ovation pharmaceuticals
concurring statement of commissioner jon leibowitz in re federal trade commission v. ovation pharmaceuticals, inc .
concurring statement of commissioner j. thomas rosch - federal trade commission v. ovation pharmaceuticals, inc .
ovation pharmaceuticals, inc. , 1 overlook point, lincolnshire, il 60069, usa. bdeutsch @ urltoken
ovation pharmaceuticals acquires rights to commercialize xenazine® (tetrabenazine) in u. s. for chorea associated with huntingtons disease
before he became governor, bruce rauner’s private - equity firm invested heavily in another aronin company, ovation pharmaceuticals of deerfield .
marathon pharmaceuticals' deflazacort, used to treat patients with a fatal ...
h. lundbeck will acquire ovation pharmaceuticals in an all - cash transaction that values ovation at up to $ 900 million (approximately dkk 5. 2 billion). the boards of both companies have unanimously approved the transaction .
consider ovation pharmaceuticals of deerfield, ill. back in august 2005, ovation bought from merck a drug called indocin iv, which at the time was the only approved product to treat a life - threatening heart condition in premature infants .
desoxyn is manufactured legally in the us for prescription use by international pharmaceutical group lundbeck, following the danish - based firm’s acquisition of the drug’s sole manufacturer, ovation pharmaceuticals .
friday, ovation received a boost when the fda approved blood treatment atryn, the first drug developed from a genetically altered animal, which ovation will market .
danish drug maker lundbeck has agreed to acquire ovation pharmaceuticals inc. for up to $ 900 million. the deal, dow jones newswires reports, is expected to close in march 2009 .
desoxyn was first produced in 1942 by abbot laboratories. in the early 21st century the rights to the drugs manufacture were bought by ovation pharmaceuticals, who were taken over by lundbeck in 2009 .
ovation pharmaceuticals, based in deerfield, ill. , rejected the commission' s allegations. it said neoprofen is superior to indocin and is not interchangeable for most premature infants with the heart defect .
( ftc file no. 081 - 0156) (ovation. final. wpd )
the federal trade commission said in a civil lawsuit that ovation pharmaceuticals illegally maintained a monopoly in drug treatments for the heart defect. the commission seeks to prevent ovation from maintaining simultaneous interest in the two drugs - - neoprofen and indocin. also, it seeks forfeiture of all unlawfully obtained profits .
we are very pleased to complete the sale of ovation to lundbeck ,
added jeff aronin .
the ovation team is excited today to begin our new partnership with lundbeck and to continue ovation' s efforts to develop drugs for severely ill patients with unmet medical needs .
also, in 2008, the ftc sued ovation pharmaceuticals, a deerfield - based company also founded and led by aronin. the ftc accused ovation of violating antitrust laws by acquiring neoprofen — the only drug in competition with a drug it already owned, indocin, to treat a congenital heart defect affecting babies born prematurely .
gtcr partnered with jeffrey s. aronin, president and ceo of ovation, and wilbur (bill) h. gantz, chairman of ovation, in 2002. since that time, with capital from gtcr, ovation has made 10 major acquisitions, purchasing 20 marketed and development - stage drugs .
ovation pharmaceuticals was acquired by lundbeck. , inc. exsxcyrcvfyxbdaxyxussewcfwsa, in march 2009. the company was founded in 2000, and as of its acquisition in 2009 it operates as a subsidiary of h. lundbeck a / s .
biovail will commercialize tetrabenazine tablets in canada (marketed under the nitoman® brand name) through the biovail pharmaceuticals canada sales force. biovail will
prestwick recently entered into an exclusive agreement with ovation pharmaceuticals, inc. , a leading u. s. - based specialty biopharmaceutical company, to commercialize xenazine® in the u. s. the products commercial launch is anticipated late - 2008 .
ovation received $ 600 million of cash consideration at closing and will receive up to an additional $ 300 million based on certain regulatory milestones for sabril® (vigabatrin), a drug currently under development by ovation .
chicago - (business wire) gtcr, one of the nation' s leading private equity firms, announced today that it has completed the previously announced sale of ovation pharmaceuticals, inc. (ovation), a leading u. s. biopharmaceutical company. ovation was acquired by h. lundbeck a / s (lundbeck), an international pharmaceutical company based in copenhagen, denmark. the all - cash transaction will include payments of up to $ 900 million .
goldman sachs advised ovation on its sale. kirkland & ellis llp and katten muchin rosenman llp provided legal counsel to ovation. morgan stanley advised gtcr on the transaction. lundbeck was advised by deutsche bank and morgan lewis .
