The Big Red Biotech Blog

Should FDA Panel Review A Bird Flu Vaccine Again?

In short, of course it should.  Science should be guided by data.  If you have new compelling data to examine, you should do it. Decisions can change if there is new data to support the change.  That should be self-evident to scientists and policy makers to my mind.

Should FDA Panel Review A Bird Flu Vaccine Again? // Pharmalot.

In this case, you are talking about purported new data that shows an elevated rate of narcolepsy being associated with persons who received the bird flu vaccine that contains a new adjuvant, AS03.  Supporters and detractors of review both rightly point out that the vaccine was approved as it battles a flu that to date has shown a 59% mortality rate in the 566 confirmed cases. The number of infected is small but the mortality is EXTREMELY high.  So I don't think we should focus too much on the original decision to approve -- it seems merited and was not capricious.

However, there is also new data developing that suggests an association with narcolepsy that is 14 times higher than what would be expected.  Couple that with the fact that narcoplepsy is considered to be an autoimmune disease manifestation, and there is also some suggestion that there might be elevated rates of rheumatoid arthritis (also autoimmune) in this vaccinated population.  It would seem prudent to check it out whether the adjuvant might be affecting this.

This seems to me to potentially be yet another very unfortunate fallout of the falisfied study linking autism to vacccination.  In that case, healthy children were placed at risk by parents choosing against vaccination against very common childhood diseases because of falsified data linking the vaccinations to autism. Scandalous really and extraordinarily damaging from a public health perspective, not to mention some unvaccinated individuals and other exposed naive populations. 

But let's don't overcompensate the other way and not look at new data coming in with regard to narcolepsy.  One fraud doesn't necessarily mean another is being perpetrated.  In this case, let's not go to sleep at the wheel without looking at the facts, and acting then on the merits of the case.

Posted by Bruce Lehr Mar 11th 2013.

EMA proposes virus testing for food sector-derived trypsin used in drugmaking

The EMA says that food industry controls on porcine-trypsin do NOT guarantee that it is virus-free. The agency is therefore proposing new procedures for drug and vaccine makers who use it as part of their process.

EMA proposes virus testing for food sector-derived trypsin used in drugmaking.

This arises most recently from the rotavirus vaccine contamination event by porcine circoviruses that was ultimately traced to porcine trypsin used in its manufacture. Based on events like this, the EMA made new recommendations:

• Use only trypsin from glands from pigs that have appropriate official health certificates
• Test for specific viruses using both porcine and primate cell lines
• It advises use of two complementary virus reduction steps in processing -- e.g. low pH and irradiation

Under the guidelines proposed the drug or vaccine producer would have the responsibility to ensure proper testing (via its vendor if desired) and safety processing steps had been undertaken.

The EMA also noted that potential alternatives to trypsin could be used from recombinant sources or could be plant-derived (like TrypZean) saying ---- "the use of bacterial or plant derived recombinant trypsin minimizes in principle the risk for animal virus contamination and the application of such alternatives is therefore encouraged."

Posted by Bruce Lehr Mar 6th 2013.

Wassup with Vaccines

Takeda has decided to become a global player in vaccines challenging some of the biggest names out there like Sanofi, Merck, GSK, Pfizer and Novartis. They've hired Tadataka Yamada, GSK's former R&D chairman to spearhead the effort. He previously also worked at the Bill Gates' foundation and gained a global view of the vaccine world in that position.

The strategy at Takeda's new unit is to advance vaccines that combat bugs for which there are no vaccines.  Last month they bought LigoCyte ($60 M) and its lead vaccine aimed at treating norovirus gastroenteritis.  Approximately 21 million Americans are afflicted by this disease annually and there is currently no vaccine. Takeda notes that vaccines take a long time to develop compared to many pharmaceuticals but have a higher rate of success than pharma products at each clinical stage. See Fierce Biotech. 

The Bill & Melinda Gates Foundation made another equity investment ($13 M) in a startup biotech company, Visterra, aiming at a universal preventive as well as therapeutic approach to influenza. Much of that money is being earmarked to take the preclinical program for VIS410--a broad-spectrum antibody -- into the clinic in 2014.  VIS410 has the potential to work against any strain of seasonal or pandemic influenza.

Visterra is taking a unique antibody approach to flu. Its scientists identified a networked cluster of amino acids on the hemagluttinin protein, which the flu virus uses to enter cells and infect the host. That target gives them a potential key to treating or preventing all flu strains, coming up with a drug that the virus won't be able to mutate away from--a key problem with today's vaccines. And Visterra emphasized that this antibody approach is not a vaccine.  This is the type of novel appproach that the Gate's Foundation likes to fund. See Fierce Biotech.

