Pfizer, Roche disappoint street

Pfizer results include Wyeth Labs for the first time but street expected mrore from the combined topline, profits

Marketwatch

Pfizer Inc. reported higher fourth-quarter earnings Wednesday, with its top line boosted by recent the drugmaker's merger with Wyeth as profit also benefited from the absence of a major year-ago charge related to its recalled pain reliever Bextra.

Pfizer (PFE 18.59, -0.65, -3.38%) also issued a financial forecast that fell below analysts' estimates for earnings. Shares of Pfizer, part of the Dow Jones Industrial Average, traded down 2% to $18.68 shortly after the opening bell.

For the December quarter, Pfizer posted net income of $767 million, or 10 cents a share, up from $266 million, or 4 cents, earned in the final three months of 2008.

The year-ago quarter saw the New York-based company take $2.3 billion in charges related to resolution of investigations into Bextra and certain other products.

Stock float rose to 7.85 billion shares up by 1.1 billion shares, with Quarterly topline at $16.54 billion agst 12.5 billion standalone a year back. The $65 billion revenue megalith was shaky about 2010 prospects with 2010 earnings adj to $2.10 to $2.20 (topline of 67-69 b) scaling back its own estimates. they shd just making forward staements till they have an idea. 2012 forecasts for a similar topline/ revenue promise cost controls with EPS of $2.25-2.35 from 66-68billion sales

Analysts were somehow expecting $2.27 for 2010 and $2.22 in 2012 Dividend for the 1st quarter at 18c is back from 16c but is down from 32 c before cash was saved up for Wyeth

ROCHE's 'honeymoon' with the flu is over as Tamiflu sales recede from here

Roche Holding on Wednesday reported a 4% rise in second-half profit, buoyed by sales of flu medication Tamiflu and eye-disease drug Lucentis as sales growth slowed toward the end of the year.

Though the company didn't provide second-half results, MarketWatch calculated Roche's (CH:ROG 179.20, -1.40, -0.78%) profit rose to 4.31 billion Swiss francs ($4 billion) from 4.15 billion francs, while sales rose to 25.05 billion francs from 23.61 billion francs.

During the fourth quarter, total sales rose just 3%, as sales of its top selling drug, Avastin, slowed to 9% on a constant-currency basis, with MabThera sales flat and Herceptin sales up just 2%. All three are cancer medications.

The company expects 2010 sales to grow in a mid-single-digit range at constant currencies -- excluding Tamiflu sales -- compared to 10% growth by that measure in 2009, and Roche sees core earnings per share up by a double-digit level compared to 20% growth in 2009.

Tamiflu sales are seen falling to 1.2 billion francs from 3.2 billion francs as worries over pandemic flu recede.

GAVI Alliance

With Novartis staying away from pro bono giveaways of its vaccination and social health products, GAVI's ten years of existence have a special proud moment for it. The Global Alliance for Vaccines and Immunization including WHO , UNICEF and the Gates Foundation was launched at the WEF in January 2000

When GAVI was publicly launched at the World Economic Forum in January 2000, immunisation rates in the world’s poorest countries were in decline and there was slow progress in introducing new vaccines against Hepatitis B and Yellow Fever.

Over the past 10 years, the Alliance has played a catalytic role in reversing these trends. Drawing on the specialized skills and knowledge of the leading public and private stakeholders in immunisation, from UNICEF and WHO to the Vaccine Industry and the World Bank, GAVI has:

- Funded the delivery of life-saving vaccines to 250 million children
- Averted five million future deaths
- Helped push immunisation rates in poor counties to an unprecedented 80% average
- Reduced the time lag between introducing new vaccines like Haemophilus influenzae type b (Hib) and Hepatitis B, into poorer countries

In Nov 2006, the International Finance Facility for Immunizations issued the first vaccine bonds and claim to serve billions thru innovative financing and not millions.

Gates Foundation on Emerging Markets

VACCINATION PROGRAM

Endorsing vaccines as the world’s most cost-effective public health measure, Bill and Melinda Gates said Friday that their foundation would more than double its spending on them over the next decade, to at least $10 billion.

The change could save the lives of as many as eight million children by 2020, Mr. Gates calculated. He said he hoped his gift would inspire other charities and donor nations to do the same.

