The Big Red Biotech Blog

Biotech Achieves a Milestone: Abbott's Humira Goes to No. 1

Humira, as noted in a post today in Xconomy, will rise to the number one revenue producing drug in the world in 2012 -- estimated at $9.3 B -- thus supplanting the old champ Lipitor that has reached its patent expiry. This is the first time that a biological drug is in the number one spot and perhaps marks a watershed when bio drugs take over from their small molecule bretheren.

According to Reuters data, Abbott's Humira is not only number one, but J&J's Remicade and Amgen's Enbrel are numbers two and three.  Thus, biological drugs, that are all anti-TNF, hold the top three slots.  And according to Reuters, 8 of the top 10 drugs are now biologicals.  That's an amazing emergence -- Humira is entering its 8th year on the market and was the third drug of its type in its class.  Hurrah!

From here on out, it looks like biologicals will now drive the growth of the world pharmaceutical market, and in addition to the leading Mab drugs we see now, we'll likely see many more non-Mab drugs emerge as the orphan disease classes begin to be better served.

Posted by Bruce Lehr Apr 16th 2012.

New Lipitor Leader in the Clubhouse -- Ranbaxy

Since it is Master's season, I thought I'd go with the golf analogy.  The WSJ Health blog reports that as of last month Ranbaxy's generic version of Lipitor is already outselling Pfizer's original drug. It just goes to show the incredible pace at which generics are now able to overtake the innovator product once it comes off patent.  Presumably this is due to the tremendous cost savings one can get with a generic. 

Incredibly (to me) Ranbaxy only began selling its generic Lipitor (atorvastin) Nov 30th last year and as of the last week in March it sold 17.5 M pills for that week compared to Pfizer's 17.2 M -- at least that is the report according to Wolters Kluer Pharma Solutions.  All I can say is WOW!

Ranbaxy may not have the fabled jacket but they do have the GREEN. 

Posted by Bruce Lehr Apr 6th 2012.

WSJ Reports BMS Still Interested in Amylin

Today's WSJ reports Bristol-Myers Squibb is still interested in acquiring Amylin (mkt cap $3.6 B) -- as one of its larger pearls.  Amylin reportedly turned down and offer from BMS earlier this year of $3.5 B -- which has triggered some furor among its shareholders -- notably one Carl Icahn who owns about 9% of the company's shares.

Amylin's lead drugs Byetta and Bydureon for the treatment of diabetes would help complement the BMS offer that includes drugs like Onglyza (co-marketed with AstraZeneca) and a drug under development called dapagliflozin.  The world wide diabetes market is expected by IMS to reach up to $48 B by 2015 -- making an Amylin acquisition attractive to BMS to replace revenue losses from medicines with expiring drug patents.  In that regard, Amylin would appear to fit neatly into BMS' string of pearls strategy for growth.

Posted by Bruce Lehr Apr 6th 2012.

Icahn Rattles Saber at Amylin Board

Amid market rumors this week that Amylin's board had rejected a $3.5 B takeover bid from BMS, with little or no word of the event, Carl Icahn seized the opportunity to attack.  Icahn (Amylin's third largest shareholder) criticized the Board for failing to discuss the supposed offer publicly and began his saber-rattling to raise a proxy fight to replace the current Board to one more friendly with "the sell the company posture". 

Icahn has a history of buying into companies when they are weak to force changes. He has successfully infiltrated both Biogen Idec and Genzyme in the recent past. Now, it looks like Amylin should prepare itself for the upcoming battle. See Seeking Alpha, Fierce Biotech, and PharmaGossip.

 

 

 

 

Posted by Bruce Lehr Apr 5th 2012.

There's 143.5 Million Reasons This Man is Smiling!

From the PharmaGossip blog via Bloomberg's, retiring J&J CEO William C. Weldon will receive a retirement package worth $143.5 M -- yes -- that's GREENBACKS.

And that's why this man is smiling today.  That's a long way from the pay he received as a sales rep back in 1971 when he joined the company.  Wow! Just think what he might have earned if J&J had been able to make artificial hips, otc medicines and vaginal mesh products over the past couple years.

Then we might have been talking some real money.

Posted by Bruce Lehr Mar 14th 2012.

 

13 Pharma, WHO & Gates To Tackle Tropical Diseases

The Gates Foundation announced that it is teaming with 13 of the largest pharma companies to find treatments for 10 neglected tropical diseases by the self-imposd deadline of 2020.  The Gates Foundation itself is pledging $363 M of the total $785 M earmarked for the project.  

