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Sanofi ( $SNY ) is not very popular among its peers today. Its decision last year to halve the cost of its colon cancer drug Zaltrap in the face of high-profile criticism has inspired more than a 100 top docs from around the world to protest the astronomical costs of cancer drugs, calling the prices immoral and tagging drugmakers as profiteers.? The rising prices of cancer treatments has been a flashpoint in healthcare for a few years. India has canceled patents on some of the priciest medicines, and cost regulators in Europe are now balking at the cost to efficacy ratios of some meds. But this is the first time that so many top physicians in the West have banned together to make the case against cancer meds, and they did it with very strong language, reports The New York Times . “Pharmaceutical companies have lost their moral sense,” Dr. Hagop M. Kantarjian, the lead author of the piece told the Times . Kantarjian is chairman of the leukemia department at MD Anderson Cancer Center in Houston.? The doctors called out as an example, Novartis' ( $NVS ) Gleevec, a treatment for chronic myeloid leukemia . They pointed out that it came on the market at a cost of $30,000 a year in 2001 and now runs three times that even though it now has competition. Novartis responded that it recognizes “that sustainability of healthcare systems is a complex topic and we welcome the opportunity to be part of the dialogue.” It pointed out that few patients pay the full price of the drug.? Some drugmakers were surprised at the attack, given that Gleevec and some other cancer drugs are considered “miracle drugs” that have turned once-lethal cancers into something akin to chronic diseases. But it is their own effectiveness that is part of the issue because it means patients have the choice of paying the high, ongoing expense, or dying. The physicians also noted that in the U.S., survival rates have not been what would be expected, suggesting some patients may not be taking the drug because they can't afford even the co-pay charges. There has been a loud refrain in India against exorbitant prices for lifesaving drugs. That country has been criticized by drugmakers and looked at as backward for allowing generics of some drugs that manufacturers believe should be protected by patents, including Gleevec . But there appears to be a rising concern in the U.S. where the drugs often cost twice what they do elsewhere. Sanofi was caught off guard last fall when three doctors at Memorial Sloan-Kettering Cancer Center announced in the New York Times that the hospital wouldn't be using Zaltrap. They said at $9,600 a month, it was more expensive than other drugs they were already using, so why should they use it? Citing “market resistance” Sanofi quickly responded by announcing discounts it said would cut the price of Zaltrap in half. – read The New York Times story Related Articles: Sanofi halves the cost of controversial new cancer drug Zaltrap Top U.S. hospital won't use pricey Sanofi cancer drug Orphan drugs join the price-squeeze club in Europe Drug-price worries don't stop with cancer With targeted cancer drugs, cost vs. benefits gets more complicated As Novartis loses Glivec bid, India's war on pharma patents threatens to spread

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Docs call drugmakers ‘profiteers’ for costs of cancer meds

Apparently, investors were right about Obagi Medical Products . After Merz Pharma trumped Valeant Pharmaceuticals'?( $VRX )?offer for the skin-care company, the stock jumped more than 8%–significantly past Merz's $22-per-share bid. They were expecting a bidding war. We were skeptical. Valeant commonly walks away when outbid for a company. But this time, the Canadian drugmaker wants Obagi badly enough–and figures it's worth enough–to justify a higher price. Valeant and Obagi have hammered out a new deal at $24 per share. That takes the price past $415 million. Valeant CEO Michael Pearson aims to dominate the dermatology market. Sales in the field are growing and the segment is fragmented, ripe for consolidation. Plus, on the aesthetic side of the business, products aren't covered by insurance, and so they're not vulnerable to payer price-squeezing. That's one thing in Obagi's favor; the California company makes beauty treatments, anti-aging products and remedies for rosacea and acne. A good chunk of its products are cosmetic, rather than medical. Pearson also likes Obagi's network of relationships with doctors. When Valeant first announced its agreement to buy the company, Pearson cited its strong reputation among dermatologists and plastic surgeons. Valeant could leverage those relationships into higher sales of its other cosmetic products, including the wrinkle-fighters it recently acquired along with Medicis Pharmaceutical . Valeant's tender offer expires April 23. Will Merz come back with a higher bid before then? The German company seemed rather intent on buying Obagi; in yesterday's letter to the company's CEO, Merz said it was ready to go, no additional due diligence required. So, Investors just might get their bidding war. – see the release from Valeant Related Articles: Merz swoops into Obagi deal with $385M bid, topping Valeant Valeant nabs skin-care specialist Obagi for $344M Valeant cuts 200 Medicis jobs as $2.6B deal closes Valeant puts $2.6B more skin in the dermatology game with Medicis buy