la jolla, calif. , sept. 9, 2013 (globe newswire) - - innovus pharmaceuticals, inc. , (
innovus pharma
) urltoken (otcbb: innv) announced today it has entered into a license and distribution agreement with ovation pharma sarl (
ovation pharma
) under which innovus pharma granted to ovation pharma an exclusive license to market and sell innovus pharma' s topical treatment for reduced penile sensitivity, circumserum™, in morocco. ovation pharma may pay innovus pharma up to approximately $ 11. 25 million for commercial milestones. in addition, ovation pharma has agreed to certain upfront minimum purchases of circumserum based upon an agreed upon transfer price and yearly minimum purchases .
the mg sales levels presented above are consistent with the mg projections provided in the ovation pharmaceuticals, inc. ( ovation ) u. s. marketing plan letter, dated as of 5 september 2008. note that the marketing plan letter is on a calendar basis while the above quantities are on a 12 month basis. thus, some variance will exist .
chief executive ulf wiinberg said during a conference call that the acquisition of ovation “definitely goes a long way” to replacing lexapro and singled out ovation’s seizure and spasm drug candidate sabril, which an expert panel recently recommended the fda approve .
prestwick pharmaceuticals recently entered into an exclusive supply and marketing agreement with ovation pharmaceuticals, inc. for xenazine® in the u. s. following biovails acquisition of prestwick, biovail will supply the product to ovation for a variable percentage of the products annual net sales. for net sales up to $ 125 million, biovails supply price will be 72% of net sales. beyond $ 125 million, biovails supply price will be 65% of net sales. at both tiers, biovail will pay a supply price of 50% of net sales to cambridge .
emanuel supporter jeffrey aronin’s northbrook - based marathon pharmaceuticals has drawn heavy criticism after listing an annual dosage of a new muscular dystrophy drug at $ 89, 000 .
once ovation acquired the rights to the competing drug, it promptly raised its price for indocin from $ 36 to $ 500 per vial. when neoprofen was launched in july 2006, ovation set a price of about $ 483 a vial .
by acquiring neoprofen, the complaint alleges, ovation preserved its u. s. monopoly in drugs used to treat patent ductus arteriosus in premature babies. following the acquisition, ovation promptly raised the price of indocin to nearly $ 500 per vial, and when it introduced neoprofen, set the price at virtually the same level. merck supplied indocin to ovation for a small fraction of the price ovation charges. nearly three years later, ovation continues to charge artificially high prices for both indocin and neoprofen. the fda approved a generic version of indocin in july 2008, but to date it has not entered the market .
ovation, a privately owned corporation based in deerfield, illinois, sells pharmaceuticals in more than 85 countries, including the united states. in august 2005, ovation purchased the rights to indocin from merck. at that time, neoprofen was awaiting regulatory approval by the food and drug administration. according to the ftc’s complaint, ovation expected that neoprofen, once approved, would take a substantial portion of sales from indocin. to eliminate the threat that neoprofen posed, the commission charges, ovation acquired the u. s. rights to neoprofen from abbott laboratories in january 2006. the neoprofen transaction fell below the regulatory threshold for reporting acquisitions to the federal antitrust authorities .
law360 (october 15, 2009, 7: 35 pm edt) - - a federal judge has refused to dismiss a putative class action accusing ovation pharmaceuticals inc. and lundbeck inc. of jacking up the prices for pharmaceutical treatments of a certain congenital heart defect suffered most frequently by premature infants .
according to the ftc, ovation preserved its u. s. monopoly in drugs used to treat pda by acquiring neoprofen. in its press release announcing the action, the agency pointed to ovation’s pricing practices following the acquisition. the ftc said: “ovation promptly raised the price of indocin to nearly $ 500 per vial, and when it introduced neoprofen, set the price at virtually the same level... nearly three years later, ovation continues to charge artificially high prices for both indocin and neoprofen. ”
deerfield, ill. , [ date ]  ovation pharmaceuticals, inc. announced today that it has acquired from prestwick pharmaceuticals the exclusive license in the united states to commercialize xenazine® (tetrabenazine), an orphan drug recently approved by the u. s. food and drug administration (fda) for the treatment of chorea associated with huntingtons disease (hd). financial terms of the deal were not disclosed. subsequently, biovail corporation, canadas largest publicly traded pharmaceutical company, acquired prestwick .
the drug had languished since 1998 when its original maker abandoned it because of the vision side effects. a tiny biotech, ovation pharmaceuticals, picked it up in 2003, and fought for six years to get it approved. its path to patients was the longest of any medicine on record - - 14 years .