Pharma, WHO & Gates To Tackle Tropical Diseases // Pharmalot.

Participating companies include, many of the world's heavy weight in drug development, many of whom have had at least some efforts for some time in going after these diseases.

• Bayer - Chagas disease
• Abbott, J&J, Pfizer, Sanofi, GSK, Eisai - lymphatic filariasis
• MSD - river blindness
• Sanofi, Bayer - sleeping sickness
• Gilead - visceral leishmaniasis
• GSK, J&J - soil helminthes
• Novartis - leprosy
• Pfizer - blinding trachoma
• Merck KGaA - schistosomiasis

Additionally, Abbott, AstraZeneca, Bayer, BMS, Eisai, GSK, J&J, MSD, Novartis, Pfizer, and Sanofi are working with the Drugs for Neglected Diseases Initiative (DNDI) to provide access to proprietary compound libraries to develop new drugs.  

"As an industry, we have the capabilies and the know-how and resources that can improve the state of the world, especially the developing world," said Paul Stoffels, worlwdie chair of the J&J pharmaceuticals business. 

Of course, others weren't quite as optimistic. Medecins Sans Frontieres (aka Doctors without Borders) argues that more research is needed and that these companies only spend a pittance on tropical diseases each year at $18.3 M -- compared to their oft cited figure of $1.3 B on a single approved drug.  See Fierce Biotech and the press release.

As Nike would say, "Just Do It".

Posted by Bruce Lehr Jan 30th 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.

What Goes Around Comes Around for KV Pharma

You may remember KV Pharma running into trouble earlier this year for pricing its drug Makena (a form of progesterone already on the market) at $1500 per dose versus the $10 to $20 charged by compounding pharmacies.  The resulting uproar caused them to lowe price to the bargain rate of $690 per dose. Too little too late though.

KV Pharma May Not Be A Going Concern Very Long // Pharmalot.

Now in a recent filing with the SEC, KV discloses that "conditions raise substantial doubt about the company's ability to continue as an ongoing concern." Karma strikes again.

Posted by Bruce Lehr Dec 14th 2011.

Samsung and Quintiles' biosimilars JV teams with Biogen Idec

Biogen Idec and Samsung announced that they are teaming up to develop and market biosimilars. The two companies will form a joint venture, based in Korea, which will be funded by $255 million from Samsung and $45 million from Biogen, giving the latter a 15 percent stake in the venture.

Samsung and Quintiles' biosimilars JV teams with Biogen Idec.

Biogen said that it expects biosimilars to constitute “a meaningful revenue stream” and that the company was working on several biosimilar molecules. Biogen emphasized today that the Samsung joint venture would not pursue biosimilar versions of proprietary Biogen drugs. 

Samsung has laid out plans to invest close to $2 billion in the biosimilar business in expectation of developing a new subsidiary that can earn roughly that amount annually in about a decade. "We are taking a significant step toward becoming a major player in the biopharmaceutical industry and investing in an important growth engine for our company," Samsung Biologics CEO Tae-han Kim said in the statement.

Biogen CEO George Scangos made no secret of his own interest in biosimilars. He indicated Samsung could shoulder sales and marketing while Biogen concentrated its efforts on the manufacturing end of the deal.

"The manufacturing facilities have costs to run them, so the more products you run through them, the more efficient they are," Scangos said. "To set ourselves up commercially could be a big distraction. I'd like a partner to take over that."  Looks like we have a match.  See Fierce Biotech and Xconomy.

 

Posted by Bruce Lehr Dec 6th 2011.

Genzyme Stumbles Again. This Time It's Cerezyme

Genzyme is at it again. After last month's letter to Fabry patients alerting them that they would not be able to get ample supplies of Fabrazyme, Genzyme is now forced to tell Gaucher's patients that they will need to ration Cerezyme for the treatment of that disease.

Genzyme Stumbles Again: New Cerezyme Problems // Pharmalot.

This just continues the multi-year saga of being unable to supply ample amounts of either drug consistently due to persistent manufacturing and quality problems -- primarily at its Allston manufacturing facility.  Genezyme now appears to be pinning its hopes on the opening of its new Framingham facility in Qtr 1 2012 -- though up to now the Company has not been too reliable with time estimates.

Analysts report that this may be another opportunity for a competitor to come in and steal share (Shire already encroaches on Fabrazyme with its Replagel).  Protalix BioTherapeutics is going to the FDA with its taliglucerase to compete with Cerezyme -- and all the quality issues may make the former's case for approval that more compelling.

