticosteroids. Analysts are projecting peak sales for the drug in the $300 M to $500 M range.  See Fierce Biotech and Xconomy.

Posted by Bruce Lehr June 16th 2011.

FDA Approves Incivek For Hepatitis C

The FDA, as promised, rendered its verdict today on Vertex's Incivek (telaprevir) by approving it for the treeatment of hepatitis C for new untreated patients and for those who have not responded well to treatment with interferon and ribavarin.

FDA Approves Incivek For Hepatitis C.

The approval was widely expected as Incivek had shown in clinical trials an ability to cure almost 80 percent of those treated and in half the time (24 weeks versus the standard 48 weeks). The sustained virologic response was between 20 and 45 percent above the current standard of care. 

It's these type of results that have analysts predicting that Incivek may hit sales totals of $2.5 billion annually within a couple of years.  The drug is expected to bring more of the estimated 3.2 million US hepatitis C patients into treatment programs.

"With the approval of Incivek, there are now two important new treatment options for hepatitis C that offer a greater chance at a cure for some patients with this serious condition," said Edward Cox, MD, director of the Office of Antimicrobial Products in the FDA's CDER.

Now it is up to Vertex and its rival team of Merck/Roche to educate the market on the new treatment options versus the interferon/ribavarin standard of care and to start converting patients to the new possibilities for a cure. Of course, there will also be a battle for share and dollars as well.  See Fierce Biotech and Xconomy.  

 

 

Posted by Bruce Lehr May 23rd 2011.

Abbott Receives FDA Approval For Molecular Test For Hepatitis C

This one seems particularly timely now that Merck's Victrelis (boceprevir) has received FDA approval for the treatment of hepatitis C, and Vertex's Incivek (telaprevir) is widely expected to receive similar approval on Monday (May 23rd). 

Abbott Receives FDA Approval For Molecular Test For Hepatitis C.

The Abbott RealTime HCV assay is intended for use as an aid in the management of HCV-infected patients undergoing antiviral therapy. The assay measures HCV RNA levels at baseline and during treatment and can be utilized to predict sustained and non-sustained virological response to HCV therapy. 

"Monitoring HCV RNA levels is important in the management of the disease with antiviral medications," said Paul Martin, M.D., a gastroenterologist and hepatitis researcher with the Schiff Liver Institute and Center for Liver Diseases in Miami, "Viral load measurements help physicians determine whether to begin antiviral therapy, influence decisions on dosing and therapy duration, and identify drug resistant strains."

 

Posted by Bruce Lehr May 23rd 2011.

 

Monday Is Vertex's Day at the FDA

If you are Vertex, Monday is looking to be a bright day to start the week. 

This Monday (May 23rd), the FDA is expected to approve Vertex's telaprevir (Incivek) for the treatment of hepatitis C infection.   This will allow them to start competing against Merck's newly approved boceprevir (Victrelis) for bragging rights. Merck received approval within the past weeks itself and just anounced it will team up with Roche to sell the new drug and cocktail treatments.

The industry anxiously is watching.  Both drugs represent a big improvement (based on trial data) on the current standard of care for hepatitis C. Analysts are favoring the Vertex drug based on slightly better clinical results -- with cure rates in trials as high as 79%.  Vertex could use the boost -- not only is it contending with Merck/Roche -- it needs to start recovering some of the $3.6 billion it shelled out to get Invcivek approved. Again, analysts think it could bring in as much as $1.5 billion in revenue by the end of 2012.  The hepatitis C market is expected to grow as big as $10 billion globally.

 

 

Posted by Bruce Lehr May 20th 2011.

