Who’s the Big Kahuna of HIV drugs? If you said GlaxoSmithKline or Abbott Laboratories, you’re wrong. It’s Gilead Sciences, at least according to sales figures compiled by Reuters.

Gilead drugs occupy the top two slots in a global ranking of HIV meds by sales. Truvada sits on top with $2.49 billion in 2009 sales; Atripla (a Gilead/Bristol-Myers Squibb med) is second with $2.38 billion; and Viread is in seventh place with $668 million. Add it up and you’ll get more than $5.5 billion.

Even the big GlaxoSmithKline-Pfizer partnership, ViiV, doesn’t come close to that. The venture’s Epzicom came in at fifth place with $855 million, while Combivir nabbed eighth place with $665 million and Epivir came in 10th with $542 million. Of course, GSK and Pfizer are hoping that their combination pipeline will eventually boost ViiV drugs up in the rankings.

Merck, Bristol-Myers, Abbott Laboratories and Johnson & Johnson all have drugs in the top 10.

Source: FiercePharma

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The scuttlebutt from Bloomberg late last week about Sanofi-Aventis’ interest in acquiring an unidentified drug developer in the pricey neighborhood of $20 billion has triggered a fevered new game of name-the-target.

For its part, the Wall Street Journal’s Michael Corkery ran a slate of five potential developers that fit the general profile: Genzyme ($13 billion market cap); Biogen Idec ($13 billion); Celgene ($23 billion); Gilead Sciences and Amgen. With a market cap of $50 billion, though, Amgen would seem to be a far larger company than Sanofi would want to swallow right now.

For its part, Reuters helped stir the pot of market rumors with its own sources discussing one or two deals worth around $15 billion each. That helped spur shares of Biogen, Genzyme and Allergan, another hotly rumored target. Of course, in the biopharma business, M&A deals are always on the table in one fashion or another.

“In big pharma, everybody is looking at everything and they all have big departments looking at possible acquisitions,” Raymond James analyst Thierry Verrecchia told Reuters.

TheStreet’s Adam Feuerstein, meanwhile, doesn’t think any of the big biotech companies are on Sanofi’s list of potential takeover targets. He likes Allergan as the company most likely to help Sanofi diversify.

“I think this is all hogwash,” counters Matthew Herper at Forbes. “I don’t know what (Sanofi CEO Chris) Viehbacher is planning, but I’ve interviewed him about mergers several times since he took over in 2008, and a deal of the size and scope we’re speculating is completely within the realm of what he’s previously discussed. And a biotech certainly could make sense for Sanofi.

Source: FierceBiotech

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Gilead Sciences will pay up to $120 million to purchase Branford, CT-based CGI Pharmaceuticals, a private developer focused on small molecule chemistry and kinase biology. The company’s lead compound is in preclinical testing for the treatment of serious inflammatory diseases, including rheumatoid arthritis.

The majority of Gilead’s $120 million will come as an upfront payment, with the remainder based on clinical development of drug targets. The deal is expected to close in the third quarter of the year. CGI will continue operations in Branford as a wholly-owned subsidiary of Gilead.

“The acquisition of CGI represents a unique opportunity to expand our research efforts in an interesting and promising area of drug discovery,” says Norbert Bischofberger, Gilead’s CSO, in a statement. “CGI has established itself in the area of protein kinase biology and small molecule discovery, and the company’s scientific leadership and expertise represents a strong strategic fit with Gilead’s existing research organization. We look forward to advancing compounds in CGI’s portfolio toward clinical development.”

Source: FierceBiotech

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Who is doing the most to get medicines to the developing world? GlaxoSmithKline, at least according to this year’s Access to Medicines Index, with Merck, Novartis, Gilead Sciences and Sanofi-Aventis rounding out the top five.

This year’s access index–which looks at pricing policies, R&D efforts, patents, access and more–includes six European companies in the top 10, with the remaining four from the U.S. Produced by a Dutch foundation and backed by institutional investors and funds that manage $3.1 trillion in assets–as Reuters notes–the index is designed to help investors compare drugmakers’ social responsibility.

Access to drugs in emerging markets isn’t only a social issue for drugmakers these days, but a key business strategy. Companies such as GSK and Sanofi have cut their prices in the developing world to help spur volume sales. Big Pharma has been buying up and partnering with drugmakers in Africa, India, China and Latin America.

As emerging markets continue to deliver the biggest growth prospects on the globe, no doubt access to Big Pharma drugs will continue to grow. ”[E]merging markets are where the larger growth is,” My-Linh Ngo, associate director of sustainable investments at Henderson, told the Financial Times. “Better access to medicines helps position them.”