The commitment is the largest ever made by a foundation, according to the Chronicle of Philanthropy, which noted that $10 billion is slightly more than the total worth of the Ford Foundation, the country’s second largest. The Gates Foundation, created in 1999 with the fortune that Mr. Gates made from Microsoft, has about $34 billion in assets; it has already spent $4.5 billion on vaccines.

“Vaccines are a real success story,” Mr. Gates said in an interview before the announcement, which he made at the World Economic Forum in Davos, Switzerland. “The cost is tiny, and yet it saves more lives than any other component of a health care system.”

Novartis December 2009 results

Great work by NVS, but it is still overpaying for Alcon while in a very infortunate attempt, mistreating the remaining minority interest in Alcon. Nestle walks away with close to $40 bn for ALCON

Novartis has already paid $11billion to Nestle last year for 25% and has agreed to pay another $28billion for 52% in Alcon still with Nestle. Hwvr, the remianing minority shareholders want the same or a fair deal while NVS expects a deep discount on the remaining

Results for December from the NY times

Drug maker Novartis (NYSE:NVS) AG on Tuesday reported a 54 percent rise in fourth-quarter net profit to $2.32 billion on strong sales and favorable exchange rates, and announced the appointment of Joe Jimenez as its new chief executive.

Earnings per share rose 53 percent to $1.01 from $0.66 in the same quarter of 2008, when Novartis posted a net profit of $1.51 billion, the company said.

Sales of its products, which include the hypertension drug Diovan and anticancer drug Glivec -- known as Gleevec in the United States, rose 28 percent to $12.93 billion in the September-December period from $10.08 billion the previous year.

"The fourth quarter has been especially strong," outgoing CEO Daniel Vasella told reporters in a conference call, noting that Novartis benefited from better exchange rates and the shipment of large orders of swine flu vaccine in the final three months of 2009.

Interestingly, as mentioned otherwise as well, NVS did pursue a patent centric strategy and lost much blood in India/elsewhere. In the vaccines market also it refuses to get into emerging market specific pricing like GSK giving away free vaccines etc.

Also its $3.5 billion Diovan (2005) runs out of patent in 2012 . It has been creating Hypertension / BP reducing extensions, esp one with Pfizer..It also has a vaccine coy purchase from 2005. It expects Galvus to give $2 b in sales by then in the Type 2 Diabetes market. Indian drugmakers and others have also marked down NVS' Gleevec for patent challenges. Gleevec is its high volume drug in Cancer with another $3b in sales

Novartis is also going after the diabetes market with Galvus, a once-daily oral treatment for type 2 diabetes. Analysts project that the drug, filed in March, could hit $2.1 billion in sales by 2012, as it competes with Merck’s Januvia.

The biggest drug approval news for Novartis came from the generic division, which received clearance in the U.S. and EU for Omnitrope, which is not a biogeneric, but a ‘follow-on version of a previously approved recombinant biotechnology drug.’ That approval may open the door to a new era of follow-on biologics, as more of the pioneer biodrugs show their age.

ACQUISITIONS

Target: Chiron Corp.
Price: $5.4 billion
Announced: May 2006

Target: NeuTec Pharma
Price: $569 million
Announced: June 2006
More Vax

In September 2005, Novartis bid to acquire beleaguered biopharma/vaccine/blood testing company Chiron for approximately $5.1 billion, a sum representing the 58% of shares that Novartis didn’t already own. The deal finally closed at $5.4 billion, giving Novartis a position in the vaccines field, a $10.8 billion market that analysts project will grow at an annual 20% clip in the next five years.

Sanofi Aventis merger

This extract from marketwatch of Dec 21 Mkt Open

French pharmaceutical Sanofi-Aventis on Monday struck a deal to buy Chattem Inc. for $1.9 billion in a bid to expand its presence in over-the-counter and consumer brands.

Sanofi (SNY 38.80, -0.31, -0.79%) (FR:SAN 54.20, -0.50, -0.91%) said it will pay $93.50 in cash for each share of Chattem (CHTT 69.98, +1.29, +1.88%) -- a 34% premium to Friday's closing price and a 44% premium to the shares' six-month average price.

Chattanooga, Tenn.-based Chattem's brands include Gold Bond, Icy Hot, ACT, Cortizone-10, Selsun Blue and Unisom.

