Teva Pharmaceutical

AstraZeneca, Teva end Pulmicort dispute

Christe Bruderlin-Nelson — Wed, 26 Nov 2008 04:08:43 -0500

Pulmicort Respules have been the subject of heated patent litigation between AstraZeneca and Teva Pharmaceuticals for quite some time, but no longer: The two companies have finally settled their dispute.

To cut the deal, Teva conceded that its generic medication infringes upon the AstraZeneca patents for Pulmicort Respules, and that AstraZeneca's patents are indeed valid and enforceable. In exchange, AstraZeneca agreed to provide an exclusive license to Teva to market and sell a generic version of the medication, beginning December 15, 2009, and agreed it will not sell its own generic version, although it will continue to market under the Pulmicort Respules brand.

It's an expensive license apparently, for which Teva will pay "significant" (though thus far secret) royalties, which will lessen if there is competition from additional copycat products hitting the market at that time.

Perhaps in anticipation of the settlement--or perhaps convinced it could win the case--Teva shipped generic versions of the medication out last week in an "at risk" launch. If Teva had lost the case, scheduled for January, it would have had to pay AstraZeneca triple charges. However, the settlement relieved Teva of that burden, although Teva will pay AstraZeneca an undisclosed penalty sum for the launch.

- check out Teva's release
- here's the CNN Money story
- find the Pharmalot blog post
- read the Wall Street Journal blog entry

Teva and Barr settle patent dispute

Calisha Myers — Wed, 19 Nov 2008 11:05:14 -0500

Albany Molecular Research (AMRI) announced this morning an agreement with Teva Pharmaceuticals and Barr Laboratories to settle patent infringement litigation. The settlement involved the U.S. dispute over Allegra and Allegra D-12 between Teva, Barr and Sanofi-Aventis.

The settlement will result in an amended licensing agreement between AMRI and Sanofi-Aventis, which will allow Sanofi-Aventis to sublicense the patents to Teva and Barr. Sanofi-Aventis will pay ARMI $10 million in sublicensing fees.

Sanofi-Aventis will continue to pay royalties to AMRI for the products, as well as for authorized generics, for the remaining term of the patents, but sales of products outside of the United States will be unchanged. The royalties will be on all products containing fexofenadine hydrochloride, or combinations of fexofenadine hydrochloride and pseudoephedrine hydrochloride, generic ingredients in Allegra and Allegra D-12.

While the settlement protects patents only having to do with companies in the current litigation, there will be ongoing patent infringement litigation for other makers of generics in the U.S. and abroad.

- view the AMRI release
- check out the Teva release
- see what Barr had to say
- read the story in the Wall Street Journal
- see what BusinessWeek said

Related Articles:
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Analyst: Singulair might draw at-risk copy

Tracy Staton — Thu, 06 Nov 2008 11:28:06 -0500

More news about Merck and Teva: The branded drugs giant could be threatened by a copycat Singulair sooner than expected, analysts say. Merck already faces a patent challenge from Teva on Singulair, the allergy-and-asthma med that brought $4.3 billion to the company's coffers last year. And that litigation raises the possibility that Teva might chance an at-risk launch of the blockbuster drug as early as August.

Credit Suisse Merck-watcher Catherine Arnold wrote in an investor note that Merck is likely to prevail when the two companies meet in court in February. But then again, Teva is known for its aggressive challenges to Big Pharma. Just consider Wyeth, as Pharmalot points out. Teva ambushed Wyeth with a generic version of the acid-reflux remedy Protonix right in the middle of the two companies' patent fight over the drug. Teva stopped shipping its Protonix copy quickly, but not before making a huge dent in Wyeth's sales.

Investors are still spooked by that prospect, Arnold writes, and justifiably so. Just the fear of it could prompt Merck to cut a deal with Teva. It might allow the Israeli company to start selling an authorized copy of Singulair some months before the 2012 patent expiration, for instance.

- read the Pharmalot post

Generics makers anticipate Obama boon

Tracy Staton — Thu, 06 Nov 2008 11:10:47 -0500

Already generics makers are crowing about a potential boost from an Obama administration. Teva Pharmaceutical Industries CEO Shlomo Yanai told Reuters yesterday that the new president can only help his company, which is the largest maker of copycat meds in the world. And election night, Barr Pharmaceuticals CEO Bruce Downey said he expects the next four years to be a "positive environment" for generics.