the federal trade commission today filed a complaint in federal district court challenging ovation pharmaceuticals, inc. ’s january 2006 acquisition of the drug neoprofen, which eliminated its only competitor for the treatment of a serious and potentially deadly congenital heart defect affecting more than 30, 000 babies born prematurely each year in the united states. when it acquired neoprofen, ovation already held the rights to indocin i. v. , the only other drug used to treat this serious condition. after ensuring that it would not face competition from neoprofen, ovation promptly raised the price of indocin nearly 1, 300 percent, from $ 36 to nearly $ 500 a vial. when it launched neoprofen in july 2006, ovation set a similarly inflated price .
in addition, biovail holds an option to develop future related products with ovation for the u. s. market in conjunction with cambridge .
in december 2008, the ftc and minnesota filed a complaint against ovation pharmaceuticals, inc. , which was later acquired by lundbeck. the suit challenged the company’s 2006 acquisition of the rights to market neoprofen (injectable ibuprofen) —a drug used to treat premature infants with a heart condition known as patent ductus arteriosus (pda) .
indocin was approved by the food and drug administration to treat the heart defect in infants in 1985. ovation bought the rights to indocin from merck. merck agreed to manufacture the drug and supply it to ovation. after the deal, the drug' s price increased to $ 36 .
the ftc says ovation bought out its only competitor, and then charged
monopoly prices ,
to the tune of about a 1, 300 percent increase in price. the competitor medication, neoprofen, was under development by abbott laboratories when ovation purchased it and subsequently received fda approval .
ovation made several additional neurology acquisitions, further transforming the company. most importantly, ovation acquired the u. s. commercial rights to xenazine, the first drug approved in the u. s. for the treatment of chorea, a debilitating movement disorder associated with huntington’s disease. ovation successfully leveraged its neurology sales force to launch xenazine in the u. s. and further establish its credibility and critical mass as a neurology specialty company .
at a meeting of the child neurology society in vancouver, shields saw a booth for a new start - up, ovation pharmaceuticals, which was seeking new products. he sold them on sabril. the fda had never closed the file on the drug, and in december 2007, shields' data formed the basis of a new drug application for infantile spasms .
innovus pharma, headquartered in la jolla, california, is an emerging pharmaceuticals company that delivers innovative and uniquely presented and packaged health solutions through its over - the - counter medicines and consumer and health products .
ovation ultimately was sold to pharmaceutical company h. lundbeck in 2009 for $ 900 million. aronin served as lundbeck' s ceo and president after the acquisition .
commissioner rosch’s concurring statement explains that like commissioner leibowitz, he would have also voted to challenge ovation’s earlier acquisition of indocin. commissioner rosch wrote “... there is reason to believe that merck’s sale of indocin to ovation had the effect of enabling ovation to exercise monopoly power in its pricing of indocin... [ and ] had the effect of substituting ovation, a firm that had an incentive to protect its ability to engage in monopoly pricing, for merck, which lacked the same incentive. ” commissioner rosch added, “... it is hard to imagine a more compelling case for application of this legal theory. ”
the acquisition of ovation delivers on lundbeck' s strategic goal to build a commercial infrastructure in the u. s. ovation has a broad portfolio of marketed products and a pipeline of products primarily focused on cns. that pipeline is expected to significantly drive growth in the coming years through multiple new product launches, according to the companies .
unfortunately for ovation, abbott laboratories was in the process of winning approval from the food and drug administration of a product that would compete with indocin. so in january 2006, ovation purchased the rights for the second drug, neoprofen. according to a complaint filed in december by the ftc, ovation then raised the price of indocin by nearly 1, 300 percent, from $ 36 per vial to nearly $ 500. when neoprofen eventually hit the market, it was priced at roughly the same level .
the company
welcomes the opportunity to demonstrate in court in minneapolis that the ftc' s allegations and claims are without merit ,
ovation said in a prepared statement .
ftc commissioner jon leibowitz said of the issue ,
ovation' s profiteering on the backs of critically ill premature babies is not only immoral, it is illegal .
marathon pharmaceuticals is only 6 years old, but this week' s uproar surrounding its $ 89, 000 muscular dystrophy drug isn' t the first time the company — or its ceo — has faced outrage over drug pricing .
“by acquiring its only competitor in the treatment of a serious heart condition affecting premature babies, ovation has been able to charge dramatically higher prices for its drugs, ” said acting ftc bureau of competition director david p. wales. “while ovation is profiting from its illegal acquisition, hospitals and ultimately consumers and american taxpayers are forced to pay millions of dollars a year more for these life - saving medications. the action taken today is intended to restore the lost competition and require ovation to give up its unlawful profits. ”
the u. s. federal trade commission alleged in december that ovation bought the only rival to its medicine treating babies with a rare heart defect and then charged “monopoly prices” for both products. the ftc asked a federal court to block ovation from owning the two drugs and to require the company disgorge all profits from the “unfair method of competition. ”
ovation pharma, headquartered in casablanca, morocco, is a fast growing specialty pharmaceutical company that in - licenses, promotes and markets prescriptions and otc products. ovation pharma' s expertise in medical promotion, regulatory affairs and marketing strategy allows it to be a partner of choice for multinational corporations expecting to break into the moroccan pharmaceutical market with emerging products .