With all the product supply problems - Genzyme is bringing new meaning to the term Orphan and Neglected Diseases.

 

Posted by Bruce Lehr Sep 16th 2011.

Gold says, "Wish I hadn't given that bullish forecast"

Today, Mitch Gold, Dendreon CEO, said that if had to do it all  over again he wished he hadn't given Wall Street a sales estimate of $350 M - $400 M for Provenge in 2011 when he (and others) didn't understand the dynamics of launching it in the market.

The result?  A mere $3.5 B in lost market capitalization and layoffs of 500 employees or about 25% of the company. See Xconomy.

DOH!  

 

 

 

 

Posted by Bruce Lehr Sep 9th 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.

Novartis, A Gleevec Patent & India

In follow up to the previous post, the Pharmalot blog published an interview with Brook Baker, a professor in the Program on Human Rights and the Global Economy at Northwestern University School of Law, and a member of Health Gap, Global Access Project. Dr. Baker explains sequence of events in the case and why advocates on both sides have latched onto it.

Novartis, A Gleevec Patent & India: Baker Explains // Pharmalot.

The Indian Supreme Court postponed its hearing this week. The case will establish patentability for changes to existing drugs, define "enhanced efficacy", set rules for evergreening and will likely have important implications to generic manufacturers and drug availability and pricing in India.

That's all.

Posted by Bruce Lehr Sep 7th 2011.

 

Novartis Patent Dispute In India Heats Up

Pharmagossip and Pharmalot below both provide coverage of an avidly watched patent case playing out before India's Supreme Court. Novartis is challenging an Indian patent office ruling that its new crystalline salt form of the cancer drug Gleevec is not patent eligible as it provides "little enhanced efficacy". 

Novartis Patent Dispute In India Heats Up // Pharmalot.

The case is important to the innovator Pharma industry, Generic producers, patient advocates and Indian health policy makers as it is effectively establishing the rules for "evergreening" by setting the standard for "enhanced efficacy". 

Novartis argues that by not granting a patent for this improvment, it (and other innovators) lose any incentive to create "new" drugs.  Patient advocates fear that allowing small changes to result in increased patent protection "up to 20 years", i.e. evergreening, will drive up medicines to unaffordable rates for the poor and gut the generics industry. Novartis' drug is a cancer drug but this same concept might be applied to AIDs medicines for example.

Thus, the case is heavily in the spotlight.  For the moment, we'll have to wait on the ruling as one of the Justices recused himself and the hearing schedule for this week was postponed.

 

 

 

 

 

Posted by Bruce Lehr Sep 7th 2011.

Market Now Dumps Dendreon Stock Price

Following yesterday's disclosure that Dendreon had fallen short of its revenue targets with its new drug Provenge, and that it was backing away from its previous sales forecasts for $350-$400 M for the year with no replacement guidance, the market dropped its stock price by 60% in after market trading.  That's nearly $2.5 B in market cap folks if it translates to today.

The failure in revenue uptake is not being blamed on supply limitations.  Rather, Dendreon said that physicians were being conservative in prescribing the $93,000 per patient drug due to concerns about reimbursement.  This is despite the fact that Medicare has agreed to reimburse and set up a more streamlined procedure to process payments.  The reluctance may be tha the $93,000 price tag hits very quickly -- in a month of treatment -- compared to other expensive cancer drugs that spread costs out more over the course of a year.

"We see this as a shift of the growth curve to the right" said Gold.  And apparently a shift of the stock price towards the X-axis.  See Xconomy.

 

Posted by Bruce Lehr Aug 4th 2011.

 

 

 

 

 

New Name New Logo for Sanofi

Sanofi is just Sanofi now.  It has dropped the Aventis as part of its appellation.

Sanofi name change sees Aventis dropped | InPharm.

I like the new logo.  I really like the back story created by the agency to explain its meaning. Their imagination never ceases to amaze.

The company hopes the image, a planet with a bird at the centre, will illustrate its ambition to put the patient at the heart of its activities.   

Posted by Bruce Lehr May 9th 2011.  

 

A Biotech is Born! East meets West and $100 M

A seasoned GSK drug developer and a China money man have pooled resources to for a new biotech company with $100 M in venture funding. The new company, Ascletis, will have sites in Research Triangle Park, NC and Hangzhou, China.  The company will focus its development efforts on infectious diseases and everyone's new favorite - cancers.