Why? Well, in a video interview excerpted by Wall Street Nation, Downey said President-elect Obama is very "pro-generic." He supports generic substitution for branded drugs. He supports legislation that would create a pathway for generic biologics. And he supports strengthening the FDA's generics office, which has come under criticism for allowing generic apps to stack up. Plus, Obama's health plan--if it gets anywhere in this economic crisis--would expand health insurance coverage, boosting drugmakers. "For us, more insurance coverage equals more sales," Downey pointed out.

As you know, Barr is in the process of being acquired by Teva. And as if to emphasize their CEOs' words, both companies reported sales growth today. Teva posted a 21 percent increase in profits to $637 million on a 20 percent rise in revenues to $2.84 billion. Part of that big growth came from a branded drug, Teva's multiple sclerosis treatment Copaxone. Barr announced that sales jumped to $737 million from $602 million, beating analysts' estimates. Adjusted earnings grew to 83 cents a share from 71 cents.

Teva's report on FDA apps also underscored Downey's comments about the agency: The Israel-based company has 145 generics drug apps cooling their heels at FDA, awaiting regulatory approval.

- see the Downey interview at Wall Street Nation
- check out Teva's earnings
- here are Barr's results

Novartis won't sell Biaxin XL copy

Christe Bruderlin-Nelson — Wed, 22 Oct 2008 05:47:06 -0400

Although Novartis' Sandoz generic drug unit was hoping to resume marketing of its version of the antibiotic Biaxin XL, the U.S. Court of Appeals for the Federal Circuit in Washington put a stop to it.

Abbott Laboratories' Biaxin XL became the subject of a patent dispute shortly after Sandoz began selling a copy in December 2006. However, the judge in the Appeals Court said that Sandoz was likely to lose anyway, so there was no reason to overturn the lower court ruling that Sandoz did indeed infringe on Abbott's patent.

Teva Pharmaceutical and Andrx, a subsidiary of Watson Pharmaceuticals, earlier reached settlements with Abbott regarding selling the drug. Abbott says overall its Biaxin XL patent is steadfast until 2017 and thus should remain free from genetic competition.

- see the story in the Daily Herald

Related Articles:
FDA approves Ranbaxy's generic Biaxin

Barr, Teva merger poised for tax-free status

Christe Bruderlin-Nelson — Wed, 20 Aug 2008 03:36:13 -0400

The tax gods were with Barr Pharmaceuticals and Teva Pharmaceutical Industries: They recently cleared some IRS requirements to have their merger deal defined as a reorganization with tax-free status.

That's quite a boon for Teva and Barr, who started the merger process in July. Barr stock will be converted into 0.6272 shares of Teva stock plus $39.60 in cash. New Jersey-based Barr will become a domestic subsidiary of Jeruselum-based Teva and the deal is expected to close later this year.

To gain tax-free status, the acquisition must meet criteria under Section 368(a)(1)(A) and Section 368(a)(2)(D) of the IRS tax code--in addition to "Helen of Troy" rules related to foreign transactions--but it seems likely it will pass these and other required tests.

Meanwhile, the companies might just need the tax break, as Barr's first quarter results didn't quite hit the mark.

--read about it at Zacks
--see more at CFO.com

Amgen profits drop, Teva's grow

Tracy Staton — Tue, 29 Jul 2008 10:44:00 -0400

It's a good news-bad news day on the earnings side, with Amgen reporting a drop in profits, but a boost in its 2008 forecast, and Ranbaxy earnings on the flat side, while Teva's are on the rise. Here are the details:

Amgen saw second-quarter net drop by 7.7 percent to $941 million, while revenue grew by a modest 1 percent to $3.76 billion. Sales figures still managed to beat analyst expectations, though. Like some other drugmakers this quarter, Amgen reported a drop in U.S. sales--of 1 percent, to $2.84 billion--offset by a big increase in international sales, namely 17 percent. The best news, though, came in the form of better-than-expected sales of its anemia drugs, which have been depressed by safety concerns for months now.
Ranbaxy Laboratories posted a $39 million profit for the quarter, virtually unchanged from the same period a year ago. Sales, however, grew by 13 percent to $440 million.
Teva Pharmaceutical's profits grew by 4.6 percent to $539 million on growth in generic sales and in its branded multiple sclerosis treatment Copaxone. Overall, revenues grew by 18 percent to $2.82 billion, beating analyst estimates. A 12 percent increase in North American sales was fueled in part by a generic version of GlaxoSmithKline's antidepressant Wellbutrin XL.
Sepracor saw its quarterly revenues increase by 6.3 percent to $294.1 million, with profits of $6.7 million, up from $4.8 million a year ago. Its insomnia treatment Lunesta grew sales slightly, to $148.1 million from $142.9 million a year ago

