kv pharmaceutical
kv pharmaceutical co: k - v pharmaceutical receives court approval of hologic set. .
kv pharmaceutical co: k - v pharmaceutical secures commitment for $ 85 million loa. .
k - v pharmaceutical company: k - v pharmaceutical announces planned transition of. .
k - v pharmaceutical company: k - v pharmaceutical use of cash collateral approved. .
kv pharmaceutical co: ther - rx corporation and perrigo company announce the avai. .
kv pharmaceutical company et al. v. medecor pharma, l. l. c .
kv pharmaceutical wraps $ 60 million generics unit sale to zydus - st. louis business journal
k - v pharmaceutical company: k - v pharmaceutical
first day
motions approved by. .
he and other health leaders have scheduled a meeting next week in washington with kv pharmaceutical representatives .
for fiscal 2011 ended march 31, kv pharmaceutical (nyse: kv - a, kv - b) reported a loss of $ 174 million on revenue of $ 27. 3 million .
kv pharmaceutical in bridgeton is shown in this file photo. photo by emily rasinski, erasinski @ urltoken
staring down at the former chief executive of kv pharmaceutical co. — what used to be among …
update: kv pharmaceutical changed its name to lumara health, two days after this post was published .
ask a question about working or interviewing at kv pharmaceutical company. our community is ready to answer .
k - v pharmaceutical company announces the completion of the sale of nesher pharmaceuticals, inc. its generic pharmaceutical business
kv then formed nesher last year to operate as the sales and marketing company for kv’s generic products .
k - v pharmaceutical company announces the completion of the sale of nesher pharmaceuticals, inc. its generic pharmaceutical business | healthcare packaging
that designation ensures kv pharmaceutical sister company, ther - rx, will be the sole source of the drug for seven years .
nesher pharmaceutical inc is the subsidiary of us - based kv pharmaceuticals and has expertise in niche therapies such as controlled release medications .
1993 • fda raids kv facilities, seizing drugs and ingredients. kv signs consent decree agreeing to improve its manufacturing practices .
kv pharmaceutical became involved about three years ago and acquired rights to the drug from a massachusetts company named hologic inc. , said divis .
lumara health, which previously did business as kv pharmaceutical, is being acquired by two different buyers in deals valued at $ 757 million .
kv pharmaceutical co. v. medecor pharma, llc, 354 f. supp. 2d 682 (e. d. la. 2003 )
the massive increase comes after st lois - based kv pharmaceutical won an exclusive government license to produce the drug makena - which was previously made by unlicensed chemists .
kv pharmaceutical co. v. medecor pharma, llc, 354 f. supp. 2d 682 (e. d. la. 2003): : justia
outrage is growing in the usa at kv pharmaceutical co' s pricing of its newly - approved premature birth drug makena despite the company announcing a 55% reduction .
kv pharmaceutical co. said monday it completed the $ 60 million sale of its generic drug unit, nesher pharmaceuticals, to zydus pharmaceuticals inc. and zynesher pharmaceuticals .
company: kv pharmaceutical, st. louis, mo company description: kv pharmaceutical is a fully integrated specialty pharmaceutical company developing and marketing technology - distinguished branded and generic / non - branded prescription pharmaceuticals. the company markets its products through ethex corporation, a national leader in pharmaceuticals competing with branded products, and ther - rx corporation, its branded drug subsidiary. nomination category: advertising categories nomination sub category: best specialty ad
june 2008 • kv initiates first of a series of recalls of its products .
st. louis, june 11 / prnewswire - firstcall / - - kv pharmaceutical company (nyse: kva / kvb), a specialty pharmaceutical company, conducted its annual meeting of shareholders on june 10, 2010 for the fiscal year ended march 31, 2009 .
it is hereby ordered that the motion for a preliminary injunction of kv pharmaceutical company, ther - rx corporation and drug tech corporation is denied. (document # 1. )
k - v pharmaceutical company is now part of amag pharmaceuticals, inc. (november 2014 )
in re k - v pharmaceutical | no. 4: 11cv01816 agf. | 20140328c25 | urltoken
nesher pharmaceuticals (usa) llc (nesher) is a growing pharmaceutical company, ...
company: kv pharmaceutical, st. louis, mo company description: kv pharmaceutical is a fully integrated specialty pharmaceutical company developing and marketing technology - distinguished branded and generic / non - branded prescription pharmaceuticals. the company markets its products through ethex corporation, a national leader in pharmaceuticals competing with branded products, and ther - rx corporation, its branded drug subsidiary. nomination category: company, office & product awards categories nomination sub category: best new product or service
for further information about k - v pharmaceutical company, please visit the companys corporate website at urltoken .
rep. allyson schwartz, d - pa. , said in an interview tuesday that she was working with several members of congress in an effort to persuade kv pharmaceutical to lower its price .
sen. brown was not alone in pointing out that kv pharmaceutical gained fda approval for makena thanks in part to millions of dollars of help from taxpayer - funded national institutes of health studies .