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Valeant fires back at Merz with $415M-plus Obagi bid

The highly anticipated number is in: Biogen Idec's ($BIIB) newly approved Tecfidera has a wholesale price of $54,900 per year, the biotech giant revealed on Friday. With the U.S. market debut of the oral multiple sclerosis drug set for Monday, Biogen plans to hit the market for MS pills with a lower price than Novartis' ($NVS) Gilenya, which is arguably the company's top competition. The Tecfidera price falls on the high end of the $50,000 to $55,000 range predicted by RBC Capital Markets analyst Michael Yee. Existing MS pills on the U.S. market include Gilenya at $58,000 per year and Sanofi's ($SNY) Aubagio for $45,000, according to the analyst's numbers. So Biogen has set a middle-of-the-field price for a pill that many analysts expect to become the top therapy in the oral MS class. “We think this price represents a solid value to the MS community and demonstrates our commitment to ensuring patient access,” Biogen Spokeswoman Monique da Silva told FiercePharma in an email.? Biogen has been a leading player in the MS market for years with top-selling injected therapy Avonex and the IV drug Tysabri, yet the company's sales organization needs to master a whole new pitch for Tecfidera with many physicians who are unfamiliar with the product. Naturally, docs will want to know how the MS pill stacks up with rival therapies. On the safety score, Tecfidera comes with a relatively clear profile compared with Aubagio, which is saddled with a black-box warning about increased risk of liver problems, and Gilenya, which regulators warn should not be used in patients with heart disease. However, Gilenya has reduced relapse rates in MS patients in studies by about 54% compared with 44% to 53% in those studied on Biogen's pill and 30% in patients taking Aubagio in clinical trials, The New York Times reported. Yet analysts expect Tecfidera to ultimately garner the most sales. EvaluatePharma pegs the consensus estimate on peak sales of Tecfidera at $3.8 billion, more than most analysts expect Gilenya and Aubagio to bring in for their pharma providers.

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Biogen prices Tecfidera below oral MS rival Gilenya

Roche, whose patents have been under attack in India, is moving forward with plans to manufacture some drugs in the country, indicating it will drop the prices by as much as 50%, even as it faces a new threat from India's compulsory license law.? The Minister of State of Chemicals and Fertilizers Srikant Kumar Jena said Roche ( $RHHBY ) had informed the ministry that it intends to use?Emcure Pharmaceuticals, “to produce its innovative biologics in India,” and had provided proposed prices for cancer drugs trastuzumab ( Herceptin ) and rituximab ( MabThera ), the Economic Times reports. He said Roche would drop the price of trastuzumab in India from its current 110,700 rupees ($2,000) to 75,000 rupees, a 31% drop. Rituximab would be reduced from about $1,456 a month to $682, a 53% reduction. He did not say when the drugs would hit the market.? This comes even as the government has started the process of granting three more compulsory licenses, this time on Herceptin, as well as Bristol-Myers Squibb's ( $BMY ) leukemia treatment Sprycel and breast cancer therapy Ixempra. In March of last year India granted its first compulsory license on Bayer 's kidney cancer treatment Nexavar . Since then, Natco Pharma has been marketing its version at a small fraction of the branded price. A year ago, Roche confirmed it was working with contract manufacturer Emcure, to produce Herceptin and MabThera for India and other developing markets, but otherwise has been pretty mum about the arrangement. Roche and other drugmakers have been trying to find their way in India where the high prices of their drugs have faced strong resistance and its patents have faced attack. In November India's patent appeals board yanked Roche's patent on Pegasys , a hepatitis C ?drug that's been on the market there since 2006. Two months earlier an Indian court upheld Roche's patent for Tarceva , but said that a generic, Erlocip, from Cipla did not step on Roche's patent. Roche has been wrestling with Cipla, Natco and Dr. Reddy's Laboratories over what it considered an illegal attack on Tarceva.? – read the Economic Times piece Related Articles: India strips patent from Roche's hep C drug Pegasys Roche loses patent fight in India as Novartis fights on India to hit Roche, BMS with compulsory licenses on 3 cancer drugs