For Sanofi, this deal will mark the first time it's been directly in the U.S. over-the-counter market. Sanofi also will seek to convert Allegra, its popular antihistamine treatment, from a prescription drug to an OTC product.

Once the drug becomes OTC, Chattem will distribute it.

CHTT 69.98, +1.29, +1.88%

and CEO Zan Guerry and other senior managers have agreed to lead Sanofi's U.S. consumer health division once the deal is completed, Sanofi said.

Earlier Monday, Sanofi gave an update on its pipeline, as it's stopping development of drugs for insomnia and atrial fibrillation but having received fast-track designation from the Food and Drug Administration for a potential treatment for prostate cancer.

Analysts at Jefferies & Co. said the updates result in the loss of 1% of estimated 2015 revenue.

Mergers got ahead of the real folks gone under - ho ho ho

The Reuters bangalore team, recently helped this story on the pharma majors' mergers

U.S. securities regulators are investigating at least nine mergers, including Pfizer Inc's takeover of Wyeth and Merck & Co Inc's acquisition of Schering-Plough Corp, for possible insider-trading violations, the Wall Street Journal reported, citing people familiar with the matter.

The Securities and Exchange Commission is probing whether deal advisers and traders illegally shared confidential information, the paper said, noting that the agency had sent out about three dozen subpoenas to hedge funds and brokerages.

It was looking at other pharmaceutical deals including Abbott Laboratories Inc's acquisition of Advanced Medical Optics and Eli Lilly & Co's buyout of ImClone Systems, the paper reported.

The Journal also said the SEC is asking questions about trading around retailer Best Buy Co Inc's 2008 acquisition of Napster Inc, investment firm Triarc Cos' acquisition of Wendy's International Inc and Ansys Inc's takeover of Ansoft Corp.

It was not clear whether the subpoenas were related to the insider-trading case unveiled in October involving New York hedge fund Galleon Group, the paper said.

The Journal said some of the recent subpoenas focus on specifics of investment bankers' involvement in deals, including Goldman Sachs Group Inc bankers' roles in roughly a dozen health-care transactions since 2006.

Goldman was an adviser to Schering-Plough and Pfizer, according to filings cited by the Journal.

"Goldman Sachs has robust policies and procedures in place to detect suspicious trading activity. If we detect suspicious activity of any kind, as required by law, we report it to the appropriate authorities," a company spokesman told the paper.

The Journal said representatives for Eli Lilly, Napster and Wendy's/Arby's Group declined to comment and that a spokesman for JER Partners said the firm cooperated with an SEC inquiry involving the Genesis HealthCare deal in 2007, but JER Partners has not heard from the SEC this year. He told the paper Genesis executives were contacted by the SEC this year, but it was not clear whether that inquiry was connected to the recent subpoenas.

(NO EDGAR REPORTS, JUST THE VERB FROM REU

via Reuters SEC report

Pneumococcal Vac

GSK signs lifetime deal with Brazil for pneumococcal vaccine - Posted on FT by Andy Jack

September 28 2009 03:00

GlaxoSmithKline has sealed an innovative €1.5bn (£1.38bn) contract with Brazil guaranteeing sales of its pneumococcal vaccine, designed to prevent pneumonia and meningitis, over the entire life of the product.

The deal marks a watershed in negotiation of a long-term contract in a way that provides GSK with an agreed price and volume, starting at €11.50 a dose and falling to €5 in future years.
Most drugs and vaccines are sold over far shorter periods and subject to uncertainties over arbitrary price reductions, as well as the threat of competition from rival low-cost generic alternatives.

The deal comes as GSK continues to expand in emerging markets and is diversifying away from drugs into vaccines and other products.

The company agreed to supply enough doses of Synflorix to vaccinate the 13m children requiring coverage each year for at least eight years, underpinned by a technology transfer agreement that will eventually allow Brazil to manufacture the vaccine itself.

Brazil's health minister and Andrew Witty, GSK's chief executive, unveiled the deal in London on Friday to strengthen Brazil's pharmaceutical research and development capacity, including a €17m joint project to develop a Dengue vaccine. Depending on the extent of technology transfer and Brazil's ability to manufacture the vaccine, which Mr Witty described as "probably the most technically complex vaccine in the world", GSK may still earn some income even after the contract ends.Some countries, including Brazil, have threatened or introduced compulsory licenses to overturn drug company patents and permit competition or force price reductions.