gregory j. divis jr, kv pharmaceutical chief executive said the cost is justified to avoid the estimated $ 50, 000 cost of mental and physical disabilities that can come with very premature births .
similarly, a joint letter to kv pharmaceutical by the presidents of the american academy of pediatrics, the american college of obstetricians and gynecologists, and the society of maternal - fetal medicine described kv' s pricing of makena as
extremely expensive
and asked the drugmaker to re - evaluate its price .
for further information about k - v pharmaceutical company, please visit the company' s corporate website at urltoken .
we are a fully integrated specialty pharmaceutical company that develops, acquires, manufactures and markets technologically distinguished branded and generic prescription pharmaceutical products. we have a broad range of dosage form capabilities including tablets, capsules, creams, liquids and
this was not what kv hoped to hear. the drugmaker does not have a patent, but the approval, effectively, eliminated competition, because kv pharma was granted seven years of market exclusivity. already forced to lower its price under mounting criticism and desperate to generate revenue, kv last fall provided the fda with samples of active pharmaceutical ingredients and compounded products that the drugmaker alleged raised concerns about potency and purity .
1950 • kv charged in a criminal complaint with shipping 51, 000 vitamins whose ingredients were deficient .
january 2009 • kv stops manufacturing and shipping all of its products and recalls most of its drugs .
bridgeton - based kv said the sale of its generic unit has been an “important goal” of the company’s board and management, and in keeping with its strategy of becoming a branded specialty pharmaceutical company focused on women’s health .
k - v pharmaceutical company is a specialty branded pharmaceutical company with a primary focus in the area of women' s healthcare. as such, we are committed to advancing the health of women across all the stages of their lives .
among the directors who were reelected in today' s shareholders' meeting was marc s. hermelin, who served as kv' s chief executive officer from 1975 until december 2008 and as a director of kv' s board continuously since the middle of the 1970s. during this period of time, kv transitioned from a small contract manufacturer of pharmaceuticals to a leader in drug delivery technology and a marketer of specialty pharmaceutical products .
kv pharmaceutical' s response to the price controversy has been to announce a comprehensive patient assistance program for makena in which households, both insured and uninsured, making less than $ 100, 000 a year will be subsidized .
kv did not present any data for sales and distribution of precare in louisiana or mississippi to establish irreparable harm. nor did kv present any data to support the allegations that the distribution of tri - care would
dirty
kv' s line; cause confusion among physicians, patients, and other health care providers; and cause general confusion that would erode kv' s good will. tr. p. 52 .
the backstory is that company that sells the drug, kv pharmaceutical, took over the sale of a drug that' s used by a vulnerable and poor patient population to prevent premature births that cause severe defects and even death. once kv had a monopoly to sell 17p it raised the price per dose more than 100 - fold .
k - v pharmaceutical company is a fully - integrated specialty pharmaceutical company that develops, manufactures, markets and acquires technology - distinguished branded prescription products. the company markets its technology - distinguished products through ther - rx corporation, its branded drug subsidiary .
sherman gene fendler, george denegre, jr. , shaun g. clarke, mark a. johnson, liskow & lewis, new orleans, la, for kv pharmaceutical company, ther - rx corporation, drugtech corporation, plaintiffs .
for further information about k - v pharmaceutical company, please visit the company' s website at www. kvpharmaceutical. com .
ther - rx corporation, a subsidiary of k - v pharmaceutical company, is a specialty branded pharmaceutical company with a primary focus in the area of women' s healthcare. as such, we are committed to advancing the health of women across all the stages of their lives. for further information about k - v pharmaceutical company, please visit the company' s corporate website at urltoken .
at first, investors appeared heartened at the interpretation offered by kv and sent kv stock rising, but the gain lasted briefly as shares lost 20 percent of their value by midday after the fda statement apparently received a closer read .
in february 2003, kv formally notified medecor to cease and desist its infringement of kv' s trademark and trade dress. the parties reached an agreement on july 10, 2003, in which medecor admitted violating kv' s trade dress and agreed to modify its labeling and packaging. kv paid medecor $ 14, 000 to compensate it for costs of revising its packaging. under the agreement, kv is entitled to injunctive relief, attorney' s fees, costs, and the return of the $ 14, 000 if medecor violates the terms and conditions of the agreement .
st. louis - based kv pharmaceutical emerged from chapter 11 bankruptcy last year with “significantly reduced debt” and a $ 375 million recapitalization. after reorganizing and naming new executives and board members, the company changed its name to lumara in may this year .
1982 • an explosion and fire in kv' s testing room causes widespread damage to an industrial building in brentwood .
hcp editor picks on news, trends, new products, and analysis of pharmaceutical, biologics, and medical device packaging image is attached .
for further information about k - v pharmaceutical company, please visit the company' s corporate web site at www. kvpharmaceutical. com .
the board believes that with his extensive pharmaceutical experience and the experience garnered during his tenure at kv, mr. divis will serve as a qualified and effective interim president and interim chief executive officer and will support him in his efforts to move the company forward .
the company’s switch in strategy came after kv agreed in february 2010 to pay $ 27. 6 million in fines and restitution to resolve a federal investigation into the company, which halted production and recalled drugs in 2008 after making oversized painkiller tablets. kv ceased operations of ethex corp. , its old generic / nonbranded pharmaceutical operations, in march 2010 and dissolved ethex in december 2010 .
