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Post by lakers on Sept 16, 2016 19:07:34 GMT -5
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Post by lakers on Sept 13, 2016 12:04:43 GMT -5
It's not a battle we fight. It doesn't make sense for MannKind to do retail on EpiInhale while also clawing for market share with Afrezza. Our product is the licensing deal. You are correct. I too expect a deal. No wonder Mgmt is confident Afrezza will have enough time and resource to fight for mkt share.
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Post by lakers on Sept 10, 2016 11:41:28 GMT -5
It's legal. Pizza followed by Afrezza Instagram, Twitter. Yeah, Pizza rhymes w/ Afrezza. Let's start that informercial.
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Post by lakers on Sept 10, 2016 11:35:41 GMT -5
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Post by lakers on Sept 10, 2016 11:22:50 GMT -5
EpiPens, which counteract potentially fatal anaphylaxis, contain the drug epinephrine. And just $1 or so worth of epinephrine is used in the auto-injection device. That device itself is believed to cost just several more dollars to make. People who have created workarounds for EpiPens have spent just $15 or so on the syringes. That gap between cost and price have delivered some very nice revenue for Mylan, where EpiPen is a leading product. The company reported $9.45 billion in revenue for 2015 — up from $7.7 billion the year before — and $1.46 billion in income. A reported $1 billion in revenue comes from EpiPen, up from the $200 million in revenue at the time Mylan first acquired the devices. While Mylan has aggressively sought to expand the market for EpiPens by getting them placed in schools and trying to get them mandated for all airlines flying in the United States, the company didn't have to spend a nickel actually creating the product. The EpiPen was acquired by Mylan in 2007, along with other products from Merck. The device itself had been around decades before that. EpiPens were invented at a Maryland company called Survival Technology in the 1970s by engineers who included a man named Sheldon Kaplan. Originally called the ComboPen, the devices were bought by the U.S. Department of Defense for use in delivering medicine that would counteract the effects of nerve agents. Kaplan later tweaked the ComboPen to deliver epinephrine to counter the effects of anaphylaxis. www.cnbc.com/2016/08/25/epipens-cost-just-several-dollars-to-make-customers-pay-more-than-600-dollars-for-them.html
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Post by lakers on Sept 10, 2016 10:57:02 GMT -5
BUSINESS SEP 6 2016, 2:40 PM ET Industry Insiders Estimate EpiPen Costs No More Than $30 by BEN POPKEN SHARE advertisement Mylan says middlemen and suppliers have forced them to jack-up the prices on EpiPens by hundreds of dollars, but two industry insiders say the company pays no more than $30 per device. Meanwhile, some patients are forced to pay a little over $600 out of pocket for a two-pack of the lifesaving medication. Mylan sparked outrage last month when it was revealed the company had hiked up costs for the drug by over 400 percent since it acquired the brand. At the same time, CEO Heather Bresch's salary soared over 600 percent to nearly $19 million in 2015. SOURCES ESTIMATE MYLAN PAYS NO MORE THAN $30 PER EPIPEN A third expert pegs Mylan's cost even lower, at about $20. Kevin Deane, head of medical technologies for PA Consulting Group, a global technology and design firm that sold a drug delivery technology company to Pfizer in 2004, told NBC News that the base components for each EpiPen, including the plastic cap, tube, and needle, might cost between $2 to $4 to purchase. Pharmacists contacted by NBC estimate that the epinephrine inside costs less than $1.
Additionally, based on industry norms, Mylan would have to pay a licensing fee to companies involved in research and development of the device. This amount might generally multiply the price that Mylan pays Pfizer's wholly owned subsidiary Meridian Medical Technologies, which manufactures the epinephrine auto-injector between two and five times, said Deane.[Cricket licensing could be a cash cow.]advertisement "What they've been doing is they've been making little updates to it, refinements to make it work better," said Deane. "But it essentially is the same core technology that was there for many years," he said. In a call with NBC News, Pfizer spokeswoman Rachel Hooper declined to comment on or confirm the pricing arrangement, citing confidential contract agreements, a position echoed by Mylan. Image: US-HEALTH-DRUGS-CONSUMER-POLITICS-MYLAN A boy holds an Epipen that he uses to counteract allergic reactions. LUCAS TRIEB / AFP - Getty Images "We do not comment on the terms of third-party contracts," said Mylan company spokeswoman Julie Knell. The System advertisement In a recent CNBC interview, embattled Mylan CEO Heather Bresch tried to shift blame for EpiPen's spiraling costs onto the "four to five hands" that touch the product between Mylan and the consumer. But under standard industry practices, besides the portion to your insurer, most of those middlemen only take a single digit percentage. And while the supply chain particulars or even the premium prices are not themselves unusual in the context of the U.S. healthcare system, Adam Fein, president of Pembroke Consulting, a healthcare firm that advises drug makers on commercial issues, said Mylan did do two things that were different. ESTIMATED GROSS PROFIT PER $600 EPIPEN 2-PACK: MYLAN $274. INSURER $249. PBM $40. PHARMACIST $27. WHOLESALER $10. SOURCE: PEMBROKE CONSULTING Mylan ended up with a monopoly because of the failure of the government and competition to put viable alternatives on the market, he said, and they "aggressively increased prices last year."In 2015 EpiPen's price rose 30 percent — more than double the average branded drug price increase of 12.4 percent, according to a recent IMS Institute report and an analysis by Connecture, a health insurance technology and data analytics company. This profit-taking led to impressive margins for Mylan, which posted $1 billion in sales for the past two years, following years of awareness campaigns and legislation that increased the number of patients being prescribed the device and schools stocking it. A model provided to NBC News by Pembroke Consulting broke down the gross profit to each of those intermediaries, based on industry norms and using the costs stated by Bresch. For illustration purposes, it assumes a list price of $600 per two-pack. Under