With Astellas Pharma and OSI Pharmaceuticals haggling over price, BNet Pharma wonders which biotechs could be next on the buyout menu. Mega-mergers might have been all the rage in 2009; however, with few targets left, the focus will shift to smaller acquisitions. Big Biotechs Biogen Idec and Gezyme could be on the menu, given Carl Icahn’s involvement in the companies.

So which smaller developers could be targets? Here’s BNet’s list:

• Vertex Pharmaceuticals’ promising hepatitis c drug telaprevir is in Phase III trials, and the company has a pipeline of drugs that features treatments for cystic fibrosis, epilepsy and inflammatory diseases

• GlaxoSmithKline is already partnered with Human Genome Sciences on its lupus drug Benlysta, which analysts predict could lead to $4 billion in sales.

• Alexion Pharmaceuticals boasts Soliris, the world’s most expensive drug, which pulls in about $400 million a year. The developer has four Phase II trials for other indications of the drug, which is currently approved for a rare blood disorder.

• Sales of pulmonary arterial hypertension drugs Remodulin and Tyvaso have led United Therapeutics to $370 million in annual revenues.

• With $844 million in sales last year, Bayer and Onyx Pharmaceuticals’ kidney and liver cancer drug Nexavar came close to the blockbuster mark. Four Phase III trials are testing the drug for additional indications

• Auxilium Pharmaceuticals is looking for more uses for its Testim testosterone gel and Xiaflex, a drug for hand contracture disease.

• Allos Therapeutics won approval last year for Folotyn as a treatment for peripheral T-cell lymphoma; trials for cutaneous T-cell lymphoma are under way.

Source: FierceBiotech

Popularity: 1% [?]

Is the iDrugstore next? Not exactly, but pharma companies are teaming up with tech to better market their drugs. Some of their first forays are in the diabetes arena: Bayer’s Didget glucometer hooks up to Nintendo gaming devices, Bloomberg reports, as a way to encourage kids to monitor their blood sugar. And Johnson & Johnson is working with Apple on an iPhone app that would allow patients to upload and share their blood-sugar data.

There are plenty of other possibilities: Apps that remind patients to take their meds or get refills, for instance. And Ernst & Young’s pharma experts say that savvy drugmakers will take advantage of the opportunities. Because with pharma sales growth slowing, companies have to take new approaches to their business models.

“It’s an opportunity to have a very vivid imagination,” Carolyn Buck-Luce, Ernst & Young’s global pharmaceutical sector leader, told Bloomberg. “It’s not enough to have your focus on the discovery, research and development of medicine. You also need to be involved in the innovation of the commercial model of your business, which is how do you get these medicines to the patient.”

Source: FiercePharma

Popularity: 1% [?]

Morgan Stanley’s experts are suggesting a new drug development model for Big Pharma that will surely tickle most biotech execs pink.

Rather than continue to develop new therapies in-house, says Morgan Stanley, pharma companies should abandon their R&D empires in favor of in-licensing drugs that have reached the proof-of-concept stage. And they add that Sanofi-Aventis and AstraZeneca–which announced plans last week to carve $1 billion out of its R&D budget–would benefit most by this strategy while Bayer and GlaxoSmithKline would see a big jump in valuations.

[ad]

The economics in play: Big Pharma companies spend a third of their R&D budget on early-stage drug development, which is an odds-makers’ nightmare. Only one in 10 early-stage drugs make it to the market, with the odds rising to 20 percent at Phase II and 50 percent at Phase III. Maximum returns dictate later-stage bets, which is where in-licensing can be most effective..

Source: FierceBiotech

Popularity: 2% [?]

The FDA has issued another wave of letters demanding changes in drug promotions. Warning letters went out to Bayer, Amylin Pharmaceuticals, Eli Lilly and Cephalon, ordering the companies to stop using DTC ads and other promos that either exaggerate a drug’s benefits or downplay its risks–or both. Here are the FDA’s beefs:

[ad]

• A Lilly print ad for the antidepressant Cymbalta “entirely omits risk information,” directing readers to another page for that information, the FDA says. Another Cymbalta ad also downplayed the drug’s risk of side effects, the agency adds. A Lilly spokesman tells Reuters that the company is now reviewing all Cymbalta marketing materials.

• Lilly and Amylin, which co-market the diabetes drug Byetta, were cited for a medical meeting last June where company representatives exaggerated Byetta’s ability to help patients lose weight. The FDA also says that the reps exaggerated the drug’s efficacy and promoted off-label uses. Both companies say they are taking action in response to the letter.

• Cephalon got a letter warning it to stop using a dosing card for its lymphoma and leukemia treatment Treanda. Handed out to doctors, the card omitted important risk information, the agency says. The company reports that it has stopped distributing the cards.