1947 • kv and its co - founders charged with shipping vitamin capsules that had less than the required amount of vitamins .
july 2008 • the fda searches kv facilities and seizes about $ 24 million in drugs that were not approved by regulators .
march 2010 • kv pleads guilty to two felony counts of failing to inform the fda of oversize drugs on the market and agrees to pay $ 27. 6 million in fines and restitution. cvs pharmacies sues kv for allegedly breaking supply contract .
medecor markets and sells a prescription prenatal vitamin known as
tri - care .
the plaintiffs allege that tri - care' s packaging
mimics
kv' s packaging in size, shape, color, terminology, and overall appearance and that the choice of packaging is a deliberate attempt to cause confusion and to appropriate the goodwill of kv' s precare products. [ 1 ] kv views medecor' s product as inferior because it does not have the proprietary formulation of the kv product and believes that medecor' s product would
dirty
its product and cause kv to lose market share to other competitors .
after weeks of public opposition to kv pharmaceutical' s pricing of makena the march of dimes, american college of obstetrics and gynecology, the american academy of pediatrics and the society for maternal fetal medicine will meet today with the company to urge them to reconsider their pricing .
march 2009 • kv signs a consent decree with the department of justice, agreeing not to make any drugs until fda approval .
mr. hermelin has advised the company that he will not return to kv in any officer or employee capacity. his stated goal is to assist building a highly functioning world - class board of directors of kv that will help to rebuild and monitor the company' s business as it returns to full profitability and growth. he plans to serve on the kv board on a transitional basis for the short period of time that he anticipates it will take to ensure that kv has weathered the challenges it currently faces .
since its launch in april 2004, primacare® one, has established itself as the fastest growing prescription prenatal product in the branded segment. the first prescription prenatal / postnatal multivitamin / mineral supplement to provide the benefits of essential fatty acids, along with core vitamin and mineral supplement, with once - a - day dosing convenience, primacare® one was launched by ther - rx corporation, the branded pharmaceutical subsidiary of kv pharmaceutical company .
the government had alleged that in may 2008, kv and ethex received complaints from a pharmacy in california and a distributor in canada of oversized morphine sulfate pills, a pain - relief medication which had been manufactured by kv and distributed by ethex. in response to the complaints, kv recalled specific lots of morphine sulfate in june 2008 and filed a field alert report regarding the oversized tablets with the fda .
may 2008 • kv ordered to stop making some cough, cold and gastrointestinal drugs. california and canadian pharmacists discover oversize morphine sulfate tablets .
amid the controversy, the fda decided to allow compounding pharmacies to continue dispensing their own versions as well, preserving progesterone access for all in need. kv pharmaceutical did not appreciate this: it sued the fda to compel it to shut down the compounders. the suit didn’t save them from bankruptcy, and a month after their filing the suit was dismissed anyway. suffice it to say that 2012 was not a great year for kv .
the three other directors who were reelected by the shareholders in yesterday' s meeting are terry hatfield, who has served as chairman since december 2008, john sampson, who joined kv' s board in january 2010, bringing more than 30 years of experience in pharmaceutical sales, marketing and research, and david hermelin, who has served as director since 2004 and who formerly served as kv' s vice president of corporate growth and strategy .
kv slashed its price to $ 595, but the fda still backed off of barring compounded versions, leaving makena open to cheap competition. kv wasn' t happy. the makena rollout floundered, and the drug ended up top of fiercepharma' s list of top drug launch disasters .
the agreement also encompasses supply and technical services agreements by which certain products of kv pharmaceuticals will be manufactured by zynesher pharmaceuticals, the company said .
the company believes that the board elected to serve at yesterday' s annual meeting should be well equipped to help kv complete its turnaround, as well as plan for the growth anticipated from the future re - launch of certain approved products and the launch of gestiva™ upon fda approval. the new directors are expected to strengthen the existing board in areas including financial management as well as adding expertise to the board in areas of legal, regulatory and quality systems. the kv board is now maximized relative to pharmaceutical industry experience to work towards rebuilding and refocusing the company' s resources to prepare and position kv for the future .
ther - rx corporation was previously the branded pharmaceuticals unit of kv pharmaceutical co. , which changed its name to lumara health, inc. in may 2014. in september 2014, lumara health, inc. announced the sale of all its assets in a two - step deal to amag pharmaceuticals, inc. and perrigo co .