this model, your insurer keeps $249. The pharmacy benefits manager that negotiates between Mylan and your insurer gets $40. Your local pharmacist keeps $27. The wholesaler gets $10. "Many people will only pay a copayment of say $50," said Fein. "The insurer would pick up the remaining cost of more than $300. But if the patient has a high deductible plan, then the insurer could pocket the $300 rebate and not share it with the patient." advertisement Bresch stated that Mylan then gets $274 in the transaction. From there, it must pay for "manufacturing, distribution, regulatory, patient assistance program, My EpiPen Savings program, disease awareness initiatives and product donations," according to a slide displayed during Bresch's CNBC interview and distributed in a press release afterward. "Mylan works with pharmacy benefit managers (PBMs) and insurers to provide coverage and access to our products; however, those entities, along with the payors, make the decision regarding choice and pricing of products," said Mylan's Knell. "As aligned with standard industry practice, we pay rebates to PBMs and insurers to allow for patient access to EpiPen at the lowest possible cost." Mylan didn't respond to an NBC News request to itemize those costs, but a Mylan spokesperson told NBC that "all of those costs would clearly make the $274 number significantly lower." "WHETHER YOU LIKE IT OR NOT, IT'S THE WAY THE WORLD WORKS." "Mylan in a very inartful way tried to deflect blame by pointing to the system," said Adam Fein, president of Pembroke Consulting. "Whether you like it or not, it's the way the world works." One lawmaker who has been vocal on the EpiPen price increase took a dim view of the information about Mylan's costs. "There's no reason an EpiPen, which costs Mylan no more than $30 to make, should cost families more than $600," said Vermont Senator Bernie Sanders in a statement emailed to NBC News. "The only explanation for Mylan's outrageous price increase is that the company values profits more than the lives of millions of Americans." PlayMylan CEO Defends Price of EpiPen, Insists Company Isn't Price-Gouging Facebook Twitter Google PlusEmbed Mylan CEO Defends Price of EpiPen, Insists Company Isn't Price-Gouging 2:40 Competition Blocked Pharmaceutical companies will sometimes pay PBMs steeper discounts in order to shut out their competition, said Fein. And, in the past, two of the biggest PBM companies have excluded EpiPen competitors from coverage: In 2014, Express Scripts excluded AuviQ (PDF), and in 2015 Caremark didn't cover Adrenaclick (PDF). This meant that if your insurance company was their customer, you would not be able to get the EpiPen alternative without paying full retail price. "In 2014 and 2015, we leveraged the competition between EpiPen and Auvi-Q to earn additional discounts for our clients," said Express Scripts spokesman Brian Henry, saving their customers $750 million and $1 billion in those two years, he said. Caremark did not respond to a request for comment. No Quick Fix Amid a backlash so widespread that it's launched its own parody video game, lawmakers have called for price rollbacks and investigations. In late August, Democratic presidential candidate Hillary Clinton announced a plan to track prescription drug price hikes, fine companies whose increases weren't justified, and make it easier for competition to bring down prices. Mylan's first round of answers to Congress were due September 5th. PlayEpiPen Prices Rocket Along with Drugmaker Executive's Pay Facebook Twitter Google PlusEmbed EpiPen Prices Rocket Along with Drugmaker Executive's Pay 1:11 In response to the upset, Mylan is giving insured patients a $300 coupon, is launching its own cheaper generic EpiPen version, and increased the number of patients eligible for financial assistance. Even before the crisis emerged, Mylan said it was taking steps to increase EpiPen access and affordability. Mylan said that it has given away more than 700,000 free EpiPens to schools since 2012. When its coupon program for insured customers was $100, it said nearly 80 percent of those customers were getting their auto-injectors for $0. "...TAKING IMMEDIATE ACTION TO HELP ENSURE THAT EVERYONE WHO NEEDS AN EPIPEN AUTO-INJECTOR GETS ONE." "We have been a long-term, committed partner to the allergy community and are taking immediate action to help ensure that everyone who needs an EpiPen Auto-Injector gets one," said Bresch in a statement. "We recognize the significant burden on patients from continued, rising insurance premiums and being forced increasingly to pay the full list price for medicines at the pharmacy counter." On Tuesday that schools program became the source of its own new controversy, with New York State state Attorney General Eric Schneiderman launching a probe into whether the company had violated antitrust laws by requiring participating schools to agree to not buy any products from Mylan competitors for 12 months. Senators Blumenthal and Klobuchar also called for a new FTC investigation into the same. "There are no purchase requirements for participation in the program, nor have there ever been to receive free EpiPen Auto-Injectors," Mylan spokeswoman Nina Devlin wrote NBC News in a statement. "Previously, schools who wished to purchase EpiPen Auto-Injectors beyond those they were eligible to receive free under the program could elect to do so at a certain discount level with a limited purchase restriction, but such restriction no longer remains." Ben Popken BEN POPKEN TWITTERFACEBOOKGOOGLE PLUSEMAIL TOPICS CONSUMER, INVESTIGATIONS FIRST PUBLISHED SEP 6 2016, 2:35 PM ET www.nbcnews.com/business/consumer/industry-insiders-estimate-epipen-costs-no-more-30-n642091
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Post by lakers on Sept 10, 2016 10:41:09 GMT -5
Teva to meet with FDA on problems with generic EpiPen September 10, 2016 12:00 AM By Patricia Sabatini / Pittsburgh Post-Gazette Teva Pharmaceutical Industries indicated Friday that U.S. regulators may be interested in speeding up another review of the company’s application to sell a generic version of Mylan’s EpiPen. After the Food and Drug Administration rejected Teva’s initial application for the emergency allergy treatment in February, Teva requested a meeting with the agency for guidance on how to proceed, said Sigurdur Olafsson, head of global generic medicines for Teva. “We didn’t get a response,” he said during a presentation to New York analysts on Friday. But in the wake of a firestorm in recent weeks over the skyrocketing cost of the EpiPen, the FDA has responded, he said.