- see Amgen's results in the Wall Street Journal
- check out Ranbaxy's figures
- get the Teva news from BusinessWeek
- read Sepracor's release

Teva seeks venture partner in Japan

Tracy Staton — Tue, 29 Jul 2008 09:42:01 -0400

Fresh off its $7.5 billion deal to buy Barr Pharmaceuticals, Teva is eyeing joint ventures in Japan. CEO Shlomo Yanai told the Financial Times that establishing a beachhead in that country is a top priority for him. Though Japan has historically stuck mostly to brand-name meds, partly because of quality concerns, Yanai believes that Teva's rep can overcome that reticence. "Right now Japan is more ripe for generics," he told the newspaper. "Japan is very important but difficult to break into."

Hence the desire for a joint venture, which would give Teva a foot in the door. That's not the only option, Yanai says, but it's "definitely the preferred option."

- see the Financial Times article

Relate darticles:
It's Teva plus Barr in a $7.46B buyout
Teva Pharmaceutical - best Pharma Stocks of 2007
Teva earmarks $1B for India

Teva gets approval to buy Bentley

Christe Bruderlin-Nelson — Wed, 23 Jul 2008 10:41:32 -0400

Teva Pharmaceutical Industries received nearly a 69 percent shareholder approval to complete its $360 million dollar purchase of Bentley Pharmaceuticals, a move the company hopes will help it to expand sales in Spain with over 170 products. Report.

It's Teva plus Barr in a $7.46B buyout

Tracy Staton — Fri, 18 Jul 2008 08:42:37 -0400

It's official: Teva and Barr are getting hitched. It's a $7.46 billion cash-and-stock deal that will combine the world's largest and fourth-largest generics makers into one big copycat drug powerhouse. Teva will get added strength in Central Europe and in fast-growing Eastern-European markets. And, as the Wall Street Journal notes, it will expand not only Teva's portfolio of generics, but its branded drug business. Barr has first-to-market rights for several new generics over the next few years, and it has a strong set of branded women's health meds. Plus, it will vault Teva forward in its strategic plan to reach $20 billion in sales with a 20 percent margin by 2012.

Under the terms of the deal, Barr's common stock will be converted to cash and Teva ADRs at a per-share rate of $39.90 and .6272 of an ADR, valuing Barr at $66.50. That's a 42 percent premium over Wednesday's price and a 16 percent premium to Thursday's--which includes a big jump in value on rumors of the takeover. Teva also will assume $1.5 billion of Barr's debt.

Just how big of a generics maker might the combined companies represent? Pro forma, 2007 revenues would have been about $11.9 billion. And together, the two companies would operate in more than 60 countries. In a note to investors before the official announcement, Goldman Sachs said a deal in the $8 billion range would quickly add to Teva's earnings on a cash basis. But, the analysts said, combining with Barr would give Teva more exposure to the U.S. market, where growth is expected to slow.

- check out Teva and Barr's release
- read the WSJ story
- see the news from the Associated Press
- get more on the financial side from Portfolio
- find Goldman's investor note in Barron's

Rumor mill: Teva mulling $7.5B deal for Barr

Tracy Staton — Thu, 17 Jul 2008 09:56:29 -0400

The world's biggest generics firm may be about to get bigger--a lot bigger. Teva is reportedly in talks to buy Barr Pharmaceuticals for upwards of $5 billion; some reports quote a price as high as $7.5 billion. The latter figure would be a 50 percent premium for Barr, which closed the regular trading day at $46.82 but after hours leapt 19 percent to $55.51 on the news.

Reports of the negotiations appeared in two Israel dailies, and a UBS analyst issued a note ticking off reasons a Barr buyout would make sense for Teva: It would give the Israeli company access to the oral contraceptive market, strengthen its European presence and boost efficiencies by "eliminating duplicate infrastructure in the U.S."--which sounds like shutdowns and layoffs to us, but given the fact that no deal's been struck, that's getting the cart before the horse.