1995 • kv pleads guilty to federal misdemeanor charges of misbranding a children' s antibiotic and agrees to pay $ 600, 000 in fines and costs .
if kv is indeed bringing value, they deserve fair compensation. but raising prices astronomically when hundreds of thousands of women, babies and their families depend on it? no. preterm births have huge emotional, physical and financial costs. what kv is doing with makena reaches beyond issues of legality into morality .
a year ago, the fda took the unusual step of inserting itself into the controversy over the kv pharmaceutical drug known as makena, which the agency had approved for premature births under the orphan drug act. the drugmaker and the fda came under fire after kv disclosed plans to charge $ 1, 500, compared with $ 10 to $ 20 a week for compounded versions of a med that has been used for decades. in response, the fda decided not to prevent compounders from compounding .
anybody, i suppose, with the right manufacturing equipment and a good lobbyist could have done what kv did. a request for comment from the company, which is based in st. louis, has not elicited a response. kv appears to have hired a public relations firm, golin harris, to deal with resulting backlash. coincidentally kv' s former ceo was sentenced to prison yesterday for mislabeling morphine pills - - in a move unrelated to the pricing of 17p .
thanks derek, you made a long story very interesting. none of the comments claim that kv just paid too much for the rights in the first place which, to me anyway, seems likely. shouldn’t fda approval protect kv from suits? apparently no one here thinks so and that is puzzling to this civilian .
cadila healthcare, a part of zydus group, on friday said its us - based unit has entered into an agreement to acquire the assets of nesher pharmaceutical inc for an undisclosed amount .
mr. lehrer has experience relating to the pharmaceutical industry. in particular, mr. lehrer was the lead attorney in the successful initial public offering of jones medical (jmed), formerly a st. louis based pharmaceutical marketer, and participated in his firm' s representation of jones medical in connection with its merger with king pharmaceuticals, inc. (kg). further, mr. lehrer was the primary counsel for bock pharmacal company, formerly a st. louis based pharmaceutical marketer specializing in women' s health, and served on its advisory board of directors .
k - v pharmaceutical company (
the company ,
k - v
) today announced the completion and closing of the previously announced sale of assets of nesher pharmaceuticals, inc .
on august 6, 2012, k - v pharmaceutical co. filed for bankruptcy and the court entered a stay in the present case with respect to that defendant. the motion to dismiss now under consideration was filed by the three individual defendants. k - v pharmaceutical co. joined in the motion after it emerged from bankruptcy and the court lifted the bankruptcy stay that had been entered .
kv also said monday it has entered into a supply agreement with zydus to provide third - party manufacturing services for clindesse and gynazole - 1, which are vaginal creams .
kv appears to only be the manufacturer of 17p - - and reportedly did nothing to discover it or prove its efficacy in early research. the fda appears to be complicit in the situation, since it gave approval to kv a month ago, even though compounding pharmacies had been making the drug on an ad hoc basis for many years prior .
according to the charges, a kv internal investigation that began in may 2008 discovered sporadic instances of various oversized kv - manufactured drugs, including morphine sulfate, propafenone and dextroamphetamine sulfate. propafenone is an anti - arrhythmia drug that is used to treat some kinds of heart disease. dextroamphetamine sulfate is used to treat attention deficit disorder in children. the charges alleged that despite the fact that kv’s internal investigation uncovered evidence of various oversized propafenone and dextroamphetamine sulfate tablets, ethex did not file the required field alert reports with the fda .
the buyout closes a chapter full of drama for makena, its original developer hologic, and kv. makena is a standardized, fda - approved version of a compounded hormonal injection long used to prevent preterm labor, and when kv launched the drug at $ 1, 500 per dose, patient groups - - and eventually politicians - - raised an outcry .
fleischman acknowledged that kv pharmaceutical, which has produced other women' s drugs in the past, was a corporate sponsor of the march of dimes. since 2002, he said, the drugmaker has contributed about $ 1 million to the march of dimes and its state chapters. but such donations do not influence the organization' s advocacy for or against any drug, he said .
“today’s settlement underscores our commitment to pursuing pharmaceutical companies that allegedly provide false information to obtain taxpayer dollars for unapproved and ineffective drugs, ” said tony west, assistant attorney general for the justice department’s civil division .
the makena treatment made headlines in 2011 due to its initial price tag of $ 1, 500 a shot, and kv eventually slashed the price of the treatment by 55 percent .
company went bankrupt in 2012 after surving about 60 years. women' s health focus as well as generic drugs. i enjoyed my career at kv but it was not for everyone .
jerry wenker, president, ther - rx corporation, joined kv pharmaceutical in april 2004 after a 17 year career with abbot laboratories where he held various general management positions, most recently vice president licensing and new business development. mr. wenker obtained a master of science in management from northwestern university in evanston, illinois. he holds a bachelor of arts in government from pomano college in claremont, california .