• Finally, in what’s surely an unintentionally amusing letter, Bayer has been cited for a program in which its intrauterine device Mirena was promoted in people’s homes. The FDA says the script for those events stated that the IUD could help women “look and feel great.” But the agency doesn’t know about “any evidence suggesting that women who are using Mirena for birth control look great or feel great.”

Source: FiercePharma

Popularity: 2% [?]

The more scientists look, the more complex cancer seems to become.

British scientists said on Wednesday they had found a batch of new gene mutations linked to kidney cancer, suggesting even this apparently “straightforward” cancer type can be divided into subtypes requiring tailored treatment.

Clear cell renal cell carcinoma (ccRCC), the most common type of kidney cancer, stands out from other cancers because it is remarkably consistent and the majority of cases are known to be driven by mutations in a single gene, called VHL.

[ad]

Yet when researchers conducted a large DNA sequencing study of more than 3,500 genes from around 100 tumor samples, they found evidence that additional mutations in other genes were also driving cells to become cancerous.

Three of the genes were involved in modifying proteins called histones, which help package DNA into chromosomes and are critical to the functioning of cells, they reported in the journal Nature.

“Even in this clearest of cases, we see evidence for substantial genetic heterogeneity,” said Andy Futreal, co-leader of the Cancer Genome Project at the Wellcome Trust Sanger Institute in Cambridge.

While none of the new mutations accounted for more than 5 percent of cancer cases, the discovery should ultimately help in diagnosis and better selection of treatments for patients.

The latest findings underline the case for personalized medicine, or tailoring drugs to the genetic make-up of individual patients.

Scientists at the Sanger Institute last month also produced genetic “maps” identifying thousands of genetic mutations behind melanoma skin cancer and lung cancer.

Several personalized drugs are already used in cancer, including Roche’s Herceptin for breast cancer and AstraZeneca’s Iressa for lung cancer.

For drugmakers, tailored medicine is both an opportunity and a challenge as sub-dividing tumors by their molecular type shrinks the market for individual therapies.

Kidney cancer kills more than 100,000 people worldwide each year. Recent new drugs against the disease include Pfizer’s Sutent and Bayer’s Nexavar, which block cell proliferation and starve tumors of blood supply.

Source: Reuters

Popularity: 3% [?]

As usual when oncologists get together to talk shop, lots of pharma news hit the streets over the weekend during the annual Breast Cancer Symposium in San Antonio. Here’s a sampling of developments for already approved therapies:

• Nexavar, the Bayer/Onyx Pharmaceuticals drug, may trounce some cancers’ resistance to treatments, helping hormone-blocking therapies work longer. Hormone-receptor positive breast cancers are wily things that eventually figure out how to circumvent hormonal therapies, but the kidney-and-liver cancer drug Nexavar seemed to “put the brakes” on treatment resistance. That could open up a whole new world for Nexavar, but the companies first would have to mount a late-stage study.

• Doctors shouldn’t wait to use Genentech’s Herceptin until after chemotherapy, according to a Mayo Clinic study. When women were given chemo and Herceptin at the same time, the five-year survival rate increased to 84 percent from 80 percent among those taking chemo then Herceptin, and from 72 percent in those using chemo alone. “Concurrent use is the best way” to decrease the risk of cancer recurrence,” Dr. Edith Perez told the Los Angeles Times.

• An older class of chemo meds carries greater risk of side effects than newer versions when used with Herceptin, a study found. Both anthracyclines and non-anthracyclines were effective in combination with the drug, but patients on the former had more heart damage. Some doctors suggest that the standard of care be updated to privilege the non-anthracyclines, but others say more data is needed.

[ad]

Plus, there was news of studies-to-come: Concurrent with the symposium, Roche announced that FDA had cleared it to go ahead with a study of Avastin in early breast cancer. Enrollment was suspended back in September because of six cases of heart failure, but the study’s safety board has since concluded that the risk-benefit analysis of Avastin in combo with three difference drugs was “unchanged.”

Source: FiercePharma

Popularity: 3% [?]

Bayer Schering Pharma AG, Germany, is progressing with the development of florbetaben to support Alzheimer diagnosis.

On the occasion of the 95th Scientific Assembly and Annual Meeting of the Radiological Society of North America (RSNA), the company announced the enrollment of first patients in an international clinical Phase III trial to evaluate the efficacy and safety of florbetaben (BAY 94-9172) PET imaging in the detection of beta-Amyloid deposition in the brain. The trial will include both subjects with and without manifest dementia (e.g. Alzheimer’s disease [AD]). In the previous Phase II trial, florbetaben has successfully demonstrated its potential to detect beta-Amyloid deposition in the brain as a pathological hallmark of disease in AD patients.

[ad]

“Currently, there is no diagnostic tool on the market to facilitate the in vivo diagnosis of the various dementia types including Alzheimer’s disease,” said Dr. Thomas Balzer, Head of Global Clinical Development Diagnostic Imaging at Bayer Schering Pharma. “This Phase III study could proof that florbetaben can be used as a new tool to detect beta-Amyloid depositions in the brain in vivo. The ability to image beta-Amyloid depositions already during life, is expected to be beneficial for a better and earlier diagnosis of this devastating disease and to eventually enable also an earlier and more specific treatment.”