ovation also faced charges of inflating the prices of its products. at the time, aronin replied that it costs huge sums for his company to develop and market its products .
this letter and attachments are an update to the march 2007 xenazine® u. s. marketing plan prepared by prestwick pharmaceuticals. inc. ( prestwick ) and the ovation pharmaceuticals, inc. (ovation) u. s. marketing plan letter, dated as of 30 july 2008 (in the event the details of the original marketing plan and the two subsequent update letters conflict the terms of this update letter shall prevail). this update to the marketing plan incorporates the topics we discussed in our meeting held this week in chicago including our pricing strategy for xenazine and our plan for reimbursement and patient assistance. per your request, we are providing you with detail regarding our pricing assumptions and associated sales and quantity projections as well as detailed projections and estimates of gross to net adjustments associated with specialty pharmacy fees, patient assistance and co - pay assistance programs .
the company strongly disputes the claims in the complaint, strongly disputes the ftc' s characterization of the facts and the propriety of seeking disgorgement ,
ovation said in a statement .
the commission’s complaint charges that ovation’s acquisition of neoprofen substantially reduced competition in violation of section 7 of the clayton act, and illegally maintained the company’s monopoly of drug treatments for patent ductus arteriosus in violation of section 5 (a) of the ftc act. the commission is seeking equitable relief, including divestiture and disgorgement of unlawfully obtained profits from ovation’s sales of indocin and neoprofen .
overall from 2002 to 2009, gtcr and its management partners at ovation strategically transformed 10 separate acquisitions of pharmaceutical assets into a neurology - focused biopharmaceutical company with an excellent commercial platform and a portfolio of clinically unique drugs targeting largely unmet medical needs. in february 2009, after a robust sale process, ovation announced an agreement to sell the company to lundbeck, an international pharmaceutical company .
closely - held ovation has 283 employees and expected earnings before interest and taxes of $ 32 million in 2008. the deerfield, ill. , company develops drugs mainly for central nervous system disorders .
ovation' s profiteering on the backs of critically ill premature babies is not only immoral, it is illegal ,
ftc commissioner jon leibowitz said in a statement issued separately from the lawsuit .
this marketing, distribution and supply agreement (this  agreement ) is dated as of september 16, 2008 (the  effective date ) by and between prestwick pharmaceuticals, inc. , a company incorporated under the laws of the state of delaware and having a principal place of business at 1825 k street nw, suite 1475, washington, d. c. 20006 ( prestwick ), and ovation pharmaceuticals, inc. , a company incorporated under the laws of the state of illinois and having a principal place of business at four parkway north, deerfield, illinois 60015 ( distributor ). prestwick and distributor are sometimes referred to herein individually as a  party  and collectively as the  parties  .
jeffrey aronin, ceo of northbrook - based marathon pharmaceuticals, is photographed in 2015. after the price of his company' s duchenne muscular dystrophy drug came under fire, aronin said feb. 13, 2017, that marathon would pause the commercial launch of the drug .
when ovation originally purchased the product from merck, it raised the price from $ 10 to $ 36 per vial, but after buying the competing drug in 2006, the ftc says it raised the price of both indocin and neoprofen to nearly $ 500 per vial. the ftc is hoping that the federal court will prevent ovation' s ownership from the competing products and spill the profits it gained in the interim .
under the terms of the agreement, biovail and ovation will jointly develop additional follow - on indications for xenazine and related products in the u. s. in conjunction with cambridge laboratories limited, the worldwide license holder of the drug. xenazine is the first and only fda - approved treatment for any hd - related disorders. ovation expects to launch the product in the u. s. by the end of this year .
lundbeck will pay $ 600 million immediately upon closing of the transaction, and will pay an additional up to $ 300 million within a year afterward if ovation achieves certain milestones related to regulatory approval of drug candidate sabril .
ovation pharmaceuticals may be in hot water. the company, which dedicates itself to drugs for rare medical conditions, purchased the rights to merck' s indocin in 2005, bought a rival drug in 2006 and then hiked the prices of both, according to allegations made by the federal trade commission. indocin is a medication used to treat a congenital condition called patent ductus arteriosus (pda), which occurs in some premature babies and can be fatal without medication. about 30, 000 newborns a year receive medication to treat a pda .