mr. hartman is a seasoned executive healthcare professional with extensive sales, marketing and management experience in the generic pharmaceutical industry. he has achieved significant accomplishments in building and leading highperforming businesses, developing and executing product launch plans
in 2011, a company called kv pharmaceutical received fda approval for its own brand - name version of progesterone, makena. the approval came with seven years of market exclusivity. monopoly in hand, kv set a price of $ 1, 500 per dose for makena, compared to $ 10 - $ 20 for compounded versions. the public noticed, and got mad. the company responded by cutting makena’s price in half, but it still got a well - deserved public scolding. patients, medical organizations and members of congress issued statements of protest. the march of dimes, which had championed fda approval of makena, broke off its close relationship with kv and its subsidiary, ther - rx, when the price was made public. for more, here’s an overview of the saga .
an official at the march of dimes — which effusively praised the food and drug administration' s decision last month to approve makena — called kv' s price
outlandish
on tuesday .
the pricing tactic has outraged doctors, patients, and leading maternity advocates, and several organizations and public officials have sent letters to kv pharmaceuticals urging them to amend their business plan. the march of dimes, american college of obstetrics and gynecology, the american academy of pediatrics and the society for maternal fetal medicine will meet march 29 with the company to urge kv to reconsider their pricing .
the fda has no power to set prices but it implied that kv may be pushing its luck, given its minimal r & d investment (some $ 60 million) on the drug. it noted that kv
received considerable assistance from the federal government in connection with the development of makena by relying on research funded by the national institutes of health to demonstrate the drug' s effectiveness
.
fda understands that the manufacturer of makena, kv pharmaceuticals, has sent letters to pharmacists indicating that fda will no longer exercise enforcement discretion with regard to compounded versions of makena. this is not correct .
pharmaceutical, biologics, and medical device packaging and logistics professionals can keep pace with the rapidly changing landscape of good distribution practices, brand security, temperature sensitive drug storage and delivery, serialization, etc. , with this monthly newsletter offering .
k - v pharmaceutical company, defendant, represented by eric c. schmale, gibson and dunn, f. joseph warin, gibson and dunn, jason morrow, gibson and dunn & robert p. berry, berry and maxson, llc .
“zydus pharmaceuticals usa inc through its subsidiary zynesher pharmaceuticals usa llc has entered into an agreement to acquire the assets of us - based pharmaceutical company nesher pharmaceuticals inc, ” cadila healthcare said in a filing to the bombay stock exchange (bse) .
the company got a break when quality problems at compounding pharmacies cropped up, giving it a marketing edge, but that wasn' t enough to prevent kv' s descent into bankruptcy. after the company was forced to file for protection from its creditors, hologic sued to regain the rights to makena, but the two companies ended up settling. kv emerged from chapter 11 early this year and in may rebranded itself as lumara .
william heiden, president and ceo of amag, said in a statement that the acquisition of lumara will “propel amag into a profitable, high - growth multi - product specialty pharmaceutical company” and will facilitate future acquisitions “in an attractive new therapeutic area. ”
law360, new york (march 30, 2012, 1: 22 pm edt) - - on feb. 7, 2012, the delaware chancery court decided hermelin v. kv pharmaceutical co. [ 1 ] in hermelin, the court determined that certain aspects of former ceo marc hermelin’s actions were not entitled to mandatory indemnification because hermelin failed to meet the “successful on the merits” requirements under section 145 (c) of the delaware general corporation law (“dgcl”) .
the company and the board of directors expresses its appreciation to former directors kevin carlie, norm schellenger, jonathan kilmer and jean bellin for their tireless efforts during their terms of service as members of kv' s board .
the approval meant that kv was granted seven years' marketing exclusivity for makena under the orphan drug act and the company sent letters to pharmacies that compound hydroxyprogesterone that they should desist or face the wrath of the fda .
3. on july 5, 2012, k - v pharmaceutical co. sued the fda in the federal district court for the district of columbia, alleging that the fda (and related parties) violated the oda by failing to take action against compound pharmacies that created a cheaper alternative to makena. k - v pharmaceutical co. sought declaratory and injunctive relief. on september 6, 2012, the court granted the defendants' motion to dismiss, holding that the fda' s decision was judicially unreviewable .
kv execs, however, are trying to create the impression that makena now has an edge .
we believe the announcements from these two key agencies are a clear signal that the compounding of hydroxyprogesterone caproate should not exceed the scope of traditional pharmacy compounding and that payers who have made access to makena difficult should remove roadblocks that have prevented patients from receiving the only fda - approved drug for their condition ,
kv ceo and president greg divis says .
october 20, 2010, st. louis, mo - k - v pharmaceutical company (ny5e: kva / kvb) today announced the establishment of a new generic marketing subsidiary, nesher pharmaceuticals, inc. and the appointment of mark hartman as its president .
but things have since turned around for the company. by early 2014, kv had emerged from bankruptcy, and attitudes and laws regarding compounders had changed (in no small part due to this tragic outbreak). this past january, a u. s. court of appeals in washington, d. c. , reversed the dismissal. in other words, kv is again actively suing the fda to shut down compounders and secure its monopoly on progesterone .