This year Teva's already announced a buyout of Bentley Pharmaceuticals, which has a strong presence in Spain, and a deal for CoGenesys, a biotech. Though the company is sitting on some $3.6 billion in cash, a whopper Barr deal would require it to take on more debt and do some kind of equity payment, too, an Israeli investment bank predicted. Teva refused to comment on "market rumors."

- see the story at MarketWatch
- read the Globes article

Teva faces double Copaxone woes

Tracy Staton — Mon, 14 Jul 2008 09:33:32 -0400

Israeli generics giant Teva Pharmaceutical Industries is suffering a couple of Copaxone-related headaches. First, Israel's health ministry appointed a special committee to probe a trial of the MS drug. Allegedly, Teva tested Copaxone on ALS patients--despite the fact that previous trials on mice had failed. Teva maintains that testing Copaxone in human ALS patients was perfectly safe despite the deaths seen in mice taking the drug, because Copaxone had already made it through plenty of human trials for its approval as an MS drug. But an internal investigation by the health ministry's comptroller found that the company didn't submit all the necessary info before trial approval. So the special committee will take a look at the evidence to see whether the ministry and/or the company did anything wrong.

Then, Momenta Pharmaceuticals announced late Friday that the FDA will review its generic version of Copaxone, which is an injectable med. Momenta wants to sell its copycat form in partnership with Sandoz, the generics arm of Novartis. Teva immediately struck back, saying that it will fight a patent challenge and sue the two companies for infringement. Teva contends that Copaxone is protected in the U.S. till 2014 and in Europe through 2015. But Momenta's incipient challenge follows another from Mylan, which last month licensed a version made by India's NATCO Pharma--which is already on the market on the subcontinent and in Ukraine.

Shareholders didn't like the news, and Teva stock plummeted. Will Teva ultimately prevail? Hoping to quell investor panic, CEO Shlomo Yanai told an Israeli newspaper that Momenta/Sandoz probably will have to mount clinical trials of their copycat drug because, unlike many generics, it's an injectable. And even if he's wrong about that, he said, "Teva has a clear answer on the commercial side... We are 'mister generic' and we will know how to do this."

- see the trial probe news at Globes
- check out the Momenta story at Haaretz
- read Yanai's comments at Pharmalot

AstraZeneca wins Seroquel patent fight

Christe Bruderlin-Nelson — Wed, 02 Jul 2008 10:25:52 -0400

AstraZeneca is celebrating today--or at least relaxing a bit. It has avoided a full-blown trial today to protect its top-selling antipsychotic medication, Seroquel. The trial would have taken place on August 11, 2008, setting off a battle over the medication used to treat bipolar disorder.

Hoping to market a generic version of the medication, which has a current patent expiration date in September of 2011, Teva Pharmaceutical brought a case against AstraZeneca based on a no inequitable conduct challenge, but a federal court in New Jersey dropped the case. AstraZeneca investors are responding, and its stock prices are already seeing a jump this morning.

A patent extension for specifically for pediatric use will extend AstraZeneca's protection to March 2012. Seroquel brought in about $4 billion for the drugmaker last year. Stay tuned, however, as Teva might still appeal the ruling.

- read the full story at Forbes
- get Pharmalot's take
- find out more at MarketWatch

J&J fights Teva with generic Risperdal

Tracy Staton — Tue, 01 Jul 2008 07:27:42 -0400

It's a watershed moment: Risperdal has gone generic. The Johnson & Johnson antipsychotic med now has copycat competition from Teva Pharmaceutical, which got the final FDA go-ahead yesterday. As soon as the agency gave its OK, Teva started shipping. And no wonder it was ready to go; it has 180 days of market exclusivity, that golden period when a generics maker has no other copycat competition and so the sticker price remains fairly high. Lower than the branded version, of course, but not as low as it will go when other generics makers jump into the market.

But wait a minute. J&J quickly struck a blow against that exclusivity. It launched its own authorized generic to compete with the Teva version. If its drug is going to sell for a lower price, why not capture some of that lower-priced revenue, too? After all, J&J has a lot to lose on a Risperdal generic. The branded version sold to the tune of $2.5 billion last year. It's not J&J's biggest drug, but still a major contributor to the drugmaker's income statements with 6 percent of company-wide sales. And Risperdal's follow-up, Invega, didn't exactly hit the ground running.