ovation will market xenazine® to u. s. specialists through a 48 - person sales force, which already markets a number of other products targeting cns disorders, including epilepsy and attention deficit disorder. as part of the agreement, biovail holds an option to co - promote xenazine® in the united states. should this option be exercised, biovail has the right to utilize ovations existing infrastructure to assist in the recruitment, training and operational management of a sales force .
jeffrey aronin, ceo of northbrook - based marathon pharmaceuticals, is photographed in 2015. after the price of his company' s duchenne muscular dystrophy drug came under fire, aronin said feb. 13, 2017, that marathon would pause the commercial launch of the drug. (andrew a. nelles / chicago tribune )
the commission vote approving the complaint was 4 - 0, with commissioners jon leibowitz and j. thomas rosch issuing separate concurring statements. in his statement commissioner leibowitz wrote, “ovation’s profiteering on the backs of critically ill premature babies is not only immoral, it is illegal. ovation’s behavior is a stark reminder of why america desperately needs health care reform and why vigorous antitrust enforcement is as relevant today as it was when the agency was created almost one hundred years ago in 1914. ”
under the terms of the agreement, biovail will pay $ 100 million to acquire 100% of prestwick pharmaceuticals and related license rights. beyond xenazine®, the acquisition also provides biovail with other early - stage products, including lisuride sub q (advanced parkinsons disease), lisuride patch (parkinsons disease) and d - serine (schizophrenia) .
the commission said ovation bought the rights to indocin in august 2005 and then acquired the rights to neoprofen five months later. it set the price for the two medicines at about $ 500. before the second acquisition, indocin was priced at $ 36 .
ovation is not some rogue drug company. its slimy behavior reflects the way the industry thinks, the way it behaves and the way it prefers to “compete. ” which is why it is crucial for the government to bring closer scrutiny to industry mega - mergers .
minnesota attorney general lori swanson made similar assertions when announcing the state’s claims. “ovation acquired a monopoly over the only two drugs that treat this particular heart problem in premature babies, then it unfairly increased the cost by nearly 1, 300% , ” swanson said .
when ovation acquired neoprofen, it already held the rights to indocin iv (injectable indomethacin) —the only drug available to treat pda in the united states. neoprofen had not yet been approved by the food and drug administration to treat pda but was used in europe to treat the disease .
noting ovations strong commercial capabilities to support the launch of xenazine, aronin added, we will be able to efficiently and effectively reach patients suffering from this devastating neurodegenerative and ultimately fatal disease. we are pleased that we can bring to these patients the first approved therapy to treat this disorder. 
the commission said ovation knew it faced the threat of imminent entry from a new drug to treat the heart defect. it bought the u. s. rights to that competitor in january 2006 from abbott laboratories. the size of the transaction fell below the threshold for reporting to federal antitrust agencies .
as a result, hospitals have little choice but to pay ovation' s monopoly price ,
the commission said in the lawsuit .
the artificially high prices that hospitals are forced to pay ultimately raise costs for families, tax - supported programs such as medicaid, and other public and private purchasers .
because there are no other drugs available to treat patent ductus arteriosus, hospitals treating babies with this critical condition have no choice but to pay ovation’s monopoly price. and ultimately, the artificially high prices paid by hospitals are passed on to families, government programs such as medicaid, and other public and private purchasers .
specialty pharmacy hub services fees will also be incurred as part of the specialty pharmacy management and distribution of xenazine. ovation is estimating these expenses to be approximately { * * * }  in 2008, { * * * }  in 2009 and { * * * }  annually in 2010 and thereafter .
any time you have a drug company raising prices, they' re going to talk about their patents and innovation ,
said michael carrier, a law professor at rutgers university who specializes in intellectual property and antitrust law in pharmaceuticals .
to the extent that this looks like an investment opportunity for a company coming in after all the hard work has already been done then that innovation - based argument seem less persuasive .
jeff and bill have built a truly unique and valuable biopharmaceutical business, and they have been fantastic partners for gtcr ,
commented dean mihas, principal of gtcr .
ovation has been an excellent investment for gtcr, and we look forward to investing additional capital in the pharmaceutical industry in partnership with outstanding management teams .
this is the fee - for - service portion of the specialty pharmacy program. contract negotiations have not been finalized yet, however. ovation is targeting achieving a low { * * * }  for this component. by comparison. traditional fee - for - service arrangements are typically in the { * * * }  range .
the fda finally convened its panel in january 2009, and the panelists voted unanimously that sabril should be approved both for babies with infantile spasms and for adults who had run out of options. in february, lundbeck, a danish drug maker, bought ovation for $ 900 million. the press release announcing the deal trumpeted that sabril was in the final stages of fda review .