in a statement to abc news, drugmakers kv pharmaceuticals and partner company ther - rx, write :
we are committed to taking the appropriate steps to help ensure that all clinically - eligible patients have access to makena .
our commercial strategy includes expanding our portfolio through the in - license or acquisition of additional pharmaceutical products or companies, including revenue - generating commercial products and late - state development assets. as of june 30, 2016, we were a party to the following collaborations :
the march of dimes is teaming up with the leading maternity experts to lobby for kv pharmaceuticals to reconsider its decision to boost the price of a drug that prevents premature birth from $ 10 a shot to $ 1, 500 a shot .
in a letter march 14 to kv pharmaceutical president greg divis, fleischman and march of dimes president jennifer howse voiced concerns about makena' s pricing, saying :
we remain deeply concerned that the cost of this lifesaving treatment could be put out of reach to thousands of women at risk for preterm delivery. therefore, we respectfully request that you reconsider the market price of makena and commit your company to the promise that every eligible woman who is offered the drug will receive it without regard to ability to pay .
many doctors are particularly frustrated with the price hike because to date, kv pharmaceuticals has not had to bear the cost of the clinical trials used to get the drug approved, but they have announced plans to conduct further trials in the future .
kv was very structured and organized. great benefits package. hourly pay was average could of been more but benefits made up from it. loved working with the people there. would still be working there if it didn' t close down .
st. louis, january 24, 2013 - ther - rx corporation, a women' s health - focused pharmaceutical company and subsidiary of k - v pharmaceutical company (otcqb marketplace: kvpha / kvphb), and perrigo company (nasdaq: prgo; tase) announced today that gynazole - 1® (butoconazole nitrate vaginal cream usp, 2 %), indicated for the local treatment of yeast infections (vulvovaginal candidiasis infections caused by candida) in non - pregnant women1, is now available for prescribing. gynazole - 1 is available at major national and regional retail pharmacy chains across the country .
in a securities filing on tuesday, kv pharmacuetical co. acknowledged that it had received a torrent of criticism over the high price of its newly approved prenatal drug, makena, and that it could face challenges in getting the government and insurance companies to pay .
kv went through some very difficult times, but the people there were always great to work with. the environment was good but there were great challenges. after emerging from bankruptcy the company was renamed to lumara health and was once again a successful growing business .
with just two weeks’ worth of compounded progesterone left, i called makena care connection, set up by kv to help a subset of women afford their pricey meds. they promptly sent me a free vial of five doses. thanks, guys, that finishes off my treatment. but what about everyone else? that’s not a rhetorical question: my commonhealth editor, rachel zimmerman, asked kv directly. to hear them tell it, $ 690 a dose is just a formality. here’s part of the statement they sent over :
, kv and hologic had modified their agreement – kv had already paid up nearly $ 80 million, with another $ 12. 5 million due with the approval, and has further payments to make to hologic which would take the total purchase price up to nearly $ 200 million. that’s been their main expense for the drug, by far. the fda has asked them to continue two ongoing studies of makena – one placebo - controlled trial to look at neonatal mortality and morbidity, and one observational study to see if there are any later developmental effects. those studies will report in late 2016, and kv has said that their costs will be in the “tens of millions”. so they paid more for the rights to makena than it’s costing them to get it studied in the clinic .
kv executives are banking on a successful launch of makena to help steer the company back to profitability after two tough years that saw drug recalls, mass layoffs and guilty pleas to criminal charges by its wholly owned subsdiary, ethex corp. , for shipping oversized morphine tablets .
kv' s future success is
largely dependent
on its negotiations with third - party payers including health insurance companies, pharmacy benefit managers and medicaid management companies as well as its ability to respond to media and political pressure, the company said in a securities and exchange commission filing .
now, the results are in and there appears to be little to no change in the fda stance and the implications for kv may be grim, as investor reaction indicates. in a statement late last week, the fda disclosed that samples - some of which were provided by kv and others gathered by the fda from compounding pharmacies, doctor’s offices, api distributors, and apis offered for importation - did not reveal any safety problems. of 16 samples collected by the agency, none yielded any issues with potency or purity standards using methods set by the united states pharmacopeia .
k - v asked u. s. bankruptcy judge allan l. gropper to bless the deal between the zydus parties and debtors k - v pharmaceutical co. , k - v generic pharmaceuticals inc. and drugtech corp. , which is aimed at tying up the loose ends of the asset purchase agreement and related deals between ...
kv officials did not respond to requests for comment. but it addressed the criticism on its website :
we appreciate the concerns expressed by multiple audiences, and are committed to working collaboratively with all interested parties to make this vital medication even more available and affordable to women across the country .
the board' s primary focus is two - fold: to continue to work with the food and drug administration to reinstate kv to good manufacturing practice compliance; and to continue to explore a variety of financial alternatives currently under review as a means with which to strengthen the company' s cash position .
the joint letter also said that kv' s financial assistance program for patients
is not sufficient and does not extend to certain groups of women .