It's the end of an era for Risperdal. We'll be playing Taps more and more often for blockbuster meds as the sun sets on their patent protection. Some 11 times this year, to be exact.

- read the Wall Street Journal Health Blog post

Mylan to sell copycat of Teva MS drug

Tracy Staton — Tue, 10 Jun 2008 10:47:27 -0400

Here's a turnabout-is-fair-play story. Generics maker Teva Pharmaceuticals, known for its aggressive challenges to brand-name drugs, is getting challenged itself. The company has one very big branded product: Copaxone, a multiple sclerosis treatment. Well, Mylan Pharmaceuticals is copying it, with the help of India's NATCO Pharma. Mylan will market the generic version in the U.S., Europe, Australia, New Zealand, Japan, and Canada; NATCO already sells it in India and Ukraine.

Copaxone is a big moneymaker for Teva, with $542 million in first-quarter sales alone, up 35 percent year-over-year. So it's no surprise that the company's shares faltered on the Mylan news. Copaxone isn't supposed to go off patent in the U.S. till 2014; we'll see how Teva strikes back.

- check out Mylan's release
- see the MarketWatch news

Vasella: 'Teva is better than we are'

Tracy Staton — Thu, 05 Jun 2008 09:44:12 -0400

Novartis CEO Daniel Vasella has a knack for the quotable quote. Here's the latest: "Teva is better than we are, and that's hard to take."

You'll recall that Vasella has been talking a lot about diversification lately, what with Novartis beefing up its optical biz with a big chunk of Alcon and pushing to expand its vaccine operations. Well, the company's generics unit, Sandoz, is another big component of that diversification strategy. And Vasella isn't satisfied with Sandoz's performance. Teva is bigger, it's vertically integrated--and it's been outpacing Sandoz on various key benchmarks. In a glass-half-full take on the difference, Vasella told the WSJ Health Blog that Teva's successes could serve as inspiration. "It is good to look at how we could be better," he said.

- read the Health Blog post

Abbott's patent-tweaking draws fire

Tracy Staton — Mon, 02 Jun 2008 10:07:08 -0400

To your list of patent-lawsuits-to-watch, add a set of cases over TriCor, the Abbott Laboratories cholesterol med. TriCor is 33 years old, but it's still on patent, thanks to a series of formulation and other tweaks Abbot made along the way. That's no small thing, either: TriCor snared $1.2 billion in 2007 sales.

The thing is, state and federal officials are probing whether all those tweaks--and Abbott's tactics in protecting TriCor from generic poaching--amount to antitrust violations. In one instance, Teva mounted a patent challenge on TriCor, but during the mandated Hatch-Waxman 30-month waiting period, Abbott reformulated the drug into a tablet and repurchased all the capsules. When the 30 months expired, Teva's capsules were no longer bioequivalent. So Teva applied to make tablets. During the 30-month waiting period, Abbott reformulated again.

Teva has since counter-sued, alleging antitrust violations. Now, some 25 state attorneys general have sued, too, siding (in effect) with Teva. The Israeli generics maker's lawsuit is set for trial in November. Count on it to be closely watched, because the outcome may set patent-extending ground rules for the entire industry.

- see the Wall Street Journal article

Wyeth pounces on Sandoz's copycat Protonix

Tracy Staton — Wed, 21 May 2008 10:46:11 -0400

Wyeth is going toe-to-toe with Novartis. The Protonix maker--and its partner, Nycomed--filed suit against Novartis' generics arm, saying its copycat drug violates the heartburn med's U.S. patent. Sandoz, you'll recall, filed last month for FDA approval of an injectable form of the drug.

It's just the latest twist in the rapidly lengthening story of copycat Protonix. Last year, Teva Pharmaceuticals launched its version, but stopped shipping to sit down with Wyeth at the negotiating table. No settlement of the companies' patent fight has yet been reached, but in the meantime, Wyeth teamed up with Prasco Laboratories to sell an authorized generic. Soon after, a division of India's Sun Pharmaceuticals released its own version.