The price represents a significant discount tothat of about €35-€40 a dose at which the vaccine is sold in Europe, but the high volumes and long timescale provide unusual certainty to the company. The action also sets a baseline for sales in other middle-income countries, and for the Advance Market Commitment, a bulk purchase agreement with donor governments to help buy the vaccine for low- income countries.Mr Witty said: "This wasn't the first and I don't believe it will be the last such contract. It shows GSK and Brazil are really coming together with the same mindset."

Paulo Gadelha, president of the Fiocruz institute, which will produce the vaccine, stressed that the technology received could also be used to help it make other vaccines in future. He said his institute was already pledging to provide technology transfer to make low-cost drugs and vaccines for African countries, in what could provide a challenge for large pharmaceutical companies. Mr Witty said "there has to be enough economic flow to encourage GSK to continue" developing vaccines for predominantly low- income countries. Prevnar from Wyeth will be a big competitor, Pfizer getting Prevnar approval in EMEA from European Authorities last Friday from FT.com Braxil

Since Chartnuts, no surprise, since the loon ignores competing products & other "subtractive factors", had never heard of Synflorix before I told the loser about it, here is a summary of some differences, relying to some extent on Wiki:

Pneumococcal conjugate vaccine (PCV) is a vaccine used to protect infants & young children against disease caused by the bacterium Streptococcus pneumoniae (pneumococcus). There are currently two PCV vaccines available on the global market: Prevnar (sometimes called Prevenar) & Synflorix.

Prevnar, trade name of manufacturer WYE, is a heptavalent vaccine, meaning that it contains the cell membrane sugars of seven serotypes of pneumococcus, conjugated with Diphtheria proteins. In the US, vaccination with Prevnar is recommended for all children younger than two years, & for unvaccinated children between 24 & 59 months old who are at high risk for pneumococcal infections.

The vaccine was primarily developed for US & European epidemiological situation, & therefore it has only a limited coverage of serotypes causing serious pneumococcal infections in most developing countries.

Prevnar is produced from the seven most prevalent strains of Streptococcus pneumoniae bacteria in the US. The bacterial capsule sugars, a characteristic of these pathogens, are linked to CRM197, a nontoxic recombinant variant of diphtheria toxin (Corynebacterium diphtheriae).

The vaccine's polysaccharide sugars are grown separately in soy peptone broths. Through reductive amination, the sugars are directly conjugated to the protein carrier CRM197 to form the glycoconjugate. CRM197 is grown in Corynebacterium diphtheriae strain C7 in a medium of casamino acids and yeast extracts.

The current 7-valent formulation contains serotypes 4, 6B, 9V, 14, 18C, 19F & 23F, & results in a 98% probability of protection against these strains, which caused 80% of the pneumococcal disease in infants in the US.

In 2009, WYE will introduce Prevnar 13, which contains six additional strains (1, 3, 5, 6A, 19A & 7F), protecting against the majority of remaining pneumococcal infections.

Synflorix, manufactured by GSK, received a positive opinion from the European Medicines Agency for use in the European Union in January 2009. Synflorix is a ten valent vaccine meaning that it contains ten serotypes of pneumococcus (1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F & 23F) which are conjugated to a carrier protein. GSK received European Commission authorization for Synflorix in March 2009.

Synflorix contains the same seven pneumococcal serotypes in Prevnar. In addition, Synflorix protects against serotypes 1, 5 & 7F. Eight of the ten serotypes are linked to a protein carrier derived from non typeable Haemophilus influenzae.

Here then is a summary:

Prevnar 13: 1, 3, 4, 5, 6A, 6B, 7F 9V, 14, 18C, 19A, 19F & 23F.
Synflorix: 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F & 23F.

I don't know whether Synflorix' carrier offers advantages over Prevnar's, or was selected to avoid patent issues. Nor do I know if the added serotypes are more prevalent in the developing world.

Many have questioned whether Prevnar, optimized against ear infections, is worth the price. WYE may agree, since they widened its serotype spectrum.

In the developing world, whence future growth must come, price will certainly be an issue.