Ascletis will pursue a two-pronged model in order to provide greater revenues for investors at an earlier stage - that being in-licensing of drugs that can be offered in the China market and development of its own pipeline from proof-of-concept through phase II before partnering, out-licensing or selling the property developed.

The company is curently starting to spend cash on building its scientific staff with plans of adding up to 50 this year and possibly reaching 100 by the end of next year.  The bulk of the staff will be situated in China to take advantage of a highly-trained work force at a more economical cost.  Maybe 10-20% of the staff will reside in RTP.  The founders say the strategy is formed in the US and the execution will occur in China. See Fierce Biotech.

Posted by Bruce Lehr April 6th 2011.

 

 

 

Dendreon Shareholder Uprising (or Not) and 'Mammoth Potential'

Is there a shareholder uprising at Dendreon brewing?  Or not? According to a story from Xconomy, there is one afoot led by a disgruntled Kansas investor who'd like to see the Dendreon Board add one or too new memebers to represent the retail investor's point of view. 

To hear, Seeking Alpha's Saul Kerpelman tell it.  It would be great if Dendreon or perhaps most public companies added Board members to represent the little guy - but to say Dendreon is experiencing or about to experience a stockholder revolt is -- well -- Balderdash!

And two more articles from writers at Seeking Alpha aimed at propping up Dendreon's potential and hopefully stock price going forward - one claiming that Dendreon gives the rest of pharma "pipeline envy" as Provenge according to it can be a pipeline in and of itself through the various stages of prostate cancer -- not to mention that Neuvenge is following hot on its heels for various cancers including: kidney, colon, cervical, lung and breast.

The second SA article proclaims Dendreon to have "mammoth potential" from its impending Provenge sales over the next few years and states that concensus analyst estimates put the target value of the stock in the $55 range which would represent a 47% premium over where it is today. 

So who is an investor to believe?   Read and do your due diligence I always say.  Buy low, sell high, borrow early and pay late.

Posted by Bruce Lehr April 4th 2011.

March of Dimes Cuts Ties with KV over Makena Pricing

Late yesterday, the March of Dimes made it official.  They cut ties with KV Pharmaceuticals, despite a 10-year relationship, over the latter's decision to introduce the "preemie drug" Makena at a price of $1500 per dose (up from its previous $20 per dose price). 

The St. Louis Post-Dispatch quotes a March of Dimes spokesman as saying the company's Friday price reduction ($690 vs $1500) and expansion of financial coverage were "steps in the right direction" but not enough.  March of Dimes President Jennifer Howse asked KV to "immediately cease and desist the use, distribution or publication of or reference to the March of Dimes name and/or logo on any materials or communications in connection with KV Pharmaceuticals."

Sen. Amy Klobuchar, D-Minn, office also issued a statement following KV's price reduction, saying:

At a time when rising prices for prescription drugs are stretching the budgets of middle-class families, we can't allow pharmaceutical companies to price gouge pregnant women when it comes to vital medicines. 

Sen. Klobuchar recently joined fellow Sen. Sherrod Brown, D-Ohio, in asking the Federal Trade Commission for an investigation into Makena's pricing.  There is no indication that this request has been/will be withdrawn after KV's announced price reduction yesterday.  The $690 list price is still about 45 times the former $20 list for the compounded drug.

It looks like we're getting a real-life class in consumer marketing, pricing and public relations with this whole fiasco.

 

Posted by Bruce Lehr April 2nd 2011.

More Gouging Part 2

Here's more commentary and explanation on KV Pharma's new premie-prevention drug, Makena, and the pricing decisions aroudn it.  KV is now also enforcing its rights as an orphan drug provider and it aggressively pursuing cease and desist letters with compounders who would copy (for real cheap) its drug.

In ints defense, KV points out that Makena is FDA approved, unlike products provided by compounders.  It will also save money with its expected treatment course of $27,000-33,000 per patient versus an average cost of $51,000 to treat a premature newborn. Analysts say KV shyold be able to hit $1.1 B in annual sales of the new drug by 2015.

Stories from the WSJ Health blog and the Pharmalot blog.

 

 

 

Posted by Bruce Lehr Mar 10th 2011.

Biotech Job Happiness - We're No. 1. We're No. 1!

As covered by Forbes, people who work in biotech are happiest in their jobs, ranking No. 1 in a recent survey by CareerBliss.  According to CareerBliss CEO Heidi Golledge,"In biotech, the people that they work with and more specifically the person that they work for [ed. note - Listening bosses?], tends to rank higher in terms of importance, and employees are overwhelmingly happy with those conditions."