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Roche dropping Herceptin price in India 30%

Former Pfizer CEO Hank McKinnell has a new gig. He'll be running Optimer Pharmaceuticals ( $OPTR ), at least until the company finishes exploring “a full range of strategic alternatives”–a.k.a. shopping itself for sale. What brought Optimer to this crossroads? Where to begin. Last year, former chairman Michael Chang was forced out after he accepted a stock grant from an affiliated company, and two other executives lost their jobs for failing to follow conflicts-of-interest rules once they found out. McKinnell stepped in to replace the disgraced Chang as chairman. And now, he's replacing CEO Pedro Lichtinger, another casualty of the same scandal. Optimer's board asked Lichtinger and his general counsel and chief compliance officer, Kurt Hartmann, to resign after a “review of prior compliance, record keeping and conflict-of-interest issues,” the company said in a statement. All of this–and the U.S. government investigations that ensued–could complicate a sale. At the least, it could force the price downward, RW Baird analyst Brian Skorney wrote in an investor note. “The question is, what sort of value can we get from an acquirer at this point given there has to be some kind of legal liability attached to it,” Skorney told Bloomberg . Optimer's sole marketed product is the antibiotic Dificid , used to treat patients with C. difficile-related diarrhea, a nasty intestinal malady often acquired in the hospital. Approved in May 2011, the drug is expected to eventually top $400 million in sales, but it's been a slow launch, with sales of only $74.4 million in 2012. Its current market value, Bloomberg notes, is around $578 million. McKinnell could be a big help in finding a buyer, Skorney said, because of his network of pharma contacts. Bloomberg noted Pfizer ( $PFE )–where McKinnell served as CEO from 2001-2006–as one potential suitor, as well as Johnson & Johnson ( $JNJ ). Leerink Swann analyst Marko Kozul suggests Cubist Pharmaceuticals ($CBST), Optimer's U.S. marketing partner; it's developing its own C. difficile drug that may not hit the market till 2017. And there's Astellas Pharma, which is Optimer's European marketing partner. McKinnell is somewhat notorious in the pharma industry for his $200 million golden parachute. Pfizer handed over $122 million in retirement money and $78 million in deferred compensation when he left, touching off protests at the company's annual meeting–protests only surpassed, perhaps, by last week's brouhaha over Novartis' ($NVS) proposed-and-cancelled $78 million non-compete with departing chairman Daniel Vasella. – see the release from Optimer – check out the Bloomberg article Special Report: Pharma's Top 5 Golden Handshakes of the Last 5 Years Related Articles: Optimer seeking buyout offers as CEO is shown the door Board, Vasella slammed for handling of retirement prize Optimer ousts chairman, top execs over a grant of shares in affiliate Optimer inks $90M C. difficile drug pact with Astellas

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Ex-Pfizer chief takes helm as Optimer puts out for-sale sign

The FDA has halted a study in children of the Amgen ( $AMGN ) drug Sensipar after a 14-year-old died during the trial. While the FDA says it does not know yet if the drug was the cause of the death, it halted the trial as a precaution. Sensipar stirred up ire last month when it was learned that the drug received special price protections in the fiscal cliff bill. “Posting this information does not mean that FDA has concluded whether or not Sensipar had a role in the patient's death,” the FDA said in a statement. “This communication is intended to inform health care professionals that we are evaluating the information and will communicate our final conclusions and recommendations when our review is complete.”? Amgen said it is “working as rapidly as possible to understand the circumstances of what happened,” CBS News reported. Sensipar was approved a decade ago for the treatment in adults of overactive parathyroid glands. Amgen initiated the new trial to see if the drug could be used for the same purpose in children. Last month, Amgen hit the spotlight during the fiscal cliff fight, when The New York Times reported that a provision in a bill postponed new pricing rules for oral drugs used by patients on dialysis . Because most drugs for end-stage renal disease are injectable, the pill versions are a small group of products–a group dominated by Sensipar. The Times pointed out that Amgen is a big donor to several of the lawmakers who backed the delay and lobbied hard for the provision that was slipped into the fiscal cliff bill. Other drugs are subject to bundled payments, which were instituted because it was believed previous pricing rewarded providers to use more drugs. The discovery of the special deal for Amgen led to an immediate backlash. Just last week, Amgen issued a statement defending the price protections, saying that “contrary to the implications of past media reports,” an analysis by the Congressional Budget Office indicates that keeping current pricing for oral-only drugs will create savings for Medicare and taxpayers over time.? – here's the FDA announcement – read the CBS news story – see the New York Times article – here's Amgen's statement on Sensipar pricing Related Articles: Lawmakers lash out at Amgen-friendly legislation Amgen's Sensipar scored pricing shield from Congress Kidney rules exempt oral meds from Amgen, Genzyme