Phase III Trial Design
The pivotal Phase III trial is a worldwide open-label, multi-center, non-randomized single dose study to assess the safety and to determine the sensitivity and specificity of the visual and quantitative assessment of regional tracer uptake of florbetaben in the brain using PET imaging. Approximately 400 individuals are expected to be enrolled in this study. The florbetaben uptake pattern will be visually assessed by independent, nuclear medicine physicians blinded to the clinical diagnosis and all other clinical data. The images will be compared for the presence or absence of cerebral beta-Amyloid respective to corresponding histo-pathological specimens. Both volunteers without dementia and patients with dementia will be included, therefore enrolling subjects with either a high probability of cerebral beta-Amyloid deposition (e.g. subjects with AD) or a low probability of cerebral beta-Amyloid deposition (e.g.non-demented volunteers).

The primary and secondary objectives of the trial are the evaluation of the sensitivity and specificity of the visual assessment of regional tracer uptake in the florbetaben PET images compared to histological verification as well as the quantitative assessment of regional tracer uptake. The primary completion of the study is anticipated for 2011. However, due to histopathology examinations the study is not anticipated to be completed before 2014.

Source: The FINANCIAL

Popularity: 2% [?]

The U.K.’s cost-effectiveness watchdog has struck another blow against high-priced cancer meds. The National Institute for Health and Clinical Excellence has deemed Roche’s Avastin too expensive for use in bowel cancer patients on the National Health Service. The rejection comes even after Roche offered to subsidize treatment with the drug.

[ad]

The drugmaker said its “patient access package” brought the all-important cost per quality-adjusted life year–the formula NICE uses to determine yea or nay–down to $59,800, or £36,000. But that’s still one-fifth higher than NICE’s current threshold of £30,000. And NICE said Roche’s subsidy plan was too complicated and that it deviated from “routine clinical practice.”

This isn’t the last word from NICE, however. It’s just the agency’s preliminary opinion. But if this debate goes the way of recent cancer drug rulings, Roche will have a lot to prove to change NICE’s mind. The agency has rejected pricey cancer drugs right and left lately, most recently Bayer’s liver cancer treatment Nexavar, which NICE nixed even after the company made a four-for-the-price-of-three offer.

Source: FiercePharma

Popularity: 3% [?]

Britain’s healthcare cost-effectiveness watchdog strikes again. The National Institute for Health and Clinical Excellence proclaimed Bayer’s Nexavar too expensive for use in liver cancer patients on the National Health Service, despite Bayer’s four-for-the-price-of-three offer. The price, which still runs about $4,500 per month, was “simply too high,” NICE said, adding that the NHS’s money would be better spent on cancer treatments that offer more value for the money.

[ad]

Of course this isn’t the first time NICE has rejected a pricey, cutting-edge cancer treatment. Over the past couple of years, the agency has rejected one drug after another. But in some cases, the treatments end up on the NHS formulary after drugmakers come back with a better price. The NICE rejections have even spawned some innovative risk-sharing agreements, under which a NICE only pays if a drug works (Johnson & Johnson’s multiple myeloma treatment Velcade) or the drugmaker foots the bill for the first round of treatement (Pfizer’s kidney cancer med Sutent).

Nor is this the first time that a drugmaker’s first discount offer was rejected, either. After NICE first said no to GlaxoSmithKline’s breast cancer treatment Tyverb, the company came back with a cost-sharing offer. NICE still said no. So Bayer needn’t despair at the rejection of its offer to throw in an additional pack of Nexavar for every three packs bought by the NHS. It’s not alone. And there’s still hope: It could make a better offer on appeal.

Source: FiercePharma

Popularity: 3% [?]

The FDA has expressed testing and quality concerns to Bayer regarding its Bergkamen, Germany, facility. The concerns relate to released API batches used in drugs intended for the U.S. market.

[ad]

The just-released letter dates from early August, and it follows an FDA inspection of the facility in March. Inspectors found “significant deviations” from good manufacturing practices.

Bayer responded to the findings in April, outlining the steps it planned to take to bring the facility back up to snuff. The August FDA response recaps initial findings and acknowledges the corrective actions Bayer described, but also notes that some deficiencies remain. Among them: out-of-spec results that Bayer contends are “within the accepted variation of the analytical method” used and product quality was unaffected.

“We disagree with your rationale and conclusion,” the regulator writes. “We believe these batches should not have been released for distribution.”

A Bayer spokeswoman this week said the company is analyzing the points raised in the FDA letter, according to a Reuters report. “At this point, we have identified no safety and efficacy impact on our products in relation to the issues cited by the FDA.”

Source: FiercePharma

Popularity: 3% [?]