Looking at this year’s top 10, we have Roche, AstraZeneca, Novo Nordisk, Johnson & Johnson, and Abbott Laboratories in sixth through tenth place. Among the rest are Pfizer, Bayer, Eli Lilly, and Boehringer Ingelheim. According to the foundation, Bayer, Bristol-Myers Squibb, Merck KGaA and Novo Nordisk dropped in this year’s rankings, while Gilead and Pfizer moved up.

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Two extra mutations set the stage for the seasonal influenza virus to evolve into a form that now resists three of the four drugs designed to fight it, researchers reported on Thursday.

Their study, published in the journal Science, provides a way for scientists to keep an eye out for dangerous mutations in new flu viruses, including the ongoing pandemic of H1N1 swine flu.

Only four drugs are on the market to treat flu and two, the adamantines, are useless against virtually all circulating strains because the viruses have evolved resistance.

Tamiflu, known generically as oseltamivir, is the current drug of choice. It comes as a pill made by Roche AG under license from Gilead Sciences. GlaxoSmithKline makes an inhaled drug that works in a similar manner called Relenza, or zanamivir generically.

Both can help reduce flu symptoms if taken quickly and can keep the most vulnerable patients out of the hospital, or keep them alive if they are severely ill. But two years ago the common circulating strain of seasonal H1N1 developed resistance to Tamiflu.

Doctors were surprised, because the mutation that help the virus evade the effects of Tamiflu also usually made it a weak virus that did not infect or spread well.

“People have known about this H274Y mutation for over a decade, but the mutation seemed to interfere with the virus’s ability to replicate and be transmitted,” Jesse Bloom of the California Institute of Technology, who led the study, said in a statement.

“Something happened to make the Tamiflu-resistant virus also capable of replicating and spreading like wild-type flu viruses.”

Bloom and Dr. David Baltimore, an expert on AIDS and on the genetic functions of cells and viruses at Caltech, led a study to find out how this happened.

They found two other mutations in the virus allowed it not only to evade the effects of Tamiflu but to survive and spread.

In addition, the mutations took place before the third and final mutation allowing the virus to evade the drugs. This means that scientists can monitor flu viruses for the initial two mutations to give early warning that they are about to become drug resistant.

This is important in planning for both seasonal influenza and pandemics. Seasonal flu kills between 250,000 and 500,000 people every year globally.

H1N1 swine flu may have been just slightly more deadly — statistics will take years to gather — but it affects younger adults and children in contrast to seasonal flu, which kills more elderly people.

Currently swine flu is easily treated by Tamiflu but that could change at any time.

So doctors need drugs on hand to save lives and if one drug will be useless, they need to know that because flu must be treated within days of onset for treatment to be useful.

Earlier on Thursday the World Health Organization said the H1N1 pandemic was not yet over although its most intense activity has passed in many parts of the world.

Source: Reuters

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Scientists have identified a chemical compound that can stop the H5N1 bird flu virus as well as seasonal human flu viruses from replicating.

Finding new flu drugs is essential as flu viruses mutate and are adept at evading the limited array of antiviral drugs.

In a paper published in Nature Biotechnology, scientists from Hong Kong and Canada said they had found a chemical “nucleozin,” which fought off both seasonal flu viruses and the H5N1 in mice as well as in cell culture.

“We have now brand-new weapons to combat influenza virus resistant to … (antiviral drugs like) oseltamivir and zanamivir,” said microbiologist Richard Yao at the University of Hong Kong, who led the study.

Nearly all of the seasonal H1N1 viruses circulating in the United States in the 2008-2009 flu season were resistant to Roche AG and Gilead Sciences Inc’s Tamiflu, known generically as oseltamivir, according to the paper.

Adamantanes, an older class of drugs, was also powerless against seasonal H3N2 flu viruses in the United States during that same period.

Zanamivir is the generic name for Relenza, GlaxoSmithKline and Biota Inc’s flu drug

Nucleozin targeted a protein in flu viruses, called nucleoprotein, that was responsible for virus replication, Yao said in reply to questions from Reuters.

Yao said they selected nucleozin from a chemical library with more than 50,000 compounds, the same library which experts here used to study the SARS virus.

“Nucleozin is highly potent in cell culture and also in mice infected with the highly pathogenic influenza virus H5N1 … (it can) stop the virus from replicating,” Yao said.

The compound was effective against H1N1, H3N2, and H5N1 viruses and researchers can now target nucleoprotein to fight flu, Yao said.

“Scientists could now use nucleoprotein as a target to develop antiviral therapeutics for the treatment of influenza infection,” he said.

A cousin of the new H1N1 swine flu virus, the seasonal H1N1, has been circulating widely for a long time. SARS surfaced in southern China in 2003, killing about 800 people world-wide.

The H5N1, although mainly a disease in birds, has a mortality rate of 60 percent on the rare occasions when it infects people. It was first discovered in people in 1997.