“The FDA has come back to us and we will have a meeting with them very, very quickly,” Mr. Olafsson said. “I think everybody understands that there is an opportunity.”The EpiPen auto-injector, which has limited competition, has risen in price some 500 percent in recent years, triggering a backlash from users, lawmakers and consumer and medical groups who accuse Mylan of price-gouging. With a near monopoly on the market for delivering a pre-filled dose of potentially life-saving epinephrine, Mylan steadily raised the price of the EpiPen from around $100 a pair when it acquired the product in 2007 to more than $600. The sting for many families who must keep the medication on-hand is compounded by the device’s one-year shelf-life. Mylan has responded to the recent uproar by expanding its discount assistance program and promising to start selling a half-price generic version of the EpiPen that is identical to the brand name product. Teva’s Mr. Olafsson didn’t say when Israel-based Teva, the world’s biggest generic drug maker, might re-submit its marketing application for its generic auto-injector. But he reiterated his forecast for bringing the lower-cost alternative to the EpiPen to market late next year or early in 2018. [This coincides w/ Mnkd's time frame. Teva could acquire EpiHale as another delivering method as an insurance for second time failure.]Meanwhile, lawmakers continue to probe Mylan’s pricing practices on several fronts. Most recently, the U.S. Senate’s permanent subcommittee on investigations this week announced a preliminary inquiry into the matter. Also on Friday, Sen. Chuck Grassley, R-Iowa, said he wasn’t satisfied with Mylan’s response to a letter he sent to the company Aug. 22 with questions about EpiPen pricing. Mylan’s seven-page reply, which Mr. Grassley released publicly, “doesn’t provide the full picture that I requested, and it doesn’t answer all of my questions,” he said in a statement. “It’s an incomplete response and wouldn’t satisfy my constituents.” www.post-gazette.com/business/healthcare-business/2016/09/10/Teva-to-meet-with-FDA-on-problems-with-generic-EpiPen/stories/201609100058But without strong competitors, Mylan's EpiPen still holds an estimated 94 percent market share in the United States. Teva's application for a copycat version has been in question since February, when the Food and Drug Administration flagged "major deficiencies" in the Israeli drugmaker's device. "We requested a meeting with the FDA," Sigurdur Olafsson, Teva's head of global generic medicines, said in a webcast overview of the company's generics medicines business. He said Teva did not get a response, but after "the media attention in the last two weeks, the FDA has come back to us and we will have a meeting very, very quickly."
Given the recent "political noise on EpiPen," the FDA may now be more inclined to approve Teva's generic version, Evercore ISI analyst Umer Raffat said in a webcast message to clients. [EpiHale is guaranteed to be expedited by FDA.] Analysts had expected Teva to alter its autoinjector's design to remedy a dosing issue cited by the FDA, but Olaffson said the company was not planning any modifications to its device at this point. mobile.reuters.com/article/idUSKCN11F25K
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Post by lakers on Sept 8, 2016 10:52:23 GMT -5
As of June 30, the company had $63.7 million in cash, enough to stay afloat into the first quarter of next year, Chief Executive Matthew Pfeffer told analysts last month. That’s when MannKind expects to file an application with the FDA and potentially begin clinical trials of its inhalable epinephrine. A rare stumble for biotech pioneer Alfred Mann A rare stumble for biotech pioneer Alfred Mann Financially, the question for MannKind is whether sales of Afrezza can pick up enough over the rest of this year to offset the potential cost of clinical trials for the new product. Pfeffer said that question should be answered well before the company would hope to start new trials. “I think we’ll know the future of Afrezza before we get to that stage,” he said. Another option might be for the company to find a strategic partner — a prospect made more likely by the intense media coverage of Mylan’s series of steep increases in the price of the EpiPen, from about $50 per shot in 2007 to more than $300 today. “There’s a lot of interest in [EpiPen] alternatives,” he said. “It’s not inconceivable that we could get a partner to help us with the funding of that trial. That’s not our current game plan, but it’s something we could consider.”
MannKind also expects that the clinical trials would take much less time than those for Afrezza, which needed to prove that long-term use did not decrease lung function. That was a problem with an earlier inhalable insulin developed by Pfizer that was pulled off the market.
When the FDA approved Afrezza, it required a warning that it should not be used by people with asthma and other lung conditions. But diabetics may take insulin several times a day, while life-threatening allergic reactions are generally rare events.