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FDA halts pediatric study of Amgen’s Sensipar after death

India is considering killing compulsory licenses in some cases, replacing that detested provision with price controls–another law Western drugmakers dislike but prefer over having their patents rendered meaningless. The Department of Pharmaceuticals has issued a draft guidance that says once patented drugs come under proposed price controls, their cost should be considered reasonable and it should not be possible to issue a compulsory license based on affordability, the Economic Times reports. Other reasons might still be invoked. Compulsory licenses can be granted to makers of generic drugs when the government believes the price of a lifesaving drug keeps many patients from affording it. Last year, India granted its first compulsory license to Natco Pharma to make a generic version of Bayer 's kidney cancer drug Nexavar . It justified the decision on price. Natco began selling it for $170 a month, compared with Bayer's $5,000 a month price. Cipla , another Indian generics maker, jumped right in as well, offering it at $130 a month. Bayer fought but lost the decision, which generated great angst among Western drugmakers fearful of losing their pricing leverage on their most expensive drugs in a market they believe is ripe for expansion. Natco and others have said they intend to seek compulsory licenses for other drugs. Western drugmakers are also leery of the price controls that India is instituting. India for years had prices set for about 75 generic drugs but has upped that now to about 350. Generic drugs made by the Indian subsidiaries of Western drugmakers are believed to be hardest hit because they are priced higher than locally made generics. Western drugmakers believed their brand name gave them an edge in the market. India is also creating a health program that would pay for more drugs for the poor, which should benefit drugmakers but is too new to determine by how much.? – read the Economic Times story Related Articles: Natco?may next attack Pfizer, Roche drugs with compulsory license Indian government forces Bayer to accept generic?Nexavar?competition New Indian price caps would raise another hurdle to Big?Pharma Even some domestic firms rail at India's price control plan

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India may kill compulsory licensing based on price

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CEO John Lechleiter Pharma executives often warn that this price cut or that government move will stymie innovation. They've been known to threaten cutbacks and pull-outs in response to policies they find unfavorable. Consider the industry's response to new German pricing rules or Spanish price cuts or Indian patent-stomping, to name a few. But Eli Lilly ( $LLY ) CEO John Lechleiter has taken the lament to a new level. In a meeting with the Canadian newspaper The Globe & Mail , Lechleiter railed against court rulings that struck down three of Lilly's patents. The loss of exclusivity on those drugs, including the ADHD treatment Strattera, cost Lilly more than $1 billion in Canadian sales and triggered at least 280 job cuts since 2006, Lechleiter told the paper's editorial board. “If that sort of pattern persists, it's not a question of would we stay in Canada, it's a question of would we have any business in Canada,” Lechleiter said. Lilly has, in fact, officially challenged a particular patent interpretation that's come up in Canadian courts. But as the Globe & Mail notes, Canadian patent rulings have fallen more or less in line with those in other countries, taken as a whole. And generic drugmakers in Canada counter Lilly's complaints with their own arguments. One of the rulings Lilly is challenging is the loss of a patent on Zyprexa . That antipsychotic drug fell off patent in the U.S. in 2011, and it's lost more than $1 billion in sales since then. And it's just one of Lilly's patent-cliff drugs. So, Canadian patent rulings may not be the only reasons why Lilly cut jobs there. – read the Globe & Mail piece Related Articles: Lilly gets patent support from appeals court Big Pharma overhauls its marketing methods Lilly sales and profits slide, but analysts expected worse

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Lilly chief threatens Canada after courts toss patents