Posted by Bruce Lehr Nov 9th 2012.

 

 

New Pharma Facility News

A few tidbits on the wires yesterday about new pharma facilities.  Firstly, GE and iBio announced they are designing a new plant-cell based vaccine facility for a client pharma company. The identity of the client was not disclosed. However, iBio's own SEC filing shows that Brazil's Fiocruz/Bio-Manguinhosin is the only company who has a license at present to use iBio's plant cell based platform for vaccine work.

The iBioLaunch platform is touted by its promoters to have the potential to manufacture proteins that cannot be made in other systems, and could also significantly reduce the capital and operating costs associated with biotherapeutic production.

GE and iBio designing plant-cell based vaccine facility.

CMC announced that it will be buying Xoma's manufacturing facility in Berkeley, CA. The facility has 31,000 sq ft of space and 3 x 2750 L bioreactors.  CMC also has facilities in Denmark and Bothell, WA (acquired from Icos) to serve the biopharm industry. A CMC spokesman said that acquisition of a new facility in the Bay area was a big plus as many new start up companies are there in need of manufacturing help. The new facility doubles CMC's US capacity. See Xconomy.

Covidien has officially cut the ribbon on its new $45 million R&D facility in Shanghai, where it plans to employ more than 300 in new research efforts.  Covidien is just one of the latest western companies to open a new facility in China.

"China is a key market in our global strategy, and this investment is a reflection of our strategic initiatives," said Covidien CEO José E. Almeida in a statement. And Covidien--a device and pharma developer--boasted that the operation covers more than 100,000 square feet with 17 labs and surgical and simulation suites.  See Fierce Biotech.

Posted by Bruce Lehr Aug 2nd 2012.

India to Invest cGMP Compliance for Vaccines

Four years ago, Indian regulators suspended licenses on 3 vaccine manufacturing facilities due to quality issues.  The suspensions resulted in vaccine shortages to great hue and outcry by the populace.  The government will now invest $37 M in plant upgrades to cGMP.

India plans $37m investment in vaccine cGMP compliance.

The DPT vaccine facility in Coonoor and BCG vaccine facility in Chennai will receive the bulk of the new investment.  Upgrades are nearly complete now at the third facility in Kasauli.  The government wants to see the improvement in quality and to boost vaccine output. 

HLL, a company best known for producing condoms, is responsible for making the upgrades.  Now, that's what I call real prophylaxis.

Posted by Bruce Lehr May 2nd 2012.

Vertex Continues to Run its Hep C Race

Vertex, despite the licensing of its well-received new hep C drug Incivek this year, is still in hot pursuit of an oral treatment for hep c that does NOT require interferon. And, it still wants to show elimination of virus in patients by week 12. 

This week it shared results of a small study that combined Incivek, its developmental drug VX-222 and ribavarin to treat virus genotype 1a and 1 b patients with 83% of those treated showing viral loads below lower levels of quantitation by week 12. Now, it will push on to a phase IIb trial based on that success. It is targeting an NDA submission to the FDA by 2014.

Additionally, not one to rest on its laurels, Vertex is also looking at other non-interferon combination therapies using Incivek, VX-222 and two other nucleoside polymerase inhibitor drugs licensed from Alios, ALS-2200 and ALS-2158. Thus, they hope to stay ahead in the hepatitis C treatment market and defend their current share.

Their stock responded yesterday by jumping 3.4% on the news. See Fierce Biotech and Xconomy.

Posted by Bruce Lehr Feb 24th 2012.

Novartis Hops the Hep C Train

Novartis is the latest big pharma to take the hep C train looking for a chance at a multi-billion dollar payout.  It signed a pact for $440 M with Enanta Pharmaceuticals for its preclinical NS5A drug.  The deal calls for $34 M upfront and a possible milestone-based payout up to $406 M more.

The Enanta drug, EDP-239, is directed to the NS5A target that should provide effects across all three hep C genotypes and does not require the use of interferon.  Avoiding the use of interferon is seen as the goal by most of the leading contenders for the estimated $20 B plus hep C treatment market -- where an ever increasing crowd is now jockeying for position. See Fierce Biotech.

Posted by Bruce Lehr Feb 21st 2012.

Gilead Still Liking Its $11B Hep C Deal?

Can this be the beginning of an $11 B hepatitis C mistake? Gilead, after shelling out that much for Pharmasset and its purported GS-7977 wonder drug, has experienced its first set back after the purchase. This morning Gilead announced the 6 of 10 patients with the genotype 1 form of the disease had viral relapses within 4 weeks of ending treatment. So much for permanent cures on oral doses without the use of interferon.