“It's hopefully something you never have to use, which makes that less of an issue," said Pfeffer, who hopes clinical trials could begin and end next year, with the product hitting the market by late 2018.MannKind is developing two other inhalable drugs, one that treats nausea in patients undergoing chemotherapy and another to treat a cardiovascular disease called pulmonary arterial hypertension, but epinephrine is the priority. The company started work on epinephrine about a year ago, long before the recent spate of news stories about the EpiPen price increases. While it’s not clear how much a dose of inhalable insulin might cost, Pfeffer said the product would almost certainly be cheaper than EpiPen. He noted a study that showed it’s difficult to get enough epinephrine into the body by inhaling it — though that study looked at older epinephrine inhalers used to control asthma attacks. Pfeffer said MannKind’s product would carry a stronger dose of epinephrine aimed specifically at stopping anaphylaxis. Pistiner also said that respiratory symptoms, such as shortness of breath, often accompany severe allergic reactions. If someone can’t breathe, an inhaler doesn’t do much good. “Most kids who experience anaphylaxis have respiratory [symptoms],” he said. “That’s a very real challenge.” Pfeffer said MannKind is aware of that issue, but that since respiratory symptoms typically don’t start until several minutes into an anaphylactic attack, there would be time to use an inhaler before symptoms become life-threatening.
“Most people want to be pretty sure before they stab themselves in the leg with a big needle,” he said. “That’s often why people wait too long. We thought we could put epinephrine into a form that’s not as intimidating to people so that people would use it sooner in the process with less hesitation.”www.latimes.com/business/la-fi-mannkind-epipen-20160901-snap-story.html
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Post by lakers on Sept 7, 2016 23:54:11 GMT -5
www.npr.org/sections/health-shots/2016/09/07/492964464/epipen-s-dominance-driven-by-competitors-stumbles-and-tragic-deathsEpiPen's Dominance Driven By Competitors' Stumbles And Tragic Deaths Mylan lobbied state legislatures for laws that require schools to stock EpiPens. Rich Pedroncelli/AP Thirteen year-old Natalie Giorgi probably didn't know the name of the company that makes EpiPen. But the Sacramento, Calif., girl's death from a peanut-induced allergy attack in 2013 inspired passage of the California law that made the Mylan product a staple at every school in the state. It was Giorgi's story, not industry lobbying, that state Senate Minority Leader Bob Huff says inspired him to usher through the requirement that public schools stock the injectors. He says he was also influenced by one of his staffers, who has a child with life-threatening allergies. "It was just sort of organic," Huff says about carrying the bill. "It seemed like we ought to do better to protect these kids." Mylan, the company that raked in $1 billion last year for the EpiPen, takes credit for passing legislation in 48 states to ensure schools have them. But its political maneuvering is only one reason the company has, in its own words, become "the number one dispensed epinephrine autoinjector." High-profile deaths in several states, particularly among school-age children, have helped fuel demand for consumer-dispensed epinephrine. At the same time, no other company has been able to effectively compete with Mylan's drug-delivery device. Patent rules, and competitors' manufacturing foibles, also have helped the company reign over the consumer epinephrine market. When someone with a severe allergy goes into anaphylactic shock and can't breathe, "seconds count," Mylan CEO Heather Bresch said in a recent CNBC interview about the EpiPen, which now has a sticker price of $608 per two-pack. That's why, she said, "they need to be everywhere." Bresch said lobbying is just one way the company has spent hundreds of millions "developing" the EpiPen since it acquired the patent in 2007. Indeed, Mylan's presence in statehouses across the country has grown exponentially. The company added lobbyists in 36 states between 2010 and 2014, according to the Center for Public Integrity, outpacing every other U.S. company. And it spent more than $1.3 million lobbying in 16 states since 2012, according to the National Institute on Money in State Politics (Those are not the exact states that passed the school requirements, however.) Just in the past several years, 10 states have passed laws requiring epinephrine in schools. Another 38 states have passed laws permitting them, according to the Food Allergy Research and Education advocacy group (FARE). Nebraska appears to have been the first state with a school epinephrine requirement. High asthma rates in the state, as well as a couple of school-based child fatalities due to the respiratory illness, created an emergency response protocol that became law in 2006. In California's case, Huff said he had never even heard of Mylan until the recent uproar over the EpiPen price increases. But the company is listed as a supporter of his bill, and FARE, which is partially funded by Mylan, was an official sponsor. Heather Bresch, CEO of Mylan, says that EpiPens "need to be everywhere." Michael Nagle/Bloomberg via Getty Images FARE asserts that Mylan's money goes toward its education work, not its advocacy. It didn't disclose exactly how much of its funding comes from Mylan, but says funding from corporate partners amounts to less than 10 percent of its budget. "In some states, momentum has been garnered by a fatality," says Jennifer Jobrack, senior national director of Advocacy at FARE, who says local lawmakers and activists call them in for help to craft policy. "Legislators are looking for something they know will have a positive impact," Jobrack says. Virginia's law, passed in 2012, came after 7-year-old Amarria Johnson died at a Chesterfield County school from a reaction to peanuts. A Texas teenager's death from fire ant bites led to that state's law permitting epinephrine in schools. The push to require EpiPens got a high-level boost in 2013, as President Obama disclosed his daughter Malia's peanut allergy when he signed off on the federal law, which gives financial incentives to states that require the medication in schools. Co-author of the federal legislation, Rep. Steny Hoyer, D-Md., cited his 11-year-old granddaughter's peanut allergy when the EpiPen law passed the House. FARE and Mylan supported that as well. With the help of these laws, Mylan's EpiPens are at 63,000 schools nationwide. The company also has distributed 500,000 of them for free through EpiPens4Schools. The school giveaway program brings visibility and credibility to the EpiPen brand, building a consumer base beyond schools. "It's kind of like the first hit's for free," says Nicholson Price, an assistant professor at the University of Michigan Law School. "You want to start people off with your product, and getting these products in at schools is a great way." New York State's attorney general announced Tuesday it will investigate Mylan to determine whether it introduced "anticompetitive terms" into school contracts. STAT recently reported that participants of Mylan's EpiPen4schools program had to agree not to purchase EpiPen-like products for 12 months in order to get a discount. Mylan also has a virtual monopoly on epinephrine autoinjectors simply because there are almost no other products like it, either branded or generic.