h. lundbeck a / s (lun. co, lun dc, hluky) is an international pharmaceutical company engaged in the research and development, production, marketing and sale of pharmaceuticals for the treatment of psychiatric and neurological disorders. in 2008, the company' s revenue was dkk 11. 3 billion (approximately eur 1. 5 billion or usd 2. 2 billion). the number of employees is approx 5, 500 globally. for more information, please visit www. lundbeck. com .
bassam damaj, president and chief executive officer of innovus pharma commented ,
we are very excited about this major north african collaboration with ovation pharma and we look forward to expanding the reach of our circumserum product for reduced penile sensitivity in morocco. this is an important milestone in our strategy to make circumserum available worldwide and the successful continuation of the execution of our commercialization strategy of the company .
but pharmaceuticals is an industry that doesn' t lend itself to traditional market analysis. because the bulk of profits in the industry come from temporary monopolies – government - granted patents – the current marketplace is not where the important competition takes place. rather, the real rivalry takes place “upstream, ” as companies compete to innovate, either by developing medicines in their labs or by buying up promising patents and biotech start - ups. and in that “market for innovation, ” it is hard to see how further consolidation would be good for consumers .
toronto, canada, september xx, 2008 - biovail corporation (nyse, tsx: bvf) today announced it has acquired prestwick pharmaceuticals, inc. , a privately held, u. s. - based pharmaceutical company that holds the canadian and u. s. licensing rights to xenazine® (tetrabenazine tablets). xenazine® was recently approved by the united states food and drug administration (fda) for the treatment of chorea associated with huntingtons disease. xenazine® was granted orphan drug designation by the fda, which provides the product with seven years of market exclusivity in the united states .
unlike the controversy over, say, the dendreon cancer treatment provenge, there have been few protests and little noise made about the delay. even now, ovation' s parent company, lundbeck, will probably make more from selling sabril to adult epileptics than to babies. figuring out how to help small groups of people who desperately need a drug without exposing the population at large to necessary risks may be the biggest challenge facing the fda .
obtaining the rights to xenazine in the u. s. adds another important growth driver to our series of multiple specialty product launches expected over the next several years,  said jeffrey s. aronin, president and chief executive officer of ovation. this drug represents a strong strategic fit and complements our existing portfolio of central nervous system products, in addition to continuing our business strategy of pursuing opportunities to bring important new medicines to severely ill patients with unmet medical needs. 
the marketing plan means the ovation second u. s. marketing plan letter, dated as of 11 september 2008 as attached below, (in conjunction with the original march 2007 xenazine u. s. marketing plan prepared by prestwick, as modified by the first u. s. marketing plan letter, dated as of 30 july 2008, each as attached below) and as amended thereafter, subject to section 10. 10 of this agreement, under the cambridge agreement .
note: schedule 6 contains the bottle quantity of binding purchases for year 1. additionally, conversion to mgs is also provided. these amounts represent both demand and inventory build in the trade and at ovation. for minimum sales quantities, the unit of measure provided below is mgs per year. the exact strength mix of 12. 5mg and 25mg will be determined by initial market uptake and titration. in subsequent years, when firm forecast are established per mutual agreement of the parties, strength detail can be provided .
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lundbeck, inc. , a biopharmaceutical company, engages in developing, manufacturing, and selling pharmaceutical products primarily in the united states. its products include methamphetamine hydrochloride tablets, mephobarbital tablets, pentobarbital sodium injections, ethotoin tablets, and clorazepate dipotassium and tetrabenazine tablets. the companyâ€™s products also include antithrombin, dactinomycin, asparaginase, mechlorethamine, and hemin injections; and succimer, benztropine mesylate, indomethacin, and ibuprofen lysine injections. in addition, lundbeck offers sabril (vigabatrin) tablets and powder for oral solutions. its products are used for central nervous system, hematology, and oncology - related diseases and disorders, as well as used in hospitals .
the company markets its products in argentina, brazil, canada, costa rica, guatemala, honduras, mexico, australia, hong kong, korea, malaysia, new zealand, the philippines, singapore, taiwan, thailand, austria, belgium, bulgaria, the czech republic, denmark, estonia, finland, france, germany, iceland, ireland, italy, latvia, lithuania, luxembourg, the netherlands, norway, portugal, spain, sweden, switzerland, the united kingdom, and israel .