Gilead And Its $11B Hep C Deal: So Far, Bad News // Pharmalot.

The effect seen in the market today?  Shares of Achillion and Idenix Pharmaceuticals shot up as they are developing rival treatments for hep C.  Both are looked at as takeover candidates.  Shares of Gilead dropped 15%.  Hep C buyers might take note when putting together their bids for the former two companies.  As Sanofi's CEO Viehbacher noted earlier in the week, the price premiums of these companies in the Hep C market seem overblown.

They used to say nobody gets fired for buying IBM.  How about buyers of Pharmasset?

Posted by Bruce Lehr Feb 17th 2012.

Hep C Companies Rumored as Next Takeovers

Fierce Biotech reported today on the continued hype by investors and analysts for the companies that are pursuing hepatitis C therapies and have gotten good clinical (or preclinical) results.  Two of the leaders who have not yet been swallowed, Achillion and Idenix, are rumored to be takeover targets as big pharma suitors cast an eye toward a purported $20 billion hepatitis C treatment market.

Achillion's CEO, Michael Kishbauch, is out shopping the company to large, as yet unnamed, players. He says he is looking for a premium that would "put a silly grin on all our faces."  He might just get it too.  But other Big Pharma CEO's like Sanofi's Viehbacher are saying the premium's are too high and the value is not there.  This is echoed by GSK's Moncef Slaoui, R&D chief. 

Next thing you know, Sanofi and GSK will be putting in a bid. 

Posted by Bruce Lehr Feb 15th 2012.

Paragon Making the World Safer from Bioterrorism

The US Department of Defense awarded Paragon Bioservices a $15 M contract to develop a large scale mammalian cell culture process to produce vaccines to filoviruses. This virus class has long been considered by DoD to be a potential biological weapon and in this case is focusing on the Venezuelan equine encephalitis (VEE) virus and related viruses like Ebola and Marburg.

US DoD awards CMO Paragon Bioservices $15m vaccine deal.

The DoD expects the contract to be completed in 2020 and it is just another step in a long standing program by the agency to protect the US from potential filovirus events.

Posted by Bruce Lehr Jan 18th 2012.

China Wants to Boost Its Local Vaccine Industry

China has a goal of making itself the primary producer of vaccines that are used domestically.  To further that aim, the government is encouraging the development of production processes with proprietary IP rights. China is supporting the creation of new strains and technologies within this program.

China wants vaccine production innovation to boost local sector.

"It is clear from the plan that the Chinese government intends to create a favorable environment for the growth and development of China's domestic vaccine industry and to achieve self-reliance in the supply of vaccines", law firm Sidley Austin LLP released.

This is another example where the East is rapidly investing to make itself more market competitive.  It is also another example of where government policy is used in a strong way to drive economic development and technological advancement in a programmed direction.  The US policies need to support similar initiatives in the US biotechnology industry.

Posted by Bruce Lehr Jan 16th 2012.

Does Big Pharma Have More Dollars Than Sense?

On the heels of BMS acquisition of a Phase 1 hepatitis C therapy through its $2.5 B acquisition of Inhibitex, some industry naysayers question whether the risk is worth it at such an early stage and such a high price (Gilead's $11 B buy of Pharmasset can also be thrown into the discussion). It looks like the competitive bidding embodied by "auction fever" may be taking over as some company's scramble to fill in their revenue holes.

Pharma Pays A Premium For Its Shopping Spree // Pharmalot.

Analysts note that Pharma in general pays a 44% premium in their takeover efforts with biopharma -- as compared to 26 percent in other industries. That may seem eye popping to some but is nothing compared to the 89% premium that Gilead's purchase represents and BMS upped the bar to a 163% premium for Inhibitex. 

Investors and analysts can now hold their breath for several years to see if these deals pay off or not -- there will always be plenty of ammunition available for second guessing if it doesn't work out.

Posted by Bruce Lehr Jan 11th 2012.

 

Hepatitis C Deals Take Center Stage

Market analysts have projected that sales of products that are newly on the market or in late phase clinicals to treat hepatitis C could have worldwide sales in excess of $20 B by 2020. That's a big number! See Pharmalot.

So it is easy to see why more deals are happening in this area with a few more possibilities looming.  In just the past few weeks and months, Gilead bought Pharmasset for its PSI-7977 therapy for $11 B.  BMS followed suit to buy Inhibitex for its phase I hepatitis C drug for an impressive $2.5 B - a startling sum for a phase I compound that is still years from the market. Both acquiring companies are trying to introduce an oral hepatitis C treatment that does NOT rely on interferon (and its well described side-effects). See Fierce Biotech and PharmaGossip.