Mylan has a patent on the drug-device combo until 2025. If companies want to make a generic EpiPen, they have to sue Mylan in court to try to invalidate its exclusive rights on the injector, according to Jacob Sherkow, an associate professor at New York Law School.
Trying to create an EpiPen generic is an expensive and risky endeavor, says Sherkow. Even if a company is successful in court, manufacturing the device, which must be identical to the EpiPen, is also challenging.
Copying a chemical compound, like ibuprofen, is easier than reproducing a piece of hardware like the iPhone, says Sherkow. Patents are publicly available, and can act as an "instruction manual," but a lot can go wrong in the actual production of EpiPen syringes.
"The drug inside can't degrade or leak; they need to withstand shipping; they need to work at a wide range of temperatures; they need to be handled safely — to not accidentally inject the user with the needle," says Sherkow.
Teva Pharmaceuticals took on these challenges. It was granted FDA approval to make a generic EpiPen, but was blocked earlier this year after Mylan successfully argued that Teva's device was not identical, and was therefore unsafe.
Other companies have tried to make their own version of the epinephrine injector without attempting to copy the EpiPen. But their efforts haven't been very successful either.
Amedra pharmaceuticals makes Adrenaclick, which has an injector with two caps (EpiPen has only one.) But Amedra has limited manufacturing capabilities for the device and a barely visible market share, according to Price.
Auvi-Q, made by Sanofi, was taken off the market in October 2015 after concerns the device wasn't dispensing the proper dose of epinephrine.
More epinephrine products will be on the market in 2017. Teva's generic version of the EpiPen is expected to be reintroduced then, and Mylan will put out its own generic in the coming weeks.It's too early to tell if more consumer choices will bring down EpiPen's price. This story is part of a collaboration between NPR and Kaiser Health News. Former Kaiser Health News intern Zhai Yun Tan contributed to this report. [ Mnkd might be forced to partner for EpiHale or sell it outright to Teva, RLS, Sanofi to raise cash for Afrezza. If Mylan were smart, they should preempt by acquiring EpiHale. Together w/ EpiPen they would monopolize the Epi mkt for decades to come. It would be ironic that Mnkd may make more money from EpiHale than Afrezza. Lung risk is not an issue as EpiHale is an insurance but seldom used. Clinical trial should be short as Ray said. Kudos to Ray for single-handedly persuading the Boards to invest and expedite it when money is so tight.
Depending on how much or how desperate the BoD wants to right the financials, Mnkd could fetch between $1 and $2 per share from the outright sale of EpiHale in the IND stage. That's $470.5M to $951M. Incidentally $925M is the SNY's milestone bonus for Afrezza. What do you think is fair value for EpiHale at IND stage?The proceed can be used to unlock SH value by commercializing Afrezza with sufficient time and funding, developing two other inhalable drugs, one that treats nausea in patients undergoing chemotherapy and another to treat a cardiovascular disease called pulmonary arterial hypertension, another large market, and more drugs. Mnkd may have to sacrifice EpiHale for the good of the co. EpiHale might be an Ace in the hole.]
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Post by lakers on Sept 6, 2016 18:13:14 GMT -5
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Post by lakers on Sept 4, 2016 0:35:39 GMT -5
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Post by lakers on Aug 25, 2016 15:55:26 GMT -5
The EpiPen delivers a shot of epinephrine, a synthetic version of adrenaline, which is an old medicine that has long been off patent. Mylan’s special ingredient is the hand-held delivery device that allows users to easily inject themselves in an emergency. Making such sterile injectables is expensive because of the need to keep out contaminants at every step, adding another hurdle for any rival. The upfront costs on that are “pretty high,” says David Lebo, a Temple University professor specializing in pharmaceutical manufacturing. A few competitors have tried but so far have failed at challenging EpiPen. Auvi-Q was prescribed 353,600 times last year, according to IMS Health, before Sanofi was forced to recall the product because of dosing problems. It is still off the market. Other brands weren’t nearly as successful. They “couldn’t get a lot of market share. Doctors just wrote EpiPen on prescriptions,” says Ronny Gal, a Sanford C. Bernstein & Co. analyst. Teva Pharmaceutical Industries Ltd. has sought to sell a generic version. But Mylan has argued that Teva’s version endangers patients trained to use the EpiPen, because Teva’s isn’t an exact copy. In February, the Food and Drug Administration rejected Teva’s application for approval, the company said, without specifying the reasons. “Teva expects that its epinephrine product will be significantly delayed and that any launch will not take place before 2017,” the company said. Impax Laboratories Inc. raised the price of another rival, called Adrenaclick, to about the same level a week before Auvi-Q’s recall in late October 2015. Impax “can only manufacture so much product” because plant workers assemble the components by hand, says Mark Donohue, a company spokesman. The company is investing in automating the manufacturing of Adrenaclick, he says, but it will take a few years. EpiPen became an iconic brand, like Xerox or Band-Aids. It was prescribed by name by doctors and sought out by parents and patients who liked the pen’s ease of use, Sanford C. Bernstein’s Mr. Gal says. The threat to Mylan, he says, is that the controversy turns off patients, prompts health plans to find alternatives and prods regulators to approve Teva’s generic version. news.google.com/news/ampviewer?caurl=http%3A%2F%2Fwww.wsj.com%2Famp%2Farticles%2Fmylans-epipen-price-increases-highlight-its-grip-on-the-market-1472154769#pt0-386729[Mnkd is looking for a TS Epi partner. The price gouging helps its case. It's mfgr prowess is an advantage.]