Biotechnology employees were also among the most happy with their daily tasks and the level of control they feel they have over that work.  Golledge adds that biotechnology is a growth industry, which makes growth opportunities in the field another key ingredient to its workers overall happiness.

Which career was No. 2 on the list?  Surprisingly (perhaps), it was Customer Service.  Just think how happy a customer service representative in biotech must be!

 

Posted by Bruce Lehr March 4th 2011.

Biogen Reports 6 New PML Cases with Tysabri

As reported in Reuter's on Friday, Biogen acknowledged that 6 new cases of progressive multifocal leukoencephalopathy (or PML) occurred in December bringing the total now to 85 reported cases.  Of the 85 cases of PML reported, 16 patients have died, while 69 are still alive with varying degrees of disability.  

Biogen temporarily withdrew Tysabri from the market in 2005 after it was first associated with the condition; it was brought back, with stricter safety warnings, in 2006.The drug is widely considered the most effective on the market, but its sales have been crimped by concerns over PML. The risk of the condition increases with the length of treatment.After two years of monthly infusions, the incidence of PML is now 2.13 per 1,000 patients.

The overall rate of PML in clinical trials was 1 in 1000, a benchmark that has now been exceeded.  Biogen is developing a test that it hopes will allow doctors to screen patients to identify which might be more likely to develop PML.  Biogen shares were down $2.02 or 2.9 percent on the news. 

 

 

Posted by Bruce Lehr Jan 23rd 2011.

 

 

Pfizer’s Falling Share Price Couldn’t Be Cured & Kindler is Out

PharmaGossip, WSJ and Forbes all offer tidbits about why Jeff Kindler chose to leave Pfizer - but mainly it appears to be a case where the stock price was suffering and the road to recovery is still projected to be a long one.  Couple that with the pressures of the executive suite -- particularly as lead executive and a decision to leave is probably quite rational.

PharmaGossip: Pfizer’s Falling Share Price Couldn’t Be Cured.

Keep in mind, Pfizer's stock price has declined by more than 20% sinceKindler began his tenure.  Lipitor and its $11 B in 2009 revenue will soon lose a large part of its value after its patent expiration.  The Wyeth acquisition has yet to pay dividends - albeit - the jury is still out on the final grade for that deal.  Forbes also points out that Pfizer's PE ratio (7.3) is lower than 91 percent of pharmaceutical companies and 97 percent of the S&P 500 index.  Ouch!  Is there really an doubt to the decision when pondering "Should I stay or should I go?"  Afterall, if I stay it could be double.

 

Posted by Bruce Lehr December 7th 2010.

 

Sanofi's Viehbacher Replaces Pfizer's Kindler at PhRMA

PhRMA published a press release announcing that Sanofi's CEO Chris Viehbacher will take over as the new Board Chairman for the outgoing Jeff Kindler of Pfizer.  Viehbacher took the opportunity of his appointment to outline the pharma industy's priorities:

• Putting patients first by delivering innovative medicines that address unmet medical needs
• Prevention and better management of chronic diseases

Chronic diseases give rise to 75% of the national healthcare spend so addressing these is an important measure of controlling overall costs - albeit through better health for patients.  PhRMA will continue to stress medical innovation to patients, policies that reward investment in R&D, economic growth and jobs.

 

 

Posted by Bruce Lehr December 6th 2010.

 

Dendreon's Commercial Launch lead for Provenge Leaves

Dendreon's senior vice president of global commercial operations - who was hired to run the Provenge launch - has decided to leave at a time when the drug is just moving into the market.  Varun Nanda was considered to be a key hire by Dendreon as he had experience with similar programs related to Roche's Avastin and Rituxan.

Dendreon’s chief operating officer, Hans Bishop, said in a statement on April 8 shortly after Nanda's hire. “Varun’s depth of experience launching Avastin and leading several breakthrough global oncology products will be highly relevant to our transformation from a purely R&D organization into a world-class commercial organization.”

  Provenge has been plagued with manufacturing capacity issues hindering its suppply.  It's been able to sustain sales of $9-10 M per month but ths falls far short of the $350-400M in sales the product is expected to generate annually.

Now, Nanda is gone without much explanation and Bishop assumes control in the interim while a replacement is found. See Xconomy.

 

 

Posted by Bruce Lehr November 19th 2010.