Source: Reuters

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Vertex Pharmaceuticals is expected to soon announce late-stage data on its hepatitis C treatment from the first of three key studies–and the Street is waiting with great anticipation, a Dow Jones report notes. Many anticipate the study data–expected by the end of June–will be positive, and they could help further gains as confidence grows in the drug’s role in the lucrative but increasingly competitive hepatitis C market.

Although it has several promising pipeline products, Vertex’s $7.7 billion market valuation is primarily tied to the success of telaprevir, Dow Jones reports. Telaprevir is likely to face competition from Merck’s boceprevir, which is on a similar development timeline. However, in April 2009, Schering-Plough, now part of Merck, reported data showing that half of the patients receiving the experimental drug developed anemia.

Other companies developing hep C treatments include Bristol-Myers Squibb, Gilead Sciences and Roche.

Wells Fargo & Co. has initiated coverage on Vertex with a “Market Perform” rating and a valuation range of $38-$43. “Telaprevir is one of the most-watched drug development programs in healthcare, given its multibillion dollar potential. We are in agreement with the Street that a positive outcome for the trial is virtually a foregone conclusion and that telaprevir will be commercially successful,” it says in a note, as quoted by American Banking News.

“However, given the high expectations being placed on trial outcomes, …we believe it may be difficult for trial results to dramatically exceed expectations, which may be required to see significant share appreciation given current market conditions,” it adds.

Last month, Vertex and Johnson & Johnson announced that telaprevir combined with older anti-viral treatments peginterferon and ribavirin cured 93 percent to 100 percent of patients with hepatitis C genotype 1 after 48 weeks of treatment.

Source: FierceBiotech

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Another day, another slew of earnings reports. Today, it’s Abbott Laboratories beating the Street’s expectations, and Gilead Sciences posting a big increase in earnings. Here are the high points.

Abbott Laboratories reported better-than-expected earnings on a return of booming sales growth for arthritis drug Humira and strong demand for its other medicines, medical devices and nutritional products. Revenues grew 15 percent to $7.7 billion; earnings were down to $1 billion from $1.44 billion a year ago, but that higher number came on a one-time gain. So, excluding items, EPS grew to 81 cents from 70 cents.

Gilead’s earnings for Q1 rose by 45 percent as revenue grew 36 percent to $2.09 billion. But sales of its HIV drugs Truvada and Atripla came in lower than analysts had expected: Truvada brought in $657.8 million, compared with estimates of $680 million, while Atripla sales were $692.9 million, compared with estimates of $726 million.

Elan narrowed its first-quarter loss, helped by revenue from MS blockbuster Tysabri. CFO Shane Cooke forecast full-year revenue growth, and predicted that adjusted earnings before interest, tax, depreciation and amortization would reach more than $150 million.

Forest Laboratories reported a drop in profits, as a one-time licensing charge weighed income down to $22.6 million, down from $92.8 million year-over-year. Without that charge, EPS of 83 cents was in line with analyst expectations. It has $4 billion in cash available for licensing and buyouts, but it’s not looking for a big deal, CFO Frank Perier said. “We don’t see the need to do some kind of big, transformative merger,” he said.

There’s more to come; most of Big Pharma hasn’t reported yet. So you numbers hounds will have plenty to chew on.

Source: FiercePharma

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The FDA today disclosed several warning letters it had sent to drug makers and weight-loss spas for “false” and-or “misleading” claims for their products. Here’s a rundown:

• Biogen Idec was cited for a promotional Webcast involving the multiple sclerosis drug Tysabri because it minimized the risk of a serious brain infection, the FDA said. The letter also cited the company for failing to submit the Webcast for FDA review 30 days in advance. Tysabri is sold jointly by Biogen and Elan.

• Gilead Sciences was cited for a print ad for involving its HIV drug Truvada, which the FDA said overstated the effectiveness of the products and minimized the risks associated with the drug.

• Half a dozen spas offering “lipodissolve” injections to get rid of small fat deposits received letters because the FDA said the therapy hasn’t been cleared by regulators. “The claims made for your lipodissolve products are false and misleading in that they are not supported by substantial evidence or substantial clinical experience,” one letter said.

Update: A Biogen spokeswoman told Dow Jones Newswires that the company believed “the content and means for communicating this safety information was appropriate, timely, factual and non-promotional, and we plan to have further conversation with the agency.” Gilead said in a statement that takes the FDA’s concerns regarding the advertisements seriously “and we will be working to respond to the FDA promptly,” according to DJ Newswires.

Source: The Wall Street Journal

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Gilead Sciences (GILD) said darusentan, the company’s experimental drug to treat resistant hypertension, failed in a late-stage clinical trial. Darusentan, an endothelin receptor antagonist, did not achieve its two primary endpoints in a comparison to a placebo. “We are disappointed that darusentan did not achieve its primary endpoints in this study,” said Norbert Bischofberger, Gilead’s executive vice president of research and development and chief scientific officer. “As a result, we think it would be challenging to define an expedient path forward. We would likely be required to initiate another phase III study and would rather allocate our resources to other promising research and development opportunities in our pipeline.”