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Post by lakers on Aug 25, 2016 12:01:53 GMT -5
Competition derails Until last year, Mylan's EpiPen was battling for market share with Sanofi's Auvi-Q, an auto-injector that received the FDA's green light in 2012. After Auvi-Q's launch, the EpiPen remained the dominant auto-injector on the market, but Auvi-Q's presence did help keep a lid on prices. That changed, however, when reports surfaced that Auvi-Q patients were having troubles with it. Through Oct. 26, 2015, there were 26 reports of suspected Auvi-Q device malfunctions in the U.S. and Canada, and while there were no fatalities, Sanofi voluntarily recalled all of its Auvi-Q auto-injectors and exited the U.S. market. Sanofi's departure made Mylan's EpiPen the only game in town for patients wanting an auto-injector, but that was initially thought to be a short-term advantage. Teva Pharmaceutical (NYSE:TEVA) won the right to begin marketing a generic EpiPen in 2016, as part of a 2012 patent settlement. However, Teva Pharmaceutical's plans were derailed earlier this year when the FDA rejected its application. The rejection extended Mylan's monopoly until at least 2017, when Teva Pharmaceutical hopes to refile for approval. [This coincides w/ Mnkd's filing IND in 1H17.] www.fool.com/investing/2016/08/25/why-mylans-epipen-is-sparking-epi-rage.aspx
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Post by lakers on Aug 25, 2016 2:14:12 GMT -5
Mylan CEO Blamed Obamacare for EpiPen Sticker Shock fortune.com/2016/08/24/mylan-ceo-epipen-heather-bresch/Mylan CEO Heather Bresch speaks during a Bloomberg Television interview in New York, U.S., on Thursday, Aug. 6, 2015. Bloomberg Bloomberg via Getty Images CEO Heather Bresch had planned to hike the price further. The price of the EpiPen has soared 500% since generic drug company Mylan MYL -5.41% bought the treatment nine years ago. Yet Mylan’s controversial CEO Heather Bresch says she and her company aren’t solely to blame for the fact that patients are paying more for the must-have allergy medication. Another culprit, according to Bresch: President Obama. On an earnings call earlier this month, Bresch blamed EpiPen sticker shock in part on Obamacare. She said that employers’ increased use of high-deductible plans, one of the side-effects of the law, has resulted in patients paying more out of pocket for the drug, and that’s “where you’re seeing a lot of noise around EpiPen.” What’s more, Bresch, citing the roughly $600 wholesale cost, added that when you look at other treatments, the EpiPen does not fall into the category of “an expensive product.” Mylan is no stranger to controversy (see my profile last year, “Why Wall Street Loves to Hate Mylan’s CEO”). But EpiPen, a portable device that counteracts potentially life-threatening allergic reactions known as anaphylaxis, is supposed to be the company’s shining success story. In fact, prior to the recent price hike backlash, Mylan was looking to make the EpiPen more expensive. The company has been actively trying to renegotiate contracts with pharmacies and distributors this year that kept the EpiPen competitively priced with is biggest competitor, Sanofi’s Auvi-Q. But now that the Sanofi SNYNF -0.83% drug is no longer on the market—the company recalled its entire supply last fall, and has since abandoned it—Mylan is looking to ditch contracts that constrained EpiPen’s price. “I think you’ll see opportunities for us to continue to have that price per pen increase,” CEO Bresch said at a conference in May. Mylan CEO Heather Bresch speaks during a Bloomberg Television interview in New York, U.S., on Thursday, Aug. 6, 2015. Bloomberg Bloomberg via Getty Images CEO Heather Bresch had planned to hike the price further. The price of the EpiPen has soared 500% since generic drug company Mylan MYL -5.41% bought the treatment nine years ago. Yet Mylan’s controversial CEO Heather Bresch says she and her company aren’t solely to blame for the fact that patients are paying more for the must-have allergy medication. Another culprit, according to Bresch: President Obama. On an earnings call earlier this month, Bresch blamed EpiPen sticker shock in part on Obamacare. She said that employers’ increased use of high-deductible plans, one of the side-effects of the law, has resulted in patients paying more out of pocket for the drug, and that’s “where you’re seeing a lot of noise around EpiPen.” What’s more, Bresch, citing the roughly $600 wholesale cost, added that when you look at other treatments, the EpiPen does not fall into the category of “an expensive product.” Mylan is no stranger to controversy (see my profile last year, “Why Wall Street Loves to Hate Mylan’s CEO”). But EpiPen, a portable device that counteracts potentially life-threatening allergic reactions known as anaphylaxis, is supposed to be the company’s shining success story. In fact, prior to the recent price hike backlash, Mylan was looking to make the EpiPen more expensive. The company has been actively trying to renegotiate contracts with pharmacies and distributors this year that kept the EpiPen competitively priced with is biggest competitor, Sanofi’s Auvi-Q. But now that the Sanofi SNYNF -0.83% drug is no longer on the market—the company recalled its entire supply last fall, and has since abandoned it—Mylan