Wyeth's sales--both branded and generic--dropped by 66 percent during the first quarter--a painful loss, considering the fact that Protonix once was the drugmaker's biggest seller. It's still defending its Protonix patent, though, and plans to ask for lost profits and damages from both Teva and Sun when the patent case goes to trial.

- see the Wall Street Journal story

FDA probe clears generic Wellbutrin

Thu, 17 Apr 2008 06:59:54 -0400

Listen to all those generics makers heaving sighs of relief. The FDA has given the thumbs-up to Teva's generic Wellbutrin XL, which has been under investigation since early last year. Patients who'd switched from GlaxoSmithKline's branded form of 300 mg pill to Teva's Budeprion XL 300 mg complained that the drug simply didn't work. They also cited new side effects such as headaches and anxiety. ConsumerLab.com tested the copycat drug, finding that it released 34 percent of its active ingredient within two hours, compared with 8 percent for the branded form.

The FDA, however, concluded that the generic is "bioequivalent and therapeutically equivalent." The agency cited some "small differences" in the two different formulations, but said they're not outside the boundaries for equivalence. Depression does tend to recur, the agency said, so patients may simply have begun a new episode at the same time they switched meds.

But ConsumerLab.com said the FDA cites bioequivalency data not for the 300 mg pill in question but for the 150 mg form. "On top of that, the data they have clearly shows the drug is releasing much faster than the original," said lab chief Tod Cooperman, calling the agency's conclusion "a huge leap of faith."

Teva, on the other hand, says it's pleased with the outcome. And so are other generics makers, no doubt. If the agency had found Teva's version wanting, who knows what new regulations and trials new generics might have had to withstand?

- read the story in the LA Times
- check out the Pharmalot item

Related Articles:
Biovail loses effort to stop generic Wellbutrin. Report
Teva plans aggressive move into biogenerics. Report

ALSO NOTED: J&J reports big revenue growth; Drugmakers fight U.K.'s Aricept ruling;

Tue, 15 Apr 2008 06:59:50 -0400

> Johnson & Johnson reported a 7.7 percent increase in first-quarter sales, to a record-setting $16.2 billion; EPS grew by 8.6 percent to $1.26 excluding special charges. Report

> Eisai, Pfizer, and Shire are fighting a U.K. ruling that restricts access to Alzheimer's drugs such as Aricept to patients in later stages of the disease. Report

> Schering-Plough will report its first-quarter results tomorrow with a conference call; CEO Fred Hassan will offer an update on the company's business and its "major initiatives," most likely including Schering's new $1.5 billion cost-cutting plan. Report

> Abbott Laboratories is prepping for an antitrust trial over the AIDS drug Norvir, scheduled to start Friday. Report

> A combo of Lipitor and Celebrex--both made by Pfizer--inhibited the growth of prostate cancer cells in mice; human trials are being planned. Report | Report

> Genentech and its partner Biogen Idec said their blockbuster lymphoma and rheumatoid arthritis med Rituxan didn't show efficacy against multiple sclerosis in a 96-week trial. Report

> Forest Labs reported fourth-quarter earnings of $172.8 million on a 12 percent increase in revenues to $990.9 million. Release

> Laureate Pharma said it's made a deal with Alopexx Pharmaceuticals to manufacture the latter's product candidate mAb F598 antibody for use in clinical trials. Release

> Teva Pharmaceuticals got 180-day exclusivity for a generic version of the Ortho-McNeil antipsychotic med Risperdal. Report

> Roche said it would pay $160 million for the British pharma Piramed, which is developing meds for cancer and inflammatory diseases such as rheumatoid arthritis. Release

> The European commission gave Bristol-Myers Squibb and Otsuka permission to market their Abilify drug for treatment and prevention of mania in bipolar patients. Report

> Belgian healthcare group Omega Pharma will distribute Chrisal International's anti-dust mite spray in Europe, a Belgian newspaper reports. Report

> Hit by a clinical trial delay triggered by a surprise change-up at the FDA, Canada's Vasogen has hit the brakes on spending and announced plans to lay off 85 percent of its work force. Report

> Shares of AtheroGenics shot up this morning on the news that an interim analysis of late-stage data for AGI-1067 showed a statistically significant reduction in Hemoglobin A1c--a standard measure for blood sugar control. Report

And Finally... New York still feels the effects of a cholera epidemic almost 200 years ago. Report