the company has stated that it would expand a program to help patients afford the drug, but hasn' t disclosed the amount of the planned subsidy .
kv pharmaceuticals plans to offer financial assistance to low - come households in need of the drug, but how private health insurance companies and medicaid will respond to this price spike remains to be seen. many doctors fear that access to this treatment will become severely limited or interrupted for those currently mid - treatment .
assuming arguendo that precare' s packaging is protected, the plaintiffs have not carried their burden of persuasion that the similarity in the packaging of tri - care and precare is likely to confuse consumers. the plaintiffs presented the testimony of kv' s counsel, eugene defelice, that three field representatives told him that nurses and others who worked in some doctors' offices thought that tri - care was aligned with kv' s precare. tr. at 20. on cross - examination, defelice was unable to identify any of the doctors or nurses who were allegedly confused or the markets in which the confusion took place. tr. at 111 .
law360, new york (october 22, 2012, 7: 13 pm edt) - - k - v pharmaceutical co. asked a new york bankruptcy judge to approve a $ 7. 5 million settlement between several of its subsidiaries and zydus pharmaceuticals (usa) inc. and nesher pharmaceuticals (usa) llc to resolve outstanding claims related to an asset purchase agreement .
troubled kv pharmaceuticals started a new life earlier this year, emerging from bankruptcy and changing its name to lumara health. now, it' s selling out. amag pharmaceuticals agreed to pay up to $ 1. 25 billion for the company' s maternal health business and its once - controversial preterm - labor treatment makena .
however the response to the price cut has not been particularly enthusiastic. the american college of obstetricians and gynecologists says kv' s declaration is
clearly acknowledging the negative impact of their original pricing strategy
. it adds that
although this may seem like a relatively significant price reduction, unfortunately it remains a woefully inadequate response
.
now kv' s ther - rx corp subsidiary has reduced the price of makena by nearly 55% to $ 690 per injection. the firm says it will also offer supplemental rebates that, in conjunction with the aforementioned cut
and the standard medicaid rebate of 23. 1% , will result in a substantially - reduced cost per injection .
mr. divis continued ,
a key business objective remains for k - v to maximize the value of our generic business in alignment with our long - term strategy. we believe that the addition of mark to our team coupled with the introduction of nesher pharmaceuticals, inc. provides kv with flexibility and capability to execute on this business priority .
in other words, the fda was careful to say that enforcement actions will continue to be pursued against pharmacies compounding makena, which the agency refers to as hydroxyprogresterone caproate, if there is a safety issue. the implications for kv are significant. more than once in recent months, the drugmaker has filed statements with the us securities and exchange commission indicating that its ability to continue as a going concern is questionable and its fate largely hinges on its ability to jumpstart makena sales. of course, revenue projections made around the time of makena approval early last year were dashed after kv was forced to cut the price of the drug (see page 23 of this filing, which was made last week) .
diaz said if the drug had been $ 1500 a shot ,
i think the price would have definitely locked me out, which means i could have potentially had a second or third premature child with disabilities .
she added ,
i would say to the pharmaceutical company, if there is any way they can cut the cost. i would ask them to consider these are lives at stake .
/ prnewswire / - - k - v pharmaceutical company (
the company ,
k - v
) (nyse: kva / kvb) today announced the completion and closing of the previously announced sale of assets of nesher pharmaceuticals, inc. (
nesher
), the company' s wholly - owned generic subsidiary, and the company' s generic business and assets to zydus pharmaceuticals (
all the upfront development of the drug was done by the national institute of health. you and i paid for that with our tax dollars, it' s not like this pharmaceutical company is trying to recoup its investments in research and development, as is usually the reason for the price of new drugs ,
says dr. kevin ault, associate professor of gynecology and obstetrics at emory university school of medicine .
derek – kv mgmt demonstared what goes on in many companies. mgmt does not believe in market research or in soliciting customer insights and feedback. had they done that, they would have have known that the many stakeholders would not respond well to a $ 1500 price tag. the result is usually commercial failure of a brand / drug that has so much promise .
we are pleased to be able to once again offer gynazole - 1 to prescribing healthcare providers and to patients in need of therapy ,
said greg divis, president of ther - rx and ceo of k - v pharmaceutical company .
the availability of gynazole - 1 represents a positive step forward for the company as we continue to provide quality, patient - friendly products to support the health of women across the stages of their lives .
hmm, fda, i’m no expert, but maybe it was those “ guidance documents ” for compounders you released just days after the new law went into effect? but why did my compounder take months to act? did lawmakers and the fda realize the dqsa would give kv what it is suing for? i don’t know. but i’m keen to find out if someone has a clear answer .
defendants are k - v pharmaceutical company and three of its officers (collectively ,
k - v
). the putative class of plaintiffs consists of all purchasers of publicly traded securities of k - v between february 14, 2011, and april 4, 2011. this litigation is based on allegedly materially false and misleading statements and omissions made by k - v during the class period regarding k - v' s distribution and sale of the prescription medicine makena .