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Elan (ELN) and Transition Therapeutics (TTHI) said they have modified a clinical trial of their experimental Alzheimer’s drug to remove the two high doses uses after concerns about adverse events including the death of nine patients. The companies said the decision was made in concurrence with the Independent Safety Monitoring Committee following a review of the ongoing ELND005-AD201 study. A direct relationship between ELND005 and the deaths has not been established. The Independent Safety Monitoring Committee and both companies agreed that the tolerability and safety data are acceptable among patients receiving the lower dose of the drug and that the blinded study should continue for this dose and the placebo group.

Addex Pharmaceuticals said it decided to end prematurely a study of its experimental drug ADX10059 for the prevention of migraine because of safety concerns. The Swiss company said a routine safety monitoring of blinded data revealed an incidence of abnormalities in liver function tests that is higher than expected. The abnormalities are apparent from day 28 of dosing but the incidence and severity appear to increase progressively with increasing duration of participation in the study. Despite the fact that the treatment allocation remains blinded, Addex said it believes that the risk-to-benefit profile of the drug observed in the study is not sufficiently favorable to justify continuation of the trial.

A gel designed to prevent AIDS infections produced by Chadds Ford, Pennsylvania-based Endo Pharmaceuticals (ENDP) failed in a clinical trial in Africa, according to the funders of the trial. The largest international clinical trial to date into a preventative HIV gel found no evidence that the vaginal microbicide PRO 2000 reduces the risk of HIV infection in women, researchers reported. The Department for International Development and the U.K. Medical Research Council funded the trial. To date, no microbicide has been shown to be effective against HIV infection.

A U.S. Food and Drug Administration advisory panel rejected early use of OSI Pharmaceuticals’ (OSIP) and Genentech’s (DNA) Tarceva. The Oncologic Drugs Advisory Committee voted 12 to one recommending against approval of the daily pill Tarceva for first-line maintenance use in people with advanced or metastatic non-small cell lung cancer whose cancer has not progressed following first-line treatment with platinum-based chemotherapy. The FDA is not bound by the recommendations of its advisory committees and the agency is expected to make a decision on whether to approve Tarceva for this use by January 18, 2010.

Memphis-based GTx (GTXI) said it laying off nearly 30 percent of its staff as a result of the delay in the potential commercialization of toremifene 80 mg to reduce fractures in men with prostate cancer on androgen deprivation therapy. Employees remaining with the company will not receive an increase in base salaries for 2010 or any bonus compensation for 2009. GTx is retaining its senior commercial and medical leadership team in order to remain prepared for the potential commercialization of toremifene. GTx expects to record a charge of approximately $1.1 million related to the workforce reduction in the fourth quarter of 2009.

Hawaii Biotech filed for Chapter 11 bankruptcy protection. The privately-held Hawaii-based vaccine maker plans to continue to develop vaccines to protect against West Nile virus, dengue fever, and tick-borne encephalitis.

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Vion Pharmaceuticals (VION.OB) filed for Chapter 11 bankruptcy protection and plans to continue to operate its business as a debtor-in-possession. The bankruptcy fining became necessary as a result of the U.S. Food and Drug Administration’s complete response letter relating to its application to begin marketing Onrigin, a treatment for acute myeloid leukemia and high-risk myelopysplasia. The FDA wants Vion to conduct an additional trial to demonstrate the efficacy and safety of Onrigin in the patient population proposed for the indication, which Vion cannot afford to do.

Quebec City-based AEterna Zentaris (AEZS) said Sanofi-Aventis (SNY) will terminate their agreement for the development, commercialization and licensing of cetrorelix in benign prostatic hyperplasia for the U.S. market effective January 9. The announcement follows the release of data from a late-stage clinical study for cetrorelix in BPH that showed the experimental drug failed to meet its primary endpoint.

Ark Therapeutics Group (ARKTF.PK) said that it has received notice from the European Medicines Agency that the European Committee for Medicinal Products for Human Use has recommended that the company’s application to begin marketing its gene-based therapy to treat operable brain cancer Cerepro should not be approved based on data provided by the company. Ark said it intends to provide additional data to support re-examination through the standard appeal procedure. The main underlying objection from the regulator that had not been resolved concerns specifically whether or not patients treated with Cerepro might for some reason, have been left longer by surgeons prior to re-intervention than those who did not receive Cerepro. As time to re-intervention is the main efficacy measure in the primary endpoint, the assessors determined that they could not recommend approval based on the data presented by Ark so far.

Source: Seeking Alpha

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