 

EU's CHMP Gives Thumbs Up to Host of New Drugs

 

 

Fierce Biotech reported this morning that the European Medicine Agency's Committee for Medicinal Products for Human Use (CHMP) voted to recommend several drugs for approval in Europe.  Normally, CHMP's recommendation is followed and these would expected to receive formal approval in the next 3 months. With no further ado, the winners are:

• GSK and HGS received a recommendation for their new lupus drug, Benlysta (approved in US in March). It's the first new drug for lupus in 50 years and analysts have projected worldwide annual sales potential of $3 billion.
• CHMP reveresed itself and recommended Accorda Therapeutics' Fampyra for MS.  Biogen Idec will be marketing the drug in Europe. Approval of Fampyra will trigger a $25 M milestone payment for Accorda.
• BMS received the good word on its new drug Yervoy (ipilimumab) for the treatment of metastatic melanoma. It will be the first new melanoma drug in Europe in a decade.
• Amgen's Xgeva (denosumab) got the okay for the prevention of skeletal-related events in adult cancer patients. The durg is also approved under the Prolia name for the treatment of osteoporosis.
• Finally, Pfizer and BMS got the European Commission's approval for Eliquis (apixaban) for the prevention of venous thromboembolic events (VTE) in adults who have undergone hip or knee replacements. It is the first market to approve this drug.

That's the next wave of new drugs one can expect on the European market and the next source of important revenues for these companies.

 

 

 

 

Posted by Bruce Lehr May 20th 2011.

Pfizer Lung Cancer Drug to Get Priority Review

Pfizer scores again with the FDA is gaining the agency's agreement to provide priority review for it drug crizotinib for the treatment of specific non-small cell lung cancers (NSCLC).  The company said it had also filed a marketign application with regulatory authorities in Japan.

Pfizer Lung Cancer Drug to Get Priority Review.

Crizotinib is viewed as one of Pfizer's next best chances at a blockbuster to help replace lost revenues that will come from its drugs like Lipitor coming off patent.

"Given the clinical trial results seen to date, we believe that crizotinib, if approved, may change the treatment paradigm for patients with ALK-positive advanced NSCLC," said Garry Nicholson, president and general manager, Pfizer Oncology Business Unit.  See Fierce Biotech.

 

 

Posted by Bruce Lehr May 17th 2011.

 

What The Wags Say about Merck Hepatitis C Drug?

Merck got its Hepatitis C approval last week, and the analysts are speculating what that will be worth as it goes to market with a wee head start over rival Vertex -- with BMS and Roche coming later in the not too distant future.

The Merck Hepatitis C Med: What The Wags Say // Pharmalot.

Merck's boceprevir, or Victrelis, is expected to cost about $1100 per week (or $31,000 to $48,000 per patient depending upon status) and garner between $604 M and $875 M by 2015 according to the "experts". This is especially true as it received no labeling restrictions and will be used in conjunction with peg interferon and ribavarin as the current standard of care -- and can be used with both Merck's own PEG-intron and Roche's Pegasys (even though not tested with the latter).  The Roche allowance was considered a bonus by analysts.

The target market in the US alone is more than 3.2 million patients and China has 10 times that many -- at least --as many remain undiagnosed. Analysts again project the Hep C market could rerach as much as $10 billion annually to divide up amongst the players.  

The real short-term battle should now commence between Merck and Vertex -- when it's rival drug telaprevir (or Incivek) gains approval this month. The Vertex drug had slightly better clinical cure rates and is expected to get similar labeling.  With that, some project it to grab as much as 2/3 of the early market compared to Merck's 1/3.   Merck plans to get cracking to gain as much share as quickly as possible -- and its pricing reflects a more aggressive posture than expected pre-approval.

 

 

Posted by Bruce Lehr May 16th 2011.

Genentech and Plexxikon File for FDA Approval

Genentech and Plexxikon have applied for market approval with the FDA for their jointly developed skin cancer drug, vemurafenib or PLX4032.  The drug has been shown to extend lives of melanoma patients in clinical trials. Roche has also submitted an application in the European Union.

Plexxikon has agreed to be acquired by Daiichi Sankyo for $805 million to bost the latter's cancer portfolio. See Xconomy.

 

 

Posted by Bruce Lehr May 11th 2011.