the court finds that the testimonial evidence of confusion is inadequate to persuade that there is confusion as to the source of medecor' s products or an affiliation with kv among the doctors who are writing prescriptions and distributing samples of the prenatal vitamins. accordingly, the plaintiffs have not carried their burden of showing that there is a substantial likelihood of success on the merits of the claim of trade - dress infringement .
typically, once a drug is approved by the agency, pharmacy compounding is no longer allowed but last week the fda took the unusual step of stating that the information in the kv letter
is not correct
and
in order to support access to this important drug, at this time and under this unique situation, it does not intend to take enforcement action against pharmacies that compound hydroxyprogesterone caproate
.
mr. david van vliet, who was appointed on december 5, 2008 as interim president and interim chief executive officer is no longer with the company. the board has made the decision to focus on its efforts to identify external chief executive candidates who have many years of pharmaceutical experience. until such time a candidate can be identified and hired, the board has appointed mr. gregory j. divis to act as the new interim president and interim chief executive officer of the company .
drug tech is the owner of the trademark
primacare
and kv and ther - rx are licensees to that intellectual property. the plaintiffs market a line of prescription - vitamin products across the united states under the
precare
trademark. this case involves the prenatal vitamins in the
precare family
line of vitamins, which are packaged in a yellow, blue, and pink box bearing a photo of a woman and a baby .
hydroxyprogesterone caproate injections have been around since 1956, and were commercially available up until 1999 when squibb, the pharmaceutical company making them, withdrew the product from the market. in the past few years however, studies have shown that these injections had a positive effect in preventing pre - term birth among women who had previously had a spontaneous pre - term birth in the past. since then, doctors have been able to fill prescriptions for the synthetic progesterone using compounding pharmacies at a price of $ 10 to $ 15 per injection .
mark has held senior leadership positions at well - known companies in the pharmaceutical industry including, president, north america operations for wockhardt usa, llc; president north america generics for dr. reddys laboratories, inc. ; vice president of sales and marketing for watson laboratories generics division, and director of marketing prescription products for alpharma. in his role at dr. reddys laboratories, mark was a key player in growing that business from zero to over $ 540 million in four years, into the 7th largest generic company in the u. s .
through various measures, kv now says 85% of patients will pay $ 20 or less. chief executive greg divis said
we understand the concerns that key stakeholders raised under our original pricing structure
and
the current budget challenges facing state medicaid programmes and other payers
. he added that along with
our substantial reduction in price, it is our sincere hope that all committed stakeholders will take appropriate action to provide timely access to this important fda - approved medication
.
on april 1, 2011, k - v announced that it was reducing makena' s list price to $ 690 per injection. the price of k - v class a common stock continued to decline. the closing price of kv' s class a common stock on april 4, 2011 was at $ 5. 00, a drop of over 28% from the stock' s price of $ 6. 95 at the opening of the markets on march 30, 2011 .
kv pharmaceuticals has been citing fda law in saying that doctors will be legally obligated to stop using the cheaper version of this drug, but an fda spokesperson informed abc news on tuesday that this will not be the case for makena. the agency says it intends to
preserve the status quo that existed before makena' s approval with regard to compounding of this drug ,
the fda representative said. what effect this loophole will have on makena' s price remains to be seen .
normally, the fda would have banned the sale of older, unapproved drugs. and kv was already pushing in that direction itself by sending letters to compounders threatening legal action. but the obama adminstration was concerned about the searing publicity over makena pricing since a federal agency had allowed a monopoly to develop (read this, this and this), and the fda decision not to pursue enforcement actions against compounders unless there was a safety issue was a significant development because the fda was dragged into a debate over cost .
id. at 813 (internal quotations and citations omitted). the plaintiffs contend, and medecor does not disagree, that the packaging is nonfunctional because the combination of features used in kv' s package is not necessary to package competing products. the court must then determine whether the trade dress is entitled to protection because it is distinctive or has acquired a secondary meaning. id. if the trade dress is protected, infringement is
shown by demonstrating that the substantial similarity in trade dress is likely to confuse consumers .
id.
kv pharmaceutical company ( kv ) was an american drug company that brought generic and non-branded pharmaceutical products to the market . headquartered in st. louis , missouri , it had research and manufacturing facilities , as well as marketing and sales operations , the latter activities conducted through its subsidiaries , ther-rx corporation and nesher pharmaceuticals inc .
kv pharmaceutical company (kv) was an american drug company that brought generic and non-branded pharmaceutical products to the market. headquartered in st. louis, missouri, it had research and manufacturing facilities, as well as marketing and sales operations, the latter activities conducted through its subsidiaries, ther-rx corporation and nesher pharmaceuticals inc.
kv pharmaceutical company (kv) was an american drug company that brought generic and non-branded pharmaceutical products to the market. headquartered in st. louis, missouri, it had research and manufacturing facilities, as well as marketing and sales operations, the latter activities conducted through its subsidiaries, ther-rx corporation and nesher pharmaceuticals inc.