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news corp is a network of leading companies in the worlds of diversified media, news, education, and information services .
volkswagen’s all - electric effort to climb out of its p. r. hole
it’s not quite pfizer buying wyeth, but two more drugmakers announced another deal monday designed to bolster an aging pipeline .
lundbeck, based in copenhagen, is preparing for the 2012 patent expiration of depression treatment lexapro / cipralex, which made up nearly two - thirds of lundbeck’s third - quarter sales. forest labs has turned lexapro into a blockbuster .
bonus bucks: well, we sort of thought lundbeck would be part of a deal, but figured it was more likely to be the prey. see our post on irresistible m & a targets from 2007 .
federal regulators alleged yesterday that an illinois - based company bought the only two medicines approved to treat premature babies born with a potentially life - threatening congenital heart defect and then increased prices nearly 1, 300 percent .
the ftc said the only alternative to treating the heart defect, known as patent ductus arteriosus, is surgery, but that option carries a risk of serious complications and costs far more than treatment with drugs .
the lawsuit was filed in the u. s. district court in minnesota .
the ftc filed its complaint in the u. s. district court for the district of minnesota. indocin and neoprofen are the only two pharmaceutical treatments sold in the u. s. for a condition known as patent ductus arteriosus, a disorder that primarily affects very low birth - weight premature infants. in babies with this condition, the blood vessel connecting two major arteries of the heart fails to close on its own soon after birth. patent ductus arteriosus can be fatal if not treated. the only treatment other than drug therapy is surgery, which carries the risk of serious complications and costs far more than treatment with either indocin or neoprofen .
note: the commission authorizes the filing of a complaint when it has “reason to believe” that the law has or is being violated, and it appears to the commission that a proceeding is in the public interest. a complaint is not a finding or ruling that the defendants have actually violated the law .
copies of the commission’s complaint will be available soon from the ftc’s web site at urltoken and also from the ftc’s consumer response center, room 130, 600 pennsylvania avenue, n. w. , washington, d. c. 20580. the ftc’s bureau of competition works with the bureau of economics to investigate alleged anticompetitive business practices and, when appropriate, recommends that the commission take law enforcement action. to inform the bureau about particular business practices, call 202 - 326 - 3300, send an e - mail to antitrust @ urltoken, or write to the office of policy and coordination, room 383, bureau of competition, federal trade commission, 600 pennsylvania ave, n. w. , washington, dc 20580. to learn more about the bureau of competition, read “competition counts” at urltoken / competitioncounts .
media contact: mitchell j. katz, office of public affairs 202 - 326 - 2161 staff contact: markus h. meier, bureau of competition 202 - 326 - 3759
our media resources library provides one - stop collections of materials on numerous issues in which the ftc has been actively engaged. these pages are especially useful for members of the media .
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founded in 1980, gtcr golder rauner, llc is a leading private equity investment firm and long - term strategic partner for outstanding management teams. the chicago - based firm pioneered the investment strategy of identifying and partnering with exceptional executives to acquire and build companies through a combination of acquisitions and strong internal growth. gtcr currently manages more than $ 8 billion of equity capital invested in a wide range of companies and industries. more information about gtcr can be found at urltoken
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lundbeck will make an up - front payment of $ 600 million (or approximately dkk 3. 5 billion) immediately upon closing of the transaction. additional payments of up to $ 300 million (or approximately dkk 1. 7 billion) within one year of closing are contingent upon the achievement of certain product regulatory milestones relating to the approvals of sabril® by the fda .
money will be used to advance new drug into clinical studies later this year and to further phase ii depression candidate .
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portions of this exhibit have been redacted pursuant to a request for confidential treatment under rule 24b - 2 of the general rules and regulations under the securities exchange act of 1934, as amended. such redacted portions have been replaced with  { * * * }  in this exhibit. an unredacted version of this document has been filed separately with the securities and exchange commission along with the request for confidential treatment .
effect of termination by prestwick pursuant to sections 11. 2. 1 (a) or (b) or 11. 3
effect of termination by distributor pursuant to section 11. 2. 3 or 11. 3
effect of termination by prestwick pursuant to section 11. 2. 1, 11. 3 or 15. 6. 2 or by distributor in accordance with section 11. 4 or 15. 6. 2, or under section 11. 5
whereas, distributor desires to be appointed the exclusive distributor for such product to commercialize such product in the territory to maximize the commercial value of such product .
1. 2  a & p  means activities exclusively and directly related to the marketing and promotion of product in the territory to the relevant specialist audience, including promotional materials, and branded items for detailing activities, marketing publications, market research studies, non personal promotion and advertisements, public and professional relations (including activities at local and national congresses in the territory and satellite symposia), medical education programs and promotional meetings. for purposes of clarity, a & p shall not include detailing .
1. 3  affiliate  means any individual, corporation, company, partnership, trust, limited liability company, association or other business entity ( person ) which directly or indirectly controls, is controlled by or is under common control with the party in question. as used in this
definition of affiliate,  the term control shall mean, as to any person, (a) direct or indirect ownership of fifty percent (50 %) or more of the voting interests or other ownership interests in the person in question; (b) direct or indirect ownership of fifty percent (50 %) or more of the interest in the income of the person in question; or (c) possession, directly or indirectly, of the power to direct or cause the direction of management or policies of the person in question (whether through ownership of securities or other ownership interests, by contract or otherwise). notwithstanding the foregoing, the direct or indirect owners of equity securities of a party such as financial institutions, venture capital funds and private equity investors (and other direct or indirect portfolio companies or investments of such financial institutions, venture capital funds and private equity investors) will not be its affiliates for purposes of this agreement .