SeaGen Gets Expedited FDA Review

Seattle Genetics announced today that the FDA had accepted its BLA on its antibody drug conjugate (ADC),  SGN-35 or brentuximab vedotin, for the treatment of Hodgkin's disease and anaplastic large cell lymphoma. This is good news for Seattle Genetics and the patients with these two diseases.

SeaGen FDA Deadline Set for Aug. 30.

SGN-35 will now receive a review date from the agency by August 30th.  This new type of therapy for cancer is expected to pass muster at that time and would be the first ADC approved.

 

Posted by Bruce Lehr May 2nd 2011.

 

Sanofi and Regeneron Get Positive Phase 3 with Aflibercept

Just weeks after Sanofi-Aventis and Regeneron reported poor results with their cancer drug aflibercept in a late-stage study of non-small cell lung cancer, researchers gave a thumbs-up to their top-line results produced in a Phase III study for colon cancer. The two developers said that the drug--to be sold as Zaltrap--will be filed for marketing approval later this year.

"We are pleased with the results of the Zaltrap Phase III study in this group of patients," said Debasish Roychowdhury, senior vice president and head of Sanofi's global oncology division. "We are committed to bringing Zaltrap to patients with advanced colorectal cancer and maximizing the therapeutic potential of this unique and exciting medicine."

Zaltrap is expected to grab about $200 million per year of the colon cancer market it addresses.  In addition to the stopped lung cancer trial, aflibercept has been discontinued in an ovarian cancer trial but still is being used in an ongoing trial for metastatic prostate cancer. See Fierce Biotech.

J&J Gets Early Prostate Cancer Drug Approval

J&J’s got some very good news when it learned that the FDA approved abiraterone acetate (Zytiga) for the treatment of men with metastatic castration-resistant prostate cancer who have received prior chemotherapy.  The drug inhibits an enzyme that stimulates androgen production, offering a new approach to fighting the disease.

In clinical trials, those who received Zytiga and prednisone had a median overall survival of 14.8 months compared to 10.9 months for patients receiving the placebo and prednisone, according to a statement. The decision comes almost two months ahead of the June 20 deadline.

Wells Fargo analyst Larry Biegelson estimates annual sales of $800 million for the therapy by 2015. The treatment is likely to compete with Dendreon's Provenge, which costs $93,000 for a full course of treatment. The approval could also have implications for Medivation, which has been developing MDV-3100 for prostate cancer. See Xconomy and Fierce Biotech.

So we go from having no good treatments for this prostate cancer to two choices within a matter of months.

 

 

 

Posted by Bruce Lehr April 30th 2011.

Hep Hep Hooray! Vertex and Merck Earn C's

Both Merck's boceprevir and Vertex's telaprevir earned thumbs up's from the FDA advisory panel this week for the treatment of hepatitis C.  Both drugs received an unanimous 18-0 vote to approve from the panel. 

In trial data, Vertex's telaprevir improved cure rates of 40% from current standard of care to as high as 80%.  Merck similarly made improvements on the standard cure rate 38% up to 65%.  Telaprevir could shorten the current course of treatment by half as well. 

“Hepatitis C is a curable disease with potentially devastating consequences if left untreated, so we are pleased by the committee’s unanimous recommendation to approve telaprevir for a broad group of people with hepatitis C,” said Peter Mueller, Vertex’s chief scientific officer, in a statement. “We look forward to working with the FDA as it prepares to make its decision next month.”

Debra Birkrant, the director of FDA's antiviral-drugs division, according to a report in the Wall Street Journal, said, boceprevir and telaprevir improve cure rates "to more than 30% above what we have today."

The FDA will make the final approval of both drugs official by May 23rd.  More than 3 billion people in the US are infected with hepatitis C.  Analysts believe both drugs will become blockbusters with annual sales in excess of $2 billion each within a couple of years.  Some estimates have both drugs garnering more than $7 billion in annual sales combined at their peak. See Fierce Biotech and Xconomy.

Posted by Bruce Lehr April 30th 2011.