It is over. Fini. Kaput. Sun Pharmaceutical Industries has taken its $685 million offer and gone home. At least for now. After 6 years of trying to buy the 40% of Taro Pharmaceutical Industries ( $TARO ) it didn't own, Sun says it has given up on it. “We concluded that Taro shareholders wouldn't agree to the deal unless the offer price was increased substantially,” Bloomberg reports Sun Managing Director Dilip Shanghvi saying during an earnings call today. Taro's board in August was fine with the $39.50 a share offer that the Indian company had made. That was up substantially from the $24.50 a share offer it had sneered at the month before. But Taro shareholders just couldn't get their enthusiasm up for a price they believe still sells the company short. The market agrees. Taro's stock price closed at $50.55 Thursday in trading in New York. When Sun first offered to buy the company in May 2007 for $454 million, Taro was losing money. Taro has expertise in dermatology and pediatrics drugs and sells mostly to the U.S., a market into which Sun wanted to expand. But during the drawn-out negotiation process, Taro got its act together and in November reported that its second-quarter sales were up 16% to $161 million. In 2011, it sold about $436 million in generic treatments for things such as head lice. “As earnings keep coming in stronger and stronger for Taro, there was obviously a lot of disconnect with the price Sun was willing to offer,” IDFC Securities analyst Nitin Agarwal told Bloomberg from Mumbai, India. “It was fairly unlikely that the deal would have gone through.” – read the Bloomberg ? story Special Reports:? Sun Pharmaceutical Industries — Top 11 Fastest-Growing Generics Companies | Taro Pharmaceutical Industries — Top 11 Fastest-Growing Generics Companies Related Articles: Taro stiff-arms yet another Sun Pharma bid Tug-of-war between Sun and Taro continues Sun gets Taro investor support for buyout

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Sun calls it quits in 6-year effort to swallow Taro

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Kynamro treats a rare and dangerous form of high cholesterol.–Courtesy of NIH Sanofi's ( $SNY ) Genzyme unit has set the price on its new rare-disease drug Kynamro: $176,000. That's steep, but it's part and parcel the super-niche-market strategy that's Big Pharma's new bread and butter. Targeted cancer drugs, orphan drugs, ultra-orphan drugs–they come with prices big, bigger and biggest. But Kynamro, for homozygous familial hypercholeseterolemia, illustrates a couple of pitfalls on the rare-disease path. It's expensive, but not as expensive as its only competitor, approved just last month. That Aegerion Pharmaceuticals ( $AEGR ) treatment, Juxtapid, runs $235,000 to $295,000 a year, depending on the patient, The Wall Street Journal reports. Whether Kynamro can compete with Juxtapid on price remains to be seen–there are other differences between the two drugs, obviously, including side-effects profiles. When patients suffer from life-threatening, rare diseases, insurers have a hard time saying no. But the Sanofi drug's discount is one more variable for the treatment-choice equation. Payers are never eager to spend extra if they don't have to. And as Sanofi's recent experience with oncologist pushback on its Zaltrap price shows, doctors are considering price tags these days, too. With more and more drugmakers piling into niche markets, companies will be under more and more pressure to prove their drugs are superior to their rivals and worth whatever price they choose to set. They'll also be under pressure to perform on the marketing-and-customer-service side. As The Street 's interview with Aegerion CEO Marc Beer shows, rare-disease drugs are hands-on products. Unlike mass-market drugs, they don't launch and then take on a life of their own, with some DTC support and pharma rep detailing to keep things fresh. With rare-disease drugs, every patient is shepherded through the reimbursement process. Many patients get assistance, whether from the company or from patient groups. And patient relationships are managed as therapy continues. Genzyme knows this process well. It's been working with patients who use its rare-disease drugs Fabrazyme , Cerezyme and Myozyme for years. And it hasn't been easy; when the company's manufacturing foundered and supplies constricted, Genzyme had to contend with rationing, dose restrictions and plenty of unhappy patients. So, Aegerion–actually, any company learning the rare-disease marketing ropes–needs to build an effective marketing and customer support machine. Fewer people might be necessary. But those few will have to know their stuff. – read the WSJ piece (sub. req.) – get more from The New York Times (sub. req.) – see The Street 's interview Related Articles: FDA hands Sanofi, Isis an approval for HoFH drug Kynamro FDA approves Aegerion's lomitapide for rare cases of HoFH EMA committee shoots down Sanofi's cholesterol drug mipomersen Genzyme's mipomersen wins key FDA panel vote for rare cases of HoFH FDA frets over safety of Genzyme's rival drug for rare cholesterol disease

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Genzyme’s $176K Kynamro price undercuts its $250K-plus rival

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