is looking to ditch contracts that constrained EpiPen’s price. “I think you’ll see opportunities for us to continue to have that price per pen increase,” CEO Bresch said at a conference in May. EpiPen_Wholesale_Prices Mylan, already the most dominant maker of epinephrine auto-injectors, now enjoys a near-monopoly on the market since Auvi-Q’s withdrawal: After the recall, EpiPen’s market share immediately jumped from 85% to 95% at the end of last year. That lead remains safe at least into 2017, after an attempt by Teva Pharmaceutical Industries TEVA -2.63% to release a generic version failed to pass FDA muster earlier this year. The only other product on the market, the lower-cost Adrenaclick by Impax Laboratories IPXL -0.34% , has recently grown from 2% market share to 7%, but it’s still only considered interchangeable with EpiPen in 21 states, according to a research note Wednesday from RBC Capital Markets. Mylan did not return Fortune’s request for comment about the Obamacare connection. But in a statement on Monday, Mylan says it has tried to make EpiPen accessible and affordable to people who really need it, offering rebate cards that allowed 80% of patients with commercial insurance to get the product for free last year. Still Mylan appears to be learning the same hard lesson this week that Martin Shkreli and Valeant VRX -2.12% learned last year: Investors love when pharmaceutical companies raise drug prices—until everybody else gets really upset about it. Shares of Mylan MYL -5.41% have dropped more than 11% this week, down more than 5% on Wednesday alone. And the EpiPen controversy is drawing comments from some high-profile figures, including Hillary Clinton and Martin Shkreli himself, who tweeted that he thought the EpiPen’s price should even be higher. On Wednesday, Clinton said there was no justification for the price hikes. Her comments came shortly after the Senate Committee on Aging asked Mylan to provide information on the reasoning behind what it called the “drastic” price increase of EpiPen, and the American Medical Association “urge[d]” Mylan to “rein in these exorbitant costs.” The pricing scandal is happening at the worst possible time for Mylan. This is typically the company’s biggest season, driven by EpiPen sales, which peak during back-to-school shopping as parents and schools equip for the coming year. And EpiPen is a huge point of pride for Mylan as well as for Bresch herself. Inside Mylan, executives including Bresch all refer to EpiPen as her “baby”: It’s Mylan’s first billion-dollar drug, reaching $1 billion in annual sales in 2014 and 2015—making it what the pharmaceutical industry calls a “blockbuster.” That’s an even rarer feat for a generic drug maker such as Mylan, which makes most of its revenue not on brand-name drugs, but on cheaper, equivalent versions of other companies’ branded medications. When Mylan acquired EpiPen as part of a transaction with Merck MRK -1.34% in 2007, the drug had already been on the market for about 25 years—its initial approval in the U.S. was way back in 1939—yet it was such a no-name it wasn’t even mentioned in the press release of the $6.7 billion deal. At the time, EpiPen was making less than $250 million in sales. “This was a side show at best,” Bresch told me last year. Bresch, who at the time was overseeing the Merck integration as president of Mylan (she became CEO in 2012), saw EpiPen as a hidden gem. She poured marketing resources into the product, and embarked on an awareness and political campaign to get more EpiPens into schools and other public institutions. Today, 47 states have laws about making epinephrine auto-injectors available at school in case of an anaphylaxis incident, largely as a result of Bresch’s efforts. Mylan signed on famous spokespeople for EpiPen, including actress Sarah Jessica Parker and celebrity chef Amanda Freitag. Actress Sarah Jessica Parker has been a spokesperson for Mylan’s EpiPen. Under Mylan, sales of EpiPen grew at an average annual rate of 33%, more than doubling their 13% annualized growth rate before Bresch took charge. A lot of that growth came from increasing EpiPen prescriptions as the product became more mainstream: In the first seven years Mylan owned EpiPen, the number of patients using it grew 67%, according to Bloomberg. But price increases also drove sales growth. In the first year Mylan owned EpiPen, its price increased nearly 5%, to about $99 for a set of two EpiPens. But the following year, in 2009, the wholesale acquisition price of EpiPen jumped 26%; since 2012, prices have increased almost 30% each year. In May, Mylan raised the price of EpiPen another 15%, to $608.61 for a pack of two, according to Elsevier Clinical Solutions’ Gold Standard Drug Database. In total, that amounts to a more than six-fold increase in the wholesale price of EpiPen since Mylan bought it. Still, if anyone is equipped to defend Mylan’s unpopular moves—say, its tax inversion to the Netherlands last year—it’s Bresch. “There’s going to be good things that get you and there’s going to be bad things that get you, so you better be willing and your skin better be thick,” Bresch told Fortune last year, quoting her father, U.S. Senator Joe Manchin. “I try to look at it from the perspective of I should be flattered that so many people are trying to tear us down.”