1. 4  business day  means any monday, tuesday, wednesday, thursday or friday that is not a day on which banking institutions in the state of new york are authorized by law to close .
1. 5  calendar quarter  means that three (3) month period during the term of each calendar year ending march 31, june 30, september 30 and december 31; provided, however, that the calendar quarter in which this agreement expires or is terminated shall extend from the first day of such calendar quarter until the effective date of such expiration or termination of this agreement .
1. 6  calendar year  means (a) for the calendar year this agreement is entered into, the period commencing on the effective date and ending on december 31 of the same year, (b) for each successive period beginning on january 1 and ending twelve consecutive calendar months later on december 31, and (c) for the calendar year in which this agreement expires or is terminated, the period beginning on january 1 of such calendar year and ending on the effective date of the expiration or termination of this agreement .
1. 7  cambridge agreement  means the second amended and restated agreement between prestwick and cambridge laboratories (ireland) limited ( licensor ) dated november 18, 2005 and any amendments thereto or modifications thereto .
1. 8  cambridge amendment  means that certain amendment to the cambridge agreement, dated september 12, 2008, by and among licensor, prestwick holdings, inc. , prestwick, biovail americas corp. and distributor .
1. 9  change of control  means, with respect to a party, (a) the acquisition (directly or indirectly, whether by merger, consolidation, purchase and sale, share exchange or otherwise) by a third party of a beneficial interest in the securities of such party representing more than fifty percent (50 %) of the combined voting power of such partys then outstanding securities; or (b) the transfer, sale or assignment of more than fifty percent (50 %) of the assets of such party to a third party .
1. 10  commercialization  means activities directed to the marketing, promotion, selling, or offering for sale of a product for an indication, including pre - marketing, advertising, educating, planning, obtaining pricing approvals, marketing, promoting, detailing, distributing and post - marketing safety surveillance and preparation of filings for reporting to the fda. when used as a verb,  commercialize  means to engage in such activities .
1. 11  commercialization plan  means the plan pursuant to which product shall be commercialized in a calendar year in the territory and at a minimum shall include the following: (a) market research, including market size, dynamics, growth, customer segmentation, competitive analysis, and product positioning, (b) annual sales forecasts broken down by calendar quarter, (c) advertising and promotion programs and strategies, (d) sales plans and activities, including sales force allocations, both in number of representatives and the deployment of such representatives, (e) phase 4 studies to be conducted, (f) number of and position of details to be performed in a calendar year ( detail requirements ) and (g) budget for performing the above noted activities in a calendar year ( commercialization budget ). notwithstanding the foregoing, the commercialization plan for the current calendar year and following calendar year shall be the initial marketing plan .
1. 12  commercially reasonable efforts  means carrying out of obligations or tasks consistent with the reasonable practices of the pharmaceutical industry for the development or commercialization of a pharmaceutical product having similar market potential or profit potential as product, based on conditions then prevailing.
ovation pharmaceuticals is an american manufacturer and distributor of pharmaceuticals products . it was founded in 2000 by jeffrey aronin and is headquartered in deerfield , illinois . a major office is also located near lebanon , new jersey . ovation is a privately held corporation based on a business model of acquiring mature but under-promoted pharmaceuticals , as well as pharmaceutical candidates which are far along the development and fda certification processes . since 2009 the company has been wholly owned by the danish pharmaceutical company lundbeck . 
ovation pharmaceuticals is an american manufacturer and distributor of pharmaceuticals products. it was founded in 2000 by jeffrey aronin and is headquartered in deerfield, illinois. a major office is also located near lebanon, new jersey. ovation is a privately held corporation based on a business model of acquiring mature but under-promoted pharmaceuticals, as well as pharmaceutical candidates which are far along the development and fda certification processes. since 2009 the company has been wholly owned by the danish pharmaceutical company lundbeck.
ovation pharmaceuticals is an american manufacturer and distributor of pharmaceuticals products. it was founded in 2000 by jeffrey aronin and is headquartered in deerfield, illinois. a major office is also located near lebanon, new jersey. ovation is a privately held corporation based on a business model of acquiring mature but under-promoted pharmaceuticals, as well as pharmaceutical candidates which are far along the development and fda certification processes. since 2009 the company has been wholly owned by the danish pharmaceutical company lundbeck.