Now Merck is rumored to be a leading suitor to buy perhaps, Achillion for its hepatitis C treatments.  This would add to Merck's newly approved Victrellis and its mid-stage drug MK-5172 still in development. Merck also had previously announced a collaboration with Roche.

Said Merck's Roger Pomeranz at a recent JP Morgan Healthcare Conference, "Our goal is to be a leader in hepatitis C, and we will do what it takes to get there."  Merck is ready to do small or larger deals to rapidly build its position.  See Fierce Biotech.

The Game is On.

Posted by Bruce Lehr Jan 10th 2012.

ViiV teams with Russian manufacturer

ViiV, GSK and Pfizer’s HIV joint venture, has partnered with Russia’s JSC Binnopharm to boost manufacturing capacity in the country.  The deal extends GSK and Binnopharm's manufacturing pact for GSK range of cervical cancer, pneumoncoccal and rotavirus vaccines.

ViiV teams with Russian manufacturer.

The deal is another example of the recent trend of Western pharma manufacturers partnering with Russian firms to manufacture products in Russia in accordance with the government's Pharma 20-20 plan.  The plan calls for increased investment in Russian manufacturing capability and creation of more highly skilled jobs to support the growth of a local Russian pharma industry to more international standards. The ViiV partners plan full manufacturing transfer of core antiretroviral products from overseas to the Russian Federation.

Independently, Pfizer has further bolstered its Russian manufacturing presence through a deal with Petrovax Pharm.  Petrovax will make Pfizer's pneumococcal vaccine.  One can expect more of these deals in alignment with Russian goverment priorities -- especially if one plans to grow sales in this pharmerging market.

Posted by Bruce Lehr Nov 3rd 2011.

GSK Hooks Up with Alnylam on siRNA Enabled Vaccines

GSK and the RNAi-company Alnylam announced a new licensing deal where by GSK will use siRNAs from the latter to apply to its vaccine program.  The Alnylam technology involved is termed VaxiRNA.  The deal is initially focused on influenza vaccine production. Under terms of the agreement, GSK will provide research funding and certain milestone payments to Alnylam. 

Alnylam’s VaxiRNA platform applies siRNAs for the silencing of specific genes that limit or prevent efficient growth of viruses in vaccine manufacturing systems, including those in cell culture.  Alnylam says this new platform addresses the significant unmet commercial need for innovative technologies that can improve the manufacture of vaccine products, especially where vaccine production is a limiting factor for the scale and speed of global immunization needs.

The deal comes at a good time for Alnylam, which lost partnerships with Novartis and Roche earlier in the year, and is expected to report a loss of 35 cents per share for Qtr 3 in a late day earnings call. They could use the shot in the arm so to speak. See GEN and Xconomy.

 

 

Posted by Bruce Lehr Nov 1st 2011.

Sanofi Bets on Vaccines in India

According to Chris Viehbacher, CEO Sanofi, India is the place to be for Sanofi to capture 40% of its sales from emerging markets by 2015 -- as compared to only 29% now. Thus, Sanofi acquired Shantha Biotech for 550 M euros in 2009, and plans to invest another 220 M euros in a new Hyderabad vaccine facility.  The facility -- touted to be Asia's largest -- is slated to open its doors by March 2012.

Sanofi is targeting vaccines as one of its 6 key initiatives to help replace the 1/3 of its sales and 50% of its profits that it will be losing through patent expirations.  One of the other key initiatives is to grow fast in the emerging markets. So building a new vaccine plant in India couples growth plans between vaccines and emerging markets.  See European Biotechnology News.

 

 

 

 

Posted by Bruce Lehr Oct 10th 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.

Top 10 Vaccines of All Time

I've seen it stated many times that vaccines are more responsible for saving lives than any other field of medicine -- which of course makes it all the more vital that PEOPLE actually go get their vaccinations rather than worry about a plethora of rare side effects or pseudo-science claims stemming from BAD science and histrionics.

I saw this post on the "10 MOST Important Vaccines in Human History" and thought people might to remind themselves about how much disease and death vaccines prevent on an annual basis.  Vaccines have effectively eliminated diseases like Small Pox and Polio - once feared killers.

Posted by Bruce Lehr Sep 18th 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.

Takeda and Baxter Cell Culture Based Flu Vaccine Advances

Takeda and Baxter formed a collaboration in August 2010 to commercialize cell culture based flu vaccines in Baxter's Vero cell system.  Today, Takeda announced it has received a $313 million grant from the Japanese government to build a new flu plant in Hikari that is slated to be operational in 2013.

Takeda gets 24bn yen Govt grant for cell culture vacc plant.