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Post by lakers on Aug 24, 2016 16:27:39 GMT -5
How Marketing Turned the EpiPen Into a Billion-Dollar Business In a 2007 purchase of medicines from Merck KGaA, drugmaker Mylan picked up a decades-old product, the EpiPen auto injector for food allergy and bee-sting emergencies. Management first thought to divest the aging device, which logged only $200 million in revenue. Then Heather Bresch, now Mylan’s chief executive officer, hit on the idea of using old-fashioned marketing in part to boost sales among concerned parents of children with allergies. That started EpiPen, which delivers about $1 worth of the hormone epinephrine, on a run that’s resulted in its becoming a $1 billion-a-year product that clobbers its rivals and provides about 40 percent of Mylan’s operating profits, says researcher ABR|Healthco. EpiPen margins were 55 percent in 2014, up from 9 percent in 2008, ABR|Healthco estimates. Photo illustration: 731 How Mylan pulled that off is a textbook case in savvy branding combined with a massive public awareness campaign on the dangers of child allergies. Along the way, EpiPen’s wholesale price rose roughly 400 percent from about $57 each when Mylan acquired the product. “They have done a tremendous job of taking an asset that nobody thought you could do much with and making it a blockbuster product,” says Jason Gerberry, a Leerink Partners analyst. But while EpiPen has given countless parents a sense of security that their children can go out in the world safely, the device’s soaring price—up 32 percent in the past year alone—has forced some families to make difficult choices in order to afford the life-saving medicine. The price increases are among the biggest of any top-selling brand drug, according to DRX, a unit of Connecture that tracks drug pricing. After insurance company discounts, a package of two EpiPens costs about $415, DRX says. By comparison, in France, where Meda sells the drug, two EpiPens cost about $85. “There is a danger with that,” says George Sillup, chairman of the pharmaceutical and health-care marketing department at Saint Joseph’s University. If the company raises the price too much, “that could create some backlash.” The company sees it differently. “Mylan has worked tirelessly over the past years advocating for increased anaphylaxis awareness, preparedness, and access to treatment,” Mylan spokeswoman Nina Devlin said in a statement. She said the company doesn’t control final retail prices for EpiPen and offers coupons that eliminate co-pays for most patients. Bresch declined to comment for this story. The CEO has made no secret of her strategy to increase demand for EpiPens by getting them stocked for emergency use in more schools and other public places. (So-called entity prescriptions allow for this.) “We are continuing to open up new markets, new access with public entity legislation that would allow restaurants and hotels and really anywhere you are congregating, there should be access to an EpiPen,” Bresch said at a conference on Sept. 17. Over the past seven years, Mylan has hired consultants who had worked with Medtronic to get defibrillators stocked in public places. Bresch, the daughter of Senator Joe Manchin (D-W.Va.), turned to Washington for help. Along with patient groups, Mylan pushed for federal legislation encouraging states to stock epinephrine devices in schools. CEO Bresch Photographer: Chris Goodney/Bloomberg In 2010 new federal guidelines said patients who had severe allergic reactions should be prescribed two epinephrine doses, and soon after Mylan stopped selling single pens in favor of twin-packs. At the time, 35 percent of prescriptions were for single EpiPens. The U.S. Food and Drug Administration had changed label rules to allow the devices to be marketed to anyone at risk, rather than only those who’d already had an anaphylaxis reaction. “Those were both big events that we’ve started to capitalize on,” Bresch said in October 2011. In 2013, the year following the widely publicized death of a 7-year-old girl at a school in Virginia after an allergic reaction to peanuts, Congress passed legislation encouraging states to have epinephrine devices on hand in schools. Now 47 states require or encourage schools to stock the devices. Since 2012, Mylan has helped popularize its brand by handing out free EpiPens to more than 59,000 schools. Last year it signed a deal with Walt Disney to stock EpiPens in Disney’s theme parks and on cruise ships. And Mylan spent $35.2 million on EpiPen TV ads in 2014, up from $4.8 million in 2011, according to researcher Nielsen. Mylan disputes the ad spending figures but declines to offer alternatives. In part because of Mylan’s efforts, the number of patients using EpiPen has grown 67 percent over the past seven years. Many kids with allergies own multiple sets, for school and home. And for doctors, who write prescriptions for the name they know best, the EpiPen brand “is like Kleenex,” says Robert Wood, a pediatric allergist at Johns Hopkins University School of Medicine. So far rivals haven’t been able to break Mylan’s market grip. Sanofi’s Auvi-Q, introduced in 2013, is in the shape of a credit card and—unlike EpiPen—gives step-by step audio instructions. But Sanofi priced Auvi-Q about the same as EpiPen, and the product struggled initially to gain insurance coverage. Sanofi says 9 out of 10 patients with commercial insurance can now receive coverage for Auvi-Q prescriptions. Yet in the first half of 2015, EpiPen had about an 85 percent share of epinephrine prescriptions vs. only 10 percent for Auvi-Q, according to Symphony Health Solutions data compiled by Bloomberg. Still, allergy sufferers without generous health benefits feel the pain. Denise Ure, a social worker in Seattle, has a peanut allergy so severe that the last time she ingested a nut crumb in 2011, she needed three EpiPens and was hospitalized. Ure says she cried last year when she found out a prescription for two EpiPens would cost her about $350. “I was terrified because there’s this life-saving medicine that I needed, and I couldn’t afford it,” she says. Ure now carries two EpiPens she got in Canada, where they cost about half as much. The biggest threat to EpiPen could come from Teva Pharmaceutical Industries. It settled a patent lawsuit in 2012 allowing it to market a generic version of EpiPen as early as this year, if it wins FDA approval. Mylan isn’t too worried. Predicted Bresch in August: “You would not see the traditional market loss because of just the brand equity with EpiPen.” The bottom line: When Mylan bought EpiPen in 2007, the devices had $200 million in annual sales. Today revenue exceeds $1 billion. www.bloomberg.com/news/articles/2015-09-23/how-marketing-turned-the-epipen-into-a-billion-dollar-business
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