Takeda is looking to supply the flu vaccine to the Japanese public as soon as possible thereafter.  In the medium to long term, the Company says it continue to develop vaccines for unmet medical need with a high social demand. These will include combinaton vaccines, high value vaccines using new technology and supply to other Asian and emerging markets outside of Japan.

This is another example of the rebirth of the vaccine industry after decades of slow decline as more and more governments put emphasis back on creating new vaccines to prevent widespread disease.

Posted by Bruce Lehr Aug 23rd 2011.

Wall Street Says Hep Hep Hooray for Vertex's Incivek

Vertex exceeded all Wall Street projections for sales of its new anti-hepatitis C agent Incivek when it reported revenues of $74.5 million.  This was more than double the consensus estimates of $31 million and were achieved in a period of only 6 weeks post-market approval. WOW!

Incivek has shown in clinical trials that when it is added to a couple standard treatments, it can double the cure rate to about 80 percent of patients, while cutting the course of treatment in half, to about six months.  Many patients are lining up to get treatment for the first time for this chronic liver damaging disease, since the cure rate is so much higher, and the Vertex drug enables patients to shorten the time they must endure the flu-like side effects of the standard drugs.  See Xconomy.

See what can happen if you deliver a novel therapeutic for an unmet need that really delivers the goods in the clinic?  Patients like it.  Payers like it.  Wall Street and investors like it. 

 

 

 Posted by Bruce Lehr July 29th 2011.

Vical and Astellas Agree on CMV Vaccine Deal

Astellas will pay Vical $130 M for rights to its cytomegalovirus (CMV) vaccine to prevent the virus' reactivation in immunosuppressed transplant patients.  A phase III trial of TransVax in hematopoietic stem cell transplant patients and a phase II study in solid organ transplant recipients will begin in 2012.

Astellas will develop and commercialize the vaccine in the US and for the rest of the world.  It will also take on all development and commercialization costs.  Vical will retain rights to co-promote in the US and provide manufacturing support. The deal extends Astellas offering in the transplant market -- a key focus area. See Fierce Biotech.

 

 

 

Posted by Bruce Lehr July 15th 2011.

 

J&J at Odds with Hep C Partners?

Fierce Biotech reported yesterday that J&J's partner, Medivir, on a late stage hep C therapy, called TMC435, is upset with J&J's promotion of Vertex Pharmaceutical's newly approved hep C therapy - Incivek.  It seems J&J's sales force woudl be representing both products to the same use community of prescribing physicians.  Medivir CEO Ron Long says he can't see how this won't result in conflicts of interest.

"They have to resolve that issue," Long said, "You can't use best eforts if you are prioritizing one drug over the other.  I think their positon is unsustainable and I've told them so."

This seems freakishly similar to the back and forth we've been seeing between Lilly and Amylin over Lilly's plans to promote both Amylin's and Boehringer's diabetes treatments to the same user base.  That one has resulted in Amylin's filing suit against Lilly.  I wonder how common these type of issues are going to become with Big Pharma buying up molecules from biotech's -- apparently from the same therapeutic areas. 

 

 

Posted by Bruce Lehr July 14th 2011.

Vertex Deals with Alios on Hepatitis C Extension

Vertex Pharmaceuticals, fresh off its recent FDA approval of Incivek (telaprevir) for the treatment of hepatitis C infection, announced a new deal with Alios Pharmaceuticals for up to $775 million in development milestones for two programs - ALS 2200 and ALS 2158.  By acquiring these, Vertex hopes to develop hepatitis C cocktails that will cement its leadership position in the market by removing the need to continue the use of interferon.   

ALS 2000 and ALS 2158 are both nucleotide analogs that offer a high barrier to drug resistance, can be taken orally, and may only require a once a day dosage.  Further, both have fewer side effects than interferon that often causes flu-like symptoms to the patient. Thus the combined package of Incivek and the new drugs offer the opportunity to improve the safety, efficacy and ease of administration for the patient. See Fierce Biotech.

 

Posted by Bruce Lehr June 14th 2011.

Penn and Teller: Why Childhood Vaccinations Make Sense and Maintain Public Health

A big thank you to the Bio Job Blog for posting this YouTube video staring Penn and Teller explaining the benefits of childhood vaccination versus saying worrying about getting autism or other similar folly.

Penn and Teller: Why Childhood Vaccinations Make Sense and Maintain Public Health.

Simply stated, vaccines have saved more lives than any other form of medicine and it's not even close.  The now discredited Lancet publication may have been the most detrimental paper of the last century. 

Watch the Video people and get your children their vaccinations.

Posted by Bruce Lehr June 12th 2011